Brigham & Women’s Hospital, et al. v. Perrigo Company et al.

Docket No. 2017-1950, -2021, -2555, 2018-1243

February 28, 2019

Brief summary: DC grant of JMOL of noninfringement affirmed.

Summary: Perrigo appealed DC denial of judgment as a matter of law (JMOL) that Brigham’s (Johnson & Johnson (J&J) is the exclusive licensee and markets the product Pepcid Complete) US 5,229,137 directed to “[a] method of providing immediate and sustained relief from pain” etc. by administering an antacid and a histamine H2-receptor antagonist is invalid for anticipation (§ 102) and obviousness (§ 103). Brigham cross-appealed DC order granting judgment of noninfringement as a matter of law. The FC panel opinion explains that “[t]he dispositive issue on appeal is whether Perrigo’s product meets the ‘immediate and sustained relief’ limitation.” Perrigo filed an ANDA for a combination tablet, sent Brigham a Paragraph IV notice letter, and eventually launched its product. Brigham asserted claims 1, 4-7 and 12 of the ‘137 patent against Perrigo (J&J declined to do so). The DC construed “immediate and sustained relief” to mean “relief obtained from pain, discomfort, and/or symptoms associated with episodic heartburn which starts within about 5-10 minutes following ingestion of the active ingredients and continues for at least about 4-6 hours.” Brigham argued that “since Perrigo’s generic product has the same active ingredients and dosages as Pepcid Complete, Perrigo’s product must also provide immediate relief”, relying in part on Pepcid Complete clinical data from the NDA application. The jury returned a verdict of willful infringement and awarded Brigham damages of about $10 million. The DC then “granted JMOL of noninfringement because…Brigham failed to present sufficient evidence of direct infringement” (i.e., “the clinical evidence did not demonstrate that Pepcid Complete provided immediate relief from episodic heartburn”). The FC panel first confirmed that it had jurisdiction over the case, and then reviewed the DC’s grant of JMOL under First Circuit law (“a rational jury could find in favor of the party who prevailed”). It explained that “[a]t trial, Brigham alleged only literal infringement”, “a question of fact” requiring “every limitation in the claim to be found in the accused product” (Akzo, FC 2016; Mas-Hamilton, FC 1998)) and for which the “patentee has the burden of proving…by a preponderance of the evidence” (Enercon, FC 1998). The FC panel agreed with the DC’s analysis of the evidence regarding “immediate relief” (e.g., “Figure 7 could not prove that the patients…were provided with immediate relief” as defined, the data was “untethered to any symptomatic relief” and “[a]t most, the study suggests Pepcid Complete might provide immediate and sustained relief…such speculative data, however, cannot sustain Brigham’s burden of proof”). The FC panel also agreed with the DC’s analysis of the data related to “symptomatic relief” (e.g., “Studies 110 and 127…did report symptomatic relief” but only “adequate” and “not immediate”…expert testimony “that the measured parameter would ‘correlate to’ the claimed result” which “does not suffice to prove literal infringement” (Phillip M. Adams, FC 2013 (“reasonable inferences…must be more than speculation and conjecture”); Medtronic, FC 2014 (“conclusory statements are insufficient”)). The DC judgment was therefore affirmed. The FC panel also explained that it did not reach invalidity issues but could have since “a judgment of noninfringement does not moot a counterclaim of invalidity” (Cardinal Chem., US 1993; see FN1).

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