A patentee, merely pleading that an alleged infringer filed an ANDA for unpatented indications, may satisfy jurisdictional requirements but will not satisfy Rule 12’s pleading requirement for an infringement claim under § 271(e)(2) of the Hatch-Waxman Act.

The patents at issue covered methods for using a cholesterol-lowering drug for certain indications.  The patentees filed an NDA on the drug and listed the patents at issue in the Orange Book.  The FDA approved the drug for a number of indications, some of which were not protected by the patentee’s patents. The alleged infringers filed Section viii ANDAs carving out the patented indications from their proposed labeling and thus seeking approval to market the drug only for unpatented uses.  The Federal Circuit affirmed. 

The district court granted the alleged infringers’ motions to dismiss the finding that the patentee did not present a “valid” § 271(e)(2) claim based on the alleged infringer’s ANDA for unpatented indications, and that the patentee’s claims were unripe to the extent they relied on presumptive future labeling requirements.

The Federal Circuit first held that the district court erred in holding that its subject matter jurisdiction hinged on whether the patentees filed a “valid” claim under § 271(e)(2).  Here, the patentees’ allegations that its listed patents were infringed under § 271(e)(2) were enough to overcome a motion to dismiss on jurisdictional grounds. On the underlying claim, the Federal Circuit held that an ANDA seeking to market a drug for unpatented indications is not patent infringement under § 271(e)(2) and such a claim is subject to dismissal under Rule 12.  In addition, patentees cannot claim patent infringement under the theory that the FDA may require ANDA filers to list the patented indications in the future, because such claims are not ripe.

The patentee won a separate lawsuit on its patent directed to the composition of the drug, which was appealed separately.

A copy of the opinion can be found here.