Biotechnology At The Supreme Court'Will The U.S. Government Back Amgen's Petition?

• Published date: 06 May 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Law Firm: Cozen O'Connor
• Author: Aaron Lukas and W. Blake Coblentz

"After examining the history of this case, and specifically Judge Andrews' application of the long-standing Wands factors.leaving enablement as a question of law based on underlying facts may be the best course of action."

Earlier this year, we discussed Amgen's petition for Supreme Court review of the Federal Circuit's affirmance invalidating several antibody patent claims based on a lack of enablement for genus claims. At that time, we believed Amgen had a slim chance of its petition being granted-mainly because the Supreme Court denied a similar petition from Idenix in 2021 (No. 20-380, January 19, 2021).

However, on April 18, the Supreme Court invited the Solicitor General to file a brief expressing the views of the U.S. government on the questions presented. The Supreme Court's likelihood of granting cert. in any particular case increases by about 10-fold when a Solicitor General's brief is requested, but more importantly, the Supreme Court follows the Solicitor General's recommendation about 75% of the time. See P. Gugliuzza, "The Supreme Court Bar at the Bar of Patents," Working Paper (2019) at 23. While any real handicapping of cert. being granted in Amgen's case will have to wait until the Solicitor General's brief is filed later this year, in the meantime we're reminded of Jim Carrey's line from Dumb and Dumber: "So you're telling me there's a chance."

Returning to Amgen's first question presented in its petition, one is left to wonder whether enablement lends itself to a pure question of fact or whether the current Federal Circuit standard (under which it is a question of law based on underlying facts) is the correct interpretation. Interestingly, in footnote 2 of its petition, Amgen dismissed the Federal Circuit panel's attempt to liken enablement to obviousness. But given that both enablement and obviousness invoke complicated, multi-factorial tests (the Wands and Graham factors, respectively), the panel's comparison seems apt.

After examining the history of this case, and specifically Judge Andrews' application of the long-standing Wands factors, 858 F.2d 731 (Fed. Cir. 1988), leaving enablement as a question of law based on underlying facts may be the best course of action.

Lack of Enablement at the District Court

The dispute between Amgen and Sanofi goes back to 2014, when Amgen alleged that Sanofi's and Regeneron's PCSK9-blocking antibody product, Praluent^' (alirocumab) injection, which is Food and Drug Administration (FDA)-approved to...