Brigham and Women’s Hospital, Inc. et al. v. Perrigo Company et al. (13-cv-11640).

Judge Zobel denied Perrigo’s renewed motion for judgment as a matter of law that B&W lacked standing to sue and that U.S. Patent 5,229,137 was anticipated or obvious, but granted Perrigo’s motion that it did not infringe the patent.  The ‘137 Patent is directed to methods of treatment of episodic heartburn that involve co-administration of an antacid and a histamine H2-receptor antagonist in an amount effective to provide “immediate and sustained relief,” which was construed to mean relief that starts within 5-10 minutes and lasts for at least 4-6 hours.  In December of 2016, a jury had found the patent valid and infringed, and awarded B&W $10,210,071 in damages.

Perrigo’s standing objection was based on a requirement that B&W notify its then-licensee, Johnson & Johnson Merck Consumer Pharmaceuticals, of the suspected infringement and allow Johnson & Johnson 120 days to file suit before B&W could sue.  Judge Zobel agreed that there was a notice requirement that was not met, but nevertheless found that B&W had standing because the license did not grant all substantial rights to JJMCP, leaving B&W as the owner of the patent.  On the validity issue, Judge Zobel agreed with Perrigo that B&W failed to corroborate its claim to a priority date that predated the filing of the application because B&W presented only unwitnessed lab notebooks as corroboration.  Despite this, she found that the prior art references at issue failed to disclose or teach the “immediate and sustained relief” limitation.  Judge Zobel did, however, rule in Perrigo’s favor on infringement.  B&W did not present direct evidence on how Perrigo’s drug performed, instead relying on Perrigo’s bioequivalence data from its ANDA as proof that it performed the same as JJMCP’s branded Pepcid Complete product.  Accordingly, to prove infringement, B&W had to prove that Pepcid Complete met all of the claim limitations.  Judge Zobel found that the data presented on Pepcid Complete failed to prove that it met the “immediate and sustained relief” limitation because the clinical studies from JJMCP’s FDA submission did not begin with a low enough pH to qualify as “episodic heartburn,” and that the pH data was not correlated with “relief from pain, discomfort, and/or symptoms associated with episodic heartburn” as the claim required.  In light of this, the damages award was overturned.

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