The US Supreme Court has ruled in favour of Sun Pharma unit Caraco Pharmaceuticals, allowing the generic drug manufacturer to fight brand-name rivals.
The ruling will allow Caraco to sue a brand-name drug manufacturer in order to narrow its patent description with the US Food and Drug Administration.
Caraco is seeking to have the patent description for Novo Nordisk‘s Prandin, a diabetes medication, changed, as it alleges the description is too broad, preventing generics from entering the market.
The main patent on Prandin, approved for three separate uses in the treatment of Type 2 diabetes, has already expired, but the drug is protected by another patent that covers the use of the drug in combination with metformin.
Caraco could request the FDA to remove the two other uses of the drug without infringing on the specific patent, allowing them to produce a generic copy of the drug without breaking US patent law. Novo responded by submitting a more general description of its remaining Prandin patent, covering all three uses of the drug, claiming that its description of the remaining patent fulfilled FDA requirements.
The US government backed Caraco’s claim, confirming its stance that generic drugs save consumers billions of dollars per year, and overturned a US appeals court ruling forbidding Caraco from challenging Novo Nordisk’s patent.
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Backing Caraco’s challenge of Novo’s changed patent description, Justice Elena Kagan said, "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."