Late last month, the Federal Circuit handed Exela Pharma Sciences its latest defeat in litigation relating to its ANDA filing on Cadence Pharmaceuticals' injectable acetaminophen-based drug Ofirmev®, in Exela Pharma Sciences...more
Senju PharmaceuticalEarlier this month, the Federal Circuit affirmed a District Court judgment of obviousness in ANDA litigation under the Hatch Waxman Act having a long provenance of earlier litigation, in Senju...more
That it is more difficult today to be a patentee able to defend her patent rights than any time since the 1940's is nicely illustrated by the Federal Circuit's decision in Par Pharmaceutical, Inc. v. TWI Pharmaceuticals,...more
Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more
In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust...more
9/25/2014
/ Abbreviated New Drug Application (ANDA) ,
Antitrust Investigations ,
Antitrust Provisions ,
Class Action ,
Complex Litigation ,
Generic Drugs ,
Motion to Dismiss ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Settlement ,
Sherman Act
In the second of a pair of decisions issued last Friday, styled Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that the generic ANDA challenger had not shown the...more
In the first of a pair of decisions issued last Friday, Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that a generic company could moot ANDA litigation by amending its...more
Every once in a while a Federal Circuit panel construes a common claim term contrary to how it has been construed in prior precedent, usually based on the particular situation or circumstance the Court is addressing and...more
The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more
Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for...more
In a move that will surprise almost no one (except perhaps members of the Supreme Court majority in FTC v. Actavis), the Federal Trade Commission has filed an amicus curiae brief with the District Court of New Jersey in In re...more
Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more
The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more
6/26/2013
/ Abbreviated New Drug Application (ANDA) ,
Certiorari ,
Food and Drug Administration (FDA) ,
Infringement ,
Patents ,
Pharmaceutical Industry ,
Preliminary Injunctions ,
Prescription Drugs ,
Safe Harbors ,
SCOTUS ,
Split of Authority
The Supreme Court ruled 5-3 on June 17, 2013 in favor of the Federal Trade Commission in FTC v. Actavis. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer’s opinion...more
6/19/2013
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reverse Payment Settlement Agreements ,
SCOTUS
The Supreme Court ruled 5-3 today in favor of the Federal Trade Commission in FTC v. Actavis, Inc. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer's opinion reversed the...more
The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more
4/2/2013
/ Abbreviated New Drug Application (ANDA) ,
Competition ,
Food and Drug Administration (FDA) ,
FTC v Actavis ,
Generic Drugs ,
Manufacturers ,
Patents ,
Pharmaceutical Industry ,
Reverse Payment Settlement Agreements ,
SCOTUS ,
Watson Pharmaceuticals
Paul Bender, former Clinton-era Principal Deputy Solicitor General, and his colleagues Christopher A. Mohr and Michael Kippler at the University of Arizona Law School, published a White Paper entitled "S. 214's inappropriate...more
Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more
Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more
Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more
2/15/2013
/ Abbreviated New Drug Application (ANDA) ,
Cephalon ,
Clear and Convincing Evidence ,
Expert Testimony ,
Generic Drugs ,
Hatch-Waxman ,
Infringement ,
Patents ,
Pharmaceutical Industry ,
Presumption of Validity ,
Reversal ,
Reverse Payment Settlement Agreements ,
Standard of Proof
As it has frequently in the past decade, the Federal Trade Commission on Thursday released a Report on the frequency of reverse payment settlement agreements in ANDA litigation between generic and branded drug makers,...more