Patent first, ask questions later: morality and biotechnology in patent law

This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article explores how the United States has come to be in this position, exposes latent problems with the "patent first" approach, and considers the benefits and disadvantages of the "ask questions first, patents later" approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.     

The contract theory of patents

Two distinct theories of patents, the “reward theory” and the “contract theory,” are customarily adopted by the courts to justify the patent system. The reward theory maintains that the function of the patent system is to remunerate successful innovators so as to encourage R&D effort. In contrast, the contract theory holds that the function of the patent system is to promote the diffusion of innovative knowledge. Assuming that in the absence of patent protection innovators would rely on trade secrecy, it views patents as a contract between innovators and society whereby a property right is granted in exchange for disclosure.This paper develops an economic analysis of the contract theory of patents. To disentangle the disclosure from the reward motive for granting patents, we assume that the innovation process is entirely serendipitous, so that R&D effort is not a concern. Our main finding is that the disclosure motive alone suffices to justify the grant of patents. The optimal patent duration should strike a balance between the incentive to induce disclosure and the aim of limiting the monopoly distortion induced by patents.     

DNA as patentable subject matter and a narrow framework for addressing the perceived problems caused by gene patents

Concerns about the alleged harmful effects of gene patents--including hindered research and innovation and impeded patient access to high-quality genetic diagnostic tests--have resulted in overreactions from the public and throughout the legal profession. These overreactions are exemplified by Association for Molecular Pathology v. U.S. Patent and Trademark Office, a 2010 case in the Southern District of New York that held that isolated DNA is unpatentable subject matter under 35 U.S.C. § 101. The problem with these responses is that they fail to adequately consider the role that gene patents and patents on similar biomolecules play in facilitating investment in the costly and risky developmental processes required to transform the underlying inventions into marketable products. Accordingly, a more precisely refined solution is advisable. This Note proposes a narrowly tailored set of solutions to address the concerns about gene patents without destroying the incentives for companies to create and commercialize inventions derived from these and similar patents.     

The nexus between science and industry: evidence from faculty inventions

Knowledge transfer from science to industry has been shown to be beneficial for the corporate partner. In order to get a better understanding of the reasons behind these positive effects, this study focuses on the junction of science and industry by comparing characteristics of academic inventions that are transferred to industry and those staying in the public sector. Academic inventions are identified via patent applications of German academic scientists. We find that academic patents assigned to corporations are more likely to enable firms reaping short term rather than, possibly more uncertain, long-run returns, in contrast to patents that stay in the public sector. Firms also strive for academic inventions with a high blocking potential in technology markets. Academic patents issued to corporations appear to reflect less complex inventions as compared to inventions that are patented by the public science sector.     

The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research

This case study presents the tale of the academic discovery of a rare mutation for early-onset Alzheimer''s disease that was patented by a sole inventor and licensed to a non-practicing entity (NPE), the Alzheimer''s Institute of America (AIA). Our aims are (1) to relate this story about patents, research tools, and impediments to medical progress, and (2) to inform ongoing debates about how patents affect research, disposition of university inventions, and the distribution of benefits from publicly funded research. We present an account of the hunt for Alzheimer''s genes, their patenting, assignment, and enforcement based on literature, litigation records and judicial decisions. While AIA''s litigation eventually failed, its suits against 18 defendants, including one university, one foundation, and three non-profit organizations were costly in court years, legal fees, and expert time. Reasons for the failure included non-disclosure of co-inventors, State laws on ownership and assignment of university inventions, and enablement. We discuss the policy implications of the litigation, questioning the value of patents in the research ecosystem and the role of NPEs (“patent trolls”) in biotechnological innovation. The case illustrates tactics that may be deployed against NPEs, including, avenues to invalidate patent claims, Authorization and Consent, legislative reforms specifically targeting NPEs, reforms in the America Invents Act, and judicial action and rules for judicial proceedings. In the highly competitive research environment of Alzheimer''s genetics in the 1990s, patents played a minor, subordinate role in spurring innovation. The case produces a mixed message about the patent system. It illustrates many mistakes in how patents were obtained, administered, and enforced, but, eventually, the legal system rectified these mistakes, albeit slowly, laboriously, and at great cost.     

Patent construction after Amgen: are patent claims construed more widely or narrowly than previously?

Legal context. This article considers the UK Courts' approachto patent construction since the House of Lords' decision inKirin-Amgen Inc v Hoechst Marion Roussel Limited, which washanded down in October 2004, and seeks to examine whether theUK Courts' construction of patents is wider or narrower thanpreviously. Key points. The available data appear to suggest that thereis little difference in outcome, whether the old Improver testis applied or the new Kirin-Amgen test; of more significanceremains the nature of the wording of the patent claims themselvesand the correct identification by the trial judge of the inventionunderlying the patent. Practical significance. By eschewing a literal approach andrefining the test used in order to ensure both compliance withthe EPC and consistency with courts in other European countries,the UK Courts continue to provide an attractive forum for resolutionof patent disputes.     

Biotechnological invention patents: a legal-economic analysis]

Not without controversy, patents have traditionally been considered as elements which stimulate and protect inventive activity. In this article, we look at the economic advantages of a patent system and also at the possible critcisms. We then examine the application of patents in modern biotechnology. After concluding that current intellectual property laws do not come out clearly against the protection of biotechnology inventions, we then review the proposals for European Union regulation in the form of a directive which would clarify patenting possibilities.     

Science Is Golden: Academic R&D and University Patents

Many studies have shown indirect effects of academic research by linking academic research to firm patents. However, since the Bayh-Dole Act, universities are allowed to patent inventions that were funded by federal money and to retain the royalties that these patents generate. As a consequence, universities now are interested in protecting their profitable discoveries, just like any commercial firm doing R&D. In this paper, we apply the econometric techniques traditionally used to estimate the patent production function of firms to data on the patents of American universities. We find that more money spent on academic research leads to more university patents, with elasticities that are similar to those found for commercial firms. In addition, we provide estimates of the effect of establishing a Technology Transfer Office on a university's patent output.     

论专利申请人之现有技术披露义务

问题专利产生了严重的社会后果,提高专利授权质量具有迫切性。高质量的现有技术检索是提高专利授权质量的前提,这在专利申请数量巨大的背景下显得尤为重要。专利申请人及其代理人在专利审查过程中,应向专利审查部门依诚信原则披露其所知悉的、对申请案之可专利性具有关键性价值的参考资料。建立具有法律效力的现有技术披露义务符合专利制度的立法目的和利益平衡原则,节约现有技术检索的社会成本,从而保障专利审查中现有技术检索的质量。我国《专利法》第36条规定了该义务,但没有规定相应的法律后果。我国应通过立法和司法两方面来完善申请人的现有技术披露义务。     

Patenting nanotechnology

Universities and companies are rushing to the patent office in record numbers to patent nanotechnology inventions. This rush to the patent office is so significant that many law firms have established nanotechnology practice groups and the U.S. Patent and Trademark Office has now created a new technology class designed to track nanotechnology products. Three big differences between the emerging science of nanotechnology and other inventions make the role of patents more significant in this arena than elsewhere. First, this is almost the first new field in a century in which the basic ideas are being patented at the outset. In many of the most important fields of invention over the past century--computer hardware, software, the Internet, even biotechnology--the basic building blocks of the field were either unpatented or the patents were made available to all users by government regulation. In others, patents were delayed by interferences for so long that the industry developed free from their influence. In nanotechnology, by contrast, companies and universities alike are patenting early and often. A second factor distinguishing nanotechnology is its unique cross-industry structure. Unlike other new industries, in which the patentees are largely actual or at least potential participants in the market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well. This overlap may significantly affect their incentives to license the patents. Finally, a large number of the basic nanotechnology patents have been issued to universities, which have become far more active in patenting in the last twenty-five years. While universities have no direct incentive to restrict competition, their interests may or may not align with the optimal implementation of building-block nanotechnology inventions. The result is a nascent market in which a patent thicket is in theory a serious risk. Whether it will prove a problem in practice depends in large part on how efficient the licensing market turns out to be.     

美国非显而易见性判定实践的误区和难点

非显而易见性要求是专利诉讼焦点之一,也是判定实践的难点之一,特别是对生物技术等一些新兴的领域。2009年Kubin案对非显而易见性的判定结果引发了关于基因专利非显而易见性的激烈讨论。通过结合相关实践案例分析,指出美国专利非显而易见性的判定实践的误区和难点。     

Is there still a place for gene patents in Australia? Implications of recent United States and European case law

This article considers the ramifications of recent United States and European litigation relating to patents claiming rights to genes associated with hereditary forms of breast cancer (the so-called BRCA genes) for recently commenced Australian litigation relating to the same subject matter. The article is contextualised with brief summaries of the relevant patent law, the science of genetics, the history of the BRCA genes and an overview of the activities of the patent holder. The analysis of first instance and appeal decisions on the validity of the United States BRCA patents shows the final outcome is still highly uncertain in that jurisdiction, while the European litigation provides little assistance in predicting the outcome of the Australian action. This article concludes that the outcome of the Australian litigation is an issue that cannot be determined with any certainty due to the lack of specific, relevant precedents both in Australia and in other jurisdictions.     

Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule

The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes.     

Recent developments in the patentability of software in the UK

Over the past few months there has been renewed debate at the UK Intellectual Property Office (“UK IPO”) and in the UK courts over whether computer programs can be considered patentable inventions. In particular, concern persists that the UK authorities and the European Patent Office (“EPO”) are applying different tests for the patentability of computer software, even though they are applying the same legislation. This article reviews the positions taken by the UK and the EPO tribunals, and how these impact upon businesses wishing to patent inventions encompassed in software.     

case Report —: BT HYPERLINK PATENT DISPUTE — DID BT INVENT THE HYPERLINK? OBVIOUSLY NOT AS THE US COURTS HAVE SAID SO

On 13 December 2000, British Telecom (BT) filed what must be one of the more unlikely patent infringement actions to have come before the courts recently. As a result of a routine review of its global patent portfolio, BT made the somewhat serendipitous discovery that it owns an old US patent which, according to BT, covers the concept of hyperlinking. The patent was granted in 1989 and is due to run until 2006. Similar patents were filed around the world, but have all now expired. This article explores the passage of the dispute in the US courts and explains how BT’s case came to flounder at the first hurdle.     

生物技术对专利制度的挑战与中国专利法修改探讨

蓬勃发展的现代生物技术已对传统专利制度形成了挑战。美国率先对基因、转基因技术授予专利 ,欧盟随之对生物技术发明出台法律保护指令 ,中国虽早有水稻等基因技术产品的发明与大面积种植 ,却在 2 0 0 1年修订的专利法中回避了生物技术发明的可专利性 ,使生物技术陷入努力开发但得不到充分法律保护的窘境。因此 ,阐明生物技术对专利制度的挑战 ,比较欧盟立法 ,探讨中国生物技术专利保护对生物技术发展的影响 ,及生物技术专利的国际合法性 ,对中国专利法修改提出意见 ,当前亟具意义     

Claim construction and the extent of patent protection: A comparative analysis of the Phillips en banc Federal Circuit decision

Legal context. The United Kingdom's House of Loads in Kirin-Amgenand the United States Court of Appeals for the Federal Circuitin Phillips addressed similar issues with respect to the methodologyof claim interpretation and the fundamental rules and policiesfor determining the extent of patent protection. This articlewill review Phillips and Kirin-Amgen from the comparative lawperspective. It will compare the UK and US rules and patentpolicies with their German and Japanese counterparts, discussingthe bases for these differences and examining them from theperspective of patent policies, specifically with respect tofair protection and legal certainty. Key points. Despite the use of the same rule and methodology,legal commentators and patent professionals emphasize the differencesin the extent of patent protection in different jurisdictions.Such differences result from the availability of the doctrineof equivalents. For jurisdictions such as the UK, the US andJapan, where courts seldom apply the doctrine of equivalents,the differences result from the way in which the courts conductclaim construction. These courts use the perspective of a hypotheticalperson to support a broad or narrow claim construction, reflectingthe weight given to the competing patent policies. Practical significance. This article cites key cases for claimconstruction and the doctrine of equivalents in four major patentjurisdictions: the UK, the US, Germany and Japan. Knowledgeof the case law trends in these jurisdictions is essential fordrafting patents documents and enforcing patents.     

The Proposal for a Directive on the Patentability of Computer-implemented Inventions

The European Commission Proposal for a Directive on the Patentability of Computer-implemented Inventions is an important step towards harmonising and clarifying the patent protection available for such inventions in European Member States. This paper discusses the proposed Directive, its potential impact and some initial reactions from those in the software industry. It outlines the background to the Proposal, discussing briefly the exclusion of computer programs 'as such' from patent protection under the European Patent Convention (EPC). The paper observes that, in its current form, the proposed Directive will narrow the protection currently available to patentees and that some thought should be given to transitional provisions. It concludes that, whatever balance is struck as the Directive progresses to adoption, the Directive will have the benefit of providing a mechanism for aligning the approach of European Member States to patenting computer-implemented inventions. 'Educational initiatives' may, however, be required if European companies, in particular Small and Mediumsized Enterprises (SMEs), are, as intended by the Commission, to view the harmonization and greater transparency provided by the proposed Directive as an incentive to use patents to exploit their computer-implemented inventions.