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Full-Text Articles in Law
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Diagnostics Need Not Apply, Rebecca S. Eisenberg
Articles
Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Articles & Chapters
Predicting the outcome of the ongoing patent disputes surrounding genome-editing technology is equal parts patent analysis and history.
Genome-editing technology based on clustered, regularly interspaced, short palindromic repeats (CRISPR) and CRISPR associated protein 9 (Cas9) has generated great excitement in both academia and industry. But a potential patent dispute between two sets of inventors has left the biotech community pondering its fate. Understanding several facets of patent law and history may provide some lessons about the probable — and best — outcome for the dispute.
Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott
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.
When Condoms Fail: Making Room Under The Aca Blanket For Prep Hiv Prevention, Jason Potter Burda
When Condoms Fail: Making Room Under The Aca Blanket For Prep Hiv Prevention, Jason Potter Burda
Faculty Publications
Given the alarming upward trend in HIV infection rates and the downward trend in condom usage, we need a new approach to HIV prevention in the United States. One such approach, HIV Pre-Exposure Prophylaxis (commonly known as “PrEP”), has the potential to significantly reduce HIV incidence. The FDA recently approved a daily dose of Truvada® — an antiretroviral drug that suppresses the virus in HIV-positive individuals — for daily use by high-risk HIV-negative individuals to prevent infection. Despite an effectiveness above ninety percent and significant regulatory momentum, this pharmacological prevention modality has proven difficult to implement. In this Article, I …
Agricultural Biotechnology: Drawing On International Law To Promote Progress, J. Janewa Oseitutu
Agricultural Biotechnology: Drawing On International Law To Promote Progress, J. Janewa Oseitutu
Faculty Publications
In Bowman v. Monsanto, the Supreme Court declined to apply the principle of exhaustion to limit the patentee’s ability to control the reproduction of self-replicating inventions. This decision was justified from a patent law perspective on the basis that patent holder has a right to prevent others from making the invention. But what happens when we take other perspectives into account? For instance, a farmer might have human rights or other rights that may need to be balanced against the patentee’s right. Since globalized intellectual property standards were established through international agreements and much of the resistance to intellectual property …
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman
Faculty Works
Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …
Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response To Our Divided Patent System, Christopher M. Holman
Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response To Our Divided Patent System, Christopher M. Holman
Faculty Works
On October 14, 2014, Stanford’s Professor Mark Lemley tweeted “My new study with Allison & Schwartz shows that software and biotech patent lawsuits overwhelmingly lose.” He was referring to an article entitled Our Divided Patent System, co-authored by Lemley and two other prominent law professors. Taken at face value, the assertion that “biotech patent lawsuits overwhelmingly lose” would seem to hold troubling implications for biotechnology. In order to better understand the basis for Lemley’s assertion, I reanalyzed the underlying data and found that the situation is not nearly as bleak as his tweet might suggest. My significantly different interpretation of …
Bowman V. Monsanto Co.: Bellweather For The Emerging Issue Of Patentable Self-Replicating Technologies And Inadvertent Infringement., Christopher M. Holman
Bowman V. Monsanto Co.: Bellweather For The Emerging Issue Of Patentable Self-Replicating Technologies And Inadvertent Infringement., Christopher M. Holman
Faculty Works
The inherent tendency of patented seeds to self-replicate has led to fears that farmers might face liability for inadvertent patent infringement. To address the perceived problem, some have proposed severely limiting the availability of effective patent protection for self-replicating technologies. Typical examples include denying patent rights to "second generation" self-replicating products, and even broadly declaring such technologies ineligible for patent protection. The fact is, lawsuits against inadvertently infringing farmers remain of largely hypothetical concern. However, changes in the market could soon render such lawsuits a reality. In addressing the resulting policy concerns, Congress and the courts have at their disposal …
Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman
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 …