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Regulatory Framework For Follow-On Biologics In Health Care Bill

In the early evening of March 25, 2010, the House voted, finalizing the budget reconciliation package earlier passed by the Senate, that contained some relatively minor amendments to the version of the Senate Bill that the House passed in the historic (and tense) vote on Sunday night, and President Obama signed on Wednesday. Unremarked upon by most of the press is that this bill, HR. 3590, public law 111-48 contains the entirety of the legal and regulatory approval process for “biosimilars” or generic biological products. This is Title VII, “Improving Access to Innovative Medical Therapies – Subtitle A,” and is to be referred to as the “Biologics Price Competition and Innovation Act of 2009”. It can be most easily accessed by printing (roughly) pages 1827-1869 of the PDF of H.R. 3590 as it can be found at with a little searching. (A copy of the PDF is attached at the end of this post.) The Act amends section 351 of 42 U.S.C. 262 and 35 U.S.C. 271(e). I have read some short blog posts that say that this is nothing like the Hatch-Waxman procedures currently in place for “small molecules”. To the contrary, it is a lot like the Hatch-Waxman procedures, but without the Orange Book (although one may eventually be needed to keep track of approved drugs). Most writers have noted that innovators (who are called “reference product sponsors” — “RPS”) get 12 years of exclusivity from approval (and there is a four year wait before a “subsection (k) applicant” can even file an application for a biosimilar). Additional six month extensions are available for pediatric use approval and for approval for rare diseases. The biosimilar in fact does not have to be chemically identical to the reference biological, but it must be “highly similar” and there must be no “clinically meaningful differences in terms of the safety, purity and potency” of the biosimilar and that it must be “expected to produce the same clinical result.” The FDA is assigned the task of fleshing out these requirements, which can be established by analytic, animal and /or human studies, as determined by the agency. The first approved biosimilar gets market exclusivity that seems modeled after Hatch-Waxman exclusivity: 18 months after final decision of Fed. Cir. – not district court, if first (k) applicant is sued, or from dismissal of suit and up to 42 months of exclusivity from approval if litigation continues. First (k) applicant gets 18 months of exclusivity from approval if there is no suit by the RPS. Instead of the Hatch-Waxman certification, para. IV notification, suit or no suit scheme, the Biologics Price Competition Act contains a complex, short deadline system wherein the FDA notifies the RDS that an ss. (k) application for a biosimilar has been filed, the RDS then must supply the (k) applicant with a list of patents that it believes will be infringed and/or an offer to license. The applicant then provides an answer that sounds a lot like a PIV notification letter. Within 60 days the RDS provides its response, which is a detailed opinion as to why the applicant infringes. Then the Act contains a requirement that the parties negotiate a settlement in good faith, after which there is another exchange of patent lists. Then and only then can the suit commence. This is only a general summary of small parts of the 46 page Act and I am sure that the most affected organizations will soon be announcing conferences to explain these provisions, so I will quit for now and rest my eyes. This is a full employment act for biotech patent attorneys with opinion experience, so it may be time for us to get that spring break in now. HR 3590 12_24_09


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