*1 (2009). right ed to submit new materials for a 90- L.Ed.2d 532 cannot. We The Vet- day period following required mailing. that, erans Court made no determination if gave No law Mr. Carter’s counsel notice Mr. Carter’s counsel had received the no- that, upon receiving 90-day letter after fashion, tice in a timely she would have run, the deadline had she still had the submitted no evidence. government The right to have Board consider late-sub- has not sufficiently argu- made such an mitted evidence as it had timely if been ment appeal, on at making most a passing submitted. inadequate assertion preserve the point. event, in any And we have no any Veterans Court did not cite basis for thing providing finding such notice. It said that harmlessness of the notice error. been, Mr. Carter would have entitled to arguments
“raise[] Board” even Conclusion after the final had decision issued and that reasons, For foregoing we vacate the “the Board would have been required to Court, decision of the Veterans we Carter, consider them.” 26 Vet.App. at remand the case for a further remand to added). (emphases Even if the Veter Board, to which Mr. Carter can submit correct, ans Court is but Gov’t Br. at cf. new materials in accordance with the (the government 16 n. states that it is original terms of the remand order from authority “not aware of the for the Veter the Veterans Court. here”), ans Court’s statement an obligation Costs awarded to appellant. arguments” “consider is not an obli gation to consider evidence as if it were VACATED AND REMANDED timely submitted. The Veterans Court la stated, ter identifying any without authori
ty proposition, for the that Mr. Carter was “prevented from presenting additional Carter,
argument or evidence.” 26 Vet.
App. at 546. That “prevented was not he presenting”
from does not evidence mean that the Board was obliged to consider the INC., Amgen AMGEN Manufacturing submitted, timely evidence as if much less Limited, Plaintiffs-Appellants And, this was clear at the time. v. although the grants Veterans Court often appeal relief from deadlines missed on ac INC., Defendant-Appellee. SANDOZ (but initially count of an defective later- No. 2015-1499. corrected) notice, see, e.g., Ashley v. Der winski, (1992), 2 Vet.App. there Appeals, United States Court of was no clear relying basis for on that Federal Circuit. practice as applying non-appeal July 2015. at deadline issue here. circumstances, In these we conclude
the Veterans Court legally finding erred
a cure of the notice That conclu- defect. requires
sion a vacatur and remand unless
we find the error to be harmless. See 38 7261(b)(2); Sanders, Shinseki v. 396, 406,
556 U.S. 129 S.Ct. *3 Sherry, Casey Dwyer, L.
Arbus Robert J. Gajarsa. Diskant,
Gregory Belknap Patterson LLP, York, N.Y., Tyler & New Webb Biotech, amicus curiae Inc. Janssen Also Royzman; Irena Dianne represented B. Elderkin, MuHin, Gump, Akin Barbara Strauss, Feld, LLP, Philadelphia, Hauer & PA. Pensabene, O’Melveny
Lisa Barons & LLP, York, N.Y., Myers New for amicus *4 Biotechnology Industry Organiza- curiae by tion. represented Prugo. Also Filko Angulo, Spaeder Carlos T. Zuckerman LLP, DC, Washington, for amicus curiae Generic Pharmaceutical Association. Klein, B. Charles Winston & Strawn LLP, DC, Washington, for amici curiae Inc., Co., Hospira, Celltrion Healthcare Ltd., Celltrion, Inc. Also represented by Nichols; Park, Andrew C. Samuel S. Chi- IL; Perkowski, cago, Peter E. Ange- Los les, CA. NEWMAN, LOURIE, Before and Paul, Weiss,
Nicholas P. Groombridge, CHEN, Judges. Circuit Rifkind, LLP, Wharton & Garrison New York, N.Y., argued for plaintiffs-appel- Opinion for the court by filed Circuit lants. represented by Also Eric Alan Judge LOURIE. Stone, Wu, Gordon, Jennifer H. Jennifer Sandel, Wu, Peter Michael T. Arielle K. Opinion concurring part, dissenting Linsey; Whiteford, Wendy A. Lois M. part by filed Judge Circuit NEWMAN. Kwasigroch, Morley, Amgen Kimberlin L. Opinion dissenting part by filed Inc., Oaks, CA; Thousand Vernon M. Win- Judge Circuit CHEN. ters, Baxter, Sidley Alexander David Aus- LLP, Francisco, tin San CA. LOURIE, Judge. Circuit Maynard, Deanne Morrison & Foerster appeal presents This issues of im- first LLP, DC, Washington, argued for defen- pression relating Biologies Price dant-appellee. represented by Also Jo- Competition and Innovation Act of 2009 Palmore, seph Hearron; R. Marc A. Ra- (“BPCIA”), 111-148, §§ Pub.L. No. 7001- Krevans, Francisco, CA; chel San Julie (2010). 124 Stat. 804-21 Amgen Park, Diego, San CA. (col- Amgen Manufacturing Inc. and Ltd. Morin, Michael lectively, “Amgen”) A. Latham & appeal Watkins from the deci- LLP, DC, Washington, for amicus curiae sion of the United States District Court (1) represented by AbbVie Inc. Also David the Northern District of California dis- Frazier, Garre, Gregory Penn missing Amgen’s G. Melissa state law of unfair claims
1351 competition prejudice and conversion with The BPCIA has certain similarities in its (“Sandoz”) goals procedures Inc. and because Sandoz did not to the Drug Price Competition and Patent Term violate and no- Restoration information-disclosure (the Act of Act), Hateh-Waxman tice-of-commercial-marketing provisions of 98-417, (1984), Pub.L. No. Stat. BPCIA, respectively codified at 42 but it has several obvious differences. We 262(i )(2)(A) (2) (Z)(8)(A); note this as a interest, matter of historical judgment on granting pleadings but otherwise do not comment on those seeking Sandoz on its counterclaims a de- similarities and differences. claratory judgment correctly inter- (3) BPCIA; preted the Am- denying Traditionally, Drug the Food and Ad- gen’s preliminary injunction motion for a (“FDA”) ministration approves a biological based on its state law claims. Inc. for commercial marketing by Inc., 14-cv-04741, v. No. granting biologies WL license under 42 (N.D.Cal. 2015) 262(a). Mar. (“Opin- U.S.C. An applicant filing a bio- ”). (“BLA”) logies application ion license typically provides clinical data to demonstrate the below, For the reasons stated we affirm safety efficacy product. In con- Amgen’s state dismissal law claims trast, under pathway the abbreviated cre- conversion, competition of unfair va- BPCIA, ated codified at 42 U.S.C. judgment cate the on Sandoz’s counter- *5 262(k), § an applicant filing an abbreviated claims and direct the district court to enter (“aBLA” biologies license application or judgment interpreta- consistent with our (k) application”) “subsection instead sub- BPCIA, tion of the and remand for further mits information to demonstrate that proceedings opinion. consistent with this product is “biosimilar” to or “interchangea- ble” with a previously approved reference A. BACKGROUND product, together “publicly-available I. [FDAj’s information regarding previ- In as part of the Patient Protec- ous determination that the prod- reference Act, tion and Affordable Congress Care safe, uct is pure, potent.” and 42 U.S.C. BPCIA,1 enacted the which established an 262(k)(2)-(5); 262(i). § § see also id. pathway regulatory abbreviated ap- thus permits applicant BPCIA a biosimilar proval biological of follow-on products rely part on approved of a license “highly product. are similar” a reference previously ap- (“reference proved product product”). To price competi- balance innovation and 111-148, 7001-7003, §§ Pub.L. No. 124 tion, Congress enacted the to pro- (2010) (codified Stat. 804-21 four-year vide a twelve-year and a exclu- § at 42 amended U.S.C. 35 U.S.C. sivity period product, reference both 271(e), § 2201(b), § 28 U.S.C. 21 U.S.C. beginning on the date of first licensure of § seq.). Congress 355 et established such the reference product. Specifically, a sub- pathway “a biosimilar balancing innovation section application “may not be submit- BPCIA, and interests.” consumer Pub.L. Secretary.until ted the date that is 4 111-148, 7001(b), No. at years Stat. 804. after the date on which the refer- 1. london.org.uk/RusnEnig.html. Winston Churchill once described Russia as That is this wrapped mystery "a riddle in a inside an opinions, statute. these we do our best to Churchill, enigma.” Winston The Russian riddle, mystery, unravel solve and (BBC 1, 1939), Enigma radio broadcast Oct. comprehend enigma. http://www.churchill-society- available at product applicant
ence was first licensed under sub- sues the biosimilar within 30 262(i )(6). (a),” 262(k)(7)(B), approv- days, id. That section id. information ex- change application “may negotiation contemplates al thus infringement brought an immediate action by Secretary be made effective until only patents. the RPS based on listed years the date that is 12 after the date on product li- which the reference was first 262(i) Subsection also that the (a),” censed under id. applicant give notice of commercial mar- 262(k)(7)(A). Thus, sponsor ap- of an keting days prior to the RPS at least 180 (the proved product reference “reference marketing to commercial of its “RPS”) product sponsor” up receives (k), licensed under subsection which then years exclusivity against twelve follow- a period allows of time to seek a products, regardless on of patent protec- injunction preliminary patents based on tion. parties initially that the during identified exchange but were not select- information
Moreover, the a pat- BPCIA established action, infringement ed for the immediate ent-dispute-resolution regime by amending any newly as well as issued or licensed 28, 35, Titles of the United States patents (collectively, patents”). “non-listed Code. The BPCIA amended the Patent Act 262(Z)(7)-(8). §Id. infringement” to create an artificial “act of infringement and to allow suits on a based 262(Z) additionally provides, Subsection application prior ap- biosimilar to FDA (l )(9)(A), in paragraph that if proval prior to marketing of the bio- “required discloses information logical product. See (2)(A),” then neither the RPS (e)(6). 271(e)(2)(C), (e)(4), The BPCIA applicant may bring nor the a declaratory also a unique established and elaborate judgment action based on the non-listed process for exchange between patents prior to the on date which the RPS biosimilar and the RPS to receives the notice of commercial market- resolve disputes. See *6 (l )(8)(A). ing under Id. 262(i). § 262(i )(9)(A). (i)(9)(B) § Paragraphs (i)(9)(C), however, RPS, permit but process, Under that codified at 42 applicant, declaratory not the to seek relief 262(0, § the biosimilar in the event 'that fails to grants the RPS confidential access to its with certain of subsec- aBLA manufacturing and the (l). 262(l )(9)(B)-(C). § Id. regarding biosimilar no later days than 20 accepts after the FDA its II. 262(£)(l)-(2). application § for review. Id. Amgen filgrastim has marketed under parties exchange then of patents lists the brand name Neupogen® (“Neupogen”) they for which believe a claim patent 2014, In May since 1991. an Sandoz filed infringement reasonably could be asserted aBLA, seeking FDA approval of a biosimi- RPS, by the as well respective as their filgrastim product, lar Neupogen for which positions infringement, validity, on and en- 7, 2014, product. is the reference July On forceability patents. those Id. Sandoz received notification FDA from the 262(0(3). § Following exchange, that accepted that it had application Sandoz’s months, up
which could take to six for review. parties negotiate to formulate a list of (“listed patents patents”) 8, 2014, that would be the July On Amgen Sandoz notified subject of an infringement immediate ac- that it had filed a biosimilar application 262(i tion, )(4)-(5), § id. and the then referencing Neupogen; it believed application approved judgment correctly that the would be that it interpreted the 2015”; “Ql/2 actions, and that it intended to permitting BPCIA as its and that product immediately launch biosimilar its the '427 infring- was invalid and not upon approval. FDA J.A. 1472. Later in ed. July, response Amgen’s inquiry, San- 2015, In January the parties filed cross- accepted confirmed that the FDA had doz motions for judgment on the pleadings on review, application
its for but in- Sandoz Amgen’s state law claims and Sandoz’s Amgen “opted that it had not to formed interpreting counterclaims the BPCIA. provide Amgen Sandoz’s biosimilar 2015, February Amgen also filed a motion days application within 20 of the FDA’s injunction for a preliminary solely based acceptance” Amgen notification of on its state law enjoin claims to was entitled sue Sandoz under launching from Zarxio after FDA approv- 262(0(9X0. J.A. 1495-96. Sandoz al. in February Also through discov- aBLA prod- thus did not disclose its or its ery, Amgen obtained access to Sandoz’s manufacturing Amgen uct’s information to application. biosimilar 262(Z)(2)(A). according to 19, 2015, On March the district court 6, 2015, on March Subsequently, granted partial judgment pleadings on the FDA aBLA approved ap- Sandoz’s for all to Sandoz on its BPCIA counterclaims to proved Amgen’s Neupogen. uses of Al- interpretation extent that Sandoz’s though gave Sandoz has maintained that it the statute is consistent with the court’s operative notice of commercial market- interpretation. Specifically, the district ing July gave nevertheless (1) court concluded that: the BPCIA ren- marketing” “further notice of commercial permissible ders appli- a subsection approval. on the date of FDA cant’s decision not to disclose aBLA J.A. 1774. Sandoz intended to launch its manufacturing and the information to the filgrastim product under the trade name RPS, subject only consequences set Zarxio. 262(Z (2) )(9)(C); forth in 42 U.S.C. such a decision alone does not offer a basis III. relief, injunctive the RPS to obtain restitu- 2014, Amgen In October sued Sandoz in tion, against damages applicant; California, the Northern District of assert- (3) may give the applicant notice of (1) ing competition claims of unfair marketing commercial practices unlawful business under Califor- 262(Z)(8)(A) FDA approval. before nia Business & Professions Code *8, Opinion, 2015 at *11. WL *7 (“UCL”), seq. et alleged based on two interpretation Based on its the (2) BPCIA; violations of the conversion for BPCIA, the district court then dismissed allegedly wrongful Amgen’s ap- use of Amgen’s unfair competition and conversion (3) proved license on Neupogen; and in- prejudice claims with because concluded 6,162,- fringement Amgen’s U.S. Patent that Sandoz did not violate the BPCIA or (the 427 patent”), “’427 which claims a unlawfully. act Id. at *8-9. The court using filgrastim. method of Amgen al- Amgen’s prelimi- also denied motion for a leged that by Sandoz violated the BPCIA nary injunction based on its state law failing to required disclose the information claims, noting Amgen yet that “has 262(Z)(2)(A) § under by giving pre- and proceed remaining patent on its claim for mature, ineffective, notice of commercial infringement.” at Id. *10. 262(Z)(8)(A) marketing § under before motion, FDA approval product. joint of its biosimilar the parties’ On the district declaratory judgment counterclaimed for a court final to Am- entered as 1354
gen’s competition unfair and applicant may conversion subsection elect not to claims and as to Sandoz’s BPCIA counter- manufacturing disclose its aBLA and the 54(b) claims under Rule of the Federal information 42 U.S.C. 262(i parties’ )(2)(A), § Rules of Civil Procedure. The subject only to the conse- 262(Z)(9)(C). and in- relating claims counterclaims §in quences set forth Para- fringement, validity, enforceability (l )(2)(A) and of graph provides that: the '427 at pending remain the days Not later than 20 after the Secre- district court. tary the applicant notifies timely appealed from the final that the application accepted has been judgment prelimi- and from the denial of a review, for applicant injunction; nary jurisdiction we have un- provide shall to the reference product 1295(a)(1) 1292(a)(1) der 28 U.S.C. sponsor copy of the application submit- (c)(1). Secretary ted to the under subsection
(k), and such other information that de- B. Discussion scribes the process processes or used to biological product manufacture apply procedural We law of subject is the of such circuit, application.... regional Circuit, here the Ninth reviewing when a district grant court’s of a 262(i)(2)(A) added). 42 (emphasis judgment pleadings. motion for on the (l )(9)(C) Paragraph provides that: Co., Merck & Co. v. Hi-Tech Pharmacal If a subsection pro- fails (Fed.Cir.2007). 1317, 482 F.3d vide the application and information Ninth grant Circuit reviews the of judg (2)(A), required under paragraph novo, ment on pleadings de v. Peterson product sponsor, reference but not the (9th 1166, California, 604 F.3d Cir. (k) applicant, may bring an 2010), “accept[s] all allega material action under section 2201 of Title complaint tions as true and con a declaration of infringement, validity, light them the strue[s] most favorable to enforceability any patent Cook, non-moving party],” [the Turner v. biological product claims the or a use of (9th Cir.2004) (third 362 F.3d biological product. original). alteration in Issues of 262(Z)(9)(C) added). Id. (emphases Ad- interpretation are also reviewed de novo. 271(e)(2)(C)(ii), ditionally, Qantas States, Airways Ltd. v. United BPCIA, amended provides that: (Fed.Cir.1995). F.3d It infringement shall be an act of Amgen’s Because state law claims of ... if appli- submit for the competition unfair and conversion are cation the application premised on the proper interpretation of fails under section first, BPCIA, we interpret the relevant 351(Z)(2)(A) Act, application of such provisions of the BPCIA and then consider seeking approval biological product of a Amgen’s state in light law claims of that a patent pur- that could be identified interpretation. *8 351(i )(3)(A)(i) to suant section of such Act.... I. 271(e)(2)(C)(ii) §
We first consider whether the (emphasis 35 U.S.C. add- ed).2 district court erred in concluding that a 351(Z)(2)(A) 262(1 )(2)(A).
2. Section corresponds § of the Public Health Act U.S.C. language specified “shall the deadline in Amgen argues that the statute. In- (i)(2)(A) suggests deed, in provide” paragraph BPCIA refers such informa- that information disclosure is mandato- “required” tion as in provisions. other See ry, merely permissible. Amgen con- 262(i)(l)(B)(i), (l)(9)(A), 42 U.S.C. provisions tends that other of the BPCIA (l )(9)(C); 271(e)(2)(C)(ii). un- “required” refer to the information as (l )(l)(B)(i) Particularly, paragraph pro- (i)(2)(A) and also paragraph der refer (k) vides that a subsection appli- “[w]hen” as a failure to non-disclosure FDA, cant submits an aBLA to the “such that, Amgen argues by refusing Act. applicant ... provide shall confidential ac-' information, required a subsec- required, cess to the information to be pro- unlawfully applicant tion evades the (2) pursuant duced to paragraph process patent infringement detection of other information that the subsection infringement and avoids immediate ac- determines, discretion, in its sole 262(Z)(6). ar- Amgen tion under also added). appropriate” to be (emphases (l )(9)(C) merely that a gues paragraph is Thus, plain under the language para- action, declaratory judgment limitation on (l )(l)(B)(i), graph when an remedy, anot let alone the exclusive reme- pathway chooses the abbreviated regu- for dy, noncompliance paragraph (mm. latory approval product, of its biosimilar required is to disclose its aBLA and manu- responds provi- Sandoz that the “shall” facturing information to the RPS no later (i )(2)(A) paragraph only sion in a condi- than days after the FDA’s notification precedent engaging tion in the informa- acceptance, but not when the “when” (£)(3) tion-exchange process paragraphs criterion is not met. (i)(6), through mandatory not a require- reading in paragraph Such of “shall” ment in all circumstances. con- Sandoz (l )(2)(A) supported by “may” the use of that interpretation tends is consistent (l )(2)(B), in paragraph provides which (l )(6), in paragraph with the use of “shall” applicant “may” provide which that the “shall” file an RPS requested by additional information infringement suit. Sandoz notes that this by statutory deadline. Para- use of “shall” cannot mean that the RPS (i)(2)’s graph juxtaposi- use of “shall” if it violates statute chooses not to file adjacent “may” provision tion with in the an infringement suit. Sandoz re- also appear to sig- would indicate “shall” that, BPCIA, sponds if under the a subsec- requirement. nals a (k) applicant does not disclose the (l )(2)(A), paragraph information under However, provision para- the “shall” sponsor may then the file an infringement (i )(2)(A) graph cannot be read in isolation. (l )(9)(C) paragraph suit under and obtain provisions, explicitly In other the BPCIA in discovery, the information (k) appli- that a contemplates has done. also that it contends did might required cant fail to disclose the unlawfully by taking path not act ex- by It deadline. pressly contemplated by Congress and the specifically consequence sets forth the BPCIA. may bring such failure: the RPS an in- fringement action under U.S.C. that, isolation,
We conclude read 262(i )(9)(C) (l )(2)(A) “shall” in paragraph ap- 271(e)(2)(C)(ii). Those latter
pears to mean that a appli- (l )(2)(A) cant is indicate that “shall” in to disclose its aBLA and manufacturing information to the RPS does not mean “must.” And *9 Importantly, mandating compliance grants proce- no other that a
has
(i)(2)(A) in all circum
paragraph
with
with the
right
compel compliance
dural
to
(Z)(9)(C)
paragraph
stances would render
requirement
paragraph
of
disclosure
271(e)(2)(C)(ii) superflu
§
and 35 U.S.C.
(Z)(2)(A).
ous,
if
interpreted
and statutes are to be
271(e)(2)(C)(ii),
§
filing
Under 35 U.S.C.
possible
rendering any provision
to avoid
(k)
failing to
application
a subsection
superfluous.
Corp.,
Marx v. Gen. Revenue
under
required
disclose the
information
-,
1166, 1178,
568 U.S.
133 S.Ct.
(Z)(2)(A)
an artificial “act of
paragraph
is
(2013) (“[T]he
against
L.Ed.2d 242
canon
infringement”
patent
of “a
that could be
surplusage
strongest
interpre-
when an
is
pursuant
paragraph
to
identified”
superfluous
tation
render
another
would
262(0(9)(C)
(l )(3)(A)(i).
§
fur-
42 U.S.C.
scheme.”);
part
statutory
of the same
provides
ther
a subsection
“[i]f
Andrews,
19, 31, 122
TRW Inc. v.
534 U.S.
provide
application
fails to
the
(2001) (“It
S.Ct.
trict court erred in
that a
improperly
twelve-year
extends the
exclu-
(k) applicant may satisfy
its
262(k)(7)(A).
sivity period under
give
obligation to
notice
commercial
262(Z)(8)(A)
marketing
that,
under 42
agree
Amgen
U.S.C.
We
by
(Z
FDA
doing
)(8)(A),
so before the
licenses its
paragraph
ap
(Z)(8)(A)
product.
Paragraph
provides
may only
plicant
give effective notice of
(k) applicant
that “[t]he subsection
shall
marketing
commercial
after the FDA has
product
notice to the reference
product.
licensed its
lan
sponsor
days
than
later
before
guage compels such an
It
interpretation.
the date of the first commercial market
notice,
means that
to be effective under
ing
biological product
of the
licensed un
statute,
given only
must be
after the
(k).”
262(Z)(8)(A)
der subsection
Id.
product is licensed
the FDA.
added).
(emphases
(Z), only paragraph
In subsection
(Z)(8)(A)
product
refers to the
as “the bio-
a.
logical product licensed under subsection
Amgen argues
ap-
that a subsection
(k).”
(Z),
In other
of subsection
plicant may give notice of commercial
product
the statute refers to the
“the
marketing only
“biological
after it has a
subject
biological product
is the
of’
(k),”
product
licensed under subsection
application,
discussing
even when
its
only
meaning
after the FDA has licensed
marketing.
-E.g.,
commercial
product. Amgen
the biosimilar
notes that
262(Z
(Z)(3)(C);
)(3)(B)(ii)(I),
id.
(l)
elsewhere subsection
refers to the
262(Z
(Z
(Z
)(1)(D),
)(2)(A),
)(3)(A)(i),
product
biological prod-
as “the
biosimilar
(Z
(Z)(7)(B).
)(3)(B)(i),
Congress
If
intend-
subject
uct that
application,
of’ the
(Z)(8)(A)
permit
ed
effective
“li-
supports
interpretation
licensed,
notice before the
(Z)(8)(A).
in paragraph
censed”
“subject
language.
would have used the
of’
li-
explains
giving
notice after FDA
only
it is true that
a licensed
censure
time for the
While
seek
marketed, it
preliminary injunction
product may
commercially
and to resolve
be
does not follow that whenever the future
necessarily
does not
conflict
*11
commercial
marketing
yet-to-be
li-
twelve-year
exclusivity
period
discussed,
product
censed
is
it is the “li-
262(k)(7)(A).
case,
It is true that in this
product.
It
yet
censed”
is not
“the li-
infra, Amgen
as we decide
will have an
product.” Congress
censed
could have
days
additional 180
of market exclusion
phrase
biological product
used the
“the
date;
after Sandoz’s effective notice
that is
subject
that
application
is the
of’ the
only
because Sandoz
filed its aBLA 23
(l )(8)(A),
paragraph
as it did in other pro- years
after
FDA approval
obtained
visions,
See,
but it
not
e.g.,
did
do so.
of its Neupogen product. Amgen had
States,
23,
Russello v. United
464 U.S.
days,
more than an “extra” 180
that
but
is
(1983).
104 S.Ct.
Furthermore,
operative
requiring FDA
notice of commercial marketing
licensure
before notice of
marketing
only
commercial
can
given
be
after FDA licensure.
(l
)(8)(A),
Here,
July
day
interpreted
notice
as we have
it. San-
Sandoz’s
262(Z)(9)(B)
application
accepted
argues
after the FDA
doz
specify
does
review,
and ineffective.
premature
was
consequence
noncompliance
However,
approved
(l)(8)(A).
FDA
Sandoz’s
(Z)(9)(B),
Paragraph
6, 2015,
gave
March
and Sandoz
aBLA on
“[subsequent
entitled
failure to act
marketing
of commercial
a “further” notice
(k) applicant,” provides
that:
day.
1774. These facts are
on
J.A.
If a
to com-
fails
35:33-56,
Argument
Oral
at
uncontested.
plete
required'of
an action
the subsec-
*12
Inc.,
Amgen Inc. v. Sandoz
No. 2015-1499
(k) applicant
under paragraph
(Fed.Cir.
2015),
3,
http://
June
available at
(3)(B)(ii),
(5),
paragraph
paragraph
www.cafe.uscourts.gov/oral-argument-
(6)(C)(i),
(7),
paragraph
paragraph
or
in
recordings/15-1499/all. That
notice
(8)(A), the
product sponsor,
reference
the operative
March 2015 thus serves as
but not
applicant, may
the subsection
notice of commercial market-
and effective
bring
action under section 2201 of
ing in this case.
28,
Title
for a declaration of infringe-
exists, however, concerning
A question
ment, validity,
enforceability
or
any
in
provision
paragraph
whether the “shall”
patent included in the list described in
(l )(8)(A) mandatory.
We conclude
(3)(A),
paragraph
including
provided
as
(l )(2)(A)
paragraph
is. Both
(7).
under paragraph
(Z)(8)(A)
“shall,”
pre-
use the word
262(Z)(9)(B)
42
(emphases
U.S.C.
add-
signals
statutory require-
sumptively
ed).
See, e.g.,
ment.
Nat’l
Home
Ass’n of
(Z)(9)(B)
paragraph
it is true that
While
Wildlife,
Builders v.
551 U.S.
Defenders of
specifies
consequence
subsequent
for a
644, 661-62,
2518,
127 S.Ct.
168 L.Ed.2d
(Z)(8)(A)
comply
paragraph
failure to
with
(2007);
Davis,
230,
Lopez
v.
531 U.S.
complied
has
with
after
(2001).
241,
714,
121 S.Ct.
argument-recordings/15-1499/all. ing Unlike another according Amgen, (Z)(3) the actions described in paragraphs the BPCIA. Davis v. HSBC Bank Neva (Z)(7), on, through which all depend or are da, N.A., 1152, (9th 691 F.3d Cir. Superior triggered by, para- the disclosure under 2012); see also Farmers Ins. Exch. v. (Z)(2)(A), graph nothing paragraph 377, Court, Cal.4th 6 Cal.Rptr.2d (l )(8)(A) requirement conditions the notice (1992). 826 P.2d Under Cali (Z)(2)(A) paragraph on or other law, fornia UCL remedies are not available (Z). Moreover, nothing of subsection underlying when the expressly pro law (Z) excuses the from vides that remedies that law are obligation give notice of commercial exclusive. See Cal. Bus. & Prof.Code marketing to the after it has chosen 17205; v. Target Corp., 58 Loeffler (Z)(2)(A). with paragraph 1081, 171 Cal.4th Cal.Rptr.3d 324 P.3d (Z)(8)(A) purpose (2014). 50, 76 requiring clear: notice of commercial mar- one As basis of its unfair competition keting given be to allow period the RPS a claim, Amgen alleges that Sandoz violated of time to upon assess and act its patent *13 by BPCIA failing comply with rights. 262(Z)(2)(A). concluded, § As we have that, where, We therefore conclude by Sandoz did not violate the BPCIA not here, a completely disclosing its aBLA manufacturing and the fails to its aBLA and the 262(Z)(2)(A). § according manufacturing by information to the RPS path Sandoz took a expressly contemplated deadline, requirement 262(Z)(9)(C) § 42 U.S.C. and 35 U.S.C. (Z)(8)(A) mandatory. Sandoz 271(e)(2)(C)(ii), § 35 may therefore not market Zarxio before 271(e)(4) § only “the remedies days 6, 2015, i.e., Septem- from March may which granted by be a court” for the 2, ber 2015. alleged violation. We therefore affirm the Amgen’s dismissal of unfair competition III. claim based on the alleged violation of next Amgep’s We consider com- unfair 262(Z)(2)(A). § petition and conversion claims under Cali- fornia finding law. After that Sandoz did b. BPCIA, not violate the the district court As another competi- basis of its unfair Amgen’s dismissed state law claims with claim, Amgen tion also asserts that Sandoz prejudice. affirm We the dismissal based violated the by giving premature, a interpretation on our of the BPCIA.5
ineffective, notice of marketing commercial a. 262(Z)(8)(A) § 2014, July before approval FDA in March 2015. As indicat- Under Cal. Bus. & Prof.Code ed, BPCIA, interpretation under our of the 17200, competition” “unfair includes July ineffective, 2014 notice unlawful, “any unfair or fraudulent busi gave operative Sandoz notice on practice.” ness act or March Amgen’s unfair 6, Thus, indicated, 2015. competition claim is as we have solely based on the San- “unlawful” prong, requires may which a doz not show market Zarxio before 180 ing that Sandoz unlawfully by 6, 2015, ie., acted days violat- from September March 5. judgment its cross-motion for on the thus district court did not consider that pleadings, argue Sandoz did preemption preemp- issue. We therefore do not address claims, Amgen’s as a defense to state law appeal. tion in 2, And, below, 2015. as indicated we will “publicly-' use injunction pending appeal extend the available information” regarding the refer- through September Amgen’s ap- 2015. ence application.6 its unfair peal from dismissal of its com- 262(k)(2). The BPCIA 12- grants also petition alleged claim based on the viola- year RPS, exclusivity period to during 262(i)(8)(A) tion of is therefore moot. approval which of a applica- may not be made effective. Id. c. 262(k)(7)(A). Neupogen’s 12-year ex- Amgen’s We now turn to conver clusivity period long has expired. Amgen sion claim. To sustain claim for conver therefore fails to show that it has an exclu- law, sion under Amgen California must right sive to possession of approved its (1) demonstrate: ownership right its on Neupogen license to sustain its claim of (2) possession of the property; Sandoz’s conversion under California law. by wrongful conversion disposition act or We therefore affirm the dismissal of (3) property rights; damages. Amgen’s unfair-competition and conversion Petersen, Cal.App.4th Burlesci v. claims interpretation based on our of the (1998). Cal.Rptr.2d Amgen relevant of the BPCIA. wrongfully asserts used Am- gen’s approved license on Neupogen by IV. filing referencing an aBLA Neupogen but Amgen argues that the district court refusing provide Amgen the benefits to 262(l). denying erred prelimi- motion for a is entitled under San- nary injunction based on an incorrect responds doz failed to read- show *14 any ing of “wrongful act” or to establish an ex the BPCIA and an erroneous find- ownership clusive in approved ing interest that Amgen failed to show irreparable Neupogen license on to exclude Sandoz’s harm. responds Amgen’s ap- aBLA. peal sought injunc- is moot because it only tion until the district court decided agree
We with Sandoz Amgen the parties’ judgment cross-motions for on requisite failed to establish the elements to the plea’dings, already which has occurred. a sustain claim of conversion under Cali- that, responds Sandoz also even if not indicated, fornia law. As ex- moot, the district court did not abuse its plicitly contemplates that a subsection in denying discretion applicant might not disclose its aBLA motion and did and manufacturing clearly err in its findings. the stat- factual deadline, utory and that the RPS agree Amgen’s ap- We with Sandoz that may patent sue for infringement, which from peal preliminary the denial of a in- Amgen has done. Amgen thus failed to junction pre-' is moot. In its motion for a “wrongful show a act.” liminary injunction, in filed the district
Moreover,
court after it
judgment
filed its motion for
the BPCIA established
pathway
pleadings, Amgen requested
the abbreviated
for FDA
on the
approval
pre-
biological
of follow-on
products, allowing
liminary injunction
“until the Court de-
Act,
Amgen emphasizes
6.
in its briefs that Sandoz
vators. See Hatch-Waxman
Pub.L. No.
98-417,
(1984);
wrongfully benefitting
Amgen's
from
estab-
98 Stat. 1585
Ruckel
see also
Co.,
safety
efficacy
filgras-
lishment of the
and
shaus v. Monsanto
467 U.S.
may,
(1984).
tim. Be that as it
this is not the first
S.Ct.
the denial of a authorizes a biosimilar use aspect moot. We therefore dismiss that Sponsor’s safety efficacy clinical data Amgen’s appeal. approval
in order to obtain FDA license V. marketing for commercial of the biosimilar product. By acting under subsection granted partial After the district court judgment on the in favor need not obtain its own clini- pleadings of San- Amgen’s pre- doz and denied motion for a product, cal data for its biosimilar and can *15 injunction, liminary Amgen sought an in- FDA by showing receive licensure junction pending appeal, which the district biological product “the is biosimilar to a court denied. then filed emer- 262(k), product,” reference injunc- gency motion this court for an safety, and has the same characteristics of pending appeal. granted tion the mo- We efficacy, purity. and Id. light tion. we have decided what To facilitate identification of and resolu- concerning proper interpretation of issues, any patent tion of the BPCIA re- BPCIA, contested of the we (k) quires the subsection to noti- injunction accordingly pend- order that the fy Sponsor stages at two critical ing appeal through September be extended (k) FDA of the applica- review ,2, 2015. agree
tion. I the court that notice of mandatory, of the FDA issuance license C. CONCLUSION 180-day stay and that this notice starts the reasons, foregoing For the we affirm the marketing, of commercial in accordance Amgen’s competition dismissal of unfair 262(Z)(8)(A). join I with 42 U.S.C. Thus claims, and conversion vacate the district B(V) A, (B)(II), Part Part and Part of the judgment court’s on Sandoz’s counter- BPCIA, interpreting opinion. claims and direct court’s However, of acceptance preliminary injunction notice of the patent while the as- filing application of the subsection is pects are resolved: mandatory, along with the accompany- also 262(Z)(8)(B) Preliminary injunc- ing documentary and information ex- tion.—After receiving the notice under changes set in the BPCIA accordance (A) subparagraph and before such date 262G)(2)(A). with 42 I respect- of the first commercial marketing of fully holding dissent from the court’s such biological product, the reference activity is not because product may sponsor prelimi- seek a Sponsor might infringement file an suit in nary injunction prohibiting the subsec- might which it learn this information applicant from engaging in though discovery. commercial manufacture or sale of such did Sandoz with either of biological product until the court decides statutory requirements. these These delib- patent the issue of validity, enforcement, erate violations of the requirements of the infringement any patent [of identi- forfeit BPCIA Sandoz’ access to the bene- early fied stage or other defined fits of the BPCIA. proceedings.] added). (Emphasis proposed I circumvent this provision and launch its dispute Patent resolution under biosimilar immediately upon its phases. “early BPCIA has two The FDA licensure. phase” starts when the subsection ap- I share the interpretation court’s of this plication accepted by the FDA for re- statutory provision, implements view, and technical and purpose of the BPCIA “to ensure that are exchanged. phase” then The “later litigation surrounding relevant patents will starts FDA approves when the the biosimi- be expeditiously resolved prior to the lar for commercial I marketing. comment launch of the product, biosimilar providing only briefly phase, on this later I certainty applicant, the reference agree, holds, as the court that 42 U.S.C. product manufacturer, public and the at 262(ZX8) requires phase that this of in- large.” Biologies and Biosimilars: Bal- quiry dispute resolution commences ancing Incentives Innovation: Hear- when the notifies ing the Subcommittee On Courts Sponsor, after the FDA license is Before Competition Policy the House granted. My concern is that my col- Judiciary, Committee On the 111th Cong. leagues panel on this do not apply, to the 2009) (statement Eshoo) (July words, Rep. provide” earlier “shall the same added). mandatory (emphasis meaning requires as for GX8XA): give court to effect to the intent of *16 262(Z)(8)(A) Congress. Ingersoll-Rand See Co. v. § Notice commercial of McClendon, 133, 138, 498 111 (k) U.S. S.Ct.
marketing.
appli-
subsection
—The
(1990) (“To
(Emphases The explicitly BPCIA states that after licensure and The provides participants’ before com- for marketing mercial the Sponsor may recognition potential seek a of patent issues at an (2) early stage, requires pursuant paragraph any that as soon as to other (k) accepts the FDA the biosimilar application information that the subsection appli- (k) review, applicant for the subsection cant determines its sole discretion to notify Sponsor, exchanges shall the of appropriate. be patent-related information shall com- added). (Emphases are forth in 42 Details set mence. designated exchange This of information 262(Z)(2). My colleagues hold that com- purposes is fundamental to the BPCIA early pliance with these notice and infor- efficient resolution of issues. How- mandatory. mation is not I ever, my colleagues compliance hold that agree, cannot for: “The word ‘shall’ is by applicant not mandatory, citing ordinarily language of command.”' 262(Z)(9)(C), by which authorizes suit Bozeman, 146, 153, Alabama v. 533 U.S. Sponsor applicant if the pro- does not (2001). S.Ct. L.Ed.2d 188 (2)(A) paragraph vide the information: 262(Z) purpose of subsection is to 262(Z)(9)(C) (k) applica- Subsection patent-related activity, exchange initiate to (k) provided. tion not a subsection —If information, negotia- relevant to facilitate applicant provide fails to the applica- tions, expedite litigation. and to Sub- tion and information under (Z)(2)(A) requires section the subsection (2)(A), product the reference (k) notify applicant Sponsor within (k) sponsor, appli- but not the subsection days accepts after the FDA the subsec- cant, may bring an action under section (k) review, application tion for and to de- 2201 of Title for a declaration of manufacturing process: scribe the infringement, validity, enforceability or 262(Z)(2)(A) applica- Subsection any patent biological that claims the tion later than 20 information. —Not product biological prod- or a use of the days Secretary after the notifies the uct. (k) applicant subsection applica- that the added). (Emphases provision This for de- review, accepted tion has been for claratory action Sponsor is limited provide applicant shall “product” claims, and “use” and does product sponsor copy reference manufacturing process not include patents, application submitted to the Secre- although legislative record makes clear (k), tary under subsection and such oth- that for patents may biosimilars such be pro-
er information that describes the material, highly recognized and were so processes cess or used to manufacture during enactment. states that its the biological product subject that is the patents primarily here at issue relate application. such manufacture. added). (Emphases pro- Sandoz did not agree I cannot excus- information, vide this although it is re- compliance by es appli- quired, provides and the BPCIA for confi- cant, even declaratory when such action is dentiality: (Z)(9)(C) brought. 262(i )(l)(B)(i) Subsection de- Provision of confi- claratory jurisdiction only dential a subsec- information. —When adequate sup- use claims. Absent factual submits an application port complaint (k), manufacturing such claims, declaratory jurisdiction method shall persons described *17 (ii), may in be subject unsupported. Iq- clause to See v. the terms of this Ashcroft bal, 662, 678, paragraph, 1937, confidential 556 access to the U.S. 129 S.Ct. 173 (2009) (“To produced to be L.Ed.2d 868 survive a motion
1365 dismiss, may complaint to must contain suffi provide to product the reference matter, true, accepted cient as to sponsor factual additional information request- plausible ‘state a claim to relief that is on ed on or behalf of the reference ”) (citing Corp. its face.’ Bell Atl. v. Twom sponsor. 544, 570,
bly,
1955,
127
550 U.S.
S.Ct.
167
added).
(Emphases
“[W]hen the same
(2007)).
L.Ed.2d 929
Rule uses
‘may’
‘shall’,
and
both
the nor
mal inference is that each is used in its
The
balance established
the BPCIA
usual sense—the one
being permissive,
act
requires
statutorily
identified disclo-
mandatory.”
the other
Yung
Anderson v.
threshold,
sures at the
both
order
kau,
482, 485,
329
428,
U.S.
67 S.Ct.
91
expedite litigation.
avert and to
This
(1947).
L.Ed. 436
purpose pervades
legislative record,
persons
as interested
pro-
debated which
States
Siegel
United
ex rel.
v. Tho
mandatory,
visions would be
which man,
and
353, 359-60, 15
156
378,
U.S.
S.Ct.
See,
permissive.
e.g., Biologies and Bios-
(1895),
L.Ed. 450
the Court
that
stated
Balancing
imilars:
Incentives
Inno-
Congress
when
“special
uses the
contradis
Hearing
vation:
the Subcommittee
tinction” of
“may,”
“shall” and
“liberty
no
Before
on
Competition Policy
Courts and
can be taken
plain
with the
words of the
of
House
Judiciary,
Committee on the
111th statute.” As reiterated in
v.
Sebelius
—
(2009)
Cong, passim
(debating
provi-
Cloer,
U.S.-,
1886, 1894,
133 S.Ct.
1548,
sions
H.R.
provided
which
(2013),
The BPCIA as enacted leaves no uncer-
ute
compromises.
and its
The BPCIA re
tainty
which of its
quires judicial
are
implementation that con
mandatory and which
permissive.
are
For
design
forms to
“the
as a
statute
example, immediately
pro-
after the
object
“shall”
whole and
policy.”
to its
Cran
(l )(2)(A), ante,
vision of
States,
152, 158,
subsec-
don v.
United
U.S.
(i)(2)(B)
(1990).
states that
a subsection
110 S.Ct.
Subsection
in
Departure
from the
obli-
a
court when
district
gation, to achieve purposes
legis-
that the
comply
fails to
with subsection
curtail,
lation intended to
should not be
(Z),
ratify non-compliance.
but
does not
judicially ratified. See Cannon v. Univ.
party may
While “a
any provision,
waive
677, 690,
Chicago, 441 U.S.
99 S.Ct.
statute,
either of a contract or of
intend
1946,
(1979)
(Z)’s in I may be read isolation. provisions words, meaning the In other to understand statutory “It is a fundamental canon of 262(Z), §in one must any provision of one that the of a statute construction words it interrelates with the recognize first how in must be read their context and with a (Z) the and the rest of rest of place statutory view to their in the overall I understanding, this BPCIA. Based on Dep’t scheme.” v. Mich. Trea Davis fail- agree applicant’s that a subsection 1500, 103 809, sury, 489 U.S. S.Ct. information described in supply ure to the (1989). end, that L.Ed.2d 891 To the Su )(2) (Z sponsor the reference preme “statutory Court has instructed that (RPS) BPCIA, is not a violation of the language cannot be construed in a vacu (Z)(9) itself, in the BPCIA because Id.; States, um.” see also Yates v. United (e)(2)(C)(ii), the the re- RPS — U.S.-, 1074, 1081-82,191 135 S.Ct. course of action in such circum- medial (2015) (instructing L.Ed.2d 64 courts to Contrary majority, howev- stances. by text interpret reference to er, interpretation I view this context-based specific “the context in which that lan equal force to the inter- applying as with used, guage is and the broader context of (Z)(8). (Z)(8) reading in pretation of When (quotation as a the statute whole.” marks (Z) whole, it the context of subsection as a omitted)). B.I, majority In Part the prop (Z)(8) simply part clear that becomes erly recognizes that “the ‘shall’ parcel integrated litigation of the man- (Z)(2)(A) paragraph in cannot be read in (Z)(2)- in agement process contemplated Majority Op. at ma isolation.” 1355. The (Z)(7). Moreover, just all the “shall” as jority carefully larger examines the statu (Z)(3)-(Z)(7) in are obligations set forth (Z) tory context —subsection contingent applicant’s perform- on the (e)(2)(C)(ii) correctly concludes —and (Z)(2), step first in this ance of the “shall” “ (Z)(2)(A) in does that ‘shall’ obligation is also true of the “shall” notice ” Majority Op. at 1355. mean ‘must.’ (Z)(8). when, means is What this as majority recognizes, nothing in the As the here, the fails grants right a procedural RPS (Z)(S)-(Z)(8) (Z)(2), provisions cease (k) applicant’s compliance compel situation, In recog- to matter. such a (Z)(2)(Á). B.II, however, Part by majority opinion, nized the RPS’s majority holds that the word “shall” (Z)(9) clearly course of action is defined in (Z)(8)(A) meaning carries a different than 271(e)(2)(C)(ii): right the unfettered (Z)(2)(A). it does in To reach that incon infringement immediately pursue patent result, majority takes the view sistent of the tim- litigation unconstrained (Z)(8)(A) vacuum, in a that should be read ing on the number of controls limits apart from the context and framework of patents may it assert that would result (Z), including language (Z)(2)-(Z)(8) process. from the Based on (Z)(8)(B). respectfully disagree. I (Z)(8)(A) understanding, I do ‘not view provision” provides, as a “standalone A 180-day injunction implicitly, 262(Z) “Patents,” Entitled twelve-year statutory beyond express litiga- thing: patent one exclusivity majority BPCIA concerns period. Because (Z)(8) differently, Specifically, specifies tion. an elaborate opinion interprets giving exchange process tegrated between the litigation management system. (k) applicant and the up RPS that leads These also demonstrate the expected patent infringement suit that Congress anticipated the situation before during comes the pendency a subsection here, us in which the refuses *20 (k) application. process begins This in engage in litigation management (l )(2)(A) (k) with the requirement that the (k) process. Rather than forcing the ap- applicant disclose to the biosimilar plicant, by court order or some other (aBLA) application and manufacturing means, (l) in engage the subsection process Compliance information. with (k) process, conditioning or the applica- (Í )(2)(A) triggers subsection a cascade of (k) approval tion’s on applicant the fulfill- contemplated by (l), events subsection ing requirements the set forth in subsec- step with each successive reliant on the (Z), tion Congress instead the authorized performance of one or preceding more RPS in immediately this situation to file an steps. This process intricate includes: 262(Z)(9) infringement action. See and the exchange patent of par- lists that each 271(e)(2)(C)(ii). ty believes the RPS has reasonable (Z)(8), Focusing on Congress accounted (k) grounds against to assert appli- the possibility the (perhaps strong likeli- cant, exchange as well as the respective of hood) (k) of a situation in which appli- the infringement, validity, and enforceability cant has FDA approval received is on and (§ 262(l positions )(3)); process by a the verge of commercially marketing its parties may the limit patents the in in- biosimilar product but the RPS was unable (§ 262(£ fringement )(4)-(5)); lawsuit a pat- (Z)(3) to assert all of its patents listed lawsuit, infringement ent filed (k) against applicant in the limited RPS, (l )(4) patents limited to the listed in (Z)(6) patent litigation. Entitled “Notice (l)(5) (§ 262(i)(6)); or a procedure marketing commercial preliminary and updating the RPS’s previously created injunction,” (Z)(8), in part, relevant is set (l )(3) patent list with newly issued or li- forth below: (§ 262(Z)(7)); patents censed require- 8) Notice of marketing commercial ment that the applicant 180- preliminary injunction day notice ahead marketing commercial (A) marketing Notice commercial thereby giving the RPS time to seek a (l )(3) preliminary injunction pro- on shall any listed (Z)(6) vide patents not notice to the product asserted in the reference limited (§ patent infringement sponsor not later than 262(Z)(8)); days suit before authorization for the date of the first RPS to file an commercial market- immediate declaratory judgment ing of the biological product action for licensed patent (k). infringement if under subsection fails to (B) its specified obli- Preliminary injunction gations (0(2), (0(3), (0(5), recited in receiving After subpar- the notice under (0(6), (0(7), (0(8) (§ 262(0(9)(B)-(C)). or (A) agraph and before such date of the (l) Importantly, subsection does not relate first commercial marketing of bio- such (for to the FDA approval process that see logical product, product reference (k)). Nor approval pro- is the sponsor may preliminary injunc- seek a contingent any cess on related events tion prohibiting the appli- possible patent dispute occurring in paral- cant engaging from in the commercial approval lel with that process. manufacture or sale of such biological
By enacting in subsection until the court decides issue (,l), Congress comprehensive, created a in- patent enforcement, validity, and in- 3, 2015), fringement respect available http://www.cafc. at that is— uscourts.gov/oral-argument-recordings/15-
(i) provided by included in the list 1499/all. product sponsor para- reference under (Z)(8) Given the purpose of and its ex- (S)(A) or in graph provided by the list press assumption that parties have (k) applicant the subsection (Z already performed )(3), the steps in (3)(B); paragraph (Z)(4)-(Z)(5), the most logical conclusion (ii) included, applicable, on— (Z)(8) when reading in context is that (I) (Z)(8)’s vitality predicated patents per- the list of on the described (4); formance of preceding steps subsec- (Z)’s litigation management, process. (II) patents the lists of described *21 Without first in engaging proce- these (5)(B). (Z)(8) dures, meaning. lacks Similarly, for (Z)(8)(A) (k) requires Subsection ap- the example, the requirement in plicant to give days’ the RPS at least 180 (Z)(3) for parties the to exchange detailed begin commercially notice of its intent to positions on infringement and validity for marketing the product. biosimilar One of (Z)(3) patents the listed under no longer key is, questions appeal the in this “Why (k) applies if the applicant fails to comply Congress would insert a 180-day commer- (Z)(2). (Z)(8)’s Paragraph with interdepen- cial marketing provision notice in a subsec- dency preceding on the steps in subsection organizing tion devoted to patent litiga- (Z) (Z)(7)’s is further reinforced cross- (Z)(8)(B) tion?” Paragraph provides the )(8). (Z (Z)(7), reference to Paragraph above, answer. As process mentioned the process sets forth a for the RPS to (Z)(4)-(5) in can in restricting result the (Z)(3) update patent its any newly list with (Z)(6) infringement action to a subset of issued patents, or licensed any states that (Z)(3). patents the RPS’s identified in patents subject such “shall be para- to (k) Rather permit applicant than (8).” 262(Z)(7)(B). graph 42U.S.C. The launch its biosimilar while the (Z) interwoven of structure indi- RPS is blocked from enforcing some of its Congress cates that procedures viewed the (Z)(8)(B) patent rights, subsection address- (Z)(8) of as inseverable from preceding that problem by authorizing es the RPS to (Z). steps in preliminary injunction seek a prohibiting hand, commercial majority, manufacture or sale based on The on the other views (Z)(8)(A) patents that were excluded from as a provision standalone notice (Z)(6) (Z Thus, (k) )(8), action. entirety of that is not excused applicant when the (Z)(8)(A)’s including (Z)(2).1 provision, Yet, notice' comply fails to no one (Z)(3) serves to ensure that an disputes RPS will be able requirements that (Z)(7) patents assert all relevant through before the certainly are in excused applicant launches its product. (Z)(8)(A), biosimilar such a I recognize case. that (Z)(3) (Z Amgen understanding )(7), confirmed this through unlike is not express- (Z)(8)’s purpose at oral argument. ly Oral steps. conditioned on the earlier I can- Argument 20:10-20:05, not, (Z)(8)(A) Amgen, however, at Inc. v. in complete read Inc., (Fed.Cir. Sandoz (Z)(8)(B), No. 2015-1499 June isolation from which does refer- 39:30-40:30, majority 1. The terpretation. Argument states that Sandoz "concedes” Oral at (Z)(8)(A) Inc., provision, that is a standalone notice Inc. v. No. 2015-1499 citing (Fed.Cir. 3, 2015), argument. to the oral I http:// understand June available at (Z)(8)(A) position accepting Sandoz's www.cafc.uscourts.gov/oral-argument- provision possible as a recordings/15-1499/all. standalone is one in- ence, (Z)(9)(B) predicated performance and is on the provision in Con- confirms (i)(3) (Z )(5). )(4)(Z (Z)(8) of, Thus, and gress any deemed additional remedy be not serve as a provision; does standalone unnecessary. Congress created the fall- to, part parcel it is contingent (Z)(9)(C) just back for these (0(2)- upon, preceding steps in the An circumstances. RPS does not need (Z)(8) litigation management regime. The (Z)(9)(B) (Z)(9)(C) in remedy because (0 persuasive reading most of subsection 271(e)(2)(C)(ii) already grant as a whole Congress provided is that two file, right immediately, an unrestricted (1) paths to patent resolve disputes: infringement action when the (Z)(2)(Z)(8); intricate expressed route (Z)(2). fails to At (2) immediate, more flexible route this point, possesses the RPS the statuto- (Z provided )(9), should the ry right preliminary injunction to seek a any falter on obligations recited patents of its that “could be identi- (Z)(2)-(Z)(8). [262](Z)(3)(A)(i).” pursuant fied to section 271(e)(2)(C)(ii). It therefore B would have been superfluous Congress majority is also concerned with the the RPS with authorization to express absence of an consequence for additional, initiate an infringe- redundant (Z)(8)(A) noncompliance with in situations (Z)(9)(B)2 *22 ment action under if the (k) in which applicant the comply does not (cid:127) applicant later comply does not with (Z)(2). agree with I majority with the (Z)(8)(A). only Not compliance is with (Z)(9)(B) remedy the in provide does (Z)(8)(A) unnecessary under such a cir- relief in this scenario the because RPS’s cumstance, but remedy no additional is pursue to right patent litigation additional Thus, needed. after Sandoz failed per- to (Z)(9)(B) stage at this is contingent (Z)(2) form the requirement, the only rele- using on patents the that have been “in- (Z) provision vant in subsection became in cluded the list in paragraph described (Z)(9)(C) 271(e)(2)(C)(ii). a(k) (3)(A).” applicant If out never carries (Í )(2), (Z)(3) the RPS will never create C patent list. Such a failure to adhere to (Z)(2) would defeat opportunity the RPS’s The practical consequence majori- of the (Z)(9)(B) (k) to invoke if applicant re- ty’s (Z)(8)(A) is that interpretation pro- (Z)(8)(A)’s comply fuses to with notice pro- vides an inherent right to an automatic vision. 180-day injunction. majority provides The
Contrary conclusion, to the no majority’s basis in the language sup- to however, the absence of port such remedial injunction.3 this automatic This relief (Z)(9)(B) examining 2. It is worth closely unquestionably part for it are litigation of man- (Z)(8) Congress how shows agement regime, understood the defining scope of provision part notice to be one of the entire any infringement patents action listed (l) litigation management process. (Z)(3), (Z Congress )(8)(A) in evidenced that is (Z)(9)(B), a(k) applicant Under if fails to com- provision apart not a that stands from the any ply obligations with others, of its recited in part integrated but is instead of an (3)(B)(ii), (5), "paragraph paragraph para- regime part serving pur- each with a common (6)(C)(i), (7), graph paragraph pose. (8)(A),” may immediately the RPS bring an infringement (Z)(8)(A)'s action on patent the RPS 3. majority believes that notice (Z)(3). 262(Z)(9)(B) (em- role, listed in provision plays necessary when the added). (Z)(8)(A) phasis By grouping (Z)(2), applicant with comply pro- fails to with (Z)(3), (Z)(5), (Z)(6), (Z)(7), all of adequate which vide the notice of the aBLA thirty-month stay Nothing of mer. in the statute analogous supports is Act, which above, the Hatch-Waxman peculiar explained outcome. As in stay during for an automatic which (Z)(8) view, my reading the better is approve FDA cannot the ANDA unless the (Z)(3)-(Z)(7) apply, just that it does not suit is resolved or the patent infringement apply, do not when the fails See expires. (Z)(2). comply with 355(j)(5)(B)(iii). Congress If intended to 180-day stay create a automatic it under- II It have stood how to do so. could tied (Z)(8)(A) sure, To be integral part is an approval provision. FDA the notice procedures managing patent liti- Yet, ap- FDA Congress declined link gation party that arises as a result of a single in subsection proval (Z)(8)(A) Nevertheless, filing an aBLA. (Z). bottom, majority’s At view is in (Z)’s simply piece one of subsection inte- (Z)(8) purpose with the defined tension grated patent dispute puzzle that ceases to providing while the RPS with an atextual matter, just all pieces pre- like the other 180-day exclusivity windfall. (Z)(8) matter, ceding cease to once the Notably, nothing majority opinion in the (Z)(2). fails to I do suggests injunction this automatic support statutory language not find in the remedy would be available in cases where 180-day injunction. to create an automatic (Z)(2)(A) by applicant complied (Z)(2) Just as “shall” does not mean RPS, providing its aBLA to the but later “must,” the same is true for the “shall” (Z)(8)(A). In failed to notice under (Z)(8)(A), provision in once is read in fact, majority’s an un- opinion creates (Z). entirety context with the of subsection language comfortable result (Z)(8)(A) majority As the opinion recognizes, this interpreted two different riddle, case ways, requires on us to “unravel the applicant’s based actions. *23 case, present mystery, In a situation like the comprehend solve the cannot refuse to the 180- enigma” Majority Op. that is the BPCIA. notice, days’ majority’s because under the judicial at 1351 n. 1. To fulfill our obli- (Z)(8)(A) reading, authorizes an automatic is,” gation say “to what the must law we injunction. day entitlement to a 180 But if imperfect choose from a series of choices. a(k) applicant complies with all re- view, my In interpreta- the most coherent (Z)(2)-(Z)(7), quirements specified in then (Z)(8)(A) tion of that is consistent with (k) applicant may still refuse to rest of the is the one I have de- 180-day provision. with the notice In this reasons, scribed above. For these I re- scenario, there would be no automatic in- spectfully majority’s dissent from the hold- (Z)(9)(B) junction provides because (Z)(8) ing is a standalone immediately RPS with the authorization to 180-day injunc- right with inherent (Z)(3). any patent file suit on it listed under I Accordingly, tion. would dissolve the (Z)(8)(A) Thus, scenario, in one injunction pending appeal. 180-day injunction, but in the second sce- nario it does not. the result in the While lan- plain
latter scenario comes from the statute,
guage of the not so the for- meaningful opportunity injunction right cir- therefore a to assert it with an in the limited view, a(k) patent rights. my majority cumstance when fails to com- (l )(8)(A) (Z)(2). by empowering ply reads too much into