After more than two decades of being the red-headed stepchild of patent infringement before the Federal Circuit, infringement under the doctrine of equivalents has made a dramatic comeback in the past few years, the Court...more
Stipulating to infringement after a contrary claim construction is a conventional stratagem for a losing party to have a final judgment that can be challenged before the Federal Circuit. The risk of course, is that if the...more
It has long been understood that claim construction can, and frequently is, dispositive in patent litigation. This truism was the basis for the Federal Circuit affirming the District Court's decision against a generic drug...more
Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). While recognizing that this...more
11/11/2020
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
Federal Rule 12(b)(6) ,
Foreign Defendants ,
FRCP 12(b)(3) ,
Generic Drugs ,
Hatch-Waxman ,
Motion to Dismiss ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Principal Place of Business ,
Venue
The Federal Trade Commission carried out an (in)famous crusade against reverse payment (more provocatively, "pay for delay") settlements in ANDA litigation for almost a decade before eventually having the Supreme Court see...more
What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement?
The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more
ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more
8/24/2020
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Generic Drugs ,
Hatch Act ,
Irreparable Harm ,
Likelihood of Success ,
Marketing Exclusivity Periods ,
Mylan Pharmaceuticals ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Takeda Pharmaceuticals
The written description requirement has had a twenty-five year renaissance, particularly in the chemical and biotechnology arts as a way of restricting claim scope to what an inventor has actually invented (see Regents of the...more
6/22/2020
/ Abbreviated New Drug Application (ANDA) ,
Collateral Estoppel ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Written Descriptions
Infringement under the doctrine of equivalents (as a basis of a successful cause of action having renewed vigor before the Federal Circuit recently (see, e.g., "Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC") is...more
5/13/2020
/ Abbreviated New Drug Application (ANDA) ,
Declaration ,
Dedication-Disclosure Defense ,
Dismissals ,
Doctrine of Equivalents ,
Expert Witness ,
Judgment As A Matter Of Law ,
Judicial Discretion ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prosecution History Estoppel ,
Reaffirmation
In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic...more
5/4/2020
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Dismissals ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Patents ,
Reaffirmation
It seems that memes can be as compelling in the law as in social media, and the meme of the moment in patent law is inherency, particularly as applied to obviousness determinations (see, for example, Persion Pharmaceuticals...more
Transitional terms in patent law (conventionally, "comprising," "consisting of," and the more arcane "consisting essentially of") have their own provenance and meaning, denoting limitations that are "open" (comprising) or...more
Last week, the Federal Circuit affirmed a District Court decision (by Circuit Judge Bryson, sitting by designation) in an ANDA litigation, finding obvious claims asserted for treating patients having mild to moderate hepatic...more
The Federal Circuit earlier this week affirmed a District Court's decision invalidating almost all of the claims asserted against an ANDA filer, in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. Nevertheless, because a...more
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
The interplay (or perhaps utilization) of inter partes review (IPR) in ANDA litigation was illustrated by the Federal Circuit in last month's Dr. Falk Pharma GmbH v. Generico, LLC nonprecedential decision....more
Last month, the Federal Circuit affirmed decisions from four separate trials in the District of Delaware involving seven different defendants regarding validity and infringement of patents directed to an opioid addiction...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
Having a court grant a preliminary injunction is frequently an important strategic victory for a patent plaintiff in an infringement suit. The injunction not only eliminates a revenue stream for the accused infringer but...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