Takeda Pharms. Co. v. Torrent Pharms. Ltd.

Because a skilled artisan would not have had a reasonable expectation of success in modifying the prior art to come up with the claimed invention, neither of defendants’ affirmative defenses could overcome their burden to prove invalidity.

Case Name: Takeda Pharms. Co. v. Torrent Pharms. Ltd., No. 17-3186 (SRC)(CLW)(cons.), 2020 U.S. Dist. LEXIS 18069 (D.N.J. Feb. 4, 2020) (Chesler, J.)

Drug Product and Patent(s)-in-Suit: Nesina® (alogliptin), Kazano® (alogliptin and metformin HCl), and Oseni® (alogliptin and pioglitazone); U.S. Patent No. 7,807,689 (“the ’689 patent”)

Nature of the Case and Issue(s) Presented: Nesina, Kazano, and Oseni were alogliptin benzoate formulations used to treat type 2 diabetes mellitus in adults. Takeda sued Torrent and Indoco for infringement of the ’689 patent after each defendant filed ANDAs seeking to market generic versions of Nesina, Kazano, and Oseni. In a final pretrial order, the parties stipulated to a finding that the defendants’ products infringe claims 4 and 12 of the ’689 patent. Claim 4 described the structure of alogliptin, containing a scaffold and substituents. Claim 12 described the benzoate salt of alogliptin, which contained an NH₂ group on a substituent in the R absolute stereochemistry. The only remaining issues were Defendants’ invalidity defenses. Following a bench trial, the court held that Takeda had proven the ’689 patent was not invalid.

Why Takeda Prevailed: The questions before the court concerned two issues: obviousness; and obviousness-type double patenting. Following a summary of the parties’ expert testimony, the court recognized that both statutory obviousness and obviousness-type double patenting required the POSA to have a reasonable expectation of success in modifying the prior art. The court therefore required all of the defendants’ invalidity theories to meet this requirement.

Defendants offered three theories of invalidity. The court noted early in its discussion that two of defendants’ theories depended on a POSA’s ability to perform scaffolding hopping or scaffold replacement. The court stated that the evidence at trial suggested it was difficult to predict the biological effects of such modifications. The court further noted that predictability was a vital consideration in the obviousness analysis. Defendants’ third theory relied on isosteric replacement, to which the court noted there was no evidence that such modification would provide more predictable results than scaffold modification. In addition to predictability, the court recognized a number of evidentiary and explanatory holes in defendants’ theories as to why particular options, modifications, and rationales would be obvious to a POSA. In light of these findings, the court held that defendants had not met their burden of establishing by clear and convincing evidence that claims 4 and 12 of the ’689 patent were invalid.