In a turn of events that underscores the intricate complexities of patent law, a patentee’s own clinical trial has led to the rendering of several patent claims as unpatentable, due to the trial being classified as “prior art”. This development comes as part of a final written decision in an inter partes review proceeding.
The Patent Trial and Appeal Board (PTAB) found that all 12 claims of the challenged patent were unpatentable. The grounds for this ruling fell under the classifications of either being anticipated or obvious. It’s particularly notable that each instance of unpatentability relied, in whole or in part, on the Patent Owner’s own prior art. In this case, ‘prior art’ specifically refers to the results of clinical trials that the Patent Owner had previously conducted and published at ClinicalTrials.gov.
Legal professionals, particularly those specialising in intellectual property law, would do well to consider this case as a significant reminder of the importance of meticulously managing every stage of the patenting process. This includes not only the crafting of patent applications, but also the documentation and management of any associated research or trials.
This cautionary tale is a useful reminder that while it may be considered prudent to publish the results of a clinical trial, it needs to done in a careful manner, as potential conflicts with patent applications can arise, especially if such results are published before a related patent application is suitably formulated or filed.
Based on this turn of events, law professionals are advised to thoroughly scrutinise not just the text of patent applications, but also any associated pretense of the application, specifically if it involves sharing or publishing research data ahead of time.
The details of this case and the final written decision of the PTAB can be found here.