Expanding the Patent Eligibility of Diagnostic Tests and Their Methods
Jo-an Chen There is ongoing debate over whether diagnostic tests and their methods should be patent eligible. As it stands today, these tests are largely unpatentable given the restrictive interpretation of patent eligibility laws in the United States. Some argue that patent claims directed to observing a law of nature, such as diagnostic tests, should remain patent ineligible to prevent an inventor from monopolizing basic tools of science. Others argue that diagnostic tests should be patent eligible to incentivize and encourage similar types of socially beneficial discoveries and inventions. This Essay agrees with the policy rationale for expanding the patent...
Driving in Circles: Impact of American Axle on Patent Eligibility Jurisprudence and Green Initiatives in the Automotive Industry
Zoë Haggerty A recent executive order signed by President Biden establishes a National Climate Task Force to oversee the conversion of the federal fleet to all-electric vehicles. If the President’s goal is to be achieved, the Supreme Court must review patent eligibility jurisprudence and provide guidance to the “bitterly divided” Federal Circuit. Fortuitously, the Supreme Court has the opportunity to do precisely that by granting certiorari to American Axle & Manufacturing v. Neapco Holdings LLC and clarifying the exact standard courts are to apply when determining cases of patent eligibility. Given the ever more pressing need for intelligibility in patent eligibility jurisprudence...
Patentability of COVID-19 Vaccines
Zoë Haggerty In many ways, the COVID-19 crisis has disproportionately affected the most vulnerable and underprivileged members of society. National lockdowns, halted economies, and overburdened hospital systems have significantly exacerbated the obstacles faced by those already financially insecure. In light of these unique and widespread challenges, it is crucial that the marginalized members of society not be neglected as global and domestic health agencies push for efficient vaccine distribution. The implications of patenting COVID-19 vaccines are likely to disadvantage such members unless measures are taken to ensure the accessibility of such vaccines. This Essay explores the options of expanding or...
A Welcome Limit on Design Patent Protection: Curver Luxembourg, Sarl v. Home Expressions
Casey Houlton In 2019, the United States Court of Appeals for the Federal Circuit addressed the scope of design patent law in Curver Luxembourg, SARL v. Home Expressions. The court held that a design patent must be limited to a particular article of manufacture. As such, claim language may be used to limit the scope of a design patent to a particular article of manufacture if an article is not specified in the claim’s figures. Although the court’s failure to define an article of manufacture may result in some difficulties with Curver’s application, the court’s decision is consistent with the...
Potential Impact of Section 106 of the Stronger Patents Act on the Biotechnology Industry
Jeffrey Buckman A permanent injunction is the strongest remedy available to a patent holder in a patent infringement case. Throughout much of U.S. patent litigation history, plaintiffs were presumptively entitled to a permanent injunction when a defendant infringed the plaintiff’s valid patent. In 2006, however, in eBay Inc. v. MercExchange, the Supreme Court of the United States altered the standard for awarding permanent injunctions in patent infringement cases. In eBay, the Court held that patent holders are not presumptively entitled to permanent injunctions and instead must satisfy the traditional four-factor permanent injunction test. In June 2019, the House of Representatives...
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...
Patent Law in Space
Marie Weisfeiler The potential for private technological expansion into space raises questions of how to protect intellectual property rights of inventions that are both brought into space and made in space. While there are international treaties governing space law, none of these treaties discuss how to designate or enforce patent rights in space. The International Space Station has implemented a solution of quasi-territoriality to establish patent rights. This essay suggests, however, that this solution will be deficient when private entities venture further into space exploration. This essay then explores the possibility of a universal approach to patent law in space...
Litigation Misconduct and the Inequitable Conduct Defense: An Argument for Limiting Regeneron Pharmaceuticals, Inc. v. Merus N.V.
Connor Romm Inequitable conduct is a defense to a claim of patent infringement that can invalidate the underlying patent. At its inception, the defense was meant to encourage honest representations in the patent prosecution process. It later morphed into a source of troubling litigation tactics. In May 2011, in Therasense, Inc. v. Becton, Dickinson & Co., the United States Court of Appeals for the Federal Circuit, sitting en banc, sought to address disturbing trends in the doctrine and raised the standard required to prevail on the defense. In July 2017, in Regeneron Pharmaceuticals, Inc. v. Merus N.V., the same court...
The Cancer Immunotherapy Pilot Program and Chimeric Antigen Receptor-T Cell Treatments
Ellen Shamansky The Cancer Immunotherapy Pilot Program (also known as Patents 4 Patients) provides fast-track review to patent applications describing methods of treating cancer with immunotherapy, such as chimeric antigen receptor (“CAR”)- T cell treatments. This article explores considerations for claiming CAR-T cell treatments, including court rulings and examiner guidelines on patentable subject matter in the life sciences, the Federal Circuit’s decision in NantKwest, Inc. v. Lee in 2017, and pending applications and current litigation over CAR-T cell treatments. Read Full Text Here
IP Protection for Startups: The Role of Legislation in Stopping Patent Trolls and Encouraging Innovation
Kristin Garr In the past five years, the rate of startups entering the market has drastically increased, and it continues to see an upward trend, giving rise to the phenomenon known as the “startup boom.” While the United States Patent and Trademark Office (“USPTO”) has implemented major changes to the patent system in the past decade, the agency has not been able to address the problem that is crippling the success of emerging companies: patent trolls. Various states’ legislatures have recognized this issue and enacted statutes prohibiting bad faith patent assertions as a result. This article explains the startup industry’s...