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At 40 Years Old, the Orange Book Gets a Fresh Look as FDA Seeks Comments on Patent Listability

Back in June, the United States Food and Drug Administration (FDA), “as part of an Agency-wide effort to modernize the Orange Book,” published a request for comments relating to patent listing. Apparently prompting this request was FDA’s recognition that New Drug Application Sponsors have “submitted patents for listing in the Orange Book, including certain types … Continue Reading

New Treatments for COVID-19: Recent International Activity Relating to IP and Some Tools the US Already Has in Place

As potential COVID-19 treatments enter human trials, the question of pricing, access, and intellectual property has naturally entered the discussion. With numerous private entities working on a cure, the industry, governments, payers, healthcare groups, and other stakeholders are quickly pushing their respective (and, in most cases, expected) positions relating to the balance between IP rights … Continue Reading

February Issue of Bio Pharma Beat Now Available

Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from January 2020, including: The Federal Circuit holds that post-priority evidence can be used to show inherency in the obviousness context The Federal Circuit explains that enablement of an allegedly anticipatory … Continue Reading
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