Teva v. Novartis: Generic Declaratory Judgment Actions

Teva v. Novartis (Fed. Cir. 2007).

Novartis markets Famvir — a treatment for genital herpes. Hoping to get-in on the action, Teva filed an ANDA and later a declaratory judgment suit to invalidate the related Novartis patents.  Teva’s action was dismissed after the generic manufacturer failed to establish “a reasonable apprehension of imminent suit.” (Meanwhile, Novartis had sued Teva on an additional patent covering Famvir).

Since the Supreme Court’s decision in MedImmune, however, the reasonable apprehension test has been eliminated. The new test, written generally in MedImmune, is “whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”  Under Article III of the constitution, the controversy must include an ‘injury-in-fact.’

Here, Novartis argued that there was no injury-in-fact because Novartis had not threatened suit on the patents in suit and that another ongoing patent suit against Teva was unrelated. The CAFC disagreed, finding that Novartis had created a controversy. In particular, a combination of the following actions were sufficient to create DJ Jurisdiction:

  • Novartis’ listing of the patents in the Orange Book. (“may not be sufficient” to create Article III jurisdiction)
  • Teva’s submission of an ANDA and certifying that it did not infringe. (“The very act of submitting an ANDA is an act of infringement.”)
  • Novartis’ ongoing lawsuit on a related patent covering the same drug. (“[R]elated litigation involving the same technology and the same parties is relevant in determining whether a justiciable declaratory judgment controversy exists on other related patents…. Novartis’ suit on [only one patent] leaves open the possibility of future litigation.”)

The court attempted to cabin the expanded jurisdiction scope by focusing on the facts:

“The type of legal uncertainty as to the legal status of Teva’s ANDA that Novartis has created by suing on only one of the five paragraph IV certified Famvir® patents listed in the Orange Book is a present injury sufficient for a justiciable controversy.”

Friedman Concurring: Senior Judge Friedman saw a simpler path to finding jurisdiction: Listing of the patents in the Orange Book combined with Teva’s noninfringement certification created an existing controversy.

“[B]y listing those five patents in the Orange Book, “Novartis represent[ed] that a ‘claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use or sale’ of generic famciclovir covered by the claims of its listed Famvir® patents.” Maj. Op. at 15. In its Abbreviated New Drug Application filed with the Food and Drug Administration, Teva certified … that “its drug did not infringe” any of the five Novartis Famvir® Orange Book patents or that the patents were invalid. There thus is an existing controversy between the parties over whether Teva’s generic version of Famvir® would infringe the four other Famvir® patents listed in the Orange Book, and whether these patents are valid.”