Tris Pharma, Inc. v. Teva Pharms. USA, Inc.,

QuilliChew ER® (methylphenidate)

August 16, 2022

GENERICally Speaking

Case Name: Tris Pharma, Inc. v. Teva Pharms. USA, Inc., Civ. No. 20-5212 (KM)(ESK) (D.N.J. Aug. 16, 2022) (McNulty, J.) 

Drug Product and Patent(s)-in-Suit: QuilliChew ER® (methylphenidate); U.S. Patents Nos. 9,545,399 (“the ’399 patent”), 9,844,544 (“the ’544 patent”), 9,844,545 (“the ’545 patent”), 11,103,494 (“the ’494 patent”), and 11,103,495 (“the ’495 patent”)

Nature of the Case and Issue(s) Presented: QuilliChew is a chewable extended-release product indicated for the treatment of ADHD. Prior to QuilliChew, there were extended-release pill formulations and chewable immediate release formulations, but there were no chewable extended-release formulations. Tris sued Teva alleging infringement of the patents-in-suit. In response, Teva raised obviousness and indefiniteness defenses. The court conducted a four-day bench trial and found all asserted claims infringed and rejected Teva’s defenses.

Why Tris Prevailed: Teva acknowledged that a chewable extended-release formulation was not disclosed in a single prior art reference, but nevertheless argued that the claims were obvious because multiple prior art references disclosed chewable extended-release products. But the court concluded that collectively the art taught that extended-release formulations could not be chewed or crushed while maintaining their effectiveness, and in many cases taught that they should not be chewed. The court also found that long felt need and industry praise supported a finding of non-obviousness. And while the court found that certain PK limitations would have been obvious, each dependent claim reciting such a limitation depended from an independent claim reciting a chewable extended-release product. As a result, no claims were invalid as obvious.

Next, Teva relies on indefiniteness arguments because the claims used the language “essentially the same.” Teva argued that this was a term of degree without objective boundaries because a POSA would not understand if the drug’s PK profile was essentially the same as Figure 1. The court disagreed, explaining that a POSA would know how to conduct a visual comparison, examining AUC, Tmax, Cmax, and a single-mean profile.

On infringement, Teva argued that it did not infringe the claim limitation requiring a therapeutic effect that lasts longer than 10.8 hours. The court explained that this limitation was infringed because the label noted only a 20.6% chance that the difference between the QuilliChew and control group’s scores were the result of random variation and thus a reciprocal 79.4% chance that the differences were the result of QuilliChew’s therapeutic effect. Because this metric was greater than 50%, Tris satisfied its burden to prove infringement.

Teva next argued that it could not infringe the limitations reciting 18% to 55% w/w for the barrier coating. Teva’s product had a barrier coating of 17% w/w. In particular, Teva argued that the disclosure-dedication rule precluded application of the doctrine of equivalents because the specification included various coating ranges, including between 10% and 70% w/w. But the court found that the broader range in the specification was not a mutually exclusive alternative to the claimed range, and thus the disclosure-dedication rule was not applicable.

Teva next argued that it did not infringe claims reciting a single mean plasma concentration peak between about 4 hours to about 5.25 hours under fasted conditions. Teva argued that it could not infringe because its ANDA product reaches its maximum concentration before the claimed range. The court explained, however, that the relevant inquiry was not the location of Tmax, but where the peak was located. Because 51% of the length of Teva ANDA product’s range occurred within the claimed range, it was found to infringe.

Finally, the court found that Teva’s ANDA product infringed the Figure 1 claims because the proposed label included Figure 1. Specifically, the only difference between Teva’s ANDA product and Tris’s label was a statement that the Figure 1 graph depicts, not QuilliChew, but methylphenidate hydrochloride extended-release chewable tablets.

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