Pediatric Exclusivity 101

Shortly before Alex Azar’s confirmation hearing (to be Secretary of HHS), a reporter called me with questions.  She had an angle she wanted to pursue: that Lilly had “gamed” a patent, using pediatric exclusivity, under Azar’s watch.  I explained pediatric exclusivity – what it was designed for, how it works, and how Lilly seemed to have used it precisely as designed. I mentioned the constraints that apply to company requests for pediatric exclusivity and told her that they were meaningful, mentioning Amgen’s ongoing litigation against FDA regarding exclusivity for Sensipar.

My explanation had little impact; the story ran as initially conceived.  Judge Moss ruled in the Sensipar dispute in late January, however, and Amgen has confirmed that it plans to appeal the ruling.  This is therefore the first of two posts on the issue of pediatric exclusivity.  Below I explain how pediatric exclusivity works; in the next post I will explain the Sensipar dispute.

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Food Additive Approvals — and Patents

I spend a lot of time thinking about the intersection of FDA regulation and intellectual property, and I have been constructing a large dataset relating to the patents claiming different types of FDA-regulated products.  Recently, I have also been thinking a great deal about the regulation of food (because Mizzou is now allowing me to teach Food Law & Policy, in addition to Drug & Device Law).  These two areas of interest intersected this past week, giving me some modest insights into premarket review of food additives and some very modest data to contribute to discussions about the (in?)efficiency of FDA’s food additive review process.

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You Can Dance if You Want To

On December 14, the Federal Circuit handed down the latest decision in the dispute between Sandoz and Amgen concerning the process for patent litigation under the Biologics Price Competition and Innovation Act amendments to the Public Health Service Act (PHSA). The matter was on remand from the Supreme Court. Judge Lourie, writing for a unanimous panel, concluded that Sandoz had not waived its argument that Amgen’s state law claims were preempted by federal law and, moreover, that those state law claims were indeed preempted.  A dive into the decision below, with apologies for the length. Continue reading “You Can Dance if You Want To”

Could FDA Enforce the “Requirement” to Provide the Biosimilar Marketing Application ?

I am writing again about the Supreme Court’s June 12 ruling that Amgen was not entitled to a federal injunction ordering Sandoz to share its biosimilar marketing application and manufacturing information.  The Court’s opinion refers ten times to providing those materials as “required” or a “requirement” (Slip Op. at 2, 4, 7, 9, 10, 13, 13, 14, 15, and 15).  What does this mean, as a practical matter?

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Origins of the Theory that the “Patent Dance” Might Not Be Required: Omission of Process Patents

I recently wrote a preliminary reaction to the Supreme Court’s Sandoz v. Amgen decision on Health Affairs Blog.  This was the Court’s first foray into the Biologics Price Competition and Innovation Act (BPCIA), which created a pathway for licensure of biosimilar biologics.  As my essay for Health Affairs notes, the issues presented by this litigation are not entirely resolved.  There is fodder for a great deal of further discussion.

Today I am starting with the Court’s ruling that Amgen was not entitled to a federal injunction ordering Sandoz to share its marketing application and manufacturing information with Amgen.  The topic here is the origin of the argument that Sandoz made to the Court — the omission of manufacturing process patents from the declaratory judgment provision.

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