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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Decade In Review: Biopharma's Shifting Legal Landscape
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.
Supreme Court Takes Pass on Clarifying Patent Eligibility, Disappointing BioPharma
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.
Patent Eligibility Bill May Carve Out Patenting Of Research
Witnesses at US Senate hearings debate bill's impact on drug pricing; discuss limiting it to medical diagnostics.