Supreme Court Hears Arguments on First Patent Case of New Session

By Joseph Mandour on December 8, 2011

LA Patent Lawyer Los Angeles – On Monday, December 5, 2011, the Supreme Court heard opening arguments regarding a generic drug manufacturer’s attempt to narrow the description of a method of use patent submitted to the Food and Drug Administration (FDA) by a pharmaceutical company.

Novo Nordisk produces a drug called Prandin (generic name: repaglinide), a type II diabetes drug, that has been approved for three separate uses to help patients control their blood sugar. The main patent for Prandin for two of those uses has expired. However, Novo Nordisk has another patent with Prandin for use with Metformin, another diabetes drug that expires in 2018. Novo’s description to the FDA for the use of Prandin in this current patent has been held broad enough to cover all three of these uses in the original Prandin patent. Under the Hatch-Waxman Act, the FDA uses the description given to it from patent holders, in this case – Novo Nordisk, to decide whether to approve a generic version when the drug’s patent expires.

Caraco, a unit of Sun Pharmaceutical Industries, wants to produce a generic version of Prandin for its two expired uses. They argue that Novo Nordisk’s patent on Prandin with Metforin is too broad because it covers all three uses, excluding it from producing Prandin for two of its expired uses. They have asked the Supreme Court to “carve out” the two expired uses from the current Novo Nordisk patent on Prandin with Metforin. The Obama administration has sided with Caraco and in its brief to the Court contends that the strong patent protection could “preclude generic [drug] competition by [patent holders] submitting an overbroad description of its method-of-use patent to FDA.” In 2010, the FDA approved 11 generic drug manufacturers to “carve out” uses otherwise covered by descriptions to the FDA by patent holders.

During questioning, several justices alluded to the original intent of Hatch-Waxman to get generic versions of patented drugs to consumers in a more efficient and efficacious manner. Justice Sonia Sotomayor questioned whether generic drug manufacturers would be “boxed out” by overly broad FDA descriptions by patent holders and asked, “Do you actually think that that’s what Congress intended?”

Novo Nordisk contends that allowing Caraco to “carve out” FDA descriptions would likely lead to increased litigation over FDA descriptions submitted by patent holders and delay the delivery of generic drugs to the public, ultimately defeating the purpose of Hatch-Waxman. The case is Caraco Pharmaceutical Laboratories v. Novo Nordisk, 10-844.

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