Analysis Shows Patent Use Codes Have Doubled Since August 2003

July 8, 2010

By Kurt R. Karst

With all of the hubbub over Patent Use Codes (“PUCs”) since the U.S. Court of Appeals for the Federal Circuit issued its April 2010 decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. addressing whether the patent delisting counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I), as added by the Medicare Modernization Act,  may be used to correct or delete an Orange Book-listed PUC, we thought it would be interesting to analyze the growth of PUCs. 

In Novo Nordisk, the Federal Circuit, in a 2-1 decision, reversed and vacated a 2009 judgment and order and injunction requiring Novo Nordisk to change an Orange Book-listed PUC for a patent on its drug product, PRANDIN (repaglinide) Tablets.  The Court ruled that “the Hatch-Waxman Act authorizes a counterclaim only if the listed patent does not claim any approved methods of using the listed drug,” and that “the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use code narrative.” (See our previous posts here and here)  Caraco has filed a petition for panel rehearing and rehearing en banc.  Several amicus briefs have been filed in the case in support of Caraco’s rehearing petition, including briefs from GPhA, Mylan, Teva, Apotex, and the Consumers Federation of America.  Meanwhile, others have alleged that the PRANDIN use code change is anticompetitive and violates § 2 of the Sherman Act because it stalls generic competition (here, here, and here).

By way of background, PUCs are listed in an Orange Book Addendum with a number and a descriptor.  Those PUCs correspond with various patents with method-of-use claims listed in the Orange Book for a particular approved drug product.  Although FDA created PUC descriptors prior to August 18, 2003, when the Agency’s June 2003 regulations went into effect revising the Orange Book patent submission and listing requirements, with the new regulations, NDA sponsors are now required under 21 C.F.R. § 314.53(c)(2)(ii)(P)(3) to supply the PUC descriptor language on Form FDA 3542.  (FDA still assigns the PUC number.)

The first PUCs appearing in an annual edition of the Orange Book are from 1988 (Orange Book 8th Ed.); however, FDA began adding them to its monthly cumulative supplements beginning in 1987.  In the 1988 annual edition of the Orange Book, 25 PUCs were listed.  Over 16.5 years – from 1988 to August 2003 – FDA created 530 PUCs.  Over the next 7.5 years – from August 2003 to today – 532 new PUCs have been designed by NDA holders (for a grand total of 1062 PUCs from 1988 to today).  The tables below show the year-by-year growth of PUCs.

PUC Table

PUC Numbers

So what general conclusions can be gleaned from the doubling of PUCs in just 7.5 years (since August 2003)?  First, NDA holders, although free to use “old” PUCs (whether those created by FDA pre-August 2003 or those created by NDA sponsors post August 2003), appear to be favoring the creation of new PUCs.  Second, new PUCs offer NDA holders a greater ability to tailor the use code descriptor to the approved drug product. 

PUCs will certainly continue to be an interesting area of Hatch-Waxman litigation.  We will be keeping one eye on the Federal Circuit as it considers Caraco’s rehearing petition, and another on Congress to see whether it will take interest in the issue and further amend the Hatch-Waxman Amendments.

Categories: Hatch-Waxman