a member in the Intellectual Property Department of Dinsmore & Shohl LLP. She represents clients ranging from small businesses to Fortune 500 companies. She has experience in all aspects of patent law and related business matters in the U.S. and around the world. She began her career in the labs of biotech and pharmaceutical companies. Her technical knowledge encompasses chemistry, pharmaceuticals, biotechnology, medical device, agrochemical and oil/gas industries. For more information, and to contact Aubrey, please visit her firm profile page.
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. State law claims are preempted by the BPCIA on both field and conflict grounds, which means only remedy available against biosimilar applicants refusing to engage in the patent dance is filing for a declaration of infringement, validity, or enforceability of a patent that claims the biological product or its use. Notably, this must be done before receiving manufacturing information from the biosimilar company. Patent lawsuits are notoriously costly so, in the short term, the decision will have the greatest impact on innovator start-ups with limited financial resources. In the long term, relying on costly litigations to keep biosimilar drugs off the market will likely increase the consumer price for any biologic drug.