Federal Circuit Tosses Diagnostic Patent, Spurring Biopharma Calls For Congressional Action
A divided panel finds Athena Diagnostics' patent on method to diagnose myasthenia gravis is invalid; in dissent, Judge Newman cites industry concerns that the decision will deter development of new diagnostic methods.
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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.
Industry now needs to wait for a more appealing appeal or a revived legislative effort after the high court declines review of Athena Diagnostics v. Mayo Collaborative Services, which created a sharp divide in the Federal Circuit, and Hikma v. Vanda; biopharma and others contend eligibility issue is biggest problem in patent system.
Witnesses at US Senate hearings debate bill's impact on drug pricing; discuss limiting it to medical diagnostics.