United States Court of Appeals 

for the Federal Circuit 

__________________________ 

NOVO NORDISK A/S AND NOVO NORDISK, INC., 

Plaintiffs-Appellants, 

v. 

CARACO PHARMACEUTICAL LABORATORIES, 

LTD., 

AND SUN PHARMACEUTICAL INDUSTRIES, LTD., 

Defendants-Appellees. 

__________________________ 

2010-1001 

__________________________ 

Appeal from the United States District Court for the 

Eastern District of Michigan in case no. 2:05-CV-40188, 

Judge Avern Cohn. 

ON PETITION FOR PANEL REHEARING AND 

REHEARING EN BANC 

__________________________ 

Before RADER, Chief Judge,

∗

 NEWMAN, CLEVENGER,

∗∗

LOURIE, BRYSON, GAJARSA, LINN, DYK, PROST, and 

MOORE, Circuit Judges. 

PER CURIAM. 

 ∗

 Randall R. Rader assumed the position of Chief 

Judge on June 1, 2010. ∗∗ Raymond C. Clevenger, III took part in the decision on the panel rehearing. 
NOVO NORDISK v. CARACO PHARMA 2

GAJARSA, Circuit Judge, with whom DYK, Circuit 

Judge, joins, dissents from the denial of the petition for 

rehearing en banc. 

__________________________ 

JAMES F. HURST, Winston & Strawn LLP, of Chicago, 

Illinois, filed a combined petition for panel hearing and 

rehearing en banc for defendants-appellees. With him on 

the petition were CHARLES B. KLEIN, STEFFEN N.

JOHNSON, SCOTT H. BLACKMAN, and ANDREW C. NICHOLS, 

of Washington, DC; DAVID S. BLOCH, of San Francisco, 

California. 

JOSH A. KREVITT, Gibson, Dunn & Crutcher LLP, of 

New York, New York, filed a response to the petition for 

plaintiffs-appellants. With him on the response were 

MARK A. PERRY, of Washington, DC; WAYNE BARSKY, of 

Los Angeles, California; and MICHAEL A. SITZMAN, of San 

Francisco, California. 

WILLIAM A. RAKOCZY, Rakoczy Molino Mazzochi Siwik 

LLP, of Chicago, Illinois, for amicus curiae Generic Pharmaceutical Association. 

SHASHANK UPADHYE, Apotex, Inc., of Toronto, ON 

Canada, for amicus curiae Apotex, Inc. With him on the 

brief was MICHAEL A. BERTA, Wilson Sonsini Goodrich & 

Rosati, of San Francisco, California, for Impax Laboratories, Inc. 

DAVID A. BALTO, The Law Offices of David A. Balto, of 

Washington, DC, for amici curiae Consumer Federation of 

America and National Legislative Association on Prescription Drug Prices. 
3 NOVO NORDISK v. CARACO PHARMA

SHANNON M. BLOODWORTH, Perkins Coie LLP, of 

Washington, DC, for amicus curiae Mylan Pharmaceuticals Inc. 

MICHAEL D. SHUMSKY, Kirkland & Ellis LLP, of Washington, DC for amicus curiae Teva Pharmaceuticals USA, 

Inc. 

__________________________ 

O R D E R 

Defendants-Appellees Caraco Pharmaceutical Laboratories, Ltd. and Sun Pharmaceutical Industries, Ltd. 

(“Caraco and Sun”) filed a combined petition for panel 

rehearing and rehearing en banc. The panel invited a 

response from Plaintiffs-Appellants Novo Nordisk A/S and 

Novo Nordisk, Inc. The court granted leave to file briefs 

amici curiae to Teva Pharmaceuticals, USA, Inc., Mylan 

Pharmaceuticals Inc., Apotex Inc. and Impax Laboratories, Inc., Consumer Federation of America and National 

Legislative Association on Prescription Drug Prices, and 

Generic Pharmaceutical Association. 

The petition for rehearing was considered by the 

panel that heard the appeal, and thereafter the petition 

for rehearing en banc, the response to the petition, and 

briefs amici curiae were referred to the circuit judges who 

are authorized to request a poll on whether to rehear the 

appeal en banc. A poll was requested, taken, and failed. 

Upon consideration thereof, 

IT IS ORDERED THAT: 

(1) The petition of Defendants-Appellees Caraco and 

Sun for panel rehearing is denied. 

(2) The petition of Defendants-Appellees Caraco and 

Sun for rehearing en banc is denied. 
NOVO NORDISK v. CARACO PHARMA 4

(3) The mandate of the court will issue on August 5, 

2010. 

FOR THE COURT

July 29, 2010 

—————————— 

Date 

/s/ Jan Horbaly 

—————————— 

Jan Horbaly 

Clerk 

cc: Josh A. Krevitt, Esq. 

James F. Hurst, Esq. 

William A. Rakoczy, Esq. 

Michael D. Shumsky, Esq. 

Shannon M. Bloodworth, Esq. 

Shashank Upadhye, Esq. 

Michael A. Berta, Esq. 

David A. Balto, Esq. 
United States Court of Appeals 

for the Federal Circuit 

__________________________ 

NOVO NORDISK A/S AND NOVO NORDISK, INC., 

Plaintiffs-Appellants, 

v. 

CARACO PHARMACEUTICAL LABORATORIES, 

LTD. AND 

SUN PHARMACEUTICAL INDUSTRIES, LTD., 

Defendants-Appellees. 

__________________________ 

2010-1001 

__________________________ 

Appeal from the United States District Court for the 

Eastern District of Michigan in case no. 2:05-CV-40188, 

Judge Avern Cohn. 

ON PETITION FOR REHEARING EN BANC 

GAJARSA, Circuit Judge, with whom DYK, Circuit 

Judge, joins, dissenting from the denial of the petition for 

rehearing en banc. 

__________________________ 

This case involves the statutory construction of 21 

U.S.C. § 355(j)(5)(C)(ii) (“counterclaim provision”), a 

critical provision of the Hatch-Waxman Act (“HWA”) that 

has not previously been construed.1 In 2003, Congress 

 1 The counterclaim provision provides: 
NOVO NORDISK v. CARACO PHARMA 2

enacted the counterclaim provision in order to prevent 

patent holders from making unwarranted or inaccurate 

claims of patent coverage in the Orange Book.2 Patent 

holders previously made such claims in order to delay the 

onset of competition from generic drug manufacturers, by 

preventing or delaying FDA approval of a generic manufacturer’s Abbreviated New Drug Application (“ANDA”).3 

In Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 

1323 (Fed. Cir. 2001), this court held that generic drug 

manufacturers could not sue to correct inaccurate and 

expansive Orange Book listings, thus inspiring Congress 

 

ii) Counterclaim to infringement action 

(I) In general 

If an owner of the patent or the holder of the approved 

application under subsection (b) of this section for the 

drug that is claimed by the patent or a use of which is 

claimed by the patent brings a patent infringement action 

against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or 

delete the patent information submitted by the holder 

under subsection (b) or (c) of this section on the ground 

that the patent does not claim either-- 

(aa) the drug for which the application was approved; 

or 

(bb) an approved method of using the drug. 

2 Under the HWA, Congress required the Food 

and Drug Administration (“FDA”) to maintain and publish a list of patents associated with approved drugs and 

methods of use. See 21 U.S.C. § 355(b)(1) (2006). The 

Orange Book, or the Approved Drug Products with 

Therapeutic Equivalence Evaluations, implements this 

statutory mandate. See 21 C.F.R. § 314.53(c)(2)(i)(O). 

3 A generic manufacturer may piggyback on the 

safety and efficacy data the original drug manufacturer 

submitted in its “New Drug Application” (“NDA”), and 

may seek approval for an identical method of use for its 

identical generic product by submitting an ANDA. See 21 

U.S.C. § 355(j). 
3 NOVO NORDISK v. CARACO PHARMA

to amend the HWA to include the counterclaim provision. 

The majority’s opinion construes the counterclaim provision contrary to its manifest Congressional purpose. That 

construction renders 21 U.S.C. § 355(j)(2)(A)(viii) (“Section viii”) carve-out statements a virtual nullity and 

leaves generic drug manufacturers without a remedy to 

challenge inaccurate Orange Book listings with respect to 

method of use patents. Therefore, I respectfully dissent 

from the court’s denial of Caraco’s petition for rehearing 

en banc. 

The background and facts of this case are well laid out 

in Judge Dyk’s dissent in the original panel decision. See

Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 

1359, 1370-78 (Fed. Cir. 2010) (Dyk, J., dissenting). As 

the dissent explains, the majority’s opinion adopts an 

overly narrow construction of “patent information” and an 

overly broad construction of “an approved method of using 

the drug.” See id. at 1370-72, 1376-78. Both constructions are irreconcilable with pre-existing FDA regulations, 

the text of the HWA, and Congressional intent. See id. at 

1370-78. I believe rehearing the case en banc is necessary 

to rectify these improper constructions. 

Not only is the majority’s construction of the counterclaim provision erroneous, it also eliminates the careful 

balance Congress has struck between encouraging pharmaceutical discoveries and ensuring that the American 

people have access to low cost generic drugs. Specifically, 

the majority’s opinion seriously undermines Section viii, a 

critical provision of the HWA that facilitates the approval 

and marketing of lower-cost generic drugs for uses no 

longer protected by a patent. 

Under the HWA, Section viii comes into play when a 

patent listed in the Orange Book “claims one, but not all, 

approved methods of using a drug.” Id. at 1365. Sec-
NOVO NORDISK v. CARACO PHARMA 4

tion viii permits a generic manufacturer seeking to market an approved use of a drug to certify that its method of 

using the drug (as described on its label) is not covered by 

a patent in the Orange Book. Normally, the label associated with the generic version of a drug must be exactly 

the same as the label associated with the drug approved 

in the original New Drug Application. 21 U.S.C. § 

355(j)(2)(A)(v), (j)(4)(G); 21 C.F.R. § 14.94(a)(8)(iv). A 

Section viii statement allows a generic manufacturer to 

avoid infringement by deleting patented used from its 

proposed label information, thus allowing it to avoid 

infringement. 21 U.S.C. § 355(j)(2)(A)(viii). 

Congress intended Section viii to facilitate the approval and marketing of lower-cost generic drugs, while 

still respecting the patent rights of pioneering drug manufacturers. Pioneering drug manufacturers, however, have 

found another way to game the system by subverting 

Section viii carve-out statements and delaying the onset 

of generic competition by submitting overbroad and 

inaccurate use codes. Use codes are codes created by 

patent holders in Orange Book listings to identify the 

scope of their Orange Book patents. The FDA will not 

approve a generic manufacturer’s Section viii proposed 

label amendment if a use code covers the proposed label. 

Importantly, the FDA makes no effort to determine the 

accuracy of use codes.4 

 4 The FDA has maintained, and we have affirmed, that its role in listing patents in the Orange Book 

is “ministerial”; it simply lists the patent information that 

it receives from brand manufacturers, expecting those 

parties to properly abide by the statutory and regulatory 

mandates. See Apotex, Inc. v. Thompson, 347 F.3d 1335, 

1349 (Fed. Cir. 2003); Applications for FDA Approval to 

Market a New Drug: Patent Submission and Listing 

Requirements and Application of 30-Month Stays on 
5 NOVO NORDISK v. CARACO PHARMA

In this case, Novo Nordisk (the brand drug manufacturer) owns a patent on the chemical composition of 

repaglinide, which expired on March 14, 2009. See

U.S. Patent No. RE 37,035 (‘the ’035 patent). Novo also 

owns a patent on the use of repaglinide in combination 

with metformin to treat diabetes, which does not expire 

until 2018. See U.S. Patent No. 6,677,358 (“the ’358 

patent”). In addition to its combination with metformin to 

treat diabetes, the FDA had approved repaglinide for two 

other uses: (1) by itself, i.e. monotherapy and (2) in combination with thiazolidinediones. See Novo Nordisk, 601 

F.3d at 1362. Novo does not own any patents covering the 

latter two approved uses. 

In anticipation of the ’035 patent’s expiration, Caraco, 

the generic manufacturer, sought to market the monotherapy use of repaglinide to treat diabetes, a use no 

longer covered by a patent. In June 2005, Novo sued 

Caraco, claiming that if Caraco marketed repaglinide, it 

would nonetheless infringe the ’358 patent because Caraco’s label would suggest the use of repaglinide together 

with metformin. Following the FDA’s suggestion, Caraco 

sought a Section viii carve-out statement, making clear 

that it was not seeking approval to market the use of 

repaglinide in combination with metformin and limiting 

its label to the monotherapy use. 

To defeat this Section viii carve-out statement, Novo 

changed the Orange Book use code associated with the 

’358 patent from “use of repaglinide in combination with 

metformin to lower blood glucose” to “a method for improving glycemic control in adults with type 2 diabetes 

 

Approval of Abbreviated New Drug Applications Certifying that a Patent Claiming a Drug Is Invalid or Will Not 

Be Infringed, 68 Fed. Reg. 36,676, 36,683 (June 18, 2003) 

(codified at 21 C.F.R. pt. 314). 
NOVO NORDISK v. CARACO PHARMA 6

mellitus.” See id. at 1362-63. The latter use code unmistakably covering both patented and unpatented uses. 

Because the FDA declined to police this inaccurate listing, 

Caraco asserted the counterclaim provision in the underlying HWA litigation and requested that Novo revise its 

use code to reflect the ’358 patent’s true scope.5 The 

majority opinion, however, held that counterclaim relief is 

not available because the ’358 patent covered at least one 

approved use. See id. at 1364-65. This effectively allows 

a patent holder to extend its monopoly to unpatented 

uses. 

The majority opinion thus eviscerates Section viii. A 

generic, like Caraco, cannot use Section viii if the pioneering manufacturer’s use code is erroneously broad. With 

the majority’s blessing, pioneering drug manufacturers 

now have every incentive to follow Novo’s lead and draft 

exceedingly broad use codes thereby insulating themselves from generic competition and rendering Section viii 

a dead letter. 

The evisceration of Section viii is exacerbated by the 

fact that, as Judge Clevenger points out in his concurring 

opinion in the panel decision, the majority decision likely 

leaves generic manufacturers such as Caraco with no 

other remedy. See Novo Nordisk, 601 F.3d at 1367-68 

(Clevenger, J., concurring). The FDA declined to grant 

Caraco’s Section viii carve-out because the broad use code 

for the ’358 patent now appears to cover Caraco’s pro-

 5 Novo argued, and the majority and concurrence 

agreed, that this predicament was somehow the fault of 

the FDA, which had required Novo (and all oral diabetes 

drug manufacturers) to change the “Indications” part of 

the drug label for therapeutic reasons. As explained in 

the dissenting opinion, Novo admits that the FDA did not 

require Novo’s inaccurate listing. Novo Nordisk, 601 F.3d 

at 1380 (Dyk, J. dissenting). 
7 NOVO NORDISK v. CARACO PHARMA

posed carve-out label. Caraco also cannot disprove infringement in the infringement lawsuit because the FDA 

requires it to use Novo’s original label, which includes 

information regarding the patented combination therapy. 

Thus, Caraco will apparently have to wait to launch its 

generic repaglinide product until 2018, the date on which 

Novo’s ’358 patent on the combination therapy expires—

despite the fact that the ’358 patent concededly does not 

cover the use for which Caraco seeks to market the drug. 

This is an untenable and absurd result, and contravenes 

the intent of Congress in adopting the counterclaim 

provision. 

Finally, the majority opinion effectively invalidates 

the FDA’s effort to define “patent information” for the 

purposes of the counterclaim provision. See Novo Nordisk, 601 F.3d at 1366-67. This invalidation is especially 

troubling given Congress’s explicit approval of those 

regulations. See Legislative and Regulatory Responses to 

the FTC Study on Barriers to Entry in the Pharmaceutical 

Marketplace: Hearing Before the S. Comm. on the Judiciary, 108th Cong. 19 (2003) (Statement of Sen. Schumer) 

(“The bill provides a critical complement to the work the 

FDA has done in clarifying its regulations on patent 

listing, but it goes much further.”). Without even requesting the views of the FDA, the majority opinion refuses to 

give effect to the FDA’s interpretation of an important 

statutory term. See Apotex, Inc. v. Thompson, 347 F.3d 

1335, 1351-52 (Fed. Cir. 2003) (“Deference is due to an 

administrative agency’s regulations particularly when the 

subject matter of the regulatory authority is a highly 

detailed regulatory program to which the agency has 

brought its specialized expertise, a characterization that 

aptly describes the FDA’s role in the context of the regulatory scheme created pursuant to the Hatch-Waxman Act.” 

(citation and quotations omitted)). 
NOVO NORDISK v. CARACO PHARMA 8

Because the majority’s statutory construction of the 

counterclaim provision abrogates the HWA and frustrates 

the clear intent of Congress, I dissent from the court’s 

denial of Caraco’s request for rehearing en banc.