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Recent patents relating to employing metabolomic data to diagnose disease states and determine the likelihood that a patient will respond to certain treatments.
Legal barriers are preventing generic drug makers from being able to utilize the Patent Trial and Appeal Board for its intended purpose — to serve as a faster and less cumbersome alternative to district court litigation.
The COVID-19 pandemic dispelled some myths underlying intellectual property policy and revealed how stakeholders can develop policies to accelerate development and ensure access using existing tools and experimenting with open science.
Manufacturers of brand-name nebulizer solutions have employed a variety of strategies to preserve market dominance over their products but have been less successful than manufacturers of brand-name inhalers in preventing generic competition.
Even if Amarin prevails in its patent infringement lawsuit, its key patents on Vascepa are likely to be ruled invalid in ongoing litigation, opening the way for generic formulations.
An analysis of decisions related to patent eligibility by the US Court of Appeals for the Federal Circuit indicates a way to avoid rejection or invalidation of eligibility.
Licensing provisions that obligate recipients of government funding to share relevant technology and know-how for scarce drugs during pandemics and epidemics can reduce shortages and overcome obstacles that intellectual property rights present.