Federal Circuit Clarifies Obviousness-Type Double Patenting Rule

On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit (the Court) decided Allergan USA, Inc. v. MSN Laboratories Private Ltd., C.A. No. 2024-1061, finding that a first-filed, first-issued, later-expired claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.

Allergan involved U.S. Patent No. 7,741,356 (the ’356 patent), the first-ever patent to cover eluxadoline, which was filed on March 14, 2005, issued on June 22, 2010, and was awarded 1,107 days of Patent Term Adjustment (PTA). The ’356 patent was assigned to Janssen, who disclaimed all but 467 days of PTA during the application for patent term extension.

Janssen filed continuing applications claiming priority from the March 14, 2005 filing date of the ’356 patent, resulting in U.S. Patent No. 8,344,011 (the ’011 patent), filed on July 19, 2010 and issued on January 1, 2023, and U.S. Patent No. 8,609,709 (the ’709 patent), filed on November 30, 2012 and issued on December 17, 2013. The ’011 and ’709 patents received no PTA, and a terminal disclaimer was filed in the ’709 patent over the ’356 patent. Because all three patents share a priority date, all would expire on the same day but for the PTA awarded to the ’356 patent.

Reversing a decision from the United States District Court for the District of Delaware, the Court found that claim 40 of the ’356 patent was not invalid for an obviousness-type double patenting (ODP) over claim 33 of the ’011 patent and claim 5 of the ’709 patent because the ’011 and ’709 patents were not proper ODP references that can be used to invalidate the ’356 patent.

The Court emphasized that the purpose of the ODP doctrine is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter. Here, the ’356 patent was the first patent, whether measured by filing date or by issuance date, and each of the ’011 and ’709 patents was second, as neither application was filed until after the ’356 patent issued. Further, the Court found that the claims of the ’356 patent did not extend or prolong the exclusivity period of the subject matter claimed in the ’011 and ’709 patents simply because the ’356 patent expired later due to the awarded PTA.

Furthermore, the Court indicated that holding that a first-filed, first-issued patent having received PTA could be invalidated by a later-filed, later-issued child patent with less, if any, PTA, would also abrogate the benefit Congress intended to grant patentees when codifying PTA.

Finally, the Court clarified that its holding in In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023), was only controlling to the extent that it required consideration, in the ODP analysis, of the patent’s expiration date after the addition of PTA. However, this did not mean that the ’356 patent must be invalidated by the ’011 and ’709 patents simply because it expires later.

The Court also noted that “Cellect does not address, let alone resolve, any variation of the question presented here — namely, under what circumstances can a claim properly serve as an ODP reference — and therefore has little to say on the precise issue before us.” In doing so, the Court may be inviting future panels to more broadly reconsider when a claim in a family can serve as a reference claim against other claims in the same family.

The Court raised further questions about the extent to which future panels will apply both Cellect and Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), by observing that because the patentees in those cases did not make any argument about when a claim can serve as a reference claim:

• “[T]he patent owner in Cellect did not challenge whether the reference claims used to invalidate the asserted claims were proper ODP reference claims.”
• “But the court in Gilead, guided by the parties’ arguments, focused its inquiry only on whether issuance dates should remain the most relevant benchmark for evaluating ODP post-URAA…. It did not address the role of filing dates.” (If two applications have the same effective filing date because they are in the same family, perhaps no claim in the same family can serve as a reference claim. Gilead, according to Allergan, did not address that issue because it was not argued nor was it even pertinent as Gilead involved separate families.)

Please reach out to any of the authors of this Advisory or your regular Arnold & Porter contact if you have any questions or need additional information.

*Devora Champa is employed as a patent agent at Arnold & Porter’s Washington, D.C. office. Devora is not admitted to the practice of law.

© Arnold & Porter Kaye Scholer LLP 2024 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.