Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc.

United States Court of Appeals for the Federal Circuit

2009-1071

ELI LILLY AND COMPANY,

Plaintiff-Appellee,

v.

TEVA PHARMACEUTICALS USA, INC.,

Defendant-Appellant.

Charles E. Lipsey, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of
Reston, Virginia, argued for plaintiff-appellee. With him on the brief were David S.
Forman, Howard W. Levine, Laura P. Masurovsky, Jennifer A. Johnson, and J. Derek
McCorquindale, of Washington, DC. Of counsel on the brief were James P. Leeds and
Gilbert T. Voy, Eli Lilly and Company, of Indianapolis, Indiana.

Jordan A. Sigale, Loeb & Loeb LLP, of Chicago, Illinois, argued for defendant-
appellant. With him on the brief were Edward H. Rice and Marina N. Saito.

Appealed from: United States District Court for the Southern District of Indiana

Judge Sarah Evans Barker
United States Court of Appeals for the Federal Circuit

2009-1071

ELI LILLY AND COMPANY,

Plaintiff-Appellee,
v.

TEVA PHARMACEUTICALS USA, INC.,

Defendant-Appellant.

Appeal from the United States District Court for the Southern District of Indiana in case
no. 1:06-CV-1017, Judge Sarah Evans Barker.

___________________________

DECIDED: February 24, 2009
___________________________

Before MICHEL, Chief Judge, RADER and PROST, Circuit Judges.

Opinion for the court filed by Circuit Judge RADER. Dissenting opinion filed by Circuit
Judge PROST.

RADER, Circuit Judge.

Finding that Teva Pharmaceuticals USA, Inc., (“Teva”) “recast its product more

than eighteen months after it provided the original sample to Lilly and only eight months

before trial is set to commence,” the United States District Court for the Southern

District of Indiana extended the statutory thirty-month stay of 21 U.S.C. § 355(j)(5)(B)(iii)

(2003), preventing the U.S. Food and Drug Administration (“FDA”) from finally approving

Teva’s Abbreviated New Drug Application (“ANDA”). Eli Lilly & Co. v. Teva Pharms.

USA, Inc., No. 1:06-cv-1017, 2008 WL 4809963, at *4-5 (S.D. Ind. Dec. 29, 2008)
(“Extension Order”). Because the trial court did not abuse its discretion, this court

affirms.

I

This case arises under the Drug Price Competition and Patent Term Restoration

Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. §§ 355,

360cc (2003); 35 U.S.C. §§ 156 (2002), 271 (2003) (collectively, the “Hatch-Waxman

Act”). Plaintiff-Appellee Eli Lilly & Company (“Lilly”) sued Teva for patent infringement

under 35 U.S.C. § 1 et. seq. and 28 U.S.C. §§ 2201-02.

The Hatch-Waxman Act strikes a balance between the sometimes-competing

policy interests of inducing pioneering research and development of new drugs and

enabling production of low-cost, generic copies of those drugs. A manufacturer that

seeks to market a generic drug may submit an ANDA for approval by the United States

Food and Drug Administration (“FDA”), rather than submitting a full New Drug

Application (“NDA”) showing the safety and efficacy of the generic drug. Thus, the

generic manufacturer may rely on safety and efficacy studies of the pioneer

manufacturer upon showing the generic drug’s bioequivalence with the previously

approved drug product. 21 U.S.C. § 355(j)(2)(A) (2003).

The Hatch-Waxman Act also requires a pioneer drug manufacturer to notify the

FDA of all patents that “claim[ ] the drug for which the [NDA] applicant submitted the

application.” 21 U.S.C. §§ 355(b)(1) & (c)(2) (2003). The FDA lists such patents in its

Approved Drug Products With Therapeutic Equivalence Evaluations, known as the

“Orange Book”. Under 35 U.S.C. § 271(e)(2), a generic manufacturer infringes a patent

2009-1071 2
by filing an ANDA to obtain approval for a generic drug product claimed by a valid and

unexpired patent.

As part of the approval process, an ANDA applicant must make a certification

addressing each patent listed in the Orange Book that claims the drug. 21 U.S.C. §

355(j)(2)(A)(vii). The Hatch-Waxman Act specifies the certification alternatives, (I) no

such patent information has been submitted to the FDA; (II) the patent has expired; (III)

the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be

infringed by the manufacture, use, or sale of the new generic drug for which the ANDA

is submitted. 21 U.S.C. § 355(j)(2)(A)(vii)(I-IV) (2003). These are commonly referred to

as paragraph I, II, III, and IV certifications.

When an ANDA certifies under paragraph IV, the applicant must provide the

patentee a detailed basis for its belief that the patent is not infringed, that it is invalid, or

that it is unenforceable. 21 U.S.C. § 355(j)(2)(B) (2003). The patentee then has forty-

five days to sue the ANDA applicant for patent infringement. 21 U.S.C. §

355(j)(5)(B)(iii). If the patentee does not sue, the FDA may proceed to approve the

ANDA. If the patentee does file suit, the FDA may not approve the ANDA until

expiration of the patent, resolution of the suit, or thirty months after the patentee’s

receipt of notice, whichever is earlier. Id. The court entertaining the suit has discretion

under the statute to order a shorter or longer stay if “either party to the action fail[s] to

reasonably cooperate in expediting the action.” Id.

In this case, Lilly holds the approved NDA for raloxifene hydrochloride

(“raloxifene”) tablets. This product is marketed under the brand name Evista® for the

2009-1071 3
treatment and prevention of postmenopausal osteoporosis. Lilly lists twelve patents that

claim Evista® in the Orange Book.

Teva filed an ANDA with the FDA in early 2006, seeking approval to manufacture

and market generic raloxifene. As part of its ANDA, Teva filed paragraph IV

certifications. On May 16, 2006, Teva notified Lilly of its paragraph IV certifications.

Lilly sued Teva on June 29, 2006, alleging that Teva’s ANDA infringed four

method patents of its twelve listed Orange Book patents for using raloxifene to prevent

or treat postmenopausal osteoporosis: U.S. Patent Nos. RE38,968 (“the ‘968 patent”),

RE39,049 (“the ‘049 patent”), RE39,050 (“the ‘050 patent”), and 6,906,086 (“the ‘086

patent”). The FDA then stayed approval of Teva’s ANDA for thirty months, from the

date that Lilly received Teva’s paragraph IV notifications, expiring on November 16,

2008. Extension Order, 2008 WL 4809963 at *1.

On September 25, 2006, the district court entered a scheduling order, setting a

trial date of March 9, 2009—four months after expiration of the thirty-month statutory

stay. In February 2007, Lilly amended its complaint to assert that Teva infringed three

additional Evista® patents—U.S. Patent Nos. 6,458,811 (“the ‘811 patent”), 6,797,719

(“the ‘719 patent”), and 6,894,064 (“the ‘064 patent”)—covering raloxifene particle size

and formulation.

On July 8, 2008, Teva amended its ANDA to include a new particle-size

measuring methodology for the active pharmaceutical ingredient in its proposed

raloxifene tablets. Extension Order, 2008 WL 4809963 at *2. Teva disclosed this

amendment to Lilly on July 10, 2008, and provided it three batch samples on July 28,

August 19, and September 17, 2008. The district court, however, previously set a

2009-1071 4
discovery deadline of August 18, 2008. Id. at *4 n.2. By September 5, 2008, Teva also

provided Lilly with 27,000 pages of related documentation. Moreover, the district court

ordered Teva to produce additional raloxifene samples to Lilly by December 15, 2008, in

response to Lilly’s motion to compel discovery.

On September 17, 2008, Lilly moved the district court under 21 U.S.C.

§ 355(j)(5)(B)(iii) to extend the statutory thirty-month stay due to Teva’s alleged

discovery violations, prejudicing Lilly’s preparations for trial. Extension Order, 2008 WL

4809963 at *1. Lilly alleged that Teva “fail[ed] to ‘reasonably cooperate in expediting

the action’ . . . as evidenced by Teva’s last-minute alteration of its proposed drug

product and its ‘multiple delays in producing critical discovery . . . [which have]

adversely affected Lilly’s infringement case and trial preparation.’” Extension Order,

2008 WL 4809963 at *2 (citing Lilly Mot. for Ext. of Stat. Stay at I-2) (second alteration

in the original). Lilly also alleged that Teva prejudiced its preparations for trial by not

timely disclosing its plans to alter the particle-size measuring methodology of its

proposed raloxifene tablets. Id. Teva allegedly began changing its particle-size

measuring methodology as early as November 2007 with the goal of avoiding

infringement of Lilly’s asserted patents.

On October 6, 2008, Lilly moved the district court for a temporary restraining

order (“TRO”) and preliminary injunction to prevent Teva from launching its product on

November 16, 2008, after expiration of the statutory thirty-month stay. The court

granted Lilly’s motion on October 29, 2008, to extend the statutory thirty-month stay

until the beginning of trial on March 9, 2009. Extension Order, 2008 WL 4809963 at *6.

2009-1071 5
Lilly’s motions for a TRO and preliminary injunction were thus denied as moot. Id. at *6

n.5.

Given the urgency of Teva’s situation, just weeks before trial, it filed a motion in

this court for an expedited appeal from the district court’s order. Because the district

court continued the injunction against the FDA, preventing it from finally approving

Teva’s ANDA until March 9, 2009, this court has jurisdiction over this appeal under 28

U.S.C. § 1292(a)(1).

II

The standard of review in this case is abuse of discretion in both the United

States Courts of Appeals for the Federal and Seventh Circuits. See Rick’s Mushroom

Serv., Inc. v. United States, 521 F.3d 1338, 1342 (Fed. Cir. 2008) (“We review a denial

of a request for additional discovery for abuse of discretion.”); Gile v. United Airlines, 95

F.3d 492, 495 (7th Cir. 1996) (“[W]e review a district court’s discovery determinations

for an abuse of discretion.”). Therefore, this court need not decide the question of

which jurisdiction’s law applies and will apply an abuse of discretion standard to its

analysis.

“A district court would necessarily abuse its discretion if it based its ruling on an

erroneous view of the law or on a clearly erroneous assessment of the evidence.”

Cooter & Gell v. Hartmarx Corp., 496 U.S. 384, 405 (1990). While extending the thirty-

month statutory stay, the district court found,

In light of the fact that Teva has recast its product more than eighteen
months after it provided the original sample to Lilly and only eight months
before trial is set to commence, we find that, in preparation for trial, Lilly is
entitled to have sufficient opportunity to identify the nature and
composition of the raloxifene product as Teva intends for it to be sold.

2009-1071 6
Extension Order, 2008 WL 4809963 at *4-5. In making this determination, the record

contained sufficient evidence, not based on clearly erroneous factual findings, upon

which the district court rationally based its decision. The court relied on the evidence in

the record that Teva altered its proposed generic raloxifene hydrochloride tablets late in

the litigation. Specifically, Teva changed the particle size manufacturing specification of

its active pharmaceutical ingredient and the method of measuring the particle size. Id.

at *2. Teva then delivered its changed samples to Lilly past the court’s August 18,

2008, discovery deadline.

In making these findings, the district court acted within its discretion in this area.

21 U.S.C. § 355(j)(5)(B)(iii) grants district courts the discretion to adjust the statutory

thirty-month stay of ANDAs if “either party to the action failed to reasonably cooperate in

expediting the action.” Trial courts, thus, may shorten or extend the thirty-month

statutory period based on the parties’ uncooperative discovery practices before the

court. Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1337 n.5 (Fed. Cir. 2003)

(Schall, J., concurring).

In explaining the statutory language, the House Committee report specified,

“[f]ailure by either party to cooperate in a reasonable manner may be used by the court

to reduce or lengthen the time, as appropriate, before an ANDA approval becomes

effective.” H.R. Rep. No. 98-857, at 16 (1984), as reprinted in 1984 U.S.C.C.A.N. 2686,

2700. Because Teva provided Lilly with its altered raloxifene samples just eight months

before trial, the district court extended the stay “to provide Lilly with a reasonable

amount of time to allow its expert to test and report on the altered raloxifene samples

2009-1071 7
provided by Teva and for Lilly to assess and utilize that information and analysis in

preparation for trial.” Extension Order, 2008 WL 4809963 at *6.

Teva argues that this court’s opinion in Andrx Pharmaceuticals, Inc. v. Biovail

Corporation, 276 F.3d 1368 (Fed. Cir. 2002), shows that the district court erred in

extending the thirty-month stay. In Andrx, Biovail and Andrx were embroiled in patent

litigation over both infringement and validity. Id. at 1372. The filing of the action

triggered an automatic thirty-month stay of Andrx’s ANDA from the date Biovail received

Andrx’s paragraph IV certifications on February 20, 2001. Id. Before the expiration of

the thirty-month stay, Biovail acquired an exclusive license to a second patent in

January 2001 that allegedly claimed the subject matter of its NDA. Id. Biovail changed

its manufacturing process to fall within the claims of the second patent, which it

submitted to the FDA on January 8, 2001, for listing in the Orange Book. Id. at 1372-73.

In a February 2, 2001, letter to Andrx, the FDA stated that because of the listing of

Biovail’s second patent, it no longer intended to approve Andrx’s ANDA upon the

expiration of the thirty-month stay. Id. at 1372.

Andrx filed paragraph IV certifications with the FDA on February 16, 2001, that it

did not infringe the second patent and that the patent was invalid. Andrx, 276 F.3d at

1373. On April 5, 2001, forty-four days after it received the paragraph IV certifications

on February 20, 2001, Biovail filed a second suit against Andrx under 35 U.S.C. §

271(e)(2) for infringement of the second patent. Id. The second suit triggered a second

thirty-month statutory stay ending August 8, 2003. * Id.

*
In June 2003, the FDA amended its regulations so that an NDA holder
could not obtain additional thirty-month stays based on patents added to the Orange
Book after a generic manufacturer filed its ANDA. See Apotex, Inc. v. Thompson, 347

2009-1071 8
 Andrx moved for summary judgment under 21 U.S.C. § 355(j)(5)(B)(iii) that the

district court shorten the second thirty-month stay. Id. at 1374. In granting the motion,

the district court found Biovail had intentionally impeded and delayed the expeditious

resolution of the patent actions between it and Andrx. Id. at 1374-75. The district court,

thus, shortened the second statutory thirty-month stay to September 27, 2001. Id. at

1375.

On appeal, this court held that the district court exceeded its authority under 21

U.S.C. § 355(j)(5)(B)(iii), vacated the district court’s order, and remanded for further

proceedings. Andrx, 276 F.3d at 1370. This court found the district court’s reading of

the statute was overly broad. The district court concluded it could shorten the thirty-

month stay due to the alleged delay in the resolution of both patent disputes between

the parties. Id. at 1376. The district court, however, erred by basing its decision on

Biovail’s positions before the FDA. Id.

Unlike Andrx, in this case, the district court extended the statutory thirty-month

stay based on its findings of Teva’s lack of cooperation in expediting the patent litigation

in its court. The court’s findings were not based on Teva’s filing with the FDA.

Moreover, as discussed, the district court’s decision was supported by the record, its

factual findings, and proper application of the law.

F.3d 1335, 1341 (Fed. Cir. 2003); Robert A. Matthews, Jr., Annotated Patent Digest §
10:154 (2007). In late 2003, Congress amended 21 U.S.C. § 355(j)(5)(B)(iii) to
eliminate the thirty-month stay for any patent the NDA holder acquired after the generic
manufacturer filed its ANDA. Pub. L. No. 108-173, § 1101(a)(2)(A)(ii), 117 Stat. 2448
(2003).

2009-1071 9
 III

Because the district court did not abuse its discretion with its discovery findings

and extending the statutory thirty-month stay to March 9, 2009, this court affirms. Given

the short timing of this appeal, under Federal Rule of Appellate Procedure 40, a petition

for panel rehearing or rehearing en banc must be filed within seven days after entry of

judgment.

AFFIRMED

2009-1071 10
 United States Court of Appeals for the Federal Circuit
2009-1071

ELI LILLY AND COMPANY,

Plaintiff-Appellee,

v.

TEVA PHARMACEUTICALS USA, INC.,

Defendant-Appellant.

Appeal from the United States District Court for the Southern District of Indiana in case
no. 1:06-CV-1017, Judge Sarah Evans Barker.

PROST, Circuit Judge, dissenting.

The thirty-month stay described in 21 U.S.C. § 355(j)(5)(B)(iii) may be extended

for one reason and one reason only: “because either party to the action failed to

reasonably cooperate in expediting the action.” Because I believe that the majority

misapplies the law and misapprehends the facts in affirming the district court, I

respectfully dissent.

I

The question here is one of statutory construction, which we review de novo.

Although the majority is correct in that a district court’s decision to issue a stay is

generally reviewed for abuse of discretion, see, e.g., Cherokee Nation v. United States,

124 F.3d 1413, 1416 (Fed. Cir. 1997), the power to issue a stay in most cases arises

under district courts’ “broad discretionary powers to control their dockets,” Gould v.

Control Laser Corp., 705 F.2d 1340, 1341 (Fed. Cir. 1983). Where, as here, the stay is

explicitly tied to a statutory standard, that standard must be properly construed. See In

re Princo Corp., 478 F.3d 1345, 1353–55 (Fed. Cir. 2007) (construing a statute that
requires a stay by reference to dictionaries and legislative history, among other things).

In the past, we have recognized that interpretation of the stay provided in 21 U.S.C.

§ 355(j)(5)(B)(iii) is a question of law reviewed without deference. Andrx Pharm., Inc. v.

Biovail Corp., 276 F.3d 1368, 1375 (Fed. Cir. 2002). In Andrx, Biovail appealed a

district court’s decision to grant partial summary judgment, shortening the thirty-month

stay and requiring the Food and Drug Administration (“FDA”) to approve Andrx’s

Abbreviated New Drug Application (“ANDA”). We stated that “[i]nterpretation of statutes

governing the grant of summary judgment presents threshold questions of law that are

reviewed without deference,” then proceeded to do just that, ultimately vacating and

remanding. Id.

But even under an abuse of discretion standard, the district court’s decision

should not stand. Let us be clear about what the district court “found.” The district court

never made any finding related to the statutory standard, i.e., whether Teva reasonably

cooperated in expediting the action. The court briefly described the background of the

case and the parties’ relative positions, and noted that the magistrate judge had ordered

Teva to produce various documents prior to August 18, 2008. Although Teva did not

complete production until September 5, 2008, the court did not purport to base any

finding that Teva “failed to reasonably cooperate in expediting the action” on this

eighteen-day delay. Instead, the court’s findings were limited to the following:

As this Court observed in its order granting a limited extension of
the statutory stay in Eli Lilly & Co. v. Barr Laboratories, Inc., it appears
“important, perhaps essential, that the composition of the generic drug
product for which FDA approval is being sought . . . and which Lilly alleges
to be the infringing product should be definitively established.” That
proposition similarly applies here. In light of the fact that Teva has recast
its product more than eighteen months after it provided the original sample
to Lilly and only eight months before trial is set to commence, we find that,

2009-1071 2
 in preparation for trial, Lilly is entitled to have a sufficient opportunity to
identify the nature and composition of the raloxifene product as Teva
intends for it to be sold.
Teva argues that the circumstances in [Barr] are distinguishable
from the situation at hand because the defendant in Barr had failed to
provide Lilly with even one sample of its generic drug product, whereas
here, on December 12, 2006, Teva provided Lilly with its original
raloxifene sample, and has since produced to Lilly three samples of the
altered product (the first on July 28, 2008, the second on August 19, 2008,
and the third on September 17, 2008). Therefore, Teva contends that an
extension of the statutory stay here is unnecessary because it has fully
disclosed all the required information to Lilly in an expeditious fashion.
Although Teva correctly cites the factual differences between the case at
bar and the situation in Barr, those differences are not viewed by us as
determinative on this issue. In Barr, we did not simply extend the statutory
stay through the date on which the defendant produced a sample of its
product to Lilly. Instead, our order provided that, after the defendant
produced the sample, the stay would extend through “a reasonably
expeditious time period for preparing for trial.”
A similar extension is warranted here in order to provide Lilly with a
reasonable amount of time to allow its expert to test and report on the
altered raloxifene samples provided by Teva and for Lilly to assess and
utilize that information and analysis in preparation for trial, which is set to
commence on March 9, 2009. For the foregoing reasons, the Court
hereby EXTENDS until March 9, 2009, in this action the period under 21
U.S.C. § 355(j)(5)(B)(iii) during which the FDA is barred from approving
ANDA No. 78-193.

Eli Lilly & Co. v. Teva Pharm. USA, Inc., No. 1:06-CV-1017, 2008 WL 4809963, at *2

(S.D. Ind. Oct. 29, 2008) (citations and footnotes omitted) (“Order Extending Stay”). Not

once in this order did the court indicate, much less unambiguously state, that it found

Teva had failed to reasonably cooperate in expediting the action. 1 The court provided

at most two justifications for extending the stay: (1) to provide Lilly “a sufficient

1
If anything, statements by the district court suggest that the court agreed
that Teva reasonably cooperated by expeditiously “disclosing all of the required
information,” but extended the stay regardless. Order Extending Stay, 2008 WL
4809963, at *2. Specifically, Teva claimed that an extension of the stay was
unnecessary because it fully disclosed all of the required information in an expeditious
fashion. The court stated that “[a]lthough Teva correctly cite[d] the factual differences
between the case at bar and the situation in Barr, those differences are
not . . . determinative on this issue.” Id. (emphasis added).

2009-1071 3
opportunity to identify the nature and composition of the raloxifene product as Teva

intends for it to be sold,” and (2) to give Lilly “a reasonable amount of time to allow its

expert to test and report on the altered raloxifene samples provided by Teva and for Lilly

to assess and utilize that information and analysis in preparation for trial.” Id. Neither of

these reasons remotely resembles the statutorily required finding.

It is clear from the record, in my view, that the district court never related Teva’s

conduct to the statutory standard. But even if the court had made a conclusory

statement regarding Teva’s cooperation, that alone would not suffice. In Gechter v.

Davidson, we clarified that although “we review decisions, not opinions,” a district court

opinion “must contain sufficient findings and reasoning to permit meaningful appellate

scrutiny.” 116 F.3d 1454, 1458 (Fed. Cir. 1997). We went on to state the following:

A district court therefore may not merely state its findings in conclusory
terms, but must provide sufficient detail to elucidate the reasoning by
which the court reached its ultimate finding on an issue of fact or
conclusion on an issue of law; otherwise, the appellate court is unable to
carry out its appellate review function. Indeed, as to the facts it must also
find subsidiary facts “specially,” and not just the ultimate fact, here of
anticipation. If it fails to do so, its decision will ordinarily be vacated.

Id. In fact, in Nazomi Communications, Inc. v. Arm Holdings, PLC, our court vacated a

district court’s claim construction, an issue that we examine de novo, stating,

This court’s review of a district court’s claim construction, albeit
without deference, nonetheless is not an independent analysis in the first
instance. Moreover, in order to perform such a review, this court must be
furnished “sufficient findings and reasoning to permit meaningful appellate
scrutiny.” This requirement for sufficient reasoning applies with equal
force to issues of law, such as claim construction, and issues of fact, such
as infringement.
. . . Unlike Gechter and Graco, where the records were devoid of
any claim construction analysis, the district court in this case provided
some claim construction analysis. Nonetheless this analysis is inadequate
because it does not supply the basis for its reasoning sufficient for a
meaningful review.

2009-1071 4
403 F.3d. 1364, 1371 (Fed. Cir. 2005) (citing Gechter, 116 F.3d at 1458; Graco, Inc. v.

Binks Mfg., 60 F.3d 785, 791 (Fed. Cir. 1995)) (citations omitted). As in Nazomi, the

district court here did not provide sufficient findings and reasoning to permit meaningful

appellate scrutiny. Thus, regardless of whether we review the district court’s order de

novo or for an abuse of discretion, the order should be vacated.

II

The consequences of the majority opinion are of particular importance here.

Rarely have district courts had the opportunity to address the circumstances under

which the thirty-month stay may be extended or shortened. 2 Those courts that have

addressed the issue have recognized the statutory standard and strictly abided by it in

determining whether to modify the stay. See Zeneca Ltd. v. Pharmachemie B.V., 16 F.

Supp. 2d 112 (D. Mass. 1998); In re Brimonidine Patent Litig., No. 07-md-1866, 2008

WL 4809037 (D. Del. Oct. 31, 2008); Novartis Corp. v. Dr. Reddy’s Labs., Ltd., No. 04-

Civ-0757, 2004 WL 2368007 (S.D.N.Y. Oct. 21, 2004); Minn. Mining & Mfg. Co. v.

Alphapharm Pty. Ltd., No. CIV-99-13, 2002 WL 1299996 (D. Minn. Mar. 8, 2002); Eli

Lilly & Co. v. Zenith Goldline Pharm., Inc., No. IP99-0038-C-H/G, 2001 WL 238090

(S.D. Ind. Mar. 8, 2001).

Appropriate findings by the district court are especially important where, as here,

Congress set forth a clear statutory timeframe and provided one narrow exception to the

2
Even commentators have noted that “[s]tatutory stay adjustments have not
been frequent.” Gerald Sobel et al., Hatch-Waxman Litigation from the Perspective of
Pioneer Pharmaceutical Companies, in Patent Litigation Strategies Handbook 183,
196–97 (Barry L. Grossman & Gary M. Hoffman eds., 2d ed. 2005).

2009-1071 5
general rule. 3 Only once has this court examined the matter directly. In Andrx, we

analyzed a single question: whether the district court had the authority to shorten the

stay period based on one party’s conduct before the FDA. 276 F.3d at 1376. We

expressly limited our review, declining to reach the question “whether the district court’s

authority to shorten the thirty-month statutory stay is limited to those cases in which

there was a failure to expedite the infringement action once it is filed or whether the

authority extends as well to situations in which the infringement action was not

commenced expeditiously.” Id. In short, this court has not previously provided any

guidance to the district courts as to what qualifies as a “fail[ure] to reasonably cooperate

in expediting the action.” To affirm in this case is to effectively eliminate the statutorily

required finding, and to prematurely terminate the development of appropriate

standards governing modification under 21 U.S.C. § 355(j)(5)(B)(iii).

For the foregoing reasons, I respectfully dissent.

3
The legislative history indicates that the thirty-month stay was a hard-won
compromise between brand-name manufacturers, generics manufacturers, and other
stakeholders. The length of the stay was the subject of heated debate in the House.
130 Cong. Rec. H24426–31 (Sept. 6, 1984). Initially, the House version of the bill
provided for a stay of just eighteen months. H.R. 3605, 98th Cong. § 101 (as reported
by H. Comm. on the Judiciary, Aug. 1, 1984). The Senate version, which ultimately
prevailed, described a thirty-month stay. S. 2926, 98th Cong. § 101 (1984). In light of
this fact, we should be especially careful when reviewing district courts’ decisions to
modify the statutory period. That period ceases to have meaning when district courts
are able to modify the stay without articulating why the narrow circumstances described
in the statute are present.

2009-1071 6