Tag: biosimilars

The Patent Dance: A Reasonable Response to the Specter of Reasonable Royalties

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Based on the dispute between Celltrion and Genentech over Celltrion’s biosimilar version of Rituxan (rituximab), it should be clear that interpretive disputes relating to the patent dance in the 2010 biosimilar law are far from over.  The patent dance is indeed the gift that keeps on giving.  And some of the interpretive conundrums lead to ridiculous results, at least, if you’re at all interested in saving litigants money.  Look at what Genentech recently found itself doing.

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Biosimilar Patent Litigation: the “Finish What You Started” Rule

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As earlier posts on this blog have noted (here and here), the Supreme Court’s 2017 ruling in Sandoz v. Amgen effectively put an end to arguments that biosimilar applicants can be forced to participate in the “patent dance” with biologics innovators.  Even still, there are lots of interesting issues relating to the patent litigation provisions of the 2010 biosimilars law.  Here’s one percolating in the courts right now:  can a biosimilar company start to dance and then change its mind?  Or does it have to finish what it started?

This arises in a dispute between Genentech and Celltrion over a biosimilar copy of Rituxan (rituximab).  There’s a second issue in this dispute, which I will describe in another blog post.  First some background, and then I’ll unpack the litigation.

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You Can Dance if You Want To

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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” →

Thoughts on “Reciprocal Marketing Approval”

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On October 26, Senator Cruz introduced the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2017” (S. 2022), which is interesting from an FDA law perspective as well as an administrative law perspective.  We have seen this proposal before — in 2015 (S. 2388, introduced by Senator Cruz) and in 2016 (H.R. 6241, introduced by Congressman DeSantis).  Rachel Sachs wrote about it from a policy perspective in December 2015, and Zach Brennan offered more details in his own piece the same month.  I am going to dig into the details a bit more than they did and explain why I call it the “Send All the FDA Employees Home Act of 2017.”

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Hatch-Waxman Comments – Status Report (Part II)

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Last week I summarized some of the recommendations for FDA in the first 67 comments to the Hatch-Waxman docket that opened in July.  Today’s entry discusses the recommendations that relate to use and distribution restrictions, citizen petitions, and what some call “product hopping.”

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Hatch-Waxman Comments – Status Report (Part I)

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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.

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