By Kurt R. Karst –
Back in July 2010 we took a look at the historical growth of so-called “Patent Use Codes” (“PUCs”), those numbers and narratives listed in an Orange Book Addendum corresponding to a listed method-of-use patent. This was long before the U.S. Supreme Court even considered – or was asked to consider – whether the counterclaim provision added by the Medicare Modernization Act (“MMA”) at FDC Act §505(j)(5)(C)(ii)(I) can be used to challenge a PUC descriptor listed in the Orange Book for a particular method-of-use patent covering a brand-name listed drug. Our analysis showed a doubling of PUCs since FDA’s June 2003 regulations went into effect requiring NDA sponsors (under 21 C.F.R. § 314.53(c)(2)(ii)(P)(3)) to supply the PUC descriptor language on Form FDA 3542. The post was apparently popular enough that it appeared in a few briefs (here, here, and here) submitted to the Supreme Court in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. In April 2012, the Supreme Court held in Caraco (see our previous post here) that a PUC qualifies as “patent information” submitted under FDC Act §§ 505(b) and (c) and may be the subject of a counterclaim to correct or delete patent information.
Use of the counterclaim provision at FDC Act §505(j)(5)(C)(ii)(I), as well as its parallel provision at FDC Act § 505(c)(3)(D)(ii)(I) applicable to 505(b)(2) application sponsors, has been pretty low in the almost ten years it has been around. In a previous post we provided a run-down of the cases in which we know one of the counterclaim provisions has been raised, either with respect to PUCs or to seek actual delisting of Orange Book-listed patents. We suspect that other counterclaims have been filed in Hatch-Waxman patent infringement litigation, but that they may be under seal or buried in dockets we have not yet explored. With an increasing number of Orange Book-listed PUCs, however, the probability that new counterclaims will be filed appears to increase.
With that in mind, we decided to take a look at the change (i.e., growth) in PUCs over the past three years and historically. And the growth has been quite significant: from a little more than 1,000 in 2010 to a little more than 1,400 today (with new PUCs being added weekly, and sometimes daily). The tables below show the year-by-year growth of PUCs since they were first added to the annual Orange Book in 1988 (Orange Book 8th Ed.).
The growth in PUCs mirrors an overall growth in Orange Book patent listings. Between 1998 and 2012, the number of patents submitted to FDA for Orange Book listing increased from 159 to 458. Meanwhile, the number of NDAs and supplements approved by FDA has apparently decreased. For example, according to numbers put out by FDA, the Agency approved 115 NDAs in 2000, but only 86 in 2012; FDA approved 99 NDA supplements in 2000, but only 62 NDA supplements in 2009 (see, e.g., here and here). This would appear to mean that a greater number of patents are beling listed for each brand-name listed drug.
The growth of 117 PUCs from 2012 to 2013 was a record-breaker, albeit just 13 PUCs greater than the previous year. The growth for the current period (2013-2014) is on pace to shatter that record. Of course, just because there is a growth in PUCs does not necessarily mean that counterclaims challenging those PUCs will grow. The devil is in the details; that is, how the PUCs are tailored (or not) to the approved method-of-use of a listed drug. But one thing is clear: if anyone thought the Supreme Court’s Caraco decision would put the brakes on the growth in PUCs, they were wrong.