WASHINGTON, April 17 (Reuters) - The U.S. Supreme Court
ruled on Tuesday in favor of a generic drugmaker in a case over
how companies can fight brand-name rivals in an effort to get
their cheaper medicines to market.
The high court unanimously ruled that the generics company,
Caraco Pharmaceuticals, could sue a brand-name drugmaker to get
it to narrow its patent description with the Food and Drug
Administration.
The FDA uses this information to decide whether to approve a
generic "copycat" version of a medicine before the patent has
expired.
Caraco, a unit of India's Sun Pharmaceutical Industries,
argued that the description of the patent for the diabetes drug,
Prandin, was too broad and therefore prevented any generic from
entering the market. It raised a "counterclaim" to challenge the
description.
The U.S. government said generic drugs saved consumers
billions of dollars each year, and it opposed a lower court
ruling in favor of the brand-name company, Denmark's Novo
Nordisk.
The justices agreed, and overturned a U.S. appeals court
ruling that Caraco could not file a legal counterclaim to
challenge the way Novo had described its patent to the FDA.
Justice Elena Kagan said in the opinion that when the FDA
evaluated an application to market a generic drug, it considered
whether the proposed drug would infringe a patent held by the
manufacturer of the brand-name version.
The FDA requires brand-name manufacturers to submit
descriptions of the scope of their patents, known as use codes,
and it assumes the information is accurate, she said.
"We hold that a generic manufacturer may employ this
provision to force correction of a use code that inaccurately
describes the brand's patent as covering a particular method of
using the drug in question," Kagan concluded.
The FDA approved Prandin, known generically as repaglinide,
for three separate uses to help patients with Type 2 diabetes to
control their blood sugar levels.
Novo Nordisk's main patent on the drug already expired, but
it has another that covers the use of repaglinide only when it
is used in combination with another diabetes drug, metformin.
This patent expires in 2018.
That means Caraco could get FDA approval to "carve out" two
other uses for the drug without infringing on Novo Nordisk's
specific patent.
But Novo Nordisk, the world's biggest insulin producer,
submitted a more general description of its remaining Prandin
patent to the FDA, effectively covering all three uses.
Novo Nordisk said its description of the patent for Prandin
fulfilled FDA requirements and that the "counterclaim" provision
was a minor point in the law that was never supposed to fix
patent descriptions. But the Supreme Court rejected the
company's arguments.
The Supreme Court case is Caraco Pharmaceutical
Laboratories v. Novo Nordisk, No. 10-844.
For Caraco: James Hurst and Steffen Johnson of Winston &
Strawn
For Novo Nordisk: Mark Perry of Gibson Dunn & Crutcher
(Reporting by Anna Yukhananov and James Vicini)
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