The Federal Circuit recently issued a decision in SoftView LLC v. Apple Inc. clarifying the scope of patent owner estoppel set forth in 37 C.F.R. § 42.73(d)(3)(i). 2024 WL 3543902 (Fed. Cir. July 26, 2024). The regulation...more
On July 9, 2024, Director Vidal reversed and remanded a denial of institution of inter partes review (IPR) relating to three Spin Master patents. See Prime Time Toys LLC v. Spin Master, Inc., IPR Nos. 2023-01339, 2023-01348,...more
The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
7/9/2024
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Director Vidal recently vacated three discretionary denials of institution after finding that the three petitioners did not have a “significant relationship” with a prior petitioner. American Honda Motor Co., Inc. v. Neo...more
The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date...more
1/26/2024
/ En Banc Review ,
Intellectual Property Protection ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing
USPTO Director Kathi Vidal recently designated precedential section II.E.3 of Penumbra, Inc. v. RapidPulse, Inc. and clarified that the priority analysis for an AIA reference patent as prior art is different than for a...more
The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more
12/20/2023
/ Bayh-Dole Act ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health and Safety ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
March-in-Rights ,
NIST ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs
The PTAB recently issued a rare decision instituting a derivation proceeding, in Global Health Solutions LLC v. Selner, DER2017-00031 (“GHC”). The GHC institution decision provides several lessons for future petitioners...more
A podcast from JAMS featuring Steven Bauer and Sarah Geers on how ADR can play a pivotal role in resolving IP-related disputes in the life sciences industry -
In this podcast, Steven Bauer, mediator and arbitrator at...more
4/1/2022
/ Arbitration ,
Arbitrators ,
Dispute Resolution ,
Intellectual Property Litigation ,
Inventors ,
Life Sciences ,
Mediation ,
Mediators ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Trade Secrets
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
A recent post-grant review decision once again reminds patentees of the increasing scrutiny that claims are facing under the written description and enablement requirements under 35 U.S.C. § 112 (a). In this case,...more
Claims added or amended during inter partes review (“IPR”) do not become part of a patent until the Patent Office officially says so by issuing an IPR certificate under 35 U.S.C. § 318(b). The patentee needs more than a Final...more