Pharmaceutical innovators are voicing concern over public disclosures of human clinical trials being used as prior art to invalidate patents, potentially hindering investment in pharmaceutical innovation.
In the case of Salix Pharms., Ltd. v. Norwich Pharms. Inc., a district court invalidated pharmaceutical method of treatment claims for obviousness based on a clinical study protocol disclosed on ClinicalTrials.gov, showcasing the impact of public disclosures on patent validity.
The Salix case involved patents related to rifaximin, including those for treating irritable bowel syndrome with diarrhea. The district court found the patents obvious based on a clinical trial protocol and a journal article, raising concerns among pharmaceutical companies.
#human-clinical-trials #pharmaceutical-patents #innovation #patent-invalidation #pharmaceutical-industry
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