This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more
2/4/2025
/ Denial of Certiorari ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Regulatory Requirements ,
SCOTUS ,
Statutory Interpretation
In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more
On September 11, 2023, the Federal Circuit issued a precedential opinion that vacated and remanded two final written decisions of the Patent Trial and Appeal Board (the “Board”) in Apple, Inc. v. Corephotonics, Ltd.. The...more
This article compares two recent Federal Circuit opinions concerning IPR cases addressing the nexus requirement for objective indicia of non-obviousness. These cases revolve around the patentee’s use of a commercial...more
Today the Federal Circuit affirmed the December 27, 2022 judgement issued by Judge Stanley R. Chesler of the District of New Jersey in favor of Takeda Pharmaceuticals, protecting Takeda’s patented Vyvanse® product from...more
On December 27, 2022, Haug Partners LLP and Gibbons PC obtained a key victory as to all counts for its client, plaintiffs Takeda Pharmaceutical Co. Ltd. and Takeda Pharmaceuticals U.S.A., Inc., defeating a generic challenge...more
Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more
12/30/2021
/ Clinical Trials ,
Hatch-Waxman ,
Obviousness ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
POSITA ,
Prior Art ,
Section 112 ,
Standard of Care ,
Written Descriptions
On December 9, 2021, Haug Partners defeated two discovery motions brought by Environmental Manufacturing Solutions, LLC (“EMS”) against Fluid Energy Group Ltd. (“Fluid”), in an opposition proceeding before the U.S. Trademark...more
On April 7, 2021, the Federal Circuit decided Apple Inc. v. Qualcomm Inc., where it held that Apple lacked standing to appeal the final written decisions in two inter partes review (“IPR”) proceedings before the U.S. Patent...more
4/15/2021
/ Article III ,
Denial of Certiorari ,
Final Written Decisions ,
Injury-in-Fact ,
Inter Partes Review (IPR) Proceeding ,
Jurisdiction ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Standing
Since the Supreme Court’s ruling in TC Heartland, there has been increased litigation over appropriate venue in patent litigation, including Hatch-Waxman cases. 28 U.S.C. § 1400(b) provides that venue in patent infringement...more
On November 19, 2020, a unanimous panel of the Court of Appeals for the Federal Circuit (“Federal Circuit”) decided Vectura Ltd. v. GlaxoSmithKline LLC, affirming a $90 million verdict. Vectura Ltd. (“Vectura”) sued...more
12/1/2020
/ Claim Construction ,
Damages ,
Judgment As A Matter Of Law ,
Patent Applications ,
Patent Infringement ,
Patent Royalties ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post Trial Motions ,
Remittitur
Recently, the Federal Circuit issued a decision in Immunex Corp. v. Sanofi-Aventis U.S. LLC addressing the different claim construction standards used by the Patent Trial and Appeal Board (“PTAB”) (broadest reasonable...more
11/25/2020
/ Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Corporate Counsel ,
Ex Partes Reexamination ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Phillips Standard ,
Prior Art ,
Reissue Patents ,
USPTO