EpiPen RICO Ruling Opens Door for Private AKS Enforcement
On January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S. Patent Nos. 10,130,681 and 10,888,601. The PTAB...more
Federal Circuit Orders District Court to Consider Extrinsic Evidence in Claim Construction - In Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., Appeal No. 22-1889, the Federal Circuit held that where a...more
The Court of Appeals for the Federal Circuit recently addressed the issue of “analogous prior art,” a patent law doctrine fundamental to the legal determination of whether a patent is invalid as obvious over the prior art....more
On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron...more
The Federal Circuit reversed a Patent Trial and Appeal Board (“Board”) decision finding the challenged claims of Sanofi-Aventis’ ’614 patent unpatentable as obvious....more
We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept...more
In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent),...more
On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in...more
The USPTO published Revision 07.2022 of the Ninth Edition of the Manual of Patent Examining Procedure (MPEP). A change summary is available here....more
Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept. Specifically, Celltrion and Samsung have each filed petitions...more
As we previously reported, Mylan recently filed three IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept, the active ingredient in Regeneron’s Eylea...more
On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069. The PTAB ruled in...more
Anticipation of a claim generally requires that a single prior art reference explicitly discloses each and every claim element. However, absent an express teaching in the prior art, a claim may also be anticipated if it is...more
Mylan Pharmaceuticals Inc. recently filed an IPR petition, PTAB-IPR2023-00099, seeking cancellation of claims 1-3 of U.S. Patent No. 10,857,205, assigned to Regeneron Pharmaceuticals, Inc. According to the petition,...more
Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and...more
Ranges for Interdependent and Interactive Components Can Be Tricky to Derive - In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on...more
Precedential Federal Circuit Opinions - TEVA PHARMACEUTICALS USA v. CORCEPT THERAPEUTICS, INC. [OPINION] (2021-1360, 12/07/2021) (MOORE, NEWMAN, and REYNA) - Moore, C.J. The Court affirmed the PTAB’s IPR decision...more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
Originating tribunal: Patent Trial and Appeal Board - Date: March 12, 2021 - Panel: Judges Newman, Moore, and Stoll, with Judge Moore writing the precedential order - Result: Appeal dismissed, and mandamus...more
MYLAN LABS. LTD. v. JANSSEN PHARMACEUTICA, N.V. Before Newman, Moore, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: The Federal Circuit lacks jurisdiction over appeals from decisions denying...more
The written description requirement has had a twenty-five year renaissance, particularly in the chemical and biotechnology arts as a way of restricting claim scope to what an inventor has actually invented (see Regents of the...more
As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection). On May 29, 2020, the PTAB issued Final Written...more
About the PTAB Life Sciences Report: We will periodically report on developments at the PTAB involving life sciences patents. Abbott Laboratories v. Edwards Lifesciences Corp. PTAB Petition: IPR2020-00480; filed January...more
Last year, this blog discussed various strategic considerations for litigants seeking declarations of invalidity in district court actions to avoid being precluded from also seeking inter partes or other post-grant review...more
On July 20, 2018 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (Dyk, Moore and Reyna JJ) held that Native American (“Indian”) Tribes do...more