Hatch-Waxman Comments – Status Report (Part I)

What are people recommending that FDA do, to improve the current balance between drug innovation and access to generic drugs?  The docket isn’t closed yet, but I’ve read the first 67 comments. . . .

Background

FDA held a public meeting in July to consider the Hatch-Waxman Amendments, asking for comment concerning its administration of the amendments “to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”  It also opened a docket for written comments, which was originally slated to close on September 18.  On September 19, it extended the date for submission of comments to November 17.   What follows is a high level overview of some of the main recommendations for FDA in the first 67 comments.

Continue reading “Hatch-Waxman Comments – Status Report (Part I)”

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?

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

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.

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