Posted 18 April 2012
By Alexander Gaffney
The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market, reports various news sources.
"At issue was the ability of a brand-name drugmaker to block generic competition by providing the US Food and Drug Administration (FDA) with overly broad descriptions of its patents," writes Pharmalot.
Caraco's lawsuit against Novo Nordisk focused on what it called an excessively broad patent application for Prandin, which Caraco argued prevented its rightful submission for a carve-out exemption to Novo Nordisk's patent, reports Pharmalot.
Writing for the court in a unanimous decision, Justice Elena Kagan wrote Novo Nordisk was guilty of submitting "misleading patent information to the FDA," which in turn delayed Caraco's entry into the market.
Manufacturers have frequently been devising methods to delay generic competition in recent years, including frequent reformulations, additional patent applications, different dosing methods, novel scoring of drug tablets, label changes and, of course, litigation.
"At issue [in this case] was a 2003 law with a loophole used by brand-name drug makers to keep generic competitors off the market," explained Reuters.
FDA is not empowered to review the patent use codes, leaving the issue largely to the courts, added Courthouse News Service. FDA's lack of enforcement left generic companies in a situation where they felt their only option was to "take matters into their own hands."
The entire court ultimately agreed with those sentiments.
"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," wrote Kagan.
The move could stand to benefit consumers, wrote Reuters. "Presumably, consumers will [save] billions because the Supreme Court preserved the generics' right to sue over the scope of method patents."
Pharmalot - Supreme Court Rules Against Generic Delay Tactic
Reuters - What does Caraco court win mean for generic drug cos?
Reuters - U.S. top court rules for generic drugmaker on patent
Courthouse News Service - Counterclaim Over Drug Patent Uses Gets Wings
Wall Street Journal - Supreme Court Sides With Generic Drug Makers
The Pink Sheet Daily - Patent Use Codes For Brands Can Be Challenged By Generics, Supreme Court Rules
Med Page Today - Generic Drug Firms Win Right to Sue
Med India - Generic Drug Makers Find Support in US Supreme Court Ruling