Legal & IP
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Latest From Legal Issues
Roche plans to appeal against a penalty imposed by the Romanian competition authorities for implementing strategies that were said to delay the entry of competing biosimilar and generic products.
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.
A Washington Post article on price hikes for Abbvie’s Humira highlights patent ‘thickets’ and anti-biosimilar strategies. But the lack of understanding of the basic concepts of the biosimilar system are a much bigger warning sign about the viability of the pathway.
Government alleges Omnicare and its parent CVS Health filled thousands of invalid prescriptions to elderly and disabled individuals; suit follows nine settlements and two corporate integrity agreements since 2006.
FTC found Roche would not have incentive to delay or discontinue development of Spark's gene therapy for hemophilia A. Outcome shows deals can survive closer FTC scrutiny.
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