Genentech, Inc. v. Sandoz, Inc.

EsbrietĀ® (pirfenidone)

March 5, 2024

GENERICally Speaking: A Hatch-Waxman Bulletin

Case Name: Genentech, Inc. v. Sandoz, Inc., Civ No. 23-4085 (JXN)(LDW), 2024 WL 939692 (D.N.J. Mar. 5, 2024) (Wettre, M.J.)

Drug Product and Patent(s)-in-Suit: Esbriet® (pirfenidone); U.S. Patent No. 10,118,637 (“the ’637 patent”)

Nature of the Case and Issue(s) Presented: Plaintiff Hoffman-La Roche (“HLR”) owns the patents-in-suit and Plaintiff Genentech exclusively licenses it. The patent claims a novel tablet formulation of pirfenidone, a drug used to treat the lung disease idiopathic pulmonary fibrosis (“IPF”). Defendants filed and eventually obtained final approval from FDA to sell generic pirfenidone tablets. In May 2022, after an ANDA litigation between Genentech and Sandoz in the District of Delaware, defendants began to sell their generic pirfenidone product. Plaintiffs now bring suit alleging patent infringement of the ’637 patent, which does not expire until March 28, 2037. In the prior litigation, Genentech asserted twenty patents, omitting the ’637 patent. Both Genentech and Sandoz had the ability to bring the ’637 patent into that suit and opted not to do so. Of the twenty patents that were asserted in the action, only claims from six of the patents were presented at trial: four Liver Function Test (“LFT”) patents and two Drug-Drug Interaction (“DDI”) patents. None of the patents was a formulation patent like the ’637 patent. After trial, where the court found that the LFT patents were not infringed and invalid and the DDI patents were also not infringed, the court dismissed with prejudice Genentech’s claims in the fourteen other patents-in-suit that were not presented at trial. The Federal Circuit affirmed in favor of Sandoz. Now, Sandoz filed a motion to transfer venue to the District of Delaware, which the court denied.

Why Genentech Prevailed: The parties agreed that this case could have been brought in the District of Delaware. Therefore, the crux of the court’s opinion centered on the venue transfer factors set forth in Jumara v. State Farm, 55 F.3d 873 (3d Cir. 1995). HLR is a NJ plaintiff that filed in its home forum, and that choice is entitled to deference even if its co-plaintiff, Genentech, is not a NJ resident. Moreover, the prior litigation was fully concluded before this one was filed so Genentech was under no practical or legal imperative to file in Delaware to join an ongoing, related suit. To the extent Genentech forum-shopped by holding back the ’637 patent in the prior lotigation in the hopes of trying its luck on it elsewhere if the results of the Delaware action were adverse, it was with Sandoz’s acquiescence. Sandoz did not take available steps to force Genentech’s to include that patent in the prior litigation. Therefore, this “paramount” factor, plaintiffs’ forum preference, weighs against transfer.

The defendants’ forum preference analysis tips only slightly in favor of transfer. Defendants prefer to litigate in Delaware. While Sandoz is a Delaware corporation, it is a NJ resident.

Where the claims arose is a factor that disfavors transfer. At least some marketing and sales decisions regarding Sandoz’s generic pirfenidone product took place in NJ. Moreover, even if the product was developed by Lek in Slovenia, some input from Sandoz, Lek’s parent company, had to come from this district.

Factors associated with the convenience of the parties and witnesses and the location of discovery materials were found to be neutral.

Because the balance of the private interests did not tip in favor of transfer, transfer depended on whether at least one of these public interest factors—(i) practical considerations that could make the trial more expeditious; (ii) court congestion; and (iii) NJ’s lack of a local interest in deciding the dispute—or a combination of them, strongly favors transfer. Regarding (i), because there is no pending, related litigation in Delaware, there is no efficiency to be gained by transfer with respect to consolidating or coordinating this case with another action. Moreover, there are important differences between this case and the prior action that would render any head start by the D. Del. judiciary insubstantial. The ’637 patent, containing formulation claims, is unrelated to the patents, containing method claims, tried by Judge Andrews, and does not claims associated with LFT or DDI. As such, the Delaware court would have reviewed unrelated prior art and arguments concerning unrelated secondary considerations of non-obviousness. Thus, the court found that practical considerations, on balance, weigh only slightly in favor of transfer. Regarding (ii), the court found this factor was neutral given that relevant statistics did not indicate an “appreciable difference” in court congestion, and that judges in both Districts were well-versed in pharmaceutical patent litigation given the prevalence of those cases in both Delaware and New Jersey. Regarding (ii) NJ did not have a particular local interest in deciding this dispute but neither does the District of Delaware. Therefore it, too, was neutral.

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