United States Court of Appeals for the Federal Circuit
04-1300, -1384
MEDIMMUNE, INC.,
Plaintiff-Appellant,
v.
GENENTECH, INC.,
Defendant-Appellee,
and
CITY OF HOPE,
Defendant-Appellee,
and
CELLTECH R&D, LTD.,
Defendant-Appellee.
Harvey Kurzweil, Dewey Ballantine LLP, of New York, New York, argued for
plaintiff-appellant. With him on the brief were Joseph Angland, Aldo A. Badini, and
Henry J. Ricardo. Of counsel on the brief was Elliot M. Olstein, Carella, Byrne, Bain,
Gilfillan, Cecchi, Stewart & Olstein, of Roseland, New Jersey.
Daniel M. Wall, Latham & Watkins LLP, of San Francisco, California, argued for
defendant-appellee Genentech, Inc. and the City of Hope. With him on the brief were
Christopher S. Yates, and James K. Lynch; and Mark A. Flagel, of Los Angeles,
California and Dean G. Dunlavey, of Costa Mesa, California. Of counsel on the brief
were Roy E. Hofer, Cynthia A. Homan, and Meredith Martin Addy, Brinks Hofer Gilson &
Lione, of Chicago, Illinois. Also, of counsel on the brief were John W. Keker, Mark A.
Lemley, and Daralyn J. Durie, Keker & Van Nest, L.L.P., of San Francisco, California.
-2-
Joseph M. Lipner, Irell & Manella LLP, of Los Angeles, California, for defendant-
appellee City of Hope. With him on the brief were Morgan Chu and Jason D. Linder. Of
counsel on the brief was Gordon A. Goldsmith, City of Hope, Office of the General
Counsel, of Duarte, California.
Charles S. Barquist, Morrison & Foerster LLP, of Los Angeles, California, argued
for defendant-appellee Celltech R&D Ltd. With him on the brief were Steven M. Haines,
of Los Angeles, California and Jason A. Crotty, of San Francisco, California.
Appealed from: United States District Court for the Central District of California
Senior Judge Mariana R. Pfaelzer
United States Court of Appeals for the Federal Circuit
04-1300, -1384
MEDIMMUNE, INC.,
Plaintiff-Appellant,
v.
GENENTECH, INC.,
Defendant-Appellee,
and
CITY OF HOPE,
Defendant-Appellee,
and
CELLTECH R&D, LTD.,
Defendant-Appellee.
__________________________
DECIDED: October 18, 2005
__________________________
Before NEWMAN, MAYER, and CLEVENGER, Circuit Judges.
Opinion for the court filed by Circuit Judge NEWMAN. Dissenting in part opinion filed by
Circuit Judge CLEVENGER.
NEWMAN, Circuit Judge.
MedImmune, Inc., a licensee in good standing under a patent owned by Genentech,
Inc. and City of Hope (collectively "Genentech"), seeks by declaratory action to challenge
the validity and enforceability of the licensed patent on various grounds flowing from the
settlement of a patent interference between Genentech and Celltech R&D, Ltd. The United
States District Court for the Central District of California held that because MedImmune
continues to comply fully with the license terms, leaving no possibility of infringement suit or
license cancellation by Genentech, there is no "case of actual controversy" as required by
the Declaratory Judgment Act, 28 U.S.C. §2201. The district court also dismissed
MedImmune's antitrust and unfair competition counts. We affirm the judgment.1
BACKGROUND
The patented technology relates to the use of cell cultures to manufacture human
antibodies. Genentech, Inc. and the City of Hope are the owners of United States Patent
No. 4,816,567 (the Cabilly I patent) filed on April 8, 1983, and Patent No. 6,331,415 (the
Cabilly II patent), a continuation of Cabilly I, filed on June 10, 1988. Celltech owns United
States Patent No. 4,816,397 (the Boss patent), having a British priority date of March 25,
1983. In accordance with 35 U.S.C. §135 the United States Patent and Trademark Office
(PTO) declared an interference between the Boss patent and the Cabilly II application. The
PTO interference proceedings consumed seven and a half years. The Board of Patent
Appeals and Interferences decided priority in favor of the senior party Boss, holding that
Cabilly had not established an actual reduction to practice before the Boss patent's British
priority date. Cabilly v. Boss, 55 USPQ2d 1238 (Bd. Pat. App. & Int. 1988).
Genentech then filed a civil action in the United States District Court for the Northern
District of California, in accordance with 35 U.S.C. §146. After various proceedings, the
1 MedImmune, Inc. v. Genentech, Inc., CV 03-2567 (C.D. Cal. Jan. 14, 2004;
February 18, 2004; Mar. 15, 2004; April 29, 2004).
04-1300, -1384 2
district court concluded that disputed facts concerning conception and reduction to practice
required trial and, referring to the complexity of the science, stated that "[t]here appears to
be a dispute amongst highly educated and apparently well-qualified experts" as to the
interpretation and probative value of the evidence. The court urged Genentech and
Celltech to resolve the issue of priority with the aid of mediation. Genentech and Celltech
retained a mediation service, and a retired judge served as mediator. A settlement
agreement was duly reached, whereby Genentech and Celltech agreed that the Cabilly II
application was entitled to priority as against the Boss patent, based in part on new
evidence of the content of a draft patent application during the period leading to filing of the
Genentech application. Genentech and Celltech also entered into a cross-license
agreement that included a formula for sharing of royalties. The district court entered
judgment on the parties' resolution of the issue of priority, and directed the PTO to vacate
its prior decision, revoke the Boss patent, and issue a patent on the Cabilly II application.
Genentech, Inc. v. Celltech R&D, Ltd., No. 3:98cv03929 (N.D. Cal. March 16, 2001).
Genentech and Celltech jointly presented the district court's judgment to the PTO,
with a petition requesting that the PTO cancel the Boss patent and issue a patent on the
Cabilly II application. The Board entered an order that Cabilly was the prior inventor, but
did not precisely follow the requested procedure. The Board stated that the Boss patent
was cancelled by operation of law when the district court's judgment became final and was
not appealed, and that no further action by the PTO was required. The Board also
observed that an Information Disclosure Statement filed by Genentech in 1991 had not
been acted upon, and returned the Cabilly II application to the patent examiner for review of
any "ground not involved in judicial review." Genentech then cited a large number of
04-1300, -1384 3
additional references to the examiner, and provided various documents from the record of
the §146 action. After further examination the Cabilly II patent was issued on December
18, 2001, eleven years after the inception of the interference.
MedImmune had since 1997 been licensed by Genentech under the Cabilly I patent
and, by the terms of that agreement, received a license under the Cabilly II patent. In
addition, MedImmune had since 1998 been licensed by Celltech under the Boss patent.
After issuance of Cabilly II, Genentech advised MedImmune that a MedImmune product,
brand name Synagis®, was covered by Cabilly II and subject to royalties in accordance
with the license terms. MedImmune objected, and filed this declaratory judgment action in
the Central District of California, requesting a declaration that the Cabilly II patent is invalid
or unenforceable. MedImmune paid and continues to pay the license royalties to
Genentech, relying on precedent such as Cordis Corp. v. Medtronic, Inc., 780 F.2d 991
(Fed. Cir. 1985) for the holding that the licensor cannot terminate the license if the royalties
are paid to the licensor and the license agreement is not otherwise breached. The district
court, applying Gen-Probe, Inc. v. Vysis, Inc., 359 F.3d 1376 (Fed. Cir. 2004), dismissed
the suit as non-justiciable under the Declaratory Judgment Act.
DISCUSSION
I
The district court held that MedImmune, as a licensee in good standing and not in
reasonable apprehension of suit, cannot bring a declaratory action to challenge the patent
under which it is licensed. MedImmune concedes that it is free of apprehension of suit,
stating that the reason it is paying the royalties is to avoid the risk and possible
consequences of a successful infringement suit by Genentech. However, MedImmune
04-1300, -1384 4
argues that under Lear, Inc. v. Adkins, 395 U.S. 653 (1969) it has the absolute right to
challenge the validity or enforceability of the patent, whether or not it breaches the license
and whether or not it can be sued by the patentee. MedImmune states that the Gen-Probe
decision improperly resurrected the licensee estoppel that was abolished in Lear, and
should be overturned.2
Genentech responds that this is not a question of licensee estoppel under Lear, but
a question of Article III jurisdiction under the Declaratory Judgment Act. Unlike the situation
in Lear, MedImmune is paying the license royalties; and unlike the situation in Lear,
Genentech has no ground on which to cancel the license or otherwise bring suit affecting
the licensed subject matter. In Lear the licensee stopped paying royalties and the patentee
sued for royalties; there was clearly a justiciable controversy, and that aspect was not an
issue in Lear. In contrast, in Gen-Probe the licensee was complying fully with the license
terms and could not be sued by the patentee. Similarly, MedImmune is complying fully with
the license terms and cannot be sued by the patentee.
MedImmune argues that although it has no reasonable apprehension of suit, it
meets the requirements of the Declaratory Judgment Act because if it stopped paying
royalties it could be sued. MedImmune states that the Cabilly II patent is subject to
challenge on several grounds, and that it should not be shielded from such challenge.
MedImmune also distinguishes its situation from that in Gen-Probe on the ground that the
2 Panels of the Federal Circuit are bound by prior decisions of this court unless
overturned by the court en banc. See, e.g., Sacco v. Dep't of Justice, 317 F.3d 1384, 1386
(Fed. Cir. 2003).
04-1300, -1384 5
licensee in Gen-Probe negotiated for a license and then filed suit to invalidate the licensed
patent, having secured its right to operate and the royalty terms should it lose the suit;
MedImmune points out that it already had a license to Cabilly II under its license to Cabilly I
and that the royalty rate was already set.
The district court was not persuaded by these distinctions, and we agree that they
do not create a justiciable controversy. Unlike the facts in Lear, where the licensee ceased
payment and disavowed the license obligation, in Gen-Probe, as for MedImmune, breach
was assiduously avoided. Thus this case does not raise the question of whether patent
invalidity is available as a defense to suit against a defaulting licensee -- the licensee
estoppel that was laid to rest in Lear -- for there is no defaulting licensee and no possibility
of suit.
Precedent follows this pattern. For example, in Intermedics Infusaid, Inc. v. Regents
of University of Minnesota, 804 F.2d 129, 131 (Fed. Cir. 1986), where suit was ongoing in
state court for royalties under a license agreement, the court held that a federal declaratory
judgment action challenging validity was properly stayed. In Cordis v. Medtronic, 780 F.2d
at 995, the court held that to avoid breach during litigation the royalties were required to be
paid to the licensor, not into escrow. In C.R. Bard, Inc. v. Schwartz, 716 F.2d 874, 875-76
(Fed. Cir. 1983) the licensee had stopped paying royalties and the licensor was suing for
their recovery in state court but had not terminated the license; this court held that this
material breach generated an actual controversy for purposes of the federal declaratory
judgment challenge to validity. The decision in Gen-Probe is in accord with this precedent,
in holding that the jurisdictional requirements of a declaratory action are not met when
04-1300, -1384 6
royalties are fully paid to the licensor and there is no ground on which the licensor can
cancel the license or sue for infringement.
MedImmune stresses the public policy served by permitting it to attack the
Genentech patent, and argues that estoppel has been eliminated in the fields of intellectual
property as a matter of public policy. However, the issue here is not one of estoppel, but of
availability of the declaratory judgment procedure. The purpose of that procedure is to
"accommodate[] the practical situation wherein the interest of one side to the dispute may
be served by delay in taking legal action," BP Chemicals Ltd. v. Union Carbide Corp., 4
F.3d 975, 977 (Fed. Cir. 1993), by permitting the other side to initiate legal action. See
also, e.g., EMC Corp. v. Norand Corp., 89 F.3d 807, 814-15 (Fed. Cir. 1996); Arrowhead
Industrial Water, Inc. v. Ecolochem. Inc., 846 F.2d 731, 734-35 (Fed. Cir. 1988). The court
in Gen-Probe discussed the inequity when the patent owner, having contracted away its
right to sue, is in continuing risk of attack on the patent whenever the licensee chooses --
for example, if the product achieves commercial success -- while the licensee can preserve
its license and royalty rate if the attack fails. This imbalance distorts the equalizing
principles that underlie the Declaratory Judgment Act.
MedImmune states that cases from other circuits hold that a licensee need not
terminate its license in order to acquire declaratory standing. However, in each of the cited
cases there was an additional factor, such as money owed on the contract, or the plaintiff
or its indemnitee had been threatened with suit, or there was a change in circumstances
which affected performance of the contract, meeting the constitutional and statutory
requirements that there must be an actual controversy in order to invoke judicial authority.
04-1300, -1384 7
Contrary to MedImmune's argument, the fact that the licensed subject matter is intellectual
property does not create a policy-driven exception to these requirements.
In MedImmune, Inc. v. Centocor, Inc., 409 F.3d 1376 (Fed. Cir. 2005) the court
adhered to Gen-Probe in circumstances, like those at bar, where MedImmune had secured
a license and then sued to invalidate the licensed patent. The court explained that: "To
keep watch over the subtle line between an 'abstract question' and 'a controversy
contemplated by the Declaratory Judgment Act' an inquiry has been formulated [whereby]
there must be both (1) a reasonable apprehension on the part of the declaratory judgment
plaintiff that it will face an infringement suit, and (2) present activity by the declaratory
judgment plaintiff which could constitute infringement . . . ." This synthesis of the totality-of-
the-circumstances test for determining whether there is a justiciable controversy is
pragmatically useful. See BP Chemicals, 4 F.3d at 978 ("The purpose of the two-part test
is to determine whether the need for judicial attention is real and immediate, or is
prospective and uncertain of occurrence.")
Licensor and licensee always have "adverse legal interests," Aetna Life Inc. Co. v.
Haworth, 300 U.S. 227, 241 (1937), but that relationship alone does not create a justiciable
controversy. The Declaratory Judgment Act requires a "definite and concrete controversy,"
id. at 240, of "sufficient immediacy and reality," Maryland Cas. Co. v. Pacific Coal & Oil Co.,
312 U.S. 270, 273 (1941), to warrant judicial intervention. MedImmune avoided and
continues to avoid such a situation, by avoiding breach and avoiding apprehension of suit.
Thus although courts have discretion in deciding whether to accept a declaratory action
when the constitutional and statutory requirements are met, there is no discretion to accept
04-1300, -1384 8
an action when there is no controversy of immediacy or reality because there is no
reasonable apprehension of suit.
MedImmune directs us to the reference to "scarecrow" patents in Cardinal Chemical
Co. v. Morton International, Inc., 508 U.S. 83, 96 (1993). That case concerned the
appellate obligation to review a district court's decision concerning patent validity, lest an
invalid patent be revived. In Cardinal Chemical the trial court had decided the issues of
infringement and validity, and the Court held that the Federal Circuit has the power to
review both issues on appeal, and should do so, even when the patent is held not infringed.
Cardinal Chemical was an infringement suit, not a declaratory action. As commented in
Super Sack Manufacturing Corp. v. Chase Packaging Corp., 57 F.3d 1054, 1060 (Fed. Cir.
1995), "nothing in Cardinal undermines our decisions on declaratory justiciability at the trial
court level." The present case is unaffected by Cardinal Chemical.
The district court did not err in holding that MedImmune, since under no threat or
apprehension of suit, did not have standing to bring a declaratory challenge to the Cabilly II
patent.
II
MedImmune also argues that the interference settlement between Genentech and
Celltech was collusive and fraudulent, and that this provides an independent basis for
standing to attack the Cabilly II patent, whether or not the case or controversy requirement
of the Declaratory Judgment Act is met. The district court held that the joint action of
Genentech and Celltech was protected by the Noerr-Pennington doctrine.
MedImmune states that Genentech and Celltech violated federal and state antitrust
laws, citing sections 1 and 2 of the Sherman Act (15 U.S.C. §§1,2), and the California
04-1300, -1384 9
antitrust and unfair competition statutes, Cal. Bus. & Prof. Code §16720 and §17200 et
seq. MedImmune points out that the Cabilly II patent expires significantly later than the
Boss patent (because of the interference delays), and argues that extension of control of
the invention was the motivation for the agreement to award priority to Cabilly II.
MedImmune also states that Celltech's Boss patent would have retained priority based on
its British filing date if the district court had excluded the newly presented evidence of the
draft Cabilly patent application. MedImmune states that this evidence, since not before the
PTO, should not have been permitted in the district court. However, new evidence may be
presented in §146 proceedings, see 35 U.S.C. §146 ("without prejudice to the right of the
parties to take further testimony"). See also Abbott Labs. v. Brennan, 952 F.2d 1346, 1348
(Fed. Cir. 1991).
MedImmune refers to United States v. Singer Mfg. Co., 374 U.S. 174 (1963),
wherein the Court found Sherman Act violation based on interference settlements and other
agreements among domestic sewing machine manufacturers for the purpose of excluding
Japanese competitors from the United States market. MedImmune argues that settling
interferences "at least in part, to prevent an open fight over validity" of itself violates the
Sherman Act, quoting the concurring opinion in Singer, 374 U.S. at 199 (White, J.,
concurring). The settlement of disputes such as priority in patent interferences is not a
presumptive violation of antitrust law; such violation requires a showing of market power
and other antitrust predicates. A patent does not of itself confer market power or a
presumption thereof for purposes of the antitrust laws. See C.R. Bard, Inc. v. M3 Sys., Inc.,
157 F.3d 1340, 1368 (Fed. Cir. 1998) ("It is not presumed that the patent-based right to
exclude necessarily establishes market power in antitrust terms."); Abbott Labs., 952 F.2d
04-1300, -1384 10
at 1354 (Fed. Cir. 1991) ("A patent does not of itself establish a presumption of market
power in the antitrust sense."); American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725
F.2d 1350, 1367 (Fed. Cir. 1984) ("patent rights are not legal monopolies in the antitrust
sense of the word"); Jefferson Parish Hosp. Dist. No. 2 v. Hyde, 466 U.S. 2, 18 (1984)
("any inquiry into the validity of a tying arrangement must focus on the market or markets in
which the two products are sold, for that is where the anticompetitive forcing has its
impact"); In re Independent Service Organizations Antitrust Litigation, 203 F.3d 1322, 1329
(Fed. Cir. 2000) ("patent alone does not demonstrate market power"); Independent Ink,
Inc. v. Illinois Tool Works, Inc. 396 F.3d 1342, 1348 (Fed. Cir. 2003) ("the Supreme Court
has held that there is a presumption of market power in patent tying cases"), cert. granted,
125 S. Ct. 2937 (June 20, 2005); Herbert Hovenkamp, Federal Antitrust Policy: The Law of
Competition and its Practice §10.3 (3d ed. 2005) ("most patents confer absolutely no
market power on their owners").
The antitrust posture that MedImmune urges for patent interferences can discourage
if not prevent settlements, placing unnecessary burdens on the courts and the PTO.
Priority determinations may raise complex questions of law and scientific fact, and the
delays in their resolution by the PTO are notorious; settlement can, as here, expedite
resolution of difficult issues. The per se or presumptive illegality urged by MedImmune for
interference settlements is contrary to both precedent and policy, as recorded in the
Antitrust Guidelines for the Licensing of Intellectual Property, 4 Trade. Reg. Rep. (CCH)
¶13,132, §2.2 (1995).
III
04-1300, -1384 11
MedImmune also argues that Genentech and Celltech colluded in the joint
submission of their settlement agreement to the district court, and again in their joint
submission of the court's judgment order to the Patent and Trademark Office with the
request that the Boss patent be cancelled and the Cabilly II application be granted. The
district court dismissed these claims, holding that petitions for governmental action are
immune under the Noerr-Pennington doctrine that permits collaboration among competitors
to petition the government to take an action that may restrain competition, without incurring
antitrust liability by the act of collaborating. See Eastern Railroad Presidents Conference v.
Noerr Motor Freight, Inc., 365 U.S. 127, 136 (1961) (it is permissible for railroads to act in
concert to petition the legislature to take an action that creates a restraint of trade or a
monopoly); United Mine Workers of America v. Pennington, 381 U.S. 657, 671 (1965) (it is
permissible for a combination of workers and their employers to petition the Secretary of
Labor to take an action that adversely affects competitors). In California Motor Transport v.
Trucking Unlimited, 404 U.S. 508 (1972) this immunity was extended to petitions to the
courts "respecting resolution of [petitioners'] business and economic interests vis-a-vis their
competitors." Id. at 511.
A joint communication to a court of the terms of settlement of a matter before the
court, and a joint petition to the PTO to implement the court's judgment, are not actions that
would be prohibited or tainted absent immunization by Noerr-Pennington; thus it was
unnecessary for the district court to have relied on Noerr-Pennington immunity. Genentech
and Celltech, the parties to the litigation in the district court, were obligated to bring their
settlement to the court, and to bring the court's judgment to the PTO. Although
MedImmune argues that the settlement "contains misrepresentations," the putative
04-1300, -1384 12
misrepresentation was by "representing [to the district court] that Genentech was instead
entitled to priority." MedImmune Br. at 48. The district court properly rejected this theory,
observing that disputed issues from the underlying litigation cannot be recast as
misrepresentations, citing Kottle v. Northwest Kidney Centers, 146 F.3d 1056, 1063 (9th
Cir. 1998). MedImmune's disagreement with the result of the priority settlement does not
convert it into a presumptive violation of the antitrust laws, or grant MedImmune standing to
require judicial review of the evidence and the conclusion reached in the settlement.
The ensuing filing of the judgment in the PTO is set by statute, and the joint filing by
the parties to the judgment does not require Noerr-Pennington protection. See 35 U.S.C.
§146 (filing in the Patent and Trademark Office of a certified copy of the judgment). The
joint request of the litigants that the PTO implement the judgment is not a prohibited
collusion.
IV
MedImmune also argues that antitrust violation arose in Genentech's prosecution of
the Cabilly II application after it was returned to ex parte examination. MedImmune states
that the additional references that Genentech brought to the examiner's attention should
have been presented earlier, that Genentech did not tell the examiner about certain patents
under which Genentech was licensed, that Genentech made inconsistent arguments from
those it made in an opposition to the Boss patent in the European Patent Office, that
Genentech cited so many references that the most important were "buried," and that
Genentech did not tell the examiner about challenges to Cabilly II that Celltech had raised
during the interference proceeding. Thus MedImmune states that the prosecution was
fraudulent, and that enforcement of a fraudulently obtained patent violates the antitrust laws
04-1300, -1384 13
in terms of Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp., 382 U.S.
172 (1965).
The district court held that "this argument fails because in its Amended Complaint,
MedImmune does not plead fraud" and that "MedImmune's Walker Process theory is not
supported in the pleadings." Like all fraud-based claims, Walker Process allegations are
subject to the pleading requirements of Fed. R. Civ. P. 9(b). See Vess v. Ciba-Geigy Corp.
USA, 317 F.3d 1097, 1103-04 (9th Cir. 2003) (claims that are "grounded in fraud" or that
"sound in fraud" are subject to Rule 9(b)). MedImmune's counsel emphasized, on
questioning by the district court, that he was not charging fraud. The district court correctly
held that the pleadings, which charged Genentech with inequitable conduct, not fraud, fell
short of alleging a Walker Process antitrust violation.
Genentech describes MedImmune's approach as tactical. Whatever its basis, after
the grant of summary judgment MedImmune sought to amend its pleadings by filing a
Second Amended Complaint, to add the charge of fraud on the grounds that were
previously designated as inequitable conduct. The district court denied leave to amend,
referring to the litigation history and describing the proposed amendments as "prejudicial
and futile." The Ninth Circuit reviews denials of leave to amend under an abuse of
discretion standard. Bowles v. Reade, 198 F.3d 752, 757 (9th Cir. 1999).3 MedImmune
has provided no reasonable basis for deeming this ruling an abuse of the district court's
sound discretion. In Royal Insurance Co. of America v. Southwest Marine, 194 F.3d 1009,
3 Leave to amend is a procedural matter not unique to patent law, and we apply
the law of the regional circuit to review denial of leave to amend. See Ferguson
Beauregard/Logic Controls Div. of Dover Resources, Inc. v. Mega Sys. LLC, 350 F.3d
1327, 1342 (Fed. Cir. 2003).
04-1300, -1384 14
1017 (9th Cir. 1999) the court affirmed denial of leave to amend when the motion was
made after the grant of summary judgment. Although the parties have in their briefs
discussed at some length the prosecution aspects challenged by MedImmune, we discern
no error in the district court's determination that MedImmune was without a reasonable
likelihood of supporting a claim of antitrust violation, and that the proposed redesignation of
prosecution issues as constituting fraud was tardy and prejudicial.
In addition, MedImmune's charge of fraud during ex parte patent examination does
not establish standing to bring a declaratory action to invalidate a patent not involved in a
case or controversy between the parties. The standards for determining jurisdiction in a
declaratory judgment action of patent invalidity do not change when the declaration raises a
Walker Process claim. See Unitherm Food Sys., Inc. v. Swift-Eckrich, Inc., 375 F.3d 1341,
1357-58 (Fed. Cir. 2004) (as for other declaratory challenges to patent validity, reasonable
apprehension of suit is a prerequisite for standing to bring an antitrust challenge to the
patent prosecution). A person not under reasonable apprehension of suit cannot overcome
the absence of declaratory standing simply by challenging the patent prosecution and
asserting fraud. There is neither statutory nor precedential authority for collateral attack on
patent examination procedures, by a person who does not meet the requirements of
declaratory judgment standing.
MedImmune also states that it should have been permitted to file the Second
Amended Complaint after the summary judgment, to add a charge of fraud in the tardy
filing of the interference settlement agreement. The PTO accepted the filing, as authorized
by 35 U.S.C. §135(c). MedImmune challenges the sufficiency of Genentech's reason for its
tardiness. The district court held that "MedImmune has pled no facts sufficient to assert
04-1300, -1384 15
that the PTO acted inappropriately in accepting the settlement documents from
Genentech." No abuse of the district court's discretion has been shown, and no basis
whatsoever for opening to collateral attack a discretionary decision of the PTO to accept a
document in accordance with the rules of the PTO.
V
MedImmune states that if this court affirms the district court on the patent counts, the
antitrust and unfair competition counts should be transferred to the Ninth Circuit. That
procedure would violate the jurisdictional assignment to the Federal Circuit. In Texas
American Oil Co. v. Department of Energy, 44 F.3d 1557, 1564 (Fed. Cir. 1995) (en banc)
the court explained the assignment to the Federal Circuit of "case" jurisdiction, in
recognition of the burdens of "issue" jurisdiction on litigants and on the courts.
As discussed in Christianson v. Colt Indus. Operating Corp., 486 U.S. 800 (1988),
the jurisdiction of the Federal Circuit is established by the well-pleaded complaint in the
district court, whereupon the Federal Circuit must exercise jurisdiction of all of the issues in
the case. In United States v. Hohri, 482 U.S. 64 (1987) the Court explained that the
Federal Circuit must take jurisdiction of the appeal of all issues when the complaint includes
any issue exclusively assigned to the Federal Circuit, in Hohri a nontax claim under the
Little Tucker Act. See also Atari, Inc. v. JS & A Group, Inc., 747 F.2d 1422, 1431 (Fed. Cir.
1984) (en banc) (Federal Circuit must exercise jurisdiction although only copyright issue
was appealed). In Holmes Group, Inc. v. Vornado Air Circulation Systems, Inc., 535 U.S.
826, 829 (2002) the Court confirmed that the jurisdiction of the Federal Circuit arises from
the complaint, and that the entire appeal is directed to the regional circuit when the patent
count arose only by counterclaim. Similarly, when patent claims are included in order to
04-1300, -1384 16
manipulate the direction of the appeal, or are eliminated at the threshold of the pleading
stage, the entire appeal is properly taken to the regional circuit. E.g., Chamberlain Group,
Inc. v. Skylink Techs. Inc., 381 F.3d 1178, 1189-90 (Fed. Cir. 2004); Schwartzopf Dev.
Corp. v. Ti-Coating, Inc., 800 F.2d 240, 245 (Fed. Cir. 1986) (referring to "the transient
appearance of the [patent] counterclaim"). In all cases, the purpose is to avoid the burdens
of dividing the appeal between two circuits. See Texas American Oil, 44 F.3d at 1564. It
would be contrary to this careful balance and efficient design for the Federal Circuit to
decide part of an appeal and then, depending on the outcome of that part, to ship the
residue to another circuit.4 The request to transfer part of this appeal to the Ninth Circuit is
denied.
We have considered all of the arguments raised by MedImmune. The decision of
the district court is
AFFIRMED.
4 We take note of the dissent's argument that the case should now be sent to
the Ninth Circuit for decision of the Walker Process and other patent/antitrust issues raised
by the appellant, on the theory that the complaint should, after this appellate decision, be
deemed to have been "constructively amended" to have been filed without the patent
counts of the complaint. Neither statute nor precedent provides support for such a
procedure, and indeed they weigh heavily against it. In none of the "authority" mentioned
by the dissent was the complaint subject to retrospective amendment of well-pleaded
issues after the legal status of the parties had been altered. The Court in Christianson v.
Colt confirmed that jurisdiction "is determined by reference to the well-pleaded complaint,
not the well tried case." 486 U.S. at 814; see also Holmes Group v. Vornado Air Circulation
Sys., Inc., 535 U.S. 826, 832, n.3 (2002). The purpose of the rule is to determine
jurisdiction at the outset of litigation, to avoid throwing the parties into "a perpetual game of
jurisdictional ping-pong." Id. at 818. To bifurcate an appeal after some of the issues are
decided offers the worst of all possibilities, for it would not be known whether some issues
would be shipped elsewhere, to be redocketed and rebriefed and reargued and reappealed,
until after the Federal Circuit decided other issues. Such a situation is devoid of support.
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United States Court of Appeals for the Federal Circuit
04-1300, -1384
MEDIMMUNE, INC.,
Plaintiff-Appellant,
v.
GENENTECH, INC.,
Defendant-Appellee,
and
CITY OF HOPE,
Defendant-Appellee,
and
CELLTECH R&D, LTD.,
Defendant-Appellee.
CLEVENGER, Circuit Judge, dissenting in part.
MedImmune, Inc. ("MedImmune") paid, and continues to pay, royalties under a
1997 licensing agreement with Genentech, Inc. ("Genentech"), which entitles
MedImmune to produce and sell its humanized monoclonal antibody, Synagis®, free
from liability under U.S. Patent No. 6,331,415 ("Cabilly II" or "the '415 patent").
Because MedImmune's good standing under the agreement necessarily quells any
reasonable apprehension of an infringement suit brought by Genentech pursuant to the
'415 patent, I agree with the court that the declaratory judgment claims properly were
dismissed for want of jurisdiction. Indeed, the district court's dismissal is required by our
prior decisions in Gen-Probe, Inc. v. Vysis, Inc., 359 F.3d 1376 (Fed. Cir. 2004) and
MedImmune, Inc. v. Centocor, Inc., 409 F.3d 1376 (Fed. Cir. 2005). I write separately,
however, to voice my disagreement with the court's refusal to transfer the remainder of
the case to the Court of Appeals for the Ninth Circuit, pursuant to 28 U.S.C. § 1631, for
a determination as to whether the district court properly granted summary judgment
regarding MedImmune's antitrust and unfair competition claims.
Under 28 U.S.C. § 1295(a)(1), this court has exclusive jurisdiction over an appeal
from a final decision of a district court, so long as the district court's jurisdiction was
based in whole or in part upon 28 U.S.C. § 1338. See Apotex, Inc. v.
Thompson, 347 F.3d 1335, 1342 (Fed. Cir. 2003) (stating that if the district court had
jurisdiction over at least one claim in the case under section 1338, then this court has
appellate jurisdiction over the entire case). Section 1338(a) in turn provides that a
district court shall have original jurisdiction over any civil action arising under an Act of
Congress relating to patents. The "well-pleaded complaint" rule defines what "arising
under" means. See Holmes Group v. Vornado Air Circulation Sys., Inc., 535 U.S. 826,
833-34 (2002). "Under the well-pleaded complaint rule, as appropriately adapted to
§ 1338(a), whether a claim 'arises under' patent law must be determined from what
necessarily appears in the plaintiff's statement of his own claim in the bill or declaration,
unaided by anything alleged in anticipation or avoidance of defenses which it is thought
the defendant may interpose." Christianson v. Colt Indus. Operating Corp., 486 U.S.
800, 809 (1988) (internal quotation marks omitted). The focus of our jurisdictional
inquiry should thus be upon MedImmune's complaint and whether, as ultimately
04-1300, -1384 2
amended, it arises under an Act of Congress relating to patents. See Chamberlain
Group v. Skylink Tech., Inc., 381 F.3d 1178, 1189 (Fed. Cir. 2004). As ultimately
amended, I would hold that it does not.
Our precedent mandates this conclusion. First, we have stated that a dismissal
for lack of subject matter jurisdiction is usually one without prejudice because the
dismissing court has no power to render a judgment on the merits of the dismissed
claim. Textile Prods., Inc. v. Mead Corp., 134 F.3d 1481, 1486 (Fed. Cir. 1998). Such
is the case here, and nothing about the district court's dismissal bars MedImmune from
refiling its complaint. See Semtek Int'l Inc. v. Lockheed Martin Corp., 531 U.S. 497,
505-06 (2001) ("The primary meaning of 'dismissal without prejudice,' we think, is
dismissal without barring the defendant from returning later, to the same court, with the
same underlying claim."). Second, we have held, in a decision that binds this panel,
that dismissals without prejudice are "de facto amendments," or "constructive
amendments," to the complaint. See Nilssen v. Motorola, Inc., 203 F.3d 782, 784-
85 (Fed. Cir. 2000) (noting that regardless of whether the patent claims were dismissed
without prejudice or extinguished by amendment, the effect is the same because in
either case the parties are left in the same legal position with respect to the patent
claims as if they had never been filed); Gronholz v. Sears, Roebuck & Co., 836 F.2d
515, 516, 518 (Fed. Cir. 1987) (holding that plaintiff's voluntary dismissal of the patent
claim without prejudice constituted an amendment to the complaint and that the suit no
longer arose under the patent laws for jurisdictional purposes). Third, for jurisdictional
determinations, we do not differentiate between actual and constructive amendments—
04-1300, -1384 3
"both divest us of jurisdiction if they eliminate all issues of patent law." Chamberlain
Group, 381 F.3d at 1189.
Therefore, because the district court's dismissal of MedImmune's declaratory
judgment claims without prejudice is equivalent for jurisdictional purposes to an
amendment removing the declaratory judgment claims from the complaint, and because
no other claims in MedImmune's complaint "arise under" patent law, the district court's
dismissal eliminates all issues of patent law from MedImmune's well-pleaded complaint
and thus divests this court of jurisdiction over the case. Where a plaintiff lacks standing
to pursue a patent law claim, as in this case, we have no jurisdiction over the remaining
claims and must transfer the case to an appropriate court of appeals. See Fieldturf v.
Southwest Recreational Indus., 357 F.3d 1266, 1267 (Fed. Cir. 2004). Indeed,
MedImmune itself understands that a transfer is required if we affirm the absence of
jurisdiction over the declaratory judgment claims. (Appellant's Reply Br. at 12 n.8.)
Finding no jurisdiction, I would transfer the case to the Court of Appeals for the
Ninth Circuit, pursuant to 28 U.S.C. § 1631, for a determination as to whether the district
court properly granted summary judgment regarding MedImmune's antitrust and unfair
competition claims. See Christianson, 486 U.S. at 818-19 (noting that the Federal
Circuit erred in deciding to reach the merits of plaintiff’s antitrust claims after concluding
that it lacked jurisdiction).
As the majority correctly notes, our jurisdiction is determined by the complaint.
Where a patent law issue permeates the complaint, the "case" is ours, and all "issues,"
including non-patent law issues, remain with us for decision. But when the complaint
04-1300, -1384 4
contains nary a whiff of patent law, as is the situation with the amended complaint in this
case, we are powerless to adjudicate the other issues in the case.
To be sure, transfer to another circuit court involves some inconvenience to the
parties and a burden on the courts. But inconvenience and burden are insufficient
reasons to violate a fundamental limitation on federal courts: the power of judicial review
vests only where jurisdiction lies.
04-1300, -1384 5