United States: When Does The Expiration Of Pediatric Exclusivity Allow ANDA (Or 505(b)(2) NDA) Approval? The Case Of Generic BENICAR

Last Updated: March 13 2017
Article by Kurt R. Karst

It's been a couple of months since the dust has settled from FDA's October 26, 2016 approval of Mylan Pharmaceuticals Inc.'s ("Mylan's") ANDA 078276 for a generic version of Daiichi Sankyo Inc.'s (Daiichi's) BENICAR (medoxomil) Tablets, 5 mg, 20 mg, and 40 mg, so we though it might be a good time take a look back on the case. What had the potential to raise an interesting dispute over the so-called "failure-to-market" 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I) based on Mylan's Paragraph IV certification to U.S. Patent No. 6,878,703 ("the '703 patent") – see our previous post here – never materialized.  Instead, an issue concerning pediatric exclusivity applicable to U.S. Patent No. 5,616,599 ("the '599 patent") listed in the Orange Book for BENICAR cropped up just before FDA was poised to take an approval action and became the defining exclusivity issue in the case.  We've previoulsy discussed the power of pediatric exclusivity (see our previous post here).  FDA's October 26, 2016 approval of Mylan ANDA 078276 puts into action an FDA interpretation that makes it even more powerful (if just by a single day), and an interpretation we raised back in 2010 (see our previous post here).

The '599 patent expired on April 25, 2016, but was subject to a period of pediatric exclusivity that expired on October 25, 2016. The '703 patent expires on November 19, 2021, and is also subject to pediatric exclusivity that expires on May 19, 2022.  Mylan ANDA 078276 contained a Paragraph III certification to the '599 patent (which converted to a Paragraph II certification once the patent expired), and a Paragraph IV certification to the '703 patent (which, we note for completeness, is identified in the Orange Book as being subject to a request for delisting).

In September 2016, Daiichi filed a motion in U.S. District Court for the District of New Jersey seeking clarification of an August 6, 2009 Final Judgment enjoining Mylan from making, using, and selling its generic olmesartan medoxomil drug products until the expiration the '599 patent and "all extensions" thereof. The August 2009 Final Judgment doesn't identify the precise date when Mylan would be free to market generic.  According to Daiichi, however, that date should be October 26, 2016, which is the day after expiration of pediatric exclusivity applicable to the '599 patent expires:

[Daiichi] ask[s] this Court to resolve a dispute between them and [Mylan] over when, consistent with the Judgment entered herein on August 6, 2009 (D.I. 143), Mylan can begin marketing its generic versions of Daiichi Sankyo's patented olmesartan medoxomil blood pressure medicines BENICAR®, BENICAR HCT® and AZOR® (collectively, "the olmesartan medoxomil products"). The dispute is over one day—October 25, 2016, as Mylan contends, or October 26, as Daiichi Sankyo contends.  But it is significant, as North American sales of Daiichi Sankyo's olmesartan medoxomil products average over $2.2 million per day.

Mylan opposed Daiichi's motion and argued that:

Daiichi is wrong about the "one day." Because patents are in effect from midnight on the day they issue, they expire at the stroke of midnight on the day of expiration—i.e., at the very start of the day.  Because Daiichi's patent expired at the stroke of midnight on April 25, Daiichi's Pediatric Exclusivity period will expire at the stroke of midnight on October 25. . . .  In other words, FDA's approval becomes effective at that moment the calendar rolls over from October 24 to October 25, and marketing can commence immediately at that time.  Daiichi may not double count the issuance day of its patent by adding it on to the end of the term to extend its statutory monopoly, even by a single day.

Various briefs and letters filed in connection with the pediatric exclusivity issue are available here, here, here, here, and here.     

The New Jersey District Court denied Daiichi's motion for clarification on October 20, 2016, saying that Daiichi improperly employed Federal Rule of Civil Procedure 60(a) in an effort to fundamentally alter the Judgment.  In a footnote, the court also deferred to FDA on the question of pediatric exclusivity: "The question of whether Daiichi Sankyo's pediatric exclusivity expires on October 25 or 26, 2016, is a question for the FDA to answer.  It has never been before the Court in this case and is wholly improper for the Court to consider under a Rule 60(a) motion."

FDA's decision on the matter is apparent in the Agency's October 26, 2016 approval of Mylan ANDA 078276 instead of an October 25, 2016 approval. There, FDA interprets the phrase "after the date the patent expires" at FDC Act § 505A(b)(1)(B) to mean that ANDA (and 505(b)(2) NDA) approval cannot occur until the day after the expiration date identified in the Orange Book. But FDA hasn't always interpreted pediatric exclusivity applicable to a patent in this manner.  It's a relatively new FDA interpretation of the FDC Act, and one that has only been implemented by FDA in the past (approximately) six months. 

In an October 25, 2016 presentation given at the Generic Pharmaceutical Association's Fall Technical Conference (yes, we recognize the irony in the date of the presentation), FDA's Office of Generic Drugs announced (Slide 25) that "ANDA approval [is] permissible [on the] day after expiration of pediatric exclusivity pursuant to section 505A(b)(1)(B)(ii) of the FD&C Act." FDA points to the Agency's January 25, 2015 denial of a Citizen Petition (Docket No. FDA-2012-P-0661) concerning calculation of the start of the 30-month period in which an ANDA holder must obtain tentative approval or risk forfeiture of 180-day exclusivity as proof of this interpretation (see our previous posts here, here, and here).  There, in footnote 20, FDA cites various courts that have considered the term "after" in the Hatch-Waxman context and that have concluded that the relevant period begins the day after a particular trigger event.  Here's FDA's support for that proposition:

See Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1360 (Fed. Cir. 2008) (interpreting pre-MMA section 505(j)(5)(B)(iv)(II) of the FD&C Act (subsequent AND As approvable "one hundred and eighty days after the date" of notice of first commercial marketing) to permit marketing on "181 days after" after first-filer marketing); Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278, 1284 (Fed. Cir. 2008) (same); Altana PharmaAG v. Teva Pharms. USA Inc., no. 04-2355, 2010 U.S. Dist. LEXIS, at *11-12 (D.N.J. Aug. 13, 2010) (ANDA approval permissible day after expiration of pediatric exclusivity pursuant to section 505A(b)(I )(B)(ii) of the FD&C Act (which provides that ANDA approval not permissible until "six months after date the patent expires")); Takeda Pharm. Co. Ltd. v. Teva Pharms. USA, Inc., no. 06-0033, 2009 U.S. Dist. LEXIS 105324, at *7-8 (D. Del. Nov. 9, 2009) (same). See also Scott v. U.S. Veteran's Admin., 929 F.2d 146, 147 (5th Cir. 1991) (upholding like interpretation of analogous language in 28 U.S.C. 2401(b), which provides that "a tort claim against the United States shall be forever barred . . . unless action is begun within six months after the date of mailing, by certified or registered mail, of notice of final denial of the claim by the agency to which it was presented") (emphasis added); Santiago v. U.S., 2004 WL 758196, at *1-*2 (E.D.N.Y. 2004) (same).

So, for those companies out there with pending ANDAs and 505(b)(2) NDAs containing a Paragraph III certification that converts to a Paragraph II certification upon patent expiration, and to which a period of pediatric exclusivity applies, don't forget to take into consideration that FDA approval will not occur until the day (or the next business day) after the date identified in the Orange Book when pediatric exclusivity expires.

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