[Ip-health] amednews on Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S

Thirukumaran Balasubramaniam thiru at keionline.org
Wed Jan 4 05:53:56 PST 2012


http://www.ama-assn.org/amednews/2011/12/19/gvsc1219.htm

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Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S


In Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, justices are examining whether a generic drug manufacturer may sue a brand-name drug company over the scope of its patent. Novo Nordisk has a patent on the diabetes drug repaglinide, which is approved by the Food and Drug Administration for three separate uses related to the disease. Novo Nordisk's patent covers only one of the three uses, but the summary of the "patent scope" that the company submitted to the FDA covers all three uses.

A federal court ruled that the generic drug company would be violating the scope of Novo's patent by selling the drug for the other two uses. Caraco wants Novo to correct its patent description. The Supreme Court is examining whether a generic drug manufacturer has standing to sue a brand-name firm over drug patent information filed with the FDA.

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Can patents preclude all generic uses?

During Dec. 5 oral arguments in the Novo Nordisk case, James Hurst, attorney for Caraco, said preventing his firm from suing over Novo's patents harms generic drug manufacturers' freedom and goes against federal law allowing generics to enter the drug market legitimately.

"Since 1984, whenever a drug has multiple FDA-approved uses, there has been a statutory path for generic drugs to reach the market if there are specific uses not covered by a patent. Here, there is no dispute that Novo's patent does not claim the use of repaglinide when used alone, and that is 'an approved method' of using the drug," he said. "My client, Caraco, is attempting to get on the market for admittedly noninfringing uses, which occupy about 70% of the marketplace out there."

But Mark Perry, attorney for Novo, argued that the case's focus should be on the FDA's administrative process to approve patents and their scopes. "What really is at issue here" is a challenge to the FDA's administration of patents, he said. The FDA has said it does not have the authority to correct summaries of patient scopes. It should be Congress' responsibility, and not the courts', to change the current administrative process on patents, he said.

"Our position is we have complied in every respect at every moment with every bit of FDA's regulations. And again, that's what the evidence in this record shows," he said.

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org



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