United States: Pledge Not To Infringe Cannot Override Conclusion Of Infringement Based On Seeking FDA Approval To Market Generic Compound Within Scope Of Valid Patent

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., No. 13-1335 (Fed. Cir. Sept. 26, 2013), the Federal Circuit reversed the district court's grant of SJ of noninfringement, concluding that, although the district court did not err in construing the asserted claims, Sunovion Pharmaceuticals, Inc. ("Sunovion") was entitled to a judgment of infringement as a matter of law under 35 U.S.C. § 271(e)(2)(A).

U.S. Patent No. 6,444,673 ("the '673 patent"), owned by Sunovion, is directed to pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in the sleep medication marketed as Lunesta^®.  The claim recites that the compound is "in the form of its dextrorotatory isomer," i.e., eszopiclone, and "essentially free of its levorotatory isomer."  Slip op. at 3 (citation omitted).  In approving Lunesta^®, the FDA required that each tablet contain not more than 0.3% of eszopiclone's corresponding levorotatory enantiomer.  The '673 patent is listed in the FDA's publication known as the Orange Book.

Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (collectively "Reddy") submitted to the FDA an ANDA including a paragraph IV certification with respect to the '673 patent, seeking approval to market generic eszopiclone tablets prior to the expiration of the '673 patent.  Sunovion sued Reddy for patent infringement under 35 U.S.C. § 271(e)(2)(A).  Reddy's original ANDA specification requested approval for generic eszopiclone products with not less than 0.3% and not more than 1.0% of the levorotatory isomer, but the FDA required Reddy to "tighten up" the levorotatory limit to not more than 0.3%.  In response, Reddy revised its ANDA specification to restrict the levorotatory limit to not more than 0.6%.

Following a Markman hearing, the district court construed the claim term "essentially free" to mean "less than 0.25% of [the] levorotatory isomer" based on an inventor's declaration and the prosecution history.  Id. at 4 (alteration in original) (citation omitted).  Reddy moved for SJ of noninfringement.  The district court initially denied Reddy's motion, but then permitted Reddy to file a renewed motion for SJ of noninfringement accompanied by a "certification" that Reddy would not market an eszopiclone product containing less than 0.3% of the levorotatory isomer.  Reddy submitted a declaration from one of its employees vowing to the district court, but not to the FDA, that Reddy would only market generic eszopiclone tablets containing 0.3-0.6% levorotatory isomer.  The district court granted Reddy's renewed motion for SJ, and Sunovion appealed.

On appeal, the Federal Circuit first held that the district court correctly construed the claim term "essentially free" as "less than 0.25% of [the] levorotatory isomer."  The Court found that "essentially free" did not have a plain or ordinary meaning and that the specification offered no guidance on the issue.  The Court found, however, that the totality of evidence, including the prosecution history and a concurrent interference, showed that the applicants repeatedly defined their invention as containing less than 0.25% of the levorotatory isomer.

"We therefore hold that any so-called certification pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law."  Slip op. at 15.

The Federal Circuit next held that the district court erred in granting SJ of noninfringement.  The Court noted that under the Hatch-Waxman framework, "the ultimate infringement question is determined by traditional patent law principles and, if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue."  Id.  at 12.  The Court stated that "the fact that Reddy either tells the court that its manufacturing guidelines will keep it outside the scope of the claims or has even filed a declaration in the court stating that it will stay outside the scope of the claims does not overcome the basic fact that it has asked the FDA to approve, and hopes to receive from the FDA, approval to market a product within the scope of the issued claims."  Id.  The Court noted that Reddy's amended ANDA specification sought FDA approval for generic eszopiclone products with 0.0-0.6% levorotatory isomer, which fell within the scope of the "less than 0.25%" limitation of the claims.

The Court rejected as misplaced Reddy's focus on its certification, stating, "Allowing Reddy to avoid infringement based on its unconventional and unenforceable 'guarantee' when it is asking for and may receive FDA approval to market a product within the scope of the innovator's patent, would be incompatible with the basic principles of patent law."  Id. at 13.  The Court reasoned that if Reddy had no intent to infringe, it should not have requested approval to market a product within the scope of the claim.

The Court also rejected Reddy's argument that Sunovion could later test Reddy's approved and commercially available generic products, and sue Reddy for infringement under § 271(a).  The Court explained that this would unnecessarily defer resolution of infringement until after ANDA approval, going against the purpose of the Hatch-Waxman framework.  The Court disagreed with Reddy's reliance on Bayer AG v. Elan Pharmaceutical Research Corp., 212 F.3d 1241 (Fed. Cir. 2000), and Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997), which held that approved compounds outside the scope of the relevant claims did not infringe.  The Court stated that, as here, "if an ANDA specification defines a compound such that it meets the limitations of an asserted claim, then there is almost never a genuine issue of material fact that the claim is infringed."  Slip op. at 14.

The Court held that a certification pledging not to infringe could not override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is infringement as a matter of law.  Accordingly, the Court reversed the district court's SJ of noninfringement.

This article previously appeared in Last Month at the Federal Circuit, October 2013.

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