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On March 23, 2010, President Obama signed the "Patient Protection and Affordable Care Act." The Act provides a regulatory scheme for the approval of biosimilar versions of branded biologic drugs ("biosimilars") and dictates how patent litigation on biosimilars is carried out. Rules and regulations governing the Act will later need to be promulgated and codified in the Federal Register. There also remains the possibility that Congress could amend the biosimilar provisions if the Senate makes any changes to the pending Amendments to the Act that currently do not relate to biosimilar provisions. Here is an overview of key biosimilar provisions in the Act:
One year after first commercial marketing of first interchangeable biological product;
18 months after a final court decision of all patents in suit or dismissal with or without prejudice on litigation over the first interchangeable biological product;
42 months after approval if there is still ongoing patent litigation on the first interchangeable biological product; or
18 months after approval, if no patent litigation had been instituted against the first interchangeable biological product.
Companies will want to closely examine the biosimilar provisions in the Act to determine the impact on their business plans and development of biologics. For example, companies should assess how to maximize what IP rights survive the 12 years of exclusivity. Also to prepare for litigation, companies should compose lists of relevant patents and assess whether any license agreements affecting their biosimilar products need to be amended.
We look forward to discussing how this bill impacts your business. We are also available to tailor a CLE program to help your company understand this new Act. Please contact Shannon Mrksich, the chair of Brinks Hofer Gilson & Lione's Biotechnology & Pharmaceutical Group, at 312-321-4283 or firstname.lastname@example.org.
This Client Alert is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. This client alert was prepared by Eric Baude, Ph.D. and Rashad Morgan. Brinks Hofer Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention.