Justices Refuse to Hear ‘Skinny Label’ Drug Patent Case

May 15, 2023 by Dan McCue
Justices Refuse to Hear ‘Skinny Label’ Drug Patent Case
(Photo by Steve PB via Pixabay)

WASHINGTON — The Supreme Court on Monday declined to review a 2020 decision by the U.S. Circuit Court of Appeals for the Federal Circuit that resulted in Teva Pharmaceuticals being found liable for $235 million for infringing on a GlaxoSmithKline heart drug patent.

The case placed a spotlight on the use of so-called “skinny labels” for generic drugs, and justices refused to weigh in on the controversy despite a request from the U.S. solicitor general.

The underlying case began in 2014 when GlaxoSmithKline sued Teva Pharmaceuticals USA over its generic version of the Glaxo heart drug Coreg, a prescription medicine used to treat the symptoms of heart failure and high blood pressure.

Teva argued in court that it followed Food and Drug Administration instructions to “carve out” from its label a single use for the drug that would not infringe on any existing patent.

The “carve out” is a key provision of the Hatch-Waxman Act of the mid-1980s, whose drafters sought to create an innovative pathway to bring low-cost generic drugs to market.

When a brand-name drug has both patented and unpatented uses, its manufacturer must tell the FDA the specific sections of its labeling that describe the patented uses. 

That allows generic manufacturers to carve out those sections and adopt a “skinny label” — one labeled for only unpatented uses. 

Teva maintains it did just that. Nevertheless, in 2017, a jury awarded GlaxoSmithKline $235 million on its patent infringement claim.

A federal judge then overturned the verdict, but the U.S. Court of Appeals for the Federal Circuit, which specializes in patent cases, reinstated it in 2020, holding that the label, coupled with Teva’s marketing materials, did encourage doctors to prescribe its drug in a way that infringed on GlaxoSmithKline’s patent.

In its petition for a Supreme Court review of the case, Teva argued that the appeals court’s “controversial” opinion would “upend the legal rules facing the modern prescription-drug marketplace, wreaking doctrinal havoc.”

“Where there was previously clarity and ‘equilibrium to the skinny-label system,’ there is now confusion and uncertainty,” Teva said. “That uncertainty discourages generics from using carve-outs, which ‘throw[s] a wrench into Congress’ design for enabling quick public access to generic versions of unpatented drugs with unpatented uses.’” 

“The ramifications of such an outcome are enormous — skinny-label launches are extraordinarily common, and they save patients and the federal government billions,” it said.

Solicitor General Elizabeth Prelogar also urged the justices to hear the case, arguing the Federal Circuit’s decision created “significant uncertainty” for generic drugmakers.

As is their custom, the justices did not explain their rationale for rejecting the case. However, the court did note that Justice Brett Kavanaugh would have granted it a review.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

A+
a-
  • generic drugs
  • patent infringement
  • prescription drugs
  • skinny labels
  • Supreme Court
  • In The News

    Health

    Voting

    Supreme Court

    June 13, 2024
    by Tom Ramstack
    Democrats Criticize Chief Justice for Supreme Court Ethics Enforcement

    WASHINGTON — Congressional Democrats criticized the Supreme Court's chief justice Thursday for failing to enforce ethics standards on the court... Read More

    WASHINGTON — Congressional Democrats criticized the Supreme Court's chief justice Thursday for failing to enforce ethics standards on the court as they consider a proposal to intervene. Lawmakers were discussing a Senate Judiciary Committee bill to impose a new code of ethics on the Supreme Court.... Read More

    US Supreme Court Rules to Preserve Access to Abortion Pill Mifepristone

    WASHINGTON (AP) — The U.S. Supreme Court on Thursday ruled unanimously to preserve access to the abortion pill mifepristone, a pill used in the... Read More

    WASHINGTON (AP) — The U.S. Supreme Court on Thursday ruled unanimously to preserve access to the abortion pill mifepristone, a pill used in the most common way to end a pregnancy. The medication was used in nearly two-thirds of all abortions in the United States last year. The ruling is the court's... Read More

    Supreme Court Has Lots of Work to Do and Little Time to Do It With a Sizable Case Backlog

    WASHINGTON (AP) — The Supreme Court is headed into its final few weeks with nearly half of the cases heard this year... Read More

    WASHINGTON (AP) — The Supreme Court is headed into its final few weeks with nearly half of the cases heard this year still undecided, including ones that could reshape the law on everything from guns to abortion to social media. The justices are also still weighing whether former... Read More

    The Washington Post Said It Had the Alito Flag Story Three Years Ago and Chose Not to Publish

    NEW YORK (AP) — Nine days after The New York Times reported about the political symbolism of an upside-down American... Read More

    NEW YORK (AP) — Nine days after The New York Times reported about the political symbolism of an upside-down American flag that flew at U.S. Supreme Court Justice Samuel Alito's home, the Washington Post acknowledged it had the same story more than three years ago and... Read More

    May 28, 2024
    by Dan McCue
    Supreme Court to Consider Challenge to ‘Vague’ EPA Rules

    WASHINGTON — The Supreme Court on Tuesday agreed to hear San Francisco, California’s, challenge to the Environmental Protection Agency’s authority... Read More

    WASHINGTON — The Supreme Court on Tuesday agreed to hear San Francisco, California’s, challenge to the Environmental Protection Agency’s authority to tell cities not to pollute water bodies without setting specific limits to guide them. The central issue in the case revolves around the city’s practice... Read More

    Supreme Court Finds No Bias Against Black Voters in a South Carolina Congressional District

    WASHINGTON (AP) — The Supreme Court 's conservative majority on Thursday preserved a Republican-held South Carolina congressional district, rejecting a lower-court ruling... Read More

    WASHINGTON (AP) — The Supreme Court 's conservative majority on Thursday preserved a Republican-held South Carolina congressional district, rejecting a lower-court ruling that said the district discriminated against Black voters. In dissent, liberal justices warned that the court was insulating states from claims of unconstitutional racial gerrymandering. In... Read More

    News From The Well
    scroll top