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Articles 1 - 14 of 14
Full-Text Articles in Food and Drug Law
Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu
Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu
Faculty Articles
On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …
The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt
The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt
Washington and Lee Law Review
Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …
The Cost Of Novelty, Will Nicholson Price Ii
The Cost Of Novelty, Will Nicholson Price Ii
Articles
Patent law tries to spur the development of new and better innovative technology. But it focuses much more on “new” than “better”—and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innovation”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not only …
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Articles
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn
That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn
Concordia Law Review
By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …
3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom
3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom
Evan R. Youngstrom
Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii
Law Faculty Scholarship
Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …
Innovation Cooperation: Energy Biosciences And Law, Prof. Elizabeth Burleson
Innovation Cooperation: Energy Biosciences And Law, Prof. Elizabeth Burleson
Prof. Elizabeth Burleson
This Article analyzes the development and dissemination of environmentally sound technologies that can address climate change. Climate change poses catastrophic health and security risks on a global scale. Universities, individual innovators, private firms, civil society, governments, and the United Nations can unite in the common goal to address climate change. This Article recommends means by which legal, scientific, engineering, and a host of other public and private actors can bring environmentally sound innovation into widespread use to achieve sustainable development. In particular, universities can facilitate this collaboration by fostering global innovation and diffusion networks.
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Michigan Telecommunications & Technology Law Review
Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Michigan Telecommunications & Technology Law Review
Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Ariel Katz
Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Michigan Telecommunications & Technology Law Review
Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Michigan Telecommunications & Technology Law Review
Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …