ANDAs before Hatch-Waxman

Three times in the last two weeks, I have found myself explaining to someone that the Hatch-Waxman Amendments did not create the abbreviated new drug application for generic drugs.  For that matter, there were generic drugs long before 1984, and there was a generic industry long before 1984.  And that’s not even the most interesting part; at one point, FDA drafted a regulation for an ANDA pathway that would apply in the future to new NDAs and that would provide a 17-year exclusivity period.

This blog entry explains a little of the history.

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FDA Law SSRN Reading List (July 2017)

I plan to capture monthly the papers posted on SSRN that relate directly to FDA law (other than those written by me or Patti).  Here is the July 2017 edition.

Michael Carrier, Carl Minniti, and Brenna Sooy, Five Solutions to the REMS Patent Problem, forthcoming in Boston University Law Review.  There have been a number of articles exploring whether and to what extent innovators are somehow inappropriately benefiting from the access restrictions imposed by FDA under a “Risk Evaluation and Mitigation Strategy” (REMS).  Professor Carrier’s piece (co-authored with two students) makes a contribution by diving more deeply into one specific issue — the fact that several innovators with access restrictions hold patents claiming an aspect of the REMS.  Table 1 helpfully lists the 23 patents associated with REMS for five innovative products, which the authors found in the Orange Book.  The authors believe that a generic company seeking to copy a drug with a REMS protected by patent will be “stuck between the rock of FDA law and hard place of patent law” — essentially that the generic company will have no choice but to infringe.  They offer five solutions. First, they argue that REMS patents should not be listed in the Orange Book — which as a practical matter would mean that a generic applicant would not have to challenge it and (more importantly) that the patent could not give rise to an automatic 30-month stay of generic drug approval.  Second, they suggest that REMS patents may be invalid and urge use of inter partes review.  Third, they argue that in the event of infringement, an injunction should not issue.  Fourth, they propose amendments to the REMS provision of the FDCA that they believe will prevent REMS patents from blocking generic competition; the article helpfully includes the legislative language in question.  Finally, they propose that the patent act be amended so that risk management methods and systems are insufficient to differentiate a claimed invention from the prior art.  (Professor Carrier also posted slides that he presented at FDA’s recent hearing on the Hatch-Waxman Amendments; here, too, he offers proposals relating to REMS.)

Lindsey M. Edwards, The Need for Clarification on Product Hopping: Open Questions after Namenda and Doryx.  Ms. Edwards is a 2017 graduate of the Antonin Scalia Law School and will be joining Wilson Sonsini in the fall.  This brief piece published by the ABA Section of Antitrust Law summarizes two leading cases on “product hopping,” which she defines as making “an incremental change to the formulation of a drug in order to extend its exclusivity period.”  In very simple terms (mine, not hers), the allegation of “product hopping” arises when an innovator that has been marketing Brand 1.0 of its product introduces Brand 2.0.  Under the FDCA, a generic copy of Brand 1.0 can still be approved exactly when expected, but the concern arises when, for one reason or another, physicians and patients have switched to innovator’s Brand 2.0.  Generic drug companies generally rely on automatic substitution (under state pharmacy law) to achieve market penetration — meaning the automatic substitution of Generic 1.0 when a physician writes a prescription for Brand 1.0.  If physicians are now prescribing Brand 2.0, that won’t happen.  There can be variations and nuances to this basic fact pattern, and there are strongly held views on both sides of the question whether anything anti-competitive has happened.  Ms. Edwards describes two significant recent cases that came out differently in the courts of appeals (one involving Namenda and one involving Doryx), and she spends some time discussing what the courts analyzed differently (the importance of state substitution law to market penetration being one of them).

August will bring many more articles to read.

The Unapproved Drugs Conundrum

In recent years there have been a few high profile situations in which the price of a medicine has jumped sharply and suddenly, after decades of availability at a much lower price.  In some of these cases — like the case of gout treatment colchicine, which went from 10 cents to five dollars per pill in 2011 — the sudden price increase relates to FDA’s “unapproved drugs initiative.”  This refers to the agency’s approach to removing unapproved new drugs from the U.S. marketplace.

This blog entry explains the back story and the public policy conundrum that merits some attention.

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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?

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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.

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Supporting FDA Product Reviews with User Fees Alone

Cross Posted on Notice and Comment.

Budget documents released by the White House and FDA in May suggest the Administration intends to restructure medical product user fees, so that a greater percentage of the agency’s work is fully user fee funded.  The Secretary’s May 15 letter, explaining the President’s earlier Budget Blueprint, suggests the goal is for medical product user fee programs to be 100 percent user-fee supported.

Congress structures agency user fee provisions many different ways, and the current approach to medical product user fees is complex and unusual. Among other things, it ensures that annual appropriations play a role in supporting review activities. This means the Administration’s proposal would require revision of the bills currently winding their way through the legislative process.

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(FDA) User Fee Churn

Cross-posted on Notice & Comment

This post is one of several this summer that will focus on the pending FDA user fee reauthorization legislation.  It starts with a basic introduction: what is “user fee reauthorization,” and why must it pass?

The short version:  this summer we are talking about FDA’s medical product user fee legislation, which authorizes the agency to collect user fees from drug and device manufacturers.  The first medical product user fee law, in 1992, was the Prescription Drug User Fee Act (PDUFA).  The statutory provisions in question expire every five years, which means Congress must reenact them every five years if FDA is to continue collecting fees.  The process used to be called “PDUFA reauthorization,” but now user fees apply to more than prescription drugs.  This summer’s legislation relates to MDUFA (medical devices) and GDUFA (generic drugs), as well as BsUFA (biosimilars).  All must be renewed on the same five-year cycle, and the process is called “UFA reauthorization.”

Because the agency is now heavily dependent on these user fees, many view the reauthorization legislation as “must pass” — and that makes for an interesting legislative process.

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Demystifying Drug Importation after Impression v. Lexmark

(Cross-posted on PatentlyO.)

On May 30, the Supreme Court surprised many of us by ruling that exhaustion of U.S. patent rights occurs even when sale of the item takes place in a foreign country.  There is a great deal more to the ruling, and there are now very interesting questions about the characterization of transactions as something other than “sales” and about the use of contractual provisions to prevent resale into the United States following first sale of patented products elsewhere.  But for now, let’s stop with the bare bones description: U.S. patent rights are exhausted when an item is sold overseas.  This means that shipping an already-sold product into the United States for subsequent-sale to a U.S. consumer will not infringe the patents in question.  Depending on how patent owners structure their transactions overseas going forward, this ruling could give U.S. consumers access to products that are intended for foreign markets and that are priced for those markets — lower, for instance.

One of the many topics circulating now: what are the implications for pharmaceutical companies and for U.S. consumers of pharmaceuticals

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