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Latest From Legal Issues

Roche Fined For Anticompetitive Behavior In Romania

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. 

Romania Government Payers

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.

Legal Issues Biosimilars

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.

Legal Issues Intellectual Property

The Failure Of Biosimilars In The US: ‘Headline’ News

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.

Biosimilars Pricing Debate

After Decade Of Settlements And CIAs, Omnicare Faces Another DOJ Complaint

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.

Enforcement Government Payers

Roche/Spark Acquisition: First Gene Therapy Deal Clears FTC With No Divestiture

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.

M & A Gene Therapy
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