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
The Federal Circuit availed itself of another opportunity to demonstrate that the Supreme Court's recent decision in Teva v. Sandoz may be relevant in cases that are the exception rather than the rule. The Federal Circuit's...more
There has always been a tension between the need for a final arbiter of the law and the inherent power associated with such a role placed in the judicial branch. Jefferson himself was wary of this tendency, writing in a...more
On Friday, the Food and Drug Administration approved a biosimilar version of Amgen's Neupogen® (filgrastim) product for sale in the U.S. This is the first biosimilar to be approved under the provisions of the Biologics Price...more
It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more
2/26/2015
/ America Invents Act ,
Hatch-Waxman ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Market Manipulation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Price Manipulation ,
Standing
As discussed at the end of January, Myriad has given up its Quixotic quest to validate its BRCA gene testing franchise and has abandoned its several lawsuits (many of which were consolidated before the District of Utah under...more
Supreme Court Building #3It has escaped almost no one's notice that the Supreme Court has spent the past decade or so being much more involved in patent law than in preceding twenty years. Evident but perhaps less discussed...more
The recent history of Supreme Court patent cases has made the dissent a seemingly endangered species, the Court consistently deciding important patent cases by 9-0 votes and, at best, garnering concurring opinions for...more
The disconnect between patents and medicine (and more particularly, between physicians who prescribe patented drugs and the pharmaceutical companies who produce them) was illustrated nicely in a recent dustup between doctors...more
Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more
12/15/2014
/ Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...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
Federal Trade Commission Chairwoman Edith Ramirez and Debbie Feinstein, Director of the Commission's Bureau of Competition, held a thirty-minute press conference on Monday to discuss the latest foray in the Commission's...more
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
Last week, the Federal Circuit affirmed a finding of inequitable conduct in Apotex v. USB, a relatively rare occurrence in the years after the Federal Circuit's decision in Therasense v. Becton, Dickenson. In the Therasense...more
On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...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 Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more
Last week, Sherry Knowles, former chief patent counsel for GlaxoSmithKline and now principal at Knowles Intellectual Property Strategies, LLC submitted to Managing Intellectual Property magazine a detailed critique of the...more
The Federal Circuit used its decision that the District Court erred in certain of its claim construction determinations to reverse a jury award of greater than $100 million, but left intact large portions of the District...more
Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...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