Recently I spoke at the annual meeting of the Food and Drug Law Institute (FDLI) on Eagle v. Azar, which is currently on appeal to the D.C. Circuit. At first blush the case seems of limited importance, because Eagle Pharmaceuticals is simply challenging FDA’s interpretation of statutory language that has since been amended. But reading through the litigation papers reveals a more interesting disagreement between the parties, about what a court should consider, when assessing whether a statute clearly answers a particular legal question. I will unpack this after the jump. Warning: this is more of an essay than a blog post. I start with a TL;DR.
Continue reading “Case To Watch: Eagle v. Azar’s Hidden Chevron-Step-1 Issue”Category: Innovation Policy
Changes in the new Orange Book — or, too much time on my hands …
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 Puzzling Uncertainty about Umbrella Exclusivity
In the middle of July, FDA announced a public hearing on facilitating competition and innovation in the biologics marketplace. Following the hearing, September 4, comments were accepted in the docket (FDA-2018-N-2689) until last Friday, September 21.
The agency’s Federal Register notice listed a series of questions, but one of them struck me — at the time — as surprising. FDA asked for comment on the “potential application” of “umbrella exclusivity” for biologics. Why surprising? Because I would not have thought it controversial. More than five dozen comments have been filed, though, and at least one company (Mylan) has argued that the statute doesn’t permit the umbrella.
So it seems like it might be timely to back up and explain this.
Continue reading “The Puzzling Uncertainty about Umbrella Exclusivity”
Pediatric Exclusivity (3 of 3): Amgen v. Hargan
My last entry described the facts leading to Amgen’s suit against FDA over denial of pediatric exclusivity for Sensipar. Below I describe what’s at issue in the case. At bottom, this litigation relates to a federal agency developing a new standard (a new interpretation of its statute) that it will apply when ruling on applications for a benefit, after its prior interpretation suffered a defeat in federal court. Rather than announcing the standard publicly, the plaintiff in this case argues, the agency applied the standard in non-public rulings for more than a decade. Not only does the standard conflict with the statute, plaintiff adds, but the agency has not been consistent in its application of the standard. Thus the dispute is more about how a federal agency is operating than it is about the law of pediatric exclusivity.
Continue reading “Pediatric Exclusivity (3 of 3): Amgen v. Hargan”
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.
Hatch-Waxman Comments – Status Report (Part II)
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.”
Continue reading “Hatch-Waxman Comments – Status Report (Part II)”
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)”
Data Exclusivity for Medical Devices
Data exclusivity for drugs and biological products gets all the attention. (In fact, recently I read a law review article asserting that medical devices are not entitled to any sort of exclusivity period after approval. But this is wrong!) It is apparently not as well known, but sponsors of premarket approval applications (PMAs) enjoy six years of data exclusivity. Folks interested in FDA and innovation policy should know about the device scheme because it has a unique history (with a novel and clever – though unworkable – approach in place for seven years) and because at a high level it is still analogous to drug and biologic exclusivity even though the regulatory paradigms are different.