An opinion was issued on Thursday from the United States Court of Appeals for the Federal Circuit. The appellants, Adapt Pharma, Inc. and related companies, are litigating against Teva Pharmaceuticals USA, Inc. over patents held by the plaintiffs regarding the intra-nasal administration of Naloxone for opioid overdose.
Naloxone is a vital treatment of opioid overdoses and can prevent deaths. Prior to the patents at issue in this suit, Nalaxone was delivered intramuscularly using an injection, or intra-nasally using a Mucosal Atomization Device (MAD) kit, the complaint said. The downside of these methods is that an injection requires a trained medical professional, which could require longer time before application of the treatment, while a MAD kit would frequently require assembly and could apply too much medication, which could also affect treatment. The patents at issue in the original suit were for a pre-fabricated device specific to Naloxone which applied the correct amount intra-nasally and which did not require special education to use.
The trial court found that while a useful application device, the patents regarding the creation and application method of the specialized device were not novel and could be easily foreseen from the limitations of the prior devices and from literature within that time period.
The trial court cancelled the patents for obviousness and the plaintiffs appealed to the Federal Circuit. The appeals court concurred with the lower court and defendants and did not find sufficient basis in support of Adapt’s assertions that the prior art taught away from the solution used by the plaintiffs for the intra-nasal application.
A dissent concurring with the appellant-plaintiffs and stating that the biological complications that required the solution Adapt used are specific enough to overcome the non-obviousness factor.
Adapt is represented by Hogan Lovells and Williams & Connolly. Teva is represented by Walsh Pizzi O’Reilly Falanga and Sterne Kessler Goldstein & Fox.
