Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd.

CONCLUSION reasons, hold that we foregoing

For the finding fact was not master’s special Further, spe-

arbitrary capricious. of the SIDS evi- evaluation

cial master’s law, out contrary to as set was not

dence 300aa-12(a)(2)(E) Bazan. or de of Federal Claims the Court

judgment of affirmed.

AFFIRMED

COSTS its own costs. party

Each shall bear and Novo NORDISK

NOVO A/S

Nordisk, Inc., Plaintiffs-

Appellants, LABO PHARMACEUTICAL

CARACO

RATORIES, LTD., and Sun Pharma Industries, Ltd., Defendants-

ceutical

Appellees.

No. 2010-1001. Appeals,

United States Court

Federal Circuit. 14, 2010.

April

Orange Book with the former U-546 list- ing. Pharmaceutical Lab- Because Caraco (“Caraco”) oratories, Ltd. does not have a statutory basis to assert a counterclaim relief, injunctive requesting such this court injunction. reverses and vacates the I. Drug

This case arises under the Price Competition and Patent Term Restoration 98-417, Act of Pub.L. No. 98 Stat. (1984) (codified §§ U.S.C. 360cc; 156, 271), §§ 35 U.S.C. as amended by the Prescription Drug Medicare Im- provement and Modernization Act of 108-173, Pub.L. No. 117 Stat.2066 Act”). (collectively, the “Hatch-Waxman The Hatch-Waxman Act strikes a balance Gibson, Perry, Mark A. Dunn & Crutch- potentially competing policy between two LLP, DC, Washington, er argued inducing pioneering develop- interests — him plaintiffs-appellants. With pharmaceutical ment of formulations and Krevitt, York, were A. brief Josh of New facilitating methods and efficient transition NY; CA; Wayne Barsky, Angeles, of Los low-cost, to a generic copies market with Sitzman, Francisco, and Michael A. of San pioneering those inventions at the close CA. Pharms., of a term. See Andrx Hurst, F. James Winston & Strawn Inc. v. Corp., Biovail 276 F.3d LLP, IL, Chicago, argued for defen- (Fed.Cir.2002). dants-appellees. him on the With brief were B. Charles Klein and Scott H. Black- prohibits Title 21 sale of a drug new man, DC; Bloch, Washington, David S. FDA approval. without 21 U.S.C. Francisco, of San An- CA. Of counsel was 355(a). To obtain that approval, pio- Nichols, Washington, drew DC. neering manufacturer must file a drug new (“NDA”), application clinical containing RADER, CLEVENGER, Before drug’s safety efficacy. studies of the DYK, Judges. Circuit 355(b)(1). part U.S.C. As process, NDA the manufacturer must also Opinion by for the court filed Circuit identify all that claim the aor Judge Concurring RADER. opinion filed method of use: Judge Circuit CLEVENGER. Dissenting opinion Judge filed Circuit applicant shall applica- file with the DYK. tion the number the expira- any patent tion date of which claims

The United States District Court for the for which the Michigan Eastern District of entered or which claims a method injunction directing Novo Nordisk A/S “Novo”) Nordisk, and with (collectively, Novo Inc. request claim of Drug the U.S. Food and Admin- (“FDA”) replace reasonably person istration be asserted if a Novo’s use code listing engaged U-968 for Prandin® the not licensed the owner manufacture, use, drug applica- an abbreviated new or sale of the submit (“ANDA”). § 355(3). drug. process approval ANDA streamlines FDA 355(b)(1)(G) (emphases add- 21 U.S.C. by allowing manufacturer ed). rely safety efficacy of a studies described in patent If the already listed Book (b) section could not of this subsection bioequivalence. a upon showing of appli- with the submission of be filed § 355(j)(2)(A)(iv). U.S.C. of this sec- cation under subsection ..., approved ap- the holder of an part process, generic As of the ANDA a Secretary the plication shall file with the manufacturer must make a certification expiration number and the date patent addressing each identified in the for any patent which claims pertaining drug. to its application was submitted or which the § 355(j)(2)(A)(vii). Specifically, U.S.C. using which claims a method of generic manufacturer must select one of a claim and with to which permitting pat- four alternatives use of the reasonably (I) product process: ented no such pat- by person asserted if a not licensed ent information has been submitted to the manufacture, engaged in the the owner (II) (III) FDA; expired; has use, drug. or sale of the is set to on a expire certain 355(c)(2) added). § (emphases 21 U.S.C. (IV) date; is invalid or will authority promulgate FDA The has manufacture, use, infringed by not be for the efficient enforcement of regulations generic drug. or sale of the U.S.C. § provisions. these U.S.C. 371. Under (2)(A)(vii). 355(3) a manufac- regulations, pioneering those pharmaceutical Often formulations have FDA num- turer files with the multiple applications. expi uses and After any applica- ber and the date of composition ration of the by submitting ble Form 3542a itself, only may enjoy some of those uses (“Patent Information with the Submitted protection patented continued methods. NDA, Amendment, Filing Supple- generic If a manufacturer wishes to seek ment”) (“Patent or Form 3542 Information approval by FDA a for use not covered a Upon Approval Submitted and After of an drug, method-of-use for a listed Supplement”). NDA or 21 C.F.R. must make a “section viii statement.” 21 (2009). 314.53 If the claims one § 355(j)(2)(A)(viii). Along with U.S.C. drug, or more methods of the NDA statement, viii generic manu require descrip- Forms 3542a and 3542 a facturer must submit a label to processes. tion of each of those Id. This FDA description commonly patent known as the “use that does not contain the assigns code narrative.” The FDA a drug. ed method of the listed When number, code,” unique known as “use considering approval requests of these FDA description. publishes each The FDA patent, use not covered drugs, along applicable list of with the applicable patent’s relies on the use code codes, patents and their associated scope narrative to determine the Approved Drug Products With Thera- FDA patented Applications method. Evaluations, peutic Equivalence commonly Approval Drug, to Market a New 68 Fed. “Orange known Book.” (June 2003). Reg. approves the section viii statement A manufacturer seeks market generic copy drugs may overlap of these listed where there is no between the 355(j)(5)(C)(ii)(I). This coun- label submitted

proposed carve-out provision part orig- manufacturer and the use code terclaim was not generic pioneering inal Act. Rather the narrative submitted Hatch-Waxman Medi- Drug Improvement manufacturer. Prescription care Modernization Act of Pub.L. No. early Act facilitates The Hatch-Waxman 108-173, 117 Stat.2066 added this disputes pioneering between resolution permit chal- To achieve manufacturers. lenges information at the FDA. objective, Paragraph the Act makes a interpretation of this counterclaim into an act of in- IV certification provision is the central issue in this case. 271(e)(2). fringement. ge-A 35 U.S.C a Paragraph neric manufacturer files II. give IV certification must notice to the patentee provide and the NDA holder and Novo markets and distributes the pat- detailed basis for its belief that the repaglinide under the brand name PRAN- infringed. ent is invalid or not 21 U.S.C. adjunct DIN. an PRANDIN is to diet and 355(j)(2)(B)(i). patentee The then has improve glycemic exercise to in control forty-five days to sue the manufac- (non-insulin type adults with diabetes infringement. turer for U.S.C. mellitus). dependent diabetes The § 355(j)(5)(B)(iii). patentee If the approved has PRANDIN for three uses: sue, may approve not the FDA the ANDA. (1) (i.e., repaglinide by monotherapy); itself sues, If patentee the FDA (2) in repaglinide combination with metfor- approve the ANDA until min; repaglinide in combination suit, patent, thirty resolution of the or (“TZDs”). with thiazolidinediones Novo patentee’s months after the receipt no- Nordisk, approved Inc. holds the NDA for tice, whichever is earlier. 21 U.S.C. PRANDIN. § 355(j)(5)(B)(iii). The court entertaining The Book lists two

this suit has discretion to order a shorter 37,035 RE PRANDIN. U.S. Patent No. longer stay party or if “either to the action (the alia, claims, patent”) “'035 inter reasonably cooperate expedit- in fail[s] composition repaglinide. chemical ing the action.” Id. patent expired '035 on March ge- The Hatch-Waxman Act enables a (the 6,677,358 pat- U.S. Patent No. “'358 in Paragraph neric manufacturer suit IV ent”) claims, alia, repaglinide inter in com- challenging to assert a counterclaim bination with metformin: accuracy of information” sub- A treating method for non-insulin de- mitted to the FDA: (NIDDM) pendent diabetes mellitus applicant may [The ANDA] assert comprising administering patient to a counterclaim an seeking requiring order repaglinide need of such treatment the holder pat- to correct delete the combination with metformin. ent information submitted the holder (c) under subsection of this section patent, '358 claim 4. The '358 ex- ground does not pires on June 2018. Novo Nordisk A/S claim either— patent. owns the '358 Novo does not own

(aa) for which the patents claiming approved the other two approved; methods using repaglinide type to treat (bb) approved initially assigned method of diabetes. The FDA drug. the '358 the use code “U-546—Use 11, 2009, witli metfor- On June Caraco amended its combination repaglinide answer and counterclaim. Caraco added a glucose.” min to lower blood under 9, 2005, February Caraco filed On 355(j)(5)(C)(ii), requesting an order re- drug repaglinide. ANDA for quiring change Novo to use code III initially Paragraph contained a ANDA '358 reference PRANDIN for the '035 certification from U-968 U-546. Caraco claimed certification for the '358 Paragraph IV the use code U-968 was overbroad because 9, 2005, Novo initiated an On June incorrectly suggested pat- that the '358 against action Caraco. ent covered all three methods of stipulated that April Caraco using repaglinide though even it claimed if it infringe ANDA would '358 one method. Caraco also a label that discussed the combi- included defense, a patent asserting added misuse and metformin. At repaglinide nation of misrepresented scope that Novo time, around the same Caraco patent in its use code narrative. a Paragraph an amended ANDA with IV 29, 2009, for the '358 sec- certification On June Novo moved to dis- declaring that Caraco tion viii statement new miss Caraco’s counterclaim and to seeking approval repagli- for the was not strike the misuse defense. The therapy. combination nide-metformin district court denied Novo’s motions. Car- approve that it would Cara- FDA indicated summary judgment aco then moved for carve-out label. Novo proposed co’s both the new counterclaim and the ground for reconsideration on the moved summary judgment, misuse defense. On allowing the carve-out would render court granted the district Caraco’s motion less safe and effective. on the counterclaim and declined to ad- dress misuse defense. The dis- 6, 2009, May Novo an On trict court found that Novo had improperly Form for PRANDIN in amended filed an overbroad use code narrative its use code narrative updated which Novo 25, 2009, patent. September the '358 On patent. removed following the district court entered the the use code U-546 from the injunction: for PRANDIN and substituted the new hereby Novo Nordisk is directed improving use code “U-968—A method for mandatory injunction under 21 U.S.C. glycemic type control in adults with dia- 355(j)(5)(C)(ii)(l)(bb) to correct within The FDA then denied betes mellitus.” twenty days from the date of this for reconsideration as moot request Novo’s Injunction its inaccurate de- Order light According of the new use code. scription of the '358 submit- FDA, predicate factual on which ting to FDA an amended Form FDA permissive the FDA’s carve-out determi- 3542 that reinstates its former U-546 longer applied. The nation had rested no listing for Prandin and describes claim FDA then disallowed Caraco’s section viii of the '358 in section 4.2b as statement, because its carve-out covering repaglinide the “use of in com- overlapped label with the use code U-968 bination with metformin to lower blood result, As a patent. for the '358 Caraco’s glucose.” repaglinide- current label now includes the therapy, Nordisk v. Caraco Pharm. metformin combination Novo A/S Ltd., Labs., F.Supp.2d claim 4 stipulated infringe of the '358 (E.D.Mich. 2009). situation, legislative history pro- urgency of Novo’s establish Given a motion in this court for an ‘extraordinary showing Novo filed “an of con- vides ” expedited appeal from the district court’s trary (quoting intentions.’ Garcia v. granted This court Novo’s motion order. States, 469 U.S. 105 S.Ct. United expedite briefing. Novo also filed (1984)). 479, 83 L.Ed.2d 472 injunction stay pending for a motion IV. stay proceed- of trial court

appeal and stay ings. This court ordered provides The Hatch-Waxman Act injunction ap- pending disposition generic to a manufac limited counterclaim peal stay pro- but declined to trial court Paragraph turer in a IV ac ceedings. Because the district court had tion. The Act man authorizes §§ jurisdiction under 28 U.S.C. 1331 and ufacturer “on to assert 1338(e), jurisdiction this court has under ground does not claim 1292(c)(1). 28 U.S.C. (aa) applica either for which the (bb) approved; tion was III. drug.” court grant This reviews the added). 355(j)(5)(C)(ii)(I) (emphases injunction for an abuse of discretion. agree Novo and Caraco the '358 Prods., Cross Med. Inc. v. Medtronic Sofa ap- claims one of the three Danek, Inc., mor 424 F.3d 1301-02 (i.e., proved methods of PRANDIN (Fed.Cir.2005). To the extent that an in repaglinide in combination with metfor- law, junction premised upon an issue of min). Novo asserts that the counterclaim statutory interpretation, such as this court only is available if the does not '358 that reviews issue without deference. See any claim approved methods. Caraco ar- Inc., Sanofi-Synthelabo Apotex, v. 470 that it gues is entitled to the counterclaim (Fed.Cir.2006). 1368, 1374 F.3d claim because does not two Statutory “begins construction approved methods of PRANDIN ” language ‘the Hughes the statute.’ Air words, In ap- use. other Novo reads “an Jacobson, 432, 438, Co. v. 525 U.S. craft proved method” in the counterclaim stat- (1999) 755, 119 S.Ct. 142 L.Ed.2d 881 “any approved ute as method” while Cara- (quoting Estate Cowart v. Drill Nicklos co approved reads it as “all methods.” Co., 469, 475, ing 2589, 505 U.S. 112 S.Ct. court ambiguity This detects no in the (1992)). 120 L.Ed.2d 379 This court de statutory language. When indefinite plain meaning rives the of the statute from preceded qualified by nega- article is its text and structure. Electrolux Hold tive, grammar generally provides standard States, 1327, ings, Inc. v. United 491 F.3d See, that “a” “any.” e.g., means American (Fed.Cir.2007) (citation omitted). 1330 If Heritage Dictionary English Lan- statutory language unambiguous, (4th ed.2006) guage (defining “a” as Nevertheless, inquiry ends. this court “[a]ny” example drop “not a legislative history ‘only “look at the drink”); Random House Webster’s Una- determine a clear contrary whether intent (2d ed.2001) bridged Dictionary 1 (defining plain meaning Sharp exists.’” v. “any” the indefinite article “a” as or “a States, (Fed. 1234, United 580 F.3d one”); Cir.2009) single” example “not a see (quoting Operations Glaxo UK (Fed.Cir. Thomas, 20, 26, also Barnhart v. 540 U.S. Quigg, Ltd. v. 894 F.2d 1990)). plain meaning To overcome the S.Ct. 157 L.Ed.2d 333 statute, party challenging (adopting “quite it must that construction sen- (citation supports selected for this Amendment grammar”) a matter of this sible as omitted). interpretation approved court’s that “an “any approved method” means method.” of the counterclaim The rest A patent listing amongst that covers one support interpreta- Caraco’s also does not. approved using several methods of a for- case, In context of this the stat- tion. patented mulation that protects method of utory language approved “an and thus bears a direct relation to the drug” approved refers to the using the purpose listings. This using drug, the listed PRAN- methods of court does not detect a situation such as language cannot refer to DIN. This in Mylan. the one occurred generic drug, Caraco’s methods yet suggests This casé also that approved because the has not this court Therefore, relationship the Hatch- should address the Caraco’s ANDA. between provision. a counterclaim section viii and the counterclaim Act authorizes Waxman any viii if the listed does not claim Section addresses scenarios where a one, all, drug. patent methods of the listed claims at least but not using drug. methods of See statutory Although language 355(j)(2)(A)(viii). This court rec- ambiguities, court presents face no that a ognizes covering broad use code all legislative examines the histo- nonetheless pharmaceutical uses of a require ge- ry to make sure that it does not contain prove specifically neric manufacturers to contrary. Before any clear intent to the overlap their use will not with and Act the amendment Hatch-Waxman infringe patented proof, use. This un- litigants could not chal- private der procedures, Hatch-Waxman will take FDA submissions at all. Buckman lenge the form of a Paragraph IV lawsuit. Comm., Legal 531 U.S. Co. Plaintiffs’ context, generic may provide 341, 349, 148 L.Ed.2d 854 S.Ct. proof infringe- that their use will not cause (2001). agree Novo and Caraeo patented per- ment of the use. This court to this provision responded ceives that Act Hatch-Waxman will Pharms., Mylan Inc. v. court’s decision generic drug thus ensure that a for non- (Fed.Cir.2002). Thompson, 268 F.3d 1323 patented purposes will not be used for Mylan, patent Book listed patented purposes simple via a section viii covering FDA-approved drug BuS- Instead, generic certification. manu- par. Mylan, generic Id. at 1330-31. facturer will need to alleviate the risk of manufacturer, patent asserted that infringement or induced in a BuSpar claim an approved “did not proceeding fully infringe- that tests for using BuSpar.” method of implications, including poten- ment and its Mylan court held that did not have a This Thus, safety tial health and the Act risks. private alleg- cause of action to delist the again resolution facilitates efficient of dis- edly irrelevant from the putes concerning potential overlapping of Book. Id. The 2003 amendment used exact protected unprotected The Act uses. Mylan from in the new counter- language pioneering seeks to strike a balance legislative claim This choice of provision. generic manufacturers’ interests. that the 2003 Amend- language suggests out, Judge Clevenger points As Caraco’s sought specific ment to correct the issue i.e., FDA, complaint real should lie with the Mylan, pioneering raised deter that not Novo. Had it not been for the listing patents manufacturers from action, regulatory all FDA’s Caraeo could patented were not related at Thus, in a language Paragraph method. have asserted IV lawsuit product or Therefore, consistency maintain labeling infringe did not ute. that its terms, FDA, statutory not “the infor- It was the the '358 Novo, provision in mation” in the counterclaim that the careful balance tipped manufacturers. must also mean the number and pioneering the favor of expiration date. Envtl. v. Duke Def. V. 561, 574, Energy Corp., 549 U.S. 127 S.Ct. (noting 167 L.Ed.2d 295 balancing further indication of As identical used in the same act words creation of an efficient dis interests and meaning). presumed are to have the same mechanism, this court pute resolution Thus, provision only the counterclaim au- Act, terms, opaque timing hardly observations “[s]uch Thus, the Act defined the term “patent extraordinary showing amount to a ‘most intentions,’ information” patent contrary especially as “the number and when the the expiration Valley Drug language date.” See trumpets the statute its mean- Inc., ing by Co. v. Geneva Pharms. 344 Wyeth Kappos, F.3d itself.” v. 591 F.3d (11th Cir.2003) (Fed.Cir.2010). 1294, 1364, 1296-97 (referring to 1372 The counter- patent expiration number and the claim not mention the FDA information”). patent any date as “this regulations way suggest adoption The (c) reference in meaning “patent subsection to “the of a information” (b)” express statutory information described in subsection broader than the defini- Moreover, mean the number and tion. this court owes “no defer- date, expiration agency interpretations because no other ence is due “patent appears language information” in the of the statute plain stat- odds with the Betts, Sys. apply itself.” Pub. Ret. v. doctrine Employees patentee’s where 171, 2854, 109 S.Ct. U.S. misconduct toward unrelated parties (1989). above, As discussed L.Ed.2d 134 amounted to unfair market benefits be- upset this definition would broader yond scope See Mal- requires careful a full resolu- linckrodt, balance Inc., Inc. v. Medipart, 976 F.2d tion of issues potential (Fed.Cir.1992). event, In any overlapping patented and un- involved case, court, this district apparently patented uses. situation, recognizing rarity of this ex- pressly declined to address the doctrine of history legislative any does not add any misuse. finding Without clarity meaning of “patent to the informa- review, adjudicate this court declines to debate, tion.” floor During the Senators Ecolab, this issue first instance. See occasionally correct referred need to See, Inc. FMC Corp., 569 F.3d “patent e.g., Cong. information.” (Fed.Cir.2009). 2003) (daily Rec. S15746 ed. Nov.

(statement Schumer) (The of Sen. counter- VII. provision may claim “delist correct information in FDA’s court This therefore reverses the district Book.”). This court read must grant summary judgment court’s these statements use the term attempted, unsuccessful, Caraco’s but express information” consistent with the injunction counterclaim and vacates the or- statutory Accordingly, pre- definition. dering Novo to use correct its code for the serve the careful to en- Act’s balance and listed in Book for statute, force the the ex- language PRANDIN. plicit definition “the information” REVERSED and VACATED. “the number and the date” controls. CLEVENGER, Judge, Circuit concurring. VI. I with agree Judge analysis Rader’s argues that Caraeo case the relevant statutory provisions in this court does not Caraeo is entitled find join case and therefore the opinion he counterclaim, to a this court affirm should writes for the court. I am as certain injunction the district court’s under the Rader Judge ongoing Para- doctrine of misuse. Because the graph litigation cleanly IV will resolve the judicial doctrine of misuse creates dispute parties. between the infring unusual circumstance where an The dissent masks the cause for the er can escape consequences of its in dispute between the parties. Novo did fringing conduct because the victim of that nothing that was illegal forbidden. tort may have rights used voluntarily requested change to the gain competitive advantage an unfair approved indications for PRANDIN® against an unrelated third court party, this required Novo to FDA’s new allegations examines such particulari approved labeling. change per- also See, ty. e.g., Sys., C.R. Bard v. M3 mitted Novo to revise use code (“Al its as the (Fed.Cir.1998) F.3d 1372-73 form, relevant FDA “Patent Information though wrong the law should not condone Upon Approval Submitted and After of an activity, body ful commercial the of misuse Supplement,” NDA or precedent enlarged expressly law and need not instructed be “[sjubmit open-ended description into an pitfall patent-sup Novo to the commerce.”). instance, ported For the indication or method use that to The dissent’s fix would be have Unit- FDA include as ‘Use you propose changed Novo to FDA Book.” ed States District Courts dictate Code’ new PRAN- to match the its use code on the what indications should used in the record Nothing DIN® indication. approved drugs, prescribed labeling for is responsible Novo suggests that though nothing illegal, or even there is which, statutory change, given labeling incorrect, use even about Novo’s current framework, happens to regulatory and for a code. There no basis counterclaim expense. at Caraco’s Novo benefit to correct delete If a fix in order Novo. request FDA’s Novo If not for case, the circumstances of this it lies labeling to under change present broad its indication, everything Congress have worked with FDA to understand would and As ap- under relevant statutes. properly consequences changing notes, Judge dispute “efficient Rader labeling single proved repaglinide to a play. was in resolution mechanism” Cara- indication, corresponding and broad for repaglinide, co filed its ANDA and code, Laying remedy and to the situation. making Paragraph certification had its IV is wrong. blame on Novo infringe- statutory committed the act statute, The counterclaim which the dis- infringe- followed with its ment. Novo reach, expand beyond sent would its literal suit. was to defend prepared ment Caraco designed present- to cure the situation grounds proposed its use of Mylan. Congress ed in has not addressed not repaglinide would induce case. presented fact situation in this also patent. of the '358 Caraco filed Congress entity is the to read- appropriate light viii statement in then- just, necessary, if the delicate balance for PRAN- approved labeling use code original has manufac- struck between DIN®, proposed language carve-out their counterparts. turers and in its to its labeling signify non- infringing repaglinide. use of Caraco was DYK, Judge, dissenting. Circuit get bring thus set to FDA to its approval 2003, Congress In enacted the counter- generic drug to market to defend itself claim Act provision of the Hatch-Waxman Paragraph in Novo’s IV suit. prevent manipulative practices order FDA, independently, But acting by patent holders with gummed By up requiring works. listings. practices These single repaglinide indication for broad designed delay compe- were onset part approved labeling, creat- generic drug tition from manufacturers. longer ed a situation where Caraco can no See Medicare Prescription Improve- Drug, proposed labeling assert that its ment, and Modernization Act of infringe It remains to be 108-173, 1101(a)(2)(C), Pub.L. No. action will impact seen what FDA’s have Stat.2066, (codified at 21 U.S.C. ability to on Caraco’s defend itself in the (“the § 355(j)(5)(C)(ii)) ongoing Paragraph litigation, IV but amendment”). view, my majority, FDA’s threatens im- regulatory action court, con- reversing district now ability pair disprove infringe- Caraco’s contrary to manifest strues the statute inadvertently ment. FDA thus have manipulative the same purpose allows upset rep- careful balance of interests practices to continue context dispute resented the efficient resolution was de- Congress patents. The amendment mechanism created in the signed permit Act. courts cor- Hatch-Waxman to order

1369 ods) 314.53(b)-(c). published § use. 21 rection of See C.F.R. Book, yet majority’s under The cannot drug be sold until the FDA has opinion, drug erroneous Book method of particular meth- use, 355(a), cannot I 21 (b)(1), § use information be corrected. od of U.S.C. and respectfully dissent. the method of use is required appear to on label, 352(f); § 21 U.S.C. 21 C.F.R. pt.

I 314.125(b)(8). § 355(b) id. Section also requires the NDA filer to 1984, Congress list all Drug enacted the patents “with respect to which a claim of Competition Price and Patent Resto Term infringement Act, reasonably commonly be ration as the known by patent asserted” and 98-417, number Act.” “Hatch-Waxman Pub.L. No. (codified application, date with NDA U.S.C. Stat. 1585 at 21 U.S.C. 355(c)(2) 355(b)(1), § U.S.C.). while section requires § 355 and scattered sections of 35 NDA applicants provide same infor- Act, Congress Under the Hatch-Waxman mation patents issuing af- required and Drug the Food Administra ter the NDA approved, (“FDA”) id. maintain publish and a list 355(c)(2). information, § This referred to approved drugs associated with as “information ... under sub- 102(a)(1). § and use. See methods of id. (c)” information,” or or “patent implemented The FDA has this is published Book. Id. publishing this list its publication, (c)(2). 355(b)(1), § Approved Drug Therapeutic Products with (the Equivalence “Orange Evaluations generic may A piggyback manufacturer Book”). See C.F.R. safety and efficacy original data the 314.53(c)(2)(i)(O).1 § is com statute drug NDA, manufacturer submitted in its plicated, operation but its in the present approval seek identical context is not. of use generic method for its identical product by submitting an “Abbreviated

A Drug Application,” New or “ANDA.” See Food, 355(j). Under Drug, § and Cosmetic id. If a patent is listed in the (“FDCA”), Act drug must Orange drug manufacturer Book for a method NDA, secure from the approval FDA for the sale gener- covered is any ally in interstate required certify commerce. has 355(a). so, § To do expired U.S.C. the manufac- is infring- invalid will Drug turer files a New sale Application ed or use of the for which (“NDA”) with the to secure ANDA approval submitted. 355(b)(1), for a drug,” 355(j)(2)(A)(vii). “new In what is called a encompasses term which for an “paragraph new use IV” regarding certification 310.3(h)(4). existing drug, noninfringement invalidity, see C.F.R. approval application requires stayed pending the manufac- of court litiga- outcome (or specify ques- turer drugs) tion to determine and validi- (or ty.2 tion and the meth- Recognizing that some NDAs would 36,676, 36,686 (June Applications 1. Approval Infringed, Fed.Reg. See also for FDA 18, 2003) (codified 314) pt Drag: 21 C.F.R. Market New Patent Submission (“Report Accompanying and Order the Patent Listing Requirements Application of 30- Rule”). Listing Approval Stays Month of Abbreviated New Drug Applications Certifying that a Patent paragraph Where makes Claiming Drag Is Invalid Not Be or Will certification, patentee forty-five IV has by brings patent infringe- a by a both uses covered cover against applicant, ment action by patent, Congress not covered a uses viii,” assert counterclaim applicant which allows enacted “section requiring an order the holder to seeking application to to limit its ANDA delete uses, correct or approval and to secure unpatented by the holder under subsec- unpatented uses. for those (b) (c) or this section No. 355(j)(2)(A)(viii); Rep. § H.R. 98-857 of ground that the does not claim 1, (1984), reprinted at 22 in 1984 pt. 2647, either— U.S.C.C.A.N. (aa) the application for which they Some NDA filers realized approved; was generic competition making block (bb) an method to patent coverage,

unwarranted claims for of drug. by listing Orange Book a example, 355(j)(5)(C)(ii)(emphases drug or of use when in 21 add- patent for a U.S.C. ed). Thus, clearly inapplicable. was amendment allows fact police against to repeatedly applicant, defending The FDA declined the ANDA who is listings,3 patent infringement before en- suit Orange brought Book NDA, provision in of the to assert a counter- actment of the counterclaim holder we that the could not do claim correct or held courts to delete judgments. “patent ... under through declaratory so See information submitted (b) (c)” Pharms., ground Inc. Mylan Thompson, v. 268 subsection (Fed.Cir.2001). claim F.3d 1332-33 not “the approved” which the Congress responded by enacting the drug.” “an approved method part counterclaim amendment as of the previously pro- We have construed Pharmaceu- “Greater Access Affordable majority now vision. holds Bill”), (“Gregg-Schumer ticals Act” enact- provision is unavailable (2003). Cong. ed 2003. S. 108th erroneous method of informa- correct provides: The counterclaim amendment separate tion in the Book—on two (ii) infringement Counterclaim to ac- grounds. tion.— (I) general. In an owner —If II or the holder A application under subsection of this view, my majority section for the that is miscon- claimed has or a use which is claimed strued the term information sub- Sebelius, USA, days bring Inc. suit for Pharms. 595 F.3d subject is the (D.C.Cir.2010). manu certification, approval facturer’s and the stayed period thirty- the ANDA is for a consistently position 3. The FDA has held the (or infringe months until resolution listing patents that its role in suit, shorter). ment whichever See ''ministerial,” establishing and that Book is 355(j)(5)(B)(iii). ap first ANDA reviewing pat- process administrative plicant paragraph IV to make certification ents, assessing patent challenges, and de-list- marketing 180-day period benefits from ing patents issues would involve law exclusivity, 355(j)(5)(B)(iii)(IV)(iv), id. authority. beyond expertise that are encourage generic intended manu See, e.g., Report Accompanying the and Order challenges to undertake facturers Rule, 36,683. Fed.Reg. drugs. Listing claimed cover See Patent brand Teva (b) (c).” ... require under subsection or statute listing mitted does not the of § 355(j)(5)(C)(ii)(I). majority’s the patent expiration numbers and dates in the view, information method of use is not contemplates abstract. It the description The majority information.” con- “patent of the scope patent and of the the to patent strues term as limited the relationship patent the between and the expiration number and date: Act “[T]he drug use; or the the description method of ‘patent the term information’ defined as of that scope relationship and “pat- itself patent and the expiration ‘the number ent information.” The requires statute ” is, Majority Op. at 1366. There in date.’ published, this be information stating fact, no definition of information” Secretary publish “shall informa- statute, reaching and in this con- tion submitted under two preceding struction, majority ignores critical stat- sentences.” Id. utory requires language. The statute provisions Other of the statute also con- applicant NDA to template that the ANDA filer will be able patent file with the num- application to scope understand the of patent and expiration any ber and the date of pat- patent relate the information to the drug ent which claims the which the for drug or drugs being claimed and the meth- applicant application or od or being methods of use claimed. See which claims a method such 355(b)(1). § id. Describing the scope of drug respect and with which a claim patent relating and patents listed patent infringement could reasonably drug to the or method of use is essential to if person asserted licensed statute, the operation of the as the basic manufacture, engaged the owner in the idea of patent listings use, drug. or sale of the put applicants is to ANDA on notice 355(b)(1) added). (emphases 21 U.S.C. regarding drugs which listed and methods Thus, requires the statute the NDA appli- be copied drugs and which claiming drug cant list patent protected, method of use are and to respect method of use “with to which a enable the ANDA filer to submit an appro- patent infringement claim of could reason- priate required certification law. ably words, be asserted.” In other The statute an requires ANDA applicant contemplates statute its face provide, part application, scope of the must be accurately (vii) certification, opinion described and that must be applicant related to the drug or method of use for and best of his the NDA application knowledge, respect is submitted.4 with to each patent (b) application 4. Subsection refers to information after the under application; subsection, submitted with an NDA subsec- such holder of an (c) requirements describes the application Secretary shall file with the submission of information after an number date of already patent listing NDA has been filed. any patent drug which claims the for which publication requirements of 21 U.S.C. application was submitted or which 355(c)(2) 355(b)(1): parallel those claims a method of to which a claim of If the described in sub- reasonably (b) be asserted section of this could not section be filed person if a not licensed the owner en- application with the submission of under manufacture, use, gaged (b) or sale of subsection this because the drug.... Upon the submission before the was filed in- subsection, required formation was under information under the Sec- subsection retary publish it. this section or was issued shall information as to the to viewed erroneous listed referred which claims the relationship (i) scope a use in clause or which claims of use as approved drug which the such listed information” that be ordered seeking “patent this subsec- approval under is majority appears sug- to is re- corrected. The and which information for (b) limit- overruling Mylan that the of is gest under quired to be subsection filed (c) namely, of precise Mylan, to the facts ed or this section— of the in which correction of the situation (I) that has patent such information that the num- require patent error would filed, not been entirely Orange from the be deleted ber (II) patent expired, that such has not overruling See id. The would Book. (III) patent of the date on such which to a in which errone- apply situation other expire, will or involved, Orange information is ous Book (IV) will patent that is invalid or such example, patent the errone- where manufacture, not infringed the to ously respect particular listed with use, or new for which drug sale of the use, drug properly or method of but is the is submitted.... This Orange listed elsewhere Book. added). 355(j)(2)(A)(vii) (emphases Id. the of the decision. ignores Mylan context pro- Similarly, section viii certification the thing The first to is that the understand contemplate also to appears vision majority’s Orange Book description (b) information submitted under subsection relationship actual likely bears no to the (c) regard- will encompass information Orange Book is not a list document. The patented of The stat- ing the method use. particular patent of from which submit, directs ute the ANDA The is a Orange could be excised. Book re- drug if with to the listed particular pat- list of NDAs that associates (i) ferred to in was clause drugs ents with or methods of (c) under subsection filed Orange listing use. Correction of Book which patent a method use list, not patent does strike a from a appli- does not claim a use for (or corrects) listing strikes that associ- seeking approval cant is under this sub- NDA, patent particular ates the with a section, a statement the method or method of drug, use. not claim a use. 355(j)(2)(A)(viii). plainly problem Mylan The in was that statute contemplates Orange improperly information” Book described will include information that and related scope improperly describes scope of that relates of use not method method of use. Bristol- patent. Mylan, covered (“Bristol”) Myers Squibb Pat- owned U.S. B (“the 4,182,763 No. di- patent”) ent '763 Quite apart major- the fact from through to the of anxiety rected treatment ity’s limiting interpretation is inconsistent buspirone hydrochlo- the administration of structure, statutory language ride. 268 F.3d at 1327. The '763 majority’s my view interpretation is in in connec- was listed untenable for other reasons. expire. tion with that use but was about to

First, expi- majority agrees patent’s that the coun- Id. Eleven hours before ration, copies designed terclaim to over- Bristol delivered the FDA amendment (the 6,150,365 Op. “'365 Mylan. Majority rule our of U.S. Patent No. decision overruling Congress single at 1365. In which included Mylan, patent”), 355(j)(5)(C)(ii)(I). anxiety claim directed to the treatment statute thus buspirone.5 must allow correction of a misdescription a “metabolite” of Id. at patent scope that includes a drug have the '365 sought Bristol 1327-28. covered Book as cover- erroneous infor- patent listed mation relationship about the using buspi- between buspirone and a method ing if drug, and the even Mylan Id. at and other rone. properly listed elsewhere challenged the applicants listing

ANDA Book. In scope other words the that it ground relationship and its buspirone, covered metabolite of and a must be “patent information.” of buspirone of a metabolite anxiety. After the FDA re- to treat Id. Moreover, if in- “patent information” listing, Mylan fused correct the filed cludes as information to the scope a declaratory judgment that Bris- suit patent with to the drug and the improperly patent '365 in tol listed the the relationship patent between the number covering Orange buspirone Book as and drug, and the it must also Orange include a buspirone, preliminary the use of and Book describing information the a scope of Bristol injunction requiring delist the patent method of use and linking the patent. Reversing the Id. district method of use to There no is court, we held that there was no declarato- statutory basis in language or statuto- ry relief available to correct erroneous ry purpose for distinguishing between at Orange listing. 1332-33. drug information and method of use infor- mation. Either in- “patent both must be Thus, in accused Mylan, infringer formation,” or neither must in- patent be challenged accuracy listing asso- view, my formation. all Orange Book ciating patent with the meth- “patent is information.” Congress provide od of use. acted a action to counterclaim correct errors. Second, at the time the counterclaim Congress’ proper listing concern with 2003, provision was enacted the FDA in the Book does not Rule,6 adopted had the Patent Listing remotely congressional suggest myopic making agency clear that the had adopted on focus situations where be- a broad of interpretation “patent informa- Orange Book, longed nowhere (b) tion ... under subsection majority suggests. significantly, (c).” Most That interpretation is entitled to viewing Mylan the overruling of as limited Chevron even if language deference complete delisting (as would inconsistent ambiguous, the statute is and not I statutory the explicit language, contrary urge) plainly majority’s for correction of provides Book interpretation. See Chevron U.S.A. Inc. Council, that ground information “on the Natural Res. 467 U.S. Def. drug 843-44, not claim ... for which the S.Ct. L.Ed.2d 694 (1984). application approved.” By the time of the product intermediary "Applica- 5. A metabolite is The full title of the final rule "[a] was: Dictionary metabolism.” McGraw-Hill Approval tions for FDA to Market a New (6th and Technical Terms 1319 Drug: Listing Patent Submission and Re- Scientific ed.2003). We held in Hoechst-Roussel quirements Application and of 30-Month Pharms., Lehman, Inc. v. 109 F.3d Stays Drug Approval on Abbreviated New (1997), claiming that either the active Applications Claiming Certifying that a Patent ingredient drug of a or a method of that Drug Infringed,” Is Will Not Be Invalid or ingredient does not also cover metabolites of 36,676. Fed.Reg. ingredient. require- listing FDA and certification adopted had amendment 505(b). Proposed ments” in requirements for the section See submission detailed 65,457. Rule, Fed.Reg. regula- drugs for both “patent information” rule, informa- provides “patent published The 2003 itself methods. 1) “[ijnformation tion” on the Register rule in Federal includes (active includ- ingredient) patent substance late 20027 finalized six months before [wjhether amendment, claims the ing ... the counterclaim includes ingredi- in- is the active entitled substance “Submission drug product ent in in the requirements on the described formation” 2) supplement,” new listing of a Book. See “[ijnformation (eom- report accompany- drug product 21 C.F.R. 314.53. The including ... regulatory position/formulation) revision makes clear ing [wjhether drug prod- claims the defining what constitutes sought,”9 purposes approval being uct for which information” sub- 3) (c).8 “[ijnformation Additionally, re- method-of- sections each [wjhether including pat- ... accompanying Proposed Rule in port authority confirms the FDA’s ent claims one or more methods of drug product approval 2003 rule from not which arises general authority being description and of each sought FDA’s enforce § of use or indica- pending FDCA under 21 but also its related U.S.C. authority patent patent section 505 of the and related claim of the implement Act, “including being Hatch-Waxman submitted.”10 Approval Applications 7. See to Mar- holder could not have submitted for FDA NDA Listing Drug: Requirements ket a New application. Patent the patent information with its Application Stays Ap- act, 505(b)(1) and of 30-Month on we Under section of the proval Drug Applications of Abbreviated New publish patent approval information after of Certifying Claiming Drug that a Patent Is drug application NDA our Infringed, Fed.Reg. Invalid Will Not Be products Drug "Approved Prod- list entitled 65,448 (Oct. 24, 2002) Rule”). (“Proposed Therapeutic Equivalence Evalua- ucts With popularly This list is as the tions.” known Report explains why promulgating 8. The it is "Orange orange-col- Book” because of its regulation, and in fact this is because of ored cover. If information is sub- (c): the existence of subsections approval, NDA mitted after (FDA) explain why pro- To we issued the 505(c)(2) publish act of the us to directs posal, we how first describe Federal law upon information its submission. requires applicants to file NDA infor- Report Accompanying Patent and Order mation how that information Rule, Fed.Reg. Listing at 36676. approval can affect ANDA and 505(b)(2) applications.... dosage "drug product” 9. A ais "finished form 505(b)(1) (21 act Section U.S.C. substance, drug generally, ... that contains 355(b)(1)) applicants requires all NDA necessarily, but in association with one or not file, NDA, part "the number ingredients.” more 21 C.F.R. other See expiration any patent and the date of which "drug § "an active 314.3. A substance” is applicant claims the for which the ingredient pharma- that is intended to furnish submitted the or which claims a cological activity or other effect in the direct method of cure, treatment, diagnosis, mitigation, pre- to which claim of disease or to structure or vention of affect the reasonably person if a be asserted not any body.” the human function of engaged licensed the owner in the manu- facture, use, drug.” or sale of Section 505(c)(2) (21 355(c)(2)) listing requirements are described in These the act 314.53(c)(2), 314.53(c)(1) imposes 21 C.F.R. while similar obli- submission provides: applicant gation "An ... shall sub- [NDA] holders of NDAs when added). only- applicant Cong. (emphasis NDA Addi- thus tionally, places in several legislative to submit the number required part applica history regulation ap- of its is cited date as (dai- Cong. See 149 Rec. tion, required provingly. is also to describe S8690 but 2003) (statement ly ed. June Sen. and relate scope of Hatch, substance, of use Com- drug product, or method then-chairman Senate Judiciary); Fur particular patent. Cong. mittee on the Rec. question 2003) (statement thermore, an NDA ed. June regulation requires (daily S8197 Frist, FDA Form of then applicant complete Majority Sen. Senate Lead- holder er). requires the to iden claims a tify the submitted whether Chevron, Quite from is well apart substance,” “drug product,” or “drug where, here, Congress established use,” and link such information “method specifically agency’s aware of the in- to each for which information is terpretation statutory of a term See J.A. being submitted. 918-20. enacted, time the statute was this is com- provides in this form the basis pelling legislative evidence adoption listing. See interpretation. the agency’s principle This 314.53(c)(2)(ii). C.F.R. recognized by Supreme has been decades, regula- was well aware of this both in Congress Court for the context of tory interpretation existing information” reenactment of where statutes provi- terminology enacted the statutory when it had been construed Schumer, reenactment,11 As Senator one of the before agency sion. amendment, sponsors original legislation of the stat- and in the context of new utiliz- ed, provides comple- terminology bill a that ing agency previ- “The critical the had Here, the work the done in ously Congress ment to FDA has construed.12 utilized regulations clarifying patent listing, interpretation on the FDA’s of infor- goes much Legislative by enacting but further.” mation” the Gregg-Schumer Regulatory Bill Responses agency’s and FTC with full awareness of the term, Study Entry Barriers to the Phar- of the interpretation in and the FDA’s Marketplace: Hearing interpretation binding maceutical on us in constru- Before Comm, Judiciary, ing 108th the statute. S. required legislation taxpay- affecting mit the information described of (c)(2) business, Congress paragraph in as Inter- of each er's reenacted the requirements change that meets the described nal Code without Revenue substantive deduction); paragraph expense Hartley in of this section.” v. to the business Comm’r, 216, 756, 220, U.S. 295 55 S.Ct. 79 (1935) (adopting L.Ed. United 1399 IRS' construc- See States v. Bd. Comm'rs of of Ala., 110, 131-35, purposes Sheffield, tion of "basis” for the of dece- 435 U.S. 98 S.Ct. 965, (1978) property’s to be (adopting dent’s estate value L.Ed.2d 148 55 death, Attorney Congress time of decedent’s reen- interpretation General's of "state[s] pertinent acted Internal Code political politi- Revenue and subdivision” to all include provisions change). without substantive designated jurisdiction in a cal units where Attorney Congress was aware of the General’s 535, 546, interpretation Voting Turnage, Traynor when it reenacted 12. See v. 485 U.S. 1372, 1975); (1988) Rights change (adopt Act without in Cammar- 99 L.Ed.2d 108 S.Ct. 618 498, States, 510, United ing ano v. 358 U.S. 79 Veterans’ Administration’s construction 524, alcoholism, (1959) (adopting including 3 S.Ct. L.Ed.2d 462 "willful misconduct” as Congress "ordinary construction of and enacted IRS’ neces- where GI Bill sary” expenses excluding language previous business sums same misconduct” "willful Administration). persuade spent public desirability ly construed Veterans’ 1376 history regulation, including makes method of use infor-

Third, the legislative mation. Congress was concerned with clear Orange gen- correcting Book Ill history legislative suggests The

erally. view, also errs my majority brand man- preventing broad concern “an interpreting manipulating from ufacturers drug” in Book in order listing system the “any” § 355(j)(5)(C)(ii)(I)(bb) ap- to mean into the delay entry generics market. (2003) proved method of use (state- 31,200 Cong. See 149 Rec. (“The patentee’s majority’s approach The Schumer) NDA. provi-

ment of Sen. [new] fundamentally here with the inconsistent loopholes in the law end close sions admonition, Supreme a recent Court’s practices pharmaceutical the abusive Scalia, opinion “[u]ltimately by Justice industry kept lower-priced ge- which have meaning,” context determines Johnson v. cost nerics off market and consumers — States, -, U.S. dollars.”).13 United S.Ct. purpose billions 1265, 1270, (2010), L.Ed.2d statutory provision leg- as reflected repeated “[i]n Court’s instruction ex history broadly to islative refers correction statute, information, guided we not be pounding must just by a of a single sentence or member sen expira- correction of numbers tence, provisions As look to the tion dates. Senator Schumer described but law, it, object policy,” whole and to its provisions enforce list- “[T]he Indep. allowing at the FDA U.S. Nat’l Bank v. Ins. ing requirements Or. Inc., Am., Agents it has generic applicant, when been sued 508 U.S. infringement, (quot to file counter- S.Ct. 124 L.Ed.2d 402 Boisdoré, drug company ing have claim to the brand United States Heirs of (8 How.) 113, 122, 12 or comet in- U.S. L.Ed. 1009 delist (1849)). in the FDA’s Book.” formation S15,746 (daily ed. Cong. Rec. Nov. purpose evident of the counterclaim 2003) added). (emphases allow correction provision is to of circumstances, the ... “patent Under seems to me information submitted under (b) (c).” words, must or In other interpret phrase “patent that we the as discussed above, provide ... under is to designed information submitted subsec- the (c)” (b) Orange Orange or to include Book for correction of erroneous Book scope the the submitted the NDA by appli- information describes of information holder, patent cant patent including and relates the number and information with drug patent coverage drugs date the of- to of both to method and, particular, purpose infor- of use. That is re- use methods statute, the language mation” submitted under subsections flected in the of (c) applicant must be the which an ANDA defend- interpreted include allows by ing against an action to patent required information the 2003 “as- it, Cong. (daily patenting the See also 149 Rec. at S8191 ed. to do such as sub- schemes 19, 2003) (statement Schumer) body of Sen. makes when is in- June stance the the ("A drugs gested; developing computer programs lot of were on mar- blockbuster the and, patents expire. drug; listing in one ket. Their were about the the case, industry absurdly, patent ... a new was asked for came to the conclusion that could, changed. they everything they they do color of the was had to had because the bottle pull stops concept all That the of Hatch-Wax- out the to extend their mo- was never man.’j. They up crazy nopolies. came with wild and information, order re- certain in seeking a counterclaim submit sert correct or cluding patent the holder to the one quiring [NDA] “[w]hether claims by patent the submitted or more approved using delete methods of the information (c) (b) or of approved drug product under subsection the holder and a description on the the ground approved of each method use or indica either(aa) not claim the tion and claim related the approved; was being submitted.” C.F.R. (bb) 314.53(c)(2)(ii)(P)(1) added). approved using method the § (emphasis (em- 355(j)(5)(C)(ii)(I) words, drug.” regulation other requires added). words, if In other phases relate patentee ap Orange (bb) Book claims information proved method of use. is Subsection coverage drug not approved for an directly concerned with correction of the by covered or a method use Orange relating Book information patent, not covered that information approved use. method of may corrected. operation Once overall of the statu-

Thus, approved the reference to “an tory understood, is scheme the text using drug” in subsection method clear. Third New Webster’s International (bb) must refer to in the Dictionary “a” being describes “used approved concerning “an word a singular function before noun using drug.” majority’s method a restrictive followed clause or other in focusing relationship error lies modifier <a identifying man who here (which and the NDA between >.” yesterday Webster’s In- Third New information), Orange Book rather than Dictionary ternational (emphasis relationship patent and added). between the appears This definition before Orange Book the ma- listing. Under “a” as “any.” definition of See id. theAs view, jority’s no correction of erroneous illustrates, “an” in example this case permitted Book information is so be the function word before singular any long approved as the covered noun method (“approved of use NDA. The method covered drug”) conveying particular identity can be listed in Book as use of a through the restrictive clause. A, erroneously covering approved use de- implicit The restrictive clause here is —-“an patent actually the fact that the cov- spite approved logi- method of the drug” B, ers to an cally refers of use provides no mechanism for cor- provision NDA by listed the holder in the Congress This cannot rection. be what Book, as associated the listed intended.14 Thus, particular to a of “an” refers method drug, is, using particular ap- that the

Moreover, the statutory language refer proved method listed the NDA to “an holder ring approved method of in refers, Book. This is the inter- obviously again, once to the drug” that terminology pretation statutory language in Patent List of used the 2003 yields regulation plainly Rule. That that for a result is not at vari- ing required purpose of patent” legislation “each method of use NDA ance with the majority Congress suggests Op. bor- I have demonstrated 14. The at 1365. above statutory language our deci- rowed from Congress not have intended to could limit Mylan in that “an” sion and that this shows provision particular facts counterclaim "any,” Mylan the means because in Mylan. in any Majority approved did not relate to use. 1378 was to avoid. Here League, designed Mun. Nixon v.

a whole. See Mo. 1555, (“Novo”) 138, 125, 158 originally 124 S.Ct. was U.S. Novo Nordisk 541 v. (citing States 291 United com L.Ed.2d of the on the chemical owner Ass’n, 534, 543, 60 Trucking U.S. Am. 310 repaglinide, Patent No. position of U.S. (1940)). 1059, in L.Ed. “As 84 1345 S.Ct. (“the RE37,035 which ex patent”), '035 construction, statutory our task all cases 14, Novo Nor pired on March 2009. See of these statutes interpret words Ltd., Labs., v. Caraco Pharm. disk A/S sought to purposes Congress light in (E.D.Mich.2009). 729, F.Supp.2d Chapman Houston serve.” v. Welfare also the of a cover Novo is owner 600, 608, 99 S.Ct. Rights Org., U.S. monotherapy use of ing repaglinide (1979). 60 L.Ed.2d diabetes, 5,312,- Patent No. to treat U.S. short, In the statute must be construed (“the patent”), expired in '924 follows: to read as September of 2006. The (ii) ac- Counterclaim to these meant that Novo tion.— any protection claim for monothera- (I) an owner of the general. However, of PRANDIN. Novo py use —If patent or holder (the an in 2004 acquired additional (b) under subsection application suit) 1) a chemical com- claiming claimed section for that is metformin; repaglinide position or a which is claimed use of 2) depen- for treating a method non-insulin infringe- patent brings (NIDDM) compris- dent diabetes mellitus against applicant, ment action ing administering patient repaglinide to a assert a counterclaim in combination with metformin. See U.S. seeking requiring an order the holder 6,677,358 11.42-43, No. 48-51 Patent col.10 or delete correct (“the patent”). The '358 is not by the holder under subsec- expire until set to June (e) this section Following patent on issuance of the '358 not claim ground 13, 2004, an January Novo submitted either— 5, 2004, February dated associ- Form (aa) for which [associated] (for PRANDIN). NDA ated with approved; Nordisk Novo Caraco Pharm. A/S (bb) an meth- [associated] Ltd., Labs., 649 F.Supp.2d drug. od of (E.D.Mich.2009). The use code narrative code, An error Book use claiming was limited PRAN- use, unpatented which covers therapy. It DIN combination read: subject proper to correction under a OP REPAGLINIDE IN “U-546—USE reading provision. METFORMIN COMBINATION WITH IV TO LOWER BLOOD GLUCOSE.” Thus, entry in this illustrate the 664. 2004 facts case well manipulation the following: true included NAME; PATENT INGREDIENT PATENT APPL/PROD PATENT/PED CODE(S) NUMBER TRADENAME EXCL EXPIRES NUMBER 12,2018 REPAGLINIDE; DP 020741001 PRANDIN 6677358 JUN DS U546 12,2018 REPAGLINIDE; 002 PRANDIN DS DP U546 020741 6677358 JUN REPAGLINIDE; 12,2018 DP 020741003 PRANDIN 6677358 JUN DS U546 1235. clear that it seeking See J.A. was not approval to market the use of repaglinide in combina- Laboratories, Pharmaceutical Caraco (by tion with metformin limiting its label (“Caraco”) seeking Limited filed an ANDA use).16 to the monotherapy Based on the approval repaglinide to market existing U546 use code description anticipation treatment of diabetes of the of the '035 Novo Nor- PRANDIN (limiting description disk, In F.Supp.2d at 662. June to combination therapy), the FDA Caraco, if claiming Novo sued that Caraco permitted Caraco to move forward with its repaglinide, infringe.

marketed it would carving label out pertaining Nordisk, Complaint at Novo repaglinide use of in combination with 661.15 Novo not claim that F.Supp.2d did metformin. See J.A. 625-43. would the '924 infringe Caraco later, Several months Novo then broad- patent; the '035 nor could Novo make ened the use code for PRANDIN associat- sought approval such a claim since Caraco ed with patent, the '358 repaglinide only pat- changing to market after both the use Rather, expired. ents Novo claimed that code to read: “U-968—A METHOD FOR Caraco would induce IMPROVING GLYCEMIC CONTROL patent, apparently '358 because the Caraco IN ADULTS WITH TYPE 2 DIABETES suggest repaglinide label would the use of Nordisk, MELLITUS.” Novo together with metformin. F.Supp.2d at 664. The Orange Book list- ing for PRANDIN Following suggestion, the FDA’s then included Caraco the fol- certification, viii sought making a section lowing: PATENT PATENT NO PATENT NO EXPIRATION DATE CODES

APPL/PROD REPAGLINIDE —PRANDIN 12, 12, 12, N020741001 N020741002 6677358 6677358 6677358 Jun Jun Jun 2018 2018 2018 DPDS U-968 U-968 DPDS N020741003 DS DP U-968 Servs., Dep’t notherapy diabetes, See U.S. of Health & Human to treat the FDA re- rejected versed itself and pro- Caraco’s Approved Drug Therapeutic Products with carve-out, posed labeling requiring Caraco A, Equivalence Evaluations add. at 157 regarding include the information (30th ed.2010). appeared Since U-968 patented repaglinide-metformin combina- encompass the repaglinide mo- therapy generic label.17 particular, cy Stay Novo asserted that market- Mandatory Injunction Motion to ing repaglinide infringe Pending Appeal would claim of at exh. at Novo Nordisk Labs., Ltd., patent, the '358 which claimed: v. Caraco Pharm. No.2010- A/S (Fed.Cir. 7, 2009). However, Oct. at the treating depen- A method for non-insulin certification,” urging sought "split FDA's (NIDDM) comprising dent diabetes mellitus paragraph IV certification as to the administering patient to a in need of such product patent, claims of the '358 and a sec- repaglinide treatment in combination with tion viii certification as to the method claim. metformin. See J.A. 635. '358 col. 10 11.48-51. initially paragraph exception 16. Caraco made a IV cer- 17. With the of the carve-out to use, respect infringing language tification Claim of '358 avoid the paragraph and a III certification with label must otherwise match repaglinide. original drug label. See 21 U.S.C. Opposition Plaintiffs-Appellants' Emergen- 355(j)(2)(A)(v), (j)(4)(G); 21 C.F.R. FDA’s duties with monotherapeu- that acknowledges Novo and that the Orange Book are ministerial is not covered repaglinide tic use See, Op. at Majority require not e.g., Hatch-Waxman Act does patent. '358 (“Novo agree that listings and Caraco Book police FDA to the three only one of claims regulatory compliance with ensure using PRANDIN methods of statutory requirements). with met- in combination (i.e., repaglinide Second, require FDA did a while the formin).”). that use code claims But the drug label- change in oral diabetes general monotherapy cover the patent does required that a ing in November of 2007 view, precisely type my this is use. in the PRANDIN corresponding change intended the Congress that of situation label, absolutely nothing there is to address. required Novo regulations statute the FDA for concurrence blames to track this new change the use code di adopting Novo’s predicament, Caraco’s FDA did not direct or indication.18 The FDA, argument singenuous change Novo its use code request that Novo, change responsible not indication, nor was Novo reflect the new accuses code. The concurrence the use regulations to make required under By up the works. “gummfing] FDA of Indeed, response change. for re single broad indication requiring argument, at oral Novo admit- questioning labeling, of the paglinide part (“ Arg. [The this. at 1:40-1:46 ted Oral can where Caraco FDA created situation require did not 2007] [a FDA directive of labeling proposed that its longer no assert ”). ... change code] in the use infringe patent.” the '358 Con does not However, labeling argues Novo First, FDA did curring Op. 1368. FDA in “Indi- change required by the in the use code. The require change label made the use code part cation” interpret patents police FDA does not argues Novo change appropriate. listings, very source submit FDA Form 3542 allows them to that led to the counterclaim problem the indication either the method of use or administering The FDA role in provision. Appellant’s Br. 36 for the use code. simply it Orange Book is ministerial: (“FDA’s guidance expressly written information that receives lists the applicant may An describe the alternative: manufacturers, expecting from brand the indication or the method either statutory to abide parties those use.”). correct,19 partially That is but the Inc. v. Apotex, mandates. See regulatory infor- (Fed.Cir. requires that the use code form also Thompson, 347 F.3d 2003) portion that mation refer to that label position the FDA’s (upholding case, Thus, 314.94(a)(8)(iv). drugs, all antidiabetic the FDA re- in this without oral carve-out, replace separate indica- quired Novo to all Caraco would be the section viii following sentence: “PRAN- regarding the tions with the required to include information adjunct indicated as an to diet and therapy included in PRANDIN’s DIN is combination (in improve glycemic in adults “Dosage exercise to control and Administration” label sections) type 2 mellitus.” See J.A. 667- Pharmacology” in its diabetes and "Clinical J.A. 637. The inclusion of own label. See regarding thera- the combination provides alternatives with re- in- 19. The form py likely cause Caraco to induce would spect use code— to submission of fringement of the '358 "provide the the NDA holder to it directs or method of part ongo- information on the indication of an 18. In November labeling J.A. 920. professional use for the Book.” ing reevaluation change use. J.A. the use in patented part that relates to See code was “a re- label, case, in this sponse ruling An to the section viii ... in 919. patented unpat- uses and Arg. cover both December '08 from FDA.” Oral at Nothing regula- in the FDA ented uses. 3:43-4:03. suggests or FDA Form 3542

tions V Orange Book use patentee may derive Finally, majority portion opinion suggests information from that code unpatented Quite interpretation uses. the court’s restrictive referring label contrary, applicable regulations of the counterclaim is so bad are clear that the and Form 3542 because it does not leave without a Caraco patentee required por- to utilize those remedy to correct the erroneous patented that refer to the tions of the label listing. majority sanguine 314.53(e)(2)(ii)(P)(2) outcome, use. See 21 C.F.R. believing forcing about the identify the NDA holder to “the (requiring paragraph Caraco defend the IV in- specific approved labeling section of the fringement suit will efficient “facilitate!] corresponds drug product for the disputes concerning potential resolution of by use claimed the method of overlapping of protected unprotected submitted”); J.A. 919. contrast, Majority Op. uses.” the concurrence doubts that there is a Here, patentee exactly did what was remedy suit, and I expressly forbidden. For notes, agree. “[b]y As the concurrence description use code submitted on the requiring single broad indication for re- FDA Form Novo submitted the fol- paglinide part approved labeling, improving “A lowing: glycemic method for FDA created a situation where Caraco can type mel- control adults diabetes longer no assert that its proposed labeling por- 673. It thus utilized that litus.” J.A. infringe does not patent.” Con- tion of PRANDIN’s label that refers to the Indeed, curring Op. at 1368. adop- Novo’s repaglinide standing use of alone to treat tion of a broad code for use PRANDIN (an use), unpatented diabetes not to the likely prevents being Caraco from able to repaglinide together use of with metformin disprove infringement in paragraph IV (a use).20 patented justifica- There is no lawsuit, compelled because now Caraco is using a portion tion for the label refer- regarding pat- to include information an ring unpatented use to describe a ented combination therapy its label. patented use. remedy Nor would there be a in a suit manipulative nature of Novo’s ac- under the Administrative Procedure Act only by tions is confirmed not the lack of (“APA”). sure, To be we have held that justification change, also but APA (two brought an action could be to chal- years timing change after the lenge refusing police FDA action in labeling change was initiated the FDA Book, codes in the but at the same immediately after the FDA carve-out), expressed time no view as to we whether Caraco’s section viii action would succeed. See Andrx preventing approval own admission that Pharms., Corp., part ANDA was of the motivation Inc. Biovail 276 F.3d Caraco’s (Fed.Cir.2002). changing argu- the use code. At oral To succeed ment, action, Novo conceded that the decision to such the ANDA would parts "Dosage 20. Various other of the current PRAN- and Administration” sections of the therapy, DIN label reference the combination label. Pharmacology” such as the "Clinical Sebelius, to Pharmaceuticals Inc. v. that the FDA’s refusal have to establish USA (D.C.Cir.2010). F.3d 1303 There the arbitrary capri- police use codes provision another court construed cious, contrary to the statute. 5 U.S.C. concerning the NDA 2003 amendments 706(2)(A). subsequently have held We holder’s withdrawal of statutory obli- the FDA is under no (c).” under subsection par- to determine the correctness gation § 355(j)(5)(D)(i)(D(bb)(CC). The Book, Orange patent listings ticular if provided statute such information nothing in the Hatch-Waxman and that ap- the holder of the were “withdrawn Orange the FDA to screen requires Act exclusivity period plication,” applicants NDA Book submissions ANDA first filer would be forfeited. See satisfy that do not the statu- refuse those id. The court held that the with- listing. Apotex, See tory requirements resulting drawal from a successful counter- 1349; Inc. F.3d at see also aaiPharma triggered claim suit a forfeiture and not a (4th Thompson, v. 296 F.3d 238-40 Teva, voluntary withdrawal. 595 F.3d Cir.2002). Moreover, very enactment 1317. This was so because there was “not provision counterclaim assumed that single cogent why Congress reason remedy alternative was available to an no might permitted have brand manufactur- applicant challenging Orange ANDA an (CC) by with- trigger ers to subsection listing. Today’s strikingly decision Book drawing challenged patent, outside the limits the counterclaim with the scenario,” (emphasis in id. that, likelihood, in all consequence original), strong policy and because of the any applicant ANDA is left without reme- favoring 180-day mar- of the statute dy to correct an erroneous Book keting exclusivity period. Id. at 1318. listing respect with to a method of use majority Here the reaches result that is Congress cannot what patent. This unsupported by any cogent reason for intended. leaving an ANDA without a rem- edy to correct erroneous listing to a method of use summary, majority’s In crabbed patent, directly contrary and is to the con- unjustified view of the statute sanctions an gressional purpose. respectfully I dissent. manipulation Book. suit, compel Caraco seeks to Novo to cor- PRANDIN,

rect the use code for and to

reinstate the earlier U-546 use code de-

scribing covering HORNBACK, Alton B. Plaintiff- IN “USE OF REPAGLINIDE COMBI- Appellant, NATION WITH METFORMIN TO LOWER BLOOD GLUCOSE.” Under

the correct construction of the counter- STATES, Defendant-Appellee. UNITED provision, properly claim the district court No. 2009-1543. held Caraco was entitled to order Appeals, States United Court reinstating former U-546 use code. Federal Circuit. Nordisk, F.Supp.2d See Novo 729. April 2010. In holding provi- that the counterclaim Rehearing En Banc Denied unavailable, majority’s approach sion is June notably with the approach inconsistent adopted by our sister circuit in another case,

recent Act Hatch-Waxman Teva notes an erro- thorizes suits to correct or delete to counter generic allow manufacturers date. expiration neous number or listed bears no claim unless the. does not extend to the authorization drug. To more relation to the listed be again, use code narrative. Once this care- specific, pro the terms of the counterclaim language suggests ful Act use of compelling vision do not authorize an order disputes facilitates efficient resolution of change holder to code its use over potential overlap patented narrative. The counterclaim unpatented uses the form of a Para- that a manufacturer can states graph IV suit. compelling an order “the holder to request correct or delete the Approximately information six months before the the holder under subsection Amendment, promulgated the FDA (b) (c).” 355(j)(5)(Q(ii)(D § 21 U.S.C. regulation concerning the “Submission added). (b) requires (emphasis Subsection requires Patent Information” which it manufacturer to submit “the pioneering pioneering manufacturer to submit not expiration number and the date of expiration number and the any patent ... which claims a method of date, but also the use code narratives and 355(b)(1) drug.” such other information on patent-related Forms added). (c) (emphases Subsection states 3542a 3542. See C.F.R. 314.53. “[i]f described regulation appeared This include subsection this section could not use code narrative under broader filed with the an applica submission of Al- heading “patent information.” tion,” the holder “shall file with the Secre though regulation preceded the 2003 tary number and the Amendment, it change meaning did not any patent ... date which claims a statutory the term drug.” method of 21 U.S.C. clarified, information.” As this court has 355(c)(2) added). (emphases

Case Details

Case Name: Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd.

Court Name: Court of Appeals for the Federal Circuit

Date Published: Apr 14, 2010

Citation: 601 F.3d 1359

Docket Number: 2010-1001

Court Abbreviation: Fed. Cir.