In 1984, Congress amended the Patent Act to permit a patent extension for certain types of inventions — many (but not all) of those subject to premarket testing and federal government approval requirements. Some people call this patent term extension; others call it patent term restoration. Between enactment of the statute in September 1984 and the end of March 2017, the Patent and Trademark Office received 1113 applications for patent term extensions in connection with new drugs and biological products. But by April 1, 2018, it had granted only 664 extensions. Why do companies not get patent term extension? Usually because this wasn’t FDA’s first approval of the active ingredient.
More after the jump.
Continue reading “Patent Term Restoration – Denied!”
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.
Continue reading “The Patent Dance: A Reasonable Response to the Specter of Reasonable Royalties”
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.
Continue reading “Biosimilar Patent Litigation: the “Finish What You Started” Rule”
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.
Continue reading “Food Additive Approvals — and Patents”
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”
Here are three more new and noteworthy articles from October and November, including Professor Robin Feldman’s new empirical study of the pharmaceutical industry.
Continue reading “FDA Law SSRN Reading List – October and November (Part 2 of 2)”
Here’s what to read on SSRN, relating to FDA law, from September 2017. One piece contributes to a growing literature on the relationship between inter partes review and Hatch-Waxman litigation, and one piece dives into application of intended use doctrine to synthetic nicotine products.
Continue reading “FDA Law SSRN Reading List (September 2017)”