Abraxis Bioscience, Inc. v. NAVINTA LLC

United States Court of Appeals
for the Federal Circuit
__________________________

ABRAXIS BIOSCIENCE, INC.,
Plaintiff-Appellee,

v.
NAVINTA LLC,
Defendant-Appellant.
__________________________

2009-1539
__________________________

Appeal from the United States District Court for the
District of New Jersey in Case No. 07-CV-1251, Judge
Joel A. Pisano.
__________________________

Decided: November 9, 2010
__________________________

RICHARD DE BODO, Hogan & Hartson, LLP, of Los An-
geles, California argued for plaintiff-appellee. With him
on the brief were AMY M. GALLEGOS; and SIEGMUND Y.
GUTMAN, of Washington, DC.

MEREDITH MARTIN ADDY, Brinks Hofer Gison & Lione,
of Chicago, Illinois, argued for defendant-appellant. With
her on the brief were MARK H. REMUS, LAURA A.
LYDIGSEN, and LUKE A. PARSONS.
__________________________
ABRAXIS BIOSCIENCE v. NAVINTA LLC 2

Before NEWMAN, GAJARSA, and LINN, Circuit Judges.
Opinion for the court filed by Circuit Judge GAJARSA.
Dissenting opinion filed by Circuit Judge NEWMAN.

GAJARSA, Circuit Judge.

Appellant Navinta LLC appeals from a final judgment
of the United States District Court for the District of New
Jersey finding, inter alia, that Navinta’s Abbreviated New
Drug Application (“ANDA”) product would directly in-
fringe claims 1-3 of U.S. Patent No. 4,870,086 (the “’086
patent”) and contribute to and induce infringement of
claim 6 of the ’086 patent. In addition, the district court
found that Navinta’s ANDA product would contribute to
and induce infringement of claims 1 and 9 of U.S. Patent
No. 5,670,524 (the “’524 patent”) and claim 1 of U.S.
Patent No. 5,834,489 (the “’489 patent”), both disclosing
methods of using low concentrations of ropivacaine hydro-
chloride to treat pain. See Abraxis Bioscience, Inc. v.
Navinta, LLC, 640 F. Supp. 2d 553, 569-92 (D.N.J. 2009).
Because the district court erred in failing to dismiss
Abraxis Bioscience, Inc.’s (“Abraxis’s”) action for lack of
standing, we vacate the judgment below.

BACKGROUND

Abraxis markets the drug Naropin® as a local or re-
gional anesthetic indicated for use in surgery and for
acute pain management, such as pain management
during labor and delivery. Abraxis sells Naropin® in four
concentrations: 1.0%, 0.75%, 0.5%, and 0.2%. The 0.2%
concentration is the only FDA-approved strength for use
in labor and delivery. The ’086 patent discloses the sole
active ingredient in Abraxis’s Naropin® drug product,
3 ABRAXIS BIOSCIENCE v. NAVINTA LLC

ropivacaine hydrochloride monohydrate (“ropivacaine”). 1
The ’489 patent claims the use of ropivacaine for treating
pain at concentrations less than 0.5% administered
epidurally. The ’524 patent discloses the use of ropiva-
caine for treating pain at concentrations less than 0.25%.
Asserted claim 9 of the ’524 patent is a composition claim
that covers “a pharmaceutical salt of ropivacaine at a
concentration [. . .] lower than 0.25% by weight.”

The sole inventor of the ’086 patent, Rune Sandberg,
assigned his rights in the ’086 patent to Astra Lakemedel
Aktieboag (“Astra L”) on October 16, 1986. Arne Torsten
Eek, as sole inventor, assigned his rights in the ’524 and
’489 patents to AB Astra on June 19, 1994. As a result of
a merger between AB Astra and AstraZeneca AB (“AZ-
AB”), AB Astra assigned the ’524 and ’489 patents to AZ-
AB.

On April 26, 2006, Abraxis entered into an Asset Pur-
chase Agreement (“APA”) with AstraZeneca (“AZ-UK”).
The APA provides that AZ-UK “shall or shall cause one or
more of its Affiliates to, Transfer to the Purchaser, and
the Purchaser shall purchase and accept from the Seller
or its Affiliates, as applicable, all of the right, title and
interests of the Seller and its Affiliates in” the asserted
patents. Following the execution of the APA, AZ-UK and
Abraxis executed a written Intellectual Property Assign-
ment Agreement (“IP Assignment Agreement”) on June
28, 2006 purportedly assigning the asserted patents to
Abraxis. The “Further Assurances” provision of the IP
Assignment Agreement states, in pertinent part, that
“Seller will . . . execute . . . any and all further . . . as-

1 Because the ’086 patent expired on September 24,
2010, Navinta chose not to appeal the district court’s
infringement findings regarding that patent.
ABRAXIS BIOSCIENCE v. NAVINTA LLC 4

signments . . . as necessary to . . . vest in Buyer any of the
Transferred Intellectual Property.” There was a break in
the chain of title, however, because the asserted patents
were still owned by Astra L and AZ-AB, neither of which
had assigned the rights in the asserted patents to AZ-UK.
See Abraxis Bioscience, Inc. v. Navinta LLC, No. 07-1251,
2009 WL 904043, at *2 (D.N.J. Mar. 30, 2009) (order
denying motion to dismiss for lack of subject matter
jurisdiction).

On November 13, 2006, Navinta filed an ANDA for a
generic version of Naropin®. Along with the ANDA,
Navinta filed a patent certification pursuant to 21 U.S.C.
§ 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”),
which alleged that none of the claims of the ’086 patent
would be infringed by the manufacture, use, or sale of
Navinta’s generic ropivacaine hydrochloride product. At
the time of the Paragraph IV Certification, the only
patent listed by Astra in the Food and Drug Administra-
tion’s (“FDA’s”) Approved Drug Products with Therapeu-
tic Equivalence Evaluations (the “Orange Book”) for
Naropin® was the ’086 composition patent. Although the
’524 and ’489 patents issued ten years earlier, on Septem-
ber 23, 1997, and November 10, 1998, respectively, Astra
elected not to list those patents in the Orange Book.

On March 15, 2007, Abraxis filed an action against
Navinta under the Hatch-Waxman Act, triggering the
thirty-month statutory stay on approval of Navinta’s
ANDA. See Drug Price Competition and Patent Term
Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585
(1984) (codified at 21 U.S.C. §§ 355, 360cc; 35 U.S.C.
§§ 156, 271). The complaint alleged that Navinta’s ANDA
with its Paragraph IV Certification artificially infringes
the listed ’086 patent under 35 U.S.C. § 271(e)(2). See Eli
Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990)
5 ABRAXIS BIOSCIENCE v. NAVINTA LLC

(Section 271(e)(2) creates “a highly artificial act of in-
fringement that consists of submitting an ANDA . . .
containing a [Paragraph IV Certification] that is in error
as to whether commercial, manufacture, use, or sale of
the new drug (none of which, of course, has actually
occurred) violates the relevant patent.”); Glaxo Group Ltd.
v. Apotex, Inc., 376 F.3d 1339, 1351 (Fed. Cir. 2004)
(“[Section] 271(e)(2) is designed to create an artificial act
of infringement for purposes of establishing jurisdiction in
the federal courts . . . .”). Also, to avoid the listing re-
quirements under § 271(e)(2) with regards to the ’524 and
’489 method patents, the complaint erroneously alleged
indirect infringement of the method patents under 35
U.S.C. § 271(b)-(c). Abraxis could not make any such
allegation, however, because Navinta has never sold or
offered to sell ropivacaine hydrochloride products and an
act of actual commercial infringement is required for
induced or contributory infringement. See 35 U.S.C.
§ 271(b)-(c).

On the same day this action was filed, Astra L and
AZ-AB each executed nearly identical assignments of
their respective patents to AZ-UK. The assignments
reference the April 26, 2006 APA and provide that the
assignments were executed to allow AZ-UK to “further
convey” the patents to Abraxis. On November 12, 2007,
almost eight months after filing suit, AZ-UK, in a sepa-
rate document entitled “Intellectual Property Assignment
Agreement,” “confirm[ed] the sale, assignment, convey-
ance and transfer to Abraxis, for Abraxis’ sole and exclu-
sive use and enjoyment, of all of Astra Zeneca UK’s right,
title, and interest, in and to” the asserted patents. The
agreement further stated that AZ-UK and Abraxis “con-
sider and have considered Abraxis by way of assignment
and pursuant to the [APA], to own all rights, title, and
ABRAXIS BIOSCIENCE v. NAVINTA LLC 6

interest” to the asserted patents, including the right to
sue for patent infringement no later than June 28, 2006.

Awaiting the expiration of the ’086 patent on the
composition, Navinta submitted a “Section viii Statement”
along with a proposed labeling amendment seeking a use
for its generic ropivacaine hydrochloride product not
covered by the ’524 and ’489 method patents. As a gen-
eral rule, the label associated with the generic version of a
drug must be exactly the same as the label of the branded
drug approved in the original New Drug Application
(“NDA”). 21 U.S.C. § 355(j)(2)(A)(v), (j)(4)(G); 21 C.F.R.
§ 14.94(a)(8)(iv). One exception to the rule under the
Hatch-Waxman Act is if a generic manufacturer makes a
“Section viii Statement,” 21 U.S.C. § 355(j)(2)(A)(viii),
seeking FDA approval for a use not covered by a method
patent listed in the Orange Book, along with a proposed
label that “carves out” the patented method. Navinta
submitted the Section viii Statement to avoid Abraxis’s
infringement contentions regarding the unlisted method
patents. Specifically, Navinta’s labeling amendment
sought to delete the indication for acute pain manage-
ment and maintained only the indication for surgical
anesthesia with a recommended concentration of greater
than 0.5%. It is uncontested that the use of ropivacaine
for surgical anesthesia at concentrations of at least 0.5%
does not infringe the ’524 and ’489 patents because the
claims of those patents are limited to methods of treating
pain and also require concentrations less than 0.25% and
0.5%, respectively.

Initially, the FDA rejected Navinta’s labeling amend-
ment because the ’524 and ’489 patents were not listed in
the Orange Book at the time the complaint was filed, and
thus, there was no basis for the Navinta package insert to
depart from the approved NDA package insert for
7 ABRAXIS BIOSCIENCE v. NAVINTA LLC

Naropin®. Then, in late 2007, Abraxis finally listed the
’524 and ’489 patents in the Orange Book. In response,
Navinta resubmitted its Section viii Statement and the
FDA allowed the labeling amendment after Navinta made
significant changes to its package insert to “carve out” all
statements that might reasonably relate to the uses
claimed in the ’524 and ’489 patents.

Subsequently, Navinta filed a motion to dismiss the
infringement counts with respect to the ’524 and ’489
patents for lack of subject matter jurisdiction because the
counts alleged speculative future infringement of the
unlisted method patents under § 271(b)-(c). In response,
Abraxis moved to amend the complaint to add a claim of
infringement of the ’524 and ’489 patents under
§ 271(e)(2). Navinta argued that the district court also
lacked jurisdiction under § 271(e)(2) because the ’524 and
’489 method patents were not listed in the Orange Book
and, therefore, Navinta could not make a Paragraph IV
Certification as to those patents. The district court
granted Abraxis’s motion to amend its complaint to allege
that Navinta infringed the ’524 and ’489 patents pursuant
to § 271(e)(2). See Abraxis Bioscience, Inc. v. Navinta
LLC, No. 07-1251 (D.N.J. Oct. 9, 2007) (order granting
motion to amend complaint). The district court denied
Navinta’s Rule 12(b)(1) motion to dismiss for lack of
subject matter jurisdiction and exercised jurisdiction over
the method patents based on § 271(e)(2) and the Declara-
tory Judgment Act. Id. (order denying motion to dismiss
for lack of subject matter jurisdiction under 35 U.S.C.
§ 271(e)(2)).

Navinta also filed a second Rule 12(b)(1) motion to
dismiss for lack of standing alleging that Abraxis did not
own the asserted patents at the time the complaint was
filed. See Abraxis Bioscience, 2009 WL 904043, at *1.
ABRAXIS BIOSCIENCE v. NAVINTA LLC 8

While acknowledging that there was a break in the chain
of title to the patents, the district court held that the
“intent” of the various Astra entities was sufficient to
imply a nunc pro tunc assignment based on the relation-
ship between the corporate entities. Id. at *4. The dis-
trict court found that:

[a]though Defendant is correct that Astra L and
AZ-AB were not parties to the APA, neither were
they complete strangers to that transaction. They
were, respectively, a corporate affiliate and sub-
sidiary of AZ-UK, and each of the March 2007
agreements expressly recognize that they are “af-
filiate[s] of the Transferee.” So while Astra L and
AZ-AB may not have been bound by the terms of
the APA, given their relationship to the transac-
tion between Abraxis and AZ-UK, the Court finds
that their express recognition of the APA in the
March 2007 assignments is significant—it evinces
their intent that their transfer of the patents to
AZ-UK be in accordance with the terms of that
agreement, i.e., retroactive to June 28, 2006.

Id. The district court then gave the March 15, 2007,
assignments nunc pro tunc effect based on the June 28,
2006 IP Assignment Agreement between AZ-UK and
Abraxis in order to cure the defect in ownership as of the
date of filing of Abraxis’s complaint. Id.

After a seven-day bench trial, the court issued its de-
cision on August 3, 2009, two days before the expiration of
the thirty-month stay on Navinta’s ANDA. Abraxis, 640
F. Supp. 2d at 558. The district court found direct and
indirect infringement of the ’086 patent and indirect
infringement of the ’524 and ’489 patents. Id. at 569-92.
Pursuant to its findings on inducement and contributory
9 ABRAXIS BIOSCIENCE v. NAVINTA LLC

infringement, the district court ordered that the effective
date of approval of Navinta’s ANDA product be no earlier
than September 14, 2014, the expiration date of the ’524
and ’489 patents.

Navinta timely appealed to this court. We have juris-
diction under 28 U.S.C. § 1295(a)(1).

DISCUSSION

Standing is a constitutional requirement pursuant to
Article III and it is a threshold jurisdictional issue. Lujan
v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). We
review standing, a question of law, de novo. See Penning-
ton Seed, Inc. v. Produce Exch. No. 299, 457 F.3d 1334,
1338 (Fed. Cir. 2006); Enzo Apa & Son, Inc. v. Geapag
A.G., 134 F.3d 1090, 1092 (Fed. Cir. 1998). “To the extent
[any] jurisdictional facts are in dispute, however, the
findings of fact are reviewed for clear error.” Canadian
Lumber Trade Alliance v. United States, 517 F.3d 1319,
1330-31 (Fed. Cir. 2008); see SanDisk Corp. v. STMicro-
electronics, Inc., 480 F.3d 1372, 1377 (Fed. Cir. 2007);
Plumtree Software, Inc. v. Datamize, LLC, 473 F.3d 1152,
1158 (Fed. Cir. 2006).

We have stated that “[a]lthough state law governs the
interpretation of contracts generally . . . the question of
whether a patent assignment clause creates an automatic
assignment or merely an obligation to assign is intimately
bound up with the question of standing in patent cases.
We have accordingly treated it as a matter of federal law.”
DDB Techs., L.L.C. v. MLB Advanced Media, L.P., 517
F.3d 1284, 1290 (Fed. Cir. 2008); see Speedplay, Inc. v.
Bebop, Inc., 211 F.3d 1245, 1253 (Fed. Cir. 2000) (stating
that while the ownership of patent rights is typically a
question exclusively for state courts, the question of
ABRAXIS BIOSCIENCE v. NAVINTA LLC 10

whether contractual language effects a present assign-
ment of patent rights, or an agreement to assign rights in
the future, is resolved by Federal Circuit law).

A court may exercise jurisdiction only if a plaintiff has
standing to sue on the date it files suit. Keene Corp. v.
United States, 508 U.S. 200, 207 (1993) (There is a “long-
standing principle that the ‘jurisdiction of the Court
depends upon the state of things at the time of the action
brought.’”) (internal citations omitted); Minneapolis & St.
Louis R.R. v. Peoria & Perkin Union Ry. Co., 270 U.S.
580, 586 (1926) (“The jurisdiction of the lower court
depends upon the state of things existing at the time the
suit was brought.”). Based upon this Supreme Court
jurisprudence, we have held that in a patent infringement
action, “the plaintiff must demonstrate that it held en-
forceable title to the patent at the inception of the law-
suit” to assert standing. Paradise Creations, Inc. v. UV
Sales, Inc., 315 F.3d 1304, 1309-310 (Fed. Cir. 2003); see
also 35 U.S.C. §§ 100(d), 281 (A “patentee” is entitled to
bring a “civil action for infringement of his patent,” and
the patentee includes the “successors in title to the pat-
entee.”). Thus, “if the original plaintiff lacked Article III
initial standing, the suit must be dismissed, and the
jurisdictional defect cannot be cured” after the inception
of the lawsuit. Schreiber Foods, Inc. v. Beatrice Cheese,
Inc., 402 F.3d 1198, 1203 (Fed. Cir. 2005); Lans v. Digital
Equip. Corp., 252 F.3d 1320, 1328 (Fed. Cir. 2001) (af-
firming dismissal of complaint and denial of motion to
amend pleadings to substitute assignee as plaintiff when
plaintiff-inventor assigned the patent prior to filing the
action).

Whether an assignment of patent rights in an agree-
ment is automatic or merely a promise to assign depends
on the contractual language itself. DDB Techs., 517 F.3d
11 ABRAXIS BIOSCIENCE v. NAVINTA LLC

at 1290. If the contract expressly conveys rights in future
inventions, no further act is required once an invention
comes into being, and the transfer of title occurs by opera-
tion of law. Id. For example, in Speedplay, an employ-
ment agreement providing that all inventions made
during the term of employment “shall belong” to Speed-
play and that the employee “hereby conveys, transfers
and assigns . . . all right, title and interest in and to
Inventions” operated as an automatic assignment once
the invention was created. 211 F.3d at 1253 (holding that
a party had standing to assert its patent because the
assignment agreement in effect granted it all substantial
rights in the patent); see DDB Techs., 517 F.3d at 1290
(holding that an employment agreement reciting that the
employee “agrees to and does hereby grant and assign” all
rights in future inventions was an automatic assignment
to employer by operation of law with no further act re-
quired on the part of the employer).

In contrast, contracts that obligate the owner to grant
rights in the future do not vest legal title to the patents in
the assignee. Bd. of Trs. of Leland Stanford Junior Univ.
v. Roche Molecular Sys., Inc., 583 F.3d 832, 841-42 (Fed.
Cir. 2009) (cert. granted Nov. 1, 2010) (finding that “agree
to assign” contract language in a university researcher’s
patent assignment agreement with the university only
provided a promise to assign the invention in the future,
and, therefore, was trumped by “will assign and do hereby
assign” contract language in a later agreement the re-
searcher signed with a company regarding any invention
made while collaborating with the company). Thus,
contract language stating that a party “agrees to assign”
reflects a mere promise to assign rights in the future, not
an immediate transfer of expectant interests. See IpVen-
ture, Inc. v. Prostar Computer, Inc., 503 F.3d 1324, 1327
(Fed. Cir. 2007) (interpreting “agree to assign” as “an
ABRAXIS BIOSCIENCE v. NAVINTA LLC 12

agreement to assign,” requiring a subsequent written
instrument); Arachnid, Inc. v. Merit Indus., Inc., 939 F.2d
1574, 1580-81 (Fed. Cir. 1991) (holding that “will be
assigned” does not create “a present assignment of an
expectant interest”).

Here, the contractual language of the APA indicates
that the actual transfer of the asserted patents was to
occur in the future. The APA states that AZ-UK “shall, or
shall cause one or more of its Affiliates to, Transfer to the
Purchaser, and the Purchaser shall purchase and accept
from the Seller or its Affiliates, as applicable all of the
right, title and interests of the Seller and its Affiliates in”
the asserted patents. The actual transfer of the patents
was to occur by means of a separate “IP Assignment
Agreement” in the form to be mutually agreed upon by
the parties prior to a July 31, 2006 closing date. Follow-
ing the execution of the APA, AZ-UK and Abraxis exe-
cuted the written June 28, 2006 IP Assignment
Agreement. The IP Assignment Agreement purported to
assign the asserted patents from AZ-UK to Abraxis. At
that time AZ-UK could not assign the patents because it
did not possess their titles. AZ-UK had no legal title to
assign and, therefore, lacked standing to commence this
litigation. See Gaia Techs., Inc. v. Reconversion Techs.,
Inc., 93 F.3d 774, 778 (Fed. Cir. 1996) (dismissing plain-
tiff’s patent and trademark infringement claims for lack
of standing because of its “inability to prove that it was
the owner of the Intellectual Property at the time the suit
was filed”), as amended on reh’g on different grounds, 104
F.3d 1296 (Fed. Cir. 1996); see FilmTec Corp. v. Allied-
Signal, Inc., 939 F.2d 1568, 1572 (Fed. Cir. 1991) (stating
that the purported assignment is a nullity if the assignor
had nothing to assign). The district court’s ruling to the
contrary was legal error.
13 ABRAXIS BIOSCIENCE v. NAVINTA LLC

The dissent contends that our “promise to assign” line
of cases is irrelevant. Dissent Op. at 10-11. The dissent’s
contention is erroneous. Because the APA is a promise by
AZ-UK to assign the relevant patents to Abraxis when
AZ-UK obtains legal title, under our “promise to assign”
cases, a subsequent written agreement is necessary to
consummate the assignment. See IpVenture, 503 F.3d at
1327. It is clear from the record that AZ-UK did not have
legal title when it executed the June 28, 2006 IP Assign-
ment Agreement and it did not obtain legal title to the
patents until March 15, 2007. Whether, as the dissent
argues, the March 15, 2007 assignments from Astra L and
AZ-AB to AZ-UK contained nunc pro tunc provisions is
irrelevant. Even if given retroactive effect, the March 15,
2007 assignments do not automatically assign the patents
to Abraxis; a subsequent written agreement was neces-
sary. The only subsequent written agreement between
AZ-UK and Abraxis is the November 12, 2007 Intellectual
Property Assignment Agreement. This document is a
clear recognition by Abraxis that AZ-UK did not hold
legal title and therefore could not have transferred the
patents without a properly executed assignment. It was a
futile attempt by the parties to correct a critical error by a
nunc pro tunc assignment. The effect of this document—
executed eight months after the lawsuit was filed—is the
critical issue on appeal.

Even if, as the district court found, the March 15,
2007 agreements were considered to be retroactive, title
to the asserted patents did not automatically vest in
Abraxis upon the March 15, 2007 transfer to AZ-UK
because the June 28, 2006 IP Assignment Agreement did
not result in an immediate transfer of “expectant inter-
ests” to Abraxis. See Bd. of Trs. of Leland Stanford
Junior Univ., 583 F.3d at 841-42. For title to vest in
Abraxis, a further assignment by AZ-UK was required by
ABRAXIS BIOSCIENCE v. NAVINTA LLC 14

the “Further Assurances” provision of the June 28, 2006
IP Assignment Agreement. Whether Astra L, AZ-AB, and
AZ-UK are part of the same corporate structure and are
not “complete strangers,” therefore, is irrelevant because
there was no valid written assignment to Abraxis. See 35
U.S.C. § 261 (assignments of patents must be in writing);
Enzo APA, 134 F.3d at 1093 (same). Common corporate
structure does not overcome the requirement that even
between a parent and a subsidiary, an appropriate writ-
ten assignment is necessary to transfer legal title from
one to the other. Without the transfer of legal title of the
patents, Abraxis had no standing to bring this infringe-
ment action. Lans, 252 F.3d at 1328 (holding that a
plaintiff-inventor, who assigned his patent to a corpora-
tion in which he was the sole shareholder and managing
director prior to filing the action, lacked standing to sue).

AZ-UK finally assigned the asserted patents to
Abraxis on November 12, 2007, nearly eight months after
filing the complaint. 2 Abraxis contends that the Novem-
ber 12, 2007 assignment confers standing because it was
a nunc pro tunc assignment, thus, the requirement to
have legal title to the patents on the day of suit was met
retroactively. But the argument is to no avail because “if
the original plaintiff lacked Article III initial standing,
the suit must be dismissed, and the jurisdictional defect
cannot be cured by . . . the subsequent purchase of an

2 On December 5, 2008, Abraxis assigned all rights,
title, and interest in the asserted patents to APP Pharma-
ceuticals LLC and joined APP Pharmaceuticals as a
plaintiff in this action. See Abraxis Bioscience, 2009 WL
904043, at *5. Because Abraxis did not have standing at
the time it filed the complaint, the joinder of APP Phar-
maceuticals in 2008 cannot cure the jurisdictional defect
after the inception of the action.
15 ABRAXIS BIOSCIENCE v. NAVINTA LLC

interest in the patent in suit.” Schreiber Foods, 402 F.3d
at 1203. Even if the November 12, 2007 agreement is
considered to be a nunc pro tunc assignment, for purposes
of standing, Abraxis was required to have legal title to the
patents on the day it filed the complaint and that re-
quirement can not be met retroactively. 3 Enzo APA, 134
F.3d at 1093 (vacating judgment of infringement and
holding that “nunc pro tunc assignments are not sufficient
to confer retroactive standing” where no written transfer
of rights under patent had been made at the time claims
were brought); Gaia Techs., 93 F.3d at 780 (reversing
denial of motion to dismiss infringement complaint and
vacating verdict that the asserted patents were infringed
because alleged nunc pro tunc agreement was insufficient
to cure the lack of standing existing when the complaint
was filed). Thus, despite Abraxis’s delayed attempt to
obtain title to the asserted patents, the action must be
dismissed because Abraxis lacked standing on the day it
filed the action. 4

3 While Abraxis filed an amended complaint on No-
vember 16, 2007, we look to the date of the original Com-
plaint, March 15, 2007, because “the jurisdiction of the
Court depends on the state of things at the time of the
action brought.” Keene Corp. v. United States, 508 U.S.
200, 207 (1993); see Schreiber Foods, 402 F.3d at 1203, n.7
(“The initial standing of the original plaintiff is assessed
at the time of the original complaint, even if the com-
plaint is later amended.”); FED. R. CIV. P. 15(a) & (c)
(requiring an amended pleading to relate back to the date
of the original pleading when the amendment asserts a
claim that arises out of the conduct, transaction, or occur-
rence set out in the original pleading).
4 The dissent criticizes our reliance on Enzo. Dis-
sent Op. at 10. Yet, we are bound by Enzo and subse-
quent cases applying Enzo’s clear holding. As we have
stated before, “[t]his court’s precedent clearly establishes
ABRAXIS BIOSCIENCE v. NAVINTA LLC 16

The foregoing rule has a narrow exception. A party
may sue for past infringement transpiring before it ac-
quired legal title if a written assignment expressly grants
the party a right to do so. Moore v. Marsh, 74 U.S. 515,
522 (1868) (“[I]t is a great mistake to suppose that the
assignment of a patent carries with it a transfer of the
right to damages for an infringement committed before
such assignment.”); Arachnid, 939 F.2d at 1579 n.7, 1580-
81 (holding that the right to sue for past infringement
“must be express, and cannot be inferred from an assign-
ment of the patent itself”). This exception is irrelevant to
this case. Despite what the parties to the November 12,
2007 assignment believed, Abraxis was never granted the
right to sue for past infringement that occurred when
Navinta filed its ANDA and Paragraph IV Certification
on November 13, 2006. The March 15, 2007 assignments
to AZ-UK did not assign the right to sue for past in-

that a nunc pro tunc assignment executed after filing of a
lawsuit cannot retroactively cure standing that was
deficient at the time of filing.” Messagephone, Inc. v. SVI
Sys.’s, Inc., 243 F.3d 556, at *5 (Fed. Cir. 2000) (Table).

The dissent attempts to distinguish Enzo on the
grounds that there was no evidence of any intention that
the license would be exclusive before the suit was filed.
Dissent Op. at 10. The distinction is impuissant. First,
the parties in Enzo argued that the nunc pro tunc as-
signment agreement “was a memorialization [sic] of the
pre-suit oral agreement of the parties,” thereby establish-
ing evidence of an intention that the license would be
exclusive before the suit was filed. 134 F.3d at 1092.
Second, despite the dissent’s focus on intent, neither Enzo
nor any subsequent case involving nunc pro tunc assign-
ments focused on intent. Instead, Enzo and its progeny
stand for the clear proposition that irrespective of a
party’s intent, “nunc pro tunc assignments are not suffi-
cient to confer retroactive standing.” Id. at 1093 (format-
ting added).
17 ABRAXIS BIOSCIENCE v. NAVINTA LLC

fringement, thus AZ-UK could not have assigned those
rights to Abraxis on November 12, 2007, even if the
November 12, 2007 assignment is “considered” to be
retroactive. Therefore, Abraxis’s complaint must be
dismissed because Abraxis lacked standing at the time
the action was filed and continues to lack standing to sue
for past infringement.

Finally, Abraxis improperly relies on Arachnid to
support its argument that equitable title to the asserted
patents through the APA was sufficient to confer standing
to sue under the Hatch-Waxman Act. Arachnid con-
cerned a present agreement to assign rights to future
inventions. 939 F.2d at 1576, 1580. In contrast, the June
2006 IP Assignment Agreement attempted to assign
rights to existing patents, but was ineffective, because the
assignor, AZ-UK, did not own the patents at the time.
Without ownership, AZ-UK had no authority to convey
either the patents’ equitable or legal titles to Abraxis. Cf.
Arachnid, 939 F.2d at 1581. The legal title to the as-
serted patents remained with Astra L and AZ-AB until
March 15, 2007 when it was transferred to AZ-UK, leav-
ing Abraxis with defective legal title to the patents.

Accordingly, we reverse the denial of the motion to
dismiss the infringement complaint for lack of standing,
vacate the district court’s judgment, and remand with
instructions for the district court to dismiss Abraxis’s
complaint without prejudice. Because we vacate the
judgment of the district court for lack of standing, we
need not address Navinta’s alternative jurisdictional
ground for dismissal and we cannot review the merits of
Navinta’s arguments regarding infringement.

REVERSED, VACATED, AND REMANDED
 United States Court of Appeals
for the Federal Circuit
__________________________

ABRAXIS BIOSCIENCE, INC.,
Plaintiff-Appellee,

v.
NAVINTA LLC,
Defendant-Appellant.
__________________________

2009-1539
__________________________

Appeal from the United States District Court for the
District of New Jersey in Case No. 07-CV-1251, Judge Joel
A. Pisano.
__________________________

NEWMAN, Circuit Judge, dissenting.

The district court, applying the laws of contract and
property transfer, held that the three patents in suit were
owned by the plaintiff Abraxis when this suit was filed, and
that the plaintiff had standing to bring this suit. The de-
fendant did not seek interlocutory review of that ruling; and
there have been over three years of litigation, including full
trial of infringement of all three patents, and judicial de-
termination of complex questions of law and fact concerning
the Hatch-Waxman Act and its application. This court now
finds that the plaintiff did not have standing, after all.
ABRAXIS BIOSCIENCE v. NAVINTA LLC 2

The court thus erases the trial, nullifies the judgment,
cancels the appeal, and sends the case back so that the
parties and the district court and this court can do it all
again. However, the court has not shown reversible error in
the district court’s ruling on the question of standing, a
ruling based on state contract and commercial transaction
law. Instead, the panel majority creates a new and convo-
luted law unique to the patent aspect of commercial trans-
actions. No special public policy is served, and no reason
exists for creating a new commercial law, divergent from the
governing state law, when the subject of the commercial
sale is a patent. I must, respectfully, dissent.

DISCUSSION

New York law applies to these sales and transfer
agreements. All of the documents state, and the parties and
the district court agree, that the Asset Purchase Agreement
and all of the related agreements are governed by New York
law. Indeed, the choice of law is fundamental to this court’s
ruling, for my colleagues do not dispute that when New
York law is applied, the district court’s decision on standing
should be upheld. Instead, the panel majority holds, con-
trary to New York law, that these commercial contracts
cannot be given the effective date of the sales contract, on
which these patents were sold and ownership was trans-
ferred. Thus although the parties to these contracts do not
dispute their effective date, my colleagues now permit third
parties to challenge and invalidate this commercial transac-
tion, despite its undisputed validity as between the parties
to the transaction.

New York law is otherwise. Indeed, all state and federal
law is otherwise.
3 ABRAXIS BIOSCIENCE v. NAVINTA LLC

A

The master agreement between AstraZeneca UK and
Abraxis, called the Asset Purchase Agreement (APA) and
dated April 26, 2006, provided for the sale and purchase of
eight pharmaceutical products and their patents. This
master agreement contains a complex series of avowals,
warranties, covenants, and considerations provided by each
party and states that various aspects will be the subject of
“Acquisition Documents,” defining these “Acquisition Docu-
ments” as “any and all other agreements, instruments,
certificates and other documents executed and delivered in
connection with this Agreement.” APA §1.1. Section 3.1 of
the APA states that

the effectiveness of the documents, agreements,
opinions and certificates delivered in accordance
with [the APA], and the consummation of the trans-
actions contemplated hereby shall be deemed to oc-
cur at the Effective Time.

The Effective Time is defined as “12:01 a.m., New York time
on the Closing Date.” The Closing Date is defined as June
28, 2006.

The Asset Purchase Agreement defines “Transferred
Patent Rights” as the patents relating to the products that
were sold. For the Transferred Patent Rights, APA §2.1(e)
provides that AstraZeneca UK (“the Seller”)

shall, or shall cause one or more of its Affiliates to,
Transfer to the Purchaser, and the Purchaser shall
purchase and accept from the Seller or its Affiliates,
as applicable, all of the right, title and interests of
the Seller and its Affiliates in and to . . . all Trans-
ferred Patent Rights.
ABRAXIS BIOSCIENCE v. NAVINTA LLC 4

On June 28, 2006 the Intellectual Property Assignment
Agreement was executed. This agreement states that the
“provisions of this instrument are subject to the terms and
conditions of the Purchase Agreement.” The agreement
states that the seller “hereby sells, assigns, conveys and
transfers to Buyer . . . all of Seller’s right, title and interest”
in the patents on the attached Schedule A. Schedule A lists
the three patents in suit, and other patents. The Intellec-
tual Property Assignment Agreement includes a “Further
Assurances” clause, wherein AstraZeneca UK agrees that it
will “do, execute, acknowledge and deliver, or will cause to
be done, executed, acknowledged and delivered, any and all
further acts, conveyances, transfers, assignments, and
assurances as necessary to grant, sell, convey, assign,
transfer, set over to or vest in Buyer any of the Transferred
Intellectual Property.”

In early 2007 AstraZeneca UK learned that title to some
of the patents on Schedule A remained with affiliates of
AstraZeneca UK, and had not been formally assigned to
Abraxis. Astra Läkemedel Aktieboag (“Astra L”) was still
the nominal assignee of U.S. Patent 4,870,086, and Astra-
Zeneca AB was still the nominal assignee of U.S. Patents
5,670,524 and 5,834,489. AstraZeneca UK acted in accor-
dance with the Further Assurances clause, and on March
15, 2007 Astra L and AstraZeneca AB executed additional
documents assigning these patents to AstraZeneca UK, the
documents stating that “this instrument is being executed
by the parties to enable the Transferee to further convey to
Buyer that portion of the Transferred Assets" included in
the Asset Purchase Agreement, “dated as of April 26, 2006
. . . pursuant to which Transferee agreed to sell to Buyer
and Buyer agreed to purchase from Transferee the Trans-
ferred Assets, all as more particularly set out in the Pur-
chase Agreement,” with “consummation of the transactions
. . . deemed to occur at the Effective Time” on the Closing
5 ABRAXIS BIOSCIENCE v. NAVINTA LLC

Date. APA §3.1. On November 12, 2007 AstraZeneca UK
executed an additional document “confirming” that Abraxis
has owned all “right, title, and interest” to the patents in
suit “since no later than June 28, 2006.”

It is not unusual to transfer a complex set of related as-
sets through a master agreement and additional contracts
and assurances. Here the specified patent rights were
identified, and sold to Abraxis, in the Asset Purchase
Agreement dated April 26, 2006. The patents were listed on
Schedule A of the Intellectual Property Assignment Agree-
ment dated June 28, 2006, and then, pursuant to the Fur-
ther Assurances clause, on March 15, 2007 three of the
patents that had been sold were subject to the Further
Assurances of formal assignment and delivery, as required
by the Asset Purchase Agreement and implemented in the
Intellectual Property Assignment Agreement. Nonetheless,
my colleagues dismiss the suit for lack of standing, deeming
the transfer a “nullity” on inapt authority. Maj. Op. at 12.

The district court reached a different conclusion, upon
correct analysis of the transaction documents and on the
entire record.

B.

The district court, applying New York law of contracts
and property transfers, held that the March 15, 2007 as-
signment documents were “delivered in accordance with”
the terms of the Asset Purchase Agreement and were effec-
tive as of June 28, 2006, as stated therein. The district
court determined that the June 28, 2006 Closing Date
applied to all of the listed patents. The court stated: “Given
this retroactive effect, the [Intellectual Property Assignment
Agreement] would then operate to transfer title from [As-
traZeneca UK] to Abraxis as of that date as well,” and held
ABRAXIS BIOSCIENCE v. NAVINTA LLC 6

that the transfer was effective as of June 28, 2006. Abraxis
Bioscience, Inc. v. Navinta LLC, Civ. Action No. 07-1251,
2009 WL 904043, at *4 (D.N.J. Mar. 30, 2009). No error of
law or fact has been shown in this ruling.

The district court applied the New York law of con-
tracts, which recognizes provision of an effective date before
or after the date of signing of a contract. See Viacom Int’l
Inc. v. Tandem Prods., Inc., 368 F. Supp. 1264, 1270
(S.D.N.Y. 1974) (“When a written contract provides that it
shall be effective ‘as of’ an earlier date, it generally is retro-
active to the earlier date.”); Faculty Ass’n of Suffolk Cmty.
Coll. v. Public Emp’t Relations Bd., 508 N.Y.S.2d 591, 592
(App. Div. 1986) (recognizing retroactive effect of a succes-
sor agreement going back to the expiration date of the
predecessor contract); Local Union 1567, Int'l Bhd. of Elec-
trical Workers, AFL-CIO v. Orange and Rockland Utils.,
Inc., 478 N.Y.S.2d 937, 938 (App. Div. 1984) (retroactive
effective date provided by collective bargaining agreement
was binding, and applied to grievances that arose before the
agreement was executed); Matthews v. Jeremiah Burns,
Inc., 129 N.Y.S.2d 841, 847 (Sup. Ct. 1954) (amended
agreement was retroactive to the date of the original
amendment to which it referred, rather than taking effect
only from the amendment’s date of execution); see also
Mutual Life Ins. Co. of N.Y. v. Hurni Packing Co., 263 U.S.
167, 175–76 (1923) (applying New York law, “It was compe-
tent for the parties to agree that the effective date of the
policy should be one prior to its actual execution or issue;
and this, in our opinion, is what they did.”). Retroactivity
also can serve to fill an unintended omission in an earlier
agreement. See Local Union 1567, 478 N.Y.S.2d at 938;
Matthews, 129 N.Y.S.2d at 847; Buffalo Police Benevolent
Ass’n v. City of Buffalo, 453 N.Y.S.2d 314, 317 (Sup. Ct.
1982) (collective bargaining agreement was made retroac-
7 ABRAXIS BIOSCIENCE v. NAVINTA LLC

tive to cover the period between the lapse of the previous
contract and the execution of the new contract).

It is beyond cavil that parties to a contract can set the
effective date of their agreement. The district court found,
in accordance with New York law, that the June 28, 2006
Closing Date applied to all of the documents that referred to
that Closing Date, and that the March 15, 2007 assignments
were effective on the Effective Date stated therein.

My colleagues hold that despite the explicit language of
the contract documents and the intent of the parties as
stated in the contracts, the patents were not transferred on
any of the transfer dates stated in the contracts. This court
rejects the district court’s ruling that the March 15, 2007
reparative assignments were effective as of the Closing Date
of June 28, 2006, although those patents were listed and
sold in the closing documents. They even reject that the
March 15, 2007 reparative assignments were effective on
March 15, 2007. And they do not mention that even if there
were some imperfection in ownership, it was corrected by
the time the suit was filed.

C

The panel majority relies on assorted cases debating
rights to future inventions. The question in this case is not
whether or to whom an inventor assigned rights in possible
unidentified future inventions, as in the “agree to assign”
cases typified by Bd. Of Trustees of Leland Stanford Junior
Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832, 841 (Fed.
Cir. 2009). This case relates to the law governing the com-
mercial sale of existing patents, not the law of future rights
to unknown inventions.
ABRAXIS BIOSCIENCE v. NAVINTA LLC 8

Patent conveyances are contracts, and the interpreta-
tion of sales contracts is a matter of state law. New York
law permits contracts to take effect on a specified date,
when such is the parties’ intent. Viacom, 368 F. Supp. at
1270; Faculty Ass’n of Suffolk Cmty. Coll., 508 N.Y.S.2d at
592; Local Union 1567, 478 N.Y.S.2d at 938; Matthews,129
N.Y.S.2d at 847; see also Mutual Life, 263 U.S. at 175–76.
It is incorrect for this court to refuse to apply the law that
the parties have agreed to apply to these contracts. Indeed,
my colleagues misdescribe New York contract law, ignoring
the district court’s citation of authority. The district court
correctly applied New York law in holding that the listed
patents had been transferred as of June 28, 2006, the Clos-
ing Date of the transaction, and that Abraxis had title to the
patents when suit was filed. No contrary meaning has been
suggested for any of these contracts, and no conflicting law
has been cited.

New York law recognizes that correct contract interpre-
tation implements the intent of the contracting parties.
E.g., Greenfield v. Philles Records, Inc., 780 N.E.2d 166, 170
(N.Y. 2002) (“The fundamental, neutral precept of contract
interpretation is that agreements are construed in accord
with the parties’ intent.”). For the contracts before us, there
is no uncertainty or indefiniteness or ambiguity. See id.
(“Extrinsic evidence of the parties’ intent may be considered
only if the agreement is ambiguous, which is an issue of law
for the courts to decide.”). The district court relied on all of
the contract documents, and gave effect to the parties’
intent as stated in the Asset Purchase Agreement and all of
the documents. E.g., Snug Harbor Square Venture v. Never
Home Laundry, Inc., 675 N.Y.S.2d 365, 366 (App. Div. 1998)
(“In construing a contract, the document must be read as a
whole to determine the parties’ purpose and intent, giving a
practical interpretation to the language employed so that
the parties’ reasonable expectations are realized.”).
9 ABRAXIS BIOSCIENCE v. NAVINTA LLC

No evidence of a different intent was offered, nor any
plausible theory that the parties intended anything other
than transfer of the patents on the Closing Date. The
March 15, 2007 documents state that they are effective as of
June 28, 2006, “to enable the Transferee to further convey to
Buyer that portion of the Transferred Assets” included in
the Asset Purchase Agreement, “pursuant to which Trans-
feree agreed to sell to Buyer and Buyer agreed to purchase
from Transferee the Transferred Assets, all as more particu-
larly set out in the Purchase Agreement.” The Asset Pur-
chase Agreement states that the “Closing Date,” June 28,
2006, is the effective date for the transaction. As the dis-
trict court correctly held, this date applies no less to the
reparative assignments than it does to the other aspects of
this commercial transaction. See Sunrise Med. HHG, Inc. v.
AirSep Corp., 95 F. Supp. 2d 348, 436–37 (W.D. Pa. 2000)
(“[A] nunc pro tunc assignment filed before the filing date of
the action with an effective assignment date before the
action does effect a valid transfer of rights sufficient to
confer standing.”) (citing Gaia Techs., Inc. v. Reconversion
Techs., Inc., 93 F.3d 774, 779-80 (Fed. Cir.), amended on
reh’g on different grounds, 104 F.3d 1296 (Fed. Cir. 1996)).

By ignoring this clear expression of the parties’ intent,
the majority has not given a “practical interpretation” to the
agreements, and has failed to realize the parties’ intentions.
Snug Harbor, supra. The majority has done quite the
opposite, engrafting a meaning that no party could reasona-
bly or possibly have intended, and holding that despite all of
these documents, ownership of these three patents was not
transferred until the November 12, 2007 “confirmation” of
ownership “since no later than June 28, 2006.”
ABRAXIS BIOSCIENCE v. NAVINTA LLC 10

D

The panel majority states that this court has its own
law, derived not from state law but from federal patent
policy, in order to prevent litigants from filing suit before
they have achieved ownership of the assets they seek to
litigate, citing Enzo APA & Son, Inc. v. Geapag A.G., 134
F.3d 1090, 1093 (Fed. Cir. 1998). In Enzo the court held
that an exclusive license executed after a non-exclusive
licensee filed suit did not establish standing at the time of
filing, even if the exclusive license is stated to be retroac-
tive. In Enzo the court found that there was no indication
or evidence of any intention that the license would be exclu-
sive before the suit was filed, despite an alleged oral agree-
ment; thus the court held that the proposed retroactivity of
exclusivity did not track an actual intent at the earlier time.
Id. at 1093 (noting that no written license agreement
existed at the time suit was filed). In sharp contrast, for the
case at bar the Asset Purchase Agreement and the Intellec-
tual Property Assignment Agreement state the sale of all
rights to these patents. The parties intended that these
patents would be included in the sale, and they were sold on
the Closing Date of June 28, 2006. The reparative assign-
ment documents on March 15, 2007 reflected that which
was intended. See Mas-Hamilton Grp. v. LaGard, Inc., 156
F.3d 1206, 1211 (Fed. Cir. 1998) (distinguishing patentee’s
nunc pro tunc agreement correcting an earlier writing as of
the earlier date, from Enzo, where a post-filing assignment
could not retroactively cure the absence of any written pre-
suit agreement). Enzo does not affect the district court’s
ruling under New York law, for here there were explicit
written pre-suit sales and transfer agreements.

As mentioned ante, the panel majority relies on cases in-
terpreting “promise to assign” disputes, stating that these
cases mean that the district court erred in implementing the
11 ABRAXIS BIOSCIENCE v. NAVINTA LLC

Further Assurances provision of the June 28, 2006 Intellec-
tual Property Assignment Agreement. Maj. Op. at 11-12.
However, the “promise to assign” cases do not invalidate,
and indeed have no relation to this Further Assurances
provision, for they relate to the special situation of owner-
ship of future inventions not made at the time of the “prom-
ise to assign.” See, e.g., Arachnid, Inc. v. Merit Indus., Inc.,
939 F.2d 1574, 1576 (Fed. Cir. 1991) (disputing rights to an
invention that may have been conceived during a consulting
project). Issues arising from employment contracts have
arisen on a variety of facts, but do not relate even remotely
to this case. The majority’s reliance on this class of cases is
obscure.

The issue here is not an expectant interest in a future
invention, but the effect under New York law of the explicit
transfer of existing patents, as in the Intellectual Property
Assignment Agreement. Indeed, the cases on which the
majority relies do not support its thesis. For example, in
Stanford v. Roche, supra, the court held that the language
“do hereby assign” effected a present assignment, 583 F.3d
at 842, although the invention and patent did not exist
when the contract was made. Here, in contrast, all of the
patents at issue were listed in the Asset Purchase Agree-
ment. And even if this court were to conclude that the
transfer required separate remedial assignment documents,
these documents were obtained when this suit was filed.
Thus standing is established even on the majority’s position.

In addition, as a matter of contract interpretation, Fed-
eral Circuit precedent is contrary to the position of the panel
majority. For example, in Speedplay, Inc. v. Bebop, Inc., 211
F.3d 1245, 1250 (Fed. Cir. 2000) the court explained that
the “substance of what was granted” governs the interpreta-
tion of contracts, quoting Vaupel Textilmaschinen KG v.
Meccanica Euro Italia S.P.A., 944 F.2d 870, 874 (Fed. Cir.
ABRAXIS BIOSCIENCE v. NAVINTA LLC 12

1991). The court in Speedplay authorized correcting an
error in the patent number in view of the clear intent of the
parties, whereby the correction was held retroactive to the
date of the contract. As another example, in Viskase Corp.
v. American National Can Co., 261 F.3d 1316, 1328–29 (Fed.
Cir. 2001), this court held that a patent’s incorrect naming
of inventors did not impair the patent owner’s rights and
thus did not undermine standing to sue. These rulings, like
New York law and all contract law, implement contractual
intent.

No evidence of any conflicting intent or purpose has
been offered as to the Asset Purchase Agreement and any of
the related contracts. All parties to the transaction agree
that the patents were sold and transferred to Abraxis as of
the Effective Date stated in the agreements. This court’s
ruling that the transaction was legally void is negated by all
precedent, is contrary to New York law, and is not within
any federal exception to state law. The district court cor-
rectly ruled that Abraxis had standing to sue when this case
was filed. With all respect to my colleagues on this panel, I
must dissent from their ruling and their reasoning. 1

1 Although the court dismisses the case for lack of
standing, my colleagues nonetheless also offer remarks that
appear to be directed to the merits. However, if there was
no standing in the district court, the merits decision is not
before this panel for review.