Case Name: UCB, Inc. v. Accord Healthcare, Inc., Civ. No. 13-1206-LPS (Consolidated), 2016 U.S. Dist. LEXIS 109362 (D. Del. Aug. 12, 2016) (Stark, J.)
Drug Product and Patent(s)-in-Suit: Vimpat® (lacosamide); U.S. Patent No. RE38,551 (“the ´551 patent”)
Nature of the Case and Issue(s) Presented: In this ANDA litigation, the defendants stipulated that their proposed generic products would infringe three claims of the ’551 patent, which generally related to anticonvulsant drugs indicated for the treatment of epilepsy. The claims at issue cover the specific molecule lacosamide having at least 90% of the R stereoisomer, and methods of using that drug. Therefore, the issues for the court to decide were whether any of claims 9, 10 and 13 of the ’551 patent were invalid for obviousness-type double patenting, obviousness, anticipation, indefiniteness or improper reissue. The court found that the claims were not invalid.
Why UCB prevailed: The court rejected defendants’ obviousness-type double patenting argument because it found that the differences between the reference patent and the claims of the ’551 patent were not obvious. In considering the differences between the reference patent and the asserted claims, the court accepted, for the sake of argument, defendants’ argument that it must not consider whether a person or ordinary skill in the art (“POSA”) would change any of the functional groups in the reference patent’s genus that already matched functional groups in the claimed molecule. Accordingly, the court considered whether POSA, starting with a genus that it said encompasses millions of molecules, would have chosen the two specific groups that would convert the genus into lacosamide. The court identified two reasons why making those choices would not have been obvious. First, there were limited data as to the likely effects of making the choices, and this, in light of the unpredictable nature of drug development, made the choices non-obvious. Second, what data there were convinced the court that a POSA would not have chosen the two specific groups that would convert to lacosamide. Moreover, the court found that the record supported UCB’s contention that the asserted claims were not obvious. In particular, the court relied on evidence of skepticism, long-felt but unmet need, failure of others, unexpected results, praise and commercial success.
The court rejected defendants’ obviousness argument for two reasons. First, the court concluded that a POSA would not have made one of the required substitutions to its lead compound. This reasoning was the same as for the double-patenting rejection. Second, the court concluded that the lead compound defendants proffered was not a proper lead compound. Defendants’ lead compound was a functional amino acid (“FAA”). The evidence showed that (i) there were no FDA-approved molecules or even molecules having demonstrated clinical efficacy in the FAA class; and (ii) even assuming that a POSA would start with an FAA molecule, defendants picked a molecule having a bond that medicinal chemists of the time avoided because it was unstable.
Next, the court rejected defendants’ anticipation argument because the allegedly anticipatory reference did not disclose anything more than a racemic mixture containing the claimed R enantiomer, lacosamide. For a racemic mixture to anticipate an enantiomer, the court said, prior-art reference must disclose separating, identifying and characterizing the enantiomer.
The court then rejected defendants’ indefiniteness argument, finding that defendants had not offered clear and convincing evidence that the term “therapeutic composition” was indefinite. The court construed that term to mean “[a] composition suitable for use as a treatment regimen over an extended period of time (chronic administration)”, and was unpersuaded by defendants’ argument that a POSA would need “clear guidance” to distinguish chronic administration from non-chronic administration.
Finally, the court rejected defendants’ improper-reissue argument, concluding that patents may be reissued to correct or perfect a claim in priority, which is what the court found occurred here.
