What should not be lost on pharma/biotech patent attorneys or their clients, amidst all the attention given to the Supreme Court’s review of the “Patient Protection and Affordable Health Care Act” – public law 111-48, is that it contains the entirety of the legal and regulatory approval process for “biosimilars” or generic biological products. As I wrote here on March 26, 2010, Title IV of the law is “Improving Access to Innovative Medicial Therapies” – Subtitle A and is referred to as the “Biologics Price Competition and Innovation Act of 2009.” It can be most easily be followed by printing (roughly) pages 1827-1869 of the PDF of H.R. 3590. The Act amends section 351 of 42 USC 262 and 35 USC 271(e). In my March 26th post I reviewed many of its Hatch-Waxman-like features.
Since enactment, there have been many seminars, workshops and symposia about how best to implement these procedures at the FDA/USPTO, and the FDA has finally begun to work with the stakeholders to provide a regulatory pathway for generic biologicals. Without such a pathway –as currently – a generic biological has to endure the same NDA route to approval as any other new drug. Questions of what degree of “biosimilarity” should be required and what the market exclusivity period should be for the first generic biological to be approved have been hotly debated.
The media seems to have been predicting that the Court will invalidate the entire act if it chooses to invalidate the section requiring the universal purchase of health insurance (or payment of a tax penalty) as an unconstitutional extension of the ability of Congress to regulate interstate commerce. (Remember, Congress passed this law – this was not an agency or executive branch order). But the great leap forward that the act took regarding creating a pathway for follow-on biologicals is well-worth saving – at least so we don’t have to trash all those PowerPoint presentations trying to interpret and apply the law.