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 The justices opted not to take up Apotex Inc's appeal of a July
federal appeals court ruling that could delay the Canadian generic
drug maker's launch of so-called biosimilar versions of
California-based Amgen Inc's Neulasta, used to fight infection in
cancer patients.
Approved by the U.S. Food and Drug Administration in 2002, Neulasta
is one of Amgen's top-selling products, accounting for $4.7 billion
of its nearly $21 billion in sales last year.
Biologic drugs like Neulasta are made using living cells. Unlike
traditional drugs, biologic drugs cannot be copied exactly to make
generic versions. A 2010 federal law, the Biologics Price
Competition and Innovation Act, allows companies to seek approval to
sell near-copies called biosimilars.
Novartis AG's Sandoz unit also has applied to make biosimilar
versions of Neulasta and of Amgen's Neupogen, an older and less
popular drug that works similarly but must be given more often.
Neither application has yet been approved.
The biosimilars law gives the maker of a biologic drug 12 years of
exclusive rights before the U.S. Food and Drug Administration can
approve a biosimilar. It also states that a biosimilar maker must
give the original biologic drug maker 180 days' notice before
launching its copycat version.
Amgen has argued that the 180-day period cannot begin until the
biosimilar is approved. The U.S. Court of Appeals for the Federal
Circuit agreed in July, barring Apotex from launching its biosimilar
until 180 days after approval.
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In its petition asking the Supreme Court to review that decision,
Apotex said the Federal Circuit wrongly added an extra six months to
the law's 12-year exclusivity period.
It also argued that it should be exempt from the 180-day notice
requirement entirely, because it voluntarily took part in a patent
dispute resolution process under the biosimilars law.
A federal judge in Florida rejected patent infringement claims by
Amgen over Apotex's biosimilars in September.
The Obama administration's solicitor general has weighed in on a
Supreme Court petition from Sandoz unit in its similar dispute with
Amgen, coming down against the 180-day wait.
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