Applying the doctrine of claim preclusion (previously termed res judicata), a fractured majority of the Federal Circuit held that prior ANDA litigation to final judgment precluded reassertion of amended claims in the same...more
The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo...more
In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more
3/12/2014
/ AMP v Myriad ,
BRCA ,
DNA ,
Genetic Materials ,
Human Genes ,
Myriad ,
Myriad v Ambry ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Preliminary Injunctions
The Federal Circuit issued an opinion on Monday in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. illustrating how difficult it can be to overturn a district court determination based on a question of fact, at least when the...more
Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical. This has been due in part to political opposition to licensing university technology (and the purported soiling of the...more
On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013." The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories. Posts...more
1/24/2014
/ 23andMe ,
America Invents Act ,
AMP v Myriad ,
Biotechnology ,
Bowman v Monsanto ,
FTC v Actavis ,
Innovation Act ,
Life Sciences ,
Monsanto ,
Myriad ,
Patent Infringement ,
Patent Litigation ,
Patent Reform ,
Patent Trolls ,
Patents ,
Pharmaceutical Industry ,
SCOTUS
If you have ever wondered how popular eyelash enhancers like RevitaLash and Latisse produce their effects, Allergan, Inc. v. Athena Cosmetics, Inc. provides the answer: these products comprise prostaglandin derivatives. The...more
A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the...more
Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more
12/20/2013
/ Bayh-Dole Act ,
BRCA ,
GATT ,
Inventors ,
Licenses ,
Myriad ,
Patent Reform ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Prior Art ,
Royalties ,
Technology ,
Universities ,
WTO
What everybody doesn't seem to know is how to get Congress to listen to the needs of the innovation community when well-heeled sectors put their lobbying and financial support in favor of legislation purportedly aimed at...more
11/22/2013
/ America Invents Act ,
Biotechnology ,
Covered Business Method Patents ,
Discovery ,
Fee-Shifting ,
Infringement ,
Innovation Act ,
Joinder ,
Patent Litigation ,
Patent Reform ,
Patent Trolls ,
Patents ,
Pharmaceutical Industry ,
Pleading Standards ,
Proposed Legislation ,
Transparency ,
Universities
Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more
Some of our commenters have asked (with greater or lesser degrees of stridency) that we "take a position" on claims like the Myriad method claims at issue in the lawsuits brought against Ambry Genetics, Gene-by-Gene, and...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
The Federal Circuit's jurisprudence regarding obviousness as determined by the U.S. Patent and Trademark Office continues its post-KSR development in Leo Pharmaceutical Products, Ltd. v. Rea, which involves an obviousness...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
Enactment of the Leahy-Smith America Invents Act in 2011 focused the patenting community on the changes of U.S. patent law from "first to invent" under the 1952 Patent Act to "first inventor to file" under the AIA as 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
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
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
The Supreme Court granted certiorari Friday in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment settlement agreements in ANDA...more