Judge Gregory M. Sleet recently issued an Order construing various terms across U.S. Patent Nos. 6,417,175 and 8,247,400. Forest Laboratories, LLC v. Apotex Corp., C.A. No. 15-018-consol. (D. Del. Nov. 8, 2016). Notably, Judge Sleet construed the preamble term “a method for treating a bacterial infection” to be limiting. Id. at 4 n.5. Defendants argued that the preamble was not limiting and “merely statement of intended outcome.” Defendants attempted to analogize the preamble to the preamble at issue in Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001). In Bristol-Myers, “the Federal Circuit found no error in the district court’s interpretation of the phrase ‘for reducing hematologic toxicity’ as non-limiting.” The Federal Circuit found that “the steps of the claimed infusion method are performed the same way regardless of whether there is a reduction in hematologic toxicity” and that “[t]he preamble did not alter or explain the meaning of the term ‘effective amount,’ found in the body of the claim.” Id.
Judge Sleet found defendants’ argument unpersuasive, and was guided by Judge Andrews’ analysis in Sanofi v. Lupin Atlantis Holdings S.A., 2016 WL 5842327 (D. Del. Oct. 3, 2016). Judge Sleet observed that “[t]he claims at issue here do not provide a definition for ‘effective amount’ in the body of the claim. Instead, ‘effective amount’ derives its meaning from the preamble.” Judge Sleet distinguished this case from Bristol-Myers, where “the preamble did not provide antecedent basis for any terms in the body of the claims.” Rather, in Bristol-Myers, “the body of the claim provided the definition for ‘an antineoplastically effective amount’ because the dosage requirements outlined in the claims were described as antineoplastically effective in the specification.” Judge Sleet ultimately determined that “[b]ecause the meaning of effective amount is unclear without the preamble, the preamble is construed as limiting.” Id.