Effects of GSK v Teva ripple after SCOTUS denies cert


Chad Landmon, Ross Blau and Gulrukh Haroon

Effects of GSK v Teva ripple after SCOTUS denies cert

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Despite one judge’s insistence that the case was “narrow and fact dependent”, GSK v Teva could have wide-reaching implications for generic drugs, biosimilars, and how skinny labels are read, say Chad Landmon, Ross Blau, Gulrukh Haroon of Axinn, Veltrop & Harkrider.

Last week (May 15), the Supreme Court denied certiorari in GlaxoSmithKline v Teva Pharms USA (GSK v Teva), locking in the US Court of Appeals for the Federal Circuit’s second panel decision which held that Teva’s attempted section viii carve-out of an indication covered by a patented method of use was not ‘skinny’ enough to avoid being liable for infringement.

Although the court did not state why certiorari was denied—as is common—the order list stated that Justice Brett Kavanaugh would grant the petitions for certiorari. One possible reason that the court believes that certiorari is not ripe is that Teva’s affirmative defence of equitable estoppel, ie, if GSK’s representations to the US Food and Drug Administration (FDA) were at odds with its enforcement efforts in this case, still needs to be considered on remand. The opinions from the Federal Circuit concurring and dissenting from the denial for the petition for rehearing en banc have left copious notes for the district court to consider on remand regarding equitable estoppel. 

While the district court will now have to consider the issues of equitable estoppel on remand, there are still several other effects from GSK v Teva that we see in other district court cases, at the FDA, and for biosimilars.

GSK, Teva, Supreme Court, patent infringement, FDA, Federal Court, biosimilars, orphan drug, innovation, Hatch-Waxman, skinny labels