Stand your Ground

On Nov. 30, 2020, the US District Court for the District of Delaware on remand upheld the validity of various patents of Tris Pharma relating to Quillivant XR® (methylphenidate HCl aqueous extended release oral suspension) and found Actavis’s product infringing.

Court found all the asserted patents/claims valid, and Actavis directly infringe, contributorily infringe, and induce the infringement of each of the asserted claims.

Quillivant XR® is approved for treatment of ADHD in people 6 years and older and is based on LiquiXR® technology which is protected by various patents by Tris Pharma.

Tris Pharma had asserted the five Orange book listed patents against Actavis in a Hatch-Waxman suit. Actavis, in turn challenged the validity of the asserted patents based on obviousness and obviousness-type double patenting. In the first instance the district court had found all the asserted claims to be invalid as obvious. Tris appealed. On appeal, the Federal Circuit found that the district court’s conclusions of law were based on inadequate fact-findings, and therefore vacated and remanded. And remanded it back to the district court for further fact-finding.

The asserted patents/claims related to methylphenidate aqueous extended release oral suspension & its pharmacokinetic & pharmacodynamic aspects. Prior arts cited did not disclose all the limitations of the claims. The question on remand was whether Actavis has demonstrated by clear and convincing evidence that an person of ordinary skill in art would have been motivated to achieve the combination of clinical effects in question and would have had a reasonable expectation of success in doing so.

Court not only found teaching away in the prior art but also found the combination of clinical effects is unexpected over the prior art. Court also felt that there is evidence of long-felt unmet need for a liquid methylphenidate formulation with the claimed clinical effects. The available liquid formulation in market at that time was an immediate release product with a short duration of effect.

The ruling prevents Actavis from launching generic versions of Quillivant XR® until the expiration of the patent portfolio until February 2031 and is a huge win for Tris.