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Following Up On Our Conte Thought Experiment

By James M. Beck and Mark Herrmann

One of the joys of blogging is receiving feedback from our readers.

We had two reactions to Monday's "Thought Experiment On Conte v. Wyeth" that we thought we'd share with you.

One reader notes that the manufacturer of a patented drug might be able to include a disclaimer in its package insert (and thus in the PDR) that advises prescribers to consult the generic label before writing a generic or substitutable prescription. Perhaps that disclaimer would prevent prescribers from reasonably relying on the innovator's package insert.

Another reader suggests that the Hatch-Waxman Act reflected a tradeoff, allowing earlier access to market for generics while providing for patent term extension for brand name drugs. Imposing liability on a brand name manufacturer based on the ingestion of a generic version of a drug fundamentally alters the Hatch-Waxman tradeoff and is therefore preempted under a conflict preemption theory.

We're still kicking this around, and we're not sure either of these musings gets us anywhere, but we figured we'd share them with our readers. If you have better ideas, please don't be shy.

Full post as published by Drug and Device Law on February 25, 2009 (boomark / email).