IPO COMMITTEE NEWSLETTER

APRIL 2011

Written by Members of the IPO Law and Practice (International) Committee

Chair: Larry Welch, Eli Lilly & Co. Vice Chair: Samson Helfgott, Katten Muchin Rosenman LLP Board Liaison: Daniel J. Staudt, Siemens Corp.

With contributions from the European Practice Committee

Chair: Filip DeCorte, Cargill, Inc. Vice Chair: Jeanjacques Canonici, Procter & Gamble Co. Vice Chair: Hans Prins, Bird & Bird Board Liaison: Charlie Kinzig, GlaxoSmithKline

CONTENTS

The New Argentina System of Divisional ………………………….3 Martin Bensadon and Ivan Alfredo Poli, Marval, O’Farral & Mairal, Buenos Aires, Argentina

The of Biological Materials in Australia…………………………………...8 Vaughan Barlow, Pizzeys Patent and Trade Mark Attorneys, Canberra, Australia

Canadian Patentability of Monoclonal Antibody Claims……………………………13 Graeme Boocock, Borden Ladner Gervais LLP, Ottawa, Canada

Changes and Improvements in Chilean Patent Law…………………………………16 Eduardo Molina, Estudio Federico, Villasera, Chile

Amazon 1-Click: The Flip Flop In Canada Over Whether Software and Business Methods Are Patentable……………………………………………………………………22 Jason B. Hynes & Philip Mendes Da Costa, Bereskin & Parr, Ontario, Canada

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Australia Intellectual Property Laws Amendment (Raising The Bar) Draft Bill 2011…………………………………………………………….28 Michael Houlihan, Houlihan2 Patent & Trade Mark Attorneys, Melbourne, Australia

Patent Prosecution in India…………………………………………………………………32 Daniel J. Staudt, Siemens Corp., Iselin, New Jersey

EUROPEAN SECTION

EPO Petitions for Review…………………………………………………………………….35 Hans Prins, Bird & Bird, London, England

Recent Developments in the Quest for an EU Patent………………………………….40 John Richards, Ladas & Parry LLP, New York, NY

***This paper was created by the authors for the Intellectual Property Owners Association all of whom are members of the Patent Law and Practice (International) Committee to provide background to IPO members. It should not be construed as providing legal advice or as representing the views of IPO.***

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THE NEW ARGENTINA SYSTEM OF II. DIVISIONAL PRACTICE IN DIVISIONAL ARGENTINA PATENT APPLICATIONS 1. The provisions in the law Martín Bensadon and Iván Alfredo Poli Marval Argentina’s first patent law, in force from O’Farrell & Mairal 1864 to 1995, had no provisions on Buenos Aires, Argentina divisional applications,3 but they were widely accepted by the practice of the Argentine PTO. I. INTRODUCTION On the other hand, the patent law enacted in As had happened in Europe1 and was 1995 (No. 24,481) did include one such attempted in the United States,2 in 2010 provision, namely art. 17, which states that Argentina amended its system of divisional “the patent application may not comprise patent applications. Although the changes more than one only or a group of were not as far-reaching as in the U.S.A., so linked as to form a single they were not as prudent as those made to inventive concept” and that “the applications the European patent, and the first which do not meet this requirement shall be amendment, which was somewhat sweeping, divided as established in the regulatory had to be toned down only four months decree”. In turn, art. 17 of the regulatory later. decree states that “when the patent application comprises more than one We shall address here the changes invention, it shall be divided prior to its introduced by the successive changes made grant”. We shall come back later to this in 2010 and the best strategy to adjust to the provision from the regulatory decree. current system. 2. Reasons for filing divisional applications

Prior to the changes introduced in 2010, divisional applications were filed in Argentina for two reasons: when the original 1 See the Decision of the Administrative application had more than one invention Council of March 25, 2009 (lack of unity), or when it included more amending the implementing than one object and the Argentine PTO, regulations to the European Patent while prepared to allow the patent for Convention (CA/D 2/09). certain objects, would refuse to grant it until other objects were removed from the 2 See Changes to Practice for application. Continued Examination Filings, Patent Applications Containing 3 Patentably Indistinct Claims, and P.C. Breuer Moreno, TRATADO DE Examination of Claims in Patent PATENTES DE INVENCIÓN, Abeledo- Applications, 72 Fed. Reg. 46716 Perrot, Buenos Aires, 1957, vol. I, p. (Aug. 21, 2007). 286.

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uncertainty. Making matters worse, patent The lack of unity objection is no different in prosecution and judicial appeals can be Argentina from what is elsewhere, and lengthy in Argentina, thus detracting from therefore does not require any special effective protection inasmuch as the patent explanation. On the other hand, the second is granted for a term running from the date situation warrants a closer scrutiny, as in of grant up to the twentieth anniversary of many ways it is peculiar to the Argentine the application date, and the Argentine practice and arises relatively often. patent law has no provisions on provisional protection4 or term extension.5 In many cases the Argentine PTO will issue an stating that some objects are And it was precisely the divisional practice allowable but the application may not which allowed applicants to cut this Gordian proceed to grant until other objects are knot: the original application, limited to deleted. In some instances this objection what had been agreed to by the PTO, would involves patentable subject matter: the PTO proceed swiftly to grant, unencumbered by is ready to grant the patent which refers, for the objectionable subject matter; while the example, to a patent for the DNA construct, latter would be included in the divisional the modified sequences and the essentially application, which could be argued before non-biological method for obtaining a plant, the PTO or appealed before the courts, as but not for the plant itself, or for the cells or the need arose, without jeopardizing the seeds; the same can happen with former. A broad and flexible system had pharmaceutical inventions, when the PTO thus developed, which adequately met will grant the patent for the compound, the applicants’ needs without having to overhaul composition and the process for obtaining or the whole process. synthesizing compound and composition, but not for the method of treatment or the III. THE FIRST AMENDMENT: use protected in a main claim. Other DISPOSITION No. 147/2010 instances involve inventive activity, as happens with claims where the unexpected Nevertheless, citing technical reasons and advantages of the claimed compounds have arguing that this procedure had led to a not been pointed out. In some cases, finally, proliferation of unnecessary applications, on the PTO may object the support of certain June 20, 2010 the Argentine PTO issued claims and request that the scope of the application be limited to those claims it considers to be adequately supported by the 4 On the subject of provisional patent specification. protection under Argentine law, see

Martín Bensadon, LEY DE PATENTES In all these cases the applicant faces an COMENTADA Y CONCORDADA CON EL insurmountable dilemma: to either delete the ADPIC Y EL CONVENIO DE PARÍS, claims objected to by the PTO for the patent LexisNexis, Buenos Aires, 2007, p. to proceed to grant, or keep them and face a 239 et seq. certain rejection of the whole application (including the scope approved by the PTO), 5 On the patent term in Argentina, see with the subsequent need to appeal from Eugenio Hoss, Duración de las said rejection before the Federal Courts, patentes, La Ley 2010-B, p. 786 et with the attendant expenses, delay and seq.

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Disposition No. 147/2010,6 which severely average of divisional applications did not restricted the hitherto straightforward and exceed 2,2 %. Indeed, the new regulation simple divisional practice. could have the opposite effect, as it might trigger preventive divisional applications.7 The main points of the new system set up by But the main criticism was made on Disposition No. 147/2010 were the constitutional grounds: Disposition No. following: 147/2010 was unconstitutional because it went far beyond a reasonable regulation of (a) the divisional application could be the prosecution process and adversely filed only until notice of the affected applicant’s rights as it introduced a substantive examination office restriction absent from art. 17 of the action had been served (art. 1); regulatory decree (which states that the divisional application could be filed at any (b) once the substantive examination time until the grant of the basic application). had begun, if there was no unity of invention the examiner would IV. THE SECOND AMENDMENT: request that the application be DISPOSITION No. 198/2010 divided within 30 days, under the condition that otherwise the In the face of this criticism, on November application would be held as 19, 2010 the Argentine PTO issued having been abandoned (art. 2); Disposition No. 198/20108 which repealed articles 1 and 3 of Disposition No. (c) any divisional application filed 147/2010. In the surviving system, after notification of the substantive divisional applications may now be filed in examination would be rejected, the following two situations: unless it were filed in response to an explicit request from an (a) upon requirement from the examiner (art. 3); and examiner, during the substantive examination (compulsory (d) all preceding applications, divisional application); and including the first application in a series of two or more successive divisional applications, would have 7 This happened to the European to be alive and pending at the time in September 2010, the specific divisional was filed just before the October 1 deadline for (arts. 4 and 5). filing divisional applications under

the old text of Rule 36 (on European The new regulation was roundly criticized. divisional applications) of the First, the number of divisional applications European Patent Convention (EPO was too low to cause the Argentine PTO’s Divisionals deadline causes surge in backlog: between 2003 and 2008 the yearly filings, “Managing Intellectual Property”, November 2010, p. 10). 6 Published in the Official Gazette 8 Published in the Official Gazette (Boletín Oficial) No. 31939 on July (Boletín Oficial) No. 32036 on 7, 2010. November 26, 2010.

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(b) at applicant’s will, at any time application (B) whose mother is (A), it is prior to the resolution of the basic necessary for (A) to be pending at the time application (voluntary divisional divisional application (C) is filed”. application). Regardless of its cumbersome wording, the provision is clear in requiring that in a series Regarding compulsory divisional of divisional applications, absolutely all of applications, art. 2 of Disposition No. 147 them must be “alive” (i.e. pending) at the (which is still in force as this provision was time the last divisional is filed. This not repealed by Disposition No. 198) states requirement is unconstitutional because it that “once the substantive examination has introduces a restriction –the pendency of a begun, if the examiner ascertains that the preceding divisional application other than application lacks unity of invention or is a the specific application being divided– ‘complex application’, he or she shall noticeably absent from both the Patent Law request that the application be divided and its regulatory decree, which prevail over within 30 working days, under the condition any rules issued by the Argentine PTO. that otherwise the application will be held as Notwithstanding this constitutional having been abandoned”. A strict reading of argument, for practical reasons art. 5 must this provision might lead to the conclusion be taken into account, as will be explained that the application will always be declared immediately below. as having been abandoned if the applicant fails to divide it when charged to do so by V. STRATEGIES the examiner. However, no notice of abandonment may validly issue, even if the What are the practical consequences that divisional application is not filed, if may be drawn from the above analysis, and applicant has nonetheless removed the particularly which is the best strategy to take objected subject matter from the basic (and full advantage of the current divisional finally only) application and thus complied system in Argentina? Although the with the rule of unity of invention. procedure set up by Disposition No. Furthermore, a divisional application may 198/2010 restored, to a great extent, the not be rejected for having been filed after quite liberal status quo prior to the issuance the 30-day deadline set forth in Disposition of Disposition No. 147/2010, things now are No. 147, if it is nonetheless filed within the not quite as they were before. general term of art. 17 of the regulatory decree (i.e., as long as the basic application First, the requirement of art. 2 of Disposition is pending). No. 147 (i.e., the request from the examiner, issued in the substantive examination, that A contentious issue is whether all the application be divided) should not be applications must be pending in a series of taken lightly. That is precisely the point in successive divisional applications, from the time in which the applicant must study and first (basic) application up to the last decide if the original application is to be divisional application. Article 5 of divided, and, if so, whether one or more Disposition No. 147 (also not repealed by divisional applications will be filed. Disposition No. 198, and therefore still in force) unequivocally states that “if a Secondly, although we stand by our divisional application (C) is filed, which contention that it is unconstitutional to originates from another divisional require that all preceding divisional

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applications (up to the original application) be pending, it must be nevertheless be reckoned with the fact that the Argentine PTO shall refuse a divisional application filed in a series where the “grandmother” (or more remote) application is no longer pending, which in turn will trigger the need to file an appeal against this rejection. Accordingly, when studying whether to file a divisional application, it is advisable to decide at the same time whether more than one divisional application will be necessary, so as to file all of them simultaneously.

Finally, since there is no notice of allowance in the Argentine procedure, applicants must be careful not to delay filing the divisional application(s) once the objectionable subject matter has been removed, because while they are pondering their decision the basic patent may issue, and thereafter no divisional application will be accepted.

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Australian parliament. Although it has yet to be passed into law, it is highly contentious. THE PATENTABILITY OF The Bill was drafted despite a 2004 report BIOLOGICAL MATERIALS IN by the Australian Law Reform Commission AUSTRALIA (ALRC) explicitly recommending against a

ban on patenting of genes10, and despite an Vaughan Barlow9 Australian Senate Committee failing to Pizzeys Patent and Trade Mark Attorneys make any recommendations on the Canberra, Australia patentability of genes and genetic

technologies11, and despite a 2010 report by 1. Introduction the Advisory Council on Intellectual

Property (ACIP) explicitly recommending The Patent Amendment (Human Genes and against the introduction of specific Biological Materials) Bill (2010) (“the exclusions for patentability12, and despite Bill”) is currently before the Australian any Australian court ever having provided parliament. It seeks to ban the patenting of obiter dicta or ratio decidendi on the all biological material that is “identical or patentability of biological materials. substantially identical to such materials as

they exist in nature”. If passed, this Among other proposed changes, the Bill legislation would represent a major shift in seeks to amend section 18 of the Act . It may also (1990) as follows (shown in strikethrough significantly jeopardize the biotechnology, for proposed deleted text and underline for pharmaceutical, medical and agricultural proposed added text): industries in Australia. This article sets out

the proposed ban on patentable subject (1) Subject to subsection (2), matter and discusses the ramifications of an invention is a patentable such a ban. invention for the purposes

of a standard patent if the 2. The Patent Amendment (Human Genes invention, so far as claimed and Biological Materials) Bill (2010) in any claim:

(a) is a manner of The Patent Amendment (Human Genes and manufacture within Biological Materials) Bill (2010) was the meaning of recently introduced into both houses of the section 6 of the

9 . Vaughan is a legal practitioner admitted 10. Australian Law Reform Commission to the Supreme Court of New South “Genes and Ingenuity: Gene Patenting Wales and a patent attorney registered to and Human Health” (ALRC No. 99, practice before the Australian Patent 2004); Office and the Intellectual Property 11 Office of New Zealand. Vaughan is also . Senate, Community Affairs References a trade marks attorney registered to Committee: Report on inquiry into gene practice before the Australian Trade patents, 26 August 2010; Marks Office. Vaughan practices with 12. Advisory Council on Intellectual Pizzeys Patent and Trade Mark Property Report, Patentable Subject Attorneys: www.pizzeys.com.au; Matter, 23 December 2010;

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Statute of limited to “human beings and the biological Monopolies; and processes for their generation”. Proposed (b) when compared with section 18(2)(b) bans from patentability all the base as it biological materials that are “identical or existed before the substantially identical” to those existing in priority date of that nature. The ban therefore not only runs claim: counter to the recommendations made by the (i) is novel; and ALRC and the ACIP, but it is also broader (ii) involves an than the summary judgement of the New inventive step; York District Court in Association for and Molecular Pathology v United States Patent (c) is useful; and Trade Mark Office 13 (the “Myriad ...... Genetics Case”), given that the Bill makes (2) Human beings, and the no distinction on the basis of inherent biological processes for “informational” characteristics of a their generation, are not biological material. patentable inventions. (2) The following are not The legal definitional problems associated patentable inventions: with the proposed language of section (a) human beings, and 18(2)(b) are numerous, and include (1) the biological defining the scope of a “biological processes for their material”, (2) defining the scope of a generation; and “component or derivative” of a biological (b) biological materials material, (3) defining the scope of including their “substantially identical” and (4) defining the components and scope of “such materials as they exist in derivatives, whether nature”. isolated or purified or not and however In relation to defining the scope of the term made, which are “biological material”, some assistance is identical or provided under section 18(5) which substantially proposes a non-exhaustive inclusive identical to such definition including DNA, RNA, proteins, materials as they cells and fluids. Accordingly, it appears that exist in nature. any biological material from any naturally ...... occurring biological system is proposed to (5) In this section: be banned from patentability. Anti-cancer biological materials, in compounds such as paclitaxel, isolated from section 18, includes the Pacific Yew tree, would therefore be DNA, RNA, banned from patentability. Also, the ability proteins, cells and to patent autologous cell therapies, the fluids. precise aim of which is to replicate

The proposed ban on patenting of biological materials under section 18(2) is therefore far 13. No. 09-Civ-4515 (SDNY), handed down broader than the current ban, which is on 29 March 2010;

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biological material from a patient in need, significant interpretive benefit may be may also be jeopardized. translated over to issues of “biological material” as proposed under section 18(2) of The term “component or derivative” of a the (1990). Indeed, use of the biological material even further broadens the term “substantially identical” would almost scope of the ban on biological materials. On certainly result in prolonged and potentially a literal interpretation, a “component” of a expensive interpretation during patent office “biological material” (specifically defined as or court proceedings. including DNA, RNA and proteins) arguably encompasses, for example, any one In relation to defining the scope of the or more single nucleic acid residues or phrase “such materials as they exist in single amino acid residues. It is therefore nature”, it is presumably necessary to difficult to know where to reasonably draw attempt to define what biological material is the line on the scope of the term naturally occurring and what is artificial. For “component”. Equally problematic, the term example, how does one differentiate “derivative” is commonly defined as a between the human intervention involved in compound or molecule that is derived from artificially creating genetically modified a similar compound or molecule by some cotton versus the breeding of animals and chemical or physical process. The term crops to suit human needs over thousands of “derivative” can also be used for compounds years? At what point in time, or through that can at least theoretically be formed from what type of human intervention, can we a known precursor compound. Hence, it is differentiate between biological material that difficult to know whether a “derivative” of a “exists in nature” and that which does not? biological material, which may for example Such issues are particularly pertinent for be a chemically altered amino acid that does agriculture, where it is arguable that the not exist in nature, would nevertheless still continued release of genetically modified fall within the proposed banned subject crops or animals for widespread use by matter. farmers changes what defines “existing in nature” on a continual basis. In relation to defining the term “substantially identical”, it is noteworthy It is therefore clear that not only would the that section 44 of the Australian Trade proposed ban on patenting of biological Marks Act (1995) bars registration of a trade materials significantly change the scope of mark that is “substantially identical” with a patentable subject matter in Australia, but prior filed trade mark. 14 Although the term the particular language proposed is overly “substantially identical” has therefore been broad, problematic and confusing. subject to at least 15 years of interpretation in relation to Australian trade mark law, it is 3. Conclusion: Ramifications of the nevertheless difficult to see how any proposed bans on patentable subject matter

14. Registration is only barred if the It is immediately apparent that if passed into substantially identical or deceptively law, the Patent Amendment (Human Genes similar trade mark is sought to be and Biological Materials) Bill (2010) would registered in respect of similar goods or have a profound affect on the biotechnology, closely related services; pharmaceutical, medical and agricultural

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industries in Australia. Despite the clearly excludes patenting of micro- recognized expertise of the ALRC, its organisms, but Art 27(3)(b) of TRIPS recommendation that the Patents Act should disallows such exclusion. Proponents of the not be amended to exclude genetic materials amendments to section 18(2) argue that or technologies from patentability appears to TRIPS would not be contravened because have been ignored. In addition, the the banned subject matter would not qualify significant impediments to amending the as an “invention” and therefore would not be Patents Act to exclude genetic materials subject to Art 27. from patentability, including a long history of patenting such inventions, international In addition to Australia’s potential treaty obligations, and a biotechnology contravention of its obligations under industry dependent on patents and TRIPS, the commercial reality of banning inventions, has also been ignored.15 from patentability all biological material that Moreover, the approach taken goes directly exists in nature could result in the against recommendations made by the ACIP biotechnology, pharmaceutical, medical and that a specific list of unpatentable subject agricultural industries withdrawing matter should not be provided, and that “no investment in Australia. As a consequence, persuasive case has been made to introduce there is the potential for future difficulty in a specific exclusion to prevent the patenting accessing medicines and associated of human genes and genetic products.” 16 problems in the provision of healthcare. This possible lack of investment could arise not From a legal perspective, it is important to only because of diminished returns on note that Australia is a signatory to the investments through a lack of patent rights, Trade Related Aspects of Intellectual but also because of the remaining significant Property (TRIPS) agreement. Article (Art) costs in obtaining regulatory approval. 27(1) of TRIPS obliges member countries to Indeed, sources indicate that the Australian make patents “available for any inventions, Therapeutic Goods Administration, which is whether products or processes, in all fields responsible for granting market approval, is of technology…”. Various exceptions to this planning on further increasing its charges to requirement are found in Art 27(2) and Art applicants. 27(3). Although the exclusions to patentability under Art 27(2) and 27(3) are The Bill is currently before parliament and potentially broad, it appears clear that the is also the subject of a renewed Senate proposed exclusions under the Patent Inquiry. 17 Submissions from the public Amendment (Human Genes and Biological closed on 25 February 2011 and included a Materials) Bill (2010) are even broader. For diverse range of opinions. The Australian example, the proposed Australian Bill Institute of Patent Attorneys, a professional body representing patent attorneys in

15 Australia, was clear in its objection to the . Australian Law Reform Commission Bill. 18 The Senate Committee is now “Genes and Ingenuity: Gene Patenting and Human Health” (ALRC No. 99,

2004); 17 . Senate, Legal and Constitutional Affairs 16. Advisory Council on Intellectual Legislation Committee; Property Report, Patentable Subject 18. See Matter, 23 December 2010, page 14; http://www.aph.gov.au/senate/committee/ Page 11

conducting hearings and is due to report on 16 June 2011.

Patent applicants seeking to claim biological materials in Australia are therefore strongly urged to closely monitor the progress of the Patent Amendment (Human Genes and Biological Materials) Bill (2010) through the Senate Inquiry at http://www.aph.gov.au/Senate/committee/le gcon_ctte/patent_amendment/index.htm, which also provides a link to each of the 100 submissions received from academics, various professional bodies, pharmaceutical companies, patent attorneys, medical research institutes, and state and federal government.

legcon_ctte/patent_amendment/submissio ns.htm submission no. 49.

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CANADIAN COMMISSIONER OF I do not support the proposition that, given a PATENTS ENDORSES BROAD sufficiently purified protein, one would not MONOCLONAL ANTIBODY CLAIMS expect that monoclonal antibodies could be produced... If my writings are cited in Graeme R. B. Boocock, Ph.D. support of this proposition, then they are Borden Ladner Gervais LLP wrongly cited.22 Ottowa, Canada The Patent Appeal Board conceded, stating A recently published decision of the Commissioner of Patents in Re Immunex In light of this evidence, it appears there are Corporation Patent Application No. concerns with Pasteur in so far as it may be 583,98819 has provided prospective relied upon as authority for the proposition Canadian patentees of inventions relating to that a patent specification is defective for monoclonal antibodies with some long- lack of enablement because monoclonal sought clarity in this rapidly evolving antibody production was not a well practice area. developed methodology or merely because it fails to set out a detailed proposed protocol Background for the production of a monoclonal antibody to a given antigen.23 Historically, written description and enablement requirements for antibodies – However, on the front lines of patent particularly monoclonal antibodies – have prosecution, Patent Office policy with been quite high in Canada. This was due to regard to antibodies remained quite murky. the 1995 decision of the Commissioner of Patents in Re Institute Pasteur20, wherein The Immunex Decision claims to monoclonal antibodies and related hybridomas were refused on the basis of The Immunex application was filed on statements taken from a scientific reference November 28, 1988 and related to manual. These statements concerned certain interleukin-1 receptors (IL-1R). Claim 29 unpredictable aspects of antibodies, and was directed to “A monoclonal antibody were arguably taken out of context. The immunoreactive with IL-1R polypeptide.” Commissioner determined that, at the 1987 Claim 54 was added during prosecution to filing date, reference to “traditional specifically encompass an antibody directed techniques” for antibody production to polypeptides defined by sequence, while constituted insufficient description. claim 58 was a parallel product-by-process claim. The Examiner objected to these More recently, in 2008, Commissioner’s claims in a Final Action for being decision #128321 considered an affidavit insufficiently supported by the description, submitted by the scientist whose statements citing a lack of specific examples of such an were relied upon in Pasteur. In the affidavit, antibody, and no supporting biological Dr. James Goding stated deposit.

19 (2011) 89 C.P.R. (4th) 34. 22 Ibid. at [119]. 20 (1995) 76 C.P.R. (3d) 206. 23 21 Ibid. at [121]. (2008) Commissioner’s Decision #1283. Page 13

the antigen was in hand, the work which The Applicant argued that the subject matter followed did not, in the Board’s view, of the claims, though not specifically involve undue experimental burden. The exemplified, was supported by a full, actual techniques used post-filing closely enabling disclosure of how to make and use mirrored the general protocol taught in the the claimed monoclonal antibodies; the IL- description. 1R protein had been fully described, and detailed protocols for making antibodies had The Board stated been included. These methods were routine at filing, according to the Applicant. … the skilled person would appreciate that monoclonal antibodies can be adequately In its decision, the Patent Appeal Board described based on a combination of a noted that U.S. and U.K. courts have structural description of the antigen, recently recognized that no undue functional identity [i.e. specific experimental burden is required to raise immunoreactivity] between the antibody and monoclonal antibodies targeted to a defined antigen, and knowledge of predictable polypeptide. Broad claims to such production methods. antibodies have been allowed in these jurisdictions without specific Of particular note, the Board seems to have exemplification, in view of the maturity of indicated that a target polypeptide can be antibody production technologies. “fully characterized” by providing a complete amino acid sequence. Turning to the case at hand, the Board noted that two types of IL-1R polypeptides exist: However, the Board cautioned that claims to Type I and Type II. The specification antibodies having special functional disclosed the construction, expression, and attributes, such as diagnostic or therapeutic purification of an extracellular domain of a antibodies, may require correspondingly Type I IL-1R. Thus, the Board concluded detailed support. that the specification was only enabling for antibodies directed to Type I polypeptides, What does it mean for prospective while the claims in question encompassed patentees? both types. However, the Board was willing to allow the claims if the scope of the Publication of the Immunex decision in the antibody target was limited to Type I IL-1R Canadian Patent Reporter explains and polypeptides, and invited the Applicant to clarifies a recently observed but, until now, effect the necessary amendments. somewhat mysterious24 trend for Canadian

In arriving at its decision, the Board noted 24 The Immunnex application was filed that the description taught the cloning and before the Canadian Patent Act was protein expression techniques required to amended on October 1, 1989 to prepare the immunogen. It also considered a allow publication of an application 1989 (i.e. post-filing) publication from a and its file history (which includes third party, as well as an affidavit signed by this Commissioner’s decision) prior one of the inventors, to support its to issuance. Though the decision conclusions that generation of monoclonal was handed down in 2010, the antibodies was sufficiently supported. Once application has not yet issued and, Page 14

Patent Examiners to allow broader claims to whether there are indications of success or monoclonal antibodies in some applications failure on record. when novel antigens and epitopes are disclosed. What about other types of antibodies?

This decision sheds light on the underlying While claims to monoclonal and chimeric reasons for this change, and supports the antibodies are now being entertained in the argument that monoclonal antibodies can be absence specific examples, claims to routinely generated without undue humanized antibodies are still being experimentation when a well-defined target routinely objected to unless they have been protein is disclosed, for example, by specifically exemplified in the description. sequence and/or structure. It also highlights the importance of providing general A basis for this Patent Office policy may lie protocols and prophetic examples in patent in the 2009 Commissioner’s Decision in Re specifications for the purposes of support. Sloan-Kettering Institute for Cancer Research Patent Application No. In drafting and prosecuting antibody-related 2,072,01725 in which the Board considered a applications in Canada, it may also be claim encompassing humanized antibodies helpful to bear in mind the non-exhaustive to be neither supported nor enabled because, list of considerations for support and amongst other considerations, few enablement which were set out in laboratories (“in the neighbourhood of ten”) Commissioners decision #1283 (and applied were active in the field of antibody in the Immunex decision), briefly humanization at the filing date (December summarized and consolidated below: 14, 1990), and because the steps to a humanized antibody were then whether there is more than merely a general "considerably more involved” than those description of the polypeptide, including an involved in constructing a chimeric explicit description of specific epitopes; antibody. whether there is a description of a paratope of a monoclonal antibody; The recent decision in Re Immunex whether the scope of an antibody claim in Corporation should embolden prospective respect of the polypeptide is appropriate; patentees to argue that the standards set the availability and/or ease of production of forth therein should apply equally to other the polypeptide; sub-types of antibodies, particularly in view whether there are indications on record of technological advancements since 1990. which suggest a requirement for undue experimentation or undue adaptation of the

known methods;

whether an antibody was actually prepared,

and whether the applicant was in a position

to provide a biological deposit of a

hybridoma; and

hence, the decision has not been published by the Patent Office. 25 (2009) 82 C.P.R. (4th) 33.

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CHANGES AND IMPROVEMENTS IN Important to include in this short overview CHILEAN PATENT LAW is the entrance of Chile to the Organization for Economice Co-operation and Edwardo Molina Development (OECD) in May of 2010, thus Etudio Federico being the first South American country to be Villasera, Chile accepted in this exclusive club of developed countries. The above has meant an I. CHILE SHORT OVERVIEW – international recognition to our country after SOME FACTS AND FIGURES two decades of reformulations to the democratic and economic systems. President Obama has just completed a two days visit to Chile on March 21-22, 2011 II. SOME HISTORY OF THE IP confirming the good standing of the bilateral DEVELOPMENTS relations. The incredible success of the Free Trade Agreement FTA signed between the The Chilean Industrial Property Law has U.S. and Chile in 2003 has meant that the undergone in the last years mayor changes commerce has raised 164%, and in 2010 a aimed to modernize and improve the year marked by the consequences of the standards of protection to IP holders. earthquake and the reconstructions of large areas of the country, the bilateral exchange The first important change was produced in raised to more than 15 billion dollars. 1991 with the entrance into force of a completely new and modernized Industrial Nearly 15 thousand companies among Property Law (CL IP Law), text which has importers and exporters with more than 7 been amended twice in the last years. New thousand different products participate in IP Law 19.039 issued on 30 September 1991 this exchange generating almost 4 thousand included such new articles as for instance employments in the U.S., thus this treaty has the allowance to patentability of proved to be an excellent instrument to pharmaceutical products per se, which in develop a healthy commercial relationship does days was a revolutionary step forward between Chile and the United States of for a Latin American country and the America. addition of Chile to the Paris Convention.

Commercially speaking, Chile is the world’s Following Chilean modernization standards, opened country, having in force FTAs and a first amendment to the IP law was made other commercial agreements with a large on 1st December 2005 with the issuance of number of countries and regions within can Law 19.996 which in short terms upgraded be found the European Union, EFTA, China, the CL IP law to TRIPS standards and to India, Japan, Korea, Australia, Canada, some aspects of the EU and US FTAs. This Central America and Mexico among others. first amendment included so radical concepts for those days such as the 6 months Intellectual Property was one of the hot grace period term for disclosures made prior topics discussed in this visit as there are to the filing of the application. some issues included in the IP Chapter of the FTA that need some harmonization Continuing with the modernization spirit efforts to have full implementation. and to complement some missing aspects of the FTAs with the EU and US, the Chilean

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IP law was further amended in Law 20.160 the product. This kind of two-dimensional dated 26 January 2007. This new right is granted for a non-renewable period amendment to law 19.039 included further of 10 years from the application. improvements in the IP law as for instance the extension of the grace period from 6 to Schemes and Topographies of 12 months as well as others which are Semiconductor Products: protection of the discussed herein below. three-dimensional shape of elements in an integrated-circuit semiconductor chip. A once new modernization of the IP Protection is for a non-renewable term of 10 standards in the last years was the entrance years from the application or from its first into effect of the Patent Cooperation Treaty commercial exploitation in any part of the (PCT) as of 2 June 2009, which meant that world. any international application filed on or after June 2, 2009, Chile (country code: CL) is Trade Secrets: protection of trade secrets is automatically designated, and as it is bound defined as the knowledge of products or by Chapter II of the Treaty. industrial processes, of which continued secrecy confers on the owner an The PCT is in full force in Chile and improvement or competitive advantage. international applications filed as of 2 June 2009 are already entering national phase Undisclosed Information: The undisclosed within the 30 months term from the priority information refers to the data submitted to application. the national authority that grants sanitary registrations and marketing approvals to Finally, it is important to state that pharmaceutical products (in Chile the Public Intellectual property issues in Chile are Health Institute -ISP), or the Cattle and managed by two separate laws, the Agronomic Service (SAG) for agronomic Industrial Property Law - which governs products. According to the new legislation patents, trade marks, industrial designs and this data shall be undisclosed and secret for models, and the Copyright Law five years for pharmaceutical products and number 17,336 which governs copyrights ten years for chemical-agricultural products, and was recently amended to comply with during time the official agent cannot give TRIPS and FTAs standards as well. commercialization licenses to third parties using the secret data. In order to be eligible III. NEW IP STANDARDS for data exclusivity protection, security and safety data must refer to undisclosed studies. 3.1. NEW FORMS OF PROTECTION Law provides that “data are deemed undisclosed when reasonable measures have In addition to existing forms of protection, been taken to maintain them as such and if such as patents, trade marks, utility models they are generally not known or not readily and industrial designs, the new IP law accessible by people belonging to circles inn includes the following new forms: which the information is generally uses”. The ISP has also stated that data will still be Industrial Drawings: figures in a two- considered as eligible for protection when dimensional plane, for incorporation in an the disclosure refers to information provided article of manufacture, with ornamental to the authority in order to fulfil with legal purpose. They must offer a novel aspect to requirements. Once data exclusivity

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authorization is recognized, the ISP cannot In civil cases concerning process patents, the rely on such studies to allow registrations court may establish the reversal of the for third parties who lack authorization from burden of the proof, i.e. that the burden of the owner of such data for a period of 5 proof falls on the defendant when the years counted as form the date of issuance of products directly obtained by the patented registration of the protected product. method are new.

3.2. IMPROVED AND BETTER Finally, it is important to state that patent ENFORCEMENT term was extended to 20 years from the application date, compared to the prior 15- Formerly, criminal proceedings were the year term awarded from the date of grant. only effective way to enforce IP rights in Chile. This made it very difficult for rights 3.3. COMPULSORY LICENCES owners successfully to seek remedies because winning such procedures requires Former IP Law 19.039 allowed for the plaintiff to prove bad faith on the part of compulsory licences in the case of the infringer. Although civil actions were monopolistic abuse, but in the amendment also possible, they were governed by the two main causes are added, namely reasons general legislation, which is inadequate for of public health, national security, non- these kinds of matters. The amendments of commercial public use, national emergency the law maintained criminal actions but also or others of extreme urgency declared by the established special civil actions to enforce IP proper authority, and when the exploitation rights. The law amendments were aimed at of a patent cannot be done without a stopping infringement, obtaining previous patent when, for instance, the new compensation, and getting the necessary patent covers an invention of a considerable court-sanctioned measures to prevent repeat economic importance. infringements. The process and requirements for granting The plaintiff may choose how compensation compulsory licences meet all TRIPs is evaluated, either using the traditional form Agreement guarantees, and shall be of lost profits and emerging damages, or an overseen in the first instance by the Free alternative according to one of the following Competition Court in cases of monopolistic criteria: the profits that the plaintiff has abuse, and by the head of the National ceased to obtain as a consequence of the Institute of Industrial Property (INAPI) in infringement; the profit that the infringer has cases of public health, emergency, urgent or made by means of the infringement; and the non-commercial public use, and by the payment of a royalty. ordinary courts in the event of dependent patents. Precautionary and prejudicial remedies were also included in the law amendment in case The amended IP law also provided for the of infringement of any IP rights and in international exhaustion of rights for all IP general Criminal proceedings were institutions. This criterion is consistent with simplified in a major general law the free trade and open commercial policy amendment. that Chile has adopted in the past three decades. Further, this general concept is in

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line with article 6 of the TRIPs Agreement, The possibility of requesting the extension which refers to the exhaustion of IP rights. of the patent term has been included in the last modification introduced to the Chilean Former law provided for a Special Court of Industrial Property Law of 2007, stating that Appeals to hear cases judged in the first within 6 months as from the granting of a instance by the Chilean Industrial Property patent, the owner shall be entitled to request Department, the members of this court were a term of Supplementary Protection, always not IP specialists. Under the amendments, at provided that unjustified administrative least six of the 10 members of the court are delay has existed in the granting of the selected from specialized IP lawyers. patent, and the prosecution term has lapsed Additionally, the court will have more more than 5 years counted as from the filing space, with two regular rooms instead of date of the application or 3 years counted as one, and even three in special circumstances. from the examination request, whichever is According to the new text of the law, the longer. The Supplementary Protection will intervention of the Supreme Court as a last last only for the accredited unjustified recourse is envisaged in all kinds of cases, administrative delay. whether administrative or judicial. The Supplementary Patent Term shall be 3.4. GRACE PERIOD also requested if delay is produced in the sanitary registration for a pharmaceutical As discussed before, our last law product protected by a patent. Specifically, amendment of 2007 extended the Grace Art. 53 Bis 2 of the CL IP Law : "Within the Period disposition to 12 moths from first 6 months of obtaining a Sanitary disclosure of the invention, provided that the Registration for a pharmaceutical product public disclosure: protected by a patent, the owner will be entitled to request a term of Supplementary a) Was made, authorized or comes from Protection for that part of the invention the applicant of the patent, or containing the pharmaceutical product, always provided that unjustified delay has b) Has been made or arises from abuse existed in the granting of the said or unfair practices of which has been an registration. This Supplementary Protection object the applicant or the . may be requested by those owners which sanitary registration lasted more than 1 year This special disposition has included an counted from the application date. The exception to the absolute Supplementary Protection will last only for requirement permitting for instance the the accredited unjustified administrative presentation of applications having an delay." international filing date that is prior to the entrance of Chile to the PCT (2 June 2009) 3.6 PATENT EXCEPTIONS but a first disclosure (usually the international publication date) that is less The new Chilean Patent Law includes some than 12 months from the CL filing date. exceptions to patent rights in very special cases, as for instance the right to prevent 3.5. SUPPLEMENTARY PATENT third parties from importing, exporting, PROTECTION manufacturing or producing the matter protected by a patent with the purpose of

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obtaining a sanitary registration or created basically establishing regulations for authorization of a pharmaceutical product. clearance of goods suspect of infringing intellectual property rights. However, our law is very clear to say that such an exception does not enable for This new Law establishes two types of commercialization of said products without procedures: 1) upon the request of the authorization of the holder of the patent. interested party; and 2) upon the request of the Customs Administration. IV. OTHER GOVERMENTAL EFFORTS In this regard, Customs are authorized to suspend clearance of suspicious goods for 4.1. CREATION OF THE up to 5 working days due to copyright NATIONAL INSTITUTE OF infringement or trademark counterfeiting, INDUSTRIAL PROPERTY (INAPI) without prejudice of the sphere of competence of the qualified judge. The old Industrial Property Department (DPI), a public repartition depending from According to our law, IP infringement the Ministry of Economics was replaced by actions can not be initiated ex-officio neither the much modern National Institute of by the Prosecutor, Customs or the Police, Industrial Property (INAPI), still a the only way to seek the seizure and governmental institution but having higher destruction of the infringing products is to budget and capabilities which has permitted file the corresponding criminal or civil among other improvements, the shortening action for the trademark infringement and/or in the prosecution of patent applications in counterfeit, requesting to the Court for the 21% with respect to 2008 as well as the judicial seizure and finally, the destruction reduction of timeframes in other of the infringing goods. administrative proceedings. This improvement goes beyond TRIPS 4.2. NEW IP SPECIALIZED POLICE standards as it comprises all IP issues FORCE including patent enforcement.

Among the efforts made by the Chilean V. EXPECTED TO COME government to improve the enforcement of IP rights, the Police (PDI) created in 2008 a 5.1. ADOPTION OF UPOV 91 ACT specialized task force called BRIDEPI, which only objective is to conduct The current Chilean Law is being adapted as investigations in connection to IP crimes. per UPOV 91 Act.

In the last years this specialized force has As a result of the above, the protection seized important amounts of counterfeited standards will be improved since (i) the fruit products as well as pirate software. will also be protected, (ii) the protection deadlines will increase from 18 to 25 years 4.3. BORDER MEASURES in the case of trees and grapes varieties, and from 15 to 20 years for the rest; (iii) the Border Rules for the Observance of provisional protection will cover from the Intellectual Property Rights have been publication date of the variety to the

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granting date. Other improvements as stated the further improvement of our IP in UPOV 91 Act will be available as from legislation, the training of our specialized IP issuance of the new law which is expected to courts so as to have better enforcement are occur very soon. among others missing issues that our authorities and IP specialist are working on. 5.2. APPROVAL OF THE BUDAPEST TREATY ON THE The amended IP law has meant that DEPOSIT OF MICROORGANISMS IN international IP holders have in Chile a THE FINAL STEP country with known international standards, where options available for protection of IP On September 14, 2010 the Chamber of rights equate to standards in developed Deputies of Chile approved the Budapest countries, where enforcement is possible, Treaty on the International Recognition of and most importantly, where legislation is the Deposit of Microorganisms for the acquiring the significance that all of us wish Purposes of Patent Procedure, done at to see. Now it is in the hands of holders of Budapest on April 28, 1977. Consequently, IP rights to demonstrate that the adoption of the text has passed its final stage in the these high levels will also result in benefits Senate of Chile where it is expected to be for a developing nation. approved within the next months.

The objective of the treaty is to allow or require the deposit of microorganisms for patent registration procedure on biological material to an "international depositary authority, whether such authority is located in or outside the territory of the State in question.

VI. CONCLUSIONS

As discussed before, the Chilean IP Law has been continuously improving its standards in the last years. This, mainly as a consequence of three major reason: i) the general modernization of the country in view of our general policy of an open market nation; ii) to fulfil the minimum standards imposed by the TRIPs Agreement; and iii) due to obligations incurred after the signature of a number of free trade agreements and other commercial treaties which have obliged us the harmonization of our laws and the adoption higher standards in this area.

However, there is still work to be done, as for instance the ongoing war against piracy,

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business methods. Specifically, the 2005 AMAZON 1-CLICK: THE FLIP FLOP version of the MOPOP provided as follows. IN CANADA OVER WHETHER SOFTWARE AND BUSINESS Computer-related subject matter is not METHODS ARE PATENTABLE excluded from patentability if the traditional criteria for patentability are satisfied. Jason B. Hynes and Philip C. Mendes da Costa Software that has been integrated with Bereskin & Parr, LLP traditionally patentable subject matter Ontario, Canada may be patentable.

The Amazon 1-Click case has been a The expression “business methods” refers to rallying point in the debate over the a broad category of subject matter, which patentability of software patents in the often relates to financial, marketing and United States for many years.26 For other commercial activities. These methods example, in 1999 Amazon.com, Inc. sued its are not automatically excluded from rival Barnes&Noble.com (resulting in a patentability, since there is no authority in settlement in 2002), and an ex parte the Patent Act or Rules, or in the reexamination in the U.S. lasted four years Jurisprudence to sanction or preclude before ultimately upholding the patent in patentability based on their inclusion in this 2010.27 The Amazon case has raised a category. similar debate in Canada about software and business methods and has pitted the Patent The Amazon.com patent application (“the Office against the Federal Court in a fight ‘933 Application”) describes purchasing that has the potential to radically reshape the items over the Internet using a single-action landscape on patentable subject matter. (e.g. clicking a mouse button) by transmitting a client identifier associated Software and Business Methods Initially with information about the buyer, which Appear Patentable may be stored in a “cookie”.28 Originally filed in 1998, the Canadian application was In February 2005, the Patent Office finally rejected by the Canadian patent amended two chapters of the Manual of examiner in June of 2004 on grounds that all Patent Office Practice (MOPOP) related to the claims were both obvious and covered patentable subject matter: Chapter 12 non-statutory subject matter. However, the (“Utility and Subject Matter”), and Chapter subject matter of the ‘933 Application 16 (“Computer-implemented Inventions”). seemed fairly technical and based on the These chapters reflected a significant policy revisions to MOPOP in 2005, there appeared relaxation by the Patent Office that opened to be a good argument that the examiner was the door for the patentability of software and wrong, at least on the question of subject matter, and that the ‘933 Application would

26 be allowed on appeal. The U.S. application issued as Patent No. 5,960,411 on September 28, 1999. 27 Reexamination No. 90/007,946 resulted in 28 Canadian patent application no. an ex parte re-examination certificate 2,246,933, filed September 11, 1998 being issued July 13, 2010, by Amazon.com, Inc.

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discovered or added to human knowledge) The Patent Appeal Board Rewrites the when determining whether the claims fall Law on Patentable Subject Matter into one of the defined statutory categories under section 2 of the Patent Act. A claimed The Patent Appeal Board (PAB) first heard invention could not be considered as Amazon’s appeal in late 2005, after the statutory if the particular feature (or group revised chapters of MPOP had been of features) that made it new and unobvious released. However, the decision by the fell into excluded subject matter. Board was delayed. In fact, in an unusual Furthermore, in order for an art or process and somewhat controversial move, in July of to be patentable, it must “cause a change in 2008 the PAB informed Amazon that two the character or condition of some physical members of that original panel had retired object”.31 before the decision could be finalized. Therefore the case would need to be The Board also took a very hard line with reargued at a second hearing in late 2008. respect to business method patents, and Following this hearing, in March 2009 stated matter-of-factly that business methods (nearly five years after the examiner’s final are not patentable in Canada, relying on a rejection and more than ten years after the dissenting judgment from the Supreme ‘933 Application was filed!) the PAB Court of Canada in Monsanto v. released its decision.29 Schmeiser,32 and several UK and US cases.33 This was a surprising conclusion as The Board found that all claims of the ‘933 it clearly conflicts with the position of the Application were inventive and therefore Patent Office as set out in the 2005 version overturned the examiner’s conclusions on of MOPOP,34 and other previous PAB obviousness. However, the PAB rejected all the claims as being directed to non-statutory subject matter, including both the method 30 and system claims. 31 See Lawson v. Commissioner of Patents The Board stated that it was necessary to (1970), 62 C.P.R. 101 (Ex. Ct.). separately consider both the form of the 32 Monsanto Canada Inc. v. Schmeiser, claims (e.g. whether each claim on its face [2004] 1 S.C.R., 2004 SCC 34, see appears to define statutory subject matter) Justice Arbour’s dissent. and their substance (e.g. what has been 33 Including the Federal Circuit decision of

29 In re Bilski (2008), 88 USPQ2d 1385 Decision #1290, Re Application No. (CAFC) which has since been 2,246,933, (March 5, 2009) online overturned: Bilski v. Kappos, 130 S. at: Ct. 3218 (2010). http://patents.ic.gc.ca/opic- 34 See Manual of Patent Office Practice, cipo/comdec/eng/decision/1290/imag Chapter 12.04.04 (Rev. February e.html 2005), online at: 30 e.g. an art, process, machine, manufacture http://www.cipo.ic.gc.ca/eic/site/cipo and composition of matter, see internet- section 2 of the Patent Act, R.S.C. internetopic.nsf/eng/wr00723.html#n 1985, c. P-4. o12.04.04

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decisions.35 The Board also held that any non-technological subject matter would be This inconsistency was resolved in a rather rejected as being non-statutory, since each Kafkaesque fashion, as work was already of the five categories of invention that are underway to rewrite the MOPOP. By the identified in section 2 of the Patent Act end of 2009, which was about 7 months inherently relate to technology. after the decision of the PAB, new versions of Chapter 12 on patentable subject matter The Board ultimately concluded that all and Chapter 13 on examination were in claims of the ‘933 Application were rules force.36 These revised chapters incorporated for carrying out an online order, and were the language of the PAB decision and therefore unpatentable since they did not completely flip-flopped on the question of change the character or condition of any the patentability of software and business physical object. The Board also stated that methods. Soon after, a new draft of chapter the invention claimed in the ‘933 16 was also released,37 which provided a Application was nothing more than a narrow definition of “computer- “method of doing business” and moreover implemented invention,” and made it clear was not technological, and for these that a “technological solution to a additional reasons was also unpatentable. technological problem” is required in order for a computerized invention to be patentable. Given the similarity of the The PAB Amazon Decision and the language and concepts used in the PAB MOPOP decision and revised Chapters 12 and 13, the PAB decision was probably written Overall the PAB decision conflicted greatly concurrently with, or with knowledge of, with the text of the 2005 version of the revised Chapters 12 and 13. MOPOP. The decision took a very negative view on the patentability of software and This flip-flopping is very troubling, and business methods and moreover suggested clearly shows that the PAB decision was not that this view was rooted in the depths of an isolated incident but rather was a Canadian law. This is quite simply incorrect symptom of a major policy shift that spans and was in direct contrast to the permissive the entire Patent Office. language of the MOPOP in force at that time, which clearly stated that there was no The Federal Court Responds and Soundly authority in the Patent Act or Rules, or in Rejects the Patent Appeal Board Canadian jurisprudence to preclude the patentability of business methods. Perhaps unsurprisingly, Amazon appealed. On October 14, 2010, the Federal Court

35 See for example Decision #1272, Re Application No. 2,298,467 (March 5, 2009) online at: 36 http://brevets-patents.ic.gc.ca/opic- Both available online at: cipo/comdec/eng/decision/1272/sum http://www.ic.gc.ca/eic/site/cipointer mary.html, which upheld claims to a net- computer system used for purchasing internetopic.nsf/eng/h_wr00720.html 37 diamonds. Ibid.

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released a harshly worded decision38 Justice Phelan also unequivocally stated that overturning the PAB and chastising virtually business methods could be patentable, every one of its holdings. Quite bluntly, the explaining that there is an “absolute lack of Federal Court made it clear that software authority in Canada for a ‘business method’ and business methods could be patentable exclusion.” He also clearly took issue with subject matter in Canada. the policy driven nature of the PAB decision, referring to it as a “test case” as The tone of the decision was unbelievably evidenced by “the questionable strong for a Canadian Court. Justice Phelan interpretation of legal authorities in support explained that “the Commissioner’s of the Commissioner’s approach to conclusions [on the question of “form and assessing subject matters[sic].”43 In his substance”] are not supported by Canadian opinion, the “misapprehension of the law,”39 since the Free World decision had Commissioner and the Examiner as to the made it clear that the claims of a patent must patentability of the subject-matter in these be interpreted in a “purposive manner”. claims is a fundamental error of law.”44 Any “form and substance” approach had been explicitly rejected.40 Moreover, the However, in spite of the scathing tone of his Patent Office simply cannot “parse the decision, Justice Phelan refused to order that claims into their ‘novel’ and ‘non-novel’ a patent be granted for the ‘933 Application. components in order to evaluate Instead, he remanded the case back to the patentability” as claimed by the PAB.41 Patent Office for expedited re-examination now that (in his view) the subject-matter The Court then explained that a issue had been resolved. “technological requirement” is not a part of , and moreover that the Commissioner had absolutely no authority The Battle Continues… to introduce such a requirement. In any event, introducing such a “technological” Predictably the Commissioner of Patents requirement would do nothing but render the was not satisfied with Justice Phelan’s Canadian patent system overly restrictive decision and appealed. On March 3, 2011, and confusing, since “[t]echnology is in the Commissioner filed a Memorandum of such a state of flux that to attempt to define Law and Facts setting out the framework for it would serve to defeat the flexibility which the appeal.45 According to the is so crucial to the Act.”42 Memorandum, the PAB’s approach to “parsing” the claims was not inconsistent with the Free World decision, but simply

38 builds on it. In particular, when considering Amazon.com, Inc. v. The A.G. of Canada patentable subject matter, the Court must and the Commissioner of Patents, first identify the “actual invention”. This is 2010 F.C. 1011 (FC Decision). 39 Ibid., para. 43 43 Ibid., para. 78. 40 44 Free World Trust v. Électro Santé Inc., Ibid., para. 81. [2000] 2 S.C.R. 1024 (Free World). 45 41 Available online at: FC Decision, supra at para. 42. http://www.ippractice.ca/files/Amaz 42 Ibid. 71. onAppellantMemo.pdf

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done so that it can be determined whether of over fifty domestic and foreign banks that the invention is a justified exception to the manage close to $3.1 trillion in assets. historical public interest prohibition against monopolies. According to the The CLHIA and CBA argue that the Commissioner, this approach goes beyond outcome of the Amazon appeal will affect the approach to claim construction as not only the ‘933 Application, but many required under Free World for invalidity and more applications in infringement analysis, and in some cases Canada. In their opinion, the net result of the may require further analysis that leads to Amazon decision would be to allow the different “essential elements” being patenting of ideas and mental steps, such as identified. Then, with specific reference to those involved in various financial sectors, the ‘933 Application, the Commissioner and that all aspects of a bank or insurance argues that Amazon’s “actual invention” is company will be affected. In particular, merely a set of instructions by which known CLHIA argues that business method patents elements are used to process pre-existing will create: information. Since these do not result in any physical changes, the claims of the ‘933 “an elaborate thicket of permissions… Application cannot fall within section 2 of whereby each bank and broker, regardless the Patent Act and should be held to be of institution or asset size, would need to unpatentable. negotiate a full portfolio of licenses in order to carry on business, or worse, perhaps would not even be able to obtain such The Financial Institutions Seek Leave to licenses.” Intervene This would lead to increased costs for Shortly after the Commissioner’s consumers and erect barriers to entry, Memorandum was submitted, the Canadian stiffing competition and negatively Life and Health Insurance Association Inc. impacting the financial services that would ("CLHIA") and the Canadian Bankers be available across the country. Association ("CBA") submitted a request to be granted intervener status in the appeal.46 Both the CLHIA and CBA are actively Both parties represent financial intuitions, involved in government lobbying, and have including a large number of banks and been strongly advocating against business insurance companies both in Canada and method patents since at least early 2008. abroad. In particular, the CLHIA was Conveniently enough, this was around the established in 1894 as a voluntary trade same time that the PAB decided to hold its organization and represents the collective second hearing in the Amazon case and interests of nearly all life and health insurers begin revising the MOPOP. It appears across Canada, with total assets of over $475 therefore that their lobbying efforts have billion. The CBA similarly works on behalf borne fruit.

46 Available online at: http://www.ippractice.ca/files/Amaz onInterventionByCLHIAandCBA.pd f

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Navigating the Subject Matter Waters During the Ongoing Battle

At the time of writing, Amazon.com has just responded to the Commissioner’s Memorandum, however it will be many months before a hearing is held and even more before a decision is rendered. Moreover, many predict this dispute to end with an appeal to the Supreme Court of Canada, which means that a final resolution to the question of patentable subject matter in Canada is likely several years away.

It is now clear that companies around the world are watching this case closely, particularly by financial intuitions and software companies with an interest in Canada, as the outcome is likely to have a significant impact on the landscape of patentable subject matter. In the meantime, patent applications continue to be filed and prosecuted and Canadian patent agents work and develop new strategies and techniques for obtaining broad patent protection. While challenging, progress continues to be made and sophisticated applicants should consider speaking with experienced Canadian patent agents to seek advice on how to successfully obtain protection for their software and business method innovations in Canada.

As an interesting side note, the current Commissioner of Patents, Mary Carman, will be replaced on April 15, 2011 by Sylvain Laporte. Some speculate this may signal a shift in Patent Office policy, including the Office’s approach to patentable subject matter, but only time will tell.

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The following are some of the changes AUSTRALIA INTELLECTUAL proposed in the Bill: PROPERTY LAWS AMENDMENT (RAISING THE BAR) DRAFT BILL Inventive Step 2011 The current Australian Patents Act 1990 Michael Houlihan requires that the invention is assessed by the Houlihan2 Patent & Trade Mark Attorneys person skilled in the art in light of the Melbourne, Australia common general knowledge in Australia. The Bill proposes to remove this territorial The Australian Government has unveiled its limitation. This will allow experts from any Intellectual Property Laws Amendment jurisdiction to provide evidence on the (Raising the Bar) Draft Bill 2011 (“the common general knowledge of an invention Bill”) for public comment. The deadline for as at the priority date of the claim. the responses ends on 4 April 2011. The purpose of the Bill and the intended Coupled with the international view on amendments to the current Patents Act “common general knowledge”, the present which may flow therefrom is to improve three (3) part test that the information under Australian Patent Law to be more in tune consideration by the person skilled in the art with that of our major trading partners. in assessing the patentability of the invention must have been 1. Ascertained, 2. It is the hope of any resultant changes that Understood and 3. Regarded as relevant, is the validity of any granted Patent will be to be removed. That said, information which stronger because of expanded grounds of the skilled addressee would not have objection being available to the Patent appreciated as being relevant would be Examiner, the resolution of Patent excluded under the new test. Applications will be quicker and that genuine research and experimentation of a Formal Introduction of an Enabling Patent will not be stifled. Requirement and the Need to Describe the Invention Fully Normally, Transitional Provisions operate to exempt pending Patent Applications from There is no requirement under the current the impact of any new laws introduced after Australian Patents Act to describe the their filing date. Not so, with the present invention fully in the basic Application Draft Bill. A potential major downside is the (only the nature of the invention has to be proposal that the below new described). However, many of our trading standards/requirements on inventive step, partners require an enabling disclosure to be utility, support and sufficiency will apply to present in the basic Application. Given that all pending Applications for which an an Australian basic Application (or as it is Examination Report has not yet issued. known in Australia, a Provisional Therefore, the goalposts may be shifted Application) is usually relied upon to justify while the “game is in progress” and a priority claim in an Australian PCT Applicants cannot control whether an Application or an overseas convention Examiner’s Report will issue on their cases Application, Australian practitioners prepare before the new rules apply. their basic/Provisional Applications with the foreign enabling disclosure requirement in

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mind. However, the draft Bill wants to documents and acts and thus any prior use of ensure that any basic or Provisional the invention anywhere in the world. Application contains a comprehensive The present “Grace Period” provisions of enabling disclosure regardless of whether it the Australian Patents Act will be altered to is to be relied upon in Australia or in an also cover secret use. overseas jurisdiction or not. Utility/Usefulness – Specific, Substantial As a corollary thereto, the complete and Credible specification will be required to provide sufficient information to enable the claimed Utility or usefulness will be another new invention to be produced across the full strike weapon for the Examiner. The present scope of each claim. The “best method definition of “useful” is proposed to be known to the Applicant of performing the replaced by the need that the specification invention” requirement remains intact. discloses a “specific, substantial and credible” use for the claimed invention. The Since these are already standards that have change is to reflect the meaning of to be met by most foreign originating Patent “usefulness” as given by the U.S. Courts and specifications, we do not see that overseas the USPTO. practitioners have to alter their drafting techniques in the preparation of basic Modified Examination is OUT for the Applications. Count

Fair Basis Requirement Modified to a Australia currently provides the Patent “Support” Requirement Applicant with a choice of two (2) Examination Routes. Normal Examination, The expression “Fair Basis” as used in which is self explanatory and the one most Australia is proposed to be amended to a favoured by Applicants. The other less often “support” requirement. This also follows on elected option of Modified Examination, from the enabling requirement discussed wherein the Australian specification must be above, since the present concept of “Fair brought into substantial word-for-word Basis” does not require a degree of conformity (save for a few minor enablement. The new “support” formalities) with a corresponding granted requirement seeks to encompass that there overseas Patent which had issued from must be basis in the description for each prescribed country. claim and that the scope of the claims must If an Applicant was to elect Modified not be broader than is justified by the extent Examination, Australian practitioners would of description, drawings and contribution in generally counsel otherwise. It seems that the art. our prayers will be answered by the Draft Again, we find that for overseas Bill in that the Modified Examination option practitioners their specifications already will be removed. comply with such a proposed new standard. Whole of Contents Considerations Prior Use considered during Examination The requirements for a Whole of Contents Examiners will be permitted to consider all novelty objection to hold are being publicly available information, including simplified, wherein the relevant information

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only now needs to have appeared at filing in Re-Examination considerations the cited earlier Patent specification. It was Expanded previously also required to have appeared in the cited Patent specification on its The Bill introduces all grounds for attacking publication. the patentability of an invention which are available to the Patent Examiner can be used Amendments during re-examination by a third party. Currently, only novelty and inventive step of Amendments which attempt to expand the the invention can be contested at the re- disclosure or claim matter beyond that examination stage. which appeared in the specification at filing will not be permitted. Amendments to Again, the burden of proof test will be correct a clerical error or obvious mistake altered to be determined on the “balance of will still be allowed. probabilities”.

Standard of proof for Acceptance Therefore, there is now to be alignment/consistency of the burden of The current practice calls for the Patent proof and also the grounds of invalidity on Examiner to accept a Patent Application which the invention whether it is covered in “unless it appears practically certain” that a granted Patent or still in a pending Patent the Patent, if granted, would be invalid. The Application. Bill recommends a new and lower standard of on the “balance of probabilities”, which Research and Experimental Activities test already applies during litigation of a Exempt from Infringement Patent. Infringement exemption provisions have Divisional Patent Applications been provided for genuine research and experimental activities. Divisional Applications will no longer be permitted to be filed during the post-grant The Draft Bill includes a list of activities Opposition period of an Application. that are deemed to be experimental. The list Divisional Applications or the conversion of is not exhaustive. The exemption is not a standard Patent Application to be a intended to apply where the main purpose is divisional must take place within three (3) to commercialise the invention or months of the date of advertisement of manufacture the invention for the purpose of acceptance of the parent case. sale or use for commercial purpose. Market research of a patented invention by making It is believed by stopping the filing of and using the invention to ascertain whether Divisionals during a pre-grant opposition there exists and the level of commercial that this will lead to a speedier resolution of demand for it would be an infringement. Patent Applications. Spring-boarding Provisions to be Expanded and are Exempt from Infringement

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The Bill expands the current spring- certainty for the Patentee in the validity of boarding provisions (presently limited to any granted Australian Patent. pharmaceutical Patents) to include inventions in all fields of technology for the It is however disappointing to see that there purpose of gaining regulatory approval as has been no real effort made to align the not constituting an infringement of the Patent laws of both Australia and New Patent. Zealand (there is also a Bill being pending in New Zealand), since the two countries Gene Technology announced in February 2011 their joint intention to have a single examination Gene-specific technologies are not dealt process for both countries. with in the Draft Bill. Gene-specific issues are currently being considered separately by the Senate Legal and Constitutional Affairs Legislation Committee and by the Government.

Formality Matters

It is proposed that Patents will no longer be deemed invalid merely because the Patent was granted to a “person” who was not entitled to it. This has been a favoured ground of attack in pre-grant oppositions.

An opposed Patent Application will only be permitted to be withdrawn with the Commissioner’s consent.

At last, the Commissioner will be allowed to revoke the acceptance of a standard Patent Application, if it is reasonable to do so in all the circumstances. It is contemplated such power would be used where an administrative error has occurred during the process of accepting an Application.

Final Verdict

We consider that the Draft Bill improves many aspects of the current Act and will make the Australian Patent System stronger. In addition, the Australian Patents Act will be more harmonious with our major trading partners, which brings with it better

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Patent Protection in India EIL currently employs 3500 employees and Enercon Indian Patent Invalidation has about $550 million in revenue. EIL was established 1995, but in 2005 a dispute arose Daniel Staudt between the two parent companies. In this Siemens Corporation dispute Enercon GmbH filed a complaint Iselin, New Jersey against the EIL management for mismanagement of the EIL joint venture. An interim injunction was granted in Oct 2007 effectively limiting the authority of the EIL management to only perform day-to-day operations. Although 2 years past, it appears that in retaliation of this injunction by the German company, in January 2009 EIL filed a petition for revocation of 19 Indian patents of Enercon GmbH, that were actually used by the joint venture. (nothing like having your joint venture company try to invalidate your own patents. That’s Gutsy!) The results of this, as mentioned, was the Indian Intellectual Property Appellate Board (IPAB) revoking 12 of the patents. The patents were invalidated mostly based on obviousness type rejections. Currently the other 7 of the 19 patent Late last fall, the Indian IP Appellate Board invalidity actions are still pending for a revoked 12 Indian patents of Enercon decision from the IPAB. As would be GmbH, a German wind power company. As expected, Enercon GmbH appealed the 12 the need to dramatize is always found by the decisions of the IPAB to the High Court in news media worldwide, the German New Delhi. Oral arguments have already newspapers drafted articles raising concerns been held but no decision from the court has about possible corruption and a biased been announced. decision from the Indian appellate board for “national interest”, since these patents cover Once the decision on the invalidity of these technology that can be used in the 12 patents was published by the IPAB the installation and operation of wind turbines in headlines that appeared in the German India. Enercon was viewed by the German Newspaper “Handelsblatt” on January 25, news media as being targets to allow such 2011 read; technology to be used more freely in India without restrictions due to the energy needs ”Patents Gone with the Wind” "…. This of India. court [IPAB] declared the patent during the proceedings, India, national interest was' to Enercon India Ltd. (EIL), the company who evaluate higher than the rights of a company brought the invalidity action, is a joint on its technology. The background to this venture of Enercon GmbH (56% share) and argument: The wind power plays in meeting the Indian Mehra Group (44% share). future energy needs of India's important role. "

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come out with more such On February 2nd 2011 another German technologies, which are useful newspaper, “Faz Net” wrote “Coldblooded to the society. But the patent Outser from India” “ …the line of system is designed to strike a argument adopted by the patent Judge in the proper balance between the EIL case nevertheless makes one sit up and inventor's interest and the take note: India’s national interest should be public interest. ….. 26. In view placed higher than the rights of any of the above findings we also individual company to its technology. “With feel and are of the opinion, that this justification, almost every patent could to avoid delay […], this matter be annulled in future in the name of the shall be disposed of along with development interests of India”, is what all the other points in the main Enercon is saying.” The general conclusions matter when all the ORA's are of these articles ware that there seems to be being heard immediately, […], a case of self-serving logic here, with so as to have speedier justice in government sanction. Of course this got the the matter, such that these attention of many major European alternate sources of production companies including Siemens who has its of electrical energy can be own wind power business and is also well tapped and utilized for the know in the Indian market for many betterment of society and the products. public at large, either by way of upholding the patent grant We wanted to determine if the newspapers or in the alternative, throwing were correct in their own analysis of the open the same technology to situation so we embarked on our own the concerned industries to investigation of these actions to either utilize the same in an confirm that this may be a concern for expeditious and benevolent foreign companies who are doing business manner for the benefit of the in India operating under the assumption that industry and the public as well they are protected by having Indian patents as the nation." interim order or was this just the news media making 166-2010 of IPAB from 27th news on its own again. July 2010)

Here is what we found out: We did some investigating on the foreign counterparts for these invalidated patents The order itself invalidating these and found the following: patents states that; 14. […] This is a case of . Several of corresponding EP invention dealing with the wind patents have been revoked in power mills technology. The oppositions at the EPO. invention in this field are very . much needed for the society, . Two of the EP patents were […] Every such technology unenforceable in UK because of needs to be protected and such prior art. protection kindles the fuel of . interest in the inventor so as to

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. A review of one of the orders patents for which such license (for IN202947) found significant could be requested. weaknesses in the patent. . The absence of case law can also be seen as an opportunity to be Thus, at least the decision to revoke the actively involved in creating patent by the IPAB is not obviously wrong jurisprudence in our favor. and does have some merit. We did find out that there have been some patent cases in the With all this said it remains difficult to past where there was some corruption at determine if there really is any merit to the Indian courts. However, in this case it German news media’s conclusion on appears there is no evidence of corruption national protectionism by India and one can and there are some facts supporting the draw a conclusion for either side. One thing invalidity of the patents. Also, we must keep for certain is that when dealing with any in mind that if the patents are valid then the emerging market that has not dealt high court will likely overrule the decisions. consistently in the past or is just developing We will have to wait for the decision. legal precedence, on IP matters, one can never be sure of the outcome, or real The news media in Germany may also be protection, that they can count on from the part of Enercon’s campaign to increase patents they have in these emerging markets. political pressure from German authorities towards India. Another interesting fact is that this case was a hot topic at the IP conference in New Delhi, on March 10th & 11th 2011, which had high ranking Indian and German officials as participants.

Some other considerations of India’s patent system should also be noted to understand some of the background for these cases, including:

. Indian patent act has a long history and was made TRIPS conforming in 2005. . There is not much case law and practical experience with enforceability of patents in India. . There is more experience with trademarks and decisions are made without much delay (recent Siemens case: ex-parte injunction within a few weeks). . The Chief litigator of Roche in India has stated that compulsory license has not been relevant until now, although Roche has

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EPO PETITIONs FOR REVIEW Examining Divisions, the Opposition Divisions, and the Legal Division form the Hans Prins European Patent Office (EPO) . An appeal Bird & Bird may only be filed by a party that is London, England adversely affected by a decision

I. Introduction Approximately 2000 appeals are filed annually. These appeals are distributed One of the changes in the renewed European among the 26 Technical Boards and the Patent Convention (also known as the Legal Board. 1600 decisions are rendered EPC2000) was the introduction of a review each year, which occur – usually – at the end procedure for decisions of its Boards of of Oral Proceedings that are held before the Appeal by the Enlarged Board of Appeal Board. The written decision follows at a (EBA). This review procedure was adopted later stage. as the Petition for review and codified as article 112(a) in the EPC2000,. Both the EPC, and the Rules of Procedure of the Boards of Appeal (RPBA) specify The wording of article 112(a) implies that principles in order to organize the appeal only fundamental procedural defects can process that envisions procedural form a basis for review. Only intolerable expediency while ensuring legitimate deficiencies occurring during the appeal expectations of the involved parties. Those procedure may be reviewed. It is neither principles are: intended to extend the appeal procedure nor to ensure uniform application of the law by 1. The right to be heard: A decision may the Boards of Appeal. only be based on grounds or evidence on which the parties have had an Since the EPC2000 became effective on 13 opportunity to comment (art 113(1) December 2007, more than 40 petitions have EPC); been reviewed. Merely in one case the petition was successful and consequently the 2. The restriction to the submitted request decision of the Board of Appeal was set (such as the claims): the request is either aside and the appeal procedure reopened. acceptable or not acceptable (art 113(2) EPC); and The evident message is that this petition for review procedure is not a strategy for 3. Time limits and form of the appeal (art success. This article reviews decisions of 108 EPC); the full scope of the appeal such petitions by the EBA in order to must be presented in the grounds of identify relevant factors, and particularly appeal submitted within 2 months of the failures. filing of the appeal (or in the respondent’s first reply) (art 12 RPBA). Any later submission may be rejected as II. The Boards of Appeal within the EPO late-filed, unless it is a response to the other party or an opinion of the Board According to Art. 21 (2) EPC2000, the (art 13 RPBA). Boards of Appeal are hearing appeals from decisions of the Receiving Section, the

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4. In case of oral proceedings, the (e)), but not later than 5 years for the Chairman of the Board shall state the notification of the decision. final requests of the parties and declare the debate closed prior to taking and The petition fee is high, i.e. €2625, and is announcing the decision. The board will only refunded when the petition is accepted. ensure that a case is ready for decision at the conclusion of the oral proceedings The petition is admissible only if the (art 15 RPBA). procedural defect was objected by the party during the appeal procedure and rejected by 5. Minutes of Oral Proceedings will be the board unless, such objection could not be drawn up, containing the essentials of raised during the appeal procedure, e.g. the the oral proceedings, including any defect occurs when the decision is relevant statement made by the parties announced at the end of the procedure or (R 124(1) EPC). occurs in the written decision.

It is the objective that the Boards apply the Statistics law in a harmonized manner. In case of conflicting decisions of Boards and for To date 55 petitions have been filed since 13 important points of law referral may be December 2007. 42 petitions have been made by a Board of Appeal to the EBA. examined and decided. 1 petition (R7/09) The average number of decisions rendered has been accepted and is presently under by the EBA per year is between zero and review. Of the 42 concluded cases, 36 three. Currently, two referrals to the EBA petitions related to appeals in opposition are pending. The EBA has been made proceedings; the other 6 petitions related to responsible for examining Petitions for appeals in the examination proceedings. review. Presently, 13 petitions are pending (http://www.epo.org/law-practice/case-law- III. Petitions for review procedure appeals/eba/pending-petitions.html).

Article 112a(2) EPC2000, defines the five The ground (c) in relation to the types of acceptable grounds on which a fundamental violation of Article 113, in Petition for review can be based. These particular the right to be heard, is most grounds include: (a) a member of the Board frequently developed in the petitions. In took part in the appeal decision, (b) the relation to the ground (d), i.e., any other Board included a member not appointed as a fundamental procedural defect, petitioners member of the Boards of Appeal, (c) do not always take account the limitations fundamental violation of article 113 EPC, set by Rule104. These limitations are failure (d) any other fundamental procedural to hold requested oral proceedings and not defects, and (e) a criminal act may have had deciding on a party request. impact on the decision. Concluded review cases did not relate to The petition is to be filed within 2 months ground (b) on a non- appointed member of from the notification of the decision for the Board of Appeal, and not to ground (e) grounds (a) to (d), and 2 months form on criminal act. establishment of the criminal act (ground

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Table 1: Summary of concluded petitions for review divided by the petition ground pursuant article 112aEPC, in relation to ground (6) a subdivision was made; some petitions were based on more than one ground (a) (b) (c) (d) (d) (e)

Subject partiality or Non- Fundamental no decision Other Criminal exclusion of a appointed violation of not was made on defect act Board board being heard relevant member member request

Occurrence 2 0 32 9 8 0 in petitions

Ground for the decision on the petition for review

Most petitions are dismissed as being Inadmissibility most frequently resulted “clearly unallowable”. The decision usually from the fact that the petitioner has not made appears to use the expression “clearly the objection during Oral Proceedings unallowable”, in order to emphasize that the and/or that the minutes of the oral case for the petition was evidently not proceedings did provide no evidence for the complying with the requirements. alleged defect.

Table 2: Outcome of petitions for review

Outcome Nr of Comments petitions Allowable 1 Party was not properly informed of the Board and was taken by surprise by the decision without having the chance to comment on the appeal filed Clearly 9 Petition not properly filed (fee paid too late etc), or no inadmissible objection made during Oral Proceedings or not in minutes Clearly 26 Material issue and/or no violation found or no causal effect unallowable between violation and decision Withdrawn 6 Typically after a negative opinion of the Enlarged Board

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IV. Discussion: relevance of Oral The Enlarged Board attributes the full Proceedings responsibility (for the alleged procedural violation) to the party and its representative. As stated above, most Petitions for review It is moreover expressed that there is no resulted from appeals in opposition right for the parties to be informed, in proceedings in which generally oral advance, of the reasoning that the Board will proceedings have been held. The conduct in adopt ultimately in the written decision. oral proceedings appears to be very relevant Oral Proceedings give the parties the in relation to possible procedural violations. possibility to take a position on the facts and Here, the parties – and particularly their the decisive arguments, but nothing more representatives – bear the primary than that. Furthermore, a Board will not responsibility. Many decisions concluded generally provide guidance as to requests a that no review of the appeal procedure was party is to present. considered necessary in view of one of following reasons: Conduct for the party

i. the party involved did not object Apparently, there is a need for the party to against the procedural violation be prepared for oral proceedings and an during oral proceedings when understanding what to expect during oral possible. Consequently, the proceedings. It is not surprising that the violation was not entered into the EPO looks here to the party (and the party minutes of the appeal patent attorney) first. A good understanding proceedings as an essential of the RBPA is highy relevant. Generally, a statement, and hence there is a patent attorney attends a few oral lack of basis for a Petition of proceedings per year, whereas a Board of review; Appeal renders on average 60 decisions, probably on the basis of a similar number of ii. the party involved had the oral proceedings. Hence, a patent attorney opportunity to giving its appears less experienced and might not arguments to support a request or oversee during the appeal procedure and in even file a new request, but did particular during oral proceedings formal not do so (at least did not identify and procedural requirements and pitfalls, the request that could have saved such as to oversee an (ultimate) opportunity its patent), thus the decision was to present his case or file a request. delivered on a party request; Thus, in order to be avoid the occurrence of iii. there is no procedural violation, but a defect forming a sound ground for ultimate the party involved is not satisfied review, or when such defect occurs, it is of with the decision or the eminent importance that the party brings arguments therein of the board of such occurrence immediately to the attention appeal of the Board of Appeal, When rejected by the Board, the party should request that the A regular complaint formulated in petitions rejection is entered into the minutes of the is an alleged surprise that the oral proceedings. Operating this way, such defect proceedings have been closed and the may form a sound basis for review. decision rendered earlier than expected. Obviously, defects in the oral or written

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decision by the Board are beyond the control of a party to the proceedings.

V. Conclusion

Yearly, about 1600 decisions are delivered by the Boards of Appeal. Not more than 55 petitions for review have been filed over the past 3.5 years. The number of petitions thus represents a low percentage. Apparently, the frequency of fundamental procedural defects in appeal decisions is low. Although, the low chance of success and the high burden of proof may have be factors which establish a high barrier of entry.

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RECENT DEVELOPMENTS IN THE provides for the EU to set up an EU patent QUEST FOR AN EU PATENT by use of normal legislative means (which require a qualified majority of the member John Richards states to agree), however the language Ladas & Parry LLP regime for such a patent would require New York, NY unanimous agreement of the member states.

March has seen two significant In 1975 the Community Patent Convention developments in the long-running saga of was signed by the then member states of the creating a unitary patent system for Europe European Community to create a unitary as opposed to the current system governed right and define the rights given by a patent. by the European patent Convention (a stand It was revised twice to meet criticisms of the alone treaty open to all countries in Europe original text but never came into effect. In irrespective of whether they are members of 2000, efforts where the European the European Union) in which a “European Commission proposed a regulation to bring Patent” issued by the European Patent this about has suffered a decade of Office breaks down into a bundle of national frustration for its efforts. rights enforceable by national laws after grant. On March 8, the Court of Justice of The Commission proposals for reform of the the European Union gave its opinion on European Patent System were based on the whether proposals for a European Patent idea that the European Union could itself Court system complied with the EU’s basic join the EPC by the European Union as a treaties. On Mach 10 the Council of the combined entity for which a single patent (to European Union endorsed a plan for 25 of be called a Community Patent) might be the 27 members of the European Union to granted.1 Such a patent would exist in the create a single multinational patent right for one language in which the application had themselves. been prosecuted (i.e. English French or German) except for the claims which would The idea of a single multinational patent for have to be in English, French and German. at least part of Europe has been under Additionally, the Commission proposed that consideration since proposals for Common a new court system be set up to have Market Patent were first developed in the jurisdiction over all patent disputes 1960s. However, two issues have bedeviled throughout Europe. These proposals all attempts to accomplish this objective: 1) evolved only slowly due to political the issue of language and 2) the question of difficulties. A common political position how to handle litigation relating to a was adopted at the EU Competitiveness community wide patent. On the first some countries have felt very strongly that any 1COM(2000)412 final issued on patent enforceable in their country had to be August 1, 2000. In addition to the in their language. On the second industry proposals noted above, the has been fearful about giving national courts Commission’s proposal includes a with little experience in patent matters the definition of infringement of a power to invalidate a patent across the Community Patent which is essentially whole of Europe. Feelings on the first were the same as that on the 1975 sufficiently strong that the most recent EU Community Patent Convention noted above. structural treaty, the Treaty of Lisbon

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Council meeting of March 7, 2003.2 The for declaration of lapse, including requests major features were as follows: for provisional measures.” Appeals from the Community would lie to 1) Community patents would be granted by the General Court (formerly known as Court the European Patent Office with pre-grant of First Instance) of the European procedure essentially the same as at present. Communities. The Community Patent Court Within a reasonable time after grant, would sit in panels of three judges and be however, translations of the granted claims assisted by technical experts. into a language of each EU state requiring such a translation would have been required Significant parts of industry said they would not use such a system. 2) The European Patent Office would have been be required to allow applicants having Revised drafts of a Regulation to a national language other than English, implement the Common Political Approach French and German to have the preliminary were issued in the summer of 2003.3 A steps prior to examination (including number of interesting issues emerged from searches in non-EPO official languages) the drafts, for example a provision for the carried out in a national patent office acting grant of compulsory cross licenses if on behalf of the EPO. The EPO may also exploitation of a later patent for “an have national patent offices that function in important technical advance of considerable English, French or German, carry out economic significance in relation to the searching on its behalf. invention claimed in” and earlier patent is blocked by that patent.4 Another was a 3) Renewal of Community Patents would be possible expansion of the definition of effected by fees paid directly to the EPO, infringement to cover acts carried out in the with the level of such fees being set at no EU to assist in carrying out the patented more than the “average” cost of renewing invention outside the EU,5 a broadening of European patents under the present system.

3 It appears that adoption of the 4) A unitary Court for the Community regulation is contemplated as being Patent would have been set up in carried out under Article 308 of the Luxembourg, although it will be empowered EC Treaty rather than the more to hold hearings in other Member States. usual route under Article 251. This court wold have exclusive jurisdiction Proceeding under Article 308 in “actions and claims of invalidity or reduces the involvement of the infringement proceedings of actions for a European Parliament in adopting declaration of non-infringement, of the legislation but does require proceedings relating to the use of the patent unanimity in the Council. or on the right based on prior use of the patent or requests for limitation, 4Draft Regulation Article 21. counterclaims for invalidity or applications The language seems to be TRIPS- compliant. TRIPS adopted such 2Available on line at language to try to reduce the old http://register.consilium.eu.int/pdf/en/0 “patent-flooding” problems in 3/st07/st07159en03.pdf Japan 5Draft Regulation Article 8 Page 41

the exemptions from to precautionary step of submitting its cover acts authorized by certain other EU proposals for a patent court system to the regulations and directives6 and introduction Court of Justice of the European Union for of a statute of limitation for starting a patent an opinion as to whether the proposals infringement action of ten years from the complied with the basic treaties governing infringement subject to a requirement that the European Union. the action must be brought within five years of the date on which the patent owner knew By December 2010 it became clear or should have known of the infringement.7 that it was highly unlikely that Spain and Italy would agree to the Commission’s proposals on the translation requirements At the March 2004 meeting of the and 12 European countries requested EU’s Competitiveness Council there were permission to work towards a single patent signs that adoption of the regulation might covering all of them under the EU’s not be proceeding smoothly when disputes enhanced cooperation procedure rather than arose as to how to deal with errors in waiting for the political problems relating to translation of claims that were found to have a single patent for the whole EU to be occurred when a patent came to be litigated. resolved. Since then all other EU member These differences widened at the May 2004 states except Spain and Italy have joined this meeting. request.

Following a review of the situation Enhanced cooperation procedures in 2006, the Commission indicated that it have been available in the EU since 1999 would make one final effort to secure and subject to certain requirements provide a agreement for a Community Patent mechanism to permit groups of at least nine regulation, this time with reduced translation countries within the EU to cooperate more requirements and a litigation system having extensively than is required under the EU regional courts of first instance for patent treaties themselves. The only previous use infringement and validity trials but a of the procedure so far has been in the field common court of appeal for the entire EU.8 of divorce law to try to settle issues of Further attempts to resolve the differences jurisdiction in divorce proceedings of between the member states continued and transnational EU couples. the European Commission took the In order for enhanced cooperation to

6 be permitted all of the Commission, the Draft Regulation Article 9 7 European Parliament and the Council must Draft Regulation Article 45 8 agree. The March agreement by the Council See the European was the final agreement required. The Commission’s publication Commission at the request of the original “Enhancing the Patent System in twelve countries seeking enhanced Europe” COM (2007) 29-03-07 cooperation published its proposal for available on-line at enhanced cooperation in December, and http://documents.epo.org/projects/b Parliament approved the enhanced abylon/eponet.nsf/0/028A3690A78 cooperation route on February 15. A516FC12572C6003F5A7B/$File/

communication_en.pdf

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The main provisions of the proposal9 (2) A proposal for a Council Regulation on are as follows: the translation arrangements for the unitary patent. This would include the following (1) A proposal for a Regulation of the European Parliament and the Council – It is envisaged that the specification of the creating unitary patent be published by the EPO in unitary patent protection. This would accordance with Article 14(6) EPC. Without provide that prejudice to any transitional arrangements deemed necessary, no further translations – The unitary patent protection should be would be required. Any additional optional to the users of the patent system translation requirements under such and should co-exist with national and transitional arrangements would be European patents. The unitary patent should proportionate and required only on a be a specific category of a European patent, temporary basis and not have legal value granted by the European Patent Office, thus ensuring legal certainty for the users of designating the Member States participating the patent system. In any case, transitional in enhanced cooperation on unitary basis. arrangements would terminate when high quality machine translations are made – Consequently, a single procedure in available, subject to an objective evaluation accordance with the EPC would apply to of the quality.47 unitary patents and to all other European patents. Until the moment of grant, – Translations should not have legal value applicants would have the choice between thus ensuring legal certainty for the users of (i) a European patent valid in the territories the patent system of the participating Member States for which this patent would have unitary character, (ii) – In case of a dispute relating to a unitary a European patent valid in the territories of patent, a full manual translation of the patent the participating Member States for which specification would have to be provided by this patent would have unitary character but the patent proprietor at his expense: also designating selected other Contracting (a) into an official language of the Member States of the EPC, or (iii) a European patent State in which either the alleged designating only selected Contracting States infringement took place or in which the of the EPC. alleged infringer is domiciled (at the choice of the alleged infringer); and – The unitary patent should be of autonomous nature and provide equal protection throughout the territories of the 47 On March 24, 2011, the European Patent participating Member States. It may only be Office announced that it had made an granted, transferred, revoked or may lapse in agreement with Google to use respect of those territories as a whole. Google Translate technology European Patents into into 28 European languages, as well as into Chinese, Japanese, Korean and

9 Russian.. It is hoped that the project See COM (2010) 790 final will be completed by the end of dated December 14, 2010 2014.

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(b) into the language of proceedings of the On the question of the proposed patent court court hearing the dispute (at the request of system. The Court of Justice held that as the court). they stood, the proposals were not in compliance with the EU treaties. The – A scheme for compensating the costs of Commission’s proposal is for a Patent Court translating patent applications filed in an open to all members of the European Patent official language of the Union into an Convention and having a court of first official language of the EPO at the instance, comprising a central division and beginning of the procedure for applicants local and regional divisions, and a court of based in the Member States which have an appeal, that court having jurisdiction to hear official language other than one of the appeals brought against decisions delivered official languages of the EPO, should be set by the court of first instance. A third body of up in addition to what is currently in place the Patent Court would be a joint registry. for other European patents, including The proposal specifically permits the first financial and technical assistance for instance patent court to refer any question of preparing those translations. EU law to the Court of Justice of the European Union and requires that the Patent In its statement approving the adoption of Appeal Court refers any such question to the enhanced cooperation, the Council noted Court of Justice of the European Union. that the requirements of Article 20 of the These provisions are analogous to those Treaty on European Union and Articles 326 which apply generally to national courts. to 334 of the Treaty on Functioning of the European Union in that Enhanced The Court of Justice held, however, Cooperation had only been adopted as a last that there was an important difference resort after attempts to deal with the issue on between its relations with national courts an EU-wide basis had failed, that the legal and its relation with the proposed Patent area in question was not one in which the Court system in that whereas it was possible EU had exclusive competence, that the to take action against countries or national proposal furthered the objectives of the EU courts that did not follow the rulings of the by fostering the internal market and Court of Justice of the European Union, no promoting scientific and technological such remedies would be available against advance andwas not discriminatory against the proposed Patent Court. Furthermore by members of the EU not participating in the removing jurisdiction over patent matters cooperation and did not distort competition. from national courts, the proposed agreement would deprive the national courts It will now be for the Commission to of their right to refer questions of EU law in produce drafts of the two regulations that fields within the jurisdiction of the Patent have been proposed. These will probably Court to the Court of Justice for a include features relating to the nature of preliminary opinion. The Court of Justice patent infringement, exceptions from patent therefore concluded that, as proposed at infringement and other “property law” present, aspects of patents as set out in the Community Patent Convention and the the envisaged agreement, by conferring on subsequent proposed regulations. an international court which is outside the institutional and judicial framework of the European Union an exclusive jurisdiction to

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hear a significant number of actions brought by individuals in the field of the Community patent and to interpret and apply European Union law in that field, would deprive courts of Member States of their powers in relation to the interpretation and application of European Union law and the Court of its powers to reply, by preliminary ruling, to questions referred by those courts and, consequently, would alter the essential character of the powers which the Treaties confer on the institutions of the European Union and on the Member States and which are indispensable to the preservation of the very nature of European Union law.

Consequently, the proposal is not compatible with the basic governing treaties of the European Union. The Commission has stated that it will analyze the Court’s decision “very carefully with a view to identifying appropriate solutions”.

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