This edition of Gibson Dunn’s Federal Circuit Update for March summarizes the current status of petitions pending before the Supreme Court and recent Federal Circuit decisions concerning forfeiture, obviousness, patent term extensions, whether separately recited components in a claim must refer to distinct components in the patented invention, and 35 U.S.C. § 102(e).~~Federal Circuit News~~Noteworthy Petitions for a Writ of Certiorari :

There were no new potentially impactful petitions filed before the Supreme Court in March 2025. We provide an update below of the petitions pending before the Supreme Court, which were summarized in our February 2025 update:~~Upcoming Oral Argument Calendar~~The list of upcoming arguments at the Federal Circuit is available on the court’s website. .~~Key Case Summaries (March 2025)~~Odyssey Logistics & Technology Corp. v. Stewart, No. 23-2077 (Fed. Cir. Mar. 6, 2025):  Odyssey appealed an examiner’s rejection of its patent application, which was affirmed by the Federal Circuit in 2020.  Over a year later, the Supreme Court issued its decision in United States v. Arthrex, Inc., 594 U.S. 1 (2021), which held that administrative patent judges’ unreviewable authority in inter partes review proceedings violated the Appointments Clause.  Odyssey petitioned for review by the Director of the United States Patent and Trademark Office (USPTO) based on that decision.  The Director denied the request.  Odyssey then filed a complaint in district court to compel Director review, but the district court dismissed Odyssey’s complaint for lack of subject matter jurisdiction, reasoning that whether the Director decides to review Odyssey’s request was committed to the agency’s discretion and judicial review of that decision is improper.

The Federal Circuit (Dyk, J., joined by Reyna and Stoll, JJ.) affirmed.  The Court held that Odyssey had forfeited its Appointments Clause challenge by not raising it in its first appeal despite its knowledge of the Appointments Clause challenge addressed by the Federal Circuit in Arthrex in 2019.  Considering the standard set forth in Fed. R. Civ. P. 60(b), the Federal Circuit found no extraordinary circumstances existed that would excuse Odyssey’s failure to raise its stated ground for relief earlier and decided that the USPTO did not abuse its discretion in denying Odyssey’s request for review.  Therefore, the Court concluded that Odyssey’s complaint failed to state a claim for relief and affirmed the district court’s decision on that basis, rather than for lack of subject matter jurisdiction.

ImmunoGen, Inc. v. Stewart, No. 23-1762 (Fed. Cir. March 6, 2025):  ImmunoGen’s patent application is directed to a dosing regimen for administering IMGN853, an antibody drug conjugate (ADC) for treating certain ovarian and peritoneal cancers.  While a promising cancer therapy, the drug was known to cause ocular toxicity, including keratitis and blurred vision.  ImmunoGen developed an effective dosing regimen that resulted in minimal adverse effects and sought to patent its solution, which included limitations reciting the administration of IMGN853 at a dose of 6 mg/kg based on an adjusted ideal body weight (AIBW) of the patient (the “dosing limitation”).  The examiner rejected the claims as obvious primarily relying on ImmunoGen’s own prior patent publication related to IMGN853, which disclosed the 6mg/kg AIBW dosage.  ImmunoGen brought an action under 35 U.S.C. § 145, and the district court determined that the claims are unpatentable as obvious.

The Federal Circuit (Lourie, J., joined by Dyk and Prost, JJ.) affirmed.  ImmunoGen argued that the prior art did not disclose that IMGN853 caused ocular toxicity in humans and therefore did not render the dosing limitation obvious.  However, the Federal Circuit held that a solution to “an unknown problem is not necessarily non-obvious.”  Instead, “any need or problem known in the field of endeavor at the time of invention can provide a reason for combining the elements in the manner claimed.”  Accordingly, the Court determined that it would have been obvious to a skilled artisan to experiment with changing the dosage to reduce toxicity, and AIBW was a known dosing methodology for anticancer drugs.  Furthermore, the Court found that ImmunoGen’s own prior patent publication disclosed the 6mg/kg AIBW dosing regimen for ADCs.  Thus, the Court concluded that a person of ordinary skill in the art would have been motivated to try an AIBW dosing methodology with IMGN853 at the 6 mg/kg AIBW dosage.

Merck Sharp & Dohme B.V. et al v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. Mar. 13, 2025):  Merck owns a patent directed to sugammadex, which is the active ingredient in BRIDION®, a drug that reverses neuromuscular blockade, which is a certain form of paralysis induced by certain types of surgery.  While regulatory review for sugammadex was pending, Merck filed an application to reissue the patent.  After both the patent reissued and the regulatory process concluded, Merck sought and received a five-year patent term extension (PTE) under 35 U.S.C. § 156(c), which provides limited extensions of patent terms due to regulatory review delay.  Merck sued Aurobindo for infringement of its reissued patent based on Aurobindo’s filing of an abbreviated new drug application (ANDA) for approval to sell generic versions of BRIDION®.  Aurobindo challenged the length of the reissued patent’s PTE and argued that 35 U.S.C. § 156(c) requires calculating the extension for “the patent,” as recited in the statute, from the date of issuance of the reissued patent, not the original patent.  The district court disagreed, concluding that the amount of delay should be calculated from the date of issuance of the original patent.

The Federal Circuit (Dyk, J., joined by Mayer and Reyna, JJ.) affirmed.  The Court held that, when calculating a patent term extension for reissued patents that include “the same claims directed to a drug product subject to FDA review” as the original patent, the statutory language of “the patent” in 35 U.S.C. § 156(c) refers to the original patent.  The Court reasoned that the purpose of the Hatch-Waxman Act, in providing patent term extensions to recover a portion of market exclusivity lost during regulatory review, required interpreting “the patent” as the original patent in the context of reissued patents to fully compensate patent owners for the period of exclusivity lost due to regulatory delay.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 24-2351 (Fed. Cir. March 14, 2025):  Regeneron owns a patent directed to pharmaceutical formulations for a fusion protein known as aflibercept, claiming “a vascular endothelial growth factor (VEGF) antagonist” and “a buffer,” among other limitations.  The patent covers Regeneron’s biologic product EYLEA® (“Eylea”) and is listed in FDA’s Purple Book, which is a searchable online database that lists all FDA-approved biological products.  Eylea is used to treat angiogenic eye disorders associated with uncontrolled blood vessel growth in the retina, which can cause vision loss or blindness.  Amgen filed an abbreviated Biologics License Application (aBLA) at the FDA, which stated that its formulation differs from Regeneron’s formulation because it does not contain a separate buffer protein.  Regeneron sued Amgen alleging infringement of its patent and filed a motion for preliminary injunction.  Amgen opposed the preliminary injection arguing that the claims separately require a VEGF antagonist and a buffer, so Amgen’s formulation did not infringe.  The district court determined that the claims required that the claimed VEGF antagonist be a separate component from the claimed buffer, concluded that Regeneron had not demonstrated a likelihood of success on the merits, and denied the preliminary injunction.

The Federal Circuit (Lourie, J., joined by Moore, C.J. and Stark, J.) affirmed.  The Court held that “where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention,” citing Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249 (Fed. Cir. 2010).  The Court further determined that the claims and specification only reinforced the interpretation that the claimed components are distinct, and therefore, the implication of separateness had not been overcome.

In re Riggs et al., No. 22-1945 (Fed. Cir. March 24, 2025):  The named inventors (collectively, “Riggs”) filed a patent application directed to an integrated logistics system, which an examiner rejected in part as anticipated by prior art reference, Lettich, under 35 U.S.C. § 102(e).  Riggs appealed to the Patent Trial and Appeal Board (Board), and the Board sustained the examiner’s rejections.  Applying Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015), the Board determined that Lettich was entitled to the priority date of its provisional application as at least one claim in the Lettich non-provisional application was supported by the Lettich provisional application, and thus, qualified as prior art.

The Federal Circuit (Stoll, J., joined by Moore, C.J., and Cunningham, J.) vacated and remanded.  The Court explained that while Dynamic Drinkware held that a patent “cannot be accorded the benefit of its provisional application’s filing date absent a showing that the provisional application provides support for the claims of the patent or published application,” it did not stand for the conclusion that support for only one claim from the provisional would be sufficient for the other portions of the specification to be afforded the provisional’s filing date.  Instead, the Board needed to analyze whether Lettich’s provisional application provided “written description support for the specific disclosures in Lettich that the Examiner identified and relied on in the prior art rejections.”~~The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Audrey Yang, Al Suarez, Hannah Bedard, and Michelle Zhu.~~Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding developments at the Federal Circuit. Please contact the Gibson Dunn lawyer with whom you usually work, any leader or member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups, or the following authors:

Blaine H. Evanson – Orange County (+1 949.451.3805, bevanson@gibsondunn.com) Audrey Yang – Dallas (+1 214.698.3215, ayang@gibsondunn.com)

Appellate and Constitutional Law: Thomas H. Dupree Jr. – Washington, D.C. (+1 202.955.8547, tdupree@gibsondunn.com) Allyson N. Ho – Dallas (+1 214.698.3233, aho@gibsondunn.com) Julian W. Poon – Los Angeles (+ 213.229.7758, jpoon@gibsondunn.com)

Intellectual Property: Kate Dominguez – New York (+1 212.351.2338, kdominguez@gibsondunn.com) Josh Krevitt – New York (+1 212.351.4000, jkrevitt@gibsondunn.com) Jane M. Love, Ph.D. – New York (+1 212.351.3922, jlove@gibsondunn.com)~~© 2025 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.~~Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.~~~~Download PDF~~