Gleason IP provided expert testimony on behalf of Teva Pharmaceuticals to establish that the asserted patent claims allegedly covering Adapt Pharma’s opioid overdose drug were invalid due to obviousness, and that the marketplace performance of Narcan® was attributable to features already known in the prior art, among other extrinsic factors unrelated to the Patents-in-Suit.
In a Hatch-Waxman pharmaceutical patent infringement matter, Ivan Hofmann and the team at Gleason IP analyzed commercial success as a potential secondary consideration of non-obviousness on behalf of Teva Pharmaceuticals to assist the trier of fact in assessing the validity of the Patents-in-Suit that allegedly covered Narcan®.
Gleason IP analyzed and responded to the Plaintiffs’ claims that Narcan® was a marketplace success and that there was a nexus between such alleged success and the asserted claims of the Patents-in-Suit by focusing on non-patented features that drove the performance of Narcan®.
Gleason IP’s Role and Result
Gleason IP performed an analysis of the marketplace performance of Narcan® and determined that the marketplace performance of Narcan® failed to provide objective indicia of nonobviousness of the asserted claims of the Patents-in-Suit. Ivan Hofmann, Vice President and Managing Director at Gleason IP, testified at trial in the District Court of New Jersey before Judge Martinotti, offering testimony related to the marketplace performance of Narcan® and whether a nexus existed between the marketplace performance of Narcan® and the asserted claims, as well as an assessment of purported third-party praise.
Mr. Hofmann testified that the purported benefits of the asserted claims of the Patents-in-Suit were already known in the prior art, that the marketplace performance of Narcan® was attributable to extrinsic factors unrelated to the asserted claims of the Patents-in-Suit, and that evidence demonstrated that there was a lack of economic incentive for a Person of Ordinary Skill in the Art to develop a naloxone product that practiced the alleged patent claims.
Mr. Hofmann also addressed the Plaintiffs’ expert’s assertion of third-party praise for Narcan®, and argued that the alleged praise was simply information about features that were previously known and not novel to the asserted claims.
In June 2020, the District Court Opinion ruled in favor of Teva Pharmaceuticals and invalidated the asserted claims of the Patents-in-Suit due to obviousness. Specifically, the District Court found that no nexus existed between the purported secondary considerations of nonobviousness and the asserted claims of the Patents-in-Suit.
Judge Martinotti credited the testimony of Mr. Hofmann that the marketplace performance of Narcan® was attributable to features already known in the prior art, Adapt Pharma’s marketing strategies, and Adapt Pharma’s strategic pricing of Narcan®, rather than the alleged novel features of the Patents-in-Suit. In addition, the District Court found the Plaintiffs’ contention of substantial commercial incentive to develop the claimed invention to be “tenuous.”
The District Court found Mr. Hofmann to be a more credible witness than the Plaintiffs’ economic expert and technical expert on the issues, stating:
“Overall, the Court found Mr. Hofmann to be a highly credible and persuasive witness, and credited his testimony over that offered by Dr. Vigil and Dr. Majumdar.”
This was an exciting win for our client and Gleason IP was able to provide meaningful independent and objective expert analyses and opinions that contributed to our client’s success.
The case is ADAPT PHARMA OPERATIONS LIMITED, et al., v. TEVA PHARMACEUTICALS USA, INC., et al. C.A. No. 2:16-cv-7721 (BRM) (JAD)