Biogen Int'l GMBH V. Banner Life Scis. LLC: Exploring the Other Possibility that Could Have Resulted

Biogen Int'l GMBH V. Banner Life Scis. LLC: Exploring the Other Possibility that Could Have Resulted

Journal article

1 online resource (pages 51-69)

The intersection of patents and pharmaceuticals plays a crucial role in the development and commercialization of new medications. Once a company has patent rights they tend to dominate the market for a period of time before generic versions can enter the market. If a generic brand tries to enter the market earlier than allowed, it leads to an infringement. For a generic drug to enter the market, they must share the same active ingredient as the brand name drug product. Generic drugs go through a slightly different process of getting on the market since the brand name drug has already undergone research, development, and extensive clinical trials. Therefore, name brand drugs are often given patent term extension rights to help make up time spent on regulatory review of the drug. However, a key question remains, as to what is covered under the patent term extension statute: 35 U.S.C. § 156. This question is important as it impacts the market exclusivity period of a name brand drug and affects how soon a generic drug can enter the market. This case note focuses on the holding of Biogen Int’l GmbH v. Banner Life Scis. LLC and compares it to another case. Both cases are centered around what constitutes as an “active ingredient” and what qualifies as an “ester of an active ingredient” in order to be covered under a patent term extension. The interpretation of these terms varies under 35 U.S.C. § 156. This case note explores how the Biogen court ruled differently than the court in a prior case and explains how the Biogen court could have reached a different holding regarding what is covered by the patent term extension.

Crossref

John Marshal Review of Intellectual Property Law, Volume 24, Issue 1, 2024, page 51-69

John Marshal Review of Intellectual Property Law

[Chicago, Illinois] : UIC Review of Intellectual Property Law, 2024.

English

https://repository.law.uic.edu/cgi/viewcontent.cgi?article=1528&context=ripl

External Online Journals > The John Marshall Review of Intellectual Property Law