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Mylan Pharm. v. Research Corp. Tech.: Federal Circuit Upholds Patentability of Epilepsy Drug

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Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., No. 17-2088 (Fed. Cir. 2019), opinion hosted by Justia.

The U.S. Court of Appeals for the Federal Circuit upheld the patentability of a compound used to treat epilepsy against challenge from generic drug companies. Writing for a unanimous panel, Judge Alan D. Lourie upheld the Patent Trial and Appeal Board (“PTAB”) ruling. The court affirmed that the drug companies failed to show any of the challenged innovations protected by the RE38,551 patent to be obvious and therefore invalid.

In late 2015, Argentum Pharmaceuticals initiated an inter partes review (“IPR”) of the ‘551 patent. Argentum claimed that the ‘551 patent was invalid because it drew on published research that would have led an “ordinary artisan” to create an antiepileptic compound that the patent protects. After the PTAB initiated Argentum’s IPR petition, three generic drug companies—Mylan Pharmaceuticals, Breckenridge Pharmaceutical, and Alembic Pharmaceuticals—successfully filed motions to join Argentum.

The PTAB sided with patentholder Research Corporation Technologies (“RCT”). It rejected the drug companies’ argument that claims in the ‘551 patent were obvious modifications of a substance identified in a published paper as “compound 31.” In its analysis, the PTAB emphasized that, if an artisan of ordinary skill were to think to modify the compound 31 to develop an antiepileptic drug, she would optimize for potency and based on the latest research. The ‘551 patent, however, includes modifications that the record evidence suggested would create a drug with less biological activity than obvious alternative transformations. Thus, the PTAB ultimately found that the generic drug companies failed to show obviousness. On the same grounds, the Federal Circuit ruled that the PTAB’s findings were “supported by substantial evidence.”

Before the court reached that conclusion it addressed the threshold question of whether the drug companies who joined Argentum had the right to appeal after Argentum dropped from the case. RCT argued that the appellants had no right to higher court review for two reasons. First, RCT suggested that because it had sued all three appellants for patent infringement more than a year prior to when they petitioned for an IPR, they were barred from making those petitions in the first instance under 35 U.S.C. § 315(b). Second, RCT noted that the PTAB granted the appellants’ original motions to join Argentum on the condition that they limit themselves to an “understudy role, evidence and arguments advanced in the Argentum Petition.” This kind of limited role, they argued, did not encompass the right to appeal without Argentum, who all parties agreed lacked standing.

The Federal Circuit rejected RCT’s reasoning. Relying on the plain text of the statute, Judge Laurie found “no support for the proposition that a party subject to such restrictions in its IPR should be considered to have less standing to appeal.” The PTAB allowed the appellants to join as “parties” under 35 U.S.C. § 315 and “parties” are permitted to appeal IPR decisions under 35 U.S.C. § 319. The court was unwilling to read “party” differently in § 315 and § 319.

Law360 provides summary of this case and others relating to the ‘551 patent.