Federal Circuit Rules That Defendants’ Abbreviated New Drug Applications Did Not Infringe Plaintiffs’ Drug Patents
IP Litigation
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  • Federal Circuit Rules That Defendants’ Abbreviated New Drug Applications Did Not Infringe Plaintiffs’ Drug Patents


    On December 7, 2023, the United States Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion affirming the decision of the District Court of Delaware, which found non-infringement by Lupin Ltd., Lupin Pharmaceuticals, Inc. (“Lupin”) and other defendants of U.S. Patent Nos. 9,278,096 and 9,125,910 (’096 and ’910 patents, respectively), and infringement by Lupin of claim 12 of U.S. Patent No. 9,101,626 (’626 patent). All three patents are owned by H Lundbeck A/S (“Lundbeck”).

    A new drug cannot be marketed for use without FDA approval of its New Drug Application (“NDA”). The Hatch-Waxman Act permits generic manufacturers to “piggyback” on a branded drug’s FDA approved NDA by submitting an Abbreviated New Drug Application (“ANDA”) for a generic version of the drug. To facilitate approval of generic drugs, the Hatch Waxman Amendments and FDA regulations direct brand manufacturers to file relevant patent information in what is called the Orange Book.

    In the event an ANDA applicant desires to market a drug prior to the expiration of patents listed in the Orange Book, an applicant may—if the patent claims a method of use—propose a label that “carves out” a patented use and submit a statement to that effect. If the FDA approves the carved-out label, the applicant may market the drug “only for a subset of approved uses—i.e., those not covered by the brand’s patents.”

    Following the initial FDA approval of branded drug Trintellix for treatment of major depressive order (“MDD”) in adults, Lundbeck obtained the ’096 and ’910 patents. The patents relate to additional uses of vortioxetine, the active ingredient in Trintellix, including for the treatment of MDD in patients who have previously taken certain other drugs but were forced to cease or reduce usage due to certain side effects. Lundbeck listed the patents in the Orange Book. Their expiration dates are March 21, 2032, and June 15, 2027, respectively.

    Lupin and the other defendants submitted ANDAs for approval to market vortioxetine intended to be used solely for the treatment of MDD in adults, a method of use not covered by the ’096 and ’910 patents.

    Alleging infringement, co-plaintiffs Lundbeck and Takeda U.S.A., Inc. and related entities sued defendants seeking to enjoin the marketing of a generic version of Trintellix until the expiration of the ’096 and ’910 patents. After a bench trial, the District Court of Delaware determined that defendants’ ANDAs neither induced infringement of nor contributorily infringed the patents at issue. Plaintiffs appealed, raising several arguments.

    Plaintiffs’ first contention was that it makes no difference whether the drug is proposed to be sold for a use not covered by the ’096 and ’910 patents because the drug could be prescribed for those uses. The CAFC disagreed, citing to precedent that states “the use claimed in a patent” under 35 U.S.C. § 271(e)(2)(A) must be the use for which an applicant is seeking marketing approval. Specifically, the use under the statute refers to the use for which the FDA granted an NDA (and for which the ANDA was submitted). Therefore, it is not an act of infringement to submit an ANDA for a drug just because any use of said drug has been claimed in a patent.

    Regarding induced infringement specifically, plaintiffs primarily argued that because the ’096 patent exists and clinicians will prescribe the ANDA products for uses claimed in the ’096 patent, defendants have induced infringement and should be denied approval for their ANDAs. The CAFC disagreed, noting that a patentee cannot use Hatch-Waxman to maintain its exclusivity simply by filing a new patent application claiming a narrower method of use not covered by its NDA.

    Regarding contributory infringement, plaintiffs’ main contention was that defendants will contributorily infringe by selling their ANDA products because physicians will prescribe them in accordance with the methods claimed in the ’096 and ’910 patents. The CAFC rejected this argument as well, noting there is no liability for contributory infringement because there are substantial non-infringing uses for vortioxetine.

    Finding plaintiffs’ remaining arguments to be unpersuasive, the CAFC next addressed Lupin’s cross-appeal, which challenged the district court’s ruling that Lupin infringed the ’626 Patent relating to the manufacture of vortioxetine. In rejecting the cross-appeal, the CAFC affirmed the district court’s construction of the term “reacting” as having its plain and ordinary meaning and its finding of infringement under that construction.

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