Supreme Court: Generic drugmaker may sue over brand patent

The ultimate outcome could be that such drug manufacturers can introduce their products sooner.

By Alicia Gallegos — Posted April 30, 2012

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The U.S. Supreme Court has ruled that a generic drugmaker may challenge a brand-name rival over the scope of its patent, providing a legal remedy for generic manufacturers that believe unfair patents are keeping them from the market.

The high court said April 17 that Caraco Pharmaceutical Laboratories Inc. has the right to sue Novo Nordisk Inc. USA over its patent description of the diabetes drug Prandin (repaglinide). Caraco said the “use code” describing the drug’s uses is overly broad and that the company wants to sell a generic version of the medication.

The ruling is a victory for generic competition and for patients in need of lower-cost drugs, said Ralph G. Neas, president and CEO of the Generic Pharmaceutical Assn.

“We commend the Supreme Court for preventing Novo Nordisk’s actions from becoming a playbook for all brands and costing consumers millions of dollars by delaying the introduction of affordable, lifesaving generic drugs,” Neas said in a statement.

Novo Nordisk said it was disappointed by the ruling. A company attorney said the opinion was narrowly construed and that the case’s merits will be decided by a lower court.

“It appears the Supreme Court has held only that Caraco may challenge the use code narrative for Novo Nordisk’s patented method of treating diabetes with repaglinide in combination with metformin,” said James Shehan, vice president and general counsel for Novo Nordisk. “Novo Nordisk’s use code narrative is, and has always been, correct, and we are confident that further proceedings will show Caraco’s challenge to the use code narrative is meritless.”

At this article’s deadline, messages left with Caraco had not been returned.

Caraco and Novo Nordisk’s patent disagreement started in 2010, when Caraco applied for Food and Drug Administration approval to sell repaglinide. Novo sued for patent infringement. The FDA said Caraco could not move forward because Caraco’s drug proposal overlapped with Novo’s patent scope. The patent covers only one of the drug’s three uses, while the summary of Novo’s “use code” covers all three uses, according to court documents.

To make Novo revise its patent description, Caraco filed a counterclaim against Novo. A federal court ruled in favor of Novo, saying Caraco did not have a statutory basis to assert its claim.

In a unanimous decision, the Supreme Court reversed the ruling. Justices said Congress intended generic drugmakers to have a remedy when such use code disagreements arise.

“The [law] contemplates that one patented use will not foreclose marketing a generic drug for other unpatented ones,” the high court said. “A generic manufacturer may employ the counterclaim provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using a drug.”

At this article’s deadline, no dates had been set for a lower court to consider the case.

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Case at a glance

Can generic drugmakers sue brand-name companies over the scope of their patents?

The U.S. Supreme Court said yes. The high court said that when disagreements about patent descriptions arise, generic drug manufacturers have the right to challenge brand-name drugmakers in court.

Impact: Allowing such legal remedies for generic drugmakers could lead to generic drugs entering the market sooner.

Caraco Pharmaceutical Laboratories v. Novo Nordisk, U.S. Supreme Court, April 17 (link)

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External links

Caraco Pharmaceutical Laboratories v. Novo Nordisk, U.S. Supreme Court, April 17 (link)

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