Doni Bloomfield (Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School; Yale Law School) has posted Speech, Drugs, and Patent Infringement on SSRN. Here is the abstract:
The modern law of induced patent infringement violates the First Amendment. As read by the Federal Circuit, the law unconstitutionally restricts speech, discourages the entry of generic drugs, and helps keep medicine prices high.
Under current doctrine, a generic drugmaker is liable for induced infringement if its drug label so much as hints at using a product in a way that is covered by a patent. This is true even when there is no evidence that prescribers read generic drug labels and in cases when only an in-depth inquiry into the language of the label might promote infringement. This doctrine flies in the face of a simple reading of the statute. And by restricting lawful and non-misleading speech for such an attenuated purpose, it also violates the First Amendment.
This doctrine, already unlawful, took a yet more radical turn in the Federal Circuit’s recent decision in GlaxoSmithKline v. Teva. Under GlaxoSmithKine, a generic drug manufacturer may be liable for hundreds of millions of dollars if it truthfully states that its product is bioequivalent to a brand-name drug. If the decision stands, the law of patent inducement not only threatens to unconstitutionally prolong drug monopolies—it will also undermine a key statutory path to generic competition.
