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.