Bayh-Dole March-In Rights in a Post Chevron World The bipartisan Bayh-Dole Act of 1980 which transferred ownership of patents arising from US government funded research to universities has yielded a remarkable return on investment. In its 44 years of existence, Bayh-Dole has led to over $1.3 trillion in U.S. economic growth and over 4.2 million jobs. Products ranging from pharmaceuticals Allegra, Lyrica, and […] Read Post →
USPTO CALLED TO STEP UP INTERAGENCY COOPERATION In the immediate wake of the Belcher v. Hospira case where the patent holder made contradictory statements to the USPTO and the FDA regarding prior art, Senators Leahy and Tillis called for “the creation of a smooth, predictable, and regular channel of information from other federal agencies to the Patent Office” in a letter to […] Read Post →
COVID-19 VACCINE IP WAIVERS AND PLATFORM PATENTS The recent announcement by US Trade Representative Katherine Tai that the “US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic” has led to concern over the potential scope and effect of such waivers. Forced disclosure of trade secrets related to vaccine manufacturing processes has generated the most concern since […] Read Post →
Antibody Claim Strategies After the Amgen v. Sanofi Decisions Monoclonal antibodies (“mAb”) which specifically bind therapeutic targets dominate the biopharmaceutical market with global sales revenues estimated at nearly US$163 billion in 2019. Prior to the 2017, mAb were often protected in the US by broad claims which described the therapeutic target (i.e., the “antigen”) that the mAb could bind since such mAb could be […] Read Post →