Skinny Label Lives – Section viii Carve-Out and Non-Infringement of Method of Treatment Patents

Back in August, the Federal Circuit’s GSK v. Teva opinion landed with quite a splash in the Hatch-Waxman world. In that case, Teva’s carvedilol “skinny label” (i.e. drug label with Section viii carve-out) did not serve to fend off a finding of induced infringement of a patent that claims the method of treatment that was supposedly carved out of the label. There have been many comments made on the GSK carvedilol opinion since its issuance. Although the Federal Circuit panel majority pointed to marketing efforts and statements by Teva, outside of the drug label, and partially relied on those ex-label information to support its affirmance of the district court jury finding of inducement, it was not clear at the time whether the GSK opinion signaled a shift disfavoring skinny labels. Some commentators wonder if the Section viii carve-out is still a viable way to avoid infringement, especially since the panel re-heard the case and re-issued the opinion again granting GSK the win again, and knowing the putative “death to the skinny label” arguments raised. 

Such concerns may be overblown. On September 30, Judge Stark of the District of Delaware concluded a bench trial, and found that another number of defendants utilizing “carved out” labels did not infringe a method of treatment patent. Notably, Judge Stark also presided over the GSK v. Teva trial, and he discussed the GSK opinion in his September trial opinion. So skinny label lives.

The Lundbeck et al. v. Lupin et al. Vortioxetine Trial Opinion

Lundbeck and Takeda sell Trintellix (vortioxetine), a drug indicated for the treatment of major depressive disorder (MDD). They sued a number of ANDA filers, asserting among others U.S. Patent No. 9,278,096, which claims using vortioxetine in a patient who has “previously received medication or is still receiving medication for the treatment of [depression], the mediation is ceased or reduced or has to be ceased or reduced due to sexually related adverse events [after using other drugs].” During the trial, Plaintiffs proved that clinicians did and would switch medications and prescribe vortioxetine, which would include ANDA products when they became available, after patients had encountered such “treatment emergent sexual dysfunction,” or TESD. They also proved that the defendants knew the ‘096 patent. However, they failed to prove that the defendants had a specific intent to induce post-TESD use of vortioxetine.

As the court noted, the brand label for Trintellix included TESD comparative information, but the ANDA labels carved out such comparative information. “Due to Defendants’ section viii carve-outs, Defendants’ labeling will not encourage, recommend, or promote the practice of switching MDD patients [who suffered from TESD] to vortioxetine.” The ANDA labels did mention TESD, in the “Adverse Reaction” section. Here, the data showed that “vortioxetine has placebo-like levels of TESD.” However, the court found that such data did not constitute encouragement for switching MDD treatment to vortioxetine. There was no comparison of TESD incident rates between patients using vortioxetine and patients using other medications in the accused drug labels. According to the trial court finding, the “adverse events” information would not, by itself, encourage a clinician to use vortioxetine in the infringing manner. For clinicians to be encouraged to do so, they would first involve a “scholarly scavenger hunt,” and figure out how TESD rates compare between vortioxetine users and other patients—which data were not readily available. “Vague instructions” or “alleged implicit encouragement” in the defendants’ drug labels did not constitute persuasive proof of an intent to induce infringement. 

Judge Stark noted that the Federal Circuit in its GSK v. Teva opinion pointed to both the language in Teva’s “partial” (carved out) carvedilol label and Teva’s advertising and promotional activities as substantial evidence to support the fury finding of inducement of infringement. In the Lundbeck vortioxetine case, in contrast, there was no evidence of any such statements or activities by the defendants, and the ANDA labels, by themselves or in combination with “clinicians’ supposed background knowledge,” were not enough to “encourage, recommend, or promote infringement.” 

The lesson from the vortioxetine case is that a carved-out label can work, but the ultimate case-specifics facts will matter. An ANDA filer also needs to make sure that it does not make any potentially problematic statements outside of its label.

The trial opinion, of course, may not be the last word in the vortioxetine case. Lundbeck and Takeda have filed notice of appeal in the vortioxetine case. The Federal Circuit will soon have the chance to revisit the “skinny label” inducement issue. There will probably be more twists and turns ahead. 

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Upadhye Tang LLP is an IP and FDA boutique firm concentrating on the pharmaceutical and medical device spaces. We help clients with navigating the legal landscape by helping on counseling and litigation. Clients call us to help move drug and device approvals along and to represent them in IP and commercial litigation. Call Shashank Upadhye, 312-327-3326, or by email: shashank@ipfdalaw.com, for more information. 

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