Generics makers appeal pay-for-delay ban to Ninth Circuit
A group of generics manufacturers yesterday, December 2 asked the US Court of Appeals for the Ninth Circuit to reverse California’s ban on pay-for-delay deals.
The appeal comes days after a California district court rejected the Association for Accessible Medicines’ (AAM) request to overturn the law, which passed in October.
The latest group to challenge the law comprises generic and biosimilar pharmaceutical manufacturers, including Sandoz, Accord, Amneal, and Teva.
The legislation, known as AB 824, banned so-called ‘pay-for-delay’ deals intended to keep generics of patent-protected drugs off the market.
These agreements usually see patent owners pay generic manufacturers to delay the launch of competitor drugs.
The AAM brought a legal challenge against the law, which it says is unconstitutional. According to the AAM, the law limits out of state commerce as it is not limited to deals within the state of California.
The generics association had raised multiple arguments in support of its bid for an injunction barring the law from taking effect. These included challenges that held that the law violated key clauses in the US Constitution such as the “dormant commerce clause”.
This holds that Congress has power over interstate commerce. The AAM argued that this prohibits state laws such as AB 824, which it says governs commerce across different states.
On December 31, the US District Court for the Eastern District of California rejected the AAM’s motion, ruling that it was premature given that it had as of yet not been applied in any specific cases.
The court also rejected the AAM’s argument that a preliminary injunction would be in the public interest, concluding that it was “purely speculative”.
“The court cannot predict how the market will react to this new law, nor should it. There is no comparable law in another state nor under federal law, so the court has no facts before it to base such a determination,” the decision read.
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