Late yesterday, the Federal Circuit released a nonprecedential order dismissing a case. This morning the Federal Circuit released one precedential opinion, four nonprecedential opinions, and seven nonprecedential orders. The lone precedential opinion comes in a patent case on appeal from the Northern District of West Virginia. Of the nonprecedential opinions, three come in patent cases, and one comes in a government contract case. Of the nonprecedential orders released today, three address notices of non-participation in appeals from the Patent Trial and Appeal Board, and among other things these orders ask the U.S. Patent and Trademark Office whether it will intervene in the appeals to defend the PTAB’s decisions. Two of the other nonprecedential orders grant summary affirmance, while two dismiss appeals. Here are the introductions to the opinions and the orders addressing the notices of non-participation in appeals, as well as links to the grants of summary affirmance and dismissals.
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Precedential)
Regeneron Pharmaceuticals, Inc. holds Biologics License Application (BLA) No. 125387—approved by the Food and Drug Administration (FDA)—for EYLEA®, a therapeutic product that contains the fusion protein aflibercept. Aflibercept is known as a “VEGF antagonist” or “VEGF trap” due to its ability to bind, or “trap,” a protein called vascular endothelial growth factor (VEGF) before VEGF can bind to receptors in the human body and stimulate blood-vessel growth. Aflibercept formulations have been approved by the FDA for the treatment of several angiogenic eye diseases (i.e., diseases related to blood-vessel growth in the eye) via intravitreal administration (i.e., injection into the vitreous body of the eye). Regeneron also owns U.S. Patent No. 11,084,865, which is directed to VEGF-trap formulations suitable for intravitreal injection, as well as methods for making and using such formulations. ’865 patent, col. 1, lines 45–49.
Mylan Pharmaceuticals Inc. (Mylan), Samsung Bioepis Co., Ltd. (SB), Formycon AG (Formycon), and several other companies filed abbreviated Biologics License Applications (aBLAs) with the FDA, seeking approval under the Biologics Price Competition and Innovation Act (BPCIA) to market EYLEA® biosimilars. See 42 U.S.C. § 262(k)–(l). In August 2022, Regeneron filed an action against Mylan (the earliest aBLA applicant) in the Northern District of West Virginia (where Mylan is incorporated), asserting infringement of a sizable set of patents related to EYLEA®, including the ’865 patent. In late 2023, Regeneron sued three other biosimilar applicants in the same forum, including SB and Formycon, both of which are foreign companies. Regeneron also brought an action against a fifth biosimilar applicant in the Central District of California, where that applicant is headquartered. In April 2024, the Judicial Panel on Multidistrict Litigation, under 28 U.S.C. § 1407, granted Regeneron’s motion to consolidate all the actions in the West Virginia forum. In re Aflibercept Patent Litigation, 730 F. Supp. 3d 1374, 1375–78 (J.P.M.L. 2024).
The present appeal involves Regeneron’s two suits against SB. In these cases, as well as in the case against Formycon (decided today by this panel), Regeneron filed motions for a preliminary injunction. The district court granted the motions against both SB and Formycon, enjoining them from offering for sale or selling in the United States (without a license from Regeneron) the subject of their aBLAs—which were approved by the FDA very close in time to the preliminary-injunction rulings. Both SB and Formycon appealed, each of them challenging the district court’s exercise of personal jurisdiction and awarding of preliminary-injunction relief. There is considerable overlap in the two appellants’ arguments. We decide the SB and Formycon appeals today—SB’s in the present opinion, and Formycon’s in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Fed. Cir. No. 2024-2009 (Fed. Cir. Jan. 29, 2025) (Formycon Fed. Cir. Decision).
In the present case, the district court’s June 14, 2024 confidential opinion granting preliminary-injunctive relief is at J.A. 1–181, and the public version is available at In re Aflibercept Patent Litigation, No. 1:24-MD-3103-TSK, 2024 WL 3422971 (N.D.W. Va. June 24, 2024) (SB D. Ct. Opinion). The injunction itself, issued July 10, 2024, is at J.A. 182–84 (SB Prelim. Inj.). We see no reversible error in the district court’s holding that it had personal jurisdiction over SB (on the facts established at this stage by Regeneron) or in the district court’s holding that Regeneron had made out its affirmative case for a preliminary injunction, which included a determination that SB had not raised a substantial question of invalidity of the asserted claims of the ’865 patent. Accordingly, we affirm.
A.M. v. United States (Nonprecedential)
Appellant appeals from the United States Court of Federal Claims (Claims Court) decision to dismiss his complaint for lack of subject matter jurisdiction. See A.M. v. United States, 161 Fed. Cl. 1, 6 (2022) (Decision). For the following reasons, we affirm.
Image Processing Technologies LLC v. LG Electronics, Inc. (Nonprecedential)
Image Processing Technologies, Inc. (“IPT”) sued LG Electronics, Inc. (“LG”) in the United States District Court for the Eastern District of Texas for infringement of U.S. Patent No. 6,959,293 (“’293 patent”). The district court conducted claim construction and, thereafter, the parties entered into a stipulated final judgment of invalidity. IPT appeals, arguing that the district court’s construction was erroneous. Specifically, IPT contends that the construction was improperly broader than the broadest reasonable interpretation (“BRI”) that the United States Patent and Trademark Office (“PTO”) applied when it construed the same claim term. As we agree with the district court’s construction, we affirm.
Laboratory Corporation of America Holdings v. Ravgen, Inc. (Nonprecedential)
Laboratory Corporation of America Holdings (“Labcorp”) appeals from the final written decision of the U.S. Patent Trial and Appeal Board (“the Board”) holding that claims 1–9 and 21–30 of U.S. Patent 7,727,720 (“the ’720 patent”) had not been shown to be unpatentable. Lab’y Corp. of Am. Holdings v. Ravgen, Inc., No. IPR2021-01026, 2022 WL 17583185 (P.T.A.B. Dec. 12, 2022) (“Decision”). For the following reasons, we affirm.
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Nonprecedential)
Appellant Formycon AG appeals a preliminary injunction that bars it—in the absence of a license from Regeneron Pharmaceuticals, Inc. to Regeneron’s U.S. Patent No. 11,084,865–from marketing its biologic product approved by the Food and Drug Administration (FDA) as a biosimilar to Regeneron’s FDA-approved aflibercept biologic product, EYLEA®. The district court’s June 21, 2024 confidential opinion granting preliminary-injunctive relief is at J.A. 1–203, and the public version is available at In re Aflibercept Patent Litigation, No. 1:24-MD-3103-TSK, 2024 WL 3423047 (N.D. W. Va. July 9, 2024) (Formycon D. Ct. Opinion). The preliminary injunction itself, issued July 10, 2024, is at J.A. 204–06 (Formycon Prelim. Inj.). We affirm.
Today we also reject a challenge by Samsung Bioepis Co., Ltd. (SB) to a very similar preliminary injunction issued by the same district court against SB almost simultaneously with the injunction issued against Formycon. We affirm the preliminary injunction against SB in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Fed. Cir. Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) (hereafter SB Fed. Cir. Decision). Because of the substantial overlap in facts, district-court analyses, and arguments in the Formycon and SB appeals, which were orally argued together to this panel, the present opinion avoids full repetition of common matter. For arguments made by Formycon here but already addressed in the SB Fed. Cir. Decision, we rely on that decision.
In re Staton Techiya, LLC (Nonprecedential Order)
Upon consideration of the notice of non-participation filed by Samsung Electronics Co., Ltd. and Samsung Electronics America, Inc. (collectively, “Samsung”) in these appeals from the Patent Trial and Appeal Board, ECF No. 43, and the parties’ joint stipulation of voluntary dismissal of Samsung’s cross-appeal, Appeal No. 2023-2341, pursuant to Federal Rule of Appellate Procedure 42(b), ECF No. 42,
IT IS ORDERED THAT:
(1) Appeal No. 2023-2341 is dismissed. The revised official caption and short caption for the remaining appeals, Appeal Nos. 2023-2305 and 2023-2306, are reflected in this order.
(2) Each side shall bear its own costs as to Appeal No. 2023-2341.
(3) Samsung’s principal and response brief (ECF No. 25), Staton Techiya, LLC’s response and reply brief (ECF No. 28), Samsung’s reply brief (ECF No. 31), and the joint appendix (ECF No. 32) will not be transmitted to the merits panel assigned to Appeal Nos. 2023-2305 and 2023- 2306.
(4) Staton Techiya’s principal brief (ECF No. 20) shall be transmitted to the merits panel.
(5) The United States Patent and Trademark Office (PTO) is directed to inform this court within 30 days of the date of entry of this order whether the PTO will participate in Appeal Nos. 2023-2305 and 2023-2306.
(6) If the PTO elects to participate as intervenor, its docketing statement is due within 14 days after its notice of election to intervene, and its brief is due within 40 days after its notice of election to intervene. Staton Techiya will have 21 days after the filing of the PTO’s brief to file a replacement reply brief and seven days thereafter to file a replacement joint appendix.
(7) If the PTO elects not to intervene, Staton Techiya is directed to file a replacement appendix, containing only the material cited in its principal brief, within seven days of the PTO’s election.
(8) The Clerk of Court shall transmit a copy of this order to the merits panel assigned to Appeal Nos. 2023-2305 and 2023-2306.
In re Staton Techiya, LLC (Nonprecedential Order)
Upon consideration of the notice of non-participation filed by Samsung Electronics Co., Ltd. and Samsung Electronics America, Inc. (collectively, “Samsung”) in these appeals from the Patent Trial and Appeal Board, ECF No. 49, and the parties’ joint stipulation of voluntary dismissal of Samsung’s cross-appeal, Appeal No. 2023-2342, pursuant to Federal Rule of Appellate Procedure 42(b), ECF No. 48,
IT IS ORDERED THAT:
(1) Appeal No. 2023-2342 is dismissed. The revised official caption and short caption for the remaining appeal, Appeal No. 2023-2294, are reflected in this order.
(2) Each side shall bear its own costs as to Appeal No. 2023-2342.
(3) Samsung’s principal and response brief (ECF No. 28), Staton Techiya, LLC’s response and reply brief (ECF No. 31), Samsung’s reply brief (ECF No. 34), and the joint appendix (ECF No. 35) will not be transmitted to the merits panel assigned to Appeal No. 2023-2294.
(4) Staton Techiya’s principal brief (ECF No. 23) shall be transmitted to the merits panel.
(5) The United States Patent and Trademark Office (PTO) is directed to inform this court within 30 days of the date of entry of this order whether the PTO will participate in Appeal No. 2023-2294.
(6) If the PTO elects to participate as intervenor, its docketing statement is due within 14 days after its notice of election to intervene, and its brief is due within 40 days after its notice of election to intervene. Staton Techiya will have 21 days after the filing of the PTO’s brief to file a replacement reply brief and seven days thereafter to file a replacement joint appendix.
(7) If the PTO elects not to intervene, Staton Techiya is directed to file a replacement appendix, containing only the material cited in its principal brief, within seven days of the PTO’s election.
(8) The Clerk of Court shall transmit a copy of this order to the merits panel assigned to Appeal No. 2023-2294.
In re Staton Techiya, LLC (Nonprecedential Order)
Upon consideration of the notice of non-participation filed by Samsung Electronics America, Inc. and Samsung Electronics Co., Ltd. (collectively, “Samsung”) in these appeals from the Patent Trial and Appeal Board, ECF No. 41, and the parties’ joint stipulation of voluntary dismissal of Samsung’s cross-appeal, Appeal No. 2023-2292, pursuant to Federal Rule of Appellate Procedure 42(b), ECF No. 40,
IT IS ORDERED THAT:
(1) Appeal No. 2023-2292 is dismissed. The revised official caption and short caption for the remaining appeal, Appeal No. 2023-2290, are reflected in this order.
(2) Each side shall bear its own costs as to Appeal No. 2023-2292.
(3) Samsung’s principal and response brief (ECF No. 20), Staton Techiya, LLC’s response and reply brief (ECF No. 21), Samsung’s reply brief (ECF No. 24), and the joint appendix (ECF No. 25) will not be transmitted to the merits panel assigned to Appeal No. 2023-2290.
(4) Staton Techiya’s principal brief (ECF No. 15) shall be transmitted to the merits panel.
(5) The United States Patent and Trademark Office (PTO) is directed to inform this court within 30 days of the date of entry of this order whether the PTO will participate in Appeal No. 2023-2290.
(6) If the PTO elects to participate as intervenor, its docketing statement is due within 14 days after its notice of election to intervene, and its brief is due within 40 days after its notice of election to intervene. Staton Techiya will have 21 days after the filing of the PTO’s brief to file a replacement reply brief and seven days thereafter to file a replacement joint appendix.
(7) If the PTO elects not to intervene, Staton Techiya is directed to file a replacement appendix, containing only the material cited in its principal brief, within seven days of the PTO’s election.
(8) The Clerk of Court shall transmit a copy of this order to the merits panel assigned to Appeal No. 2023-2290.
Samsung Electronics Co. v. Staton Techiya, LLC (Nonprecedential Order)
Upon consideration of the notice of non-participation filed by Samsung Electronics Co., Ltd. and Samsung Electronics America, Inc. (collectively, “Samsung”) in these appeals from the Patent Trial and Appeal Board, ECF No. 35, and the parties’ joint stipulation of voluntary dismissal of Samsung’s appeal, Appeal No. 2023-2295, pursuant to Federal Rule of Appellate Procedure 42(b), ECF No. 34,
IT IS ORDERED THAT:
(1) Appeal No. 2023-2295 is dismissed. The revised official caption for the remaining appeal, Appeal No. 2023- 2335, is reflected in this order.
(2) Each side shall bear its own costs as to Appeal No. 2023-2295.
(3) The previously-filed briefs and appendix will not be transmitted to the merits panel assigned to Appeal No. 2023-2335.
(4) Within 14 days of the date of entry of this order, Staton Techiya, LLC is directed to submit a corrected brief in Appeal No. 2023-2335 that shall be revised only to the extent that it reflects the revised caption and omits those portions of its original brief (ECF No. 19) addressing Samsung’s arguments.
(5) The United States Patent and Trademark Office (PTO) is directed to inform this court within 30 days of the date of entry of this order whether the PTO will participate in Appeal No. 2023-2335.
(6) If the PTO elects to participate as intervenor, its docketing statement is due within 14 days after its notice of election to intervene, and its brief is due within 40 days after its notice of election to intervene. Staton Techiya will have 21 days after the filing of the PTO’s brief to file a replacement reply brief and seven days thereafter to file a replacement joint appendix.
(7) If the PTO elects not to intervene, Staton Techiya is directed to file a replacement appendix, containing only the material cited in its corrected brief, within seven days of the PTO’s election.
(8) The Clerk of Court shall transmit a copy of this order to the merits panel assigned to Appeal No. 2023-2335