Law Commons^™

U.S. Executive Branch Patent Policy, Global And Domestic, Arti K. Rai

Faculty Scholarship

No abstract provided.

Diagnostic Patents At The Supreme Court, Arti K. Rai

Faculty Scholarship

No abstract provided.

Biomedical Patents At The Supreme Court: A Path Forward, Arti K. Rai

Faculty Scholarship

Although most would argue that software patents pose a bigger challenge, the U.S. Supreme Court has recently focused on biomedical patents. Two of the Court's recent decisions scaling back such patents, Mayo v. Prometheus and AMP v. Myriad, have provoked justifiable anxiety for those concerned about biomedical innovation, particularly in the area of personalized medicine. While acknowledging significant limitations in the Court's reasoning in both cases, this Essay sketches a reading that is consistent with the results and innovation-friendly.

Improving (Software) Patent Quality Through The Administrative Process, Arti K. Rai

Faculty Scholarship

The available evidence indicates that patent quality, particularly in the area of software, needs improvement. This Article argues that even an agency as institutionally constrained as the U.S. Patent and Trademark Office (“PTO”) could implement a portfolio of pragmatic, cost-effective quality improvement strategies. The argument in favor of these strategies draws upon not only legal theory and doctrine but also new data from a PTO software examination unit with relatively strict practices. Strategies that resolve around Section 112 of the patent statute could usefully be deployed at the initial examination stage. Other strategies could be deployed within the new post-issuance …

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the lens …

Overcoming The Impasse On Intellectual Property And Climate Change At The Unfccc: A Way Forward, Jerome H. Reichman, Ahmed Abdel Latif, Keith Maskus, Ruth Okediji, Pedro Roffe

Faculty Scholarship

The global spotlight is once again focused on the challenges of climate change with the annual United Nations Framework Convention on Climate Change (UNFCCC) Conference of the Parties kicking off this week (November 28th–December 7th) in Durban, South Africa. With the international community looking to Durban for results, an important opportunity exists to address one of the most contentious – and misunderstood – issues in the climate change debate: the role of intellectual property rights in the production of and access to mitigation and adaptation technologies. The rapid development and diffusion of these technologies is a key component of the …

How Trade Secrecy Law Generates A Natural Semicommons Of Innovative Know-How, Jerome H. Reichman

Faculty Scholarship

No abstract provided.

University Software Ownership And Litigation: A First Examination, Arti K. Rai, John R. Allison, Bhaven N. Sampat, Colin Crossman

Faculty Scholarship

Software patents and university-owned patents represent two of the most controversial intellectual property developments of the last twenty-five years. Despite this reality, and concerns that universities act as "patent trolls" when they assert software patents in litigation against successful commercializers, no scholar has systematically examined the ownership and litigation of university software patents. In this Article, we present the first such examination. Our empirical research reveals that software patents represent a significant and growing proportion of university patent holdings. Additionally, the most important determinant of the number of software patents a university owns is not its research and development ("R&D") …

Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman

Faculty Scholarship

This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …

Intellectual Property In The Twenty-First Century: Will The Developing Countries Lead Or Follow?, Jerome H. Reichman

Faculty Scholarship

This article continues the author's contributions on the subject of intellectual property protection in developing countries, and focuses on how those developing countries with growing technological prowess should accommodate their own national systems of innovation to the worldwide intellectual property regime emerging in the post-TRIPS period, with a view to maximizing global economic welfare in the foreseeable future.

Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman

Faculty Scholarship

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …

Is Bayh-Dole Good For Developing Countries?: Lessons From The Us Experience, Arti K. Rai, Jerome H. Reichman, Robert Weissman, Amy Kapczynski, Robert Cook-Deegan, Bhaven N. Sampat, Anthony D. So

Faculty Scholarship

Recently, countries from China and Brazil to Malaysia and South Africa have passed laws promoting the patenting of publicly funded research, and a similar proposal is under legislative consideration in India. These initiatives are modeled in part on the United States Bayh-Dole Act of 1980. Bayh-Dole (BD) encouraged American universities to acquire patents on inventions resulting from government-funded research and to issue exclusive licenses to private firms, on the assumption that exclusive licensing creates incentives to commercialize these inventions. A broader hope of BD, and the initiatives emulating it, was that patenting and licensing of public sector research would spur …

The Public Domain: Enclosing The Commons Of The Mind, James Boyle

Faculty Scholarship

Our music, our culture, our science and our economic welfare all depend on a delicate balance between those ideas that are controlled and those that are free, between intellectual property and the public domain. In his award-winning book, The Public Domain: Enclosing the Commons of the Mind (Yale University Press) James Boyle introduces readers to the idea of the public domain and describes how it is being tragically eroded by our current copyright, patent, and trademark laws. In a series of fascinating case studies, Boyle explains why gene sequences, basic business ideas and pairs of musical notes are now owned, …

Pathways Across The Valley Of Death: Novel Intellectual Property Strategies For Accelerated Drug Discovery, Arti K. Rai, Jerome H. Reichman, Paul F. Uhlir, Colin Crossman

Faculty Scholarship

Drug discovery is stagnating. Government agencies, industry analysts, and industry scientists have all noted that, despite significant increases in pharmaceutical R&D funding, the production of fundamentally new drugs - particularly drugs that work on new biological pathways and proteins - remains disappointingly low. To some extent, pharmaceutical firms are already embracing the prescription of new, more collaborative R&D organizational models suggested by industry analysts. In this Article, we build on collaborative strategies that firms are already employing by proposing a novel public-private collaboration that would help move upstream academic research across the valley of death that separates upstream research from …

“An Ingenious Man Enabled By Contract”: Entrepreneurship And The Rise Of Contract, Catherine Fisk

Faculty Scholarship

A legal ideology emerged in the 1870s that celebrated contract as the body of law with the particular purpose of facilitating the formation of productive exchanges that would enrich the parties to the contract and, therefore, society as a whole. Across the spectrum of intellectual property, courts used the legal fiction of implied contract, and a version of it particularly emphasizing liberty of contract, to shift control of workplace knowledge from skilled employees to firms while suggesting that the emergence of hierarchical control and loss of entrepreneurial opportunity for creative workers was consistent with the free labor ideology that dominated …

Using Liability Rules To Stimulate Local Innovation In Developing Countries: Application To Traditional Knowledge, Jerome H. Reichman, Tracey Lewis

Faculty Scholarship

When economists speak of an underlying legal structure that imposes an "absolute permission" requirement on access to, and use of, knowledge goods protected by intellectual property rights (IPRs), they typically have in mind the domestic patent and copyright laws. Under these and related intellectual property regimes, one cannot normally make use of a protected invention or creative work of authorship for specified purposes and for limited periods of time without prior authorization of the rights holder, typically in the form of a license.

When economists speak of liability rules, in contrast, they envision an underlying legal structure that permits third …

Fencing Off Ideas: Enclosure & The Disappearance Of The Public Domain, James Boyle

Faculty Scholarship

No abstract provided.

Cruel, Mean, Or Lavish? Economic Analysis, Price Discrimination And Digital Intellectual Property, James Boyle

Faculty Scholarship

No abstract provided.