In a pharmaceutical patent infringement matter, Ivan Hofmann and the team at Gleason IP analyzed various issues and provided expert opinions and testimony concerning objective indicia of nonobviousness related to a patent that allegedly covered a lyophilized formulation of the injectable cancer drug bortezomib (marketed as Velcade®). Specifically, Gleason IP analyzed commercial success as a secondary consideration of nonobviousness on behalf of a joint defense group of numerous defendants to assist the trier of fact in assessing the validity of the formulation patent at issue that allegedly covered Velcade®.
Gleason IP analyzed and responded to the plaintiff’s claims that Velcade® was a commercial success and that there was nexus between such alleged success and the patent claims by focusing on a blocking patent and non-patented features that drove the performance of Velcade®.
The plaintiff claimed that Velcade® was a commercial success due to the product’s sales levels and sales growth, formulary acceptance, pricing, and prescribing behavior. The plaintiff further argued that a nexus exists between the performance of Velcade® and the asserted claims of the patent at issue.
Gleason IP’s Role and Result
Gleason IP performed an analysis of Velcade® and determined that the performance of Velcade® failed to provide objective indicia of nonobviousness because no other company had the economic incentive or ability to commercialize a bortezomib product as a result of a compound patent (not at issue in this litigation) that covered the active ingredient bortezomib. This blocking patent provided an economic disincentive for others to research and develop a bortezomib formulation, since those companies would not be able to launch a product until the blocking patent expires in 2017. In addition, Gleason IP found that the underlying bortezomib compound drove the performance of Velcade®, rather than any purported attributes of the patent at issue. Gleason IP also worked in conjunction with technical experts to analyze evidence regarding potential alternative bortezomib formulations that would provide characteristics similar to the current formulation. Ivan Hofmann testified in the District of Delaware before Judge Sleet at trial in November 2014 regarding the analysis and opinions.
In August 2015, the District Court found in favor of the defendants and invalidated the asserted claims of the patent at issue due to obviousness. The District Court opinion specifically discusses our argument that the blocking patent “precluded alternative inventions from competing in the market…[and that] No persuasive evidence was provided to show any advantage attributable to the claimed formulation over the other potential formulations available to [the plaintiffs].” This was an exciting win for our clients, and Gleason IP was able to provide meaningful independent expert analyses and opinions that contributed to our clients’ success.
The case is Millenium Pharmaceuticals, Inc. v. Sandoz, Inc. et. al. (12cv1011-GMS)