Sunovion v. Reddys: Promise to Manufacture Non-Infringing Generic Does not Avoid Infringement

Category: Infringement
 By: Jesus Hernandez, Blog Editor/Contributor
TitleSunovion Pharma., Inc. v. Dr. Reddy's Lab., Ltd., No. 2013-1335 (Fed. Cir. Sept. 26, 2013).
Issue[1] Sunovion argues that the claim limitation “essentially free” should be defined as “largely but not wholly free” of the levorotatory isomer, which encompasses greater than approximately 90% dextrorotatory isomer by weight of the total weight of zopiclone.
Sunovion, at *7.
[2] Reddy […] argues that the Cappuccino certification [, which promises a non-infringing generic product under ANDA,] 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.”
Id. at *11.
Holding[1] [Because the specification was silent on the meaning of the term "essentially free",] [t]he applicants’ repeated and consistent attribution [in the prosecution history] of the purity level of less than 0.25% levorotatory isomer to “the invention” and “the instant invention” thus gives meaning to the term “essentially free.”
Sunovion, at *10 (text added).
[2] We therefore hold that any so-called certification [to a district court] 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.
Id. at *15 (text added).

Procedrual HistorySunovion Pharmaceuticals, Inc. (“Sunovion”) appeals 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”).
Sunovion, at *2.
Legal Reasoning
I. Claim Construction of "essentially free"
Legal StandardWhen construing claim terms, we first look to, and primarily rely on, the intrinsic evidence, including the claims themselves, the specification, and the prosecution history of the patent, which is usually dispositive. Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc); […] Claim terms “are generally given their ordinary and customary meaning,” Phillips, 415 F.3d at 1312 (quoting Vitronics, 90 F.3d at 1582), but […] there is no plain or ordinary meaning to the claim term “essentially free” because terms of approximation such as “essentially” are capable of multiple meanings. […]
Sunovion, at *7-8.
Scant Support in SpecificationThe term “essentially free” appears only in the claims of the ’673 patent and does not appear anywhere in the written description. Except for the claims, the specification is devoid of any reference to the degree of enantiopurity of the claimed dextrorotatory isomer of zopiclone. The written description refers to the subject of the claimed invention merely as the dextrorotatory isomer of zopiclone, distinguished from the racemate, which is by definition a 50/50 mixture of the two enantiomers. […]
Id. at *8.
Prosecution History Arguments Define "essentially free"[T]he prosecution history of the application that matured into the ’673 patent demonstrates that the applicants repeatedly and consistently defined their claimed invention to be as exhibited by Example 1 [demonstrating less than 0.25% of the levorotatory isomer.]. […] At one point, the applicants relied on the disclosure of Example 1 as “evidence of the fact that the material of the instant invention consists essentially of the [dextrorotatory]-isomer of zopiclone.” J.A. 2174. In overcoming an obviousness rejection at another point, the applicants again identified their invention as Example 1, arguing that there was “no suggestion in the prior art which would lead one of ordinary skill [to] achieve the claimed result, namely, resolution of the racemate to yield the [dextrorotatory]-isomer.
Id. at *8 (text added).
Bound by Words in Prosecution HistoryThe totality of the record evidence thus supports the interpretation of the term “essentially free” as less than 0.25% levorotatory isomer. The definition of a claim term can be affected through “repeated and definitive remarks,” and it is also appropriate to rely on the record of interference proceedings in construing claim terms.
Id. at *9.
II. Summary Judgment Finding of Infringement
Promise (certification) of non-infringement)The district court initially denied Reddy’s motion without prejudice, but permitted Reddy to file a renewed motion for summary judgment of noninfringement accompanied by a so-called “certification” that Reddy would not market an eszopiclone product contain- ing less than 0.3% of the levorotatory isomer. Sunovion, 2013 WL 211289, at *2. Reddy subsequently 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. Id.; J.A. 5665–67 (the “Cappuccino certification”) […]
Sunovion, at *3.
Patent Infringement and ANDA, generallyAlthough no traditional patent infringement has occurred until a patented product is made, used, or sold, under the Hatch-Waxman frame- work, the filing of an ANDA itself constitutes a technical infringement for jurisdictional purposes. […] But 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 *11-12.
Certification 'Not to Infringe" does not Overcome ANDAWhat Reddy has asked the FDA to approve as a regulatory matter is the subject matter that determines whether infringement will occur, and 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. at *12.
No issues of fact when ANDA is the grounds for infringement[I]f 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. Id. Unlike the circumstances in Bayer and Glaxo, that is the case before us. Reddy’s ANDA specification clearly describes a product that meets the limitations of the asserted claims.
Id. at *14-15.
In view of the foregoing, we conclude that the district court’s construction of the asserted claims was correct, but we also conclude that the court erred in granting sum- mary judgment of noninfringement to Reddy. Therefore, because Reddy’s ANDA specification infringes claim 1 of Sunovion’s ’673 patent as a matter of law, the judgment of the district court is reversed. REVERSED
Sunovion, at *15.

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