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Life Sciences Podcast Series - Patent Applications Based on Clinical Trials

USA - February 26 2021 The Life Sciences industry can be particularly challenging for companies to navigate, often requiring careful navigation through rigorous testing and…

Oulu (Lulu) Wang, Sara A. Leiman, Ph.D..

Update to the Purple Book in Recent COVID-19 Stimulus Bill and Implications for BPCIA Litigation

USA - December 23 2020 On December 21, 2020, Congress passed a second COVID-19 stimulus bill. Buried among the 5500 pages of the 900 billion dollar relief package was…

Amanda K. Murphy.

Considerations in Demonstrating Interchangeability with a Reference Biologic Product

USA - August 12 2019 N May 9, 2019, FDA issued final guidance, Considerations in Demonstrating Interchangeability with a Reference Product (1). This article provides a…

Amanda K. Murphy, Yicong Du.

Federal Circuit Casts Doubt on Antibodies Claimed by Epitope

USA - October 12 2017 In Amgen Inc. v. Sanofi, No. 2017-1480, the Federal Circuit reversed and remanded for a new trial because the district court (1) incorrectly excluded…

The Safe Harbor Provision of 35 U.S.C. § 121 Against Double Patenting Rejections Just Got A Little Less Safe

USA - June 2 2017 Ever since the Federal Circuit held that a later-issuing but earlier-expiring patent could serve as an obviousness-type double patenting (OTDP)…