Apotex, Inc. v. Daiichi Sankyo, Inc.

All that was required to constitute standing by ANDA filer was to show that a patent’s listing constituted an independent barrier to entry into the drug market and that a judicial decision could remove that barrier.

April 07, 2016

GENERICally Speaking

Case Name: Apotex, Inc. v. Daiichi Sankyo, Inc., C.A. Nos. 12-cv-9295, 15-cv-3695, 2016 U.S. Dist. LEXIS 2126 (N.D. Ill. Jan. 8, 2016) (Coleman, J.)

Drug Product and Patent(s)-in-Suit: Benicar® and Benicar® HCT (olmesartan medoxomil); U.S. Patent No. 6,878,703 (“the ’703 patent”)

Nature of the Case and Issue(s) Presented: Daiichi holds approved NDAs for Benicar and Benicar HCT. Daiichi listed two patents in the FDA’s Orange Book in connection with that drug: the ’703 patent and U.S. Patent No. 5,616,599 (“the ’599 patent”). Mylan was the first applicant to file ANDAs containing Paragraph IV certifications against both patents. In response, Daiichi statutorily disclaimed the ’703 patent, but initiated infringement actions based on the ’599 patent. Mylan’s ANDAs were found to have infringed that patent, and Mylan converted its Paragraph IV certifications into Paragraph III certifications. Mylan’s ANDAs, however, retained their Paragraph IV certifications as to the ’703 patent because that patent, although disclaimed, remained listed in the Orange Book. Thus, Mylan’s ANDAs  continue to be entitled to receive 180-day exclusivity periods, unless a subsequent filer obtains a final judgment of invalidity or non-infringement with respect to the ’703 patent, which may forfeit Mylan’s exclusivity if it does not market its product within 75 days.

Here, Apotex sought final judgments of validity and non-infringement regarding the ’703 patent. Mylan intervened in both cases, because such judgments would potentially eliminate its exclusivity periods. Apotex initially filed a declaratory judgment action in 2012 to which Daiichi responded with a motion to dismiss for lack of subject matter jurisdiction, arguing that there can be no justiciable dispute concerning a disclaimed patent that is no longer enforceable. This court granted that motion, but was reversed by the Federal Circuit, which held that Apotex’s allegations established a justiciable controversy. Apotex now moved for summary judgment declaring that the ’703 patent is not infringed by the filing of Apotex’s ANDAs. Daiichi and Mylan, in separate briefs, opposed the motions. The court granted Apotex’s motions.

Why Apotex Prevailed: Mylan argued that the court could not grant summary judgment in Apotex’s favor because Apotex had failed to present evidence demonstrating that it had standing. Mylan argued that Apotex failed to adduce evidence demonstrating injury-in-fact because it had not shown that it had pending ANDAs in good standing such that the listing of the ’703 patent in the Orange Book served as a “but-for” barrier to regulatory approval and market entry. Mylan further argued that Apotex had failed to demonstrate redressability because Mylan did not believe that Apotex would be able to obtain FDA approval to market its ANDA products in the US.

But the court found that all that was required to constitute an injury and establish redressability was to show that a patent’s listing constituted an independent barrier to entry into the drug market and that a judicial decision could remove that barrier. There was no need to show that it was the only remaining barrier to entry. Here, the ’703 patent’s listing in the Orange Book constitutes an independent barrier to the drug market for both of Apotex’s ANDAs that may be removed through a favorable decision from the court. Because Apotex had filed ANDA’s containing Paragraph IV disclaimers with respect to the ’703 patent, it had standing to ask the court to determine whether its ANDAs would infringe upon that patent which, although disclaimed, nonetheless served as a barrier to entry into the marketplace by virtue of its continued Orange Book listing.

With respect to the substantive arguments concerning the ’703 patent, it was undisputed that Daiichi disclaimed every claim under the ’703 patent. Non-infringement of the ’703 patent followed as a matter of law from the fact that it had been formally disclaimed.

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