Orange Book Declaratory Judgment Question Goes to Supreme Court

Apotex v. Pfizer (On petition for certiorari).

In 2005, the CAFC decided Teva v. Pfizer and declared that the court does not have declaratory judgment jurisdiction over a case between an ANDA filer and the patent holder unless the patent holder at least threatens suit.  Orange Book listing - on its own– does not create a reasonable apprehension of suit.

Apotex is facing the same situation in the present case.  They filed their ANDA request, Pfizer did not file suit or threaten litigation.  However, Apotex is afraid that as soon as it begins to manufacture the new drug that Pfizer will sue and potential force Apotex to pay “massive patent liability.”

Thus, Apotex has asked the Supreme Court to determine whether declaratory judgment jurisdiction can exist based on this “prospect of massive patent liability that deters generic manufacturers from entering the marketplace.”

The Supreme Court has asked the Solicitor General to present the government’s view on whether declaratory judgment jurisdiction can exist in this situation.  This request by the High Court is seen as a potential stepping stone to grant of Petitioner's request for certiorari.  The FTC made its position clear on this issue in a recent brief in the Tamoxifen Citrate Antitrust Litigation (“Under the panel ruling, pharmaceutical companies are now free to pursue this anticompetitive ploy without fear of antitrust liability.”).


One thought on “Orange Book Declaratory Judgment Question Goes to Supreme Court

  1. 1

    The cert petition is really more about Medicare Amendments Act purpose and scope than Orange Book listing. In particular, scope of 35 USC 271(e)(5) is in question. Interpretation of case law on declaratory judgment jurisdiction is also being contested.

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