In a landmark decision for generic companies, the Supreme Court recently ruled in favor of Caraco Pharmaceutical Laboratories Inc., an arm of India's Sun Pharmaceutical, in its patent litigation against Novo Nordisk. The dispute was over Caraco's generic version of diabetes treatment Prandin.
The court ruled that Caraco could challenge Denmark-based Novo for filing an overly broad patent claim description with the FDA, thus preventing Caraco from marketing a competing generic of Prandin. Now, Caraco can bring a counterclaim to correct Novo's use code.
The Supreme Court, in a unanimous opinion, concluded that Caraco can seek correction of Novo Nordisk's inaccurate use code regarding the combination use of repaglinide and metformin for the treatment of type 2 diabetes.
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Regulations on use code requirements, however, have not yet been commented on by the FDA or US government, and it remains to be seen whether this will come soon.
Justice Elena Kagan wrote, "a generic manufacturer may employ a 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."
The ruling is considered as a significant positive for the generics industry which alleges that the branded pharma companies try to delay cheaper generic alternatives by abusing the Food and Drug Administration approval process to avoid competition.
Caraco and Sun Pharma allege that Novo extended its monopoly over Prandin until 2018 by overstating the reach of their patents.
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"This is a win for the generics industry regarding delaying tactics (like this one) by the branded sector," UBS analyst Marc Goodman wrote in a note to clients.
However, it is uncertain whether this ruling will prevent future lawsuits, as the current FDA guidance to branded manufacturers as to what is required in use codes is "remarkably opaque" according to Justice Sonia Sotomayor.
Sun Pharma is pleased that this landmark decision will help all generic companies prevent brand companies from improperly delaying or preventing the marketing of generic drugs against their products by misrepresenting their patents to the USFDA.
Caraco's abbreviated new drug
application (ANDA) for generic Prandin, which fetched about $230 million sales
in the U.S., is still awaiting approval at the USFDA. Also, a separate appeal
concerning the validity of patents for Prandin is currently pending before the
Court of Appeals for the Federal Circuit after a lower court ruled in favor of Caraco.