In a recent Report and Recommendation, Magistrate Judge Christopher J. Burke construed seven claim terms from U.S. Patent No. RE40,000 (the “’000 patent”), which is directed to a method of using carvedilol to decrease the risk of mortality caused by congestive heart failure (“CHF”). GlaxoSmithKline LLC et al. v. Glenmark Pharmaceuticals Inc., USA, et al., C.A. Nos. 14-877, 14-878-LPS-CJB (D. Del. June 3, 2016). In the course of construing those terms, Judge Burke found that the term “”decreasing mortality caused by congestive heart failure,” which appears in the preamble of claim 1, should limit the claim. In support of this finding, Judge Burke first noted that as in this case, “[t]he Federal Circuit has held that language in the preamble of a claim constitutes a limitation if the preamble sets forth the objective of the method, and the body of the claim directs that the method be performed on someone ‘in need.’” Id. at 14. Second, Judge Burke found that “the term ‘said patient’ in the claim body relies on and derives antecedent basis from ‘a patient in need [of having their risk of mortality decreased]’ in the preamble.” Id. at 15. Third, Judge Burke noted that “[i]t cannot be seriously disputed that, at a minimum, a significant portion of the applicant’s arguments for patentability was that the drug’s usefulness in decreasing mortality of CHF patients was something distinct from its usefulness in treating symptoms of CHF.” Id. at 16.
In support of their argument that the preamble limitation was non-limiting–which was ultimately rejected–defendants had asserted that “GSK’s claims impermissibly recite merely a particular result of a known use.” Id. at 9. Judge Burke concluded, however, that whether “the claims improperly recite a particular result of a known use of carvedilol is more amenable to resolution on a motion for summary judgment of invalidity.” Id. at 17.
UPDATE: On February 17, 2017, Judge Stark considered objections to Judge Burke’s Report and Recommendation. GlaxoSmithKline LLC et al. v. Glenmark Pharmaceuticals Inc., USA, et al., C.A. Nos. 14-877, 14-878-LPS-CJB (D. Del. Feb. 17, 2017). Regarding Judge Burke’s construction of “maintenance” doses, Judge Stark sustained plaintiffs’ objections and construed the term to mean “dosages in the therapeutic amount.” Id. at 2. Judge Stark otherwise overruled the parties’ objections and adopted Judge Burke’s recommended claim constructions.