On September 26, 2013, the United States Court of Appeals for the Federal Circuit issued a panel decision in Sunovion Pharmaceuticals v. Teva Pharmaceuticals USA et al.
Sunovion appealed from the decision of the United States District Court for the District of New Jersey granting summary judgment that Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively “Reddy”) do not infringe claims 1, 2, and 8 of Sunovion’s U.S. Patent 6,444,673 (the “’673 patent”). The Federal Circuit panel, per Judge Lourie, with Judges Schall and Reyna joining in the decision, concluded that, although the district court did not err in construing the asserted claims, Sunovion was entitled to a judgment of infringement as a matter of law under 35 U.S.C. § 271(e)(2)(A).
Sunovion owns the rights to the ’673 patent, which is directed to pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in the chiral drug marketed as a sleep medication under the brand name LUNESTA®. Pursuant to 21 U.S.C. § 355(b)(1), the ’673 patent is listed as referenced to LUNESTA® in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (commonly known as the “Orange Book”). During the second quarter of 2013 alone, LUNESTA® had sales of nearly $200 million.
The dispute started when Reddy submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, which included a so-called paragraph IV certification with respect to the ’673 patent under the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), seeking approval to manufacture, use, and sell 1 mg, 2 mg, and 3 mg eszopiclone tablets as generic versions of Lunesta® prior to the expiration of the ’673 patent. As the Hatch-Waxman Act allows Sunovion to do, they then initiated a patent infringement lawsuit, asserting that Reddy’s ANDA submission constituted an act of infringement of claims 1, 2, and 8 of the ’673 patent according to 35 U.S.C. § 271(e)(2)(A).
The primary issue in the case was whether Dr. Reddy’s promise not to infringe was enough to avoid a finding of infringement. This is an issue in these types of cases because no active act of infringement has occurred, but rather the mere act of filing an ANDA with a paragraph IV certification is legally deemed sufficient to trigger the patent holder’s right to bring a patent infringement lawsuit.
Reddy submitted a declaration to the district court from one of its employees vowing to the court, but not to the FDA, that Reddy would only market generic eszopiclone tablets containing 0.3– 0.6% levorotatory isomer, notwithstanding that Reddy had not (and still has not) gained regulatory approval for products with that level of impurity.
The district court accordingly granted Reddy’s renewed motion for summary judgment of noninfringement. The district court found that the eszopiclone products that Reddy presumes to market would likely be “outside the infringing range of less than 0.25% of levorotatory isomer” because of Reddy’s internal manufacturing guidelines and the employee’s certification in which they pledged to constrain the amount of levorotatory isomer to not less than 0.3%, despite the contrary representations made to the FDA in Reddy’s amended ANDA specification.
Sunovion argued that Reddy’s amended ANDA specification controls the issue of infringement because it expressly defines Reddy’s product in a way that directly addresses the infringement question (i.e., eszopiclone with 0.0–0.6% levorotatory isomer), which includes the “less than 0.25%” purity range that would allow Reddy to sell infringing products.
Reddy responded that it does not infringe because, despite conceding that it is “bound by its ANDA specification,” its internal manufacturing guidelines require its generic eszopiclone products to contain at least 0.3% levorotatory isomer. Further, Reddy also argued that the declaration filed assured the district court that Reddy would only market generic eszopiclone tablets containing 0.3–0.6% levorotatory isomer, asserting that “literal non-infringement is as simple as 0.3 is more than 0.25.”
The Federal Circuit, however, pointed out that 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, and Reddy’s ANDA specification clearly describes a product that meets the limitations of the asserted claims. Further, the Federal Circuit explained: “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.” Which is, of course, a correct statement of law since the statement in the ANDA is what provokes a technical infringement claim, or statutory infringement claim under the Hatch-Waxman framework, despite no actual act of infringement.
Thus, the Federal Circuit reversed the district court and held 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. Simply saying ‘But I won’t do it’ is not enough to avoid infringement.”
Tags: CAFC, Federal Circuit, LUNESTA, patent, patents, pharma, pharmaceuitcal patents, PharmaPatents blog
You share in the PLI Practice Center community, so we just ask that you keep things civil. Leave out the personal attacks. Do not use profanity, ethnic or racial slurs, or take shots at anyone's sexual orientation or religion. If you can't be nice, we reserve the right to remove your material and ban users who violate our Terms of Service.