While the unanimous Supreme Court’s decision (see our previous blog post here) made it clear that “Caraco may bring a counterclaim seeking to ‘correct’ Novo’s use code ‘on the ground that’ the [method of use] patent ‘does not claim an approved method of using the drug,'” Justice Sonia Maria Sotomayor’s concurrence indicates that the Court has neither answered all the questions nor fixed all the problems associated with the counterclaim provisions. She initially noted “the counterclaim can only lessen the difficulties created by an overly broad use code; it cannot fix them.” The concurrence summarized how a generic manufacturer now will be able to challenge an overbroad use code: “submit an ANDA with a paragraph IV certification . . . wait for the brand [to sue], file a counterclaim, litigate the counterclaim, and, if successful [in obtaining a corrected use code] . . . file an ANDA with a section viii statement.”
Sotomayor, however, identified two problems with this process. First, the process introduces a delay and litigation expense that the statutory scheme does not envision when the generic applicant deliberately carves out uses protected by a patent and files a section viii statement. Second, there is no guarantee that it would be in the interest of a brand company to instigate a lawsuit against the generic applicant that files a Paragraph IV certification when a section viii statement is initially not available for an overly broad use code that overlaps with an indication for the listed method of use patent. In this case, the generic applicant may obtain approval for the broader use(s) and then be at risk for a claim of induced infringement for selling a product with a label “that suggests that the product be used for a patented method of use.”
Sotomayor concluded by criticizing FDA’s minimal guidance on this issue. She highlighted how “remarkably opaque” FDA’s guidance on what is required of a brand manufacturer when submitting use codes and even noted that “FDA’s opacity” was part of the reason this case came to the Supreme Court. While recognizing that Novo’s interpretation of the counterclaim provision is erroneous, Sotomayor expressed some sympathy for the drug company, because it only changed its use code to “correspond” to new labeling required by FDA. She noted that a fix to this statutory scheme likely would require a fix from Congress or FDA, and that “[a]bsent greater clarity from FDA concerning what is required of brand manufactures in use codes, Congress’ fears of undue litigation may be realized.”
Over a year ago, prior to the Court’s ruling and Sotomayor’s observations, FLH Partners Brian J. Malkin and Andrew S. Wasson published a FDLI Policy article, “Should FDA Undertake More Than a Ministerial Role With Respect to Patent Information?” In this article, Malkin and Wasson noted that for many years FDA has argued that it lacks the resources and expertise to review patents substantively, calling its hands-off role as “ministerial.” While many courts have upheld FDA’s position, they note, it is not the case that courts have mandated that FDA take this position. Instead, the authors suggest that hiring a few competent patent attorneys, trained in biotechnology or the pharmaceutical sciences, could result in the more efficient administration of the Hatch-Waxman Act Amendments to the Federal Food, Drug, and Cosmetic Act. Following Sotomayor’s concurrence, perhaps their recommendations should be considered again.