Transparency is a Misplaced Regulatory Focus for Holding Adaptive Software as Medical Devices (SaMDs) Accountable
Quy Mai Adaptive Software as Medical Devices (SaMDs) play an increasingly critical role within clinical settings, assisting physicians with illness detection, diagnosis, and analysis. Use of Artificial Intelligence/Machine Learning (AI/ML) techniques, such as deep machine learning and neural networks, lends adaptive SaMDs unparalleled analytical power, but not without risks. Adaptive SaMDs are typically “black-box,” meaning that they compute data such that no one can determine how it rendered outputs. “Transparency,” in the form of explainability, is frequently raised in policy discussions as a solution to track when the SaMD has erred in computing outputs. The FDA, in seeking to uphold...
The Supreme Court’s Missed Opportunity to Save Genus Claims in Life Sciences Patents
Alexander Franzosa The life sciences industry is a vital sector of the American economy, and its success is reliant on the protection of patent holder rights. One common feature in life sciences patents is the genus claim, a claim type traditionally allowing the patent holder to claim a group of related species based on common functionality. A novel interpretation of “written description,” a required element for patent applications, has emerged in recent decisions by the Court of Appeals for the Federal Circuit. This new interpretation has caused concern among some members of the life sciences industry regarding the validity of...
Square Peg in a Round Hole: Manipulating Patent Law to Reduce the Prices of Pharmaceutical Products
Jasmine Daniel Pharmaceutical companies are commonly criticized for charging exorbitantly high prices for their products which can make it difficult for many patients to access life-saving drugs. Competitors, such as generic manufacturers, often cannot manufacture cheaper alternatives to these drugs due to strong patents which protect against product copying. Both the Bayh-Dole Act and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) include provisions which allow competitors to circumvent pharmaceutical patent protection under limited circumstances. Although there are instances in which such circumvention is necessary, ambiguities in these statutes allow countries to bypass pharmaceutical patents and encourage production...
Cannabis and Patent Law: Lessons from a Canadian Cannabis Case Study
Katherine Minorini Cannabis is illegal under federal law in the United States, yet individual states have legalized it for both medicinal and recreational use. Additionally, the United States Patent and Trademark Office (USPTO) routinely issues patents for cannabis-related inventions despite the drug’s federal prohibition. As the prospect of federal legalization becomes more likely, patent protection will play a crucial role in the budding cannabis market. By evaluating Canada’s legal cannabis system, this Essay identifies lessons the United States can take from the Canadian legalization framework. Ultimately, this Essay asserts that the United States should take quick action and legalize cannabis...
Can a Two-Pronged Attack from Congress and the FDA Make Up for the BPCIA’s Limitations?
Guodong Fu The Biologic Product Competition and Innovation Act (BPCIA) of 2009, modeled after the Hatch-Waxman Act of 1984, has been largely criticized as ineffective in promoting significant competition in the pharmaceutical industry. Biosimilar sponsors lack guidance from the U.S. Food and Drug Administration (FDA) on how to obtain interchangeable designation for follow-on biologics. In addition, biosimilar sponsors face patent infringement litigation from reference drug companies as part of the “patent dance” set forth by the Supreme Court in 2017 in Sandoz v. Amgen. The FDA’s Biosimilar Action Plan (BAP) and a proposed bill from Congress, the Biologic Patent Transparency...
Obtaining Marijuana Patents
Natali De Corso In the midst of a boom in the marijuana industry, marijuana breeders and companies have increasingly sought protection of their unique marijuana strains through patents. Their success, however, is limited given the fact that marijuana remains illegal under federal law and the United States Patent and Trademark Office has been reluctant to grant such patents. This article explores the current patentability of marijuana strains, discusses the difficulties marijuana breeders and companies face in patenting their product, and introduces successful marijuana-related patent applications. Read Full Text Here
The Patent Utility Requirement and Its Impact on Alternative Medical Treatments for Lyme Disease
Sarah Murphy Alternative medicine has made its way to the forefront of medical innovation, changing the way both doctors and patients approach complex health issues. Patenting medical inventions promotes advancement by increasing the exchange of vital information. This crucial benefit to society is particularly important for patients suffering from chronic illnesses who are dissatisfied with conventional medicine. Though the patent system requires that patented inventions are “useful,” there is no guarantee that the product is effective or even safe to use. The medical field must grapple with this trade-off between the benefit of new treatments made easily available to people...
Antitrust Issues in Reverse Payment Settlements: Federal Trade Commission v. Actavis, Inc. et al., a Case Study
Amanda Creedon In Federal Trade Commission v. Actavis, Inc., the Federal Trade Commission (FTC) filed a complaint alleging that reverse settlement payments were unfair restraints of trade and therefore violated federal antitrust laws. The Supreme Court held that reverse payment settlements in patent infringement litigation are not presumptively unlawful but can sometimes violate antitrust laws, to be determined on a case-by-case basis. The settlements are not immune from antitrust attack even if the agreement’s anticompetitive effects fell within the scope of the exclusionary potential of the patent. Read Full Text Here
Data Exclusivity for Biologic Drugs: The TPP’s Potential Poison Pill?
Tina Cheung On October 5, 2015, after many years of secretive negotiations, the US government with 11 other countries across the Asia Pacific and Latin America reached an agreement on the largest free-trade deal in history, the Trans-Pacific Partnership (TPP). Addressing everything from wildlife conservation and tax reductions for agriculture, to the free flow of information on the Internet and intellectual-property rights for movies and pharmaceutical drugs, this far-reaching agreement has the potential to impact up to one-third of world trade. One of the most contentious parts of the agreement involves intellectual property rights of pharma companies to data exclusivity...
A Review of the Modern IPR Process
Michael Thomas Once a patent is issued for a drug there is still a chance that the validity of the patent may be challenged. One such way a purported infringer or competitor can challenge a patent’s validity is through an inter partes review (IPR) Process allowed by the United States Patent and Trademark Office (USPTO). Until recently the use of this process by generic drug-makers to invalidate patents has had no success. However, a recent decision by the Patent Trial and Appeal Board (PTAB) gave generic drug-makers their first break when they invalidated the patent for the multiple sclerosis drug...