Novo Nordisk A/s v. Caraco Pharmaceutical Laboratories, Ltd.
688 F.3d 766
Fed. Cir.
2012
Check Treatment
Docket

*1 NORDISK NOVO

Nordisk, Inc., Plaintiffs-

Appellants,

v.

CARACO PHARMACEUTICAL LABO

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

ceutical Defendants-

Appellees.

No. 2010-1001. Appeals,

United States

Federal Circuit.

July 2012.

767 Hurst, argues that two issues remain to Strawn Novo F. Winston & James (1) Blackman, IL, H. this court on remand: LLP, by be resolved Chicago, Scott Klein, Johnson, N. An- is “cor- B. Steffen whether Novo’s current use code Charles Nichols, LLP, rect”; & Strawn Winston and the district court drew whether Bloch, DC, Winston Washington, David S. issuing injunction in a erred CA, Francisco, LLP, for San & Strawn requiring prior its Novo reinstate use Defendant-Appellee. code. Gibson, Krevitt, A. Dunn & Josh finds, light This court in of the NY, York, LLP, Wayne New M. Crutcher case, in this that admitted facts Su LLP, Gibson, Dunn Barsky, & Crutcher any argu preme Court decision forecloses CA, Perry, Mark A. Minodo- Angeles, Los ment that Novo’s “correct.” Gibson, Vancea, Dunn

ra & Crutcher D. pro that the counterclaim Court held DC, A. Sitz- LLP, Michael Washington, 355(j)(5)(C)(ii)(I) 21 can vided U.S.C. LLP, man, Gibson, Dunn & San Crutcher “to correction of a used force use code Francisco, CA, Plaintiff-Appellant. for inaccurately

that describes the brand’s RADER, Judge, Before Chief particular covering as a method of Judges. and DYK Circuit CLEVENGER Caraco, question.” in 132 using drug Drug at 1675. The Food and Admin S.Ct. Judge court filed Chief Order (“FDA”) has istration found Novo’s cur Opinion concurring part and RADER. FDA-ap rent use code covers all three part Judge filed dissenting by Circuit proved using repaglinide. methods of Id. DYK. 1679; at see Novo Nordisk v. Caraco Labs., Ltd., Pharm. 601 F.3d AFFIRM TO ON MOTION (Fed.Cir.2010). undisputed It that OF THE INJUNCTION (“'358 6,677,358 Patent Novo’s U.S. No. DISTRICT COURT only patent”) claims one those three RADER, Judge. Chief Caraco, of use. approved methods Novo, 1678-79; at 601 F.3d at 1364. S.Ct. Defendants-Appellees Caraco Pharma Thus, inaccurately the current Laboratories, Ltd. and Phar ceutical Sun covering Novo’s as two describes Industries, (collectively, Ltd. maceutical repagli FDA-approved using methods of “Caraco”) summary affirmance of move for admittedly nide does that '358 District of the United States (hold Caraco, at cover. S.Ct. Michigan for the Eastern District of ing may bring a counterclaim “Caraco Supreme Court decision in pursuant ‘on seeking to ‘correct’ Novo’s use code Laboratories, Ltd. Caraco Pharmaceutical A/S, ground that’ the '358 ‘does not - U.S. -, v. Novo Nordisk using ... an (2012), approved claim 1670, 182 L.Ed.2d 678 which S.Ct. (em ”) drug’ indeed, does not claim two and judgment this court’s re reversed — added) phasis (quoting Plain proceedings. for further manded 355(j)(5)(C)(ii)(I)). Novo tiffs-Appellants Nordisk AJS “Novo”) Nordisk, (collectively, Inc. a district court’s court reviews For replies. the reasons oppose. Caraco permanent and the below, grant of affirms-in-part this court set forth that for abuse of discre modifies-in-part the District Court’s Flakt, Inc., Techs., Joy tion. Inc. v. F.3d injunction. (Fed.Cir.1993). i.e., approved The counterclaim method of use use”— remedy is “an claimed in the provides statute 314.53(c)(2)(ii)(P)(3) added). (emphasis the holder to requiring order correct or *3 Here, patent the '358 claims method patent by “[a] information submitted delete the treating for non-insulin dependent the to the FDA. 21 diabetes holder” U.S.C. (NIDDM) mellitus comprising Damages § administer- 355(j)(5)(C)(ii)(I). prohib- are ing in patient to a need of such treatment 355(j)(5)(C)(ii)(III). § ited. Id. in repaglinide combination with metfor- injunction Court entered an The District min.” patent, claim appropriate '358 4. An 25, 2009, which September provided: on use code therefore must be limited to use hereby is by Novo Nordisk directed of in “repaglinide with combination metfor- mandatory under 21 U.S.C. min” to treat NIDDM. to 355(j)(5)(C)(ii)(I)(bb) correct within court holds that while the Dis (20) days the twenty from date of this trict Court was issuing correct in an in Injunction Order and its inaccurate de- junction requiring correction Novo’s use by of the scription patent '358 submit- code listing the patent, '358 it abused ting FDA an form to amended FDA its in dictating precise discretion the terms reinstates its U-5I6 former of the use code to be submitted on FDA for Prandin listing and describes claim 4 clear, Form 3542. To be is appropriate it '358 in the section 4.2b as for district courts to construe the scope of covering the “use of in repaglinide com- the provide claims and clear limits with to bination metformin lower blood on appropriate the scope the corre glucose.’’ sponding limits, use code. Within those Novo Nordisk v. Caraco Pharm. the company branded given opportu the Ltd., Labs., (E.D.Mich. F.Supp.2d nity propose specific to language of the 2009) added). (emphasis Therefore, use code. this court modifies regulations The relevant FDA make the as follows permit to Novo to company responsible branded for drafting draft an appropriate use in light appropriate codes submitting guidance Contrary above. to the dis them to the FDA. See concerns, sent’s this holding give does not 314.53(c)(2)(ii)(P) (describing informa- Novo unbounded to propose discretion tion to submitted on FDA Form 3542 new overbroad use If code. the revised for each patent). method-of-use The com- overbroad, code offered is the district pany certify penalty must under of perjury power has the to correct the error. “that this is an and complete accurate Therefore, submission information.” FDA It Is Ordered That: 3542, context, Form Part 6.1. In this an Novo Nordisk hereby directed appropriate order relief granting under 21 under U.S.C. 355(j)(5)(C)(ii)(I) will give the § 355(j)(5)(C)(ii)(I)(bb) to correct within company opportunity branded to draft (20) days twenty from the date of this its own corrected use code. Injunction Order and its inaccurate de- use code offered scription brand patent by '358 submit- ed must company “sweep more broadly ting an to FDA amended form FDA Caraco, than patent.” 132 S.Ct. at accurately for Prandin that de- Rather, 1683 n. 7. must accu scribes the of claim of the '358 rately patented describe “the in section 4.2b. The Bowles, row.”); 321, Hecht Co. v. dearly repagli- to use of U.S. limited shall be to in with metformin 64 S.Ct. 88 L.Ed. 754 nide combination diabetes dependent that district courts have (noting treat non-insulin inherent equitable authority mellitus. to “mould each decree case”). necessities of the particular DYK, in Judge, concurring part Circuit particular, it In is established that courts dissenting part. authority require specific have affirma majority that I with the agree through mandatory injunctions. tive acts Phar Supreme Court’s decision Caraco Co., v. Am. See Stores U.S. California Laboratories, v. Novo Ltd. maceutical *4 271, 280-83, 1853, 110 S.Ct. 109 L.Ed.2d —A/S, -, U.S. 132 S.Ct. Nordisk (1990) entitling 240 that a statute (holding (2012), 1670, use 182 L.Ed.2d 678 Novo’s injunctive to party a “have relief’ entitles correct and is entitled code is not Caraco parties prohibitory mandatory to both Novo to correct requiring to an injunctions princi under the “traditional I to the respectfully its use code. dissent Work, ples equity”); v. of Morrison 266 majority suggests the dis extent that the 481, 490, 149, U.S. S.Ct. 69 L.Ed. 394 adopt to a trict court cannot order Caraco (1925) (stating that a only enjoin use compliant use code but the may granted “in the a exercise of sound origi an As in the improper of use code. discretion”); Dobbs, judicial Dan B. decision, approach nal such an would read (2d § Law 2.9 ed. Dobbs Remedies not into the statute limitations that are 1993). there. provision comprehensiveness counterclaim entitles Car- of this equita- “[T]he The requiring jurisdiction is to remedy aco the of “an order ble not be denied or limit- to [i.e., the to correct ed in the absence of a clear and valid Novo] holder [NDA] [i.e., legislative Weinberger ... the the use command.” v. information Romero-Barcelo, 305, 355(j)(5)(C)(ii)(I). 313, 21 U.S.C. On 456 U.S. code].” 1798, (1982) (emphasis to the 72 L.Ed.2d 91 provision appears its face this allow S.Ct. added) particular (quoting Holding to require district court a Porter v. Warner Co., 398, 1086, 395, as a corrective measure. See Web- 328 U.S. 66 S.Ct. (1946)); Dictionary see Third New International L.Ed. 1332 also United States ster’s correct, (defining year Buyers’ Coop., in the v. Oakland Cannabis 483, 496, provision’s enact- U.S. 121 S.Ct. 149 L.Ed.2d before counterclaim (2001). ment, right,” as “to make or set “remove 722 There is no “clear and valid from,” legislative or constraining the faults or errors or “alter command” the dis- adjust bring discretionary to to standard or trict court’s broad power so as some condition”). Traditionally, required scope requiring dis- over the of the order authority to trict courts have broad inherent correct its use code. See injunctive 355(j)(5)(C)(ii)(I). majority may shape to remedial orders. See Kurtzman, 192, 200, suggest Lemon v. 411 U.S. that district court’s (1973) (“In reg- FDA improper S.Ct. 36 L.Ed.2d was somehow because decrees, re- company the trial court is ulations make the branded shaping equity discretionary sponsible initially a use power; proposing vested with broad code,1 not con- correspondingly regulations nar- but those do appellate review is days approval drug, drug of a new fer each that claims the substance 1. Within 30 (active (formulation drug applicant ingredient), product submit FDA Form 3542 "the shall (“[W]e authority court’s strain the conclude that De- Soon-Shiong and provision to order a counterclaim correc- sai are coinventors with Tao of the com- tion, purport not so. and do to do No pounds claimed in patent, the '653 but that regulation says or that a use Holton, statute Nadizadeh, not.”). Yang are cannot be corrected a court under the opinion case, In its in this the Supreme provision. counterclaim The use code in- noted “[a]n overbroad use simply formation is code” like-Novo’s “throws a into wrench scope routinely Courts con- ability approve FDA’s to generic protection, strue the so drugs,” and that provi- the counterclaim hardly anything there unusual in the sion remedy problem. was enacted to this doing exactly thing court’s same Caraco, 132 at S.Ct. 1684. Novo should context of the counterclaim provision. be permitted throw a new wrench Analogously, when the a inventorship of each time one is offering removed new challenged, 35 U.S.C. 256 al- forcing overbroad codes and Caraco to lows “order correction *5 seek correction ap- of each one. Such an patent.” As filings, with the FDA proach potentially could hamstring the dis- patent applicant is required to list trict denying court it the authority to in the inventors first instance file an state what the correct code is. is a or oath declaration indicating that the in- particularly easy case because the district is correct. ventor list 37 C.F.R. 1.63. merely ordered the reinstatement of We have never limited district courts’ au- the use code originally proposed by Novo. thority provision ordering this only general correction of an incorrect list inventors, rather than directing who

should be added or removed as a co-inven- See, e.g., tor. Bd. Educ. ex rel. Bd. Bioscience, Fla. Trs. State Univ. v. Am.

Inc., (Fed.Cir.2003) 333 F.3d composition), approved or "[t]he patented method 314.53(c)(2)(ii). use.” The re- use” for each method-of-use Id. quired information on 314.52(c)(2)(ii)(P)(3). Form 3542 includes

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