UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 14-1522

MYLAN PHARMACEUTICALS, INCORPORATED,

Plaintiff – Appellant,

and

WATSON LABORATORIES, INCORPORATED; LUPIN PHARMACEUTICALS, 

INCORPORATED,

Intervenors/Plaintiffs,

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

Defendant – Appellee,

TEVA PHARMACEUTICALS USA, INCORPORATED,

Intervenor/Defendant – Appellee.

No. 14-1529

MYLAN PHARMACEUTICALS, INCORPORATED,

 Plaintiff,

WATSON LABORATORIES, INCORPORATED,

 Intervenor/Plaintiff,

 and
2

LUPIN PHARMACEUTICALS, INCORPORATED,

 Intervenor/Plaintiff – Appellant,

 v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

 Defendant – Appellee,

TEVA PHARMACEUTICALS USA, INCORPORATED,

 Intervenor/Defendant – Appellee.

No. 14-1593

MYLAN PHARMACEUTICALS, INCORPORATED,

 Plaintiff,

LUPIN PHARMACEUTICALS, INCORPORATED,

 Intervenor/Plaintiff,

 and

WATSON LABORATORIES, INCORPORATED,

 Intervenor/Plaintiff – Appellant,

 v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

 Defendant – Appellee,

TEVA PHARMACEUTICALS USA, INCORPORATED,

 Intervenor/Defendant – Appellee.
3

Appeals from the United States District Court for the Northern

District of West Virginia, at Clarksburg. Irene M. Keeley, 

District Judge. (1:14-cv-00075-IMK)

Argued: September 17, 2014 Decided: December 16, 2014

Before WILKINSON, SHEDD, and WYNN, Circuit Judges.

Reversed and remanded by unpublished opinion. Judge Wynn wrote 

the opinion, in which Judge Wilkinson and Judge Shedd joined.

ARGUED: Douglas Brooke Farquhar, HYMAN, PHELPS & MACNAMARA,

P.C., Washington, D.C.; Chad Allen Landmon, AXINN, VELTROP & 

HARKRIDER LLP, Hartford, Connecticut; Arthur Y. Tsien, OLSSON 

FRANK WEEDA TERMAN MATZ, PC, Washington, D.C., for Appellants. 

Daniel Tenny, UNITED STATES DEPARTMENT OF JUSTICE, Washington, 

D.C.; Michael David Shumsky, KIRKLAND & ELLIS LLP, Washington, 

D.C., for Appellees. ON BRIEF: John H. Tinney, Jr., THE TINNEY 

LAW FIRM, PLLC, Charleston, West Virginia, for Appellant Lupin 

Pharmaceuticals, Incorporated. Jennifer M. Thomas, HYMAN, 

PHELPS & MCNAMARA, P.C., Washington, D.C.; Ralph S. Tyler, 

VENABLE LLP, Washington, D.C., for Appellant Mylan 

Pharmaceuticals, Incorporated. Mark D. Alexander, AXINN, 

VELTROP & HARKRIDER LLP, Hartford, Connecticut, for Appellant 

Watson Laboratories, Incorporated. Stuart F. Delery, Assistant 

Attorney General, William B. Schultz, General Counsel, Scott R. 

McIntosh, Civil Division, UNITED STATES DEPARTMENT OF JUSTICE, 

Washington, D.C.; William J. Ihlenfeld, II, United States 

Attorney, OFFICE OF THE UNITED STATES ATTORNEY, Wheeling, West 

Virginia; Elizabeth H. Dickinson, Associate General Counsel, 

Annamarie Kempic, Deputy Chief Counsel, UNITED STATES FOOD AND 

DRUG ADMINISTRATION, Rockville, Maryland; Shoshana Hutchinson, 

Associate Chief Counsel, UNITED STATES DEPARTMENT OF HEALTH AND 

HUMAN SERVICES, Washington, D.C., for Appellee United States 

Food and Drug Administration. John C. O'Quinn, John K. Crisham, 

Stephen S. Schwartz, KIRKLAND & ELLIS LLP, Washington, D.C., for 

Appellee TEVA Pharmaceuticals USA, Incorporated.

Unpublished opinions are not binding precedent in this circuit.
4

WYNN, Circuit Judge:

In April 2014, the U.S. Food and Drug Administration 

(“FDA”) issued a letter decision regarding the rights of patent 

holders and the ease with which generic drugs could enter the 

market place under the Hatch-Waxman Act. Though disclaiming

that it was adjudicating the rights of any specific parties, 

this letter effectively prevents Appellants Mylan 

Pharmaceuticals, Inc., Watson Laboratories, Inc., and Lupin 

Pharmaceuticals, Inc. from bringing their generic versions of 

celecoxib, an arthritis treatment drug currently sold under the 

brand name Celebrex, to the market until June 2015. The FDA 

based its decision on its interpretation of a Hatch-Waxman Act

provision it deemed ambiguous. However, as explained below, we 

find the pertinent provision unambiguous in context. 

Accordingly, we reverse the district court’s opinion upholding

the FDA’s letter decision.

I.

In 1984, Congress amended the Food, Drug, and Cosmetic Act 

to “make available more low cost generic drugs by establishing a 

generic drug approval procedure for pioneer drugs first approved 

after 1962.” H.R. Rep. No. 98-857, part 1, at 14. See The Drug 

Price Competition and Patent Term Restoration Act of 1984 (the 

“Hatch-Waxman Act” or “Hatch-Waxman”), Pub. L. No. 98-417, 98 
5

Stat. 1585 (1984), formerly codified at 21 U.S.C. § 355 and 35 

U.S.C. §§ 156, 271, 282. In furtherance of this goal, the 

Hatch-Waxman Act created a truncated approval process for 

generic drugs and, crucially for this case, the potential for a 

180-day period of market exclusivity for the first company to 

bring its generic drugs to market. The statute, and 

specifically the language at issue in this case, has since been 

amended by the Medicare Prescription Drug Improvement and 

Modernization Act, Pub L. No. 108-173, 117 Stat. 2066 (2003). 

Because the initial Abbreviated New Drug Applications at issue 

in this case were filed prior to the enactment of this revision, 

the pre-amendment version of the statute applies.

Before marketing a new drug, a drug company must submit a 

New Drug Application, an elaborate document detailing, among 

other things, the drug’s safety and efficacy. See 21 U.S.C. § 

355(b)(1). A New Drug Application also must contain “the patent 

number and the expiration date of any patent which claims the

drug . . . or which claims a method of using such drug[.]” Id. 

The FDA publishes information about those patents and methods of 

use “in a fat, brightly hued volume called the Orange Book[.]” 

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 

1676 (2012).

Generic drug companies, by contrast, need not submit a 

complete New Drug Application to seek FDA approval of their 
6

drugs. Under Hatch-Waxman, they may instead file an Abbreviated 

New Drug Application, in which they may “rely on the clinical 

studies performed by the pioneer drug manufacturer” instead of 

having “to prove the safety and effectiveness of [their] generic 

drug from scratch.” aaiPharma, Inc. v. Thompson, 296 F.3d 227, 

231 (4th Cir. 2002). “[T]he generic manufacturer must prove 

only that its drug is bioequivalent to the brand name drug it 

wants to copy.” Id. 

In its Abbreviated New Drug Application, a generic drug 

company must make one of four certifications regarding the noninfringement of “listed” patents referenced in the Orange Book. 

See 21 U.S.C. § 355(j)(2)(A)(vii). With the fourth

certification option (a “Paragraph IV certification”), the 

relevant one for this case, generic drug makers confirm that any

patent for the pioneer drug is invalid or will not be infringed. 

Id. Additionally, the Abbreviated New Drug Application 

applicant must also certify to “later-listed patents” when they 

are published in the Orange Book. Id. § 355(j)(2)(B).

If, as in this case, a generic drug company makes a

Paragraph IV certification, it must provide notice of its 

Abbreviated New Drug Application to the owner of any patent 

covered by the Paragraph IV certification and to the brand-name 

company that filed the New Drug Application. Id. §

355(j)(2)(B)(i). Hatch-Waxman treats a Paragraph IV 
7

certification as an artificial act of patent infringement by the 

generic drug company. Id. §§ 355(j)(2)(B)(i)-(ii); Eli Lilly & 

Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990). If the brandname company wants to defend its patent, it must bring an 

infringement action within forty-five days of receiving the 

generic company’s notice. 21 U.S.C. § 355(j)(5)(B)(iii).

In general, the FDA “shall approve or disapprove” the 

generic drug application within 180 days of receiving the 

Abbreviated New Drug Application. Id. § 355(j)(5)(A). However, 

the effective date of the FDA’s approval is dependent on several 

factors, including which of the four certifications the generic 

company used. In the case of a Paragraph IV certification, the 

timing of the FDA’s approval of an Abbreviated New Drug 

Application depends on whether the brand-name company brings an 

action to defend its patent. If it does, the FDA’s approval of 

the Abbreviated New Drug Application is stayed for 30 months. 

Id. If, during that 30-month stay, “a court decides that such 

patent is invalid or not infringed, the approval shall be made 

effective on the date of the court decision.” Id. § 

(j)(5)(B)(iii)(I). 

If more than one applicant submits an Abbreviated New Drug 

Application with a Paragraph IV certification, the statute 

provides that a later-filed “application shall be made effective 

not earlier than one hundred and eighty days after” either (1) 
8

the date that the FDA received notice that the first-filer began 

marketing the drug; or (2) “the date of a decision of a court in 

an action [brought by the brand-name company against the company 

filing the Abbreviated New Drug Application] holding the patent 

which is the subject of the certification to be invalid or not 

infringed”—also known as the “court-decision trigger.” Id. §

(j)(5)(B)(iv). This 180-day exclusivity period, potentially 

worth millions of dollars, is meant to incentivize generic 

pharmaceutical companies to bear the costs of the patent 

infringement lawsuit. Teva Pharm., USA, Inc. v. Leavitt, 548 

F.3d 103, 104 (D.C. Cir. 2008).

Finally, when multiple patents protect a brand-name drug 

from competition, the FDA, under the pre-amendment version of 

Hatch-Waxman at issue in this case, took a “patent-by-patent 

approach” in determining whether a generic drug company is 

entitled to the 180-day exclusivity period. As it explained in 

its letter decision: 

eligibility for 180-day exclusivity would be based on 

which company submitted the first paragraph IV 

certification challenging each listed patent. 

Therefore, in cases where multiple patents are listed, 

different applicants may have the first paragraph IV 

certification as to different patents and multiple 

ANDA applicants may simultaneously be eligible for 

180-day exclusivity as to the particular patents on 

which they were first. 
9

J.A. 43. None of the parties challenge the FDA’s patent-bypatent approach (while recognizing that the law has, in the 

interim, changed and that the FDA now uses a drug-by-drug 

approach).

II.

Pfizer produces the brand-name arthritis drug Celebrex. 

Celebrex was protected by the following patents listed in the 

Orange Book as of 2003: 5,466,823 (“the ‘823 patent”); 5,563,165 

(“the ‘165 patent”); 5,760,068 (“the ‘068 patent”); and one 

other patent not at issue in this case. In 2003, Teva filed 

Abbreviated New Drug Application 76-898, which contained 

Paragraph IV certifications as to the ‘823, ‘165, and ‘068 

patents. Pfizer sued Teva for patent infringement, and the 

District Court of New Jersey held that all three patents were 

valid and infringed by Teva. Pfizer, Inc. v. Teva Pharms. USA, 

Inc., 482 F. Supp. 2d 390 (D.N.J. 2007). The Federal Circuit, 

however, reversed in part, deeming eleven of the claims in the 

‘068 patent invalid. Pfizer, Inc. v. Teva Pharms. USA, Inc., 

518 F.3d 1253 (Fed. Cir. 2008). 

Teva then resubmitted its certifications as to the ‘823 and 

‘165 patents as “Paragraph III certifications”—that is, they

sought approval of their Abbreviated New Drug Application only 

subsequent to the expiration of those two patents. See 21
10

U.S.C. § 355(j)(2)(A)(vii). Meanwhile, several other generic 

drug manufacturers, including Mylan, Watson and Lupin, filed 

Abbreviated New Drug Applications for Celebrex based on

Paragraph IV certifications.

On March 5, 2013, the United States Patent and Trademark 

Office (“PTO”) reissued the invalidated ‘068 patent as RE44048 

(“the ‘048 patent”), Pfizer notified the FDA, and two days 

later, the FDA listed the ‘048 patent in the Orange Book. On 

March 7, 2013, Teva, Mylan, and Watson amended their Abbreviated 

New Drug Applications so that their Paragraph IV certifications 

included the reissued patent. And Lupin amended its Abbreviated 

New Drug Application on March 28, 2013. Again, Pfizer sued for 

patent infringement.

One year later, in March 2014, the District Court for the 

Eastern District of Virginia deemed the ‘048 patent invalid for 

substantially the same reasons that the ‘068 patent had been 

invalidated. G.D. Searle LLC v. Lupin Pharms., Inc., No. 2:13-

cv-00121 (E.D. Va. Mar. 12, 2014). Teva and Pfizer entered into 

a settlement agreement allowing Teva to market celecoxib in 

December 2014. Mylan and Watson also settled with Pfizer. Only 

Lupin remains in the appeal of that decision, which is pending 

in the Federal Circuit.

During the litigation of the ‘048 patent, the various drug 

manufacturers engaged in letter writing and private meetings 
11

with the FDA inquiring into how the agency would approach 

approval of their celecoxib Abbreviated New Drug Applications. 

On April 24, 2014, the FDA issued a letter decision addressed to 

“Celecoxib ANDA Applicant.” The question the FDA purported to 

answer was “whether a prior court decision on the original 

patent triggered (and exhausted) any exclusivity to which a 

first applicant on the original patent was entitled.” J.A. 41. 

Underlying the FDA’s question was the assumption “that the 

reissued patent cannot be the basis for a new period of 180-day 

exclusivity[.]” J.A. 49. The FDA concluded that:

for purposes of 180-day exclusivity, upon the listing 

of a reissued patent, a prior court decision on the 

original patent is not regarded as having triggered 

180-day exclusivity for the single bundle of patent 

rights represented by the original and reissued 

patent. In such a case, eligibility for 180-day 

exclusivity is only available to the applicant that 

first filed a paragraph IV certification to the 

original patent, and that applicant must make a timely 

submission of a paragraph IV certification to the 

reissued patent to remain eligible for 180-day 

exclusivity.

J.A. 51. The letter decision stated that the FDA was merely 

clarifying “the regulatory framework to be applied to the 

relevant ANDAs when such exclusivity determination is made[,]” 

and “not making a determination with respect to 180-day 

exclusivity in a particular case[.]” J.A. 46. 

The following day, April 25, 2014, Mylan sought injunctive 

and declaratory relief against the FDA regarding its letter 
12

decision. Mylan sought to prevent the FDA from granting any 

other company a 180-day exclusivity period. Watson and Lupin 

intervened as plaintiffs, and Teva intervened as a defendant. 

The district court consolidated the hearing on Mylan’s 

preliminary injunction motion with a trial on the merits, 

granted Mylan’s motion for judgment, but in favor of the FDA, 

and dismissed the case. Mylan Pharmaceuticals, Inc., v. FDA, 

No. 1:14-cv-00075-IMK Doc. 125 (N.D. W.Va. June 16, 2014). This 

appeal followed. 

III.

Summary judgment is appropriate “if the movant shows that 

there is no genuine dispute as to any material fact and the 

movant is entitled to judgment as a matter of law.” Fed. R. 

Civ. P. 56(a). We review a grant of summary judgment de novo, 

Nat’l Audubon Soc’y v. Dep’t of the Navy, 422 F.3d 174, 185 (4th 

Cir. 2005), taking the facts in the light most favorable to the 

non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 

242, 255 (1986).

Under the Administrative Procedure Act, 5 U.S.C. § 551 et 

seq., we must set aside an agency action that is “not in 

accordance with law.” Id. § 706(2)(A). To determine whether 

the FDA’s interpretation of the Hatch-Waxman Act was “in 

accordance with law,” we engage in the analysis set out by 
13

Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 

837, 842 (1984). The first inquiry under Chevron is whether 

“Congress has directly spoken to the precise question at issue.” 

Id. at 842. “If the statute is clear and unambiguous ‘that is 

the end of the matter, for the court, as well as the agency, 

must give effect to the unambiguously expressed intent of 

Congress.’” Bd. of Governors of the Fed. Reserve Sys. v. 

Dimension Fin. Corp., 474 U.S. 361, 368 (1986) (quoting Chevron, 

467 U.S. at 842-43). In determining whether Congress has 

“directly spoken,” we “begin by examining the plain language and 

give the relevant terms their common and ordinary meaning.” Yi 

Ni v. Holder, 613 F.3d 415, 424 (4th Cir. 2010) (internal 

quotation marks and citation omitted). “This is because we must 

‘assum[e] that the ordinary meaning of that language accurately 

expresses the legislative purpose.’” Id. (quoting Gross v. FBL 

Fin. Servs., Inc., 557 U.S. 167, 175 (2009)). When ascertaining 

the ordinary meaning of words we may refer to standard reference 

works such as legal dictionaries. See, e.g., Id. at 425; 

Dickenson-Russell Coal Co., LLC v. Sec'y of Labor, 747 F.3d 251, 

258 (4th Cir. 2014). Further, we are not to limit our inquiry 

solely to a precise statutory provision in isolation, as “[t]he 

meaning—or ambiguity—of certain words or phrases may only become 

evident when placed in context.” Food & Drug Admin. v. Brown & 

Williamson Tobacco Corp., 529 U.S. 120, 132 (2000).
14

If step one leads to the conclusion that Congress has 

spoken clearly, that is the end of the Chevron inquiry. We move 

to Chevron step two only if “devices of judicial construction 

have been tried and found to yield no clear sense of 

congressional intent.” Gen. Dynamics Land Sys., Inc. v. Cline, 

540 U.S. 581, 600 (2004). See also Chamber of Commerce of U.S. 

v. N.L.R.B., 721 F.3d 152, 160 (4th Cir. 2013) (“Only if the 

statute is silent or ambiguous with respect to the specific 

issue are we to proceed to Chevron’s second step, asking whether 

the agency’s answer is based on a permissible construction of 

the statute.” (internal quotation marks omitted)).

Here, Congress has spoken directly regarding the courtdecision trigger. The statute makes plain that the 180-day 

exclusivity runs from “the date of a decision of a court in an 

action . . . holding the patent which is the subject of the 

certification to be invalid or not infringed.” 21 U.S.C. 

§355(j)(5)(B)(iv). As to generic celecoxib, such a decision was 

reached by the Federal Circuit in 2008. Pfizer Inc. v. Teva 

Pharms. USA, Inc., 518 F.3d 1253 (Fed. Cir. 2008). That 

decision struck eleven of the claims in Pfizer’s ‘068 patent as

invalid. Id. The ‘068 patent was the subject of the Paragraph 

IV certification that Teva submitted to FDA. Teva’s 180-day 

exclusivity period as to the ‘068 patent began to run from the 

date the Federal Circuit issued its mandate in May 2008. And
15

the exclusivity period expired on November 9, 2008, i.e., 180 

days later. 

Hatch-Waxman does not define “patent” nor does it 

specifically speak to reissued patents. This does not, however, 

render the statute ambiguous. The “court-decision trigger” 

speaks of “the patent which is the subject of the

certification.” 21 U.S.C. §355(j)(5)(B)(iv) (emphasis added). 

FDA’s interpretation of this language treats the original patent 

and the reissued patent as a single “bundle of rights” which can 

only be the subject of one Paragraph IV certification and 

therefore provides only a single 180-day exclusivity period. 

However, this interpretation is contrary to the plain statutory 

language.

Black’s Law Dictionary defines “patent” as “[t]he 

governmental grant of a right, privilege, or authority.” 

Black’s Law Dictionary 1300 (10th ed. 2014). It also defines 

“reissue patent” as “[a] patent that is issued to correct 

unintentional or unavoidable errors in an original patent, such 

as to revise the specification or to fix an invalid claim.” Id. 

at 1301. In other words, a reissue patent exists because of 

some mistake in the original patent. It does not grant the same 

“right[s], privilege[s], or authorit[ies]” as the original 

patent because the original cannot protect the rights it claims—

it was issued in error or was otherwise mistake-ridden. 
16

Instead, it is a separate grant of rights, even if elements of 

the reissued patent overlap with those of the original patent. 

See 35 U.S.C. § 251 (describing the reissue of defective 

patents).

The original 2008 court decision triggered a 180-day 

exclusivity period regarding the ‘068 patent. That patent was 

thus “the patent which” was “the subject of the certification”

Teva sent to FDA in 2003. Because the ‘068 patent could not 

protect the rights it claimed, Teva’s marketing of celecoxib 

would not infringe the original patent, at least to the eleven 

invalidated claims. Teva’s successful challenge of the ‘068 

patent, however, could not address its rights as to the ‘048 

patent, which did not come into existence until years later. 

The reissued ‘048 patent represented a new set of rights granted 

by the PTO, due to the court-recognized mistake in the original 

‘068 patent. The reissue necessitated new Paragraph IV 

certifications and a subsequent legal challenge to determine the 

patent’s validity. Because the statute requires recertification 

as to a reissued patent, the ‘048 reissued patent thus was also 

“the patent which” was “the subject of the certification[s]” 

that Mylan, Teva, and Watson issued in 2013 and that led to 

litigation.

The plain language of the statute indicates that each 

patent that is the subject of a certification may trigger 
17

exclusivity. The Hatch-Waxman Act required Abbreviated New Drug 

Application applicants to certify as to both the original and 

reissued patents; each could be “the patent which is the subject 

of the certification.” 21 U.S.C. §355(j)(5)(B)(iv). Because we 

find that FDA’s interpretation to the contrary violated the 

plain statutory language, we must set it aside. Household 

Credit Servs., Inc. v. Pfennig, 541 U.S. 232, 239 (2004) (“If 

[Congress has spoken to the question at issue], courts, as well 

as the agency, must give effect to the unambiguously expressed 

intent of Congress.”). See also Mylan Pharms., Inc. v. FDA, 454 

F.3d 270, 274-75, 276-77 (4th Cir. 2006) (holding that 21 U.S.C. 

§ 355(j)(5)(B)(iv) was plain and therefore the court had no 

choice but to enforce the language as written).

IV.

For the reasons above, we reverse and remand with 

instructions for the district court to proceed with adjudicating 

the rights of the Abbreviated New Drug Application applicants 

consistent with this opinion.

REVERSED AND REMANDED