If FDA Won’t Regulate, Maybe the Courts Will: First Circuit Opines on Listing Device Patents in the Orange Book

March 16, 2020By Sara W. Koblitz

Since as early as 2005, industry has asked FDA for its input on the listing of device patents in the Orange Book (see our previous post here).  FDA has, for the most part, refused to address this question.  As such, industry has decided to just go for it and list device patents in the Orange Book as long as the device is integral to the safety or efficacy of the drug product and the patent is reasonably likely to be infringed if a generic version of the drug is approved.  Consistent with its ministerial role in Orange Book patent listing, FDA has listed these patents.  Though former Commissioner Gottlieb implied that FDA would soon address this issue, it hasn’t.  Indeed, in the 15 years since industry has been doing this, FDA has not said a word.

While FDA has been silent, the First Circuit recently opined on the issue.  In a different context than we’d expect—antitrust litigation—the Court made a bold declaration that device component patents that do not explicitly claim the drug product cannot be listed in the Orange Book in In Re Lantus Direct Purchaser Antitrust Litigation.  Unfortunately for industry, the Court did not tease out what it means by “drug product,” merely stating that a patent must claim the drug for which the applicant submitted the application.

In Re Lantus Direct Purchaser Antitrust Litigation challenges Sanofi’s patent listings for Lantus, an insulin glargine approved by FDA in 2000.  At approval, Sanofi listed one patent covering the drug substance, which expired in August 2014.  In 2007, Sanofi received approval of Lantus Solostar, which contains the same active ingredient but is a combination product including a self-injection drug delivery device.  Sanofi submitted an additional patent covering the “drive mechanism” component of the Solostar self-injection delivery system to the Orange Book in 2013.  In 2013-2015, several competitors submitted 505(b)(2) applications to FDA referencing Lantus, including paragraph IV certifications to the Solostar drive mechanism patent; they each culminated in a licensing agreement between the parties.

As a result of the Solostar drive mechanism patent listing, the plaintiffs in In Re Lantus Direct Purchaser Antitrust Litigation, a putative class of direct insulin glargine purchasers, allege that Sanofi artificially restricted competition in the insulin glargine market.  Because, they allege, the Solostar drive mechanism patent was improperly listed in the Orange Book, any litigation commenced in response to Paragraph IV certifications for this patent was a “sham” initiated to trigger an automatic 30 month stay.  The District Court dismissed the plaintiff’s antitrust claims predicated on the improper listing of the Solostar drive mechanism patent because of the “ambiguities in the FDA’s listing requirements.”  On appeal, the First Circuit disagreed.

Interpreting the plain wording of the Hatch-Waxman provisions, the Court determined that a patent listed in the Orange Book must not only be a patent that claims a drug, but “it must be a patent that claims the drug (or method of using the drug) ‘for which the applicant submitted’ the sNDA.”  According to the Court, because the Solostar drive mechanism patent “does not claim or even mention the Lantus Solostar,” it does not “claim the drug” and was improperly listed in the Orange Book.  Though the patent may claim an “integral component” of the drug product, the Court stated that it sees “nothing in the statute or regulations that welcomes such a further expansion of the already stretched statutory terms, whereby an integral part of an injector pen becomes the pen itself, and in turn is a drug.”

Once the Court determined that Sanofi should not have listed the Solostar drive mechanism patent, it followed that Sanofi could be held liable for antitrust injury arising from the restricted competition.  Sanofi argued that because it was required to list all patents that reasonably relate to the drug product, it should not be liable for antitrust violations, as it was merely trying to fulfill its statutory responsibilities under the Hatch-Waxman Amendments.  While the Court agreed to some degree, it maintained that regulatory responsibilities do not immunize improper patent submissions from antitrust scrutiny.  Nevertheless, a good faith defense may be applicable here.  Thus, the Court held that the Solostar drive mechanism patents were improperly listed, but “the defenses to antitrust liability as a result of such an improper submission include proving that the submission was the result of a reasonable, good-faith attempt to comply with the Hatch-Waxman scheme. . . .”  The case will go back to the District Court to litigate this issue.

Because the patent at issue here claimed only a device component rather than the pen injector itself, the decision here is not at odds with industry’s current practices.  Indeed, it is arguable whether a specific device component is integral to the safety or efficacy of the drug product, particularly if it’s not detailed in product labeling.  Nevertheless, the Court’s decision is vague and open to interpretation.  When it states that the “drug” must be claimed in the patent to be properly listed in the Orange Book under the plain language of the statute, it is not clear whether the patent would need to include the drug substance or if a patent that claimed only the delivery device for the approved drug would suffice.  The Court doesn’t go that far; instead, it states the patent needed to claim either insulin glargine or Lantus Solostar to be eligible for listing: the question goes to whether “Lantus Solostar” means the drug substance for use with the Solostar pen, or whether the pen would have been enough.  Perhaps this is a question that the Court would rather defer to FDA, but, as we know, FDA isn’t offering up any opinions here.

The fact pattern here is narrow enough that this decision is not likely to be explosive—the patent claims only a component of the delivery device and two versions of the same product are approved under the same NDA with only one requiring use of the device—and the decision is limited to the First Circuit.  But the implication here is that if FDA doesn’t take a stance here, courts are going to make up their own rules.  It’s rare for a court to opine on a regulatory procedure when FDA won’t.  And if courts are making up their own procedures, those procedures could be completely at odds with industry practices—practices that industry was forced to adopt specifically because FDA would not make a determination on the issue.  And it is apparently not a full defense to antitrust allegations that the listing is consistent with the ambiguous FDA policies on device patent listing.

Again, the fact pattern here precludes widespread application to the practices adopted by most drug/device product manufacturers, and that’s likely why the Court could make such a sweeping assertion in this matter, but the implications of this decision suggest that courts will act even where FDA has not provided clear direction.  This raises significant risks where regulatory uncertainty pervades.  The takeaway, therefore, is that just because FDA hasn’t objected (even when asked repeatedly to opine on conduct), a court still may.