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.
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.
Very few folks posted papers in December and January relating to FDA law, but hopefully the February law journal submission cycle will yield a rich crop. Here are two essays and one article of potential interest – one each on medical devices, biological products, and food. (I am excluding my own paper.)
Sarah Duranske, Reforming Regenerative Medicine Regulation
In this article forthcoming in the Georgia State Law Review, Duranske (currently a fellow at Stanford) (* edited to correct the spelling of her last name!) evaluates proposals for regulation of regenerative medicine. She has several interesting ideas tucked in here, any of which could have been the basis for an article in its own right. Section I contains a nice overview of the current regulatory paradigm for therapies that fall within the umbrella of “regenerative medicine” — including the recently enacted accelerated approval pathway for “regenerative medicine advanced therapies.” Section II responds to deregulation arguments, arguing that FDA regulation is necessary to protect patients and to ensure the development of meaningful data. Much of this retreads familiar ground, but the discussion of “Baptists and bootleggers” alliances with respect to regenerative medicine is very interesting. This phenomenon is pervasive in food and drug law and merits more discussion in scholarship. Section III is where the article gets interesting. Here, she considers proposals for “adaptive licensing” of regenerative products. The basic idea is that FDA would approve a product on the basis of less evidence, but would restrict access while the sponsor gathered more evidence from clinical use. She characterizes adaptive licensing as a type of adaptive management — a particular type of process that an agency might use to produce a regulatory outcome. She then assesses the suitability of regenerative medicine for adaptive licensing by running it through the various rationales in the administrative law literature for adaptive management at agencies. This leads her to the conclusion that the benefits of adaptive licensing do not outweigh its risks. Section IV contains a brief discussion of her proposals — for instance, shifting some regenerative therapies to the more loose regulatory paradigm governing human tissue and cell products. But I wanted to read much more about her ideas.
Jane R. Bambauer, Dr. Robot
In this essay published in the UC Davis Law Review, Professor Bambauer considers whether health and medical artificial intelligence (AI) should be regulated more like physicians or medical devices. When the application is a “knowledge” app rather than a “measurement” app, she argues, physicians are the better analogy. Some of the duties of a physician (such as the duty of competence and the duty of confidentiality) translate well, but she is more guarded about other rules (rules of informed consent, for instance, and the duty to disclose conflicts of interest).
Laurie Beyranevand, Regulating Inherently Subjective Food Labeling Claims
In this essay published in Environmental Law, Professor Beyranevand essentially argues that FDA should ban claims like “natural” and “healthy” in food labeling. The statute imposes clear rules governing specific types of claims, such as “health claims” and “nutrient content claims.” She is focused on claims that are not covered by these specific claims-authorizing provisions of the statute. And she argues that FDA should subject these claims to a standard of “significant scientific agreement” — that is, permitting them only if there is significant scientific agreement. The FDCA already uses this standard for health claims, which generally characterize a specific relationship between a food product and a health condition or disease. She also believes it would be virtually impossible to support a claim like “natural” and “healthy” under this standard. So, in essence, she is arguing for a ban. Finally, although the federal courts have concluded that the First Amendment requires FDA to consider disclaimers for health claims that lack significant scientific agreement, she contends that the First Amendment is no impediment to the proposal. I think the idea is that if a claim is inherently subjective, then a disclaimer isn’t going to clear things up (there’s x amount of data, but not y). It’s just going to confuse consumers more.
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”
Cross-posted on Stanford’s Law and the Biosciences Blog
In late November, FDA posted a statement on its website about the “self-administration of gene therapy”—which various media outlets interpreted as a reaction to some companies recently posting videos of consumers “self-experimenting” with gene therapy. One question that arose in some of the reporting—and in an exchange on twitter—is, what is FDA’s authority to regulate do-it-yourself (DIY) gene therapy?
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. . . .
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.
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?
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.