Archive for the ‘Follow-On Biologics’ Category

“Obamacare” Survives – Including Path to Generic Biologicals

Thursday, June 28th, 2012

Biotech patent attorneys rejoice – no matter if you represent generic companies or NDA holders,  the 5-4 decision of the Supreme Court upholding the “individual mandate” – not under the commerce clause, but as an appropriate use of Congress’ power to tax – means that all the CLE charges you incurred to attend seminars on the future of generic biologics was not wasted. (A copy of the decision and dissents is available at the end of this post.) If the “Patient Protection and Affordable Care Act” had been voided in its entirety, the path to generic biologics that was included in the Act in some detail would have vanished (Title IV, subtitle A).  I summarized the features of the Act in my post of March 26, 2010 and posted an alert on March 29, 2012.

I am not versed enough in regulatory law to opine on how, or if, the FDA would have continued to promulgate regulations and hold hearings on this touchy subject, but given that bureaucracies seldom opt for more work without direction from Congress, my guess is that the current process would have simply gone into limbo. I welcome your opinions on the way forward, but amidst the furious debate about whether the Act would waste or save the taxpayers’ dollars, it cannot be denied that generic versions of older biologicals would save patients a lot of money.

Legal Challenge To “ObamaCare” Threatens Generic Biologicals

Thursday, March 29th, 2012

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.


Regulatory Framework For Follow-On Biologics In Health Care Bill

Friday, March 26th, 2010

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