Patent Rights in a Pandemic: Does the Race for a Covid-19 Vaccine Mean Inequitable Access?

(Source)   The coronavirus pandemic has changed life as we know it. The world has come a long way since the initial outbreak, but the uncertainty surrounding a potential Covid-19 vaccine persists. Even with mounting uncertainty, the demand for a safe and effective vaccine continues to increase. The Food and Drug Administration’s approvals and authorizations for the Covid-19 vaccine are only some of the obstacles in this respect. Even if these approvals come through and a vaccine becomes marketable, there is no guarantee that the vaccine will be widely accessible. This is where intellectual property starts playing a crucial role in the distribution and affordability of a potentially successful vaccine. If this vaccine is patented, it would grant exclusive rights to the patent holder to exclude others from making, using, importing, and selling the patented innovation for the duration of the patent grant, within the boundaries of the United States. In the pharmaceutical industry, it is necessary to strike a balance between innovation  and the ethical implications of patents for human health. Patent protection is required to stimulate innovation and incentivize pharma companies given the extensive time and resources needed for the development of a new drug. This incentive is [read more]

Diagnostic Methods as a Category of Patent-Ineligible Subject Matter

(Source) The authority to grant to patents arises from Article Eight of the United States Constitution. Specifically, Clause Eight grants Congress the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and inventors the exclusive right to their respective Writings and Discoveries.” Through this clause, Congress is empowered by the Constitution to grant copyrights and patents. Under this authority, Congress has enacted and promulgated various statutes in furtherance of promoting the progress of science and the useful arts. One such statute is 35 U.S.C. § 101, whose interpretation has been embroiled in controversy over the past decade. The statute delineates the types of subject matter that are patentable. Section 101 renders patentable “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Laws of nature and natural phenomena are prima facie unpatentable. Additionally, a mathematical formula is unpatentable because it “is merely a statement of a law of nature.” Similarly, medical diagnostic processes should be deemed as a category of patent-ineligible subject matter for numerous reasons. First, courts have repeatedly struck down patent claims to medical diagnostic processes unless they include a step of [read more]