Assertions of obviousness based on prior art references in combination with “routine optimization” by one skilled in the art are common in the chemical and biological fields. The Federal Circuit recently addressed this issue...more
10/10/2018
/ Appeals ,
Biologics ,
Burden-Shifting ,
Chemicals ,
Inter Partes Review (IPR) Proceeding ,
Nonobvious ,
Obviousness ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Reversal ,
Substantial Evidence Standard
During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more
Throughout the past year, substantial investment continued to pour into digital health and personalized medicine. Personalized medicine involves the discovery of particular genetic variations that contribute to human...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
MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC -
(Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) -
This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more
On May 17, 2017, Vertex Pharmaceuticals small molecule drug Kalydeco® (ivacaftor) was approved by the U.S. Food and Drug Administration (FDA) for use in treating an expanded population of cystic fibrosis patients with...more
An MIT group consisting of the CRISPR pioneer Feng Zhang and 18 of his colleagues recently published a paper in Science demonstrating a new platform for using CRISPR technology as a diagnostic tool for detecting nucleic...more
On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more
Once considered parasites, free riders, or “opportunistic pathogens,” in recent years the roughly 100 trillion symbiotic bacteria that inhabit the various tissues of the human body have been increasingly recognized for their...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
On January 12, 2016, President Barack Obama announced his goal of a nationwide “Cancer Moonshot,” with the ultimate goal of accelerating cancer research “to end cancer as we know it” during his State of the Union Address As...more