“Sandoz v. Amgen”: High Court to Weigh in on Biosimilars’ “Patent Dance”

Kaminski_Jeffri_LRFeatured Expert Contributor – Intellectual Property (Patents)

Jeffri A. Kaminski, Partner, Venable LLP, with Tyler Hale, Associate, Venable LLP.

In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act, and redrew the legal landscape for intellectual property in the pharmaceutical industry.  The law balanced the need for brand-name drug innovators to profit from their research and development investments with the public good of low-cost generic drugs by creating a pathway for swift FDA approval of generic drugs immediately following the expiration of patent exclusivity.  By all accounts, the law has been a success, creating the drug lifecycle we know and expect today: new drugs enter the market at a high price with a limited period of exclusivity, after which several generic competitors enter the market and drive prices down to a fraction of their original cost. Continue reading ““Sandoz v. Amgen”: High Court to Weigh in on Biosimilars’ “Patent Dance””