Imposition of liability under the equitable doctrine of inequitable conduct (as it has been variously defined) can result in a patent being held unenforceable; for this reason, former Chief Judge Rader called it the "atomic...more
On June 11th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Responsive Preliminary Motion No. 1 in Interference No. 106,127 to be...more
The Federal Circuit issued three decisions on Monday relating to Eli Lilly & Co's. challenge in separate inter partes review proceedings on obviousness grounds of nine patents licensed by Teva Pharmaceuticals Int'l, with...more
In June, Senior Party ToolGen filed its Substantive Preliminary Motion No. 2 to deny Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") priority...more
Most judicial outcomes, particularly on appeal, are broadly based on varying combinations of process and outcome. The law is replete with process-based decisions (standing, jurisdiction, waiver, to name a few) and of course...more
8/13/2021
/ Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Induced Infringement ,
Judgment As A Matter Of Law ,
Jury Verdicts ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular
Last week the U.S. Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval notable because it is the first approved interchangeable biosimilar product. The product is Semglee...more
The Federal Circuit continues its recent run of decisions extending the reach of the enablement requirement of 35 U.S.C. 112(a) to invalidate patents in Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies,...more
Dennis Crouch, our colleague at Patently-O, tweeted last week that there have Dennis Crouch, our colleague at Patently-O, tweeted last week that there have been 148 U.S. patents granted having disclosure related to (COVID-19...more
And everybody knows that suspending patent rights is necessary to provide sufficient vaccine to stem the global pandemic caused by the SARS-CoV-2 virus known as COVID-19. It is always a sign of intellectual weakness and pack...more
Earlier this month, Eric Sagonowsky reviewed the top ten drugs in the U.S. (in terms of sales) losing patent exclusivity in an article published by Fierce Pharma....more
The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more
4/16/2021
/ Abbreviated New Drug Application (ANDA) ,
Exclusivity ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Hatch-Waxman ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reverse Payment Settlement Agreements ,
Rule-of-Reason Analysis ,
SCOTUS
Last week, the Federal Circuit affirmed a jury verdict against Baxalta Inc., Baxalta US Inc., and Nektar Therapeutics for infringing Bayer Healthcare's patent to human blood clotting factor conjugates in Bayer Healthcare LLC...more
A little less than four years ago, 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...more
In a terse, non-precedential opinion, the Federal Circuit affirmed a district court's judgment that Defendants Torrent Pharmaceuticals and Indoco Remedies Ltd. had failed to prove that the claims asserted by...more
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
The Federal Circuit has taken the occasion, in appeals from the Patent Trial and Appeal Board as well as district courts, to remand judgments whenever the Court believes that the record below is devoid of sufficient detail to...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
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
Novelty is perhaps the principal, most fundamental requirement for patentability, and depriving the public of anything in the prior art must be avoided. The Federal Circuit recently reinforced the primacy of these rubrics in...more
On September 3rd, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma...more
9/5/2020
/ Amarin ,
Appeals ,
Generic Drugs ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Reaffirmation ,
Rule 36
The Federal Circuit recently applied well-established principles of obviousness in affirming the Patent Trial and Appeals Board's invalidation of several patents related to antifungal formulations in Anacor Pharmaceuticals,...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 Federal Circuit has spent the past few years applying the Supreme Court's most recent precedent, Nautilus, Inc. v. Biosig Instruments, Inc., on the indefiniteness standards in the patent statute. 35 U.S.C. § 112(b). The...more
8/14/2020
/ Appeals ,
Claim Construction ,
Extrinsic Evidence ,
Indefiniteness ,
Nautilus Inc. v. Biosig Instruments ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Reaffirmation