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Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

No. 15-5021 September Term, 2015

 FILED ON: JULY 15, 2016

TAKEDA PHARMACEUTICALS U.S.A., INC.,

APPELLANT

ELLIOTT ASSOCIATES, L.P., ET AL.,

APPELLEES

v.

SYLVIA MATHEWS BURWELL, IN HER OFFICIAL CAPACITY AS SECRETARY, U.S. DEPARTMENT OF

HEALTH AND HUMAN SERVICES, ET AL.,

APPELLEES

Consolidated with 15-5022 

Appeals from the United States District Court

for the District of Columbia

(No. 1:14-cv-01668)

(No. 1:14-cv-01850)

Before: KAVANAUGH and WILKINS, Circuit Judges, and SILBERMAN, Senior Circuit

Judge.

J U D G M E N T

This appeal was considered on the record from the United States District Court for the

District of Columbia and on the briefs and oral arguments of the parties. The Court has afforded the

issues full consideration and has determined that they do not warrant a published opinion. See D.C.

Cir. R. 36(d). It is

ORDERED and ADJUDGED that the portion of the appeal seeking review of FDA’s

decision to approve Mitigare without Hikma’s certifying to the Colcrys patents be DISMISSED AS

MOOT and that this portion of the judgment of the District Court be VACATED. It is

FURTHER ORDERED and ADJUDGED that the portion of the judgment of the District

Court regarding Takeda’s challenge to FDA’s approval of the Mitigare label be AFFIRMED.

USCA Case #15-5021 Document #1624886 Filed: 07/15/2016 Page 1 of 4
In 2009, the Food and Drug Administration approved Colcrys, a drug for the prevention and

treatment of acute gout flares. Five years later, FDA approved a new drug – Mitigare – also for the

prevention of gout flares.

When an applicant seeks FDA approval for a new drug under the Food, Drug, and Cosmetic

Act, the applicant must generally certify to any patents “relied upon by the applicant for approval of

the application.” 21 U.S.C. § 355(b)(2). One such certification is called a Paragraph IV

certification. A Paragraph IV certification is generally used when an applicant seeks to market a new

drug that is essentially identical to a previously approved drug and the applicant claims that the

patent for the previously approved drug “is invalid or will not be infringed by the manufacture, use,

or sale of the new drug for which the application is submitted.” Id. § 355(b)(2)(A)(iv). As relevant

here, an applicant filing a Paragraph IV certification must also notify the owner of the patents for the

previously approved drug. Id. § 355(b)(3).

Once the applicant has made the Paragraph IV certification, FDA’s “approval shall be made

effective immediately.” Id. § 355(c)(3)(C). If, however, the patent owner brings an infringement

action against the applicant within 45 days of receiving notice, then FDA must stay its approval for

up to 30 months or until specified events happen in the patent litigation. See id. Of relevance here,

if a district court decides “that the patent is invalid or not infringed,” then FDA “approval shall be

made effective on the date on which the court enters judgment reflecting the decision.” Id.

§ 355(c)(3)(C)(i)(I). For present purposes, the most important point is this: If a patent infringement

action is brought, then FDA approval of the application must be made effective on the date of any

district court judgment concluding that the patent is not infringed.

When Hikma Pharmaceuticals applied for FDA approval of Mitigare, Hikma did not certify

to the Colcrys patents. As a result, Colcrys’s manufacturer – Takeda Pharmaceuticals – was not able

to obtain a 30-month stay of FDA’s approval of Mitigare. When Takeda discovered that FDA had

approved Mitigare, Takeda sued Hikma for patent infringement in the U.S. District Court for the

District of Delaware. The District Court of Delaware recently found no infringement of Takeda’s

patents and dismissed Takeda’s infringement suit. See Takeda Pharmaceuticals U.S.A., Inc. v. WestWard Pharmaceutical Corp., Civ. No. 14-1268-SLR (May 18, 2016).

Meanwhile, Takeda also sued FDA in the U.S. District Court for the District of Columbia,

alleging that the agency had acted arbitrarily and capriciously for purposes of the Administrative

Procedure Act. The D.C. District Court consolidated Takeda’s suit with a similar suit brought by

Elliott Associates, a hedge fund with rights to a percentage of royalties from the domestic sale of

Colcrys. First, Takeda and Elliott claimed that Hikma should have certified to the Colcrys patents

under Paragraph IV and that FDA should not have approved Hikma’s application without that

certification. Second, Takeda also alleged that FDA had impermissibly departed from agency

precedent in approving the Mitigare label.

We conclude that the first issue – whether Hikma should have certified to the Colcrys patents

under Paragraph IV – is moot because the underlying issue of infringement has alreadybeen resolved

in Hikma’s favor by the District Court of Delaware. “A case is moot if events have so transpired that

the decision will neither presently affect the parties’ rights nor have a more-than-speculative chance

USCA Case #15-5021 Document #1624886 Filed: 07/15/2016 Page 2 of 4
of affecting them in the future.” Pharmachemie B.V. v. Barr Laboratories, Inc., 276 F.3d 627, 631

(D.C. Cir. 2002) (internal quotation marks omitted). Here, even if we were to hold that Hikma

should have certified to Takeda’s patents, that decision would at most entitle Takeda to a stay of

FDA’s approval of Mitigare pending a district court decision on the patent infringement suit. But

there has already been a district court judgment on the patent infringement suit, so Takeda would not

receive any stay of FDA’s approval of Mitigare. Without the possibility of such a stay, Takeda’s and

Elliott’s claims about Hikma’s failure to certify to the Colcrys patents are academic and moot. Cf.

id.

Takeda and Elliott offer three other primary reasons why the certification issue is not moot. 

First, Takeda and Elliott argue that Hikma should be made to go through the motions of re-applying

to FDA for approval of Mitigare. But given the District Court of Delaware’s decision, forcing

Hikma to reapply would provide no meaningful redress to Takeda and Elliott. Second, Takeda also

refers to the bond it posted in the District Court of Delaware. But that is an issue for the District

Court of Delaware to resolve, as explained more fully below. Third, Elliott (but importantly not

Takeda) argues that the District Court of Delaware did not purport to adjudicate all of the patents that

Hikma was allegedly obligated to certify to. So, Elliott contends, Takeda could still sue Hikma for

infringement and obtain the 30-month stay. But the reason that the District Court of Delaware did

not adjudicate all of the patents is because Takeda did not sue Hikma based on all of the patents. 

That no doubt is whyTakeda has not joined Elliott in advancing this argument as a basis for rejecting

mootness. In short, Elliott’s argument is unavailing.

We have carefullyconsidered all of the arguments about mootness. We conclude that Takeda

and Elliott’s challenge to FDA’s decision to approve Mitigare without Hikma’s certifying to the

Colcrys patents is moot. To state the obvious, if FDA ever concludes that Mitigare is no longer safe

and effective, FDA has an array of statutory and regulatory tools to pull it off the market. See 21

U.S.C. § 355(e). But the dispute over whether Hikma should have certified to the Colcrys patents

under Paragraph IV is moot.

In so ruling, we emphasize that our decision should have no impact on the District Court of

Delaware’s ruling on the Rule 65 bond issue. In particular, the District Court of Delaware may

independently decide whether Hikma should have certified under Paragraph IV to the Colcrys

patents, as well as whether and how the answer to that question should affect the District Court’s

resolution of the Rule 65 bond issue. In that regard, we note that the District Court of Delaware’s

initial ruling on the TRO stated that “Hikma has effectively side-stepped” the Paragraph IV

certification process “in an effort to get its generic product to market without appropriate legal

underpinnings.” Memorandum Order at 6, Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward

Pharmaceutical Corp., No. 14-1268 (D. Del. Oct. 9, 2014). The District Court of Delaware factored

that point into its analysis of the balance of hardships and the public interest, and the court may do

so again if it believes doing so would be relevant to resolution of the Rule 65 bond issue.

Apart from its claim about Hikma’s failure to certify, Takeda also argues that the Mitigare

label impermissibly omits critical safety information. That claim is not moot, but we disagree on

the merits with Takeda. When FDA makes scientific judgments, this Court owes the agency the

“most deferential” review. Baltimore Gas & Electric Co. v. Natural Resources Defense Council,

USCA Case #15-5021 Document #1624886 Filed: 07/15/2016 Page 3 of 4
Inc., 462 U.S. 87, 103 (1983). Here, FDA affirmatively chose to depart from some past statements

it had made about the labeling of products for the prevention and treatment of acute gout flares. As

the record makes clear, the agency “employed its scientific expertise to reach” each of those

decisions. Takeda Pharmaceuticals, U.S.A., Inc. v. Burwell, 78 F. Supp. 3d. 65, 107 (D.D.C. 2015). 

FDAthen adequately explained those decisions through “various memos detailing its considerations

and conclusions.” Id. As the District Court concluded, “Takeda has not established that the APA

requires anything more.” Id.

In sum, we dismiss as moot the portion of the appeal seeking review of FDA’s decision to

approve Mitigare without Hikma’s certifying to the Colcrys patents, and we affirm the judgment of

the District Court with respect to Takeda’s challenge to FDA’s approval of the Mitigare label.

Pursuant to D.C. Circuit Rule 36, this disposition will not be published. The Clerk is directed

to withhold issuance of the mandate herein until seven days after resolution of any timely petition

for rehearing or rehearing en banc. See Fed. R. App. P. 41(b); D.C. Cir. R. 41.

Per Curiam

FOR THE COURT:

Mark J. Langer, Clerk

BY: /s/

Ken Meadows

Deputy Clerk

USCA Case #15-5021 Document #1624886 Filed: 07/15/2016 Page 4 of 4