Biologics Face Tougher Patent Scrutiny After Amgen Ruling

By Dani Kass (February 18, 2021, 8:07 PM EST) -- A recent Federal Circuit decision clamping down on broad antibody patent claims may have some biologics makers scrambling to save their existing intellectual property and questioning whether to patent future drugs at all.

In Amgen v. Sanofi, the Federal Circuit ruled Feb. 11 that, with rare exceptions, patenting antibodies based on what they bind to doesn't meet enablement requirements under Section 112 of the Patent Act. While the ruling falls in line with past Federal Circuit decisions, it veers from how the scientific community defines antibodies and puts existing patents for top-dollar biologics on the road to invalidation.

"I think it's fair to say...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!