Caraco Pharm. Labs. v. Novo Nordisk, No. 10-844 (U.S. 2011)
Last week, in response to the Supreme Court’s request for its views, the Solicitor General’s office filed an amicus brief in Caraco v. Novo Nordisk and urged the Court to take the case. At issue is the “patent delisting counterclaim” provision of the 2003 Medicare Modernization Act. The case is an appeal from a Federal Circuit decision last year holding that the provision is not available to compel a change to a patent use code in the Orange Book.
Patent use codes relate specifically to method-of-use patents. FDA regulations require an NDA holder submitting a method-of-use patent for Orange Book listing to also submit a patent use code for the patent. The purpose of the use code is to indicate “the approved indications or other conditions of use covered by [the] patent.” 21 C.F.R. 314.53(e).
When a company files an ANDA with a section viii statement, asserting that it does not seek approval of its drug for a patented use, FDA compares the ANDA applicant’s proposed drug labeling to the patent use code to determine whether the section viii statement is acceptable. If there is any overlap between the proposed labeling and the use code, FDA will reject the section viii statement and require the ANDA applicant to file a Paragraph IV certification instead.
In this case, Novo’s U.S. Patent No. 6,677,358 claimed a method for treating diabetes comprising administering repaglinide in combination with metformin and its use code for the ‘358 patent was “a method for improving glycemic control in adults with type 2 diabetes mellitus.” Caraco filed an ANDA for a generic version of PRANDIN (repaglinide) and included a section viii statement, asserting that it sought approval for repaglinide used alone—not in combination with metformin. In other words, Caraco sought to “carve out” the patented use from its labeling, thereby trying to avoid inducing infringement of the ‘358 patent.
Because Caraco’s proposed use overlapped with Novo’s use code, however, FDA rejected Caraco’s section viii statement, rejected Caraco’s carve-out labeling, required Caraco to file a Paragraph IV certification, and required Caraco to copy Novo’s PRANDIN labeling. It did not matter that Caraco’s proposed use did not overlap with Novo’s patent claim—the FDA only checks the use code. In the Paragraph IV litigation, Caraco filed a counterclaim seeking to compel Novo to revise the use code for the ‘358 patent to more narrowly tailor the use code to the method claimed in the ‘358 patent: administering repaglinide in combination with metformin. The district court sided with Caraco and ordered Novo to change the use code, but the Federal Circuit reversed. Caraco then appealed to the Supreme Court.
The Federal Circuit’s decision has caused a great deal of concern to the generic drug industry, as seen in the five amicus briefs filed in support of Caraco’s cert petition (and none opposed). Briefs in support were filed by Apotex; the Consumer Federation of America and U.S. PIRG; the Generic Pharmaceutical Association (GPhA); Mylan; and Teva. In March, the Supreme Court asked the Solicitor General’s office for its views on the case, which many in the generic pharmaceutical industry took as a positive sign. After the Solicitor General filed its brief last week, urging the Court to grant certiorari, the generic industry was even more encouraged, as reflected in GPhA’s press release.
According to the Solicitor General:
Under the Federal Circuit's decision, a brand-name manufacturer can effectively preclude generic competition by submitting an overbroad description of its method-of-use patent to FDA. Congress enacted the counterclaim provision at issue here to combat precisely that sort of manipulation. The court's ruling significantly impairs ANDA applicants' ability to secure FDA approval for their products, and hence deprives consumers the full benefit of generic competition.
Despite the complex regulatory background and policy arguments, this case presents a relatively straightforward question of statutory interpretation: does the term "patent information" in the counterclaim provision encompass patent use codes or not? By the end of June, the Supreme Court will announce whether it has decided to take up the case.
- SCOTUSblog, with links to all briefs