Pharmaceutical Life Cycle Management: Navigating the New IP, FDA, and Antitrust Terrain

By BakerHostetler on February 24, 2016 Posted in Uncategorized

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory, and antitrust … Continue Reading

IP Provisions of the TPP May Not Satisfy the Pharmaceutical Industry

By Maurice Valla on November 30, 2015 Posted in Uncategorized

On October 5, 2015, agreement was reached on the text for the Trans-Pacific Partnership (TPP) trade agreement. The 12 signatories (United States, Canada, Mexico, Australia, New Zealand, Japan, Malaysia, Vietnam, Singapore, Brunei, Chile, and Peru) now have two years to ratify the agreement in order for it to take effect. The White House released the … Continue Reading

Never Fear Regulatory Violations – Focus on Conditions to Payment

By Robert M. Wolin on March 11, 2014 Posted in Uncategorized

The U.S. Court of Appeals for the Fourth Circuit recently upheld the dismissal of a False Claims Act (FCA) suit against Omnicare, Inc., in which the relator alleged that certain drugs repackaged by Omnicare’s subsidiary were adulterated and ineligible for Medicare or Medicaid reimbursement because of Food and Drug Administration (FDA) regulation violations and that … Continue Reading