by Dennis Crouch
This case provides an example of the all-elements-rule of infringement. Here, the patentee failed to prove that the accused infringer each-and-every element of the claimed invention. Here, the failed element was providing “immediate relief” after administration of the generic Pepcid Complete
Brigham & Women’s Hospital, Inc., v. Perrigo Company (Fed. Cir. 2019) (non-precedential)
Brigham’s U.S. Patent 5,229,137 covers a method of treating heartburn using H2-blockers and antacids. Both ingredients were known in the art to provide relief with antacids having a immediate-but-fleeting action and H2-blockers providing slower but sustained relief. The invention here is to use both drugs at once and – surprise – the result is “immediate and sustained relief.”
The asserted claims are directed to a “method of providing immediate and sustained relief” by providing an effective amount of antacid and H2-blocker “for providing the human with immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn.” The claims go on to require that “the immediate and sustained relief” of the combined treatment must last longer “than when the human is orally treated with only the antacid” and must be more immediate “as when the human is orally treated with only the histamine H2 -receptor antagonist.”
The specification also particularly defines the term: “immediate and sustained relief:”
It means herein immediate, temporary and sustained relief which starts within about 5-10 minutes following ingestion of the active ingredients and continues and remains constant for at least about 4-6 hours after ingestion of the active ingredients.
Johnson & Johnson exclusively licensed the patent and listed it in the Orange Book listing for Pepcid Complete. However, when Perrigo filed its generic ANDA and Paragraph IV certification, J&J chose not to file suit, but rather sued on a different listed patent and lost. At that time, the ‘137 patent was also removed from from the FDA Orange Book listing. (I don’t know why).
In the present case, the Massachusetts jury sided with the patent holder — finding the patent enforceable and infringed and awarding $10 million in past damages (the patent expired in 2012). However, in a post verdict decision the district court rejected the jury verdict — holding instead that no reasonable jury could have found infringement based upon the evidence presented.
Looking here at the infringement analysis, the patentee argued that the accused product included the same ingredients as Pepcid Complete, which is covered by the patent claims. In this copy-cat situation, however, the decision maker has to be careful to focus on the patent claims, not simply compare the copied products. Here, the district court considered the clinical evidence presented at trial and found that it “did not demonstrate that Pepcid Complete provided immediate relief from episodic heartburn.” In particular, the evidence showed relief within 15 minutes, but not the 5-10 minutes required by the definition of immediate.
On appeal, the Federal Circuit has affirmed. Although the patentee presented evidence of very rapid change in esophageal pH after taking the drug (within 5-10 minutes), the court found that a change in esophageal pH does not directly correlate with immediate relief of episodic heartburn.
At most, the study suggests that Pepcid Complete might provide immediate and sustained relief; such speculative data, however, cannot sustain Brigham’s burden of proof.
A related study did show fairly-rapid action, but the shortest period measured was 15 minutes.
There is no dispute that adequate relief first measured at 15 minutes after administration is a parameter different from relief starting 5–10 minutes after administration. . . . As Studies 110 and 127 did not measure the result that Brigham claimed in the ’137 patent, we agree with the district court that they do not support the jury verdict. . . . Because only speculation supports Brigham’s contention that data showing adequate relief at 15 minutes implies that relief started within 5–10 minutes, it cannot sustain the jury verdict.
I’ll also note that the the inventor of the ‘137 patent (Wolfe) participated at trial as an expert witness. Wolfe testified that he took the Perrigo product and that it worked on him within five to ten minutes. On appeal, the Federal Circuit rejected that statement as “uncorroborated, conclusory, and interested testimony … insufficient to carry Brigham’s burden of proof and to sustain the jury verdict.”