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
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
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
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
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
The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that prior art disclosing a class of 957 salts could not inherently anticipate claims to a salt within the class because...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
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
On March 26, 2021, the PTAB issued its Final Written Decision in Mylan Pharmaceuticals, Inc. v. Sanofi-Aventis Deutschland GMBH, IPR2019-01657, which involved Sanofi’s Patent RE47,614 (“’614 patent”) relating to its LANTUS...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
PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more
Mylan Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Akron, Inc. petitioned for inter partes review (IPR) of various patents owned by Allergan, Inc., which the Board instituted. One week before the scheduled IPR...more
Earlier this month, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB) that the claims of U.S. Reissue Patent No. RE38,551 challenged in inter partes review were not unpatentable for...more
Federal Circuit Finds Claims Directed to Tabbed Spreadsheets Patent Eligible and Claims Directed to Tracking Changes in Documents Ineligible Under Section 101 - In Data Engine Technologies LLC v. Google LLC, Appeal No....more
The Federal Circuit recently affirmed the Patent Trial and Appeal Board’s (“PTAB”) final written decisions finding the claims of Yeda Research and Development Co., Ltd.’s (“Yeda”) U.S. Patent Nos. 8,232,250, 8,399,413, and...more
Federal Circuit Summary - Before Judges Reyna, Bryson, and Stoll. Appeals from the Patent Trial and Appeal Board and the United States District Court for the District of Delaware. Summary: Non-prior art evidence may...more
As we previously reported, a panel of the Federal Circuit in St. Regis Mohawk Tribe v. Mylan held that “tribal immunity cannot be asserted in IPRs.” The Federal Circuit’s decision, if upheld, means that Allergan’s sale and...more
On July 20 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 not...more