The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more
1/21/2022
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inducement ,
Intellectual Property Protection ,
Life Sciences ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Background -
On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
9/21/2021
/ Generic Drugs ,
GlaxoSmithKline ,
Hatch-Waxman ,
Induced Infringement ,
JMOL ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
In a recent decision, a district court in the District of Delaware applied estoppel under 35 U.S.C. § 315(e)(2) to a defendant in Hatch-Waxman litigation, two and half years after the court conducted a bench trial on...more
The Federal Circuit upholds the validity of a patent covering a polymorphic form of a chemical compound.
The United States Court of Appeals for the Federal Circuit recently held in Grünenthal Gmbh v. Alkem Labs. Ltd. that...more
Article III of the Constitution imposes a “case or controversy” limitation on the jurisdiction of federal courts: an actual case or controversy must exist between the parties at all stages of the federal court proceedings,...more
The USPTO has proposed a pilot program intended to make it easier to amend claims before the PTAB. (See the USPTO’s Request for Comments on Motion to Amend Practice and Procedures in Trial Proceedings under the America...more
11/5/2018
/ America Invents Act ,
Claim Amendments ,
Comment Period ,
Federal Pilot Programs ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Reform ,
Patent Trial and Appeal Board ,
Patents
In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more
7/30/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
In orders entered July 10 and 12, 2017, the PTAB instituted further inter partes review (IPR) of six Allergan Inc. (“Allergan”) patents relating to cyclosporine compositions. Each of U.S. Patent Nos. 8,633,162, 8,685,930,...more
Allergan is typically the patent holder in these types of disputes, however, it recently successfully played the role of petitioner in an IPR against 1474791 Ontario Ltd.’s U.S. Patent No. 6,806,251 covering the use of...more