Digest of Apotex Inc. v. Daiichi Sankyo, Inc., No. 2014-1282 (Fed. Cir. March 31, 2015) (precedential). On appeal from N.D. Ill. Before Taranto, Mayer, Clevenger.

Procedural Posture: Plaintiff-Appellant-Apotex appealed the district court’s dismissal of the declaratory judgment complaint for lack of case or controversy. CAFC reversed. CAFC also reversed the district court’s denial of Mylan’s motion to intervene.

  • Subject Matter Jurisdiction: The Federal Circuit found that a case or controversy exists, even though Daiichi had disclaimed the ’703 patent at issue. When Mylan became the first applicant to file an abbreviated new drug application with the FDA relating to BENICAR®, it certified that the two patents Daiichi had listed in the Orange Book were invalid or would not be infringed (a paragraph IV certification), which made Mylan eligible for a 180-day exclusivity period. Subsequently, the ’703 patent was disclaimed by Daiichi for unspecified reasons, while the validity of the ’599 patent was upheld in litigation. However, the FDA continues to list the ’703 patent in the Orange Book despite a delisting request from Daiichi. The listing of the ’703 patent in the Orange Book prevents FDA approval during Mylan’s presumptive exclusivity period and the parties thus have adverse concrete interests in the truncation or preservation of that period. Specifically, the Medicare Modernization Act of 2003 added forfeiture provisions for the exclusivity period the first ANDA filer could be entitled to, which could potentially be triggered here if Apotex were able to obtain a judgment of invalidity, unenforceability or noninfringement for the ’703 patent. Such a judgment could allow Apotex to receive marketing approval from the FDA and enter the market sooner.
  • Exclusivity Period: Apotex’s desire to advance FDA approval and enter the market are not too speculative a consequence of the requested non-infringement judgment. Daiichi is causally responsible for the current existence of the exclusivity period via its original listing of the ’703 patent. Apotex seeks a judgment to possibly bring an end to Mylan’s exclusivity period. Therefore it is likely that the resolution of a case or controversy could have the concrete result of advancing the date of FDA approval and market entry by Apotex. The legislative history makes clear that tentative FDA approval for Apotex’s proposed drug is not a prerequisite for a case or controversy under the present facts.
  • Intervention: The district court incorrectly concluded that Cross-Appellant-Mylan’s interest in the case was rendered moot by the dismissal of the declaratory judgment complaint for lack of case or controversy. The Federal Circuit held that “Mylan has a strong, concrete interest in defending the dismissal” because it “‘will either gain or lose by the direct legal operation and effect of the judgment’ sought by Apotex” (citations omitted).