Industry faces new issues concerning generic drug regulations

NEW YORK — While settlements constitute the most prominent patent-related issue for generic drugs, two others have cropped up this year as well.

In June, the Supreme Court said it would hear the case of Caraco Pharmaceutical Labs, Ltd. v. Novo Nordisk A/S, concerning Novo Nordisk’s Type 2 diabetes drug Prandin (repaglinide). Novo Nordisk had patent protection for the drug when combined with metformin, but not as a stand-alone therapy. Caraco sought approval of generic repaglinide for use alone, without metformin, under a provision of the Hatch-Waxman Act that allows the Food and Drug Administration to approve a generic version of a drug for approved uses not covered by any patent, allowing Caraco to avoid patent litigation. But Novo Nordisk changed its use code, a description of the patent required for FDA filing, to encompass use of Prandin alone, thus requiring the FDA to turn down Caraco’s approval application. Caraco filed a counterclaim requesting that Novo Nordisk be required to change the use code back to the original because its patents only cover Prandin in combination with metformin. 

Another issue is the America Invents Act, introduced in March. The Generic Pharmaceutical Association has expressed opposition to a provision of the bill that it said would allow patent holders who knowingly falsify or omit information in their original patent applications to retroactively correct their filings without any consequences. Generic drug companies frequently use falsifications and omissions in patent applications as a basis for challenging the validity of patents when they wish to market a generic version of a drug prior to patent expiration.

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