Return To Sender: Early ANDA Notice Ineffective

Posted on | June 16, 2008 | No Comments

2008-1414 SB Pharmco v. Mutual Pharmaceutical
ED/PA 08-cv-0549
Judge R. Barclay Surrick

Defendant Mutual appeals from the grant by Judge R. Barclay Surrick of Judgment on the Pleadings, finding that Mutual’s December 21, 2007 ANDA Paragraph IV Notice to SB d/b/a Glaxosmithkline (GSK) was premature and did not trigger the 45-day period to file a lawsuit under 21 U.S.C. § 355(b)(5)(B)(iii).  Case dismissed.

GSK owns 7,268,156 directed to compositions and treatment methods for carvedilol phosphate salts or solvates, which it sells as COREG CR®, an extended release formulation for treating hypertension, myocardial infarction and heart failure.  The ‘156 is listed in the Orange Book.  Mutual filed an ANDA on November 19, 2007, and an amendment with Paragraph IV certification on December 21, 2007, sending GSK notice on that later date.  However, the FDA did not acknowledge the ANDA until March 17, 2008.  The question before the court was whether Mutual’s notice was timely or premature.

ANDA Overview.  Under Hatch-Waxman Act, a company seeking to market a generic version of a drug may file an Abbreviated New Drug Application (ANDA), relying on the clinic studies performed by the pioneer drug manufacturer.  It need not prove the safety and effectiveness of the proposed generic so long as it can show it is bioequivalent to the drug for which it will serve as a substitute. 

In addition, the applicant must certify that the generic will not infringe any of the patents listed in the Orange Book for that drug.  One type of certification is Paragraph IV, stating that the patent is invalid or will not be infringed by the generic for which the applicant seeks approval.  See 21 U.S.C. § 355(j)(2)(A)(vii)(I-IV).

The applicant must serve the patentee with notice of the Paragraph IV certification, following which the patentee has 45-days to file an action for patent infringement.  If the patentee files a suit, the ANDA cannot be approved until the earlier of the patent being held invalid or not infringed, or 30-months.

Timing of Notice.  Mutual served GSK with notice of its Paragraph IV certification on the same day it filed its ANDA amendment–and before the FDA had deemed the ANDA received.  Over the next several weeks, GSK requested Mutual to withdraw the notice as premature–when Mutual refused, GSK (on the 45th day) filed a declaratory judgment action for determination that the notice was premature–and asserting a claim for patent infringement "just in case."

21 U.S.C. § 355(j)(2)(B)(ii) states, in pertinent part: 

Timing of notice.—

An applicant that makes a certification described in subparagraph
(A)(vii)(IV) shall give notice as required under this subparagraph—

(I)
if the certification is in the application, not later than 20 days
after the date of the postmark on the notice with which the Secretary
informs the applicant that the application has been filed….

The FDA has promulgated regulations that provide that it has "received" an ANDA and will send notice of receipt only after it has preliminarily determined that it is sufficiently complete to permit substantive review.  21 C.F.R. § 314.101(b)(1) and § 314.95(b).

The FDA’s position–and that of GSK–is that the "notice" to trigger the 45 day statutory period can not be sent until after Mutual received the filing notice from the FDA.  Mutual argued that the statute only provided the latest the notice could be sent, claiming that the notice could be sent any time after the filing of the ANDA and before the expiration of 20 days after the FDA confirmation.  The issue is whether the trigger is the act of submitting or the receipt of the submission, the latter being defined by the FDA pursuant to regulation.

The court agreed with GSK and the FDA.  Reviewing the entire purpose of Hatch-Waxman, the court found that having the FDA first confirm a substantially complete filing before allowing an effective notice to be sent avoided unnecessary patent infringement litigation over incomplete ANDAs.  Also, it prevented entities from purposefully filing incomplete or sham ANDAs simply to become the first ANDA filer (and thereby possibly gaining the 180 day exclusivity). 

The court also rejected Mutual’s argument that the notice was timely–and indeed required–under § 355(j)(2)(B)(ii)(II) regarding ANDA amendments:

(II) if the certification is in an amendment
or supplement to the application, at the time at which the applicant
submits the amendment or supplement, regardless of whether the
applicant has already given notice with respect to another such
certification contained in the application or in an amendment or
supplement to the application.

Mutual’s certification was filed with an amendment to the ANDA.  Although the statute explicitly states that the notice must be sent "at the time . . . the applicant submits the amendment"–the court held that this provision assumed that the initial application had been "received" (i.e., "accepted") by the FDA. 

Finally, the court rejected Mutual’s argument that the case should proceed because GSK sued it for patent infringement upon the filing of the ANDA–thus, GSK’s "backup infringement claim" provides jurisdiction to the court to hear the case.  Again, the court found that no "case or controversy" existed at the time the case was filed–under either a DJ or infringement theory:

In this case, there was no actual or substantial controversy at the time that Plaintiffs’ filed their Complaint. Plaintiffs’ claim of patent infringement was based upon service of an invalid Paragraph IV notice for an amendment to an ANDA that had not yet been received by the FDA.  During the preliminary review stage, ANDA 90-132 could not have been approved by the FDA. Under the circumstances, Defendants’ ANDA could not cause an injury-in-fact to Plaintiffs. It was potentially incomplete and could not constitute an act of infringement. Under the statute and the case law, we conclude that Defendants’ delivery of the ANDA to the FDA did not create the actual or imminent controversy necessary to satisfy the Declaratory Judgment Act.

Notes:  On March 17, 2008, following FDA acceptance of the ANDA, Mutual sent another paragraph IV notice.  I could not find a new lawsuit on PACER by SB/GSK on against Mutual.

More reading:

Opinion

Counsel:

SB/GSK: Wilmer Cutler Pickering Hale & Dorr (Amy K. Wigmore, Jasmine S. Mcghee, Mark L. Rienzi, William F. Lee, William G. Mcelwain) and Dechert (Joseph R. Heffern, Kevin M. Flannery, Martin J. Black).

Mutual: Curtis, Mallett-Prevost, Colt & Mosle (Eliot Lauer, Jacques Semmelman, Rachael Yocum), Dilworth Paxson (James J. Rodgers) and Cantor Colburn (Leah M. Reimer, Leslie-Anne Maxwell, Steven M. Coyle).

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