Key Takeaways:

• Justices seemingly agree that Teva v. GSK case is too-fact specific for certiorari, and so petition is denied.
• Other trial court decisions emphasize that “skinny label” carve-outs are a viable way to avoid infringing method of use patents.
• Court’s denying certiorari should not affect generic access or pricing overall. 

On May 15, 2023, the Supreme Court denied certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC et al., a case some argued had enormous implications for so-called “skinny labeling” practices amongst generic drug makers—whereby they can avoid infringing patents that cover methods of use—while others argued the underlying jury verdict was so weighed down by the convoluted factual issues that granting certiorari could give no clarity to the law. (See our May 11, 2023 summary of the facts and background at Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition.)

The case centers on GSK’s branded drug product, Coreg®, which uses the active ingredient carvedilol to treat high blood pressure and heart failure. Teva developed and sells a generic version of that product, but for several years used a skinny label that “carved out” GSK’s patented indication of using carvedilol to treat heart failure.

Teva’s certiorari petition argued that the Federal Circuit’s decision reinstating a jury’s verdict of infringement creates “competition-killing uncertainty” that the U.S. healthcare system “cannot sustain.” The Solicitor General—in a brief signed by the U.S. Patent & Trademark Office, Department of Health and Human Services, and the Food and Drug Administration—agreed, urging that certiorari be granted. GSK argued in response, however, that “the jury heard voluminous additional evidence of Teva’s intent, including testimony of Teva’s commercial witnesses …, statements in Teva’s product brochures … [and] press releases publicizing that Teva’s generic” should be used for the patented indication even though that indication was deleted from Teva’s skinny label. Today’s Order provides no explanation for the Court’s denial of the certiorari petition and only states that Justice Kavanaugh would have granted certiorari.

Meanwhile…

As Teva was grabbing the headlines, other cases involving generics using skinny labels to avoid inducing method patents have continued to make their way through the courts. These cases reinforce that generics can still find safe harbor by skinny label carve-outs in some circumstances.

Just months after the Federal Circuit’s first panel decision in GSK v. Teva, the District of Delaware dismissed a case involving a generic manufacturer’s skinny label in Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. et al. In ruling in favor of generic drug maker Hikma, the district court suggested that the skinny label was still a viable non-infringement route, despite the GSK decision, because Hikma’s skinny label did not instruct the user or encourage anyone to use the patented method and its promotional materials also did not induce infringement of the patented method. No. 20-C-01630-RGA-JLH D.I. 97 (D. Del., Jan. 4, 2021). The district court acknowledged the GSK holding but did so narrowly embracing the Federal Circuit’s admonition that GSK was “case-specific.” The decision concluded that though Hikma’s skinny label listed side effects for the patented use and its press releases said the generic was equivalent to the branded drug, Hikma was giving neither “instruction” nor “encouragement” for inducing infringement. (Notably, this case raised a separate skinny label issue concerning the role of insurer formularies inducing infringement, but that insurer settled that issue and it is outside the scope of this alert.)

Similarly, in Genentech, Inc. v. Sandoz, Inc., the District of Delaware ruled that Sandoz was also not liable for induced infringement based on its skinny label. 592 F. Supp. 3d 355, 358 (D. Del. 2022). Ruling for Sandoz, Judge Andrews distinguished the case from GSK, explaining that “Sandoz’s label does not ‘encourage both infringing and noninfringing uses.’ Unlike in [GSK v.] Teva, where ‘substantial evidence’ supported ‘the jury's determination that Teva’s partial label contained information encouraging each claimed step,’ here, the label only recommends discontinuation, which is a non-infringing use. The infringing uses are presented as options, not recommendations.” Id. at 367 (citation omitted).

On the flip side, the District of Delaware denied Apotex’s motion to dismiss Sanofi-Aventis’s amended complaint alleging, inter alia, that Apotex’s label induced infringement of its patents that cover “methods of increasing survival” in patients with certain metastatic prostate cancers. Sanofi-Aventis U.S. LLC v. Apotex Corp., No. 20-cv-804-RGA, 2022 U.S. Dist. LEXIS 120578, at *25 (D. Del. July 8, 2022). Apotex argued the proposed labels do not encourage doctors to form the intent to administer the products with the purpose of increasing survival. Judge Hall disagreed, explaining that Sanofi’s pleading—at that stage of the proceedings—plausibly alleged that Apotex’s proposed labels encourage physicians to prescribe the generic product for the claimed method of use. Id.

Moving Forward

Undoubtedly, parties will still debate what activities constitute inducing infringement – but the district courts have clearly indicated that the sky is not falling on skinny labels. It remains to be seen what activities outside of label amendments—such as the promotional activities that GSK presented to the jury—will be enough to establish liability for induced infringement even where a skinny label carves out a patented indication.