In a recent Memorandum Order, Judge Richard G. Andrews construed the terms (i) “zolmitriptan” and (ii) “buffer,” “buffered,” and “in a buffered,” from U.S. Patent Nos. 6,750,237 and 7,220,767, which are directed to pharmaceutical formulations containing zolmitriptan, an intranasal administration device containing a pharmaceutical formulation containing zolmitriptan, and an aqueous solution of zolmitriptan. Impax Laboratories, Inc., et al. v. Lannett Holdings, Inc., et al., C.A. No. 14-984-RGA (D. Del. Dec. 1, 2015).
Notably, Judge Andrews also found the preamble “[a] pharmaceutical formulation suitable for intranasal administration” to limit the pharmaceutical formulation claims. While Judge Andrews found that the preamble did not provide antecedent basis for the terms in the claim bodies, it still did “more than state an intended use for the formulations.” Id. at 6. As Judge Andrews explained, the preamble “informs the meaning of those formulations—they must possess features making them appropriate for intranasal use.” Id. Judge Andrews also observed that the fact that the “patentees did not rely on the preambles to distinguish prior art during prosecution does not suggest that the preambles are non-limiting because the patent examiner cited only intranasal art,” which provides some indication that the examiner “acknowledged that the patents claim intranasal formulations.” Id.
Judge Andrews went on to further explain why the “the entire preamble gives ‘life, meaning, and vitality’ to the pharmaceutical formulation claims.” Id. at 6-7. First, Judge Andrews observed that “the patents repeatedly refer to the invention as a pharmaceutical formulation for use in intranasal administration.” Id. at 6. Second, Judge Andrews noted that “the specifications identify issues with prior art formulations and explain that the ‘inventors devised an intranasal formulation of zolmitriptan that provided effective and improved fast relief for migraine sufferers.’” Id. at 6. Third, Judge Andrews found “Examples 1-8 of the patents are directed to intranasal formulations and Example 9 of both patents describes a method for administering such intranasal formulations.” Id. at 7. Judge Andrews thus concluded that the foregoing disclosures “demonstrate that the claimed formulation is an improved pharmaceutical formulation of zolmitriptan suitable for intranasal administration.” Id. Judge Andrews finally noted that the “specifications nowhere suggest that the invention relates to formulations not suitable for intranasal use.” Id.