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Federal Circuit Revives Induced Infringement Claims Despite "Skinny Label" Carve-Out

The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more

Inducement Suit Proceeds Against Insurance Company for Encouraging Use of Generic Drug

The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more

Federal Circuit Vacates Judgment, Reinstates Jury's Verdict of Induced Infringement

Background - On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more

FDA Launches Review of Orange Book Patent Listing Practices

Citing its priority to facilitate the timely development and approval of generic drugs, the U.S. Food and Drug Administration ("FDA") solicits stakeholder input on the types of patents that should be listed in the Orange...more

PTAB Bar Association – Thought Leader Summit Recap

In November, the PTAB Bar Association held its annual Thought Leader Summit. The Summit highlighted recent changes to PTAB practice, with a keynote address from USPTO Director Andrei Iancu. In the opening remarks, Director...more

Trial Court Denies Amendment of Contentions To Add Reexam Claims Following Successful IPR

What happens when patent claims are found unpatentable in inter partes review (“IPR”) and new claims are subsequently added to that patent through ex parte reexamination? The District Court for the Northern District of...more

Lead Compound Analysis Not Always Applicable

The Situation: In a Hatch-Waxman litigation, a district court determined that the claims covering a method of using the drug everolimus to treat kidney cancers were not obvious. The court found a motivation to "pursue"...more

Precedential: PTAB Considers § 314(a) Factors Even When Denying Under § 325(d)

When exercising its broad discretion on whether to institute review, the PTAB is not limited to consideration of factors associated with the type of denial it ultimately issues. In a recent decision that the PTAB designated...more

PTAB Grants Rare Motion for Additional Discovery

The PTAB recently granted a rare motion for additional discovery into the question of whether an unnamed party, Amneal Pharmaceuticals, LLC (“Amneal”), should have been named as a real-party-in-interest. In Kashiv LLC v....more

Delaware District Dismisses BPCIA "Private Right" Claim; Says Controversy not Sufficiently Immediate

In a recent decision involving the Biologics Price Competition and Innovation Act ("BPCIA") (Genentech, Inc. and City of Hope v. Amgen Inc.) the Delaware District Court dismissed a claim seeking to enforce a statement of...more

Supreme Court Upholds Constitutionality of IPRs

Rumors of the PTAB’s demise were greatly exaggerated, it turns out. In a 7-2 decision, the Supreme Court held on Tuesday that Inter Partes Reviews (IPRs) violate neither Article III nor the Seventh Amendment of the...more

IP Rights Reform Is Price to Pay for Revamped Trans-Pacific Partnership Agreement

The Situation: Following the U.S. withdrawal from the original Trans-Pacific Partnership ("TPP") agreement last year, the 11 remaining TPP countries agreed to implement the original text in a new "TPP-11" agreement. However,...more

Federal Circuit Rules BPCIA Preempts State Law

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Federal Circuit Clarifies Probative Value of Patent Dance Statements

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval

On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

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