One of the anticipated consequences of the Supreme Court's Loper decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of...more
In a joint appeal of two adverse decisions from the District Court, the Federal Circuit on procedural grounds rejected an appeal from the Wisconsin Alumni Research Foundation ("WARF") in Wisconsin Alumni Research Foundation...more
As posted in July, the Special Committee of the Federal Circuit voted unanimously to maintain the suspension imposed on Judge Pauline Newman (see "Judge Newman Suspended for One Year by Federal Circuit") for another year. On...more
In Natera Inc. v. NeoGenomics Laboratories, Inc. the Federal Circuit affirmed the District Court's grant of a preliminary injunction against NeoGenomics in patent infringement litigation involving Natera's U.S. Patent Nos....more
Zealous advocacy is a hallmark of adversarial proceedings, whether in district court or before the USPTO, where the opportunities for such advocacy have multiplied with the establishment by the Leahy-Smith America Invents Act...more
The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on...more
U.S. Senator Chris Coons (D-DE), along with Sen. Thom Tillis (R-NC), have been the motivating force for patent reform for almost a decade, primarily in their efforts to roll back legislative efforts and judicial decisions...more
Not surprisingly, the Special Committee of the Federal Circuit after an Oral Hearing on July 10th voted unanimously the maintain Judge Newman's suspension (see "Judge Newman Suspended for One Year by Federal Circuit") handed...more
It has been one of Justice Gorsuch's signature judicial goals to overturn the Court's Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. decision and while it has taken seven years for a case to arise giving him...more
Recent history of Congress's performance as a legislative body has been, to be kind, mixed, and a great many bills, resolutions, and other activities have appeared to be more for show than to accomplish anything worthwhile. ...more
Recently the Senate passed S.150 entitled the Affordable Prescriptions for Patients Act. Those paying attention might recall that Senator Cornyn (R-TX) introduced this bill (joined by Senator Blumenthal (D-CT) and seven other...more
Today, D.C. District Court Judge Christopher R. Cooper put an end to Judge Pauline Newman's lawsuit against her colleagues, granting the Federal Circuit Judicial Council's motion to dismiss Judge Newman's suit on due process...more
In addition to Justice Gorsuch's concurrence (to be discussed in a later post), the three "liberal" Justices on the Court differed from their colleagues and thought overturning the Chevron precedent to be both erroneous and...more
Not surprisingly, the Supreme Court overturned the "Chevron deference" principle from its 1984 Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. decision in Loper Bright Enterprises v. Raimondo (and it did so...more
In April, Ambassador Katherine Tai, U.S. Trade Representative (USTR), issued the 2024 Special 301 Report. In a press release, the USTR stated that "[m]any of the issues highlighted in the Special 301 Report demand...more
6/20/2024
/ Biden Administration ,
Counterfeit Drugs ,
Counterfeiting ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Piracy ,
Section 301 ,
Trade Representatives ,
United States-Mexico-Canada Agreement (USMCA) ,
USTR ,
WTO
In a decision characterized (somewhat remarkably) by the Circuit Court as being one of first impression, the Second Circuit affirmed dismissal with prejudice of an antitrust allegation by a class of plaintiffs* against Forest...more
Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more
Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more
6/11/2024
/ Biosimilars ,
BPCIA ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Labeling ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
USPTO
Suspended Federal Circuit Judge Pauline Newman's lawsuit (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") against Chief Judge Kimberly Moore, and Circuit Judges Sharon Prost and Richard...more
Last September, the Federal Trade Commission (FTC) promulgated a “policy statement” entitled “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” regarding the FTC’s allegations...more
The "genome revolution" over the past 30 years has resulted in the elucidation of several species, both domesticated (see, e.g., "The Genetic Basis of Coat Variation in Dogs"; "Further and More Detailed Study of Domestic Cat...more
Over the past year suspended Federal CIrcuit Judge Pauline Newman's lawsuit (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") against Chief Judge Kimberly Moore, and Circuit Judges Sharon...more
The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after...more
In its recent decision in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. the Federal Circuit reminds us that most verities in patent law are not eternal and frequently subject to case-by-case interpretation,...more
A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of...more