PTO Revising Patent Challenge Proceedings Following Listening Tour
This article was originally published in The Rose Sheet
Proposed changes to Patent Trial and Appeal Board process could permit more patent claim amendments and broaden discovery.
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Emergence of the inter partes review process dramatically changed the patent dispute arena. The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.
A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.
An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.