Determining obviousness is always a reconstruction, imperfectly done, of a past that never was. The prior art is consulted and the question asked, would the worker of ordinary skill in the art have been able to achieve the...more
On June 25, 2018, the Supreme Court granted certiorari on Helsinn Healthcare's petition to overturn the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals that its patents were invalid by application of...more
Ever since the Supreme Court loosened the reins on declaratory judgment actions in patent cases twelve years ago, in MedImmune v. Genentech, courts have decided cases fleshing out the metes and bounds of the factual...more
The sequel to the original summer blockbuster movie, Jaws, had as a tagline "Just when you thought it was safe to go back in the water." This sentiment can describe much of U.S. patent law over the last decade and a half,...more
Last month, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a)...more
The Federal Circuit reversed a finding of non-obviousness on Friday based on clear error by the District Court on factual underpinnings of its obviousness determination, in Bayer Pharma AG v. Watson Laboratories, Inc. Such...more
The Federal Circuit continues its explication of the law of obviousness post-KSR Int'l. v. Teleflex Inc. (and Judge Pauline Newman continues to disagree with her brethren in some regards) in a decision handed down last...more
In something of an anticlimax, Federal Circuit Judge William Bryson, sitting by designation on the bench of the U.S. District Court for the Eastern District of Texas, granted Allergan's motion to join the St. Regis Mohawk...more
The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office recently issued a Final Written Decision in an inter partes review styled Mylan Pharm. v. AstraZeneca AB affirming the patentability of all challenged...more
In a decision that took an inordinately long time to arrive (oral argument was held in mid-January), the Federal Circuit in Regeneron Pharmaceuticals v. Merus today affirmed the District Court's decision that the claims of...more
In multiple ANDA litigations against multiple defendants, Millennium Pharmaceuticals, Inc. had several of its asserted claims held invalid for obviousness at the district court. The Federal Circuit reversed these decisions...more
In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more
The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more
6/27/2017
/ Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen ,
SCOTUS
On June 12, 2017, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of...more
6/13/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
Last week, the Federal Circuit reviewed the rare event of a preliminary injunction being granted in a lawsuit over a chemical invention, made rarer still by the evidence of likelihood of success on the merits required for the...more
The Federal Circuit's decision on Friday, in Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc., illustrates the risks a litigant can take when agreeing to stipulation in an effort at least to reduce litigation...more
Last week, the Federal Circuit completed its review of a series of patents relating to treating Pompe disease and invalidated by inter partes review before the U.S. Patent and Trademark Office's Patent Trial and Appeal Board...more
The Federal Circuit returned to its consideration of the outcome in the District Court of The Medicines Company's ANDA litigation against Mylan and Bioniche Pharma over a proposed generic version of Medicines' bivalirudin...more
The Federal Circuit, in its third opinion involving ANDA litigation between these parties over Shire's LIALDA® (mesalamine) product, has apparently brought this case to a close in generic drug maker Watson's favor, in a...more
On Monday, President Trump made good on one of his signature campaign promises and notified the other twelve countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam)...more
On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This...more
Late last week, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...more
On December 29, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...more
The New York Times in a recent video (see "'Could You Patent the Sun?'") has returned to its theme against patenting, particularly with regard to patents for life-saving drugs. This time the paper invokes the meme of Jonas...more
The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more
12/13/2016
/ Amgen ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Sandoz ,
Sandoz v Amgen