Medical Jurisprudence Commons^™

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Faculty Works

There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …

The U.S. Culture Collection Network Responding To The Requirements Of The Nagoya Protocol On Access And Benefit Sharing, Kevin Mccluskey, Katharine B. Barker, Hazel A. Barton, Kyria Boundy-Mills, Daniel R. Brown, Jonathan A. Coddington, Kevin Cook, Philippe Desmeth, David Geiser, Jessie A. Glaeser, Stephanie Greene, Seogchan Kang, Michael W. Lomas, Ulrich Melcher, Scott E. Miller, David R. Nobles Jr., Kristina J. Owens, Jerome H. Reichman, Manuela Da Silva, John Wertz, Cale Whitworth, David Smith

Faculty Scholarship

The U.S. Culture Collection Network held a meeting to share information about how culture collections are responding to the requirements of the recently enacted Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (CBD). The meeting included representatives of many culture collections and other biological collections, the U.S. Department of State, U.S. Department of Agriculture, Secretariat of the CBD, interested scientific societies, and collection groups, including Scientific Collections International and the Global Genome Biodiversity Network. The participants learned about the policies of the United …

Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An

Minnesota Journal of Law, Science & Technology

No abstract provided.

Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii

Cardozo Law Review

Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn't ready to support that leap. In the next wave of data-driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment.

Current intellectual property law fails to provide adequate incentives for black-box medicine. The Supreme Court has sharply …

Placebo Patents: Creating Stronger Intellectual Property Protection For Pharmaceuticals Approved By The U.S. Food & Drug Administration, Sarah Renee Craig

Georgia Journal of Law & Technology

No abstract provided.

The Patenting Of Gene Based Diagnostic Assays In A Post Mayo And Myriad World, 16 J. Marshall Rev. Intell. Prop. L. 1 (2016), Michael Sanzo

UIC Review of Intellectual Property Law

Recent advances in biotechnology have given researchers the ability to comprehensively examine the genetic basis of disease in unprecedented ways and will undoubtedly result in many new and valuable gene based diagnostic assays in the near future. These advances came during a period of roughly thirty years during which the patent eligibility of such assays was essentially unquestioned. Then, beginning in 2010, the Supreme Court embarked on a series of decisions that will, in almost all cases, preclude the patenting of diagnostic assays that rely on genetic mutations or gene expression patterns. This article suggests that reason that the issue …

Can Dna Be Speech?, Jorge R. Roig

Scholarly Works

DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information, and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being. In this article we discuss myriad current and developing ways in which …

Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow

Articles & Chapters

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …

Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses A Matter Of First Impression, Christopher M. Holman, Claes Gustafsson, Andrew W. Torrance

Faculty Works

In spite of the compelling logic that would support extending copyright to engineered DNA sequences, copyright protection for genetic code has not been legally recognized in the US, or as far as we know anywhere. The Copyright Act is silent on the point, the courts do not appear to have ever addressed the question, and the Copyright Office has taken the position that an engineered genetic sequence is not copyrightable subject matter. In an attempt to advance the conversation, we submitted an engineered DNA sequence to the Copyright Office for registration, and then appealed the Office’s decision refusing to register …

Keeping The Gates Open For Human Embryonic Stem Cell Research, Ren-How Harn

Cardozo Public Law, Policy & Ethics Journal

Human embryonic stem cell research represents an area of scientific progress that promises to deliver on the wonders mankind has thus far only seen in science fiction movies. However, ethical and legal concerns threaten to stifle research in an area often regarded as the holy grail of regenerative medicine. This Note analyzes the question in patent law of whether human embryonic stem cells constitute patentable subject matter under 35 U.S.C. §101 from a legal and policy perspective after the 2013 Supreme Court decision in Association for Molecular Pathology v. Myriad. The issue has generated recent interest and debate with …

Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott

Articles & Chapters

Under the newly passed Leahy-Smith America Invents Act (AIA), the U.S. Patent and Trademark Office may hear new challenges to stem cell patents. Here, we explore how the new law affects challenges to stem cell patents, focusing on two recent cases, and discuss the future of stem cell patent disputes.

Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman

Faculty Works

While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term “synthetic biology” has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …

Gene Patents In The Wake Of Association For Molecular Pathology V. Myriad Genetics, Inc.: An International Perspective On Pharmacogenomics, Stephanie S. Lim

Cardozo Journal of International and Comparative Law

Now that the Supreme Court of the United States has held that isolated DNA fragments are not patentable subject matter under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, Inc., thousands of existing isolated gene patents can be invalidated. In the European Union, by contrast, patent protection for human genetic sequences has always been strong and the BRCA gene patents at issue in Myriad are still valid in the European Union. It remains to be seen how the differential gene patent protection regimes in these developed nations will affect the biotechnology industry.

This Note poses that question …

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

All Faculty Scholarship

As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

Generic Entry Jujitsu: Innovation And Quality In Drug Manufacturing, W. Nicholson Price Ii

IP Theory

The manufacturing side of the pharmaceutical industry has been neglected in innovation theory and policy, with the unfortunate result of stagnant manufacturing techniques driving major problems for the healthcare system. This innovation failure has roots in ineffective intellectual property incentives and high regulatory hurdles to innovative change. Changes in pure regulation or intellectual property incentives have significant potential to help the innovation deficit, but are not the only possibility for change. A relatively minor regulatory change could harness the powerful dynamics of pioneer/generic competition surrounding generic drug market entry. If pioneer firms were permitted to make label claims committing to …

Pinwheel Of Fortune, 13 J. Marshall Rev. Intell. Prop. L. 761 (2014), James Ming Chen

UIC Review of Intellectual Property Law

This paper examines public health law in the context of prospect theory, the leading behavioral account of risk aversion and risk-seeking. The paper first demonstrates how international environmental law can be mapped along prospect theory’s risk-seeking axis. It then completes this picture of prospect theory by examining National Federation of Independent Business v. Sebelius, which upheld the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Although Sebelius upheld the PPACA as an exercise of the federal government’s taxing authority, it reasoned that a directive aimed at uninsured individuals to buy health insurance lay beyond the power of Congress …

A Scientific Approach To Intellectual Property And Health: Innovation, Access, And A Forgotten Corner Of The Universal Declaration Of Human Rights, 13 J. Marshall Rev. Intell. Prop. L. 794 (2014), Adam Houston

UIC Review of Intellectual Property Law

For years, there has been vigorous debate over the relationship between intellectual property and health, especially in the context of pharmaceutical patents. Despite numerous attempts to strike a balance between innovation and access, however, few have looked to Article 27 of the Universal Declaration of Human Rights for guidance. Article 27, and its further elaboration and codification under Article 15 of the International Covenant on Economic, Social, and Cultural Rights, explicitly address this balance by pairing the right of everyone “to share in scientific advancement and its benefits” with a similarly universal right of authors to “material interests resulting” from …

Patent Eligibility Post-Myriad: Reinvigorated Judicial Wildcard Of Uncertain Effect, Christopher M. Holman

Faculty Works

In the 1970s and early 1980s the US Supreme Court issued several landmark decisions establishing the contours of patent eligibility, a judicially created doctrine that serves as a gatekeeper to prevent the patenting of subject matter deemed so fundamental as to be better left unpatented. Over the course of the next 25 years the Court of Appeals of the Federal Circuit oversaw a progressive expansion in the scope subject matter deemed patent eligible, highlighted by the adoption in the 1990’s of a “useful, concrete and tangible” test for patent eligibility that for all practical purposes seemed to subsume the patent …

Toward A Jurisprudence Of Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …

Redressing The Patent Imbalance In Genetic Testing, Cheng Lim Saw

Research Collection Yong Pung How School Of Law

In one of the most highly anticipated decisions emanating from the apex Court in the US in recent times, the US Supreme Court in Association for Molecular Pathology v Myriad Genetics Inc was asked to consider, in the main, the patentability of a naturally occurring gene sequence which had been specifically isolated from the human genome. Although the patent was eventually denied, this seminal case will certainly not be the last word on what is clearly a very controversial subject, at least outside of the US.

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow

Articles & Chapters

An imminent US Supreme Court ruling should resolve one of the thorniest legal issues facing pharmaceutical companies today.

Protecting Private Intellectual Property From Government Intrusion: Revisiting Smithkline And The Case For Just Compensation, John C. O'Quinn

Pepperdine Law Review

No abstract provided.

The En Banc Federal Circuit's Written Description Requirement: Time For The Supreme Court To Reverse Again?, Allen K. Yu

Cardozo Law Review

The Federal Circuit in Ariad v. Eli Lilly finally settled en banc the long-running dispute over whether the first paragraph of 35 U.S.C. § 112 contains a written description requirement separate from an enablement requirement. According to the Federal Circuit, such a requirement exists and exists to "convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." The problem with the Federal Circuit's written description- "possession" doctrine is twofold. First, it characterizes the quid pro quo role of disclosure beyond its traditional role of placing knowledge in the …

Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer

UIC Law Review

No abstract provided.

Dynamic Patent Governance In Europe And The United States: The Myriad Example, Kali Murray, Esther Van Zimmeren

Cardozo Journal of International and Comparative Law

This Article examines the emerging elements of a new model for patent governance. It is divided into four parts. In Section One, we develop a model of dynamic patent governance. This model extends the theoretical framework of network governance, to explain the emergence of networks in the decisionmaking infrastructure for the public and private actors in the patent system. Dynamic patent governance widens this theoretical framework in two key ways. First, dynamic patent governance, within its formal dimensions, is based on the idea that heterogeneous administrative actors regulate the grant and enforcement of patents. This challenges a perspective that sees …

Medical Alert: Alarming Challenges Facing Medical Technology Innovation, Lawrence M. Sung

Faculty Scholarship

No abstract provided.

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners …

The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison

UIC Review of Intellectual Property Law

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized …

The Human Right To Health And Hiv/Aids: South Africa And South-South Cooperation To Reframe Global Intellectual Property Principles And Promote Access To Essential Medicines, Erika George

Indiana Journal of Global Legal Studies

The HIV/AIDS pandemic has had a devastating and disproportionate impact in countries of the Global South. The experience of an individual infected with HIV in Africa is very different than that of an individual infected with HIV in America. Life expectancy varies sharply. The ability or inability to access medicines essential for treatment accounts for much of the variance. This article examines how the rhetoric of human rights used in the context of South Africa's AIDS crisis resonated across the Global South, resulted in a powerful social movement for access to medicines, and contributed to important changes in international intellectual …