Tag Archives: pharmaceutical patents

Rehearing Requested: Hikma Challenges Federal Circuit’s Skinny Label Ruling

by Dennis Crouch

[A prior version of this article's title mistakenly stated that Amarin had filed the petition]

Hikma's recent petition for rehearing en banc against Amarin asks the Federal Circuit to reconsider its "skinny label" jurisprudence.  Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. 2024)

These cases typically involve the following scenario:

  • a drug formulation with multiple approved uses;
  • the formulation/compound patents are all expired as are patents on one or more uses; but
  • at least one method of use claim is still under patent (e.g., take 100 mg each day to treat hypertension...).

The FDA will approve a generic version of the formulation, but the approved label will only mention the non-patented uses.  Thus, it is a "skinny label" because the patented uses listed on for the branded formulation have been "carved out."

Of course, everyone understands that it is the same drug and will be just as safe and effective as the branded. The generic manufacturer, along with doctors, patients, pharmacies, insurance companies, and hospitals, . . . they all understand the carveout as simply a patent legalese. While technically an 'off label' prescription, it is still for an approved use considered safe and effective. In my experience, these folks typically do not strongly support the patent system and would have no compunction against using the cheaper drug for the patented use -- so long as they do not get tagged.

Background on the Amarin case: Amarin markets Vascepa (icosapent ethyl), which was initially approved by the FDA  in 2012 to treat severe hypertriglyceridemia (triglycerides ≥500 mg/dL). In 2019, Amarin obtained a second FDA-approved indication for Vascepa to reduce cardiovascular risk in certain patients. Amarin holds method patents on this cardiovascular (CV) indication. Hikma sought approval for a generic version of Vascepa, but with a "skinny label" that carved out the patented CV indication under 21 U.S.C. § 355(j)(2)(A)(viii). After launching its generic, Hikma issued press releases referring to its product as the "generic version of Vascepa" and noting Vascepa's total sales figures, which were largely attributable to the patented (but unmentioned) CV use.  None of Hikma's statements direct others toward the patented CV use, but conspiracy minded jurists could quickly connect these dots. If you know what I mean, nudge nudge, wink wink.

The basic question in the case is whether these actions by Hikma qualify as the "clear expression or other affirmative steps taken to foster infringement" typically required by precedent.  Quoting DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (en banc in relevant part).


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Amarin v. Hikma: Federal Circuit reverses Inducement Dismissal in Skinny-Label Case

by Dennis Crouch

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 2023-1169 (Fed. Cir. June 25, 2024).

This is another "skinny label" generic pharmaceutical patent case.  The basic setup involves a drug that has several different approved uses; with the branded manufacturer holding patents covering only some of the uses.  The generic company is then permitted to sell the drug, but is labelled only for non-patented uses. These labels are known as  carve-out or "skinny" labels under 21 U.S.C. § 355(j)(2)(A)(viii).

It is inevitable that people will purchase and use the generic drugs for the patented uses, and that the generic distributer will be accused accused of inducing  those infringing acts.  Although the generic typically makes a profit on these sales, it those profits pale in comparison to the profits lost by the branded company.

Amarin v. Hickma highlights some of the challenges that generics are facing when marketing drugs with these carved-out labels.  One difficulty is that the FDA severely limits what the generic can say about the drug and its uses, and the carve-out is generally based upon statements made by the patentee.  Here, the court follows a label-plus approach. The skinny label itself will not be enough to show inducement, but that evidence can be combined with other evidence (such as marketing) to prove liability.


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Supreme Court Declines to Hear Vanda’s Patent Obviousness Appeal

by Dennis Crouch

The Supreme Court has denied Vanda Pharmaceuticals' petition for certiorari, leaving in place a Federal Circuit decision that invalidated Vanda's patents on methods of using the sleep disorder drug Hetlioz (tasimelteon) as obvious.

Vanda had argued in its cert petition that


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What I’m reading from academic journals

I'm always on the lookout for interesting new scholarship related to intellectual property and innovation policy. The following are a few of the articles that I've been delving into this past week:

  • James Hicks, Do Patents Drive Investment in Software?, 118 NW. U. L. REV. 1277 (2024).
  • Ana Santos Rutschman, From Myriad to Moderna: The Modern Pharmaceutical Company, ___ Texas A&M University Journal of Property Law ___ (2024) (forthcoming).
  • John Howells, Ron D Katznelson, Freedom to Operate analysis as competitive necessity—the Selden automobile patent case revisited, Journal of Intellectual Property Law & Practice (2024).
  • Christa Laser, Scientific Educations Among U.S. Judges, ___ American University Law Review ___ (2025) (forthcoming).
  • Garreth W. McCrudden, Drugs, Deception, and Disclosure, 38 BERKELEY TECH. L.J. 1131 (2024).

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