Drug makers ask 9th Circuit to block new state law on generics

A pharmaceutical industry group has asked the 9th U.S. Circuit Court of Appeal to block a new California law on generic drugs while its legal challenge plays out.

On New Year's Eve, U.S. District Court Judge Troy L. Nunley declined to block AB 824. The law bans so-called "pay-to-delay" deals that can keep generic versions of drugs off the market. Association for Accessible Medicines v. Becerra, 2:19-cv-02281-TLN-DB (E.D. Cal., filed Nov. 12, 2019).

The motion for injunction pending appeal was filed Thursday by Matthew D. Rowen with Kirkland & Ellis LLP in Washington, D.C.

The plaintiff "recognizes that this court only recently denied a request for preliminary injunctive relief," Rowen argued. "But the standards for the two inquiries are not identical."

The appellate court, he continued, is less bound by consideration of success on the merits in cases like this where "difficult legal questions ... suggest that the status quo should be maintained."

AB 824 applies a state antitrust law, the Cartwright Act, in an effort to address a loophole within the Hatch-Waxman Act, a 1984 federal law designed to lower drug prices. That law created a 180-day exclusivity window, but it also opened the possibility of the owner of the original drug patent paying off the generic drug maker to not go to market.

Rowen's motion references claims made within the original complaint that AB 824 conflicts with the commerce clause of the U.S. Constitution by creating a situation in which the California attorney general could attempt to take legal action against "a settlement agreement outside of California, having nothing to do with California." The lower court considered these arguments "too speculative."

"If the Ninth Circuit takes a different view from this court on the ripeness issue, then [Association for Accessible Medicines] members will undoubtedly have suffered irreparable harm from the interim implementation of an unconstitutional law," Rowen wrote.

-- Malcolm Maclachlan