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
In a recent precedential opinion, the Court of Appeals for the Federal Circuit vacated an infringement judgement against Mylan (Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 2022-1889, Fed. Cir. Nov. 6,...more
11/14/2023
/ Abbreviated New Drug Application (ANDA) ,
Claim Construction ,
Corporate Counsel ,
Healthcare ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
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
On February 6, 2019, the Federal Circuit decided Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, affirming a District Court for the District of Massachusetts decision that the claims at issue were patent...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 August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy...more
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
On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C. § 200) went into effect. The final revisions were published...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
The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisotopes, LLC, a nuclear medicine...more
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more
On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to...more
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 July 18, 2017, the United States Patent and Trademark Office Patent Trial and Appeal Board (“PTAB”) instituted a covered business method (“CBM”) patent review for U.S. Patent No. 8,955,029 (“the ’029 patent”) on grounds of...more
On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™ (dronabinol) oral solution, a Schedule II (CII) controlled substance. Syndros™ was initially approved by the FDA on July 5, 2016...more
On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were...more
On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary...more
The Federal Circuit recently found claims to a specialized graphical user interface (GUI) for trading financial securities eligible in Trading Technologies Int’l v. CQG, No. 2016-2016 (Fed. Cir. Jan. 18, 2017). The Federal...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
On August 29, 2016, the Regents of the University of Minnesota (“the University”) filed suit against Gilead Sciences (“Gilead”) for patent infringement in the District Court for the District of Minnesota. According to the...more
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
Lake Forest, Illinois-based RoundTable Healthcare Partners recently announced an agreement to acquire Symmetry Surgical, Inc. RoundTable states that the acquisition will provide a new platform in surgical instrumentation and...more
West Chester, Pennsylvania-based Animas Corporation recently announced FDA approval for the use of the Animas®Vibe® Insulin Pump and Continuous Glucose Monitoring (CGM) System for children and adolescents, ages two to...more