When an Unmet Need May Not Be Enough

ADAPT PHARMA OPERATIONS LTD. V. TEVA PHARMS. USA, INC.

Before Newman, Prost, and Stoll. Appeal from the United States District Court for the District of New Jersey.

Summary: Recent attempts by competitors to achieve patented technology, both before and after patent’s publication, not strong enough objective indicia of nonobviousness.

Adapt sued Teva for infringing their patents related to intranasal naloxone treatment for opioid overdoses. Adapt’s patented technology is embodied in their NARCAN® product. Teva’s accused infringing product is a generic version of NARCAN®.

The district court first found the patents invalid as obvious in view of two different prior art combinations. The district court then determined that the objective indicia evidence did not overcome the obviousness determination. Adapt appealed to the Federal Circuit, arguing that the district court’s consideration of the objective indicia evidence only after making an obviousness determination was legal error. Adapt further argued that the district court erred in weighing the objective indicia evidence.

The Federal Circuit affirmed. The Federal Circuit held that there is no error in considering objective indicia evidence following a prima facie obviousness conclusion. District courts are required only to “consider all evidence relating to obviousness before finding a patent invalid.” In re Cyclobenzaprine, 676 F.3d 1063, 1075 (Fed. Cir. 2012). This requirement does not preclude considering objective indicia evidence as a second step in analyzing obviousness, so long as the consideration is not an afterthought.

Most interestingly, the Federal Circuit held that the district court harmlessly erred in concluding that the asserted patents did not fill a long felt but unmet need for a needle-free and easy to use naloxone treatment. While still holding the long felt but unmet need evidence probative, the Federal Circuit nevertheless found the evidence not strong enough to overcome a finding of obviousness. First, the Federal Circuit held that the need was not “long felt.” Although NARCAN® solved many issues of its predecessor technology, such issues only existed three years before the asserted patents’ priority date. Also, the fact that competitors’ similar products could not achieve FDA approval was not strong evidence that the need was “unmet.” Although those products had trouble achieving FDA approval, there was also evidence that the products still fulfilled the need and were approved in other countries. As such, the Federal Circuit found the district court’s error harmless.

Editor: Paul Stewart

Written by: Matthew Pham & Nicole R. Townes