Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.
Addressing a decision regarding infringement by a generic version of Lunesta®, the U.S. Court of Appeals for the Federal Circuit reversed a district court's decision that the generic made by an Abbreviated New Drug Application (ANDA) applicant fell outside the scope of the patent at issue, finding that infringement occurs when the ANDA specification describes a product that meets the limitations of the asserted claims. Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 13-1335 (Fed. Cir., Sept. 26, 2013) (Lourie, J.).
At issue in this case is Sunovion's patent, which claims the dextrorotatory (or (S)-enantiomer) of a compound known as zopiclone (trade name Lunesta). The claims recite the compound "in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer." Reddy submitted an ADNA to the FDA for approval of the generic version of Lunesta. The ANDA specifies that the level of the levorotatory isomer is no more than 0.6 percent. Sunovion sued Reddy for infringement of the patent.
The district court construed the term "essentially free." The term appears only in the claims of the '673 patent and does not appear anywhere else in the specification. The specification does not provide any description regarding the degree of purity of the claimed dextrorotatory isomer. Accordingly, the district court relied on the prosecution history for claim construction, finding that during prosecution the applicant defined the term "essentially free" as containing less than 0.25 percent of levorotatory isomer. Reddy's internal manufacturing guidelines showed that the level of levorotatory isomer was more than 0.3 percent, and, therefore, the district court granted summary judgment of non-infringement.
On appeal, the Federal Circuit affirmed the lower court's claim construction, but reversed the non-infringement judgment for Reddy. The Federal Circuit found that the "applicants' repeated and consistent attribution of the purity level of less than 0.25 percent levorotatory isomer to 'the invention' and 'the instant invention'" during prosecution defined the term "essentially free." For example, in overcoming an obviousness rejection, the applicant identified the invention as exhibited by Example 1 and submitted a declaration stating that the "pure form" of the dextrorotatory isomer of zopiclone "as described in Example 1" contained "lower than 0.25%" of the levorotatory isomer. The Court found that the district court's claim construction was supported by the totality of evidence on record.
Regarding infringement, the Federal Circuit held that because Reddy's ANDA specification describes a product that meets the limitations of the asserted claims, it constitutes infringement. Reddy was seeking approval to market a generic version of the drug that could fall within the scope of the asserted claims. The district court's reliance on Reddy's internal manufacturing guidelines for non-infringement was misplaced. The Federal Circuit believed that allowing an ANDA applicant to avoid infringement based on unconventional and unenforceable guarantees while seeking to market a product that fell with the scope of asserted claims would be incompatible with principles of patent law. If it had no intent to infringe, Reddy should not have requested, or should not accept, approval to market a product within the scope of the claim. Reddy could not avoid infringement by the so-called certification pledging.
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