Special Guest Post by Beau H. Miller, Jefferies
This article was originally published as part of research issued by the Jefferies Biotechnology Equity Research group.
Since the Amgen v. Regeneron ruling that resulted in Judge Robinson of the District Court of Delaware granting a permanent injunction removing Regeneron’s Praluent from the market (pending appeal), there have been a number of media and twitter commentaries providing their insights on the case.
These reactions have overall been of the opinion that it is a “shocking” precedent for a judge to remove an FDA-approved drug from the market for patent infringement – a remedy which patent owners, even pharmaceutical manufacturers, are justly able to obtain under the circumstances outlined in eBay v. MercExchange.
Given this, there are a few facts that have been overlooked in these reviews that lead us to disagree with some of the conclusions they reach, and also which led us to anticipate an injunction in this case. Continue reading
Looking Forward: The Next Generation of Bio
February 7, 2017 12:00 PM
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product, like a generic drug.
This panel of experts will discuss the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics include how the next generation of biosimilars can improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
This event is free and open to the public. Lunch will be provided.
Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.