CASES OF THE WEEK

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development.

In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the Court’s trend of dismissing appeals from post-grant PTAB proceedings for lack of standing, arguing that pharmaceutical patent challengers should not have to make major investments in development before being able to appeal an unsuccessful patent challenge.

In Jazz Pharms. v. Avadel CNS Pharms., the Federal Circuit cut down a permanent injunction for impermissibly encroaching on the safe-harbor development provisions of 35 U.S.C. § 271(e)(3), and raised—but did not answer—a new question concerning whether submitting a new drug application could infringe under § 271(e)(2) if the patent at issue is not listed in FDA’s “Orange Book” publication.

ALSO THIS WEEK

Incyte Corp. v. Sun Pharm. Indus., Ltd., Appeal No. 2025-1162 (Fed. Cir. May 7, 2025)

In a related but distinct case from our Case of the Week, the Court dissolved a preliminary injunction in district court litigation brought by Incyte concerning one of its own patents. The district court granted the preliminary injunction, finding that Incyte would suffer irreparable harm if Sun were allowed to launch its competing product. Incyte had argued that Sun would achieve an unfair head start and obtain first mover benefits from getting its product on the market. But Incyte’s patent expires in 2026, and it is still several years away from launching its own product. Accordingly, Sun is going to have a head start regardless, even if it waits to launch when the patent expires in 2026. The Federal Circuit held it was clearly erroneous to hold there would be irreparable injury under such circumstances, and reversed the grant of the preliminary injunction.

The opinion can be found here.

Ingenico Inc. v. Ioengine, LLC, Appeal No. 2023-1367 (Fed. Cir. May 7, 2025)

In this case, the Court of Appeals affirmed the jury verdict from the district court finding challenged claims of U.S. Patent Nos. 9,059,969 (“the ’969 patent”) and 9,774,703 (“the ’703 patent”)—which relate to secure communications for portable devices—invalid as anticipated and obvious by the prior art. Among other things, the Court of Appeals rejected Appellant IOENGINE’s argument that the district court should have precluded Ingenico from introducing prior art at trial pursuant to IPR estoppel under 35 U.S.C. § 315(e)(2). Section 315(e)(2) prohibits an IPR petitioner from asserting that a claim is invalid “on any ground that the petitioner raised or reasonably could have raised” in the IPR proceedings. The panel explained that a petitioner has no opportunity to raise certain grounds for invalidity at IPR, such as that the claimed invention was known or used by others, on sale, or in public use. See Lynk Labs, Inc. v. Samsung Elecs. Co., 125 F.4th 1120, 1128 (Fed. Cir. 2025). The Court therefore concluded that IPR estoppel applies only to a petitioner’s assertions in district court that the claimed invention is invalid on grounds available in IPR, i.e. it was patented or described in a printed publication. Thus, IPR estoppel does not preclude invalidity assertions that a claimed invention was known or used by others, on sale, or in public use in district court, nor the use of patents or printed publications as evidence for these assertions.

The opinion can be found here.

In re: Miodrag Kostic, Guy Vandevelde, Appeal No. 2023-1437 (Fed. Cir. May 6, 2025)

In an appeal from the Patent Trial and Appeal Board sustaining an Examiner's rejection of a reissue claim due to improper broadening of the claim, the Court affirmed. On appeal, Appellants argued that the proper inquiry is whether the reissue claim is broader than the “intended scope” rather than the actual scope as written. However, the Court rejected the argument because it "construe[s] the claims as written, not as the patentee wish they had written it." As such, the Court compared the scope of the reissue claim with the actual scope of the original claim. Here, the scope of the reissue claim was broader because it attempted to make the processes involved optional rather than mandatory ("either/or" rather than "and"). This broadening was improper because it was more than two years after the grant of the original patent, which is a statutory bar pursuant to 35 U.S.C. § 251(d).

The opinion can be found here.

Editors:

Nika Aldrich, IP Litigation Group Leader, Schwabe

Jason A. Wrubleski, Shareholder

Contributors:

Elizabeth Graves, Associate

Jeff Liao, Associate