Government asks top court to rule for generic drugmaker

WASHINGTON Tue Dec 6, 2011 2:17pm EST

The U.S. Supreme Court building seen in Washington May 20, 2009. REUTERS/Molly Riley

The U.S. Supreme Court building seen in Washington May 20, 2009.

Credit: Reuters/Molly Riley

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WASHINGTON (Reuters) - The government urged the Supreme Court to rule in favor of a generic drugmaker in a case over how companies can fight brand-name rivals to get cheaper drugs to market.

The nation's top court on Monday heard arguments about whether 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 Sun Pharmaceutical Industries, contends that the description of the patent for the diabetes drug, Prandin, is too broad, and because of that prevents any generic from entering the market. It raised a "counterclaim" to challenge the description.

In a brief to the court, the U.S. government said generic drugs save consumers billions of dollars each year. It opposed a lower court ruling in favor of the brand-name company, Danish drugmaker Novo Nordisk.

"Under the Federal Circuit's decision, a brand-name manufacturer can effectively preclude generic competition by submitting an overbroad description of its method-of-use patent to FDA," the government wrote.

CARVING OUT

The FDA approved Prandin, known generically as repaglinide, for three separate uses to help patients with Type 2 diabetes control their blood sugar levels.

Novo Nordisk's main patent on the drug already expired, but it has another patent 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.

At issue was whether the courts could force Novo Nordisk to change the description.

In fiscal year 2010, the FDA approved 11 new generic drug applications with carve-out labeling, according to the brief from the U.S. government.

Several justices turned to the relevant law, the Hatch-Waxman Act, during the arguments.

The 1984 law was supposed to empower generic drug companies by allowing them to challenge pharmaceutical patents if they thought they were weak, while also protecting medical innovation.

"What this means practically, I believe, is that when your patent expires no generic can come in with a use that's different than yours because they're going to be boxed out by this overbroad indication," said Justice Sonia Sotomayor, speaking to the lawyer arguing for Novo Nordisk.

"Do you actually think that that's what Congress intended?" she asked.

Novo Nordisk said its description of the patent for Prandin fulfilled FDA requirements, and also argued that the "counterclaim" provision was a minor point in the law that was never supposed to fix patent descriptions.

Mark Perry, a lawyer for Novo, also said that allowing companies like Caraco to sue over such descriptions would not get generic medicines to the market sooner.

"FDA itself ... said increased litigation over use codes - patent listings - would not assure faster generic entry because you would spend years and years, as we all have, litigating these very issues," Perry told the court.

A ruling is expected by summer.

The case is Caraco Pharmaceutical Laboratories v. Novo Nordisk, 10-844.

(This version corrects paragraph 3 to say before instead of when a patent has expired)

(Reporting By Anna Yukhananov)

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Comments (1)
Hasbaya wrote:
The wording “…how companies can fight brand-name rivals to get cheaper drugs to market” is biased and inflammatory language.

This case is about “method of use patents” (as opposed to “composition of matter” patents). The matter to be heard is if Sun Pharma (based in Mumbai, India) can use Novo Nordisk’s intellectual property (clinical data) to register and manufacture a copy of Novo’s drug repaglinide. Novo holds a valid patent for the uses of this drug.

The wording chosen by the author of this article makes it sound like these are 2 competing companies, rather than a company that does research, and a company that copies others’ discoveries with no investment of its own in biomedicine.

Dec 06, 2011 3:56pm EST  --  Report as abuse
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