[Ip-health] Reuters: U.S. Supreme Court agrees to hear dispute over biologic drug sales

Thiru Balasubramaniam thiru at keionline.org
Sat Jan 14 02:04:24 PST 2017


HEALTH NEWS | Fri Jan 13, 2017 | 3:09pm EST

U.S. Supreme Court agrees to hear dispute over biologic drug sales

By Andrew Chung | NEW YORK

The U.S. Supreme Court on Friday agreed to hear a dispute over whether
companies that make copycat versions of biologic drugs must wait six months
after winning federal approval to begin selling them.

The justices will take up an appeal by Novartis AG of a 2015 federal
appeals court decision that prevented the Swiss pharmaceutical company from
selling its biosimilar version of California-based Amgen Inc's
$1-billion-a-year Neupogen until six months after the Food and Drug
Administration approved it. The case could determine how quickly patients
have access to biosimilar medicines at potentially cheaper prices.

Unlike traditional drugs, biologic drugs cannot be copied exactly to make
generic versions. A 2010 federal law allows companies to seek approval to
sell near-copies called biosimilars.

Biologic drugs are complex chemicals made inside living cells. Insurers
expect biosimilars, like generics, to be cheaper than original brands.

Novartis unit Sandoz in September 2015 began selling Zarxio, the first
biosimilar to win regulatory approval in the United States. Neupogen and
Zarxio boost white blood cell counts in cancer patients to help fight

Zarxio, which costs 15 percent less than Neupogen at list prices, has since
exceeded $100 million in sales, according to Novartis.

The dispute arose when Amgen sued Sandoz in 2014 in San Francisco federal
court alleging patent infringement and violations of the law governing
biosimilars. The companies disagreed on how to apply the law's requirement
that a biosimilar drug maker give the brand-name manufacturer 180 days
notice before launching its copycat version.

In July 2015, the U.S. Court of Appeals for the Federal Circuit in
Washington ruled that the 180-day notice must be given after FDA approval.

Novartis last February appealed that decision to the Supreme Court, saying
the Federal Circuit's ruling improperly gave the brand-name manufacturer an
extra six months of exclusivity on top of the 12 years already provided for
under the law, driving up healthcare costs.

"If not reversed, (it) will delay access by patients to all biosimilars for
six months longer than Congress intended," Novartis said in its petition
asking the Supreme Court to take up the case.

In opposing Novartis' appeal, Amgen told the Supreme Court that the statute
was meant to foster innovation and clearly states that the 180-day period
cannot begin until the biosimilar is approved.

The Supreme Court in December declined to hear a similar case involving
Canadian generic drug maker Apotex Inc and Amgen.

The justices on Friday also agreed to resolve Amgen's appeal in the same
case over whether biosimilar makers must give brand-name manufacturers a
copy of their application to make a copycat drug after it is submitted to
the FDA.

The case is Sandoz v. Amgen in the Supreme Court of the United States,
15-1039 and Amgen v. Sandoz, 15-1195.

(Reporting by Andrew Chung; Editing by Will Dunham)

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