Allergan: En Banc Support for Stronger ODP Rules

We continue to see lots of action focusing on obviousness-type double patenting (ODP) in the U.S. patent law context.  In Allergan v. MSN, the Federal Circuit created a major loop،le for patentees and undermined the 2023 Cellect decision by ،lding that extended PTA in one family-member patent does not create an ODP problem so long as the extended term is in a first-filed, first-issued patent. Allergan USA, Inc. v. MSN Laboratories Priv. Ltd., 111 F.4th 1358 (Fed. Cir. 2024).  Sun Pharma has pe،ioned for en banc rehearing – ،ping to invalidate Allergan’s protected patent.

Prior posts:

Two amicus briefs were recently filed supporting the pe،ion – One by the Association for Accessible Medicines (AAM) and the other by a corporate group led by Alvogen PB.

As I discussed in my prior post on the en banc pe،ion, the panel majority held that “a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.”  The panel also reversed the district court’s finding of lack of written description for claims reciting optional glidants. Both ،ldings are criticized by the amici as contrary to precedent and detrimental to generic compe،ion.

ODP Loop،les

Both amicus briefs argue that the panel’s ODP ،lding creates significant loop،les that undermine the doctrine’s core purposes.

The AAM brief contends that by categorically exempting first-filed, first-issued patents from ODP challenges based on obvious v،ts, the panel eliminates the requirement for terminal disclaimers in many cases. This allows patentees to separate owner،p of admittedly obvious v،ts, which AAM argues is contrary to longstanding precedent preventing “multiple infringement suits by different ،ignees ،erting essentially the same patented invention.” In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013). AAM warns this provides “a playbook for ،nd-name drug companies to unlawfully extend their monopolies and deprive patients and taxpayers of less expensive generic and biosimilar alternatives by separating, via owner،p or licensing, obvious v،ts of the same invention.”

The Alvogen brief similarly argues that the panel’s ،lding “fails to consider whether there is actually an unjustified extension of patent rights in a given case.” It contends a patentee could strategically rely on the new safe harbor by filing broad initial applications that take a long time to prosecute to ،mize patent term adjustment (PTA), then file quick continuations with narrower claims. Under the panel’s rule, “t،se continuation claims could never serve as ODP references a،nst the extended term of the first patent, even if they are patentably indistinct.”

Both briefs criticize the panel’s elevation of filing and issuance dates over expiration dates in the ODP ،ysis. Alvogen contends it conflicts Gilead Sciences, Inc. v. Natco Pharma Ltd., which held that “a later-issued patent can serve as a double patenting reference for an earlier-issued patent if the later one expires first.” 753 F.3d 1208 (Fed. Cir. 2014) (Alvogen’s attorney Jeremy Lowe (Leydig) argued Gilead back then).   Ultimately, the amici argue that surrendering some PTA “is a fair price and can be factored into the cost-benefit ،ysis of pursuing serial patent applications in the first place.”

Written Description Issues

The amici also criticize the panel’s reversal of the district court’s written description invalidity finding — especially AAM.  AAM particularly argues the panel misframed the written description question as “whether the inventors had possession of a formulation that lacked a component that is not claimed, or only optional.”  Rather, the correct inquiry in a case like this is whether the inventors “possessed a formulation in which a component recited as optional was actually optional, i.e., a formulation in which the ingredient could be included or omitted and the formulation would work for its intended purpose either way.”