Patentable subject matter determinations are ultimately based not on judicial doctrines, tests, statutes, or even on the economic rationales underlying the patent system; rather, the fundamental touchstone for what qualifies as patentable technology is simply intuition. Specifically, despite the Federal Circuit's rejection of "technological arts" as a linguistically bright-line test, patentable subject matter decisions inevitably devolve into what is, at base, an intuitive sense of what constitutes technology of the type protectable under the patient system.
Half man, half bull, the Minotaur was the most fearsome monster in Greek mythology. Human torso and bull's head, its horns were sharp as knives, its great hooves could kick the life out the strongest of heroes, and its food was human flesh. Yet under the surface, the Minotaur's myth was sad; his insatiable existence originated in jealousy and lust.
Full-text available at SSRN. See link in this record. ; The patent systems of most countries have gradually extended patent protection to inventions involving, and even consisting of, living organisms. In fact, the World Trade Organization ("WTO") Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS") mandates that, in all of its member countries, "patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application." By allowing member countries to deny patentability to "plants and animals other than micro-organisms," TRIPS implies that the default rule is that the full range of organisms, from microbes to macrobes, are indeed potentially patentable subject matter. Canada represents a marked exception. The Supreme Court of Canada ("Supreme Court") negated the patentability of animals and plants, in general, and a genetically engineered mouse, in particular, despite the fact that Canadian statutory patent law is silent on the issue. Although the Canadian government had never availed itself of the escape clause of TRIPS Article 27(3)(b), which allows member states to exclude from patentability "plants and animals other than micro-organisms," a bare majority of the Supreme Court divined that the intent of Parliament was to exclude "higher life forms" from patentability. The Supreme Court variously justified its decision on the basis of "commonly understood" distinctions of "higher" and "lower" life forms, and the striking hypothesis that "higher," though not "lower," life forms "transcend" their genomes. The Supreme Court offered no scientific evidence whatsoever to justify its demarcation of the border between patentable and unpatentable organisms, nor could they because no scientific evidence exists. Failing to cite supporting evidence in this way might be acceptable if the science purported to underlie the decision were self-evident, either through ...
Traditional medicines have and will continue to form the basis of modern pharmaceuticals. Many indigenous communities are claiming rights in pharmaceuticals derived from their traditional medicine. In the past, such knowledge derived from non-western communities was largely regarded as free information. This has led some to attack the patent system as an ex-ploitative tool of the developed world. The first part of this analysis deals with the kind of protection provided in national legislation. Methods of protecting traditional medicine in India and China receive special attention. The second major issue covered in this volume is the kind of protection offered to TM of other countries in the west, including international agreements. America is a particular focus, as it is here that many of the battles over patenting traditional medicine are fought. While no uncon-troversial answers can be given in this debate, at least the relative strengths and weaknesses of various positions can be assessed. Dr. Murray Eiland received a doctorate in Oriental Archaeology from Oxford University and an LLM from the Munich Intellectual Property Law Center. He currently works at Charles Henry & Co., London as a (non-practising) Barrister.
The landscape for patenting products and processes tied to the natural world has changed dramatically in recent times as a result of a series of decisions of the US Supreme Court, particularly Mayo Collaborative Services v Prometheus Laboratories 566 U.S. 66 (2012) and Association for Molecular Pathology v Myriad Genetics, Inc. 569 U.S. 576 (2013) (Myriad). This article critically analyses these decisions and the multitude of lower court decisions that have followed them. This analysis provides support for the growing concern in the United States that it will be increasingly difficult to use the patent system to encourage the development of therapies and research intermediates useful in developing new therapeutic interventions. One option being posited in the industry to deal with this problem is to lobby Congress to reform the threshold patent eligibility standard in US patent law. It is argued in this paper that a more nuanced approach is preferable. Using the experience in Australia as a case study, this paper argues that such an approach is feasible. Australia has been chosen for analysis because the threshold patent eligibility standard is similar in both countries, much more so that with the European Union, and because the highest court in Australia has ruled on essentially the same patent as in Myriad, in D'Arcy v Myriad Genetics, Inc [2015] HCA 35. In addition to the nuanced approach to eligibility currently exercised by the Australian courts and patent office, Australia also has a number of post-grant options for addressing the dynamics of patent monopolies. These include experimental use, compulsory licensing, and government use. It is concluded that, while it would be impractical to attempt to replicate the Australian environment in the United States, there is no reason why some lessons can't be learned from the Australian experience with patenting nature.
"This report examines the use of intellectual property rights in Federal technology transfer, focusing primarily on the Agricultural Research Service (ARS). ARS uses patenting and licensing when a technology requires additional development by a private sector partner to yield a marketable product. Licensing revenue is not a major motivation. Greater use of patenting and licensing by ARS has not reduced the use of traditional instruments of technology transfer such as scientific publication. The structure of licensing agreements affects technology transfer outcomes. Mutually advantageous revisions to license terms may at times maintain the incentives through which private companies distribute the benefits of public research." ---Taken from website. ; ERR15 ; Cover title. ; Bibliography on pg. ?. ; "This report examines the use of intellectual property rights in Federal technology transfer, focusing primarily on the Agricultural Research Service (ARS). ARS uses patenting and licensing when a technology requires additional development by a private sector partner to yield a marketable product. Licensing revenue is not a major motivation. Greater use of patenting and licensing by ARS has not reduced the use of traditional instruments of technology transfer such as scientific publication. The structure of licensing agreements affects technology transfer outcomes. Mutually advantageous revisions to license terms may at times maintain the incentives through which private companies distribute the benefits of public research." ---Taken from website. ; Mode of access: Internet.
We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO). Our analyses of fractionalized inventorships demonstrate that women's rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely to occur in academic institutions than in corporate or government environments. However, women's patents have a lower technological impact than that of men, and that gap is wider in the case of academic patents. We also provide evidence that patents to which women—and in particular academic women—contributed are associated with a higher number of International Patent Classification (IPC) codes and co-inventors than men. The policy implications of these disparities and academic setting advantages are discussed.
This article considers the efforts of the Australian Law Reform Commission to clarify the meaning of section 18(2) of the Australian Patents Act 1990 (Cth): 'Human beings and the biological processes for their generation are not patentable inventions.' It provides a critique of the proposals of the Commission with respect to patent law and stem cell research. The Commission has recommended that IP Australia should develop examination guidelines to explain how the criteria for patentability apply to inventions involving stem cell technologies. It has advised the Australian Government that the practice code of the United Kingdom Patent Office (UKPO) would be a good model for such guidelines, with its distinction between totipotent and pluripotent stem cells. Arguably, though, there is a need to codify this proposal in a legislative directive, and not merely in examination guidelines. The Commission has been reluctant to take account of the ethical considerations with respect to patent law and stem cell research. There could be greater scope for such considerations, by the use of expert advisory boards, opposition proceedings and the requirement of informed consent. The Commission has put forward a number of general and specific recommendations to enhance access to patented stem cell technologies. It recommends the development of a research exemption, and the modernisation of compulsory licensing and crown use provisions. It also explores the establishment of a stem cell bank and the promulgation of guidelines by funding agencies. Such proposals to promote greater public access to stem cell research are to be welcomed. 2004
This article considers the efforts of the Australian Law Reform Commission to clarify the meaning of section 18(2) of the Australian Patents Act 1990 (Cth): 'Human beings and the biological processes for their generation are not patentable inventions.' It provides a critique of the proposals of the Commission with respect to patent law and stem cell research. The Commission has recommended that IP Australia should develop examination guidelines to explain how the criteria for patentability apply to inventions involving stem cell technologies. It has advised the Australian Government that the practice code of the United Kingdom Patent Office (UKPO) would be a good model for such guidelines, with its distinction between totipotent and pluripotent stem cells. Arguably, though, there is a need to codify this proposal in a legislative directive, and not merely in examination guidelines. The Commission has been reluctant to take account of the ethical considerations with respect to patent law and stem cell research. There could be greater scope for such considerations, by the use of expert advisory boards, opposition proceedings and the requirement of informed consent. The Commission has put forward a number of general and specific recommendations to enhance access to patented stem cell technologies. It recommends the development of a research exemption, and the modernisation of compulsory licensing and crown use provisions. It also explores the establishment of a stem cell bank and the promulgation of guidelines by funding agencies. Such proposals to promote greater public access to stem cell research are to be welcomed. 2004
I weigh the arguments for and against the patenting of functional DNA sequences including genes, and find the objections to be compelling. Is an outright ban on DNA patenting the right policy response? Not necessarily. Governments may wish to consider options ranging from patent law reforms to the creation of new rights. There are alternative ways to protect DNA sequences that industry may choose if DNA patenting is restricted or banned. Some of these alternatives may be more harmful than patents. Such unintended consequences of patent bans mean that we should think hard before concluding that prohibition is the only response to legitimate concerns about the appropriateness of patents in the field of human genomics.
The patent system of the People's Republic of China has only a history of about 30 years, yet it hasundergone three major policy changes to keep up with the tremendous pace of economic and technologicalprogress in China. Once a country in which technological advance relies primarily on copyingand imitating foreign innovations, China is gradually shifting towards a regime that emphasizes onstrong intellectual property and indigenous innovation. It is fascinating, therefore, to witness this transition.It is important to enhance my understanding of the patent regime as a mechanism to promoteinnovation and the dissemination of knowledge, as is the purpose of the thesis.Both of the chapters in this dissertation focus on patent applicants' preference for how quickly theywant their patent applications to be processed. This is nontrivial primarily due to heterogeneity in firmcharacteristics, nature of invention, market structure, technology backgrounds and many unobservablefactors. I propose two factors that partially determine an inventor's preference for speed of patenting:the inter-temporal value patents of their invention and the speed of technological progress.The first chapter investigates the heterogeneous inter-temporal patterns of inventions' value flowand the associated applicants' patenting strategies for a small set of United States patents. To measurethe characteristics of different inventions' inter-temporal value flow, we exploit a policy lever providedby the Chinese government that allows patent applicants to freely choose between one patentprotection of short examination delay, short protection period and another patent protection of longexamination delay, long protection period. We find that the majority of applicants that favor the formerprotection (short&shot) have Electronics and Mechanics inventions, whereas applicants that favorthe latter (long&long) are mostly within Pharmaceuticals and Drugs. We then exploit this variationin patent choices under the Chinese regime with applicants' patenting strategies in the U.S., for identicalinventions. The empirical results suggest the short&short Chinese patent holders have a strongtendency of pursuing early U.S. patent issuance whereas the long&long patent holders have a strongtendency of maintaining their U.S. patents for long periods. The results are robust with or withouttechnology field fixed effects.The second chapter analyze the effect of faster technology development on firms patenting strategy.Using a dataset with information about patent applications in both China and the US, I find thatfirms are willing to secure early patent grants when technology moves ahead faster. The conventionalwisdom that a patent secures a flow of monopoly profits that depreciates at a constant speed over timeis not consistent with my empirical findings. Faster technology progress shifts the profits towards theearly periods, making early grants more important. The empirical results suggest that a more flexiblepatent regime which offers options for speed is more efficient.
This policy paper on science-industry technology transfer has four emphases: the rationale of recent changes in German science policy, the contribution of diverse transfer channels to economic development as well as the role of IPR in that context, the differences in the institutional framework between Europe and USA regarding academic patenting, and the organisational design of technology transfer offices (TTOs). The extensive literature review highlights the importance of TTOs, the necessity of supporting manifold transfer channels, and continuous government funding of intermediaries. Important open research questions are the relative importance of transfer channels and the optimal size of TTOs.
Not Available ; Intellectual property rights (IPRs) can be broadly defined as legal rights established over creative or inventive ideas. Such legal rights generally allow right holders to exclude the unauthorized commercial use of their creations/inventions by third persons. The rationale for the establishment of a legal framework on IPRs is that it is a signal to society that creative and inventive ideas will be rewarded. This does not mean that there is no other way of rewarding such ideas or that this system is absolutely necessary, even less sufficient, to reward inventiveness or creativity. Nevertheless, it would be difficult to deny that IPRs do have a role to play in setting up of any such reward system. There are two broad categories of IPRs: one, industrial property2 covering IPRs such as patents, trademarks, geographical indications and industrial designs; two, copyright and related rights covering artistic and literary works, performances, broadcasts and the like. IPRs that do not fit into this classical division are termed sui generis, meaning one-of-its-kind. Such sui generis rights include those covering lay-out designs of semi conductor chips and plant breeders' rights. This paper will in the next section distinguish the IPRs relevant to agriculture and explain these rights. In Section III the international intellectual property law for these rights will be described. Section IV sets out India's international obligations vis-a-vis her own IPR laws and Section V goes on to an analysis of the public debate in India on the controversial IPRs and the status of the legislation on these. This paper concludes in Section VI with prescriptions for public policy on IPRs and agriculture in India. ; Not Available
Despite the decline in the discovery of new chemical entities for pharmaceutical use, there is a significant proliferation of patents on products and processes that cover minor, incremental innovations. A study conducted in five developing countries - Argentina, Brazil, Colombia, India and South Africa - evidenced a significant proliferation of 'evergreening' pharmaceutical patents that can block generic competition and thereby limit access to medicines. It also found that both the nature of pharmaceutical learning and innovation and the interest of public health are best served in a framework where rigorous standards of inventive step are used to grant patents. The analysis suggests that local firms in developing countries are better supported in a framework where patent protection for minor incremental innovations is not allowed. The study also suggests that with the application of well-defined patentability standards, governments could avoid spending the political capital necessary to grant and sustain compulsory licenses/government use. If patent applications were correctly scrutinized, there would be no need to have recourse to such measures.
Bioengineered bugs, as is the scope of this journal, have great potential in various practical applications. A corollary to bringing useful products to the market is that such products need protection from copying by other people or businesses. Such government-sponsored protections are legally enforced through a patent, copyright or trademark/trade secret system commonly known as intellectual property rights. A condition for obtaining a patent is that the invention must not be disclosed to public either through seminars, informal public disclosures or publications in journals, although in the United States, there is a one year grace period that is allowed to obtain a patent after public disclosure. This article describes my personal experience in obtaining a patent in 1980 on a genetically manipulated bacterium designed for oil spill cleanup. This patent application went through a series of court cases that finally ended up in the Supreme Court of the United States. I also mention a similar contentious legal issue that is on the horizon and that the readers of Bioengineered Bugs should be aware of. Finally, I have taken the opportunity to describe my current efforts to bring to the market some unique potential multi-disease-targeting candidate drugs from Pseudomonas aeruginosa and gonococci/meningococci that, if found non-toxic and efficacious in humans, will revolutionize the drug industry. To ensure their marketability, we are trying to develop a patent portfolio that will ensure that they will be legally protected and such protections will be broad-based and enforceable.
