It’s always an exciting day when FDA issues the new annual edition of the Orange Book! (At least for me, and I’m sure also for Kurt Karst, over at FDA Law Blog.) There are a lot of changes in store at the Orange Book in the next year, all of which will get fanfare and attention, but this post is about the little changes in the annual edition (print and PDF) that don’t get called out. It’s prompted by the fact that FDA deleted a sentence in the preface last year, without telling anyone. (I had quoted it in an expert report, just a few months earlier and was annoyed to see it deleted.) I resolved that going forward I would electronically compare every new annual edition to the last year’s edition, and so I spent my Saturday doing exactly this with the new edition — and crashing my computer repeatedly. The results after the jump.Continue reading “Changes in the new Orange Book — or, too much time on my hands …”
Patent Term Restoration – Denied!
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!”
The Patent Dance: A Reasonable Response to the Specter of Reasonable Royalties
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”
Biosimilar Patent Litigation: the “Finish What You Started” Rule
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”
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.
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.
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?
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”