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 loophole for patentees and undermined the 2023 Cellect decision by holding 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 petitioned for en banc rehearing – hoping to invalidate Allergan’s protected patent.
Prior posts:
- En Banc Review in Allergan: Rehearing Petition Tackles ODP Safe Harbor and WD Essential Elements
- Family Planning Patent Style: Allergan, Cellect, and the ODP Maze
Two amicus briefs were recently filed supporting the petition – 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 petition, 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 holdings are criticized by the amici as contrary to precedent and detrimental to generic competition.
ODP Loopholes
Both amicus briefs argue that the panel’s ODP holding creates significant loopholes 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 variants, the panel eliminates the requirement for terminal disclaimers in many cases. This allows patentees to separate ownership of admittedly obvious variants, which AAM argues is contrary to longstanding precedent preventing “multiple infringement suits by different assignees asserting essentially the same patented invention.” In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013). AAM warns this provides “a playbook for brand-name drug companies to unlawfully extend their monopolies and deprive patients and taxpayers of less expensive generic and biosimilar alternatives by separating, via ownership or licensing, obvious variants of the same invention.”
The Alvogen brief similarly argues that the panel’s holding “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 maximize patent term adjustment (PTA), then file quick continuations with narrower claims. Under the panel’s rule, “those continuation claims could never serve as ODP references against 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 analysis. 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 analysis 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.”