Analysis Group Clients Prevail in PTAB Rulings Involving Patent Challenges to NSAID Drug Prolensa

August 23, 2016

The U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) recently ruled that patents held by Analysis Group clients Bausch + Lomb, Inc., and Senju Pharmaceutical Co., Ltd., were valid. Three generic drugmakers had challenged the validity of patents on the drug Prolensa, a non-steroidal anti-inflammatory drug (NSAID) used to treat inflammation and pain associated with cataract surgery, on obviousness grounds. Managing Principal John Jarosz and Manager F. Michael Nolan led an Analysis Group team that examined issues related to the commercial success of Prolensa on behalf of Bausch + Lomb and Senju. The analysis included an examination of Prolensa's absolute and relative marketplace success as well as the nexus between that success and the claims of the two challenged patents. 

Since the creation of the PTAB in 2012, which established new processes for post-grant and inter partes patent reviews, many U.S. patents have been invalidated. Patent owners have had particular difficulty demonstrating commercial success, which requires an assessment of the marketplace success of the patent-practicing product and a showing of a sufficient causal nexus between the marketplace success of the patented product and the claimed advantages of the patent. These PTAB rulings, which credited Mr. Jarosz's expert testimony and analysis as evidence of commercial success, found that Prolensa has enjoyed substantial commercial success and that petitioners had not shown that the patents are invalid as obvious.