Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 11 of 11
Full-Text Articles in Law
Eviscerating Patent Scope, Shahrokh Falati
Eviscerating Patent Scope, Shahrokh Falati
Articles & Chapters
The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …
From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham
From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham
Articles, Book Chapters, & Popular Press
Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …
The Gmo/Ge Debate, Joanna K. Sax
The Gmo/Ge Debate, Joanna K. Sax
Faculty Scholarship
The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what …
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 …
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 …
The Changing Face Of Family Law: Global Consequences Of Embedding Physicians And Biotechnology In The Parent-Child Relationship, George J. Annas
The Changing Face Of Family Law: Global Consequences Of Embedding Physicians And Biotechnology In The Parent-Child Relationship, George J. Annas
Faculty Scholarship
Sexual reproduction, also known as making babies the old-fashioned way, has always brought with it significant challenges for family law, especially regarding protecting the best interests of children, and the identification of parents with the right and responsibility to rear them. But these challenges often seem mundane in the face of what has evolved since physicians have been injected into baby making and thus into novel parent-child relationships. The addition of physicians and their "new" medical technologies, sometimes called Assisted Reproductive Technology (ART), have forced the law to reconsider the very definition of motherhood and have radically altered society's view …
Biotechnology Entrepreneurship And Ethics: Principles, Paradigms, And Products, Patricia C. Kuszler
Biotechnology Entrepreneurship And Ethics: Principles, Paradigms, And Products, Patricia C. Kuszler
Articles
Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug …
Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead
Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead
Journal Articles
The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …
The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher
The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher
Scholarly Works
No abstract provided.
The Laws Of Genetics, Michael S. Baram
The Laws Of Genetics, Michael S. Baram
Faculty Scholarship
It used to be that high technology meant nuclear physics and missile systems, and presented the threat of physical destruction. Today, "high tech" means biotechnology and electronic communication systems, and the focus has shifted to concerns about more subtle problems like loss of privacy, inability to control personal information, and the discriminations and other adversities that often follow.
The Rutabaga That Ate Pittsburgh: Federal Regulation Of Free Release Biotechnology, Michael P. Vandenbergh
The Rutabaga That Ate Pittsburgh: Federal Regulation Of Free Release Biotechnology, Michael P. Vandenbergh
Vanderbilt Law School Faculty Publications
When the Environmental Protection Agency (EPA) first approved a field test of a bioengineered microbe,' one EPA official remarked: "We're not expecting this to be the rutabaga that eats Pittsburgh.' 2 But regulators cannot afford to be wrong. Bioengineered microbes may serve many useful purposes, but they may also cause harm to the environment and to human health.3 Although the risks of an accident stemming from the deliberate release of bioengineered microbes into the environment may be low, the resulting damage could be substantial. This note examines the possible consequences of two recent trends in biotechnology-the development of bioengineered microbes …