A “Patent” Win for Generic Drug Manufacturers


Photo credit: erix! of flickr


By Lauren Guicheteau

On April 17th, the U.S. Supreme Court reined in a pharmaceutical company’s ability to unilaterally extend the scope of its patent in Caraco Pharm. Laboratories, Ltd. v. Novo Nordisk A/S. The Court held that generic-drug manufacturers can sue brand-name manufacturers to correct patentee’s use code with the Food and Drug Administration (FDA). This case originated with Novo Nordisk AS bringing an action against Caraco Pharmaceutical Laboratories Inc. for infringement of Novo’s patent for repaglinide. The difficulty with Novo’s suit revolved around the fact that repaglinide was approved by the FDA for three separate uses related to diabetes, but Novo had a patent that covered only one of these uses. However, the use code that Novo submitted to the FDA included all three uses.

Use codes are the descriptions of companies’ method-of use patents that brand name manufacturers submit to the FDA. 21 C.F.R. §§ 314.53(c)(2)(ii)(P)(3), (e) (2011). When the FDA considers an application from a manufacturer to market a generic drug, it looks to the use codes to evaluate whether marketing would infringe upon a brand-name drug manufacturer’s patent. The FDA decides whether to approve or deny a generic drug based on the description in the use code, without verifying the accuracy of the information. Overly broad use codes can prevent generic drugs, which save consumers billions of dollars each year, from entering the market.

In response to Novo’s suit, Caraco brought a counterclaim which sought an order under 21 U.S.C. § 355 to correct Novo’s overbroad description of its patent, so Caraco could market repaglinide for the non-patented uses. The U.S. Supreme Court considered whether Congress authorized a generic company to bringing this type of counterclaim in a patent infringement suit. Congress had passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which created a statutory counterclaim available to generic manufacturers sued for patent infringement. This Act was passed, in part, as a response to a study by the Federal Trade Commission that detailed how brands were submitting inaccurate patent information to the FDA. The court in Caraco Pharm. Laboratories, Ltd. v. Novo Nordisk A/S analyzed the scope of this counterclaim provision specifically interpreting the section that explains a generic company “may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted … under [two statutory subsections] on the ground that the patent does not claim … an approved method of using the drug.” 117 Stat. 2452, 21 U.S.C. § 355(j)(5)(C)(ii)(I). The Court interpreted this provision so 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.” At page 7. Hopefully, by giving generic manufacturers a way to force corrections, this ruling is a step towards accurate FDA use codes.

One thought on “A “Patent” Win for Generic Drug Manufacturers

  1. The references of patents based is difficult to assess in developing and manufacturing. we are providing advice on the most appropriate way to deal with the threat of impending infringement . For Some More Information Visit at this link:- Patent Litigation CA

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