By Kurt R. Karst –
December 16th was a good day for Hyman, Phelps & McNamara, P.C. We learned that the U.S. Court of Appeals for the Fourth Circuit handed our client, Mylan Pharmaceuticals, Inc. (“Mylan”), a significant victory. In a 3-0 panel decision (Circuit Judges Wilkinson, Shedd, and Wynn), the Court reversed and remanded by unpublished opinion a June 2014 decision from the U.S. District Court for the Northern District of West Virginia concerning 180-day exclusivity for generic versions of GD Searle LLC’s (now Pfizer Inc.’s) CELEBREX (celecoxib) Capsules, 100 mg, 200 mg, and 400 mg. The Court’s decision also puts the kibosh on FDA’s “bundle of rights” theory, under which an original patent and a reissued patent are treated as a single bundle of rights for 180-day exclusivity purposes. FDA first publicly articulated that interpretation of the law in an April 2014 Letter Decision, just before ruling on 180-day exclusivity for generic CELEBREX; however, as we previously posted (and as discussed in FDA’s Letter Decision), the Agency has applied that interpretation in other instances going back several years.
By way of background, CELEBREX (approved under NDA 020998) is currently listed in the Orange Book with two unexpired patents: U.S. Patent Nos. 5,760,068 (“the ‘068 patent) and RE44,048 (“the ‘048 patent”). Both patents expire on the same date – i.e., June 2, 2015 (and are subject to a period of pediatric exclusivity that expires on December 2, 2015) – because the ‘048 patent is a reissue of the ‘068 patent.
The first ANDA for a generic version of Celecoxib Capsules, 100 mg, 200 mg, and 400 mg, containing a certification to an Orange Book-listed patent was submitted to FDA prior to the December 2003 enactment of the Medicare Modernization Act (“MMA”). As such, 180-day exclusivity for the drug is governed by the pre-MMA version of the law. Pre-MMA 180-day exclusivity is patent-based, such that an ANDA applicant is (or different applicants are) eligible for 180-day exclusivity with respect to different Orange Book-listed patents covering the Reference Listed Drug if such applicant submitted the first ANDA to FDA containing a Paragraph IV certification to a particular patent. Pre-MMA 180-day exclusivity is triggered by the earlier of either the first commercial marketing (for all patents certified to as Paragraph IV by a first-filer), or by a court decision favorable to an ANDA applicant (with respect to a particular patent). Although the list of pre-MMA drugs is fixed (see our previous post here), disputes under the pre-MMA version of the law continue to come up – and may for years to come.
TEVA Pharmaceuticals USA, Inc. (“Teva”) was the first company to submit an ANDA (ANDA 076898) for generic CELEBREX containing Paragraph IV certifications to certain Orange Book-listed patents, including the ‘068 patent. An initial district court decision held that the CELEBREX patents were valid; however, the Federal Circuit revered in part, ruling that many of the claims of the ‘068 patent were invalid. The Federal Circuit issued its mandate on May 13, 2008.
Fast-forward to March 5, 2013, when the U.S. Patent and Trademark Office reissued the invalidated ‘068 patent as the ‘048 patent. The ‘048 patent was promptly listed in the Orange Book and several companies, including Teva and Mylan, certified Paragraph IV to the patent. In March 2014, a district court deemed the ‘048 patent invalid, and the decision was appealed to the Federal Circuit where the case remains pending.
After some ANDA applicants inquired with FDA as to how the Agency would apply, in the case of Celecoxib Capsules, 100 mg, 200 mg, and 400 mg, the pre-MMA provisions of the FDC Act concerning 180-day exclusivity, the Agency issued a Letter Decision on April 24, 2014 addressing situations involving a reissued patent. FDA concluded that:
for purposes of 180-day exclusivity, upon the listing of a reissued patent, a prior court decision on the original patent is not regarded as having triggered 180-day exclusivity for the single bundle of patent rights represented by the original and reissued patent. In such a case, eligibility for 180-day exclusivity is only available to the applicant that first filed a paragraph IV certification to the original patent, and that applicant must make a timely submission of a paragraph IV certification to the reissued patent to remain eligible for 180-day exclusivity.
In other words, FDA ruled that only Teva was eligible for 180-day exclusivity because only Teva certified Paragraph IV first to both the ‘068 and ‘048 patents, and that the Federal Circuit’s decision with respect to the ‘068 patent did not trigger 180-day exclusivity because the ‘068 patent and the reissued ‘048 patent are considered by the Agency as a single bundle of patent rights. FDA approved Teva ANDA 076898 on May 30, 2014 after the expiration of a period of pediatric exclusivity on another patent that the Federal Circuit upheld in 2008.
The day after FDA issued its Letter Decision, Mylan filed an action against FDA in the U.S. District Court for the Northern District of West Virginia seeking injunctive and declaratory relief. Other ANDA applicants, including Teva, Watson Laboratories, Inc. (“Watson”), and Lupin Pharmaceuticals, Inc. (“Lupin”) entered the lawsuit. The District Court denied Mylan’s Motion for Preliminary Injunction in a May 29, 2014 decision and subsequently entered a final judgment on June 16, 2014.
Mylan (and other ANDA sponsors with tentative approval) appealed the decision to the Fourth Circuit. In a joint brief, Mylan and Watson asked the court to address two issues:
- Whether the FDA Decision was unlawful, arbitrary, and capricious because it determined, contrary to the clear statutory language of the Hatch-Waxman Amendments, that a final court decision invalidating an original patent is not a court decision trigger for 180-day generic drug marketing exclusivity if the invalid patent is later replaced by a reissue patent.
- Whether the FDA Decision to deny eligible generic drug manufacturing companies a period of shared exclusivity tied to the reissue patent was arbitrary, capricious, or otherwise not in accordance with law.
Lupin filed a separate brief arguing that first-filers to the ‘048 patent are not entitled to shared 180-day exclusivity.
Analyzing this issues under the familiar two-step Chevron analysis, the Court was able end its analysis at Chevron Step One. “Here, Congress has spoken directly regarding the court decision trigger,” wrote the Court. “The statute makes plain that the 180-day exclusivity runs 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.’ 21 U.S.C. § 355(j)(5)(B)(iv).” Applying that language to the case at hand, the Court wrote that “[a]s to generic celecoxib, such a decision was reached by the Federal Circuit in 2008. . . . Teva’s 180-day exclusivity period as to the ‘068 patent began to run from the date the Federal Circuit issued its mandate in May 2008. And the exclusivity period expired on November 9, 2008, i.e., 180 days later.”
Moving on to FDA’s treatment of a patent and a reissue of that patent as a “bundle of rights,” the Court said that FDA’s interpretation is contrary to the statutory text, and that a reissue patent is a separate and distinct patent that can yield a separate period of 180-day exclusivity:
Hatch-Waxman does not define “patent” nor does it specifically speak to reissued patents. This does not, however, render the statute ambiguous. The “court-decision trigger” speaks of “the patent which is the subject of the certification.” 21 U.S.C. §355(j)(5)(B)(iv) (emphasis added). FDA’s interpretation of this language treats the original patent and the reissued patent as a single “bundle of rights” which can only be the subject of one Paragraph IV certification and therefore provides only a single 180-day exclusivity period. However, this interpretation is contrary to the plain statutory
language. . . .
The plain language of the statute indicates that each patent that is the subject of a certification may trigger exclusivity. The Hatch-Waxman Act required [ANDA] applicants to certify as to both the original and reissued patents; each could be “the patent which is the subject of the certification.” 21 U.S.C. §355(j)(5)(B)(iv).
Setting aside FDA’s interpretation, the Court reversed the West Virginia District Court decision and remanded the case with instructions for the District Court to proceed with adjudicating the rights of ANDA applicants consistent with the Court’s opinion.
Last week, several ANDA applicants whose approvals were blocked as a result of FDA’s now-invalidated Letter Decision announced (here, here, and here) the launch of authorized generic versions of Celecoxib Capsules, 100 mg, 200 mg and 400 mg. Teva also announced the launch of its Celecoxib drug products. As a result, any 180-day exclusivity associated with the drug has been triggered.