The Federal Circuit applied the constitutional principle under Article III that there must be a case or controversy for a federal court to enter judgment (in this case, of invalidity) in ANDA litigation that can be vitiated...more
Last week, the Federal Circuit reversed findings of non-obviousness and affirmed (over Chief Judge Prost's dissent) a finding that claims asserted in ANDA litigation were not invalid for failure to satisfy the written...more
In its decision in a consolidated appeal, Eli Lilly & Co. v. Hospira, Inc. and Eli Lilly & Co. v. Dr. Reddy's Laboratories, Ltd., the Federal Circuit had the occasion to apply the Supreme Court's distinction regarding the...more
"Solving" the problem of high prescription drug prices has been on the minds of our representatives in Congress lately, and the desire to "do something" about it has reached the point that just doing something (or being...more
There are provisions and interpretations of U.S. patent law that can be in tension depending on the circumstances under which they are argued, whether before an Examiner or during litigation. One of these is the dichotomy...more
The Federal Circuit exhibited the current status of its obviousness jurisprudence in affirming the District Court's determination that the asserted claims of U.S. Patent No. 8,410,131 were obvious in a decision handed down...more
Last Friday, May 3, 2019, the Federal Circuit affirmed a decision by the District Court that Defendants Actavis LLC and Teva Pharmaceuticals did not show by clear and convincing evidence that the claims asserted by Endo...more
Having been instructed once again by the Supreme Court that the Federal Circuit is not special when it comes to review of district court decisions (see, e.g., Teva Pharm. USA, Inc. v. Sandoz, Inc.), the Federal Circuit has...more
Earlier this month, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB) that the claims of U.S. Reissue Patent No. RE38,551 challenged in inter partes review were not unpatentable for...more
"Pigs fly!" "Hell has frozen over!" Or less dramatically, "Supreme Court affirms Federal Circuit decision!" all would be apt subtitles for any article discussing the Supreme Court's decision today in Helsinn v. Teva. The...more
1/23/2019
/ America Invents Act ,
Appeals ,
Assignment of Inventions ,
Confidentiality Agreements ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inventions ,
On-Sale Bar ,
Patent Applications ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Use ,
Reaffirmation ,
Reversal ,
SCOTUS ,
Section 102 ,
Third-Party Relationships
The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a)....more
The varying appellate fortunes of patentees regarding the question of obviousness is illustrated nicely in the Federal Circuit decision in Orexo AB v. Actavis Elizabeth LLC handed down earlier this month. The statute, 35...more
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
The Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act (colloquially called "Obamacare," Public Law 111-148). It gave the U.S. for the first time a pathway for FDA approval...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 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
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 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
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