Teva Pharms. USA v. Novartis Pharms. et al., No. 06-1181 (Fed. Cir. 2007)
For the second time in as many days, the Federal Circuit has decided a case with broad implications for innovator and generic drug companies. The decision today, in Teva v. Novartis, opens the door to many more lawsuits by generic drug companies seeking declarations of patent invalidity or noninfringement.
The Federal Circuit held as follows:
A justiciable declaratory judgment controversy arises for an ANDA filer when a patentee lists patents in the Orange Book, the ANDA applicant files its ANDA certifying the listed patents under paragraph IV, and the patentee brings an action against the submitted ANDA on one or more of the patents. The combination of these three circumstances is dispositive in establishing an actual declaratory judgment controversy as to all the paragraph IV certified patents, whether the patentee has sued on all or only some of the paragraph IV certified patents.
In the case, Teva filed an ANDA to market a generic version of Famvir, an antiviral medication. Novartis then sued Teva for infringing U.S. Patent No. 5,246,937, which covers the active ingredient in Famvir, famciclovir. Novartis chose not to sue Teva on any of its other four Orange Book-listed patents for Famvir, each of which covers methods of use. Teva then brought a declaratory judgment action on the four remaining method patents under a provision of the 2003 Medicare Modernization Act entitled "civil action to obtain patent certainty." The district court dismissed Teva's complaint, and the Federal Circuit has now reversed the dismissal.
The district court dismissed the case pursuant to the Federal Circuit's application of its "reasonable apprehension of suit" test in Teva v. Pfizer. The Supreme Court's recent decision in MedImmune, however, has forced the Federal Circuit to revisit that test. Indeed, in today's opinion the Federal Circuit expressly acknowledged that MedImmune overruled the test.
Today's decision eliminates a powerful weapon innovator drug companies had in their ongoing battle against generics: the uncertainty and risk that generics face when considering whether to launch their drug products before patent expiration. Now, generics in Teva's position will be able to file a declaratory judgment action and obtain a court decision on the validity or infringement of Orange Book-listed patents before deciding whether to launch.
In fact, the court's opinion today suggests that unless an innovator grants a covenant not to sue, the mere listing of a patent in the Orange Book coupled with a paragraph IV certification may be sufficient to establish declaratory judgment jurisdiction. In other words, generic drug companies may be able to pursue declaratory judgment actions even if the innovator declines to file suit on any of its Orange Book-listed patents.
If that turns out to be true, it would go a long way toward solving a "bottleneck problem," where delay by a 180-day generic exclusivity holder prevents subsequent ANDA filers from launching their generic drugs.
- Patently-O; Patent Baristas; Patent Docs
- Feb. 26 OBB post on this case
- Jan. 31 OBB post on a similar DJ case recently filed by Apotex
- The holding of this case does not bode well for Forest Labs' March 13 motion to dismiss Caraco's DJ complaint in the Lexapro case.