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Wisconsin Alumni Research Foundation v. Apple Inc. (Fed. Cir. 2024)

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

Special Committee's Suspension Recommendation Adopted by Federal Circuit

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

9/9/2024  /  Appeals , SCOTUS , Suspensions

Natera, Inc. v. NeoGenomics Laboratories, Inc. (Fed. Cir. 2024)

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

United Therapeutics Corp. v. Liquidia Technologies Inc. (Fed. Cir. 2024)

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

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)

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

Legislators Introduce RESTORE Act

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

Judge Newman Suspension Renewed

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

Loper Bright Enterprises v. Raimondo -- Justice Gorsuch's Triumphant Concurrence

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

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

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

Senators Get Their Colleagues to Agree on Drug Patent Litigation Legislation

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

Judge Newman's Suit Comes to an End

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

Loper Bright Enterprises v. Raimondo -- Views of the Dissenting Justices

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

Loper Bright Enterprises v. Raimondo (2024)

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

U.S. Trade Representative Releases 2023 Special 301 Report

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

CVS Pharmacy Inc. v. Forest Laboratories Inc. (2d Cir. 2024)

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

FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy

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

USPTO Unveils Examiner Guidance on Searching Drug-related Applications

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

Special Committee of the Judicial Council of the Federal Circuit Replies

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

FTC warns pharma companies it means business with its Orange Book listing policy

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

Blue Whale Genome Determined: Implications

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

Judge Newman's Suit Continues

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

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc. (Fed. Cir. 2024)

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

Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2024)

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

Biomedical Device Consultants and Laboratories of Colorado, LLC v. Vivitro Labs, Inc. (Fed. Cir. 2024)

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

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more

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