Decision: Brigham and Women’s Hospital, Inc. v. Perrigo Co., --F.3d __ (Fed. Cir. Feb. 28, 2019) (non-precedential) (LOURIE, O’Malley, and Stoll)

Background: Brigham’s U.S. Patent No. 5,229,137 (’137 patent) (now expired) claimed a method for treating episodic heartburn, in particular, by co-administering an antacid and H2-blocker to achieve a certain clinical result: “immediate and sustained relief” from pain.

Brigham’s asserted claim included reference points for the “immediate and sustained relief:” the relief had to last longer than treatment with only the antacid and it had to act faster than and last about as long as treatment with only the histamine H2-receptor antagonist.

Claim 1 reads:

1. A method of providing immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn in a human, said method comprising: orally administering to a human together or substantially together an antacid in an amount effective to substantially neutralize gastric acid and a histamine H2-receptor antagonist in an amount effective to substantially inhibit or block gastric acid secretion for providing the human with immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn, the immediate and sustained relief provided lasting longer in duration than when the human is orally treated with only the antacid and the immediate and sustained relief provided being faster than and lasting at least about as long in duration as when the human is orally treated with only the histamine H2-receptor antagonist.

Although Perrigo sent Brigham a Paragraph IV notice mentioning the ’137 patent when it filed its ANDA, Brigham’s exclusive licensee, Johnson & Johnson, did not assert the ’137 patent against Perrigo, rather sued Perrigo on another patent not involved in this lawsuit. Perrigo prevailed in the lawsuit and launched its generic product in 2008. In 2013, Brigham sued Perrigo for infringement of the’137 patent.

Brigham argued that the clinical data demonstrated that Pepcid Complete® provides immediate relief, and since Perrigo’s generic product has the same active ingredients and dosages as Pepcid Complete®, Perrigo’s generic product must also provide immediate relief.

The district court construed the claim limitation “immediate and sustained relief” according to the express definition provided in the specification, providing that the relief start within about 5-10 minutes and last about 4-6 hours:

It should therefore be appreciated that by 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; the actual ingredients being an antacid and a histamine H2-receptor antagonist.

A jury found that the asserted claims of the ’137 patent were not invalid, that Perrigo’s generic product infringed each asserted claim, and that Perrigo’s infringement was willful. The jury awarded Brigham damages of about $10 million.

The district court denied JMOL of invalidity and granted JMOL of noninfringement. “[T]he court determined that the clinical evidence did not demonstrate that Pepcid Complete® provided immediate relief from episodic heartburn.” Therefore, Perrigo’s generic product with the same active ingredients and dosages did not infringe.

Issue on Appeal: Did Pepcid Complete® (and therefore Perrigo’s generic product) meet the “immediate relief” claim limitation?

Outcome: Affirmed: No infringement.

The district court’s claim construction based, as it was, expressly on the specification, was undisputed. The Federal Circuit found sufficient evidence supported the district court’s conclusion of noninfringement. The patent owner, trying to carry its burden on infringement, pointed out that the active ingredients and dosages of the branded and generic product were the same. The evidence provided by Brigham (three clinical studies from its NDA), however, was found to not in fact show that the branded product provided immediate relief within 5-10 minutes. Other evidence showed “adequate relief” at 15 minutes, not “immediate relief within 5-10 minutes” in accord with the claim construction. Further testimony by the inventor was “uncorroborated, conclusory, and interested testimony [which was] insufficient to carry Brigham’s burden of proof and to sustain the jury verdict.” Specifically, the inventor testified, unsuccessfully to prove infringement, that he knew the allegedly infringing product met the claimed limitations because he took the medicine himself.

Prosecution Takeaways:

This case provides an example of having all the pieces of a jigsaw puzzle, but not assembling them together properly to complete the puzzle.

First, if the patent owner has clinical data it is providing to the FDA in its NDA, counsel should work carefully and diligently, in representing the patent owner, to file a U.S. provisional patent application setting forth the clinical studies and results, preferably before the results are made public. If that timing is not achieved, all may not be lost, however. In the U.S., a patent application filed within a year of the publication of the results may avoid prior art effects of the clinical results, at least in the U.S.

Align the claims to the results of the clinical trial(s). Importantly, negotiate with the FDA so that the label contains a section setting forth the clinical studies and results and also cross references those clinical studies and results in the Indications and Usage section. Sanofi and Vanda, above, are examples where all of such considerations were taken into account, and the jigsaw puzzle was completely assembled. In those two cases, the timing, pieces of the specification and claims, clinical studies, clinical results, and appropriate references in the Indications and Usage section of the label were all carefully assembled to complete the puzzle. The Brigham case apparently had all the pieces available, but the label did not provide a sufficient link to the patent specification and claims were not aligned with the clinical results. And without label evidence of induced infringement or any evidence establishing literal infringement, the patent owner was unable to prove that its product (and therefore the Perrigo product) satisfied all claim limitations to establish literal infringement.

Second, as is probably evident from the above, if the clinical data, label, and claims are carefully aligned and assembled, there may be very strong grounds for proving induced infringement based on the generic manufacturer’s label. In this Brigham case, the patent owner only alleged literal infringement of Perrigo’s commercial product and had no induced infringement (or DOE) position to fall back on. As noted above, the label apparently did not provide a sufficient link to the patent specification and claims, and the claims were not aligned with the clinical results.

Finally, the patent owner in this case provided a definition for the claim terms in the specification, and the claims were construed accordingly. To the extent that definitions can constitute a sharp sword, this was a case where the patentee died by that sword. To be sure, it can be observed that the patent owner obtained a claim construction desired by the patent specification. But that desired claim construction was not part of a broader strategic context in which the patent owner developed the record sufficiently, analogously to Sanofi and Vanda, so as to be able to prove, relatively easily, infringement of the ’137 patent, issued in 1993, by the product that Perrigo launched in 2008, i.e., years after the patent was granted. Clearly, in complex matters such as this one, approaching the claim drafting process with visionary “Nostradmus” insight in view of what will ultimately be in the label, can be difficult but highly useful if successful.