lunes, 6 de abril de 2015

FDA Law Blog: Federal Circuit Rules that a Statutory Patent Disclaimer is Sufficient to Trigger Hatch-Waxman DJ Jurisdiction; Will It Be Enough to Trigger a Forfeiture of 180-Day Exclusivity?

FDA Law Blog: Federal Circuit Rules that a Statutory Patent Disclaimer is Sufficient to Trigger Hatch-Waxman DJ Jurisdiction; Will It Be Enough to Trigger a Forfeiture of 180-Day Exclusivity?

Posted: 05 Apr 2015 06:42 PM PDT
By Kurt R. Karst –     

Last week, the U.S. Court of Appeals for the Federal Circuit ruled in Apotex Inc. v. Daiichi Sankyo, Inc., saying that there is subject matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed Orange Book-listed patent.  The decision reverses a January 2014 decision from the U.S. District Court for the Northern District of Illinois.

As we previously reported (here and here), the case stems from a November 2012 Complaint for Declaratory Judgment filed by Apotex, Inc. (“Apotex”) in an effort to obtain a court decision triggering the 75-day statutory period under the failure-to-market forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb) and that could ultimately result in a forfeiture of 180-day exclusivity eligibility for purported first-filer Mylan Pharmaceuticals Inc. (“Mylan”) for its generic version of Daiichi Sankyo Inc.’s (“Daiichi”) BENICAR (olmesartan medoxomil) Tablets approved under NDA 021286.  The patent at issue – U.S. Patent No. 6,878,703 (“the ‘703 patent”) – is apparently the only remaining exclusivity-bearing patent, and, as a result of the patent being disclaimed, is listed in the Orange Book with a “Patent Delist Request Flag.”  For those in need of some good bedtime reading, the briefs filed in the Federal Circuit are available here (Daiichi); here and here (Apotex); and here and here (Mylan).

By way of a quick review, under the 180-day exclusivity failure-to-market forfeiture provisions added to the statute by the 2003 Medicare Modernization Act (“MMA”), there must be two events – or “bookends” – to calculate a “later of” event between items (aa) and (bb).  The first bookend date under item (aa) is the earlier of the date that is:

(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or

(BB) 30 months after the date of submission of the application of the first applicant
That event has already happened with respect to generic BENICAR given the April 25, 2006 date on FDA’s List of Paragraph IV Patent Certifications: the “earlier of” date under (aa) is October 25, 2008.

The other bookend – the (bb) part of the equation – provides that the (bb) date is “the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a [Paragraph IV] certification qualifying the first applicant for the 180-day exclusivity period,” one of three events occurs:

(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.

(BB) In an infringement action or a declaratory judgment action described in [FDC Act § 505(j)(5)(D)(i)(I)(bb)(AA)], a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.

(CC) The patent information submitted under [FDC Act § 505(b) or (c)] is withdrawn by the holder of the application approved under subsection (b).
The (AA) and (BB) court decision events under item (bb) can be triggered in patent infringement litigation by “the first applicantor any other applicant (which other applicant has received tentative approval).”  We emphasize that last portion for a reason, which we’ll get to in due course.  But for now, let’s put a pin in it

Returning to the BENICAR case, the Federal Circuit nicely summarized the position of the parties:

Apotex asserted that it has a concrete stake in securing the requested declaratory judgment because, under the governing statutory provisions, the requested judgment would allow it to enter the market earlier than it could without the judgment. . . .  According to Apotex, a court judgment of non-infringement would cause Mylan to forfeit the exclusivity period if Mylan has not marketed its drug 75 days after appeal rights are exhausted (certiorari aside) and Apotex has obtained tentative approval for its generic product from the FDA. . . .

Daiichi and Mylan did not dispute that an earlier-than-otherwise Apotex entry into the market would likely have the identified effects, to Apotex’s benefit and Daiichi’s and Mylan’s detriment.  But Daiichi argued that no controversy exists because it could not now assert the disclaimed ’703 patent against Apotex.  Mylan added arguments based on the fact that Apotex lacked (and lacks) a “tentative approval” from the FDA for its ANDA.  Specifically, Mylan argued that redress of Apotex’s delayed-market-entry injury is unduly speculative before tentative approval is in hand.  Mylan also made an argument based on the fact that tentative approval is a necessary statutory condition for the forfeiture of Mylan’s presumptive exclusivity period based on the declaratory judgment requested here. § 355(j)(5)(D).  It argued that the forfeiture provision should be read to mean that, for a declaratory judgment brought by a second ANDA filer to cause forfeiture, the second ANDA filer must have had tentative FDA approval when it brought the declaratory-judgment action.  Under that interpretation, Mylan contended, the present action cannot provide Apotex forfeiture relief—even if Apotex could file an identical declaratory-judgment action as soon as it obtains tentative approval.
The Illinois District Court granted Daiichi’s Motion to Dismiss the Apotex Complaint, reasoning that “both Daiichi and Apotex no longer hold any meaningful interest in the now disclaimed patent” and that the continued listing of the ‘703 patent in the Orange Book “does not create a case or controversy by which Apotex may seek a declaratory judgment regarding a nonexistent patent.”  In addition, the Illinois District Court denied Mylan’s Motion to Intervene as moot in light of the court’s decision to grant Daiichi’s Motion to Dismiss.  Apotex subsequently appealed, and Mylan cross-appealed the District Court’s denial of intervention.

On appeal, the Federal Circuit, after confirming Mylan’s right to be a party in the case “because of its obvious stake in the dispute,” reversed the Illinois District Court’s dismissal of Apotex’s Complaint for lack of a case or controversy.  Citing and quoting the U.S. Supreme Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), the Federal Citcuit concluded that “the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”  From there, the Federal Circuit addressed four issues:

  1. whether Daiichi’s disclaimer of the patent means that the parties lack concrete stakes in the dispute over the declaratory judgment; 
  2. whether the alleged harm is traceable to Daiichi; 
  3. whether the real-world impact is too contingent on future events—specifically, FDA tentative approval of Apotex’s ANDA; and 
  4. whether Apotex’s alleged harm would not be redressed even if Apotex receives the requested judgment because ultimate relief is independently blocked by the statutory standards for triggering forfeiture of Mylan’s exclusivity period.
Our friends over at the Patent Docs blog nicely summarized each point identified by the Federal Circuit leading to the Court’s holding – that “Apotex has alleged facts supporting the conclusion ‘that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to
warrant the issuance of a declaratory judgment’” – so we refer you to that blog post for that discussion.  That means we get to spend the rest of our time on other aspects of the Federal Circuit’s decision that we find interesting.  And you’ll hardly be suprised that by “other aspects” we mean 180-day exclusivity.  (Now you can take out the pin noted above.)

In its decision, the Federal Circuit performs its own mini-forfeiture analysis, identifying October 2008 as the month when the (aa) bookend date occurs under the failure-to-market provisions at FDC Act § 505(j)(5)(D)(i)(I).  As to the (bb) bookend date, the Federal Circuit, referring to that provision says:

This provision, which separates the tentative-approval phrase from its specification of certain forfeiture-triggering dates, including the non-infringement-finality date of (AA), admits of a simple reading.  There are two requirements for forfeiture: a court must have entered a final decision of non-infringement that is no longer appealable (certiorari aside), and the second (or later) filer must have received tentative approval.  The first filer forfeits its exclusivity if it has not entered 75 days after those two requirements are satisfied.  Under that reading, Apotex can trigger forfeiture in this case by obtaining the judgment it seeks here and by obtaining tentative approval, if it does both early enough in relation to Mylan’s market entry.
This and other statements in the Court’s decision seem to indicate a preference for a non-draconian interpretation of the statute.  Under a draconian interpretation, if a subsequent applicant first obtains a court decision and then obtains tentative approval, one reading of the statute is that the court decision does not trigger the 75-day period.  Why?  Because the order of events is critical under this interpretation.  That is, for the 75-day period to be triggered, an applicant must have tentative approval at the time there is a court decision.  If not, then the court decision has no effect and there is not a (bb) event.  Other, less draconian interpretations could also result under this permutation: (1) that the 75-day period is retroactive to the date after the court decision; or (2) that the 75-day period begins on the day after the date on which a subsequent applicant completed the statutory criteria (i.e., the 75-day period begins after the date a subsequent applicant obtains tentative approval).

Continuing on, the Federal Circuit says something interesting:

Tentative approval is required before a second filer can actually trigger forfeiture, because exclusivity should not be lost unless the second filer is on the verge of having an approved product to deliver the benefits of competition.  It would be arbitrary, in terms of the discernible policy, to require tentative approval earlier.  Thus, for this case, the purpose of requiring tentative approval has nothing to do with Apotex’s approval status at the time it brought the declaratory-judgment action, and it has everything to do with its approval status when forfeiture is triggered.  Our interpretation—the 75-day clock for Mylan starts to run when Apotex has both tentative approval and a no-longer-appealable judgment of non-infringement—fits the concrete function of the provision . . . . [(Emphasis added)]
Putting aside the order of events (i.e., a final court decision and tentative approval), the Court’s conclusion (emphasized above) is pretty clear under the statute:  if “any other applicant” (i.e., a subsequent applicant) obtains tentative approval and that same subsequent applicant obtains a final court decision, then the 75-day period under FDC Act § 505(j)(5)(D)(i)(I)(bb) is triggered.  Eligibility for 180-day exclusivity would be forfeited (provided there is a subitem (aa) event) unless a first applicant timely commercially markets its drug product.  

But the Federal Circuit does not consider another option . . . .  It’s possible that FDA will interpret the “any other applicant (which other applicant has received tentative approval)” to mean that if a subsequent without tentative approval, like Apotex, obtains a court decision, then both the court decision and tentative approval requirements are met because a different subsequent applicant previously obtained tentative approval.  Under that interpretation, the 75-day period under FDC Act § 505(j)(5)(D)(i)(I)(bb) begins to run after the court decision be comes final.  Eligibility for 180-day exclusivity would be forfeited 75 days later (provided there is a subitem (aa) event), unless a first applicant commercially markets before the 75-day date.

Interestingly, that’s exactly the tentative approval situation with generic BENICAR.  Although FDA has not tentatively approved Apotex’s ANDA, the Agency has approved ANDAs submitted by two other subsequent applicants: ANDA 090237 (Sandoz) and ANDA 091079 (Teva).  If Apotex obtains a final court decision on the ‘703 patent because the company it is now able to pursue a declaratory judgment action (and if Apotex still doesn’t have tentative approval at that time), then FDA will once again be put in the position of having to make a decision on how best to interpret the 180-day exclusivity failure-to-market forfeiture provisions.

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