amgen inc. v. sandoz inc. 1347 - fish & richardson inc. v. sandoz inc. 1349 cite as 794 f.3d...

1347AMGEN INC. v. SANDOZ INC.Cite as 794 F.3d 1347 (Fed. Cir. 2015)

ed right to submit new materials for a 90–day period following the required mailing.No law gave Mr. Carter’s counsel noticethat, upon receiving the 90–day letter afterthe deadline had run, she still had theright to have the Board consider late-sub-mitted evidence as if it had been timelysubmitted.

The Veterans Court did not cite any-thing providing such notice. It said thatMr. Carter would have been entitled to‘‘raise[ ] arguments to the Board’’ evenafter the final decision had issued and that‘‘the Board would have been required toconsider them.’’ Carter, 26 Vet.App. at546 (emphases added). Even if the Veter-ans Court is correct, but cf. Gov’t Br. at16 n. 4 (the government states that it is‘‘not aware of the authority for the Veter-ans Court’s statement here’’), an obligationto ‘‘consider arguments’’ is not an obli-gation to consider evidence as if it weretimely submitted. The Veterans Court la-ter stated, without identifying any authori-ty for the proposition, that Mr. Carter wasnot ‘‘prevented from presenting additionalargument or evidence.’’ Carter, 26 Vet.App. at 546. That he was not ‘‘preventedfrom presenting’’ evidence does not meanthat the Board was obliged to consider theevidence as if timely submitted, much lessthat this was clear at the time. And,although the Veterans Court often grantsrelief from appeal deadlines missed on ac-count of an initially defective (but later-corrected) notice, see, e.g., Ashley v. Der-winski, 2 Vet.App. 307, 311 (1992), therewas no clear basis for relying on thatpractice as applying to the non-appealdeadline at issue here.

In these circumstances, we conclude thatthe Veterans Court legally erred in findinga cure of the notice defect. That conclu-sion requires a vacatur and remand unlesswe find the error to be harmless. See 38U.S.C. § 7261(b)(2); Shinseki v. Sanders,556 U.S. 396, 406, 129 S.Ct. 1696, 173

L.Ed.2d 532 (2009). We cannot. The Vet-erans Court made no determination that, ifMr. Carter’s counsel had received the no-tice in a timely fashion, she would havesubmitted no evidence. The governmenthas not sufficiently made such an argu-ment on appeal, at most making a passingassertion inadequate to preserve the point.And in any event, we have no basis forfinding harmlessness of the notice error.

CONCLUSION

For the foregoing reasons, we vacate thedecision of the Veterans Court, and weremand the case for a further remand tothe Board, to which Mr. Carter can submitnew materials in accordance with theterms of the original remand order fromthe Veterans Court.

Costs awarded to appellant.

VACATED AND REMANDED

,

AMGEN INC., Amgen ManufacturingLimited, Plaintiffs–Appellants

v.

SANDOZ INC., Defendant–Appellee.

No. 2015–1499.

United States Court of Appeals,Federal Circuit.

July 21, 2015.

Background: Reference product sponsor(RPS) brought action against biologics li-cense applicant, which was seeking license,pursuant to Biologics Price Competitionand Innovation Act (BPCIA), from theFood and Drug Administration (FDA), forits filgrastim product based on such prod-

1348 794 FEDERAL REPORTER, 3d SERIES

uct’s similarity to RPS’s product, for viola-tions of California’s unfair competitionstatute based on applicant’s alleged viola-tions of BPCIA, conversion, and patentinfringement. The United States DistrictCourt for the Northern District of Califor-nia, Richard Seeborg, J., 2015 WL1264756, entered judgment in favor of ap-plicant. RPS appealed.Holdings: In a case of first impression,the Court of Appeals, Lourie, CircuitJudge, held that:(1) applicant did not violate the BPCIA by

failing to disclose its application andmanufacturing information to RPS bythe statutory deadline;

(2) applicant did not satisfy its obligation,under the BPCIA to provide notice ofcommercial marketing to RPS, by pro-viding notice before its product waslicensed;

(3) BPCIA provision, requiring notice ofcommercial marketing, was mandatoryfor applicant, and thus applicant couldnot market its product until 180 daysafter the date it provided RPS witheffective notice;

(4) applicant did not violate California’sunfair competition statute; and

(5) RPS did not have exclusive right topossession of its approved license forits filgrastim product, as required tosupport its conversion claim under Cal-ifornia law.

Affirmed in part, vacated in part, and re-manded.Newman, Circuit Judge, filed opinion con-curring in part and dissenting in part.Chen, Circuit Judge, filed opinion dissent-ing in part.

1. Courts O96(7)The Court of Appeals applies the pro-

cedural law of the regional circuit whenreviewing a district court’s grant of a mo-tion for judgment on the pleadings.

2. Federal Courts O3587(2), 3666The Court of Appeals reviews a grant

of judgment on the pleadings de novo, andaccepts all material allegations in the com-plaint as true and construes them in thelight most favorable to the non-movingparty.

3. Federal Courts O3574Issues of statutory interpretation are

reviewed by the Court of Appeals de novo.

4. Health O319Abbreviated biologics license applicant

may elect not to disclose its applicationand manufacturing information to refer-ence product sponsor (RPS) under the Bio-logics Price Competition and InnovationAct (BPCIA) subject only to the conse-quences set forth under the BPCIA provi-sion stating that if such an applicant failsto provide such information, the RPS, butnot the applicant, may bring an action fora declaration of infringement, validity, orenforceability of any patent that claims thebiological product or a use of the biologicalproduct. 35 U.S.C.A. § 271(e)(2)(C)(ii);Public Health Service Act, § 351(l )(2)(A),(l )(9)(C), 42 U.S.C.A. § 262(l )(2)(A),(l )(9)(C).

5. Health O319Biologics license applicant, seeking li-

cense for filgrastim product based on itssimilarity to previously approved referenceproduct, did not violate the Biologics PriceCompetition and Innovation Act (BPCIA)by failing to disclose its application andmanufacturing information to referenceproduct sponsor (RPS) by the statutorydeadline, although BPCIA stated that ap-plicant ‘‘shall provide’’ that information toRPS; BPCIA and Patent Act contemplatedthat applicant would not disclose informa-tion, BPCIA allowed RPS to bring in-fringement action and prohibited applicantfrom bringing such action as consequencefor applicant’s failure to disclose, mandat-


ing that applicant complied with disclosureprovision would render BPCIA remedyprovision superfluous, and BPCIA did notgrant procedural right to compel compli-ance with disclosure. 35 U.S.C.A.§ 271(e)(2)(C)(ii), (e)(4); Public Health Ser-vice Act, § 351(l )(2)(A), (l )(9)(C), 42U.S.C.A. § 262(l )(2)(A), (l )(9)(C).

6. Statutes O1156Statutes are to be interpreted if possi-

ble to avoid rendering any provision super-fluous.

7. Health O319Biologics license applicant, seeking li-

cense for filgrastim product based on itssimilarity to previously approved referenceproduct, did not satisfy its obligation, un-der the Biologics Price Competition andInnovation Act (BPCIA), to provide noticeof commercial marketing to referenceproduct sponsor (RPS), by providing no-tice before its product was licensed;BPCIA provision requiring notice of com-mercial marketing referred to licensedproduct, rather than product that was sub-ject of application, as used in other provi-sions, and licensure requirement allowedRPS to know the scope of the approvedlicense and to determine whether, and onwhich patents, to seek preliminary injunc-tion. Public Health Service Act,§ 351(l )(8)(A), 42 U.S.C.A. § 262(l )(8)(A).

8. Health O319Abbreviated biologics license appli-

cant, seeking license under the BiologicsPrice Competition and Innovation Act(BPCIA), may only give effective notice ofcommercial marketing to reference prod-uct sponsor (RPS) after the Food andDrug Administration (FDA) has licensedits product. Public Health Service Act,§ 351(l )(8)(A), 42 U.S.C.A. § 262(l )(8)(A).

9. Health O319Biologics Price Competition and Inno-

vation Act (BPCIA) provision, requiringbiologics license applicant to provide notice

of commercial marketing to referenceproduct sponsor (RPS) after licensure ofits product no later than 180 days beforemarketing product, was mandatory for ap-plicant that failed to provide its applicationfor filgrastim product and manufacturinginformation to RPS by statutory deadline,and thus applicant could not market itsproduct until 180 days after the date itprovided RPS with effective notice; al-though BPCIA provision specified conse-quences for failing to comply with noticeprovision after applicant disclosed its ap-plication and manufacturing information,that provision did not apply to applicantthat failed to disclose that information, andnothing in the BPCIA excused applicantfrom its obligation to give notice after itchose not to comply with disclosure provi-sion. Public Health Service Act,§ 351(l )(8)(A), 42 U.S.C.A. § 262(l )(8)(A).

10. Antitrust and Trade RegulationO178, 282

Health O319Biologics license applicant, seeking li-

cense for filgrastim product based on itssimilarity to previously approved referenceproduct, did not violate California’s unfaircompetition statute by failing to complywith Biologics Price Competition and Inno-vation Act’s (BPCIA) requirement that ap-plicant disclose application and manufac-turing information to reference productsponsor (RPS), since applicant’s failure todisclose the information did not violate theBPCIA, and BPCIA and Patent Act pro-vided exclusive remedies for alleged viola-tion. 35 U.S.C.A. § 271(e)(2)(C)(ii); PublicHealth Service Act, § 351(l )(2)(A), 42U.S.C.A. § 262(l )(2)(A); West’s Ann.Cal.Bus. & Prof.Code §§ 17200, 17205.

11. Conversion and Civil Theft O100To sustain a claim for conversion un-

der California law, plaintiff must demon-strate: (1) its ownership or right to pos-


session of the property; (2) defendant’sconversion by a wrongful act or disposi-tion of property rights; and (3) damages.

12. Conversion and Civil Theft O124Reference product sponsor (RPS) did

not have exclusive right to possession of itsapproved license for its filgrastim product,as required to support its conversion claimunder California law against biologics li-cense applicant, seeking license for its fil-grastim product under Biologics PriceCompetition and Innovation Act (BPCIA)based on its similarity to RPS’s product;BPCIA allowed applicant to use public in-formation regarding reference product onits application, and RPS’s 12-year exclusiv-ity period under BPCIA had long expired.Public Health Service Act, § 351(k)(2), 42U.S.C.A. § 262(k)(2).

Patents O20916,162,427. Cited.

Nicholas P. Groombridge, Paul, Weiss,Rifkind, Wharton & Garrison LLP, NewYork, N.Y., argued for plaintiffs-appel-lants. Also represented by Eric AlanStone, Jennifer H. Wu, Jennifer Gordon,Peter Sandel, Michael T. Wu, Arielle K.Linsey; Wendy A. Whiteford, Lois M.Kwasigroch, Kimberlin L. Morley, AmgenInc., Thousand Oaks, CA; Vernon M. Win-ters, Alexander David Baxter, Sidley Aus-tin LLP, San Francisco, CA.

Deanne Maynard, Morrison & FoersterLLP, Washington, DC, argued for defen-dant-appellee. Also represented by Jo-seph R. Palmore, Marc A. Hearron; Ra-chel Krevans, San Francisco, CA; JuliePark, San Diego, CA.

Michael A. Morin, Latham & WatkinsLLP, Washington, DC, for amicus curiaeAbbVie Inc. Also represented by DavidPenn Frazier, Gregory G. Garre, Melissa

Arbus Sherry, Casey L. Dwyer, Robert J.Gajarsa.

Gregory Diskant, Patterson BelknapWebb & Tyler LLP, New York, N.Y., foramicus curiae Janssen Biotech, Inc. Alsorepresented by Irena Royzman; Dianne B.Elderkin, Barbara Mullin, Akin Gump,Strauss, Hauer & Feld, LLP, Philadelphia,PA.

Lisa Barons Pensabene, O’Melveny &Myers LLP, New York, N.Y., for amicuscuriae Biotechnology Industry Organiza-tion. Also represented by Filko Prugo.

Carlos T. Angulo, Zuckerman SpaederLLP, Washington, DC, for amicus curiaeGeneric Pharmaceutical Association.

Charles B. Klein, Winston & StrawnLLP, Washington, DC, for amici curiaeHospira, Inc., Celltrion Healthcare Co.,Ltd., Celltrion, Inc. Also represented byAndrew C. Nichols; Samuel S. Park, Chi-cago, IL; Peter E. Perkowski, Los Ange-les, CA.

Before NEWMAN, LOURIE, andCHEN, Circuit Judges.

Opinion for the court filed by CircuitJudge LOURIE.

Opinion concurring in part, dissenting inpart filed by Circuit Judge NEWMAN.

Opinion dissenting in part filed byCircuit Judge CHEN.

LOURIE, Circuit Judge.

This appeal presents issues of first im-pression relating to the Biologics PriceCompetition and Innovation Act of 2009(‘‘BPCIA’’), Pub.L. No. 111–148, §§ 7001–7003, 124 Stat. 119, 804–21 (2010). AmgenInc. and Amgen Manufacturing Ltd. (col-lectively, ‘‘Amgen’’) appeal from the deci-sion of the United States District Court forthe Northern District of California (1) dis-missing Amgen’s state law claims of unfair


competition and conversion with prejudicebecause Sandoz Inc. (‘‘Sandoz’’) did notviolate the information-disclosure and no-tice-of-commercial-marketing provisions ofthe BPCIA, respectively codified at 42U.S.C. § 262(l )(2)(A) and (l )(8)(A); (2)granting judgment on the pleadings toSandoz on its counterclaims seeking a de-claratory judgment that it correctly inter-preted the BPCIA; and (3) denying Am-gen’s motion for a preliminary injunctionbased on its state law claims. Amgen Inc.v. Sandoz Inc., No. 14–cv–04741, 2015 WL1264756 (N.D.Cal. Mar. 19, 2015) (‘‘Opin-ion ’’).

For the reasons stated below, we affirmthe dismissal of Amgen’s state law claimsof unfair competition and conversion, va-cate the judgment on Sandoz’s counter-claims and direct the district court to enterjudgment consistent with our interpreta-tion of the BPCIA, and remand for furtherproceedings consistent with this opinion.

A. BACKGROUND

I.

In 2010, as part of the Patient Protec-tion and Affordable Care Act, Congressenacted the BPCIA,1 which established anabbreviated pathway for regulatory ap-proval of follow-on biological products thatare ‘‘highly similar’’ to a previously ap-proved product (‘‘reference product’’).Pub.L. No. 111–148, §§ 7001–7003, 124Stat. 119, 804–21 (2010) (codified asamended at 42 U.S.C. § 262, 35 U.S.C.§ 271(e), 28 U.S.C. § 2201(b), 21 U.S.C.§ 355 et seq.). Congress established such‘‘a biosimilar pathway balancing innovationand consumer interests.’’ BPCIA, Pub.L.No. 111–148, § 7001(b), 124 Stat. at 804.

The BPCIA has certain similarities in itsgoals and procedures to the Drug PriceCompetition and Patent Term RestorationAct of 1984 (the Hatch–Waxman Act),Pub.L. No. 98–417, 98 Stat. 1585 (1984),but it has several obvious differences. Wenote this as a matter of historical interest,but otherwise do not comment on thosesimilarities and differences.

Traditionally, the Food and Drug Ad-ministration (‘‘FDA’’) approves a biologicalproduct for commercial marketing bygranting a biologics license under 42U.S.C. § 262(a). An applicant filing a bio-logics license application (‘‘BLA’’) typicallyprovides clinical data to demonstrate thesafety and efficacy of its product. In con-trast, under the abbreviated pathway cre-ated by the BPCIA, codified at 42 U.S.C.§ 262(k), an applicant filing an abbreviatedbiologics license application (‘‘aBLA’’ or‘‘subsection (k) application’’) instead sub-mits information to demonstrate that itsproduct is ‘‘biosimilar’’ to or ‘‘interchangea-ble’’ with a previously approved referenceproduct, together with ‘‘publicly-availableinformation regarding the [FDA]’s previ-ous determination that the reference prod-uct is safe, pure, and potent.’’ 42 U.S.C.§ 262(k)(2)-(5); see also id. § 262(i). TheBPCIA thus permits a biosimilar applicantto rely in part on the approved license of areference product.

To balance innovation and price competi-tion, Congress enacted the BPCIA to pro-vide a four-year and a twelve-year exclu-sivity period to a reference product, bothbeginning on the date of first licensure ofthe reference product. Specifically, a sub-section (k) application ‘‘may not be submit-ted to the Secretary until the date that is 4years after the date on which the refer-

1. Winston Churchill once described Russia as‘‘a riddle wrapped in a mystery inside anenigma.’’ Winston Churchill, The RussianEnigma (BBC radio broadcast Oct. 1, 1939),available at http://www.churchill-society-

london.org.uk/RusnEnig.html. That is thisstatute. In these opinions, we do our best tounravel the riddle, solve the mystery, andcomprehend the enigma.


ence product was first licensed under sub-section (a),’’ id. § 262(k)(7)(B), and approv-al of a subsection (k) application ‘‘may notbe made effective by the Secretary untilthe date that is 12 years after the date onwhich the reference product was first li-censed under subsection (a),’’ id.§ 262(k)(7)(A). Thus, a sponsor of an ap-proved reference product (the ‘‘referenceproduct sponsor’’ or ‘‘RPS’’) receives up totwelve years of exclusivity against follow-on products, regardless of patent protec-tion.

Moreover, the BPCIA established a pat-ent-dispute-resolution regime by amendingTitles 28, 35, and 42 of the United StatesCode. The BPCIA amended the Patent Actto create an artificial ‘‘act of infringement’’and to allow infringement suits based on abiosimilar application prior to FDA ap-proval and prior to marketing of the bio-logical product. See 35 U.S.C.§ 271(e)(2)(C), (e)(4), (e)(6). The BPCIAalso established a unique and elaborateprocess for information exchange betweenthe biosimilar applicant and the RPS toresolve patent disputes. See 42 U.S.C.§ 262(l ).

Under that process, codified at 42U.S.C. § 262(l ), the biosimilar applicantgrants the RPS confidential access to itsaBLA and the manufacturing informationregarding the biosimilar product no laterthan 20 days after the FDA accepts itsapplication for review. Id. § 262(l )(1)-(2).The parties then exchange lists of patentsfor which they believe a claim of patentinfringement could reasonably be assertedby the RPS, as well as their respectivepositions on infringement, validity, and en-forceability of those patents. Id.§ 262(l )(3). Following that exchange,which could take up to six months, theparties negotiate to formulate a list ofpatents (‘‘listed patents’’) that would be thesubject of an immediate infringement ac-tion, id. § 262(l )(4)-(5), and the RPS then

sues the biosimilar applicant within 30days, id. § 262(l )(6). That information ex-change and negotiation thus contemplatesan immediate infringement action broughtby the RPS based only on listed patents.

Subsection 262(l ) also provides that theapplicant give notice of commercial mar-keting to the RPS at least 180 days priorto commercial marketing of its productlicensed under subsection (k), which thenallows the RPS a period of time to seek apreliminary injunction based on patentsthat the parties initially identified duringinformation exchange but were not select-ed for the immediate infringement action,as well as any newly issued or licensedpatents (collectively, ‘‘non-listed patents’’).Id. § 262(l )(7)-(8).

Subsection 262(l ) additionally provides,in paragraph (l )(9)(A), that if the applicantdiscloses the information ‘‘required underparagraph (2)(A),’’ then neither the RPSnor the applicant may bring a declaratoryjudgment action based on the non-listedpatents prior to the date on which the RPSreceives the notice of commercial market-ing under paragraph (l )(8)(A). Id.§ 262(l )(9)(A). Paragraphs (l )(9)(B) and(l )(9)(C), however, permit the RPS, butnot the applicant, to seek declaratory reliefin the event that the applicant fails tocomply with certain provisions of subsec-tion (l ). Id. § 262(l )(9)(B)-(C).

II.

Amgen has marketed filgrastim underthe brand name Neupogenb (‘‘Neupogen’’)since 1991. In May 2014, Sandoz filed anaBLA, seeking FDA approval of a biosimi-lar filgrastim product, for which Neupogenis the reference product. On July 7, 2014,Sandoz received notification from the FDAthat it had accepted Sandoz’s applicationfor review.

On July 8, 2014, Sandoz notified Amgenthat it had filed a biosimilar applicationreferencing Neupogen; that it believed


that the application would be approved in‘‘Q1/2 of 2015’’; and that it intended tolaunch its biosimilar product immediatelyupon FDA approval. J.A. 1472. Later inJuly, in response to Amgen’s inquiry, San-doz confirmed that the FDA had acceptedits application for review, but Sandoz in-formed Amgen that it had ‘‘opted not toprovide Amgen with Sandoz’s biosimilarapplication within 20 days of the FDA’snotification of acceptance’’ and that Amgenwas entitled to sue Sandoz under§ 262(l )(9)(C). J.A. 1495–96. Sandozthus did not disclose its aBLA or its prod-uct’s manufacturing information to Amgenaccording to § 262(l )(2)(A).

Subsequently, on March 6, 2015, theFDA approved Sandoz’s aBLA for all ap-proved uses of Amgen’s Neupogen. Al-though Sandoz has maintained that it gavean operative notice of commercial market-ing in July 2014, it nevertheless gave a‘‘further notice of commercial marketing’’to Amgen on the date of FDA approval.J.A. 1774. Sandoz intended to launch itsfilgrastim product under the trade nameZarxio.

III.

In October 2014, Amgen sued Sandoz inthe Northern District of California, assert-ing claims of (1) unfair competition forunlawful business practices under Califor-nia Business & Professions Code § 17200et seq. (‘‘UCL’’), based on two allegedviolations of the BPCIA; (2) conversion forallegedly wrongful use of Amgen’s ap-proved license on Neupogen; and (3) in-fringement of Amgen’s U.S. Patent 6,162,-427 (the ‘‘ ’427 patent’’), which claims amethod of using filgrastim. Amgen al-leged that Sandoz violated the BPCIA byfailing to disclose the required informationunder § 262(l )(2)(A) and by giving a pre-mature, ineffective, notice of commercialmarketing under § 262(l )(8)(A) beforeFDA approval of its biosimilar product.Sandoz counterclaimed for a declaratory

judgment that it correctly interpreted theBPCIA as permitting its actions, and thatthe 8427 patent was invalid and not infring-ed.

In January 2015, the parties filed cross-motions for judgment on the pleadings onAmgen’s state law claims and Sandoz’scounterclaims interpreting the BPCIA. InFebruary 2015, Amgen also filed a motionfor a preliminary injunction based solelyon its state law claims to enjoin Sandozfrom launching Zarxio after FDA approv-al. Also in February 2015, through discov-ery, Amgen obtained access to Sandoz’sbiosimilar application.

On March 19, 2015, the district courtgranted partial judgment on the pleadingsto Sandoz on its BPCIA counterclaims tothe extent that Sandoz’s interpretation ofthe statute is consistent with the court’sinterpretation. Specifically, the districtcourt concluded that: (1) the BPCIA ren-ders permissible a subsection (k) appli-cant’s decision not to disclose its aBLAand the manufacturing information to theRPS, subject only to the consequences setforth in 42 U.S.C. § 262(l )(9)(C); (2) sucha decision alone does not offer a basis forthe RPS to obtain injunctive relief, restitu-tion, or damages against the applicant;and (3) the applicant may give notice ofcommercial marketing under§ 262(l )(8)(A) before FDA approval.Opinion, 2015 WL 1264756, at *8, *11.

Based on its interpretation of theBPCIA, the district court then dismissedAmgen’s unfair competition and conversionclaims with prejudice because it concludedthat Sandoz did not violate the BPCIA oract unlawfully. Id. at *8–9. The courtalso denied Amgen’s motion for a prelimi-nary injunction based on its state lawclaims, noting that Amgen ‘‘has yet toproceed on its remaining claim for patentinfringement.’’ Id. at *10.

On the parties’ joint motion, the districtcourt entered final judgment as to Am-


gen’s unfair competition and conversionclaims and as to Sandoz’s BPCIA counter-claims under Rule 54(b) of the FederalRules of Civil Procedure. The parties’claims and counterclaims relating to in-fringement, validity, and enforceability ofthe 8427 patent remain pending at thedistrict court.

Amgen timely appealed from the finaljudgment and from the denial of a prelimi-nary injunction; we have jurisdiction un-der 28 U.S.C. § 1295(a)(1) and § 1292(a)(1)and (c)(1).

B. DISCUSSION

[1–3] We apply the procedural law ofthe regional circuit, here the Ninth Circuit,when reviewing a district court’s grant of amotion for judgment on the pleadings.Merck & Co. v. Hi–Tech Pharmacal Co.,482 F.3d 1317, 1320 (Fed.Cir.2007). TheNinth Circuit reviews the grant of judg-ment on the pleadings de novo, Peterson v.California, 604 F.3d 1166, 1169 (9th Cir.2010), and ‘‘accept[s] all material allega-tions in the complaint as true and con-strue[s] them in the light most favorable to[the non-moving party],’’ Turner v. Cook,362 F.3d 1219, 1225 (9th Cir.2004) (thirdalteration in original). Issues of statutoryinterpretation are also reviewed de novo.Qantas Airways Ltd. v. United States, 62F.3d 385, 387 (Fed.Cir.1995).

Because Amgen’s state law claims ofunfair competition and conversion arepremised on the proper interpretation ofthe BPCIA, we first interpret the relevantprovisions of the BPCIA and then considerAmgen’s state law claims in light of thatinterpretation.

I.

[4, 5] We first consider whether thedistrict court erred in concluding that a

subsection (k) applicant may elect not todisclose its aBLA and the manufacturinginformation under 42 U.S.C.§ 262(l )(2)(A), subject only to the conse-quences set forth in § 262(l )(9)(C). Para-graph (l )(2)(A) provides that:

Not later than 20 days after the Secre-tary notifies the subsection (k) applicantthat the application has been acceptedfor review, the subsection (k) applicantshall provide to the reference productsponsor a copy of the application submit-ted to the Secretary under subsection(k), and such other information that de-scribes the process or processes used tomanufacture the biological product thatis the subject of such applicationTTTT

42 U.S.C. § 262(l )(2)(A) (emphasis added).Paragraph (l )(9)(C) provides that:

If a subsection (k) applicant fails to pro-vide the application and informationrequired under paragraph (2)(A), thereference product sponsor, but not thesubsection (k) applicant, may bring anaction under section 2201 of Title 28, fora declaration of infringement, validity,or enforceability of any patent thatclaims the biological product or a use ofthe biological product.

Id. § 262(l )(9)(C) (emphases added). Ad-ditionally, 35 U.S.C. § 271(e)(2)(C)(ii), asamended by the BPCIA, provides that:

It shall be an act of infringement tosubmit TTT if the applicant for the appli-cation fails to provide the applicationand information required under section351(l )(2)(A) of such Act, an applicationseeking approval of a biological productfor a patent that could be identified pur-suant to section 351(l )(3)(A)(i) of suchActTTTT

35 U.S.C. § 271(e)(2)(C)(ii) (emphasis add-ed).2

2. Section 351(l )(2)(A) of the Public Health Act corresponds to 42 U.S.C. § 262(l )(2)(A).


Amgen argues that the language ‘‘shallprovide’’ in paragraph (l )(2)(A) suggeststhat the information disclosure is mandato-ry, not merely permissible. Amgen con-tends that other provisions of the BPCIArefer to the information as ‘‘required’’ un-der paragraph (l )(2)(A) and also refer tonon-disclosure as a failure to comply withthe Act. Amgen argues that, by refusing toprovide the required information, a subsec-tion (k) applicant unlawfully evades thedetection of process patent infringementand avoids an immediate infringement ac-tion under § 262(l )(6). Amgen also ar-gues that paragraph (l )(9)(C) is merely alimitation on declaratory judgment action,not a remedy, let alone the exclusive reme-dy, for noncompliance with paragraph(l )(2)(A).

Sandoz responds that the ‘‘shall’’ provi-sion in paragraph (l )(2)(A) is only a condi-tion precedent to engaging in the informa-tion-exchange process of paragraphs (l )(3)through (l )(6), not a mandatory require-ment in all circumstances. Sandoz con-tends that this interpretation is consistentwith the use of ‘‘shall’’ in paragraph (l )(6),which provides that the RPS ‘‘shall’’ file aninfringement suit. Sandoz notes that thisuse of ‘‘shall’’ cannot mean that the RPSviolates the statute if it chooses not to filean infringement suit. Sandoz also re-sponds that, under the BPCIA, if a subsec-tion (k) applicant does not disclose theinformation under paragraph (l )(2)(A),then the sponsor may file an infringementsuit under paragraph (l )(9)(C) and obtainthe information in discovery, which Amgenhas done. Sandoz also contends that it didnot act unlawfully by taking a path ex-pressly contemplated by Congress and theBPCIA.

We conclude that, read in isolation, the‘‘shall’’ provision in paragraph (l )(2)(A) ap-pears to mean that a subsection (k) appli-cant is required to disclose its aBLA andmanufacturing information to the RPS by

the deadline specified in the statute. In-deed, the BPCIA refers to such informa-tion as ‘‘required’’ in other provisions. See42 U.S.C. § 262(l )(1)(B)(i), (l )(9)(A),(l )(9)(C); 35 U.S.C. § 271(e)(2)(C)(ii).Particularly, paragraph (l )(1)(B)(i) pro-vides that ‘‘[w]hen’’ a subsection (k) appli-cant submits an aBLA to the FDA, ‘‘suchapplicant shall provide TTT confidential ac-cess to the information required to be pro-duced pursuant to paragraph (2) and anyother information that the subsection (k)applicant determines, in its sole discretion,to be appropriate’’ (emphases added).Thus, under the plain language of para-graph (l )(1)(B)(i), when an applicantchooses the abbreviated pathway for regu-latory approval of its biosimilar product, itis required to disclose its aBLA and manu-facturing information to the RPS no laterthan 20 days after the FDA’s notificationof acceptance, but not when the ‘‘when’’criterion is not met.

Such a reading of ‘‘shall’’ in paragraph(l )(2)(A) is supported by the use of ‘‘may’’in paragraph (l )(2)(B), which provides thata subsection (k) applicant ‘‘may’’ provideadditional information requested by theRPS by the statutory deadline. Para-graph (l )(2)’s use of ‘‘shall’’ in juxtaposi-tion with ‘‘may’’ in the adjacent provisionwould appear to indicate that ‘‘shall’’ sig-nals a requirement.

However, the ‘‘shall’’ provision in para-graph (l )(2)(A) cannot be read in isolation.In other provisions, the BPCIA explicitlycontemplates that a subsection (k) appli-cant might fail to disclose the requiredinformation by the statutory deadline. Itspecifically sets forth the consequence forsuch failure: the RPS may bring an in-fringement action under 42 U.S.C.§ 262(l )(9)(C) and 35 U.S.C.§ 271(e)(2)(C)(ii). Those latter provisionsindicate that ‘‘shall’’ in paragraph (l )(2)(A)does not mean ‘‘must.’’ And the BPCIA


has no other provision that grants a proce-dural right to compel compliance with thedisclosure requirement of paragraph(l )(2)(A).

Under 35 U.S.C. § 271(e)(2)(C)(ii), filinga subsection (k) application and failing todisclose the required information underparagraph (l )(2)(A) is an artificial ‘‘act ofinfringement’’ of ‘‘a patent that could beidentified’’ pursuant to paragraph(l )(3)(A)(i). 42 U.S.C. § 262(l )(9)(C) fur-ther provides that ‘‘[i]f a subsection (k)applicant fails to provide the applicationand information required under paragraph(2)(A),’’ then the RPS, but not the subsec-tion (k) applicant, may bring a declaratoryjudgment action on ‘‘any patent that claimsthe biological product or a use of the bio-logical product.’’ 3 As a direct conse-quence of failing to comply with paragraph(l )(2)(A), paragraph (l )(9)(C) bars the sub-section (k) applicant from bringing a de-claratory judgment action on patents thatclaim the biological product or its use.

Notably, both 42 U.S.C. § 262(l )(9)(C)and 35 U.S.C. § 271(e)(2)(C)(ii) are prem-ised on a claim of patent infringement, andthe BPCIA does not specify any non-pat-ent-based remedies for a failure to complywith paragraph (l )(2)(A). Once the RPSbrings an infringement suit under thosetwo provisions, it can access the requiredinformation through discovery.4

[6] Importantly, mandating compliancewith paragraph (l )(2)(A) in all circum-stances would render paragraph (l )(9)(C)and 35 U.S.C. § 271(e)(2)(C)(ii) superflu-ous, and statutes are to be interpreted ifpossible to avoid rendering any provisionsuperfluous. Marx v. Gen. Revenue Corp.,568 U.S. ––––, 133 S.Ct. 1166, 1178, 185L.Ed.2d 242 (2013) (‘‘[T]he canon againstsurplusage is strongest when an interpre-tation would render superfluous anotherpart of the same statutory scheme.’’);TRW Inc. v. Andrews, 534 U.S. 19, 31, 122S.Ct. 441, 151 L.Ed.2d 339 (2001) (‘‘It is acardinal principle of statutory constructionthat a statute ought, upon the whole, to beso construed that, if it can be prevented,no clause, sentence, or word shall be su-perfluous, void, or insignificant.’’ (internalquotation marks omitted)).

Moreover, 35 U.S.C. § 271(e)(4) pro-vides ‘‘the only remedies which may begranted by a court for an act of infringe-ment described in paragraph (2)’’ (empha-sis added). Under § 271(e)(2)(C)(ii), filinga subsection (k) application and failing toprovide the required information underparagraph (l )(2)(A) is such an act of in-fringement. Here, Amgen alleged thatSandoz violated the BPCIA, but the al-leged violation is precisely an act of in-fringement under § 271(e)(2)(C)(ii), forwhich § 271(e)(4) provides the ‘‘only reme-dies.’’

3. While it is true that 42 U.S.C. § 262(l )(9)(C)premises the declaration judgment action on‘‘any patent that claims the biological productor a use of the biological product ’’ (emphasisadded), which does not appear to includeprocess patents, 35 U.S.C. § 271(e)(2)(C)(ii)does contemplate an infringement actionbased on ‘‘a patent that could be identifiedpursuant to [paragraph] (l )(3)(A)(i) ’’ (empha-sis added), which does not exclude processpatents. Section 271(e)(2)(C)(ii) allows theRPS to assert process patents, ‘‘if the [subsec-tion (k) ] applicant TTT fails to provide theapplication and information’’ and ‘‘the pur-pose of [the subsection (k) ] submission is to

obtain approval TTT to engage in the commer-cial manufacture, use, or sale of a TTT biologi-cal product claimed in a patent or the use ofwhich is claimed in a patent before the expi-ration of such patent.’’ 35 U.S.C. § 271(e)(2).

4. In addition, we note the existence of a re-buttable presumption in actions alleging in-fringement of a process patent under 35U.S.C. § 271(g) relating to importation ofproducts made abroad by a patented process.See, e.g., Creative Compounds, LLC v. StarmarkLabs., 651 F.3d 1303, 1314 (Fed.Cir.2011)(citing 35 U.S.C. § 295).


We therefore conclude that, even thoughunder paragraph (l )(2)(A), when read inisolation, a subsection (k) applicant wouldbe required to disclose its aBLA and themanufacturing information to the RPS bythe statutory deadline, we ultimately con-clude that when a subsection (k) applicantfails the disclosure requirement, 42 U.S.C.§ 262(l )(9)(C) and 35 U.S.C. § 271(e) ex-pressly provide the only remedies as thosebeing based on a claim of patent infringe-ment. Because Sandoz took a path ex-pressly contemplated by the BPCIA, it didnot violate the BPCIA by not disclosing itsaBLA and the manufacturing informationby the statutory deadline.

II.

[7] We next consider whether the dis-trict court erred in concluding that asubsection (k) applicant may satisfy itsobligation to give notice of commercialmarketing under 42 U.S.C. § 262(l )(8)(A)by doing so before the FDA licenses itsproduct. Paragraph (l )(8)(A) providesthat ‘‘[t]he subsection (k) applicant shallprovide notice to the reference productsponsor not later than 180 days beforethe date of the first commercial market-ing of the biological product licensed un-der subsection (k).’’ Id. § 262(l )(8)(A)(emphases added).

a.

Amgen argues that a subsection (k) ap-plicant may give notice of commercialmarketing only after it has a ‘‘biologicalproduct licensed under subsection (k),’’meaning only after the FDA has licensedthe biosimilar product. Amgen notes thatelsewhere subsection (l ) refers to thebiosimilar product as ‘‘the biological prod-uct that is the subject of’’ the application,which supports its interpretation of ‘‘li-censed’’ in paragraph (l )(8)(A). Amgenexplains that giving notice after FDA li-censure provides time for the RPS to seeka preliminary injunction and to resolve

patent disputes in a timely fashion. Am-gen contends that allowing the applicantto give notice before FDA licensure is ir-reconcilable with the statute’s text andpurpose.

Sandoz responds that the plain terms ofthe notice provision are satisfied when anapplicant provides notice at least 180 daysbefore it commercially markets its product.According to Sandoz, the word ‘‘licensed’’only means that, at the time of commercialmarketing, the product must be licensed,but it does not limit the timing of thenotice, which can be given before FDAlicensure. Sandoz also argues that Am-gen’s construction of the notice provisionwould transform it into an automatic, addi-tional, six-month bar against marketing ofevery licensed biosimilar product, whichimproperly extends the twelve-year exclu-sivity period under § 262(k)(7)(A).

[8] We agree with Amgen that, underparagraph (l )(8)(A), a subsection (k) ap-plicant may only give effective notice ofcommercial marketing after the FDA haslicensed its product. The statutory lan-guage compels such an interpretation. Itmeans that notice, to be effective underthis statute, must be given only after theproduct is licensed by the FDA.

In subsection (l ), only paragraph(l )(8)(A) refers to the product as ‘‘the bio-logical product licensed under subsection(k).’’ In other provisions of subsection (l ),the statute refers to the product as ‘‘thebiological product that is the subject of’’the application, even when discussing itscommercial marketing. E.g., 42 U.S.C.§ 262(l )(3)(B)(ii)(I), (l )(3)(C); id.§ 262(l )(1)(D), (l )(2)(A), (l )(3)(A)(i),(l )(3)(B)(i), (l )(7)(B). If Congress intend-ed paragraph (l )(8)(A) to permit effectivenotice before the product is licensed, itwould have used the ‘‘subject of’’ language.

While it is true that only a licensedproduct may be commercially marketed, it


does not follow that whenever the futurecommercial marketing of a yet-to-be li-censed product is discussed, it is the ‘‘li-censed’’ product. It is not yet ‘‘the li-censed product.’’ Congress could haveused the phrase ‘‘the biological productthat is the subject of’’ the application inparagraph (l )(8)(A), as it did in other pro-visions, but it did not do so. See, e.g.,Russello v. United States, 464 U.S. 16, 23,104 S.Ct. 296, 78 L.Ed.2d 17 (1983).

We believe that Congress intended thenotice to follow licensure, at which timethe product, its therapeutic uses, and itsmanufacturing processes are fixed. Whena subsection (k) applicant files its aBLA, itlikely does not know for certain when, orif, it will obtain FDA licensure. The FDAcould request changes to the product dur-ing the review process, or it could approvesome but not all sought-for uses. Givingnotice after FDA licensure, once the scopeof the approved license is known and themarketing of the proposed biosimilar prod-uct is imminent, allows the RPS to effec-tively determine whether, and on whichpatents, to seek a preliminary injunctionfrom the court.

Requiring that a product be licensedbefore notice of commercial marketing en-sures the existence of a fully crystallizedcontroversy regarding the need for injunc-tive relief. It provides a defined statutorywindow during which the court and theparties can fairly assess the parties’ rightsprior to the launch of the biosimilar prod-uct. If a notice of commercial marketingcould be given at any time before FDAlicensure, the RPS would be left to guessthe scope of the approved license andwhen commercial marketing would actuallybegin. Indeed, filing an aBLA only sug-gests that a subsection (k) applicant in-tends to commercially market its productsomeday in the future.

Furthermore, requiring FDA licensurebefore notice of commercial marketing

does not necessarily conflict with thetwelve-year exclusivity period of§ 262(k)(7)(A). It is true that in this case,as we decide infra, Amgen will have anadditional 180 days of market exclusionafter Sandoz’s effective notice date; that isbecause Sandoz only filed its aBLA 23years after Amgen obtained FDA approvalof its Neupogen product. Amgen hadmore than an ‘‘extra’’ 180 days, but that isapparently the way the law, business, andthe science evolved. That extra 180 dayswill not likely be the usual case, as aBLAswill often be filed during the 12–year ex-clusivity period for other products. Astatute must be interpreted as it is enact-ed, not especially in light of particular,untypical facts of a given case. Finally, itis counterintuitive to provide that notice ofcommercial marketing be given at a timebefore one knows when, or if, the productwill be approved, or licensed.

We therefore conclude that, under para-graph (l )(8)(A), a subsection (k) applicantmay only give effective notice of commer-cial marketing after the FDA has licensedits product. The district court thus erredin holding that a notice of commercial mar-keting under paragraph (l )(8)(A) may ef-fectively be given before the biologicalproduct is licensed, and we therefore re-verse its conclusion relating to its interpre-tation of § 262(l )(8)(A) and the date whenSandoz may market its product.

b.

[9] We next consider the consequencein this case of our interpretation of para-graph (l )(8)(A). Paragraph (l )(8)(A) pro-vides that the subsection (k) applicant‘‘shall provide’’ notice of commercial mar-keting to the RPS no later than 180 daysbefore commercial marketing of the li-censed product. As we have concluded, anoperative notice of commercial marketingcan only be given after FDA licensure.


Here, Sandoz’s notice in July 2014, the dayafter the FDA accepted its application forreview, was premature and ineffective.However, the FDA approved Sandoz’saBLA on March 6, 2015, and Sandoz gavea ‘‘further’’ notice of commercial marketingon that day. J.A. 1774. These facts areuncontested. Oral Argument at 35:33–56,Amgen Inc. v. Sandoz Inc., No. 2015–1499(Fed.Cir. June 3, 2015), available at http://www.cafc.uscourts.gov/oral-argument-recordings/15–1499/all. That notice inMarch 2015 thus serves as the operativeand effective notice of commercial market-ing in this case.

A question exists, however, concerningwhether the ‘‘shall’’ provision in paragraph(l )(8)(A) is mandatory. We conclude thatit is. Both paragraph (l )(2)(A) and(l )(8)(A) use the word ‘‘shall,’’ which pre-sumptively signals a statutory require-ment. See, e.g., Nat’l Ass’n of HomeBuilders v. Defenders of Wildlife, 551 U.S.644, 661–62, 127 S.Ct. 2518, 168 L.Ed.2d467 (2007); Lopez v. Davis, 531 U.S. 230,241, 121 S.Ct. 714, 148 L.Ed.2d 635 (2001).As we have noted with respect to para-graph (l )(2)(A), however, the BPCIA ex-plicitly contemplates that a subsection (k)applicant might fail to comply with therequirement of paragraph (l )(2)(A) andfurther specifies the consequence for suchfailure in 42 U.S.C. § 262(l )(9)(C) and 35U.S.C. § 271(e)(2)(C)(ii). Because of thoseexplicit statutory provisions, and to avoidconstruing the statute so as to renderthem superfluous, we have interpreted theBPCIA as allowing noncompliance withparagraph (l )(2)(A), subject to the conse-quence specified in those other provisions.

In contrast, with respect to paragraph(l )(8)(A), we do not find any provision inthe BPCIA that contemplates, or specifiesthe consequence for, noncompliance withparagraph (l )(8)(A) here, which would bethe case if Sandoz attempts to launch indisregard of the requirement of paragraph

(l )(8)(A), as we have interpreted it. San-doz argues that § 262(l )(9)(B) does specifythe consequence for noncompliance withparagraph (l )(8)(A). Paragraph (l )(9)(B),entitled ‘‘[s]ubsequent failure to act bysubsection (k) applicant,’’ provides that:

If a subsection (k) applicant fails to com-plete an action required of the subsec-tion (k) applicant under paragraph(3)(B)(ii), paragraph (5), paragraph(6)(C)(i), paragraph (7), or paragraph(8)(A), the reference product sponsor,but not the subsection (k) applicant, maybring an action under section 2201 ofTitle 28, for a declaration of infringe-ment, validity, or enforceability of anypatent included in the list described inparagraph (3)(A), including as providedunder paragraph (7).

42 U.S.C. § 262(l )(9)(B) (emphases add-ed).

While it is true that paragraph (l )(9)(B)specifies the consequence for a subsequentfailure to comply with paragraph (l )(8)(A)after the applicant has complied withparagraph (l )(2)(A), it does not apply inthis case, where Sandoz did not complywith paragraph (l )(2)(A) to begin with.Indeed, the consequence specified in para-graph (l )(9)(B) is a declaratory judgmentaction brought by the RPS based on ‘‘anypatent included in the list described inparagraph (3)(A), including as provided un-der paragraph (7).’’ 42 U.S.C.§ 262(l )(9)(B). Here, however, becauseSandoz did not provide the required infor-mation to Amgen under paragraph(l )(2)(A), Amgen was unable to compile apatent list as described in paragraph(l )(3)(A) or paragraph (l )(7).

Paragraph (l )(8)(A) is a standalone no-tice provision in subsection (l ), and Sandozconcedes as much. Oral Argument at39:30–52, Amgen Inc. v. Sandoz Inc., No.20151499 (Fed.Cir. June 3, 2015), availableat http://www.cafc.uscourts.gov/oral-


argument-recordings/15–1499/all. Unlikethe actions described in paragraphs (l )(3)through (l )(7), which all depend on, or aretriggered by, the disclosure under para-graph (l )(2)(A), nothing in paragraph(l )(8)(A) conditions the notice requirementon paragraph (l )(2)(A) or other provisionsof subsection (l ). Moreover, nothing insubsection (l ) excuses the applicant fromits obligation to give notice of commercialmarketing to the RPS after it has chosennot to comply with paragraph (l )(2)(A).The purpose of paragraph (l )(8)(A) isclear: requiring notice of commercial mar-keting be given to allow the RPS a periodof time to assess and act upon its patentrights.

We therefore conclude that, where, ashere, a subsection (k) applicant completelyfails to provide its aBLA and the requiredmanufacturing information to the RPS bythe statutory deadline, the requirement ofparagraph (l )(8)(A) is mandatory. Sandoztherefore may not market Zarxio before180 days from March 6, 2015, i.e., Septem-ber 2, 2015.

III.

We next consider Amgen’s unfair com-petition and conversion claims under Cali-fornia law. After finding that Sandoz didnot violate the BPCIA, the district courtdismissed Amgen’s state law claims withprejudice. We affirm the dismissal basedon our interpretation of the BPCIA.5

a.

[10] Under Cal. Bus. & Prof.Code§ 17200, ‘‘unfair competition’’ includes‘‘any unlawful, unfair or fraudulent busi-ness act or practice.’’ Amgen’s unfaircompetition claim is based solely on the‘‘unlawful’’ prong, which requires a show-ing that Sandoz acted unlawfully by violat-

ing another law, here, according to Amgen,the BPCIA. Davis v. HSBC Bank Neva-da, N.A., 691 F.3d 1152, 1168 (9th Cir.2012); see also Farmers Ins. Exch. v. Su-perior Court, 2 Cal.4th 377, 6 Cal.Rptr.2d487, 826 P.2d 730, 734 (1992). Under Cali-fornia law, UCL remedies are not availablewhen the underlying law expressly pro-vides that the remedies in that law areexclusive. See Cal. Bus. & Prof.Code§ 17205; Loeffler v. Target Corp., 58Cal.4th 1081, 171 Cal.Rptr.3d 189, 324 P.3d50, 76 (2014).

As one basis of its unfair competitionclaim, Amgen alleges that Sandoz violatedthe BPCIA by failing to comply with§ 262(l )(2)(A). As we have concluded,Sandoz did not violate the BPCIA by notdisclosing its aBLA and the manufacturinginformation according to § 262(l )(2)(A).Sandoz took a path expressly contemplatedby 42 U.S.C. § 262(l )(9)(C) and 35 U.S.C.§ 271(e)(2)(C)(ii), and 35 U.S.C.§ 271(e)(4) provides ‘‘the only remedieswhich may be granted by a court’’ for thealleged violation. We therefore affirm thedismissal of Amgen’s unfair competitionclaim based on the alleged violation of§ 262(l )(2)(A).

b.

As another basis of its unfair competi-tion claim, Amgen also asserts that Sandozviolated the BPCIA by giving a premature,ineffective, notice of commercial marketingunder § 262(l )(8)(A) in July 2014, beforeFDA approval in March 2015. As indicat-ed, under our interpretation of the BPCIA,the July 2014 notice is ineffective, andSandoz gave the operative notice on March6, 2015. Thus, as we have indicated, San-doz may not market Zarxio before 180days from March 6, 2015, i.e., September

5. In its cross-motion for judgment on thepleadings, Sandoz did not argue preemptionas a defense to Amgen’s state law claims, and

thus the district court did not consider thatissue. We therefore do not address preemp-tion in this appeal.


2, 2015. And, as indicated below, we willextend the injunction pending appealthrough September 2, 2015. Amgen’s ap-peal from the dismissal of its unfair com-petition claim based on the alleged viola-tion of § 262(l )(8)(A) is therefore moot.

c.

[11] We now turn to Amgen’s conver-sion claim. To sustain a claim for conver-sion under California law, Amgen mustdemonstrate: (1) its ownership or right topossession of the property; (2) Sandoz’sconversion by a wrongful act or dispositionof property rights; and (3) damages.Burlesci v. Petersen, 68 Cal.App.4th 1062,80 Cal.Rptr.2d 704, 706 (1998). Amgenasserts that Sandoz wrongfully used Am-gen’s approved license on Neupogen byfiling an aBLA referencing Neupogen butrefusing to provide Amgen the benefits towhich it is entitled under § 262(l ). San-doz responds that Amgen failed to showany ‘‘wrongful act’’ or to establish an ex-clusive ownership interest in the approvedlicense on Neupogen to exclude Sandoz’saBLA.

We agree with Sandoz that Amgenfailed to establish the requisite elements tosustain a claim of conversion under Cali-fornia law. As indicated, the BPCIA ex-plicitly contemplates that a subsection (k)applicant might not disclose its aBLA andthe manufacturing information by the stat-utory deadline, and provides that the RPSmay sue for patent infringement, whichAmgen has done. Amgen thus failed toshow a ‘‘wrongful act.’’

[12] Moreover, the BPCIA establishedthe abbreviated pathway for FDA approvalof follow-on biological products, allowing a

subsection (k) applicant to use ‘‘publicly-available information’’ regarding the refer-ence product in its application.6 42 U.S.C.§ 262(k)(2). The BPCIA also grants a 12–year exclusivity period to the RPS, duringwhich approval of a subsection (k) applica-tion may not be made effective. Id.§ 262(k)(7)(A). Neupogen’s 12–year ex-clusivity period has long expired. Amgentherefore fails to show that it has an exclu-sive right to possession of its approvedlicense on Neupogen to sustain its claim ofconversion under California law.

We therefore affirm the dismissal ofAmgen’s unfair competition and conversionclaims based on our interpretation of therelevant provisions of the BPCIA.

IV.

Amgen argues that the district courterred in denying its motion for a prelimi-nary injunction based on an incorrect read-ing of the BPCIA and an erroneous find-ing that Amgen failed to show irreparableharm. Sandoz responds that Amgen’s ap-peal is moot because it sought an injunc-tion only until the district court decidedthe parties’ cross-motions for judgment onthe pleadings, which has already occurred.Sandoz also responds that, even if notmoot, the district court did not abuse itsdiscretion in denying the motion and didnot clearly err in its factual findings.

We agree with Sandoz that Amgen’s ap-peal from the denial of a preliminary in-junction is moot. In its motion for a pre-liminary injunction, filed in the districtcourt after it filed its motion for judgmenton the pleadings, Amgen requested a pre-liminary injunction ‘‘until the Court de-

6. Amgen emphasizes in its briefs that Sandozis wrongfully benefitting from Amgen’s estab-lishment of the safety and efficacy of filgras-tim. Be that as it may, this is not the firsttime that Congress has allowed generic appli-cants to benefit from the early work of inno-

vators. See Hatch–Waxman Act, Pub.L. No.98–417, 98 Stat. 1585 (1984); see also Ruckel-shaus v. Monsanto Co., 467 U.S. 986, 104S.Ct. 2862, 81 L.Ed.2d 815 (1984). That wasa decision that Congress was entitled to makeand it did so.


cides the parties’ motions for judgment onthe pleadings,’’ and ‘‘if the Court resolvesthose motions in Amgen’s favor, until TTTthe parties have been placed in the posi-tion they would be in had Sandoz compliedwith the BPCIA.’’ Amgen Inc. v. SandozInc., No. 14–cv–04741 (N.D. Cal. Feb. 5,2015), ECF No. 56, at 25.

On March 19, 2015, the district courtrendered its decision on the parties’ cross-motions for judgment on the pleadings,deciding against Amgen on the merits anddismissing Amgen’s state law claims withprejudice. In the same order, the courtalso denied Amgen’s motion for a prelimi-nary injunction, which was based solely onits state law claims. Because Amgen onlyrequested a preliminary injunction untilthe district court decided the parties’ mo-tions for judgment on the pleadings, andthe district court has resolved those mo-tions against Amgen, Amgen’s appeal fromthe denial of a preliminary injunction ismoot. We therefore dismiss that aspect ofAmgen’s appeal.

V.

After the district court granted partialjudgment on the pleadings in favor of San-doz and denied Amgen’s motion for a pre-liminary injunction, Amgen sought an in-junction pending appeal, which the districtcourt denied. Amgen then filed an emer-gency motion in this court for an injunc-tion pending appeal. We granted the mo-tion. In light of what we have decidedconcerning the proper interpretation of thecontested provisions of the BPCIA, weaccordingly order that the injunction pend-ing appeal be extended through September2, 2015.

C. CONCLUSION

For the foregoing reasons, we affirm thedismissal of Amgen’s unfair competitionand conversion claims, vacate the districtcourt’s judgment on Sandoz’s counter-claims interpreting the BPCIA, and direct

the district court to enter judgment onthose counterclaims consistent with thisopinion. We also remand for the districtcourt to consider the patent infringementclaim and counterclaims relating to the8427 patent and any other patents properlybrought into the district court action.

AFFIRMED IN PART, VACATED INPART, AND REMANDED

COSTS

Each party shall bear its own costs.

NEWMAN, Circuit Judge, concurring inpart, dissenting in part.

The immediate issue relates to the Biosi-milar Price Competition and InnovationAct (BPCIA) and certain obligations of theinnovator/patentee (called the ‘‘referenceproduct sponsor,’’ or ‘‘Sponsor’’) and thesubsection (k) applicant. Subsection (k)authorizes a biosimilar applicant to use theSponsor’s clinical safety and efficacy datain order to obtain FDA license approvalfor commercial marketing of the biosimilarproduct. By acting under subsection (k)the applicant need not obtain its own clini-cal data for its biosimilar product, and canreceive FDA licensure by showing that‘‘the biological product is biosimilar to areference product,’’ 42 U.S.C. § 262(k),and has the same characteristics of safety,efficacy, and purity. Id.

To facilitate identification of and resolu-tion of any patent issues, the BPCIA re-quires the subsection (k) applicant to noti-fy the Sponsor at two critical stages ofFDA review of the subsection (k) applica-tion. I agree with the court that notice ofissuance of the FDA license is mandatory,and that this notice starts the 180–day stayof commercial marketing, in accordancewith 42 U.S.C. § 262(l )(8)(A). Thus I joinPart A, Part (B)(II), and Part B(V) of thecourt’s opinion.


However, notice of acceptance of thefiling of the subsection (k) application isalso mandatory, along with the accompany-ing documentary and information ex-changes set in the BPCIA in accordancewith 42 U.S.C. § 262(l )(2)(A). I respect-fully dissent from the court’s holding thatthis activity is not required because theSponsor might file an infringement suit inwhich it might learn this informationthough discovery.

Sandoz did not comply with either ofthese statutory requirements. These delib-erate violations of the requirements of theBPCIA forfeit Sandoz’ access to the bene-fits of the BPCIA.

I

Patent dispute resolution under theBPCIA has two phases. The ‘‘earlyphase’’ starts when the subsection (k) ap-plication is accepted by the FDA for re-view, and technical and patent informationare then exchanged. The ‘‘later phase’’starts when the FDA approves the biosimi-lar for commercial marketing. I commentonly briefly on this later phase, for Iagree, as the court holds, that 42 U.S.C.§ 262(l )(8) requires that this phase of in-quiry and dispute resolution commenceswhen the subsection (k) applicant notifiesthe Sponsor, after the FDA license isgranted. My concern is that my col-leagues on this panel do not apply, to theearlier ‘‘shall provide’’ words, the samemandatory meaning as for subsection(l )(8)(A):

§ 262(l )(8)(A) Notice of commercialmarketing.—The subsection (k) appli-cant shall provide notice to the refer-ence product sponsor not later than 180days before the date of the first com-mercial marketing of the biological prod-uct licensed under subsection (k).

(Emphases added). The BPCIA explicitlystates that after licensure and before com-mercial marketing the Sponsor may seek a

preliminary injunction while the patent as-pects are resolved:

§ 262(l )(8)(B) Preliminary injunc-tion.—After receiving the notice undersubparagraph (A) and before such dateof the first commercial marketing ofsuch biological product, the referenceproduct sponsor may seek a prelimi-nary injunction prohibiting the subsec-tion (k) applicant from engaging in thecommercial manufacture or sale of suchbiological product until the court decidesthe issue of patent validity, enforcement,and infringement [of any patent identi-fied in the early stage or other definedproceedings.]

(Emphasis added). Sandoz proposed tocircumvent this provision and launch itsbiosimilar product immediately upon itsFDA licensure.

I share the court’s interpretation of thisstatutory provision, which implements thepurpose of the BPCIA ‘‘to ensure thatlitigation surrounding relevant patents willbe resolved expeditiously and prior to thelaunch of the biosimilar product, providingcertainty to the applicant, the referenceproduct manufacturer, and the public atlarge.’’ Biologics and Biosimilars: Bal-ancing Incentives for Innovation: Hear-ing Before the Subcommittee On Courtsand Competition Policy of the HouseCommittee On the Judiciary, 111th Cong.9 (July 14, 2009) (statement of Rep. Eshoo)(emphasis added). The BPCIA requiresthe court to give effect to the intent ofCongress. See Ingersoll–Rand Co. v.McClendon, 498 U.S. 133, 138, 111 S.Ct.478, 112 L.Ed.2d 474 (1990) (‘‘To discernCongress’ intent we examine the explicitstatutory language and the structure andpurpose of the statute.’’)

II

The BPCIA provides for participants’recognition of potential patent issues at an


early stage, and requires that as soon asthe FDA accepts the biosimilar applicationfor review, the subsection (k) applicantshall notify the Sponsor, and exchanges ofpatent-related information shall com-mence. Details are set forth in 42 U.S.C.§ 262(l )(2). My colleagues hold that com-pliance with these early notice and infor-mation provisions is not mandatory. Icannot agree, for: ‘‘The word ‘shall’ isordinarily the language of command.’’Alabama v. Bozeman, 533 U.S. 146, 153,121 S.Ct. 2079, 150 L.Ed.2d 188 (2001).

The purpose of subsection 262(l ) is toinitiate patent-related activity, to exchangerelevant information, to facilitate negotia-tions, and to expedite any litigation. Sub-section (l )(2)(A) requires the subsection(k) applicant to notify the Sponsor within20 days after the FDA accepts the subsec-tion (k) application for review, and to de-scribe the manufacturing process:

§ 262(l )(2)(A) Subsection (k) applica-tion information.—Not later than 20days after the Secretary notifies thesubsection (k) applicant that the applica-tion has been accepted for review, thesubsection (k) applicant shall provide tothe reference product sponsor a copy ofthe application submitted to the Secre-tary under subsection (k), and such oth-er information that describes the pro-cess or processes used to manufacturethe biological product that is the subjectof such application.

(Emphases added). Sandoz did not pro-vide this information, although it is re-quired, and the BPCIA provides for confi-dentiality:

§ 262(l )(1)(B)(i) Provision of confi-dential information.—When a subsec-tion (k) applicant submits an applicationunder subsection (k), such applicantshall provide to the persons describedin clause (ii), subject to the terms of thisparagraph, confidential access to theinformation required to be produced

pursuant to paragraph (2) and any otherinformation that the subsection (k) appli-cant determines in its sole discretion tobe appropriate.

(Emphases added).

This designated exchange of informationis fundamental to the BPCIA purposes ofefficient resolution of patent issues. How-ever, my colleagues hold that complianceby the applicant is not mandatory, citing§ 262(l )(9)(C), which authorizes suit bythe Sponsor if the applicant does not pro-vide the paragraph (2)(A) information:

§ 262(l )(9)(C) Subsection (k) applica-tion not provided.—If a subsection (k)applicant fails to provide the applica-tion and information required underparagraph (2)(A), the reference productsponsor, but not the subsection (k) appli-cant, may bring an action under section2201 of Title 28, for a declaration ofinfringement, validity, or enforceabilityof any patent that claims the biologicalproduct or a use of the biological prod-uct.

(Emphases added). This provision for de-claratory action by the Sponsor is limitedto ‘‘product’’ and ‘‘use’’ claims, and doesnot include manufacturing process patents,although the legislative record makes clearthat for biosimilars such patents may behighly material, and were so recognizedduring enactment. Amgen states that itspatents here at issue relate primarily tomanufacture.

I cannot agree that this provision excus-es compliance by the subsection (k) appli-cant, even when such declaratory action isbrought. Subsection (l )(9)(C) provides de-claratory jurisdiction only for product oruse claims. Absent adequate factual sup-port in a complaint for manufacturingmethod claims, declaratory jurisdictionmay be unsupported. See Ashcroft v. Iq-bal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173L.Ed.2d 868 (2009) (‘‘To survive a motion


to dismiss, a complaint must contain suffi-cient factual matter, accepted as true, to‘state a claim to relief that is plausible onits face.’ ’’) (citing Bell Atl. Corp. v. Twom-bly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167L.Ed.2d 929 (2007)).

The balance established in the BPCIArequires the statutorily identified disclo-sures at the threshold, in order both toavert and to expedite litigation. Thispurpose pervades the legislative record,as interested persons debated which pro-visions would be mandatory, and whichpermissive. See, e.g., Biologics and Bios-imilars: Balancing Incentives for Inno-vation: Hearing Before the Subcommitteeon Courts and Competition Policy of theHouse Committee on the Judiciary, 111thCong. passim (2009) (debating the provi-sions of H.R. 1548, which provided formandatory patent exchange, and H.R.1427, which provided for discretionarypatent exchange). Compare also S. 623,110th Cong. § (3)(a)(2)(k)(17)(E) (2007)(‘‘nothing in this paragraph requires anapplicant or prospective applicant to in-voke the [patent notification and ex-change] procedures set forth in this para-graph’’) with S. 1695, 110th Cong.§ (2)(a)(2)(l )(2)(A) (2007) (the subsection(k) applicant ‘‘shall provide’’ applicationand manufacturing information). SeeChickasaw Nation v. United States, 534U.S. 84, 93, 122 S.Ct. 528, 151 L.Ed.2d474 (2001) (‘‘We ordinarily will not as-sume that Congress intended ‘to enactlanguage that it has earlier discarded infavor of other language.’ ’’ (citations omit-ted)).

The BPCIA as enacted leaves no uncer-tainty as to which of its provisions aremandatory and which are permissive. Forexample, immediately after the ‘‘shall’’ pro-vision of subsection (l )(2)(A), ante, subsec-tion (l )(2)(B) states that a subsection (k)applicant

may provide to the reference productsponsor additional information request-ed by or on behalf of the referenceproduct sponsor.

(Emphases added). ‘‘[W]hen the sameRule uses both ‘may’ and ‘shall’, the nor-mal inference is that each is used in itsusual sense—the one act being permissive,the other mandatory.’’ Anderson v. Yung-kau, 329 U.S. 482, 485, 67 S.Ct. 428, 91L.Ed. 436 (1947).

In United States ex rel. Siegel v. Tho-man, 156 U.S. 353, 359–60, 15 S.Ct. 378, 39L.Ed. 450 (1895), the Court stated thatwhen Congress uses the ‘‘special contradis-tinction’’ of ‘‘shall’’ and ‘‘may,’’ no ‘‘libertycan be taken with the plain words of thestatute.’’ As reiterated in Sebelius v.Cloer, ––– U.S. ––––, 133 S.Ct. 1886, 1894,185 L.Ed.2d 1003 (2013), ‘‘[w]here Con-gress includes particular language in onesection of a statute but omits it in anothersection of the same Act, it is generallypresumed that Congress acts intentionallyand purposely in the disparate inclusion orexclusion.’’ (alteration and internal quota-tion marks omitted). The BPCIA gestatedduring more than four years of study anddebate. The record contains frequent ref-erence to the experience of the Hatch–Waxman Act, as the BPCIA departed fromthat Act in seeking to ‘‘balance innovationand consumer interests’’ in the new andpromising scientific era of biosimilars.BPCIA, Pub.L. No. 111–148, § 7001(b),124 Stat. 119, 804 (2010). Fidelity to thatbalance is the judicial obligation.

The details enacted and included in theBPCIA demonstrate the rigor of the stat-ute and its compromises. The BPCIA re-quires judicial implementation that con-forms to ‘‘the design of the statute as awhole and to its object and policy.’’ Cran-don v. United States, 494 U.S. 152, 158,110 S.Ct. 997, 108 L.Ed.2d 132 (1990).Subsection (k) and subsection (l ) are com-


ponents of an integrated framework; toenjoy the benefits of subsection (k), thebiosimilar applicant is obligated to complywith subsection (l ). Even on the districtcourt’s (and my colleagues’) misplaced the-ory that subsection (l )(9)(C) excuses com-pliance with subsection (l )(2)(A), thiswould extend only to product and useclaims, it does not excuse compliance as tomanufacturing and process claims.

The BPCIA reflects an explicit balanceof obligations and benefits. When a bene-ficiary of the statute withholds compliancewith provisions enacted to benefit others,the withholder violates that balance. Theconsequences of the majority’s ruling aresignificant, for the structure of the BPCIArequires that the subsection (k) applicantcomply with the information exchange pro-visions, as a threshold to resolution of theSponsor’s patent rights.1

Subsection (l )(9) provides jurisdiction inthe district court when a subsection (k)applicant fails to comply with subsection(l ), but it does not ratify non-compliance.While ‘‘a party may waive any provision,either of a contract or of a statute, intend-ed for his benefit,’’ United States v. Mez-zanatto, 513 U.S. 196, 201, 115 S.Ct. 797,130 L.Ed.2d 697 (1995), the party cannotwaive or disregard a provision that bene-fits those in an adverse position. Theprovisions of 35 U.S.C. § 262(l )(9) functionas a continuing prohibition on a party whofails to comply with some aspect of thepatent exchange provisions. That is, sub-section (l )(9)(C) prevents a non-compliantparty from obtaining relief through a de-claratory judgment action, while that pro-hibition is lifted as to the aggrieved party.Subsection (l )(9)(C) states that a ‘‘refer-

ence product sponsor, but not the subsec-tion (k) applicant, may bring’’ a declarato-ry judgment action ‘‘for a declaration ofinfringement, validity, or enforceability forany patent that claims the biological prod-uct or use of the biological product’’ whena subsection (k) applicant fails to providethe information required under subsection(l )(2)(A).

35 U.S.C. § 271(e)(2)(C)(ii) similarlystates that it shall be an act of infringe-ment if the applicant fails to provide theinformation required under paragraph(l )(2)(A). However, this does not diminishthe obligation set by section (l )(1)(B)(i)that the subsection (k) applicant ‘‘shall pro-vide TTT confidential access to the informa-tion required to be produced pursuant toparagraph (2).’’ Such obligation is manda-tory.

Departure from the statutory obli-gation, to achieve purposes that the legis-lation intended to curtail, should not bejudicially ratified. See Cannon v. Univ.of Chicago, 441 U.S. 677, 690, 99 S.Ct.1946, 60 L.Ed.2d 560 (1979) (disregard ofa statute is a wrongful act). It is notdenied that Sandoz obtained the benefit ofthe Amgen data in filing under subsection(k). Sandoz should be required to respectits obligations, in fidelity to the statute. Irespectfully dissent from the majority’sfailure to require compliance with the ob-ligations of the BPCIA.

CHEN, Circuit Judge, dissenting-in-part.

I join the majority opinion except forParts B.II.b and B.V. To properly inter-

1. The record recites the benefits of subsection(k) for biosimilar applicants. A study for theCongressional Research Service cites a Tuftsreport that found in 2006 the ‘‘average cost todevelop a new biotechnology product is $1.2billion.’’ Follow–On Biologics: The Law andIntellectual Property Issues, CRS Report for

Congress, Professor John Thomas, January 15,1014, passim, n. 32. The record explains thatclinical safety and efficacy studies constitutethe major portion of this development cost,and that subsection (k) authorizes the biosimi-lar applicant to rely on these data that theSponsor provided to the FDA.


pret the BPCIA’s patent litigation man-agement process described in section262(l ), I agree that none of subsection(l )’s provisions may be read in isolation.In other words, to understand the meaningof any one provision in § 262(l ), one mustfirst recognize how it interrelates with therest of subsection (l ) and the rest of theBPCIA. Based on this understanding, Iagree that a subsection (k) applicant’s fail-ure to supply the information described in(l )(2) to the reference product sponsor(RPS) is not a violation of the BPCIA,because the BPCIA itself, in (l )(9) and§ 271(e)(2)(C)(ii), provides the RPS the re-medial course of action in such circum-stances. Contrary to the majority, howev-er, I view this context-based interpretationas applying with equal force to the inter-pretation of (l )(8). When reading (l )(8) inthe context of subsection (l ) as a whole, itbecomes clear that (l )(8) is simply partand parcel of the integrated litigation man-agement process contemplated in (l )(2)-(l )(7). Moreover, just as all the ‘‘shall’’obligations set forth in (l )(3)-(l )(7) arecontingent on the (k) applicant’s perform-ance of the first ‘‘shall’’ step in (l )(2), thisis also true of the ‘‘shall’’ notice obligationin (l )(8). What this means is when, ashere, the (k) applicant fails to comply with(l )(2), the provisions in (l )(3)-(l )(8) ceaseto matter. In such a situation, as recog-nized by the majority opinion, the RPS’scourse of action is clearly defined in (l )(9)and § 271(e)(2)(C)(ii): the unfettered rightto immediately pursue patent infringementlitigation unconstrained by any of the tim-ing controls or limits on the number ofpatents it may assert that would resultfrom the (l )(2)-(l )(8) process. Based onthis understanding, I do not view (l )(8)(A)as a ‘‘standalone provision’’ that provides,implicitly, the RPS a 180–day injunctionbeyond the express twelve-year statutoryexclusivity period. Because the majorityopinion interprets (l )(8) differently, giving

Amgen, the RPS, an extra-statutory exclu-sivity windfall, I respectfully dissent.

I

‘‘It is a fundamental canon of statutoryconstruction that the words of a statutemust be read in their context and with aview to their place in the overall statutoryscheme.’’ Davis v. Mich. Dep’t of Trea-sury, 489 U.S. 803, 809, 109 S.Ct. 1500, 103L.Ed.2d 891 (1989). To that end, the Su-preme Court has instructed that ‘‘statutorylanguage cannot be construed in a vacu-um.’’ Id.; see also Yates v. United States,––– U.S. ––––, 135 S.Ct. 1074, 1081–82, 191L.Ed.2d 64 (2015) (instructing courts tointerpret statutory text by reference to‘‘the specific context in which that lan-guage is used, and the broader context ofthe statute as a whole.’’ (quotation marksomitted)). In Part B.I, the majority prop-erly recognizes that ‘‘the ‘shall’ provisionin paragraph (l )(2)(A) cannot be read inisolation.’’ Majority Op. at 1355. The ma-jority carefully examines the larger statu-tory context—subsection (l ) and§ 271(e)(2)(C)(ii)—and correctly concludesthat ‘‘ ‘shall’ in paragraph (l )(2)(A) doesnot mean ‘must.’ ’’ Majority Op. at 1355.As the majority recognizes, nothing in theBPCIA grants the RPS a procedural rightto compel the (k) applicant’s compliancewith (l )(2)(A). In Part B.II, however, themajority holds that the word ‘‘shall’’ in(l )(8)(A) carries a different meaning thanit does in (l )(2)(A). To reach that incon-sistent result, the majority takes the viewthat (l )(8)(A) should be read in a vacuum,apart from the context and framework ofsubsection (l ), including the language of(l )(8)(B). I respectfully disagree.

A

Entitled ‘‘Patents,’’ § 262(l ) of theBPCIA concerns one thing: patent litiga-tion. Specifically, it specifies an elaborate


information exchange process between the(k) applicant and the RPS that leads up tothe expected patent infringement suit thatcomes during the pendency of a subsection(k) application. This process begins in(l )(2)(A) with the requirement that the (k)applicant disclose to the RPS its biosimilarapplication (aBLA) and manufacturingprocess information. Compliance withsubsection (l )(2)(A) triggers a cascade ofevents contemplated by subsection (l ),with each successive step reliant on theperformance of one or more precedingsteps. This intricate process includes:the exchange of patent lists that each par-ty believes the RPS has reasonablegrounds to assert against the (k) appli-cant, as well as the exchange of respectiveinfringement, validity, and enforceabilitypositions (§ 262(l )(3)); a process by whichthe parties may limit the patents in the in-fringement lawsuit (§ 262(l )(4)-(5)); a pat-ent infringement lawsuit, filed by theRPS, limited to the patents listed in (l )(4)or (l )(5) (§ 262(l )(6)); a procedure forupdating the RPS’s previously created(l )(3) patent list with newly issued or li-censed patents (§ 262(l )(7)); a require-ment that the (k) applicant provide a 180–day notice ahead of commercial marketingthereby giving the RPS time to seek apreliminary injunction on any (l )(3) listedpatents not asserted in the limited (l )(6)patent infringement suit (§ 262(l )(8));and authorization for the RPS to file animmediate declaratory judgment action forpatent infringement if the (k) applicantfails to comply with its specified obli-gations recited in (l )(2), (l )(3), (l )(5),(l )(6), (l )(7), or (l )(8) (§ 262(l )(9)(B)-(C)).Importantly, subsection (l ) does not relateto the FDA approval process (for that seesubsection (k)). Nor is the approval pro-cess contingent on any events related to apossible patent dispute occurring in paral-lel with that approval process.

By enacting the provisions in subsection(l ), Congress created a comprehensive, in-

tegrated litigation management system.These provisions also demonstrate thatCongress anticipated the situation beforeus here, in which the (k) applicant refusesto engage in this litigation managementprocess. Rather than forcing the (k) ap-plicant, by court order or some othermeans, to engage in the subsection (l )process, or conditioning the (k) applica-tion’s approval on the (k) applicant fulfill-ing the requirements set forth in subsec-tion (l ), Congress instead authorized theRPS in this situation to immediately file aninfringement action. See § 262(l )(9) and35 U.S.C. § 271(e)(2)(C)(ii).

Focusing on (l )(8), Congress accountedfor the possibility (perhaps strong likeli-hood) of a situation in which the (k) appli-cant has received FDA approval and is onthe verge of commercially marketing itsbiosimilar product but the RPS was unableto assert all of its (l )(3) listed patentsagainst the (k) applicant in the limited(l )(6) patent litigation. Entitled ‘‘Noticeof commercial marketing and preliminaryinjunction,’’ (l )(8), in relevant part, is setforth below:

8) Notice of commercial marketingand preliminary injunction(A) Notice of commercial marketingThe subsection (k) applicant shall pro-vide notice to the reference productsponsor not later than 180 days beforethe date of the first commercial market-ing of the biological product licensedunder subsection (k).(B) Preliminary injunctionAfter receiving the notice under subpar-agraph (A) and before such date of thefirst commercial marketing of such bio-logical product, the reference productsponsor may seek a preliminary injunc-tion prohibiting the subsection (k) appli-cant from engaging in the commercialmanufacture or sale of such biologicalproduct until the court decides the issueof patent validity, enforcement, and in-


fringement with respect to any patentthat is—

(i) included in the list provided by thereference product sponsor under para-graph (3)(A) or in the list provided bythe subsection (k) applicant underparagraph (3)(B); and(ii) not included, as applicable, on—

(I) the list of patents described inparagraph (4); or(II) the lists of patents described inparagraph (5)(B).

Subsection (l )(8)(A) requires the (k) ap-plicant to give the RPS at least 180 days’notice of its intent to begin commerciallymarketing the biosimilar product. One ofthe key questions in this appeal is, ‘‘Whywould Congress insert a 180–day commer-cial marketing notice provision in a subsec-tion devoted to organizing patent litiga-tion?’’ Paragraph (l )(8)(B) provides theanswer. As mentioned above, the processin (l )(4)-(5) can result in restricting the(l )(6) infringement action to a subset ofthe RPS’s patents identified in (l )(3).Rather than permit the (k) applicant tolaunch its biosimilar product while theRPS is blocked from enforcing some of itspatent rights, subsection (l )(8)(B) address-es that problem by authorizing the RPS toseek a preliminary injunction prohibitingcommercial manufacture or sale based onthe patents that were excluded from the(l )(6) action. Thus, the entirety of (l )(8),including (l )(8)(A)’s notice provision,serves to ensure that an RPS will be ableto assert all relevant patents before the (k)applicant launches its biosimilar product.Amgen confirmed this understanding of(l )(8)’s purpose at oral argument. OralArgument at 20:10–20:05, Amgen, Inc. v.Sandoz Inc., No. 2015–1499 (Fed.Cir. June

3, 2015), available at http://www.cafc.uscourts.gov/oral-argument-recordings/15–1499/all.

Given the purpose of (l )(8) and its ex-press assumption that the parties havealready performed the steps in (l )(3), and(l )(4)-(l )(5), the most logical conclusionwhen reading (l )(8) in context is that(l )(8)’s vitality is predicated on the per-formance of the preceding steps in subsec-tion (l )’s litigation management process.Without first engaging in these proce-dures, (l )(8) lacks meaning. Similarly, forexample, the statutory requirement in(l )(3) for the parties to exchange detailedpositions on infringement and validity forthe patents listed under (l )(3) no longerapplies if the (k) applicant fails to complywith (l )(2). Paragraph (l )(8)’s interdepen-dency on the preceding steps in subsection(l ) is further reinforced by (l )(7)’s cross-reference to (l )(8). Paragraph (l )(7),which sets forth a process for the RPS toupdate its (l )(3) patent list with any newlyissued or licensed patents, states that anysuch patents ‘‘shall be subject to para-graph (8).’’ 42 U.S.C. § 262(l )(7)(B). Theinterwoven structure of subsection (l ) indi-cates that Congress viewed the proceduresof (l )(8) as inseverable from the precedingsteps in (l ).

The majority, on the other hand, views(l )(8)(A) as a standalone notice provisionthat is not excused when the (k) applicantfails to comply with (l )(2).1 Yet, no onedisputes that the requirements of (l )(3)through (l )(7) are certainly excused insuch a case. I recognize that (l )(8)(A),unlike (l )(3) through (l )(7), is not express-ly conditioned on the earlier steps. I can-not, however, read (l )(8)(A) in completeisolation from (l )(8)(B), which does refer-

1. The majority states that Sandoz ‘‘concedes’’that (l )(8)(A) is a standalone notice provision,citing to the oral argument. I understandSandoz’s position as accepting that (l )(8)(A)as a standalone provision is one possible in-

terpretation. Oral Argument at 39:30–40:30,Amgen Inc. v. Sandoz Inc., No. 2015–1499(Fed.Cir. June 3, 2015), available at http://www.cafc.uscourts.gov/oral-argument-recordings/15–1499/all.


ence, and is predicated on the performanceof, (l )(3) and (l )(4)(l )(5). Thus, (l )(8)does not serve as a standalone provision;it is part and parcel to, and contingentupon, the preceding steps in the (l )(2)-(l )(8) litigation management regime. Themost persuasive reading of subsection (l )as a whole is that Congress provided twopaths to resolve patent disputes: (1) theintricate route expressed in (l )(2)(l )(8);and (2) the immediate, more flexible routeprovided in (l )(9), should the (k) applicantfalter on any of its obligations recited in(l )(2)-(l )(8).

B

The majority is also concerned with theabsence of an express consequence fornoncompliance with (l )(8)(A) in situationsin which the (k) applicant does not complywith (l )(2). I agree with the majority thatthe remedy in (l )(9)(B) does not providerelief in this scenario because the RPS’sright to pursue additional patent litigationat this stage under (l )(9)(B) is contingenton using the patents that have been ‘‘in-cluded in the list described in paragraph(3)(A).’’ If a(k) applicant never carries out(l )(2), the RPS will never create an (l )(3)patent list. Such a failure to adhere to(l )(2) would defeat the RPS’s opportunityto invoke (l )(9)(B) if the (k) applicant re-fuses to comply with (l )(8)(A)’s notice pro-vision.

Contrary to the majority’s conclusion,however, the absence of such a remedial

provision in (l )(9)(B) confirms that Con-gress deemed any additional remedy to beunnecessary. Congress created the fall-back provision of (l )(9)(C) for just thesecircumstances. An RPS does not needthe remedy in (l )(9)(B) because (l )(9)(C)and § 271(e)(2)(C)(ii) already grant theright to file, immediately, an unrestrictedpatent infringement action when the (k)applicant fails to comply with (l )(2). Atthis point, the RPS possesses the statuto-ry right to seek a preliminary injunctionfor any of its patents that ‘‘could be identi-fied pursuant to section [262](l )(3)(A)(i).’’35 U.S.C. § 271(e)(2)(C)(ii). It thereforewould have been superfluous for Congressto provide the RPS with authorization toinitiate an additional, redundant infringe-ment action under (l )(9)(B) 2 if the (k)applicant later does not comply with(l )(8)(A). Not only is compliance with(l )(8)(A) unnecessary under such a cir-cumstance, but no additional remedy isneeded. Thus, after Sandoz failed to per-form the (l )(2) requirement, the only rele-vant provision in subsection (l ) became(l )(9)(C) and § 271(e)(2)(C)(ii).

C

The practical consequence of the majori-ty’s interpretation is that (l )(8)(A) pro-vides an inherent right to an automatic180–day injunction. The majority providesno basis in the statutory language to sup-port this automatic injunction.3 This relief

2. It is worth examining (l )(9)(B) closely for itshows how Congress understood the (l )(8)notice provision to be one part of the entiresubsection (l ) litigation management process.Under (l )(9)(B), if a(k) applicant fails to com-ply with any of its obligations recited in‘‘paragraph (3)(B)(ii), paragraph (5), para-graph (6)(C)(i), paragraph (7), or paragraph(8)(A),’’ the RPS may immediately bring aninfringement action on any patent the RPSlisted in (l )(3). 42 U.S.C. § 262(l )(9)(B) (em-phasis added). By grouping (l )(8)(A) with(l )(3), (l )(5), (l )(6), and (l )(7), all of which

are unquestionably part of the litigation man-agement regime, and defining the scope ofany infringement action by the patents listedin (l )(3), Congress evidenced that (l )(8)(A) isnot a provision that stands apart from theothers, but is instead part of an integratedregime with each part serving a common pur-pose.

3. The majority believes that (l )(8)(A)’s noticeprovision plays a necessary role, when the (k)applicant fails to comply with (l )(2), to pro-vide the RPS adequate notice of the aBLA and


is analogous to the thirty-month stay ofthe Hatch–Waxman Act, which providesfor an automatic stay during which theFDA cannot approve the ANDA unless thepatent infringement suit is resolved or thepatent expires. See 21 U.S.C.§ 355(j)(5)(B)(iii). If Congress intended tocreate a 180–day automatic stay it under-stood how to do so. It could have tiedFDA approval to the notice provision.Yet, Congress declined to link FDA ap-proval to a single provision in subsection(l ). At bottom, the majority’s view is intension with the defined purpose of (l )(8)while providing the RPS with an atextual180–day exclusivity windfall.

Notably, nothing in the majority opinionsuggests that this automatic injunctionremedy would be available in cases wherethe applicant complied with (l )(2)(A) byproviding its aBLA to the RPS, but laterfailed to provide notice under (l )(8)(A). Infact, the majority’s opinion creates an un-comfortable result in which the languageof (l )(8)(A) is interpreted in two differentways, based on the (k) applicant’s actions.In a situation like the present case, the (k)applicant cannot refuse to provide the 180–days’ notice, because under the majority’sreading, (l )(8)(A) authorizes an automaticentitlement to a 180 day injunction. But ifa(k) applicant complies with all the re-quirements specified in (l )(2)-(l )(7), thenthe (k) applicant may still refuse to complywith the 180–day notice provision. In thisscenario, there would be no automatic in-junction because (l )(9)(B) provides theRPS with the authorization to immediatelyfile suit on any patent it listed under (l )(3).Thus, in one scenario, (l )(8)(A) provides a180–day injunction, but in the second sce-nario it does not. While the result in thelatter scenario comes from the plain lan-guage of the statute, not so with the for-

mer. Nothing in the statute supports thispeculiar outcome. As explained above, inmy view, the better reading of (l )(8) isthat it does not apply, just as (l )(3)-(l )(7)do not apply, when the (k) applicant failsto comply with (l )(2).

II

To be sure, (l )(8)(A) is an integral partof the procedures for managing patent liti-gation that arises as a result of a partyfiling an aBLA. Nevertheless, (l )(8)(A) issimply one piece of subsection (l )’s inte-grated patent dispute puzzle that ceases tomatter, just like all the other pieces pre-ceding (l )(8) cease to matter, once the (k)applicant fails to comply with (l )(2). I donot find support in the statutory languageto create an automatic 180–day injunction.Just as ‘‘shall’’ in (l )(2) does not mean‘‘must,’’ the same is true for the ‘‘shall’’provision in (l )(8)(A), once it is read incontext with the entirety of subsection (l ).

As the majority opinion recognizes, thiscase requires us to ‘‘unravel the riddle,solve the mystery, and comprehend theenigma’’ that is the BPCIA. Majority Op.at 1351 n. 1. To fulfill our judicial obli-gation ‘‘to say what the law is,’’ we mustchoose from a series of imperfect choices.In my view, the most coherent interpreta-tion of (l )(8)(A) that is consistent with therest of the BPCIA is the one I have de-scribed above. For these reasons, I re-spectfully dissent from the majority’s hold-ing that (l )(8) is a standalone provisionwith an inherent right to a 180–day injunc-tion. Accordingly, I would dissolve theinjunction pending appeal.

,

therefore a meaningful opportunity to assertits patent rights. In my view, the majorityreads too much into (l )(8)(A) by empowering

it with an injunction right in the limited cir-cumstance when a(k) applicant fails to com-ply with (l )(2).

amgen inc. v. sandoz inc. 1347 - fish & richardson inc. v. sandoz inc. 1349 cite as 794 f.3d...

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