When an Unmet Need May Not Be Enough
In Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc. Appeal No. 21-1649, the Federal Circuit held that recent attempts by competitors to achieve patented technology, both before and after the patent’s publication, were 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 was embodied in their NARCAN® product. Teva’s accused infringing product was 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 it found 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.
Claim Limitation Not Disclosed by Any Reference but Disclosed by “Proposed Combination” of References Is Obvious
In Hoyt Augustus Fleming v. Cirrus Design Corporation, Appeal No. 21-1561, the Federal Circuit held that a claim is obvious where “the proposed combination of [the references]—rather than one of the individual references—discloses the disputed claim limitations.” A motion to amend under the Administrative Procedure Act may be denied where proposed amended claims lack written description support.
Cirrus petitioned for IPR of Fleming’s patent directed to an autopilot system that, upon receiving a parachute deployment request, positions an aircraft optimally for successful parachute deployment. During the proceeding, Mr. Fleming filed a motion to amend certain claims. The Board found the challenged claims obvious over 1) a Cirrus pilot operating handbook which disclosed that a pilot should (manually) put an aircraft in a certain optimal position before deploying the parachute, and 2) a patent relating to autopilot that initiates certain procedures in an emergency, including deploying a parachute. The Board also denied the motion to amend because the proposed claims lacked written description support. Fleming appealed.
The Federal Circuit affirmed. The Federal Circuit rejected Fleming’s argument that the Board improperly supplied a missing claim limitation. Rather, it held that even though neither prior art reference taught an autopilot that performs flight maneuvers to position the aircraft for effective parachute deployment, the claims were nonetheless obvious because one of ordinary skill would have been motivated to combine 1) manual pre-parachute-deployment flight maneuvers with 2) an autopilot system—to arrive at the claimed invention. The Federal Circuit also affirmed the denial of Fleming’s motion to amend because “Fleming pointed to no passage in the specification that supports the aircraft activation requirements of the proposed amended claims.”