Intellectual Property Law Commons^™

Genetic Technologies: Patent Protections & The Case For Technology Transfer, Smitha Gundavajhala

Washington Journal of Law, Technology & Arts

Genetic technologies range in scope from agricultural to medical applications. Most recently, during the COVID-19 pandemic, companies like Moderna developed and patented genetic technologies for diagnostic and therapeutic purposes, like the mRNA vaccine. However, patent protection provides these companies with a monopoly that ultimately limits domestic production of generic versions, thus limiting access to life-saving diagnostics and therapeutics. When a company located in one country files a patent for recognition in another country, it effectively places a hold on production of any technologies covered by that patent’s reach, whether that patent is enforced or not. However, the TRIPS Agreement, the …

“Tiktok Told Me I Have Adhd”: Regulatory Outlook For The Telehealth Revolution, Kaitlin Campanini

Washington Journal of Law, Technology & Arts

Telehealth’s expansion during the COVID-19 pandemic has drastically changed the approach to healthcare in the United States. This is particularly true in the behavioral health sector where several behavioral telehealth companies have emerged to treat Attention-Deficit/Hyperactivity Disorder (“ADHD”). These companies utilize a direct-to-consumer (“DTC”) model with a virtual platform that connects subscribing patients to medical providers who can treat them for ADHD. Although this telemedicine model emphasizes convenience and efficiency, the reality is that those benefits come at the cost of patient care. The federal regulations promulgated in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 to curtail …

Pacific Nortwest Perspective: The Impact Of The America Invents Act On Nonprofit Global Health Organizations, John Morgan, Veronica Sandoval

Washington Journal of Law, Technology & Arts

The Leahy-Smith America Invents Act of 2011 (AIA) makes fundamental changes to the legislative landscape governing patent law in the United States and will bring about corresponding changes in the manner in which inventors and attorneys address patent issues. While the law is newly implemented, inventors in all sectors of the economy are eager to formulate reactions to it. In this Article, we explore the effects of the AIA on nonprofit research organizations dedicated to global health and life sciences. We report the perspectives of counsel representing such organizations throughout the Pacific Northwest. We also consider the patent system, and …

Personalized Medicine, Genetic Exceptionalism, And The Rule Of Law: An Analysis Of The Prevailing Justification For Invalidating Brca1/2 Patents In Association Of Molecular Pathology V. Uspto, Kristen L. Burge

Washington Journal of Law, Technology & Arts

As medicine advances toward a more personalized model, the significance of genetic information is growing exponentially. While unlocking the genetic code has advanced the state of medicine, it has also reinvigorated the debate over the boundaries of patentable subject matter. The potential clash between having access to state-of-the-art medicine and protecting intellectual property investments came to a head in the case, Association of Molecular Pathology v. USPTO (“Myriad”). This Article analyzes the legal opinion rendered by the district court through the unique lens of genetic exceptionalism—a concept previously reserved to social science and public policy. Then, this Article …

Intellectual Property Rights And Stem Cell Research: Who Owns The Medical Breakthroughs?, Sean M. O'Connor

Articles

This article will not address the science and ethics of stem cell research—at least as far as those topics are normally addressed in the existing literature. Instead, this article argues that an even more contentious battle is looming on the horizon, with dire practical consequences: Namely, who will own the revolutionary medical breakthroughs that are supposed to emerge from this research? Along the way, this article will assume that stem cell research will progress in some fashion and that at least some of the purported benefits will materialize.

But the central premise is that the pitch of the ownership battle …

No "Dilettante Affair": Rethinking The Experimental Use Exception To Patent Infringement For Biomedical Research Tools, Janice M. Mueller

Washington Law Review

Scientists who require multiple "research tools" (i.e., laboratory resources such as transgenic animals and biological receptors) to develop new drugs and medical diagnostic products are frequently finding that these tools are patented or subject to other proprietary constraints. Stacking royalty obligations and heightened transaction costs resulting from the proliferation of patents on research tools threaten to slow or stop the development of new drugs and devices critical to public health. Because U.S. courts have very narrowly interpreted the common law "experimental use" defense of patent law as limited to "dilettante" uses of inventions for mere "amusement" or "philosophical" inquiry, scientists …

Patent Term Extension Of Pharmaceuticals In Japan: So You Say You Want To Rush That Generic Drug To Market In Japan . . . Good Luck!, William T. Christiansen Ii

Washington International Law Journal

With the passage of the Drug Price Competition Act of 1984 in the United States, the recent German Supreme Court decision allowing for experimental use of patented pharmaceuticals, and indirectly through the adoption of the Supplemental Protection Certificate in Europe, Japan seems to be the lone large pharmaceutical market which does not allow in some way for the experimental use of patented drugs to gain regulatory approval for a generic equivalent. Japanese generic pharmaceutical manufacturers had, until recently, operated under the assumption that the testing of a generic equivalent to a patented drug to gain regulatory approval was allowable as …