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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.
Additional changes could make the registries of drug patents published by the FDA, called the Orange and Purple Books, more useful and reduce barriers to effective competition from generic and biosimilar drugs.
As pharmaceutical companies seek patent protection for combinations of cancer therapeutics, it is worthwhile to assess what constitutes an ‘unexpected result’ for the purpose of an appropriate patent and whether randomized, controlled trials of drug combinations have the ability to generate them.