The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...more
When a prevailing challenger withdraws from an appeal in post-grant proceedings, the Director can intervene under 35 U.S.C. § 143, which is what happened in an appeal in Sage Products, LLC v. Stewart after Challenger Becton...more
The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims,...more
The dispute between the Judicial Council of the Federal Circuit and The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit has been waging for more than a year (see links below). The...more
Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more
Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the...more
3/14/2025
/ Appeals ,
Claim Construction ,
DNA ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Summary Judgment
Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more
After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more
The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit, has been battling her suspension from the Court imposed by the Judicial Council for two years (including proceedings leading...more
Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more
2/18/2025
/ Biologics ,
BPCIA ,
Multidistrict Litigation ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions
The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more
2/13/2025
/ Appeals ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Oral Argument ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Statutory Interpretation ,
USPTO
The U.S. Patent and Trademark Office has a history of attempting to challenge judicial decisions that the Office, usually for its own policy reasons, takes issue with.[1] Recently, the Office decided to challenge the...more
The Office of the U.S. Trade Representative (USTR) issued its "2024 Review of Notorious Markets for Counterfeiting and Piracy" on January 8th, directed to "prominent and illustrative examples of online and physical markets...more
1/16/2025
/ Centers for Disease Control and Prevention (CDC) ,
Counterfeiting ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trademark Infringement ,
USTR
It has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently...more
It has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently...more
It has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the propriety of the suspension (something the Judge herself recently...more
The Buckeye Institute Files Amicus Brief in Newman v. Moore et al. It has been a remarkable feature of the Federal Circuit's suspension of the Honorable Judge Pauline Newman that few have taken a stand publicly on the...more
The Honorable Pauline Newman, Circuit Judge for the U.S. Court of Appeals for the Federal Circuit, has been battling her suspension from the Court imposed by the Judicial Council for two years (including proceedings leading...more
Last month, at the Biotechnology Innovation Organization (BIO) Intellectual Property Counsels Committee (IPCC) conference in Washington, DC, the Honorable Judge Pauline Newman of the Federal Circuit gave a lunchtime address...more
As has been expected, the Director of the U.S. Patent and Trademark Office, the Honorable Kathi Vidal, has announced her resignation. Deputy Director Derrick Brent will assume her position (at least temporarily) starting in...more
The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals, wherein the District Court entered an injunction ordering...more
The metes and bounds of how courts should consider indefiniteness under 35 U.S.C. § 112(b) were addressed most recently by the Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014). Regardless,...more
The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering...more
The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering...more
In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...more
10/7/2024
/ Amicus Briefs ,
Federal Arbitration Act ,
Obviousness-Type Double Patenting (ODP) ,
Patent Ownership ,
Patent Terms ,
Patents ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Rules ,
SCOTUS ,
USPTO