Is a Statutory Patent Disclaimer Sufficient Enough to Trigger Hatch-Waxman Declaratory Judgment Jurisdiction? Two District Courts Reach Opposite Conclusions

October 15, 2014

By Kurt R. Karst –      

For several months now we have been monitoring an appeal to the U.S. Court of Appeals for the Federal Circuit concerning a patent – U.S. Patent No. 6,878,703 (“the ‘703 patent”) – listed in the Orange Book for Daiichi Sankyo Inc.’s (“Daiichi”) BENICAR (olmesartan medoxomil) Tablets (NDA 021286).  We were waiting for the case to ripen into a blog post.  That happened earlier this week, just not in the way we expected it to happen.  But before we get there, some background on the BENICAR case.

The ‘703 patent, which Daiichi statutorily disclaimed, is a 180-day exclusivity-bearing patent, and therefore, remains listed in the Orange Book, but with a “Patent Delist Request Flag.”  This flag is described by FDA in an Orange Book data file as follows:

Sponsor has requested patent be delisted.  This patent has remained listed because, under Section 505(j)(5)(D)(i) of the Act, a first applicant may retain eligibility for 180-day exclusivity based on a paragraph IV certification to this patent for a certain period.  Applicants under Section 505(b)(2) are not required to certify to patents where this flag is set to Y.  Format is Y or null.

The first ANDA applicant’s eligibility for 180-day exclusivity for Olmesartan Medoxomil Tablets – here subject to the post-Medicare Modernization Act (“MMA”) version of the statute – is apparently serving as an obstacle to Apotex, Inc. (“Apotex”), which has an ANDA pending  at FDA that is not yet tentatively approved. 

In November 2012, Apotex filed a Complaint for Declaratory Judgment in the U.S. District Court for the Northern District of Illinois in an effort to obtain a court decision triggering the 75-day statutory period under FDC Act § 505(j)(5)(D)(i)(I)(bb) and that would ultimately result in a forfeiture of 180-day exclusivity eligibility.  Daiichi filed a Motion to Dismiss the Apotex Complaint, as did non-party/proposed intervenor-defendant Mylan (here).  Earlier this year, the District Court issued a Memorandum Opinion granting Daiichi’s Motion to Dismiss, saying that “[t]he mere fact that the FDA has failed for some reason to delist Patent ‘703, despite Daiichi’s request, does not create a case or controversy by which Apotex may seek a declaratory judgment regarding a nonexistent patent.” 

Apotex appealed the District Court decision to the Federal Circuit with the following statement of the issue in the case:

Whether the district court legally erred in concluding that a patentee’s disclaimer of a patent that continues to have an exclusionary effect by virtue of the patentee’s listing of that patent in the FDA Orange Book deprives the court of subject matter jurisdiction to decide Apotex’s civil action to obtain patent certainty under 21 U.S.C. § 355(j)(5)(C) and 35 U.S.C. § 271(e)(5), where the requisites of the statutes were satisfied and where, unless Apotex can obtain the declaratory judgment sought in this action, final FDA approval of its [ANDA] will be delayed by at least 180 days.

Daiichi’s brief is on file, as well as a brief from cross-appellant Mylan challenging the District Court’s denial of the company’s motions to intervene and dismiss the Apotex Complaint.  Recently, Apotex filed its Response and Reply Brief

The BENICAR case above serves as an interesting counterpoint to a Memorandum Opinion and Order issued earlier this week by the U.S. District Court for the Eastern District of Virginia.  In that case, the court denied a Motion to Dismiss filed by patent owner Ferring B.V. (“Ferring”) seeking dismissal of a Complaint for Declaratory Judgment of Patent Unenforceability filed by ANDA applicant Glenmark Generics Ltd. (“Glenmark”) (Opposition and Reply briefs available here and here).  The drug at issue in that case is DDAVP (desmopressin acetate) Tablets, 0.1 mg and 0.2 mg, which FDA approved under NDA 019955 on September 6, 1995.  (A hat tip to the folks at Sterne, Kessler, Goldstein & Fox PLLC who represent Glenmark and who alerted us to the DDAVP decision.)

Unlike BENICAR, DDAVP is a pre-MMA drug insofar as 180-day exclusivity is concerned.  And in that pre-MMA world, which continues to generate interesting controversies (see our previous post here),  a subsequent ANDA sponsor that certifies to a newly listed patent cannot be approved until the first-filer’s exclusivity is over, or is otherwise lost because of, for example, a final court decision.  That’s because under the pre-MMA statute 180-day exclusivity is patent-by-patent and can result in multiple rounds of exclusivity. 

In the case of DDAVP, the listing of U.S. Patent No. 7,022,340 (“the ‘340 patent”) in the Orange Book for NDA 019955, and the subsequent Paragraph IV certification to that ‘340 patent by an unknown first-filer, has given rise to a new period of 180-day exclusivity eligibility.  That unknown first-filer’s period of exclusivity is blocking subsequent ANDA applicant Glenmark from obtaining final approval of its ANDA 201831 that FDA tentatively approved in Decemner 2013.  So in an attempt to relieve the bottleneck created by the fist-filer’s 180-day exclusivity eligibility, Glenmark initiated litigation. 

As with the ‘703 patent listed in the Orange Book for BENICAR, the ‘340 patent listed in the Orange Book for DDAVP has been statutorily disclaimed an is identified with a “Patent Delist Request Flag.” But unlike the Illinois District Court in the BENICAR case, the Virginia District Court in the DDAVP case ruled in its October 14, 2014 decision that notwithstanding the patent delisting, there remains a case or controversy by which Glenmark may seek a declaratory judgment regarding the disclaimed and now nonexistent patent.  Specifically, wrote the Virginia District Court:

Ferring held an exclusive license to the ‘340 patent that is listed in connection with Sanofi’s NDA for DDAVP Tablets.  The Federal Circuit has consistently held that “the alleged action taken (giving rise to the injury-in-fact) [is] [the] listing [of] particular patents in the Orange Book.”  Teva Pharms., USA, Inc. v. Eisai Co. Ltd., 620 F.3d 1341, 1346-47 (citing Caraco, 527 F.3d at 1292; and Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353, 1359-60 (Fed. Cir. 2008).  The same logic applies here.  That is, “‘but-for’ the [] list[ing] [of the ‘340] patent in the Orange Book, FDA approval of [Glenmark’s] drug would not have been independently delayed by the patent.”  Id.  The statutory disclaimer and request to delist the patent from the Orange Book does not obscure the traceability of Glenmark’s injury to Ferring.  In other words, the statutory disclaimer of the ‘340 patent, that Glenmark admits renders the patent legally nonexistent, does not eliminate the patent from obstructing the FDA’s approval of Glenmark’s ANDA.  The ‘340 patent remains the critical factor in the FDA’s approval process. . . .

Finding that it may appropriately exercise jurisdiction over the matter, the Court now finds no persuasive reason to decline to do so.  Exercising jurisdiction in this matter will not merely serve a useful purpose in settling the legal relations at issue and affording relief from the underlying controversy, but is essential to doing so.  There exists a legitimate dispute over the continued listing of the ‘340 patent in the Orange Book that the Court may resolve through “specific relief… of a conclusive character. ”  MedImmune, 549 U.S. at 127 (citations and internal quotation marks omitted).  Such relief is appropriately sought under the Declaratory Judgment Act.

The DDVAP case may be headed on to the Federal Circuit for another look, though a decision in the BENICAR case could resolve this Hatch-Waxman declaratory judgment issue sooner rather than later.