On December 27, 2023, Judge Thomas S. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s...more
On April 25th, 2023, the U.S. Food and Drug Administration (FDA) approved QalsodyTM (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene...more
Federal Circuit Summary -
On September 10, 2018, the Federal Circuit decided Regents of the University of California v. Broad Institute, Inc., affirming the Patent Trial and Appeal Board (PTAB)’s determination of no...more
9/17/2018
/ Appeals ,
CRISPR ,
Interference Proceeding ,
Life Sciences ,
Obviousness ,
Patent Applications ,
Patent Infringement ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Reaffirmation ,
Substantial Evidence Standard ,
University of California
On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research...more
In vitro gametogenesis (IVG) is a recent development in reproductive technology, and has been used for creating mouse embryos in vitro. IVG includes obtaining cells from a donor (such as skin cells), and differentiating the...more
5/25/2018
/ America Invents Act ,
Foreign Patent Applications ,
Human Genes ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Method Claims ,
Patent Cooperation Treaty ,
Patent-Eligible Subject Matter ,
Patents ,
Product of Nature Doctrine
Before Prost, O’Malley, and Wallach. Appeal from the District of Connecticut (nonprecedential).
On August 2, 2017, the Federal Circuit affirmed a decision by the U.S. District Court for the District of Connecticut granting...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
2/4/2017
/ Amgen ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Cross Motions ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
License Applications ,
Life Sciences ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remedies ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more
11/18/2016
/ Biotechnology ,
BRCA ,
Cancer ,
Clinical Trials ,
Diagnostic Tests ,
FDA Approval ,
Human Genes ,
Life Sciences ,
Medical Devices ,
Myriad ,
Pharmaceutical Industry
GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million...more