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Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution's hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

Intellectual property rights (IPRs) have increasing impacts on plant breeding. Not only varieties but also germplasm and technologies are protected. Intellectual property has also affected corporate concentration in the seed supply chain. While not very controversial in the USA, it is increasingly controversial in Europe after rulings on plant patents concerning nontransgenic crops in 2015. Both political and industry voices call for new interpretations or legislations. Industry initiatives have opened facilitated patent access systems designated 'free access, but not access for free'. Although praiseworthy, they are voluntary and so far limited to vegetable crops. This Opinion article suggests a mandatory system of declaring IPR use linked to variety registration. This compulsory licensing system with 'toll roads, not road blocks', is likely to reward IPRs without delaying breeding progress., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

The article explores limits within patent law for the constitutionalization of Intellectual Property Rights and the governance of synthetic biology in human health. To this end, it starts by explaining the inherent rationales of two fundamental limits within European patent law, namely (1) the boundary between discovery and invention (Art. 52 EPC); (2) the ordre public and public policy clause (Art. 53 (a) EPC). Both these exclusions from patent eligibility bear a normative function but rely on opposing inherent logics, functions, and regulatory aims. While in the first type of logics, "enabling access for all" is the guiding principle, in the second, converse logics, no one should have access to the technological knowledge in question. The second part contends that decisions on whether and how to grant patents in synthetic biology are not independent from institutional frameworks: The arena in which synthetic biology patenting will be dealt with will be decisive for whether and how boundaries will be deployed. From a political science perspective, the administrative, legislative and judicial arena can be distinguished. If synthetic biology will be negotiated in the legislative arena, in particular in the European Parliament, the probabilities will be higher that either the discovery clause or the ordre public clause will be applied. In contrast, patent offices and courts have, at least in the past decades, employed a narrow interpretation of these absolute exemptions from patentability and hardly ever used them. The third part asserts that metaphoric framing of synthetic biology is another crucial factor for patentability questions. Semantic framing may relate to the articulation and mobilization of consent or dissent, and thus public acceptance of synthetic biology. Whether applications of synthetic biology are conceived as "natural" or "synthetic" DNA may have an influence on whether patenting might become contested as "patenting life" or accepted as novel, and also on passing the inventive step and industrial application tests. Proceeding in such a manner can be regarded as "upstreaming" ethics, anticipatory impact assessment, and policy analysis in the biosciences and as a tool for constitutionalizing intellectual property rights.

This essay analyzes how academic institutions, government agencies, and the nascent biotech industry contested the legal ownership of recombinant DNA technology in the name of the public interest. It reconstructs the way a small but influential group of government officials and university research administrators introduced a new framework for the commercialization of academic research in the context of a national debate over scientific research's contributions to American economic prosperity and public health. They claimed that private ownership of inventions arising from public support would provide a powerful means to liberate biomedical discoveries for public benefit. This articulation of the causal link between private ownership and the public interest, it is argued, justified a new set of expectations about the use of research results arising from government or public support, in which commercialization became a new public obligation for academic researchers. By highlighting the broader economic and legal shifts that prompted the reconfiguration of the ownership of public knowledge in late twentieth-century American capitalism, the essay examines the threads of policy-informed legal ideas that came together to affirm private ownership of biomedical knowledge as germane to the public interest in the coming of age of biotechnology and genetic medicine.

Software ownership allows the owner to restrict the distribution of software and to prevent others from reading the software's source code and building upon it. However, free software is released to users under software licenses that give them the right to read the source code, modify it, reuse it, and distribute the software to others. Proponents of free software such as Richard M. Stallman and Eben Moglen argue that the social disutility of software ownership is a sufficient justification for prohibiting it. This social disutility includes the social instability of disregarding laws and agreements covering software use and distribution, inequality of software access, and the inability to help others by sharing software with them. Here I consider these and other social disutility claims against withholding specific software rights from users, in particular, the rights to read the source code, duplicate, distribute, modify, imitate, and reuse portions of the software within new programs. I find that generally while withholding these rights from software users does cause some degree of social disutility, only the rights to duplicate, modify and imitate cannot legitimately be denied to users on this basis. The social disutility of withholding the rights to distribute the software, read its source code and reuse portions of it in new programs is insufficient to prohibit software owners from denying them to users. A compromise between the software owner and user can minimise the social disutility of withholding these particular rights from users. However, the social disutility caused by software patents is sufficient for rejecting such patents as they restrict the methods of reducing social disutility possible with other forms of software ownership.

Moore v. Regents of the University of California was one of the first cases internationally that dealt with the patenting of human genetic material. The case is closely related to the development of medicine and of biotechnology applied to medicine. These developments require the utilisation of human body parts, both for experiments and for transplant, and present certain major medico-legal problems. However, the case did not produce conclusive decisions on the various key legal issues that it raised involved in biomedical research and the patenting of human genetic material. This article re-examines the case from an Indian and an international perspective. After a brief introduction in Part I, Part II of the article describes existing laws in various countries with respect to the patenting of human genetic material. Part III discusses legal regimes applicable in the context of biological materials. Part IV elaborates on the importance of the doctrine of informed consent in the context of biomedical research on human subjects. Part V discusses the significance of bioethics in research and the patenting of biotechnology, according to international law. Part VI concludes the article with an assertion of the urgent need for legislation in this area.

Purpose: Fragmented ownership of diagnostic gene patents has the potential to create an "anticommons" in the area of genomic diagnostics, making it difficult and expensive to assemble the patent rights necessary to develop a panel of genetic tests. The objectives of this study were to identify US patents that protect existing panels of genetic tests, describe how (or if) test providers acquired rights to these patents, and determine if fragmented patent ownership has inhibited the commercialization of these panels., Methods: As case studies, we selected four clinical applications of genetic testing (cystic fibrosis, maturity-onset diabetes of the young, long QT syndrome, and hereditary breast cancer) that use tests protected by > or =3 US patents. We summarized publically available information on relevant patents, test providers, licenses, and litigation., Results: For each case study, all tests of major genes/mutations were patented, and at least one party held the collective rights to conduct all relevant tests, often as a result of licensing agreements., Conclusions: We did not find evidence that fragmentation of patent rights has inhibited commercialization of genetic testing services. However, as knowledge of genetic susceptibility increases, it will be important to consider the potential consequences of fragmented ownership of diagnostic gene patents.

Background: In the past, many surgeons could practise their craft with little or no knowledge of patent law. But in the world of robotic and computerized surgery, this is increasingly a myopic approach, because the principle means of protecting high-tech surgical instruments is through the application of patent law. The issue is: does the Brookhill-Wilk patent, which covers the performance of remote robotic surgery, impede the growth of cybersurgery?, Methods: Review of the Brookhill-Wilk patent and relevant law., Results: Patent law, which first took its form in the Middle Ages, attempts to balance the rewarding of innovation with the stifling of market growth. Using US patent law as a model, it would appear that the Brookhill-Wilk patent, a particular example of a medical process patent, could inhibit the growth of cybersurgery, as potential sums of money could be demanded by the patent holder from anyone who practises cybersurgery. However, two recent US Supreme Court cases appear to have seriously undermined the validity of a number of medical process patents, including the Brookhill-Wilk patent., Conclusion: Based on recent changes in patent law, it is not expected that Brookhill-Wilk patent will hinder the growth of cybersurgery.

This article reviews the Full Federal Court decision in Grant v Commissioner of Patents (2006) 154 FCR 62; 69 IPR 221; [2006] FCAFC 120 denying patentability to a method for structuring a financial transaction so as to protect an individual's assets from a loss of ownership as a result of a legal liability. The article challenges the distinctions drawn by the Full Federal Court and argues that the decision marks a new development in setting a boundary for the Patents Act 1990 (Cth) "manner of manufacture". The article concludese that important questions now arise in assessing the possible application of the Patents Act 1990 (Cth) to promoting some inventions (and innovations) and not others, and whether there are other classes of inventions that also do not require the Patents Act 1990 (Cth) incentives.

The recently decided eBay and MedImmune cases interject both reassurance and uncertainty into the present patent licensing landscape, affecting the strategic decisions to be considered during negotiations.

With the advent of molecular biology, genomics, and proteomics, the intersection between science and law has become increasingly significant. In addition to the ethical and legal concerns surrounding the collection, storage, and use of genomic data, patent disputes for new biotechnologies are quickly becoming part of mainstream business discussions. Under current patent law, new technologies cannot be patented if they are "obvious" changes to an existing patent. The definition of "obvious," therefore, has a huge impact on determining whether a patent is granted. For example, are modifications to microarray protocols, popular in diagnostic medicine, considered "obvious" improvements of previous products? Also, inventions that are readily apparent now may not have been obvious when discovered. Polymerase chain reaction, or PCR, is now a common component of every biologist's toolbox and seems like an obvious invention, though it clearly was not in 1983. Thus, there is also a temporal component that complicates the interpretation of an invention's obviousness. The following article discusses how a recent Supreme Court decision has altered the definition of "obviousness" in patent disputes. By examining how the obviousness standard has changed, the article illuminates how legal definitions that seem wholly unrelated to biology or medicine could still potentially have enormous effects on these fields.

This essay identifies two legal lineages underlying the common heritage concept, and applies each to the human genome. The essay notes some advantages and disadvantages of each approach, and argues that patenting of human genes would be allowable under either approach.

This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells.

Big pharma's business model, which relies on a few blockbusters to generate profits, is clearly broken. Patent expiration on numerous blockbusters in recent years is already altering the drug landscape. Drug companies are also facing other challenges that necessitate development and implementation of novel R&D strategies, including those that focus on nanotechnology and miniaturization. Clearly, there is enormous excitement and expectation regarding nanomedicine's potential impact. However, securing valid and defensible patent protection will be critical. Although early forecasts for nanomedicine commercialization are encouraging, there are numerous bottlenecks as well. One of the major hurdles is an emerging thicket of patent claims, resulting primarily from patent proliferation as well as continued issuance of surprisingly broad patents by the US Patent and Trademark Office (PTO). Adding to this confusion is the fact that the US National Nanotechnology Initiative's widely cited definition of nanotechnology is inaccurate and irrelevant from a nanomedicine perspective. It is also the cause of the inadequate patent classification system that was recently unveiled by the PTO. All of this is creating a chaotic, tangled patent landscape in various sectors of nanomedicine where the competing players are unsure of the validity and enforceability of numerous issued patents. If this trend continues, it could stifle competition and limit access to some inventions. Therefore, reforms are urgently needed at the PTO to address problems ranging from poor patent quality and questionable examination practices to inadequate search capabilities, rising attrition, poor employee morale and a skyrocketing patent application backlog. Only a robust patent system will stimulate the development of commercially viable nanomedicine products that can drastically improve a patient's quality of life and reduce healthcare costs.

Debates on patenting DNA must evolve to reflect the global decline in filings and regional disparities in patenting activity.