The Burrill Report


Generic drugmakers scored a victory when the U.S. Supreme Court ruled that they can file counterclaims when pharmaceutical companies wrongly claim their patents cover a broader range of uses for a drug than they actually do in order to block others from bringing competing products to market.

Generic drugmakers are prohibited from bringing to market their own versions of branded drugs for uses protected by the branded drugmaker’s method patents. However, they can carve out indications that are not protected by valid patents. Branded drugmakers provide the U.S. Food and Drug Administration with patent numbers, expiration dates, and information about their method-of-use patents. That information is then used by the agency to determine whether or not to approve a generic version of a drug based on whether it infringes on a patent. But the FDA does not, as part of the process, verify the accuracy of the information.

In a unanimous decision authored by Justice Elena Kagan in the case of Caraco Pharmaceutical Laboratories v. Novo Nordisk the court reversed the lower court’s ruling that prevented Caraco from pursuing a counterclaim and remanded the case to the lower court for review. The case stemmed from Caraco’s effort to bring a generic version of Novo’s diabetes drug Prandin for two uses not covered by Novo’s existing patents.

The court’s decision centered on a matter of semantics and whether the counterclaim provision in the law prohibited a generic drugmakers from filing a counterclaim when there was a patent covering a specific use of a drug or whether the prohibition existed when there was any approved use of a drug.

“This ruling is a win for generic competition and, more importantly, a win for consumers,” said Ralph Neas, president and CEO of Generic Pharmaceutical Association. “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.”

The Pharmaceutical Research and Manufacturers Association of America has not commented on the decision, but in an amicus brief filed in the case the industry trade group argued courts should not be in the business of rewriting use codes. “FDA, which created the use code system,” the organization wrote, “has both the authority and the responsibility to define and regulate the content of use codes.”

Novo in a statement expressed disappointment in the decision, but said the court only ruled that Caraco can challenge Novo’s description to the FDA of its patents, but not that Caraco challenge has merit.













April 20, 2012
http://www.burrillreport.com/article-generic_drugmakers_score_victory_at_supreme_court.html