Webinar: Orange Book listing sheets under the microscope
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Summary - On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to...more
In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...more
The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more
As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
The FTC is focusing its attention on the listing of pharmaceutical patents in the FDA’s Orange Book. Patent listing may be the subject of FTC inquiry even absent infringement litigation enforcing the relevant patents....more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
The USPTO has released an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book or biologic patents, taking into account data through March 31, 2023. Highlights of the...more
On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit issued a precedential opinion in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC that affirmed a district court’s injunction requiring Jazz...more
High Stakes: Hatch-Waxman Litigation Comes for Cannabis - GW Pharma, now a subsidiary of Jazz Pharmaceuticals, is no stranger to patent litigation. It previously found itself on the receiving end of a patent infringement...more
Thank you for reading the January 2023 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss an ongoing trademark dispute between the band OK Go and cereal company Post, how to stay vigilant about...more
Prescription drug prices have long been a source of frustration for the American public and the subject of intense political debates about the best way to lower them without stifling innovation. One of the most significant...more
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more
Nearly two years before patent expiration, Merck, Sharp & Dohme Corp’s (Merck) diabetes drug, Janumet, is at the center of another patent infringement case. In response to an Abbreviated New Drug Application (ANDA) filed with...more
Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more
On April 6, 2020, the U.S. District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, No. 19-cv-10099, denied Sun’s motion to dismiss Celgene’s claims that Sun’s generic Revlimid® (lenalidomide)...more
Please see full Chart below for more information....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
The US Court of Appeals for the Federal Circuit found that a failed inter partes review (IPR) petitioner that maintained a Paragraph III certification had sufficient standing to appeal an adverse decision, but affirmed the...more
Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and...more
Case Name: Amgen Inc. v. Amneal Pharms. LLC, Civ. No. 16-0853 (MSG), 2018 U.S. Dist. LEXIS 125631 (D. Del. July 27, 2018) (Goldberg, J.)....more