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 patentability in the USA, Southampton, UK, office of D. Young & Co. Samuel H. Megerditchian Europe and Japan 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 intellectual property. The patent offices of these three economies issue the vast majority of the world’s patents 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 Trademark 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 inventor 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 & HENRY STEWART PUBLICATIONS 1478-565X. JOURNAL OF COMMERCIAL BIOTECHNOLOGY. VOL 9. NO 4. 305–331. JUNE 2003 3 0 5 Kowalski, Maschio and Megerditchian the patented invention 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 patent application. 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 prior art (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: utility, 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); 306 & HENRY STEWART PUBLICATIONS 1478-565X. JOURNAL OF COMMERCIAL BIOTECHNOLOGY. VOL 9. NO 4. 305–331. JUNE 2003 Dominating global intellectual property Table 1: Applicable sections/articles of respective patent laws Patentable subject matter/ Industrial applicability/ Enablement/support/ Novelty/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 Japanese Patent Law 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 inventions: 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 & HENRY STEWART PUBLICATIONS 1478-565X.