Ever since the Supreme Court handed down its decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), both the U.S. Patent and Trademark Office and the courts have found it easier to render a decision that a claimed...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
A day after Myriad Genetics sued Ambry Genetics for patent infringement, the company filed suit in the District of Utah, Central Divisions against Gene by Gene Ltd. (Case No. 2:13-cv-00643-EJF; complaint). The complaint is...more
The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...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's decision in the Myriad case has been almost universally hailed as being a great victory for patients, doctors, personalized medicine, and research. Precluding patenting for "merely" isolated human DNA,...more
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 ruled unanimously June 13, 2013 in favor of Plaintiffs/Petitioners in Association of Molecular Pathologists v. Myriad Genetics on the question of whether isolated DNA is patent eligible. The opinion found a...more
The Supreme Court rendered its opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. ("the Myriad case"), and in many ways it was anticlimactic: the Court adopted the Department of Justice's position...more
Much has and will continue to be written about the Federal Circuit's en banc decision in CLS Bank Int'l v. Alice Corp. last week, and most of the commentary has and will be critical of the path the court took in arriving at...more
The Supreme Court ruled unanimously yesterday in favor of Monsanto in Bowman v. Monsanto, a case involving Monsanto’s recombinant, Roundup Ready® seeds. The opinion rejected the arguments from petitioner, Indiana farmer...more
The U.S. Supreme Court heard oral argument in Association for Molecular Pathology v. Myriad Genetics, Inc. on Monday, and many have commented on the Court's interrogation of the parties' representatives (and the government)...more
With the U.S. Supreme Court set to consider the patent-eligibility of claims to isolated human DNA in AMP v. Myriad Genetics this morning, another aspect of Myriad’s control over BRCA testing technology is being contested. ...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
The U.S. Supreme Court will hear arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on April15th, and the parties and their different cadres of amici have submitted briefs of varying degrees of...more
In an amicus brief filed last week in support of respondents Myriad Genetics, Inc. et al., the Intellectual Property Owners Association (IPO) asked the Supreme Court to affirm the Federal Circuit's decision in Association for...more
There is a great cultural divide that has been illuminated by the Myriad case (AMP v. Myriad Genetics), between producers of technology and its consumers, governments and non-government organizations such as patient groups...more
Myriad Genetics filed its responsive brief with the Supreme Court last Thursday in AMP v. Myriad Genetics ("the Myriad case"). It is a certainly a serviceable brief that makes the patent law arguments that need to be made...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
A patent issue exerted its Circe-like effect on the Supreme Court again today in Gunn v. Minton, a decision overruling the Texas Supreme Court on the question of whether the existence of a patent issue in a legal malpractice...more
The Supreme Court heard oral argument today in Bowman v. Monsanto Co., with Mark P. Walters representing Farmer Bowman, Seth Waxman representing Monsanto, and Melissa Arbus Sherry representing the Department of Justice. ...more
In a paper filed earlier this week by Solicitor General Donald Verrilli, Jr., the U.S. government has asked the Supreme Court for leave to present ten minutes of argument in Bowman v. Monsanto. The request is not unusual or...more
The "conventional wisdom" surrounding the Bowman v. Monsanto case now before the Supreme Court on certiorari is that it is "David v. Goliath," the salt-of-the-earth farmer versus the corporate monolith, and an example of the...more
Over the past decade, the Supreme Court's increased interest in patent law cases was paralleled by briefs from the Solicitor General advising the Court to grant certiorari. The apparent influence of the government has waned...more