Thomas J. Kowalski Dominating global intellectual is a partner in the New York office of Frommer Lawrence & Haug LLP. property: Overview of Antonio Maschio, PhD is a partner in the in the USA, Southampton, UK, office of D. Young & Co. Samuel H. Megerditchian Europe and is an associate in the New York Thomas J. Kowalski, Antonio Maschio and Samuel H. Megerditchian office of Frommer Lawrence & Date received (in revised form): 17th March, 2003 Haug LLP.

Abstract The USA, Europe and Japan dominate . The offices of these three economies issue the vast majority of the world’s and harmonisation has been a key initiative in recent years. Corporate and academic leaders, inventors and practitioners should be aware of the examination practices in all three patent offices. The opinions expressed herein are the personal opinions of the authors, and are not to be considered the opinions of Frommer Lawrence & Haug LLP, D. Young & Co. or any of the firms’ Keywords: USPTO, EPO, JPO, patents, harmonisation, clients. Further, nothing in this paper is to be construed as legal advice, a substitute for legal patentability, trilateral advice, or as positions/strategies etc taken/employed in, or suitable for, any particular case or set of initiative facts.

It is unquestionable that the USA, Europe technologies in the pharmaceutical or and Japan dominate the intellectual biotechnology sectors. property (IP) landscape. Indeed, statistics Therefore, the public has a vested show that the patent offices of these pillars interest in understanding the examination (the United States Patent and practices of all three patent offices. And Office (USPTO), the European Patent although the three systems essentially Office (EPO) and the Japan Patent Office share the same basic rules for patentability, (JPO), respectively) issue nearly 90 per both substantive and procedural cent of the world’s patents.1 differences exist. It is the appreciation of It is not coincidental, however, that the these systems that will enable applicants patent offices of the three most powerful and practitioners to wisely prosecute global economies issue the most patents. patent applications. The consensus among corporate, academic and political leaders throughout OVERVIEW OF the USA, Europe and Japan has long been PATENTABILITY IN THE that IP is an extraordinarily valuable asset: USPTO, EPO AND JPO one that not only significantly affects The dominant policy objective of patent revenue, but also directly influences law, whether in the USA, Europe or shareholder value and academic prestige. Japan, is the balancing of two conflicting

Thomas Kowalski Additionally, since a patent is an equitable interests: rewarding an Frommer Lawrence & Haug LLP, enforceable privilege of limited duration, by granting patent exclusivity while, New York Office, the corporate and academic elite readily simultaneously, stimulating competition 745 Fifth Avenue, New York, NY 10151, USA understands that a well-prosecuted patent in the art in which the patent monopoly portfolio affords considerable strategic falls. The exclusivity enjoyed by the Tel: +1 212 588 0800 Fax: +1 212 588 0500 leverage in the marketplace, especially if patentee acts as a shield against the E-mail: tkowalski@flhlaw.com the patents are directed to pioneering unauthorised making, using or selling of

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the patented for a fixed period The drawings of the design patent of time. Competition, on the other hand, constitute the disclosure. All design is stimulated in two ways: first, by limiting patents have only a single claim which this exclusivity to the four corners of the refers to the drawing. Design patents must patent and, second, by limiting the life of satisfy the statutory requirements of the patent to that fixed term. patentability (35 USC }}112, 102 and In the USA, the USPTO is the 103) and may also be subject to government agency responsible for restriction. The term of a design patent is examining patent applications and issuing 14 years from issue. patents. A patent for an invention is the Plant patents may be granted to anyone grant of a property right to the inventor. who invents or discovers any distinct and The property right is personal, in that the new variety of plants. The plant must be patent can be sold, mortgaged, invented or discovered in a cultivated bequeathed to an heir or assigned from state and asexually reproduced. one owner to another. The right The USA follows the ‘first-to-invent’ conferred by the patent to the owner is system, whereby a patent is awarded to the right to exclude others from making, the first person to invent the subject using, offering for sale, or selling the matter of the . Europe invention in the USA or importing the and Japan, however, follow the ‘first-to- invention into the USA. More file’ system. There, a patent is awarded to specifically, what is granted is not the right the first person to file an application to to make, use, offer for sale, sell or import the patent office, even if the filer is not by the patent owner, but rather the right the first inventor. to exclude others from making, using, The USPTO, EPO and JPO, however, offering for sale, selling or importing the essentially follow similar statutory patent owner’s invention. Once a patent requirements for patentability. To be is issued, the patentee must enforce the patentable, a claim must recite patentable patent without aid of the USPTO. subject matter; be useful; adequately Generally, the term of a new patent is described and enabled in the specification; 20 years from the date on which the clear; and free from the (ie novel application for the patent was filed in the and non-obvious). These requirements USA or, in special cases, from the date an are represented in Table 1. earlier related application was filed, subject to the payment of maintenance Patentable subject matter/ fees. US patents are effective only within statutory invention Patentable subject the USA, its territories, and its In the USA, patentable subject is based on matter possessions. Section 101 of Title 35 of the US Code as Types of US patents There are generally three types of US interpreted by the Federal courts. patents: , design and plant. Utility According to Section 101: ‘To be patents may be granted to anyone who considered patent eligible subject matter invents or discovers any new and useful under 35 U.S.C. }101, the claimed process, machine, article of manufacture, invention must be a process, machine, or compositions of matter, or any new manufacture, or composition of matter useful improvement thereof. A utility that has a practical utility.’ patent covers the way something ‘works’: Thus, subject matter worthy of a patent an apparatus, machine, composition, etc. includes, for example: A design patent, by contrast, protects the exterior appearance of an article of • processes (utility patent); manufacture, ie the way an invention ‘looks’. A picture, a print or an • apparatus (utility patent); impression, however, are not articles of manufacture and, therefore, unpatentable. • articles of manufacture (utility patent);

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Table 1: Applicable sections/articles of respective patent laws

Patentable subject matter/ / Enablement/support/ /inventive step/ statutory invention utility sufficiency/written non-obviousness description and clarity

USPTO 35 USC }101 35 USC }101 35 USC }112, first and second 35 USC }}102,103 paragraphs EPO EPC Art. 52 EPC Art. 57 EPC Arts. 83, 84 EPC Arts 54,56 JPO JPL }2(1) JPL }29 (1) JPL }36 (4) (6) JPL }29(1)(2)

Japanese Patent Law • compositions of matter (utility Sect. 2(1): patent); Definition of Invention (Guidelines Part II,Chap.1, 1.) Patent • new uses of known processes (utility Law Section 2(1) defines a statutory patent); invention as a highly advanced creation of technical ideas utilizing a • ornamental, non-functional designs law of nature. for articles of manufacture (design patent); Utility/industrial applicability • asexually produced plants (plant 35 USC }101 is the statutory basis for the patent); utility requirement in the USPTO:

• biotechnological : eg stem To comply with 35 U.S.C. }101, the cells (utility patent). claimed invention must have at least one specific, substantial, and credible utility that is either asserted in the In the EPO, Article 52 of the EPC specification or is well-established. controls on the issue of patentable subject An invention must be useful, eg it must matter: solve a problem. Indeed, according to the EPC EPC Art.52(1): Supreme Court, ‘a patent is not a hunting European patents shall be granted for license. It is not a reward for the search, any inventions which are susceptible of but compensation for its successful industrial application, which are new conclusion.’2 Although mechanical and and which involve an inventive step. electrical inventions readily satisfy the requirement, pharmaceutical and EPC Art.52(2): biotechnological inventions may pose The following shall not be regarded as difficulties. inventions within the meaning of The requirements for utility and paragraph 1: enablement are closely related. According (a) discoveries, scientific theories and to In re Swartz,3 where the Federal Circuit mathematical methods; held that a claim to cold fusion failed both (b) aesthetic creations; the utility and enablement requirements, (c) schemes, rules and methods for the court explained: performing mental acts, playing games or doing business, and programs for ‘The question of whether a computers; specification provides an enabling (d) presentations of information. disclosure under Section 112, paragraph 1, and whether an In Japan, the JPO defines patentable application satisfies the utility subject matter as follows: requirement of Section 101 are closely

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related.’ In order to be enabling, a the invention is useful based on the patent specification must teach those characteristics of the invention (eg skilled in the art how to make and use properties or applications of a product the full scope of the claimed invention or process), and without undue experimentation. Under Section 101, any patentable • the utility is specific, substantial and invention must be useful and, credible. accordingly, the subject matter of the claim must be operable. As a result, if In other words: the claims in a patent application fail to meet the utility requirement because • Specific utility: specific utility for the they are either not useful or claimed invention. inoperative, they will also fail to meet the enablement requirement.4 • Substantial utility: utility that has real world value. The utility requirement finds support in both 35 USC }}101 and 112: • Credible utility: Would an artisan accept that the disclosed invention is An invention must be • 35 USC 101: ‘Whoever invents or in currently available form? Lack of useful discovers any new and useful process, credible utility normally arises where machine, manufacture, or the invention is inoperative or would composition of matter, or any new not be expected to function in the and useful improvement thereof, may disclosed manner based upon current obtain a patent therefor’. scientific understanding.

• 35 USC 112: ‘The specification shall Using a specific example, assume a contain a written description of the claim to ‘An isolated nucleic acid invention, and of the manner and comprising SEQ ID No. 1’ where process of making and using it, in such full, clear, concise, and exact terms as • the nucleic acid does not encode an to enable any person skilled in the art identified protein, and no particular to which it pertains, or with which it target of diagnostic relevance is is most nearly connected, to make and disclosed (‘1st generation expressed use the same, and shall set forth the sequence tag, EST’), or best mode contemplated by the inventor of carrying out his • the nucleic acid encodes a protein invention.’ whose function is inferred by homology (‘2nd generation EST’, and Utility Examination The USPTO, in an effort to better either assignment of function is Guidelines quantify the utility requirement, rebuttable or assignment of function published its Utility Examination lacks sufficient specificity to establish a Guidelines at 66 FR 109 (5th January, specific, substantial, substantial, 2001); 1242 OG 162 (30th January, credible utility (eg assignment as ‘IL 2001). The PTO presents a three-prong receptor’ would not be sufficient). test: specific, substantial and credible utility must be asserted in the Such a claim may not comply with the specification. More specifically, according utility requirement. to the USPTO, an invention has a well- Assume further a claim to a receptor established utility if: where neither the receptor nor its ligand has specific, substantial and credible • a person of ordinary skill in the art utility, and the receptor function cannot would immediately appreciate why be predicted from DNA or protein

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sequence homology. Where the receptor and specific. Examples of general function protein does not meet the utility include ‘secreted protein’ and ‘for requirement, claims directed to the feeding’. An example of an intermediate following also do not comply with the function is ‘receptor’. An example of a utility requirement: specific function is ‘epitope with unique activity’. In the EPO system, general and • screening methods using the receptor; intermediate functions are typically not considered to be inventive as being • ligands/agonists/antagonists in general arbitrary selections from the prior art. identified by the screening methods; In the EPO, the initial burden for demonstrating a lack of function rests • methods, uses or medicaments with the examiner. However, if the utilising the ligands/agonists/ examiner can raise substantiated doubts antagonists in general; concerning an asserted function, the burden is on applicants to establish the • methods, uses or medicaments alleged function. To this end, applicants utilising specific ligands/agonists/ should be aware that: antagonists; and • in silico evidence is acceptable; • antibodies that recognise the receptor. • credibility may be established by The EPO follows EPC Art. 57, which documents or experimental evidence; sets forth the industrial application requirement: • technical arguments brought in An invention shall be considered as support of patentability must have susceptible of industrial application if it been foreshadowed in the application; can be made or used in any kind of and industry, including agriculture. • wish lists do not properly indicate nor Examination guidelines The Guidelines for Substantive foreshadow a technical problem or in the EPO Examination of the EPO, at C-IV 4.6, solution thereto. comment on Art. 57: In general it is required that the The decision of the Opposition description of a European patent Division of the EPO in the case of application should, where this is not European Patent 0630405 (Icos) has been self-evident, indicate the way in which published.5 This decision illustrates the the invention is capable of exploitation thinking of the Examining and in industry. In relation to sequences Opposition Divisions in matters relating and partial sequences of genes this to current practice in connection with the general requirement is given specific requirement for function. form in that the industrial application The Opposition Division stated, in this of a sequence or a partial sequence of a decision: gene must be disclosed in the patent The disclosure of a predicted function application. A mere nucleic acid of a protein in combination with a sequence without indication of a method of verification of this function function is not a patentable is not necessarily adequate to invention... sufficiently disclose the function of the Current practice in the examining protein. In the absence of a disclosed divisions of the EPO considers that there compound (a ligand for a predicted are three categories for alleged function: receptor protein), methods utilising General or ‘throw away’, intermediate this compound (modulating the

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binding of the ligand) are not such methods are considered ‘industrially considered sufficiently disclosed. A list, inapplicable’ and, thus, unpatentable.8 in the description, of speculative Those countries that exclude medical functions of a protein is not in itself a treatment claims often look favourably at reliable basis for acknowledging claims directed to a ‘use’. Such ‘use’ industrial application of this protein. A claims, commonly referred to as ‘Swiss- DNA sequence encoding a protein type claims’ or ‘second medical use’ without a credible function is not a claims, are directed to the ‘use of a patentable invention. substance or composition for the manufacture of a medicament for a Although the Patent Proprietor did file a specified new and inventive therapeutic Notice of Appeal, no Statement of application.’9 One disadvantage of such a Grounds for Appeal was filed and the claim, however, is that the substance’s use Appeal was thus held inadmissible. The may be restricted ‘to the short term position taken by the Opposition Division ‘‘acceptable’’ industrial application rather has thus not been reviewed at the level of than the ultimate therapeutic use.’10 a Board of Appeal. An invention must be In Japan, the JPO follows Japanese Enablement, written enabled, adequately Patent Law Sect. 29, First Sentence, for description and clarity described and clear industrially applicability. According to the According to 35 USC }112, first Guidelines in Japan JPL Guidelines, Part VII, Chapter 2, paragraph, a patent application, to support 1.3.1, ‘Inventions ...whose utility is not a claim, must enable the claim and must described in a specification or cannot be adequately describe the subject matter of inferred, do not meet the requirements set the claim: forth in the first sentence in Section 29(1) The specification shall contain a of the Patent Law.’ written description of the invention, The Japanese patent system is geared to Industrial applicability and of the manner and process of those inventions that are industrially making and using it, in such full, clear, applicable. Industry is broadly construed concise, and exact terms as to enable to include, for example, mining, any person skilled in the art to which it agriculture, telecommunications and pertains, or with which it is most manufacturing. Commercially nearly connected, to make and use the inapplicable and, hence, industrially same, and shall set forth the best mode inapplicable, inventions include, for contemplated by the inventor of example, an invention applied only for a carrying out his invention. personal use (eg method of smoking) and an invention applied only for academic or Thus, under US law, there are two experimental purposes.6 distinct requirements: the enablement Medical treatment One area of dissimilarity between the requirement and the written description patent offices is the patentability of requirement. medical treatment. The USA takes a The test for enablement requires a liberal approach, finding that method of determination of whether any person treatment to be patentable subject matter. skilled in the art can make and use the Europe and Japan, by contrast, are more invention without undue restrictive. The EPO and JPO do not experimentation.11 The factors involved consider methods of medical treatment to in determining whether there is sufficient be patentable. Indeed, Article 52(4) of the evidence to support a finding of EPC specifically excludes as unpatentable enablement include, among others: (1) ‘methods for the treatment of the human the breadth of the claims; (2) the nature of or animal body by surgery or therapy and the invention; (3) the state of the prior diagnostic methods practiced on the art; (4) the level of one of ordinary skill; human or animal body.’7 And in Japan, (5) the level of predictability in the art; (6)

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the amount of direction provided by the as the invention. The written inventor; (7) the existence of working description requirement of the Patent examples; and (8) the quantity of Act promotes the progress of the useful experimentation needed to make or use arts by ensuring that patentees the invention based on the content of the adequately describe their inventions in disclosure.12 Analogously, Europe follows their patent specifications in exchange the ‘Sufficiency of Disclosure’ rule: that for the right to exclude others from the application must disclose the practicing the invention for the invention in a manner sufficiently clear to duration of the patent’s term. be carried out without undue To satisfy the written description experimentation by a person skilled in the requirement, a patent specification art.13 must describe the claimed invention in There are two independent sufficient detail that one skilled in the components of the enablement art can reasonably conclude that the requirement in the USA: how to make the inventor had possession of the claimed claimed invention over the scope claimed invention. An applicant shows without undue experimentation (eg possession of the claimed invention by ‘identifying’ a compound via a screening describing the claimed invention with method is not the same as teaching how all of its limitations using such to ‘make’ the compound); and how to use descriptive means as words, structures, the claimed invention over the scope figures, diagrams, and formulas that claimed without undue experimentation fully set forth the claimed invention. (note, however, that the presence of Possession may be shown in a variety specific, substantial and credible utility is of ways including description of an not by itself sufficient to meet this actual reduction to practice, or by criterion. Similarly, there are two forms of showing that the invention was ‘ready rejections that an examiner may present for patenting’ such as by the disclosure during prosecution: full scope claimed, of drawings or structural chemical but not enabled for how to make and/or formulas that show that the invention use; and a certain identified portion of was complete, or by describing scope claimed, but not enabled, ie ‘scope distinguishing identifying of enablement.’ characteristics sufficient to show that Turning to the written description Written description the applicant was in possession of the requirement, the USPTO provides claimed invention. A question as to guidance in its ‘Written Description whether a specification provides an Guidelines.’14 The Guidelines explain: adequate written description may arise in the context of an original claim The first paragraph of 35 U.S.C. 112 which is not described sufficiently, a requires that the ‘specification shall new or amended claim wherein a contain a written description of the claim limitation has been added or invention.’ This requirement is removed, or a claim to entitlement of separate and distinct from the an earlier priority date or effective enablement requirement. The written filing date under 35 U.S.C. 119, 120, description requirement has several or 365(c). Compliance with the policy objectives. ‘[T]he ‘‘essential written description requirement is a goal’’ of the description of the question of fact which must be invention requirement is to clearly resolved on a case-by-case basis.15 convey the information that an applicant has invented the subject According to the Federal Circuit’s matter which is claimed.’ Another predecessor court in In re Edwards,16 the objective is to put the public in function of the written description possession of what the applicant claims requirement is to:

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[E]nsure that the inventor had Circuit has noted that an adequate written possession, as of the filing date of the description of an invention involving application relied on, of the specific genetic material ‘requires a precise subject matter later claimed by him; to definition, such as by structure, formula, comply with the description [or] chemical name’, of the claimed requirement, it is not necessary that the subject matter sufficient to distinguish it application describe the claimed from other materials.19 A mere wish or invention in ipsis verbis; all that is plan, however, is insufficient.20 required is that it reasonably convey to Indeed, the courts warn that merely persons skilled in the art that, as of the providing a name of a molecule, knowing filing date thereof, the inventor had how to make it, and knowing what it possession of the subject matter later does, in a general sense, may not put one claimed by him.17 in possession of the molecule if the art is unpredictable.21 Thus, one of the goals of the written Genus claims are also problematic. For description requirement is to convey to a example, to support a claim to a genus skilled artisan that the patentee invented requires a representative number of the claimed subject matter. To this end, species, or sufficiently relevant identifying the specification must convey with clarity characteristics of the genus, for there to be to one skilled in the art that the patentee acceptable written description. And there had possession of the invention.18 is an inverse correlation between the Possession may be evidenced, inter alia: predictability of the technology and the number of embodiments that must be • by actual reduction to practice; described; in other words, the less predictable the technology, the more • by clear depiction in detailed drawings embodiments necessary for compliance or structural chemical formulas; and with the written description requirement.

• through written description describing Enablement and written description sufficient relevant identifying problems characteristics. Assume a claim to ‘An isolated nucleic acid comprising SEQ ID No. 1 where Whether there are sufficiently relevant nucleic acid does not encode an identified identifying characteristics, in turn, protein’ (eg a 1st generation EST). Such a requires weighing a number of factual claim would: considerations in view of the level of skill and knowledge in the art. Some factors • probably lack an adequate written include: description for ‘gene’ that falls within the scope of the claim; • complete or partial structure; • probably lack enablement with respect • physical and/or chemical properties; to what additional sequences may be added to those specifically disclosed • functional characteristics; such that the asserted utility would be present; and • correlation between structure and function; and • read on a number of non-enabled embodiments such as protein coding • method of making. regions, genes and alleles.

Pharmaceutical/biotech Pharmaceutical and biotechnology Note, however, that broader claim scope claims claims raise additional issues. The Federal in 2nd generation and 3rd generation

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DNA claims that would likely be more experimentation; or description and find enabling support in the specification. • the specification teaches how to Assume general receptor ligand/ identify compounds, rather than how agonist/antagonist reach-through claims, to make them; the specification does such as: not teach how to use the full scope of the compounds within the genus • ‘a receptor [X] agonist’; or without undue experimentation.

• ‘a product identified by the screening Thus, consider, instead, other claim process of claim 1 (wherein claim 1 strategies to cover downstream products screens for agonists of receptor [X])’; and for breadth, eg business method, or transmission of data/information, identification and claiming of novel • ‘a method of treating disease [Y] by sequences common to various species of administering a compound which is a genus, disclosure and claiming of receptor [X] agonist’ (‘functional use’ percentage homology + function, filing claim to a method of treating a disease on 2nd or 3rd generation DNA case by a compound defined not by its rather than 1st generation, claiming structure but rather by its ability to vectors, methods for expressing products, bind to a target). methods for making vectors, etc. Business methods are discussed in Such a generic claim to ‘A receptor [X] greater detail in the section ‘Business agonist’ would probably not comply with methods in the USA’. written description requirement when: According to 35 USC }112, second paragraph, a claim must be definite: • there is no description of structure of The specification shall conclude with representative number of claimed one or more claims particularly pointing compounds; or out and distinctly claiming the subject matter which the applicant regards as • there is no description of chemical or his invention. physical characteristics of representative number of claimed The definiteness requirement forces a compounds or of function of patentee to draft claims with clarity and representative number of claimed precision.22 Indeed, Section 112, second compounds (other than binding to paragraph, contains two requirements: identified receptor). first, that the claims be drafted with precision and definiteness and, second, Such a scenario is analogous to Regents that the claims be directed to the subject of the Univ. of Cal. v Eli Lilly & Co., 119 matter that the applicant regards as his or F.3d 1559 (Fed. Cir. 1997) (noting that a her invention.23 description of how to obtain compounds The Federal Circuit considers is not sufficient without description of compliance to Section 112, second what the compounds are). paragraph, necessary to preserve the A generic claim to ‘A receptor [X] notice requirement of a patent.24 The agonist’ is also not likely to comply with skilled artisan standard is used when enablement requirement when: analysing claim language for compliance with Section 112, second paragraph.25 • the specification does not teach how Further, inconsistency with the to make and use the full scope of specification may make a claim take on an agonists or antagonists within that unreasonable degree of uncertainty.26 EPO genus without undue The analogous statues in the EPO for

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enablement and clarity are EPC Arts. 83 examples, where such generalisation is and 84: technically credible and scientifically valid. JPO • EPC Art. 83: Sufficiency of The JPO tracks the EPO system: Disclosure. ‘The European patent application must disclose the invention • Japanese Patent Law Sect. 36(4): in a manner sufficiently clear and Description, Enablement complete for it to be carried out by a (Guidelines Part VII, Chapter 2, person skilled in the art’ (Guidelines 1.1.2.1). Section 36(4) of the Patent C-II, 4.9). ‘The application must Law states that ‘the detailed contain sufficient information to description of the invention shall be enable the person skilled in the art, stated ...in such a manner sufficiently using his common general knowledge, clear and complete for the invention to perform the invention over the to be carried out by a person having whole area claimed without undue ordinary skill in the art to which the burden and without needing inventive invention pertains.’ For an invention skill.’ of a product, the definition of ‘being able to carry out the invention’ is to • EPC Art. 84: Clarity and Support. make and use the product... The claims shall define the matter for which protection is sought. They shall • Japanese Patent Law Sect. 36(6): be clear and concise and be supported Clarity of Claims (Guidelines Part by the description (Guidelines C-III VII, Chapter 2, 1.1.1). According to 6.3). In order to comply with the Section 36(6)(ii) of the Patent Law, requirement of Art. 84, there must be the invention for which a patent is sufficient support of technical sought shall be clear, therefore, scope character in the description that allows of claim shall be described so that an to extend the particular teaching of invention is clearly identified on the the description to the whole field basis of statements of each claim. claimed. The JPO considers the following to be One point of departure from the an example of a claim failing the clarity USPTO system is that the EPO does not requirement: ‘A chemical compound that have a written description requirement. activates the R-receptor’. The JPO In other words, the EPO allows for more explains that if the R-receptor is novel, it generalisation than the USPTO. is presumed that a skilled artisan is not In general, a claim must be enabled capable of conceiving the chemical across its whole scope in order to be compound that has R-receptor activating allowable in the EPO.27 Notwithstanding abilities. Thus, the claim is unclear.29 this, assessment of enablement in the EPO Turning to enablement, the JPO follows the general principle that the considers the following claim to be scope of a claim granted for an invention defective: ‘Streptomyces griseus producing should be commensurate in scope with antibiotic A’. The applicant’s specification the technical contribution to the art noted that a strain of S. griseus that which the applicant has made.28 Thus, produced novel antibiotic A was obtained broad claims may be allowable where the by artificially mutating S. griseus in a applicant has provided a technical specific process. The specification, concept, which defines a patentable however, did not contain a statement that invention, and which can itself be the obtained strain was deposited. The generalised by the person skilled in the JPO would reject the claim as lacking art. In particular, the applicant is enablement for the failure to officially permitted to generalise from specific deposit the microorganism before the

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application was filed and for failure of the • EPC Art. 56: inventive step.An specification to contain a statement that invention shall be considered as more than one strain of S. griseus involving an inventive step if, having producing antibiotic A was obtained in regard to the state of the art, it is not the process in the detailed description of obvious to a person skilled in the art. the invention.30 In the USA, if a reference identically Freedom from the prior art describes the invention in every detail and Novelty/obviousness in The statutory bases for novelty and non- each and every element of the invention USPTO obviousness in the USPTO are as follows: as claimed, then the reference is said to anticipate the claimed invention.31 Each • 35 USC }102: Novelty. A claimed claim element must either be expressly or invention complies with the novelty inherently disclosed in a single prior art requirement if there is no single reference,32 and must be as arranged as in reference that expressly, implicitly or the claim.33 inherently describes the invention US prior art requirements limit certain including each claimed element. types of disclosures to acts within particular geographical limitations, such as • 35 USC }103: Non-obviousness.A territories of the USA, and limit prior art claimed invention complies with the effect depending on from whom prior art non-obviousness requirement if there originated: are no prior art references that, alone or in proper combination, teach or • 35 USC 102(a) – known or used in suggest the invention as a whole the USA. including each element of the claimed invention. In determining whether an • 35 USC 102(b) – in public use or on invention would have been obvious, sale in the USA. the examiner determines the scope and contents of the prior art, ascertains • 35 USC 102(g) – invention was made the differences between the prior art in the USA by another who has not and the claims in issue, resolves the abandoned, suppressed or concealed it. level of ordinary skill in the art, and evaluates any objective evidence of • 35 USC 102(a), (e) – disclosure non-obviousness. disqualified from being prior art if not by ‘others’ or ‘another’. The analogous statutory sections for novelty and inventive step in the EPO • 35 USC 102(e), (f), (g) – disclosure are: disqualified if unity of ownership; see 35 USC 103(c). Novelty and inventive • EPC Art. 54: Novelty. step in EPO In the USA, a ‘grace period’ is • EPC Art. 54(1). An invention shall recognised, wherein an applicant’s own be considered to be new if it does not activity or publications will not bar a form part of the state of the art. patent if the US application is filed within a year from the date of activity or • EPC Art. 54(2). The state of the art publication. In the European patent shall be held to comprise everything system, by contrast, ‘absolute novelty’ made available to the public by means controls. In other words, there is no grace of a written or oral description, by use, period in the EPO. There are no or in any other way, before the date of restrictions as to geographical location, filing of the European patent language or manner in which information application. was made available to the public or if

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prior art is from same inventor(s)/owners; • determination of the closest prior art; thus, all kinds of disclosures, wherever in and the world, are state of the art. Unlike anticipation, however, • assessment of whether arriving at the references may be combined to render a solution to the technical problem claim ‘obvious’. But if references are addressed by the patent or patent combined, there must be some suggestion application starting from said closest Obviousness approach (or motivation) to make the prior art would have been obvious to a in USPTO combination.34 In US practice, person skilled in the art. determining obviousness under 35 USC 103 follows the guidelines set forth in With respect to genus/species issues: Graham v John Deere,35 and its progeny: • USA – Obviousness of claimed Patent may not be obtained if the species when genus is in prior art: differences between the subject matter sought to be patented and the prior art The fact that a claimed compound may are such that the subject matter as a be encompassed by a disclosed generic whole would have been obvious at the formula does not by itself render that 38 time the invention was made to a compound obvious. person having ordinary skill in the art Consider size of genus, express teachings, to which said subject matter pertains; teachings of structural similarity, similarity but, patentability shall not be negatived of properties or uses, predictability. by the manner in which the invention 36 was made. • Europe – inventive step of claimed Thus, for determining ‘obviousness,’ the species when genus is in prior art. four factual inquires enunciated in Merely selecting particular chemical Graham include: compounds or compositions from a broad field does not involve an inventive step, unless claimed • determine the scope and contents of invention has advantageous properties the prior art; not possessed by prior art examples or unless claimed invention has • ascertain the differences between the unexpectedly advantageous properties prior art and the claims in issue; compared with the prior art examples.

• resolve the level of ordinary skill in the With respect to genomics: pertinent art; and • USA – Obviousness of protein or • evaluate evidence of secondary nucleic acid encoding the protein. considerations, eg unexpected results, Examiners have a difficult time commercial success, long-felt need, making a prima facie case of failure of others, copying by others, 37 obviousness using a prior art nucleic licensing, scepticism of experts, etc. acid or amino acid sequence that differs even slightly from applicant’s By contrast, the problem-solution claimed sequence because motivation Problem/solution approach is uniformly adopted by the for the specifically claimed change approach in EPO EPO and most European countries. This must be shown: (a) In re Deuel, 51 F.3d approach involves the steps of: 1552, 34 USPQ2d 1210 (Fed. Cir. 1995); (b) In re Bell, 991 F.2d 781, 26 • determination of the technical USPQ2d 1529 (Fed. Cir. 1993). problem which the invention seeks to Exceptions may include degenerate solve; codon substitutions or some

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conservative amino acid substitutions, • Japanese Patent Law Sect. 29(2): cysteine replacements, etc, if such inventive step (Sect. 29(2)). Where substitutions are shown to be an invention could easily have been functional equivalents in the art in the made, prior to the filing of the patent same context. application, by a person with ordinary skill in the art to which the invention • EPO – T939/92, ‘AgrEvo’. In the pertains, on the basis of an invention absence of a credible function for a or inventions referred to in any of the claimed compound, the problem to be paragraphs of Subsection (1), a patent solved is merely the provision of an shall not be granted for such an arbitrary new compound. Hence, a invention notwithstanding Subsection genomic sequence can only be (1). inventive if a specific and credible function has been disclosed. Japanese patent law also requires that an inventive step appear in the invention, requiring both technical judgment and The EPO applies a stringent inventive experience. step analysis to claims. In other words, according to the EPO, a genomic BUSINESS METHODS IN sequence can be inventive only if a THE USA Business method specific and credible function has been As noted above, claim strategies to cover patents disclosed. Further, according to AgrEvo, downstream products and for breadth if the inventive step is predicated on an include business method patents. alleged surprising result, substantially Corporate interest in the protection of everything within the scope of the claim business methods afforded by the patent should be capable of achieving the result. laws of the USA has been ignited in the And the trend in the EPO may be that wake of recent Federal Circuit case law disclosure of most of a nucleic acid and congressional legislation. The Federal sequence may render a complete Circuit’s 1998 decision in State Street Bank sequence obvious. & Trust Co. v Signature Financial Group, The rules of the JPO on novelty and Inc.,39 finding that business methods are inventive step closely mirror those of the patentable subject matter, and Congress’s USA: acknowledgment of this fact, have shown that patent protection of business methods • Japanese Patent Law Sect. 29(1): has the potential of generating a Novelty/inventive step novelty (Sect. 29(1)). Any person tremendous amount of wealth. Just as one in JPO who has made an invention which is example, the controversial internet industrially applicable may obtain a company Priceline.com was valued at patent therefor, except in the case of nearly ten billion dollars in 2000; a the following inventions: significant part of the valuation being (i) inventions that were publicly based on the more than 20 business known in Japan or elsewhere prior to method patents that the USPTO awarded the filing of the patent application; to the company.40 (ii) inventions that were publicly It is unquestionable that business worked in Japan or elsewhere prior to method patents are strategic corporate the filing of the patent application; assets enabling companies to exert (iii) inventions that were described in considerable influence in the marketplace. a distributed publication or made A company holding such a patent, available to the public through electric especially on an emerging business telecommunication lines in Japan or method such as bioinformatics,41 has the elsewhere prior to the filing of the potential of wielding leverage over patent application. competitors (eg in the form of licences

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and royalties) by virtue of the patent’s Although it is doubtful that one can quasi-monopoly power. Further, the point to the very first patented business company has the potential of acquiring method, the following are some historical greater market share and the heightened examples of issued US patents to methods interest of institutional investors. of doing business: Legislation was introduced in Congress Samples of business on 3rd October, 2000, amending Section • US Patent No. 63,889, issued 16th method patents 100 of title 35 of the US Code to add the April, 1867, claiming: following broad definition of ‘business A hotel register book with the margin method’: of its leaves occupied by The term ‘business method’ means – advertisements... (1) a method of – (A) administering, managing, or • US Patent No. 395,781, issued 1st otherwise operating an January, 1889, claiming: enterprise or organization, including a technique used in The improvement in the art of doing or conducting business; compiling statistics, which consists in or first, preparing a series of separate (B) processing financial data; record cards, each card representing an (2) any technique used in athletics, individual or subject; second, applying instruction, personal skills; and to each card at predetermined intervals (3) any computer-assisted circuit-controlling index-points implementation of a method arranged, according to a fixed plan of described in paragraph (1) or a distribution, to represent each item or technique described in paragraph characteristic of the individual or (2).42 subject, and, third, applying said separate record-cards successively to A is defined as circuit-controlling devices acted upon a US utility patent whose subject matter is by the index-points to designate each Business method a method of doing or conducting statistical item represented by one or defined business. Since a definition is often less more of said index-points... effective than concrete examples. The following are some business methods to • US Patent No. 853,852, issued 14th which the federal courts have been May, 1907, claiming: exposed over the years: [a] two part insurance policy consisting of a paper containing an insurance • A method of parking cars at a drive-in contract provided with suitably theatre that optimises view angles.43 designated spaces for the signature of insurer and that of the insured • A business form with novel combined with a postal card, both headings.44 bearing a number or mark of identification, and the postal card • A method of accounting and cash bearing also printed reference to the registering to prevent fraud.45 contract paper and the beneficiary thereof... • A vending process for use in selling stocks.46 The evolution of the business method patent will now be examined. Although • A method for implementing an would-be patentable inventions are interstate and national fire-fighting required by statute to fall within either a system.47 process, machine, manufacture or

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State Street composition of matter,48 it is often the Recently, the ‘business method federal courts that ultimately decide what exception’ was eliminated by the Federal subject matter is, in fact, patentable. Until Circuit in State Street v Signature quite recently, the great weight of judicial Financial,54 one of the court’s most authority has consistently held that heralded and far-reaching decisions to methods of doing business were mere date. The patent-at-issue was owned by abstract ideas and, therefore, unworthy of Signature Financial and entitled ‘Data patent protection. Processing System for Hub and Spoke The Second Circuit took the lead in Financial Services Configuration.’ The scuttling the patentability of business patent was directed to a data-processing methods in its landmark 1908 decision system for implementing an investment Hotel Security Checking Co. v Lorraine Co.49 structure by which mutual funds (the In that case, the invention involved a ‘spokes’) pooled assets in an investment bookkeeping system for cash-registering vehicle (the ‘hub’) organised as a and account-checking designed to partnership. Using the system, one could prevent fraud by waiters. In holding the easily allocate daily income, expenses and method unpatentable, the court net realized gain or loss among the mutual adamantly stated: ‘A system for transacting funds. Claim 1 was written in means- business disconnected from the means for plus-function form and recited the carrying out the system is not ...an art following: [process].’50 1. A data processing system for Other courts followed suit. For managing a financial services example, in Ex parte Murray,51 the Board Evolution of Patent Appeals and Interferences held configuration of a portfolio established as a partnership, each that an accounting method: partner being one of a plurality of [R]equiring no more than entering, funds, comprising: sorting, debiting and totaling of (a) computer processor means for expenditures as necessary preliminary processing data; steps to issuing an expense analysis statement, is, on its face, a vivid (b) storage means for storing data example of the type of ‘method of on a storage medium; doing business’ ...as outside the protection of the patent statutes...52 (c) first means for initializing the storage medium; The reasoning behind what has been (d) second means for processing called the ‘business method exception’ to data regarding assets in the patentability included the requirement portfolio and each of the funds that inventions be reduced to tangible from a previous day and data form, eg tangible things and procedures. regarding increases or decreases Consequently, mere ideas were in each of the funds, assets and unpatentable. Practitioners have also for allocating the percentage noted that, historically: share that each fund holds in [B]usiness methods as bookkeeping the portfolio; procedures and investment (e) third means for processing data management strategies were difficult to regarding daily incremental characterize as innovations in the income, expenses, and net technological or ‘useful’ arts entitled to realized gain or loss for the patent protection. Most of these portfolio and for allocating such methods were carried out by hand data among each fund; with pen and paper and did not appear to involve any technological art...53 (f) fourth means for processing

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data regarding daily net than by structure and inclusive of the unrealized gain or loss for the equivalents in the specification, a machine portfolio and for allocating such may be claimed that would naturally fall data among each fund; and within Section 101. Second, the court considered business (g) fifth means for processing data methods equivalent to other conventional regarding aggregate year-end methods or processes. Consequently, income, expenses, and capital business methods are now to be treated gain or loss for the portfolio and no differently from any other method for each of the funds. purposes of patentability. Under this The district court held that the claims rubric, Section 102, 103 and 112 analyses involved business plans and systems (ie should be the same when business method methods of doing business) and were, inventions are prosecuted (see infra). therefore, unpatentable subject matter per Third, and related to the first point se. The Federal Circuit disagreed, holding above, the decision indicates that even if that business methods were, indeed, the patent did not include any method patentable subject matter if the result was claims, but included, instead, claims a useful, tangible or concrete invention. directed to ‘means for’ performing the The Federal Circuit began its analysis business method, the patent would still be by noting that since the claims were in construed as a business method patent. Of means-plus-function format, and when course, the claimed invention, according claim 1 was properly construed in to the Federal Circuit, would be accordance to Section 112, paragraph 6, characterised as a machine and would the invention was directed to a machine. bypass the Section 101 inquiry. Further, since each claim component was Most importantly, the court recited in means-plus-function form, it promulgated a new standard for was to be inclusive of the ‘equivalents’ of patentable subject matter. As long as the the structures disclosed in the written method or process had a practical utility description. Claim 1, properly construed, in producing a ‘useful, concrete, and therefore, was a machine and, for tangible result,’ the requirements of purposes of Section 101, proper statutory Section 101 would be satisfied.58 The subject matter.55 consequences of such a standard are The court did not end there. It staggering, and renders prophetic the oft- expressly characterised the ‘business quoted statement by the Supreme Court method exception’ as ‘ill-conceived’ and that patentable subject matter is ‘anything rendered irrelevant by Section 103.56 under the sun that is made by man.’59 Tellingly, the court stated that: TRILATERAL Since the 1952 , business COOPERATION methods have been, and should have Trilateral cooperation With the understanding that globalisation been, subject to the same legal is in the best interest of the economies of requirements for patentability as the USA, Europe and Japan, applied to any other process or ‘harmonisation’ between the three patent method.57 offices has been a buzz-word for over the The Federal Circuit’s decision in State past 20 years. An approach to a more Street is important for a number of unified patenting system, however, has reasons. First, it gives a hint to the been elusive. Many of the obstacles to practitioner of how to avoid any residual such a unified, global system are based on ‘business method’ dilemmas. By reciting a lack of awareness of not only the rules the business method in proper means- underlying the examination procedure of plus-function format, ie one in which the the three patent offices, but also of an invention is defined by function rather unfamiliarity of the reasons for these rules.

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The Trilateral Cooperation initiative sequence with high similarity to that of best outlines the USPTO, EPO and JPO SEQ ID No. 1. rules in action, and the reasons behind them. The conference is held annually to Case B: A polynucleotide consisting of the exchange insight and cultural reasoning nucleotide sequence of SEQ ID No. 2 among the participants. According to the The claimed polynucleotide is 500 bp USPTO: cDNA obtained from human liver cDNA The advantage of such a system for the library and assumed to be part of a users of the patent system would be structural gene encoding human protein reduction of costs, improvement of X as a result of similarity search. (The granted patents’ quality, improvement polynucleotide demonstrated 95 per cent of patent information dissemination homology to part of a structural gene reduction of processing time in the encoding rat protein X. The deduced patent granting procedure.60 amino acid sequence also showed 95 per cent homology to amino acid sequence of More importantly, however, the rat protein X.) trilateral cooperation initiative places the The polynucleotide can be used as a public on notice. Specifically, probe in one of the steps to obtain the corporations, institutions and individual full-length DNA encoding human inventors, and the patent lawyers protein X. representing them need to know how to The size of the full-length DNA navigate the systems in each of the three encoding rat protein X is 2400 bp and the patent offices most advantageously. DNA sequence encoding rat protein X With respect to biotechnology, two was known. projects are particularly relevant: Trilateral Project B3b: Comparative study on biotechnology patent practices Case C: A polynucleotide consisting of the (patentability of DNA fragments) and nucleotide sequence of SEQ ID No. 3 Trilateral Project WM4: Comparative The claimed polynucleotide is 500 bp studies in new technologies (protein cDNA obtained from human liver cDNA 3-dimensional structure related claims). library. As the amino acid sequence These two projects are summarised deduced from the nucleotide sequence of below. SEQ ID No. 3 has a potential site of glycosylation, the polynucleotide is Trilateral Project B3b61 assumed to be part of a structural gene Six hypothetical cases were presented to encoding a glycoprotein. Project B3b the USPTO, EPO and JPO for comments The polynucleotide can be used as a on patentability. These claims, and the probe in one of the steps to obtain the comments accompanying them, were as full-length DNA. follows. There is no known nucleotide sequence with high similarity to that of Case A: A polynucleotide consisting of the SEQ ID No. 3. nucleotide sequence of SEQ ID No. 1 The claimed polynucleotide is 500 base Case D: A polynucleotide consisting of the pairs (bp) cDNA obtained from human nucleotide sequence of SEQ ID No. 4 liver cDNA library. The polynucleotide The polynucleotide is 500 bp long cDNA can be used as a probe in one of the steps whose corresponding mRNA is expressed to obtain the full-length DNA, though only in the hepatocyte of the patients there is no description of the function or with disease Y. Therefore, the biological activity of the DNA and its polynucleotide can be used as a probe to corresponding protein. diagnose disease Y. There is no known nucleotide There is no known DNA that is unique

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in the patients with disease Y or high to indicate an asserted utility similar to that of SEQ ID No. 4. (USPTO).

• Case E: A polynucleotide comprising the The mere fact that DNA fragments are nucleotide sequence of SEQ ID No. 4 derived from the same source is not Case E differs from Case D only in terms sufficient to meet the requirement for of the expression of ‘comprising’ and . ‘consisting of’ used for the claims • respectively. All nucleic acid molecule-related inventions, including full-length cDNAs and SNPs, without indication Case F: A structural gene comprising the of function or specific, substantial and nucleotide sequence of SEQ ID No. 2 credible utility, do not satisfy industrial Case F differs from Case B in terms of the applicability, enablement or written expression of the preamble language and description requirements. the transition phrase.62 According to the comparative study, all • Isolated and purified nucleic acid three patent offices indicated that Cases molecule-related inventions, including A, B, C and F are not patentable. The full-length cDNAs and SNPs, of three offices believed, however, that Case which function or specific, substantial D was patentable. The USPTO based its and credible utility is disclosed, which reasoning for unpatentability on lack of satisfy industrial applicability, utility and enablement. The EPO and the enablement, definiteness and written JPO, by contrast, noted that the cases description requirements would be failed the requirements for non- patentable as long as there is no prior obviousness and inventive step.63 The art (novelty and inventive step) or three offices made the following other reasons for rejection (such as, conclusions: where appropriate, best mode [US] or ethical grounds [EPC/JP]).64 • A mere DNA fragment without Project WM4 indication of a function or specific Trilateral Project WM465 asserted utility is not a patentable Eight cases were presented to the invention. USPTO, EPO and JPO on technology related to 3D chemical structures. • A DNA fragment, of which specific utility, eg use as a probe to diagnose a Case 1: 3D structural data of a protein specific disease, is disclosed, is a per se patentable invention as long as there is no other reasons for rejection. • Claim 1: A computer model of protein P generated with the atomic • A DNA fragment showing no coordinates listed in Figure 1 of Ref. unexpected effect, obtained by 65. conventional method, which is assumed to be part of a certain • Claim 2: A data array comprising the structural gene based on its high atomic coordinates of protein P as set homology with a known DNA forth in Figure 1 (of Ref. 65) which, encoding protein with a known when acted upon by a protein function, is not a patentable invention modeling algorithm, yields a (EPO, JPO). representation of the 3D structure of protein P. • The above-mentioned DNA fragment is unpatentable if the specification fails Background:

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• The specification asserts that protein P data and explains that administering is a novel protein. protein P lowers blood pressure.

• The description gives experimental • The structural coordinates were data and explains that the protein, derived from a solution phase protein when active, lowers blood pressure. by nuclear magnetic resonance (NMR) at 0.2 nm resolution. • Protein modelling algorithms are well known in the art. Prior art:

• The description also gives the atomic • A search of the prior art did not coordinates of protein P, and asserts identify any references that teach or these coordinates would be useful in in suggest the 3D structure of protein P. silico (computer-assisted) screening methods. • The prior art teaches a protein from the same source organism having the Prior art: same specific function and approximately the same molecular • A search of the prior art did not weight. identify any references that teach or suggest protein P. Case 4: Crystals of known proteins

Case 2: Computer-readable storage • Claim: A crystalline form of protein P medium encoded with structural data of a having unit cell dimensions of protein a ¼ 4.0 nm, b ¼ 7.8 nm and c ¼ 11.0 nm. • Claim 1: A computer-readable storage medium encoded with the atomic Background: coordinates of protein P as shown in Figure 1 of Ref. 65. • A nucleotide sequence encoding the amino acid sequence of protein P was Background and prior art: same as in known in the art. Case 1. • The description explains that Case 3: Protein defined by its tertiary administering protein P was previously structure known to result in lowering blood pressure. • Claim: An isolated and purified protein having the structure defined • The inventors assert they have newly by the structural coordinates as shown produced a stable crystalline form of in Figure 1 of Ref. 65. protein P.

Background: • Protein P in crystalline form is inactive. • The description sets forth the 3D structure of protein P, including the • The description gives experimental coordinates of the amino acid side data with explanations of how to make chains, the source organism for the crystals. protein P and the molecular weight of protein P. • Common prior art methods used in protein P crystallisation were • The description gives experimental unsuccessful, and there was clearly a

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technical difficulty in producing the position 394 to 401 of SEQ ID No. 1 claimed crystalline form of protein P. are protein domains that are able to fold into an active binding pocket of Prior art: protein P. This ability was confirmed by X-ray diffraction data. • There was no prior art reference teaching or suggesting a crystal of • The description also provides evidence protein P or related proteins. that the above domain alone shows a significantly higher signalling activity • There was no prior art reference compared with the whole protein P concerning the crystallisation method when activated by a natural ligand of of protein P. protein P.

Case 5: Binding pockets and protein Prior art: domains • Prior art suggesting the position of the • Claim 1: An isolated and purified binding pocket of protein P was not molecule comprising a binding pocket found. of protein P defined by the structural coordinates of amino acid residues • Prior art suggesting a protein structure 223, 224, 227, 295, 343, 366, 370, domain containing said binding 378 and 384 according to Figure 1 of pocket was also not found. Ref. 65. Case 6: In silico screening methods directed • Claim 2: An isolated and purified to a specific protein (1) polypeptide consisting of a portion of protein P starting at one of amino • Claim: A method of identifying acids 214 to 218 and ending at one of compounds that can bind to protein P, amino acids 394 to 401 of protein P as comprising the steps of: (1) applying a set forth in SEQ ID No. 1. 3D molecular modelling algorithm to the atomic coordinates of protein P Background: shown in Figure 1 of Ref. 65 to determine the spatial coordinates of • Protein P is a previously known the binding pocket of protein P; and protein whose amino acid sequence (2) electronically screening the stored was also previously known. spatial coordinates of a set of candidate compounds against the spatial • The description explains that coordinates of the protein P binding administering protein P was previously pocket to identify compounds that can known to result in lowering blood bind to protein P. pressure.

• The inventors assert they have newly Background: discovered that the active residues in the binding pocket of protein P • Protein P is a previously known consist of amino acids 223, 224, 227, protein whose amino acid sequence 295, 343, 366, 370, 378 and 384. was also previously known.

• The description teaches that the • The description explains that the possible peptides that begin with any activity of protein P was previously amino acid from position 214 to 218 known to result in lowering blood and end with any amino acid from pressure.

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• The description gives the atomic by comparing the 3D structure of coordinates of protein P (raw data of candidate compounds with the 3D the protein itself without any ligands molecular model shown in Figure 5 of bound to it) but does not describe the Ref. 65 which comprises the position of its binding pocket. following steps:

• Instead, the specification gives general (1) ... information on programs that predict the binding pocket of proteins (which (2) ... often give a relatively large number of amino acids related to the binding) (..) ... and general information on commonly used in silico screening programs. (n) ...

• Methods of peptide modelling and The 3D molecular model of Figure 5 binding using rational drug design are presents the positions of heteroatoms in well known in the art. the amino acids constituting the binding pocket of protein P (ie amino acids 223, • There was clearly a technical difficulty 224, 227, 295, 343, 366, 370, 378 and in obtaining the claimed atomic 384) wherein said heteroatoms can form coordinates of protein P. hydrogen bonds with hydrogen bonding functional groups in a candidate • The specification speculates that by compound. using the binding pocket prediction Steps (1) to (n) describe a data program and in silico screening processing method in which (a) the program, the person skilled in the art coordinate data of the 3D molecular can identify compounds binding to model of Figure 5 (of Ref. 65) is input in said protein. a data structure such that the interatomic distances between the atoms of protein P • The description gives no working are easily retrieved, and (b) the distances examples of identifying compounds between hydrogen-bonding heteroatoms using the atomic coordinates of of different candidate compounds and the protein P. heteroatoms that form the binding pocket in the 3D molecular model are compared, Prior art: thereby allowing the identification of those candidate compounds which would • No prior art suggesting the 3D theoretically form the most stable coordinates of protein P was found. complexes with the 3D molecular model binding pocket of protein P, based on • The prior art teaches computer optimal hydrogen bonding between the programs that predict the binding two structures. pocket of proteins.

• Several in silico screening programs • Claim 2: A compound identified by using the predicted binding pocket of the method of claim 1. proteins are also previously known. • Claim 3: A database encoded with Case 7: In silico screening methods directed data comprising names and structures to a specific protein (2) of compounds identified by the method of claim 1. • Claim 1: A method of identifying compounds that can bind to protein P Background:

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• Protein P is a previously known to optimise the interatomic distance protein whose amino acid sequence information is taught by the prior art. was also previously known. Case 8: Pharmacophores and • The description explains that the pharmacophore defined compounds activity of protein P was previously (pharmacophores defined by the distance known to result in lowering blood between atom-groups) pressure. • Claim 1: A pharmacophore having a • The description gives the atomic spatial arrangement of atoms within a coordinates of protein P as a co-crystal molecule defined by formula 1 with its natural ligand, and gives a TYPE ¼ PICT; ALT ¼ logical explanation that the active Pharmacophore of Formula 1 having residues in the binding pocket of three atoms, namely A, B and C, protein P consists of amino acids 223, wherein the distance between A and B 224, 227, 295, 343, 366, 370, 378 and is 1.59 0.50 nm, the distance 384. between B and C is 1.33 0.25 nm, and the distance between A and C is • The description explains how the 3D 0.95 0.25 nm in which A and B molecular model of Figure 5 includes both represent an electron donor the 3D structure of the binding pocket atom, C represents a carbon atom that of protein P. is part of a hydrophobic group, and the distances represent the distances • The description gives working between the centres of the respective examples of the claimed method in atoms. which a number of compounds are identified. • Claim 2: An isolated compound or its salt defined by the pharmacophore in • The description also shows claim 1. experimental data of the actual binding affinities of the compounds identified. According to the data Background: shown, the person skilled in the art can understand that the claimed • A pharmacophore is a description of a method can actually identify a number generalised concept of molecular of compounds which bind strongly features in terms of information on enough to protein P so that some spatial arrangement of chemical biological effect can be expected. elements (eg hydrophobic groups, charged/ionisable groups, hydrogen bond donors/acceptors, and Prior art: substructures) that are considered to be responsible for a desired biological • No prior art suggesting the 3D activity. coordinates of protein P was found. • Protein P is a previously known • The prior art teaches in silico screening protein whose amino acid sequence programs that compare the 3D was also previously known. structure of candidate compounds with the 3D molecular model of the • The description explains that the binding pocket of a protein of interest. activity of protein P was previously known to result in lowering blood • The method of storing coordinate data pressure.

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• A search of the prior art did not • computer models of protein; identify any references that teach or suggest the 3D structure of protein P. • data array comprising atomic coordinates of protein; • The description teaches that the pharmacophore shown in formula 1 • computer-readable storage medium was evaluated from the 3D structure encoded with atomic coordinates of of the ligand binding pocket of protein; protein P. • database encoded with data • The description also teaches that the comprising names and structures of structure of the ligand binding pocket compounds; and of protein P was estimated using conventional methods. • pharmacophore

• The description also describes that a are not patent eligible subject matter or novel ligand was designed based on statutory inventions. the pharmacophore, and shows In cases where no references teach or experimental results that the ligand suggest the 3D structure of protein but binds to the protein with relatively there is enough reason to expect that the high affinity. claimed protein would be prima facie identical with the protein of the prior art, Prior art: the claim for a protein having the structure defined by the structural • A document showing an agonist of coordinates does not comply with the protein P was found.66 requirements of novelty. A crystalline form of a protein meets all Tables 2–4 show howTrilateral Project the requirements of patent eligible subject WM4 summarised the findings of the matter, statutory invention, industrial three patent offices. applicability (application), utility, The offices also noted that the claims enablement, support, clarity, written for: description, novelty, inventive step and

Table 2: Summary of answers – EPO67

Case Claim Patent eligible Industrial Clarity/ Sufficiency Novelty and subject matter applicability Support inventive step

1 1 N N/A N/A N/A N/A 2 N N/A N/A N/A N/A 2 1 N N/A N/A N/A N/A 31 Y Y Y Y N 41 Y Y Y Y Y 51 Y Y N N N 2YYYYY 61 Y Y Y N Y 71 Y Y Y Y Y 2Y Y N N M 3 N N/A N/A N/A N/A 8 1 N N/A N/A N/A N/A 2Y Y N N N

Y ¼ Yes, N ¼ No, N/A ¼ not addressed and M ¼ Maybe.

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Table 3: Summary of answers – JPO67

Case Claim Statutory Industrial Clarity Enablement Novelty and invention applicability inventive step

1 1 N N/A N/A N/A N/A 2 N N/A N/A N/A N/A 2 1 N N/A N/A N/A N/A 31 Y Y Y Y N 41 Y Y Y Y Y 51 Y Y N N N 2Y Y Y Y Y 6 1 N Y N/A N/A N/A(N) 71 Y Y Y Y N 2 Y Y N N N/A 3 N N/A N N N/A 8 1 N N N N/A N/A 2Y Y N N N

To the general scope of the claim. Y ¼ Yes, N ¼ No, N/A ¼ not addressed and M ¼ Maybe.

Table 4: Summary of answers – USPTO67

Case Claim Patent eligible Utility Written Enablement Novelty and subject matter description inventive step

1 1 N M Y N N/A 2 N M Y N N/A 21 N M Y N N 31 Y Y Y Y N 41 Y Y Y M M 51 Y Y N N N 2Y Y Y Y Y 61 Y M Y N N 71 Y M Y M N 2Y M N N M 3 N N/A N/A N/A N/A 8 1 N N/A N/A N/A N/A 2Y M N N M

Y ¼ Yes, N ¼ No, N/A ¼ not addressed and M ¼ Maybe.

non-obviousness since a protein is • characterisation of the crystal structure composition of matter of patentable is provided in the claim (eg by subject or statutory invention, if: specifying the cell unit dimensions), and

• it is well established in the art that the • there was no prior art reference crystalline form of the protein has teaching or suggesting a crystal of the utility or industrial applicability, and protein or related proteins, and

• the specification teaches how to make • there was no particular guidance in the the claimed crystals, and art as to how to crystallise the protein.

• one skilled in the art could use the In cases where a protein is previously claimed protein crystal without undue known, the claim for an isolated and experimentation, and purified molecule comprising a binding

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pocket of protein defined by the structural The claim for compounds or their salts coordinates does not comply with all of in general defined by a pharmacophore the requirements of enablement, support, does not comply with one or more of the clarity, written description, novelty, requirements of enablement, support, inventive step and non-obviousness. clarity and/or written description because: An isolated and purified polypeptide consisting of a portion of a protein with • it would require a trial and error effort signalling activity meets all the beyond what is expected of a person requirements of patent eligible subject having ordinary skill in the art to matter, statutory invention, industrial envisage a ligand structure other than applicability (application), utility, the one described concretely in the enablement, support, clarity, written examples, and make such compounds, description, novelty, inventive step and and non-obviousness since: • the pharmacophore, which is an • it is limited to a fragment of the abstract concept, does not define a protein that contains the binding compound.68 pocket and was shown in the specification to retain binding activity CONCLUSION and the signalling activity of the Final thoughts Corporate and academic applicants must protein, and be aware that optimising the scope of patent protection requires patents from • the prior art does not teach any the USPTO, the EPO and the JPO. As polypeptide which consists of the these offices control global IP, patent claimed specific part of the protein, or counsel, in turn, must have expertise in all methods to specify parts of the three systems to efficiently (and polypeptide, and profitably) advocate their clients’ interests. • it shows a significantly higher signalling activity compared with the References and notes whole protein. 1. Press Release, United States Patent & Trademark Office (29th November, 2002) (URL: http://www.USPTO.gov/web/ The claim for compounds in general offices/com/speeches/02-70.htm). identified by in silico screening methods 2. Brenner v Manson, 383 US 519, 536, 148 does not comply with enablement, USPQ 689, 696 (1966). support, clarity and/or written 3. 2002 W.L. 31497300 (Fed. Cir. Nov. 8, description. 2002). In a case where the description gives no 4. Id.at1 (internal citations omitted). working examples of identifying compounds using the atomic coordinates 5. OJ EPO June 2002, pp. 275–343. of the protein, and the difference between 6. See Japanese Patent Office website, Requirements for Patentability (URL: the prior art and the claimed invention as http://www.deux.JPO.go.jp/cgi/search. a whole is limited to atomic coordinates cgi?query¼method+of+medical+ stored on or employed by a machine, the treatment&lang¼en&root¼short/ last visited claim for in silico screening method does 11th March, 2003). not comply with one or more of the 7. See, generally, Martin, T. (2000), ‘Patentability of methods of medical treatment: A requirements of patent eligible subject comparative study’, J. Pat. Trademark Off. Soc., matter, statutory invention, industrial Vol. 82, p. 381. applicability (application), utility, 8. See Section 29(1) of the Japanese Patent Law. enablement, support, clarity, written See also, Part II, Chap. 1(2.1) on industrial description, novelty, inventive step and/ inapplicability. or non-obviousness. 9. Supra, note 6 at 397.

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10. Id. 32. See Constant v Advanced Micro-Devices, Inc., 848 F.2d 1560, 1575 (Fed. Cir. 1988). 11. See In re Wands, 858 F.2d 731 (Fed. Cir. 1988). 33. See Lindemann Maschinefabrik v American 12. See Wands, 858 F.2d at 737. Hoist & Derrick Co., 730 F.2d 1452, 1548 13. See Art. 83 EPC. (Fed. Cir. 1984). 14. See 66 F.R. 1099. 34. See, eg, ACS Hosp. Sys., Inc. v Montefiore Hosp., 732 F.2d 1572, 1577 (Fed. Cir 1984); In re 15. Id. at 1104–05 (internal citations omitted). Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). 16. 568 F.2d 1349 (CCPA 1978). 35. 383 US 1 (1966). 17. Id. at 1351–52. 36. See id. 18. See Vas-Cath, Inc. v Mahurkar, 935 F.2d 1555, 37. See id. 1563–64 (Fed. Cir. 1991). 38. In re Baird, 29 USPQ2d 1550, 1552 (Fed. Cir. 19. Fiers v Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1994). 1983). 39. 149 F.3d 1368 (Fed. Cir. 1998). 20. See id., 984 F.2d at 1169–71. 21. See id.; see also Regents of the Univ. of Cal. v Eli 40. See Guffey, L. J. (2000), 33 Maryland Bar J., Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997). Vol. 25 (2000). 22. See In re Borkowski, 422 F.2d 904 (CCPA 41. See, eg, US Patent No. 6,185,561 (relating to 1970). computer systems and more particularly to computer systems for mining information 23. See id. at 909. (‘If the scope of the subject about gene expression levels. Claim 1 reads: ‘A matter embraced by a claim is clear, and if the computer based method for mining a plurality applicant has not otherwise indicated that he of experiment information for a pattern, said intends that claim to be of a different scope, method comprising: collecting expression then the claim does particularly point out and levels of a plurality of genes in said plurality of distinctly claim the subject matter which the experiments, wherein said expression levels are applicant regards as his invention.’) measured using nucleic acid microarray chips; collecting a plurality of attributes from 24. See Solomon v Kimberly-Clark Corporation, 216 experiments and designs of said chips; defining F.3d 1372, 1379 (Fed. Cir. 2000). (‘As has at least one of a plurality of groupings for said been noted in the context of definiteness, the experiments to be mined; selecting based upon inquiry under section 112, paragraph 2, now said at least one of a plurality of groupings, focuses on whether the claims, as interpreted information about said plurality of experiments in view of the written description, adequately to be mined, forming a plurality of resulting perform their function of notifying the public information, said plurality of resulting of the patentee’s right to exclude.’) information including at least a resulting gene 25. See Atmel Corporation v Information Storage set and said expression levels for genes of said Devices, Inc., 198 F.3d 1374, 1378 (Fed. Cir. resulting gene set; and formatting said plurality 1999). (Noting that ‘as a general matter, it is of resulting information for viewing by a well-established that the determination user.’) whether a claim is invalid as indefinite’ is 42. H.R. 5364, 106th Congress (2000). dependent upon whether those skilled in the art would understand the scope of the claim 43. See Loew’s Drive-In Theatres, Inc., v Park-In when the claim is read in light of the Theatres, Inc. 174 F.2d 547 (1st Cir. 1949). specification.) 44. See U.S. Credit System Co. v American Indemnity 26. See In re Cohn, 438 F.2d 989 (CCPA 1971). Co., 59 F. 139 (2nd Cir 1893). 27. See the Decision of the Technical Board of 45. See Hotel Checking Co. v Lorraine Co., 160 F. Appeal T409/91. 467 (2nd Cir. 1908). 28. See the Decision of the Technical Board of 46. See In re Wait, 24 USPQ 88 (CCPA 1934). Appeal T435/91. 47. See In re Patton, 127 F.2d 324 (CCPA 1942). 29. See, Japanese Patent Office website, Clarity and Enablement (URL: http://www. 48. See 35 USC }101 (‘Whoever invents or deux.JPO.go.jp/cgi/search.cgi?query discovers any new or useful process, machine, ¼enablement&lang¼en&root¼short/ last manufacture, or composition of matter, or any visited 11th March, 2003). new and useful improvement thereof, may obtain a patent therefor, subject to the 30. Id. conditions and requirements of this title.’). 31. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 49. 160 F. 467 (2nd Cir. 1908). 1990); W. L. Gore & Assoc. v Garlock, Inc., 721 F.2d 1540, 1544 (Fed. Cir. 1983). 50. Id. at 469.

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51. 9 USPQ 2nd 1819 (PTO Bd. Pat. App. & Int’f (URL: http://www.USPTO.gov/web/tws/ 1988). gen-1.htm) (last visited 11th March, 2003). 52. Id. at 1820. 61. United States Patent & Trademark Office (URL: http://www.USPTO.gov/web/tws/ 53. Scheinfeld, R. C. and Bagley, P. H. (1998), sr-3-b3b-ad.htm last visited 11th March, ‘State Street: ‘‘Virtually anything is 2003). patentable’’ ’, New York Law J., 23rd September, p. 3. 62. See id. 54. 149 F.3d 1368 (Fed. Cir. 1998). 63. See id. 55. State Street, at 1371–72. 64. See id. 56. Id. at 1375. 65. United States Patent & Trademark Office (URL: http://www.USPTO.gov/web/tws/ 57. Id. wm4/wm4_3d_rE.P.O.rt.htm last visited 13th January, 2003). 58. See id. 66. See id. 59. Diamond v Chakrabarty, 447 US 303, 309 (1980). 67. Id. 60. United States Patent & Trademark Office 68. See id.

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