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Reuters General/ ­- Article, Ter, 17 de Abril de 2012
CLIPPING INTERNACIONAL (Supreme Court)
U.S. top court rules for generic
drugmaker on patent
By Anna Yukhananov and James Vicini
WASHINGTON | Tue Apr 17, 2012 3:07pm EDT
(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. (Reporting By Anna Yukhananov and James
Vicini; Editing by Lisa Von Ahn)
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