In AIA America, Inc. v. Avid Radiopharmaceuticals, the Federal Circuit considered whether the Seventh Amendment provides the right to a jury trial to determine entitlement to attorneys’ fees.
During the case on the merits,...more
Hatch-Waxman litigators are accustomed to cases with multiple generic drug company defendants. Brand drug company plaintiffs often sue multiple defendants in the same district court, even when those defendants are not...more
On March 2, 2017, U.S. District Court Judge Mark Wolf provided guidance for determining the appropriate measure of damages in Janssen Biotech, Inc. v. Celltrion Healthcare Co. In particular, Judge Wolf described the framework...more
Torrent Pharmaceuticals (“Torrent”), Apotex Inc., and Mylan Pharmaceuticals filed two inter partes review (“IPR”) petitions in 2014 seeking review of all claims of U.S. Patent 8,324,283 (the “’283 patent”), which is related...more
All nine Supreme Court Justices heard argument on Wednesday, April 26, in Sandoz Inc., v. Amgen Inc. The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (“BPCIA”) made by the...more
5/1/2017
/ Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen
On January 9, 2017, the Federal Circuit held that Phigenix lacked standing to appeal the final written decision of nonobviousness from the U.S. Patent Trial and Appeal Board (“PTAB”) because Phigenix did not offer sufficient...more
On August 17, 2016, in Janssen Biotech, Inc. v. Celltrion Healthcare Co., District of Massachusetts Judge Mark Wolf faced a double patenting fact pattern that had not been adjudicated in a district court case since the...more
AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events...more
On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more
On May 13, 2016, the Federal Circuit determined that Merck’s crystalline calcium salt of tetrahydrofolic acid (“MTHF”) had been the subject of a commercial offer for sale, and held Merck’s MTHF claim in U.S. Patent No....more
The U.S. Court of Appeals for the Federal Circuit recently implemented significant amendments to its Rules of Practice (“Rules”). The changes apply to all cases docked on or after April 1, 2016. In large part, the...more