Mylan Pharms., Inc. v. FDA

The issue here concerns whether the Hatch-Waxman Act requires ANDA applicants to certify as to both an original and a subsequent reissue patent.

Winter 2014

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name:  Mylan Pharms., Inc. v. FDA, Civ. Nos. 14-1522, 14-1529, 14-1593, 2014 U.S. App. LEXIS 24022 (4th Cir. Dec. 16, 2014) (Circuit Judges Wilkinson, Shedd, and Wynn presiding; Opinion by Wynn, J.) (Appeal from N.D. W.V, Keeley, J.) (A reissued patent represents a new set of rights that necessitate a new paragraph IV certification and a subsequent legal challenge to determine the patent’s validity.) 

Drug Product and Patent(s)-in-Suit: Celebrex® (celecoxib); U.S. Pats. Nos. 5,466,823 (“the ’823 patent”), 5,563,165 (“the ’165 patent”), 5,760,068 (“the ’068 patent”) and RE44,048 (“the ’048 patent”) 

Nature of the Case and Issue(s) Presented:  The issue here concerns whether the Hatch-Waxman Act requires ANDA applicants to certify as to both an original and a subsequent reissue patent. The FDA issued a statement that eligibility for 180-day exclusivity was only available to the applicant that filed a paragraph IV certification in relation to the original patent.
Pfizer is the manufacturer of Celebrex, which is the commercial embodiment of the patents-in-suit and one other patent not at issue. In 2003, Teva filed an ANDA that included paragraph IV certifications against the ’823, ’165 and '068 patents. Pfizer sued Teva for patent infringement, and the District Court of New Jersey held that all three patents were valid and infringed by Teva. On appeal, the Federal Circuit reversed in part, finding eleven claims of the ’068 patent invalid.
On March 5, 2013, the USPTO reissued the invalidated ’068 patent as the ’048 patent. On March 7, 2013, Teva, Mylan and Watson amended their previously filed ANDAs to include paragraph IV certifications relating to the newly reissued patent. Lupin amended its ANDA on March 28, 2013. Pfizer sued all ANDA applicants alleging patent infringement. Various drug manufacturers engaged in letter writing and private meetings with the FDA regarding the approval of their celecoxib ANDAs. On April 24, 2014, the FDA issued a letter decision that purported to answer the question of whether a prior court decision on an original patent triggered (and exhausted) any exclusivity to which a first applicant on the original patent was entitled. The FDA concluded that a reissued patent could not be the basis for a new 180-day exclusivity period. The following day, April 25, 2014, Mylan sought injunctive and declaratory relief against the FDA regarding its letter decision. Mylan sought to prevent the FDA from granting any other company a 180-day exclusivity period. Watson and Lupin intervened as plaintiffs, and Teva intervened as a defendant. The district court consolidated the hearing on Mylan’s preliminary injunction motion with a trial on the merits, granted Mylan’s motion for judgment, but in favor of the FDA, and dismissed the case. This appeal followed. The Circuit Court reversed and remanded for further proceedings before the district court. 

Why Mylan Prevailed:  Because the district court decision involved an agency action based on the interpretation of a statute, the Circuit Court began by conducting its analysis under Chevron. Under that analysis, the Circuit Court is required to set aside any agency action that is not in accordance with the law. The first step in a Chevron analysis is to determine whether Congress has directly spoken to the precise question at issue.  If Congress has done so, the Chevron analysis ends, and the agency action is determined to be not in accordance with the law.  In this case, the Fourth Circuit determined that the statute in question unequivocally stated that the 180-day exclusivity period ran from the date of a decision of a court in an action holding the patent which is the subject of the certification to be invalid or not infringed. In this case, such a decision was handed down by the Federal Circuit when it determined that eleven claims of Pfizer’s ’068 patent were invalid. The ’068 patent was the subject of Teva’s paragraph IV certification, and therefore, Teva’s 180-day exclusivity period began to run on the date the Federal Circuit decided the case in May of 2008, and ended 180 days later on November 9, 2008.

The Circuit Court noted that although reissue patents were not specifically addressed by the statute, it did not render the language ambiguous. There was nothing in the language to suggest that an original patent and a reissue patent belonged to a combined bundle of rights that provided only a single 180-day exclusivity period. The reissued ’048 patent represented a new set of rights that necessitated a new paragraph IV certification and a subsequent legal challenge to determine the patent’s validity. These rights were separate from the rights that were previously litigated in relation to the original ’068 patent. The Circuit Court concluded that each patent that is the subject of a certification may trigger its own exclusivity period. Accordingly, the Court rejected the FDA’s interpretation of the statute as violating the plain statutory language.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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