The opinion of the court was delivered by: Walls, District Judge.
Bristol-Myers Squibb ("Bristol"), a drug manufacturer, has sued
Zenith Goldline and IVAX Corporation for infringement of two
patents*fn1 owned by Bristol that claim methods of using the
anti-cancer drug Taxol®, a drug based on a natural agent known as
paclitaxel. The plaintiff alleges that Zenith Goldline, with the
assistance of IVAX, has filed Abbreviated New Drug Application
("ANDA") 75-297 with the Food and Drug Administration, to request
approval to market paclitaxel. Bristol claims that the filing of
the ANDA constitutes infringement of Bristol's rights under U.S.
Patent No. 5,641,803 ("the '803 patent") and No. 5,670,537 ("the
'537 patent"), pursuant to the Hatch-Waxman Act,
35 U.S.C. § 271(e)(2)(A).
Zenith Goldline and Baker Norton (a subsidiary of IVAX
Corporation) assert numerous counterclaims based on federal
antitrust provisions and state law. The counterclaimants name
causes of action for unfair competition (Count I), estoppel
(Count II) and violations of the Sherman Act, 15 U.S.C. § 2
(Counts III and IV), and seek declaratory judgment (Count V).
Bristol now moves pursuant to Fed. R.Civ.P. 12(b)(6) to dismiss
all counterclaims of Baker Norton, and the estoppel claim (Count
II) of Zenith Goldline. Bristol also moves to dismiss Zenith
Goldline's counterclaims to the extent that they relate to
allegations of conduct immunized by the Noerr-Pennington doctrine
(portions of Counts I, II, III, and IV), and to strike such
portions of the pleadings pursuant to Fed.R.Civ.P. 12(f).
These motions, decided without oral argument pursuant to
Fed.R.Civ.P. 78, are granted.
Paclitaxel is the FDA-designated generic term for an
anti-cancer agent derived from the bark of the Pacific Yew tree.
Its anti-cancer properties were discovered and developed by
researchers at the National Cancer Institute ("NCI"), an
institute of the National Institutes of Health ("NIH"), beginning
in the 1960's. During this period, the federal government
developed techniques to extract paclitaxel from yew tree bark and
to create a clinically acceptable formulation for treating
In the early 1980's, the NCI conducted research and clinical
trials concerning the use of paclitaxel to treat ovarian cancer.
Eventually, the agency sought a commercial partner to bring a
paclitaxel-based drug to market, and in 1991 the NCI and Bristol
entered into a Cooperative Research and Development Agreement
("CRADA") pursuant to the Federal Technology Transfer Act,
15 U.S.C. § 3710a(b).
In 1991 and 1993, Congress held investigatory hearings to
determine the extent of Bristol's power to exclude competition
pursuant to the CRADA, and to examine Bristol's pricing
arrangements. Bristol made various oral and written statements
during these hearings.
Beginning in 1991, purportedly relying on public assurances by
Bristol not to block competition in the development of
paclitaxel-related drugs, Baker Norton began to conduct clinical
trials involving the use of paclitaxel to treat breast cancer. In
1995, Baker Norton learned that the NCI had obtained U.S. Patent
No. 5,496,846 ("the '846 patent"), known as the Wilson patent,
which described the use of paclitaxel to treat breast cancer.
Accordingly, Baker Norton sought a nonexclusive license to this
patent in the spring of 1996 and formally applied to the NIH in
September 1996. Soon after, NIH informed Baker Norton that no
license was available because the agency had determined that the
Wilson patent was a subject invention of the CRADA. And because
Bristol had exercised its option under the CRADA for an exclusive
license to this patent, Baker Norton's application was rejected.
Countercl. ¶¶ 45-60.
Baker Norton, seeking to market a paclitaxel-based drug to
treat Kaposi's sarcoma, a life-threatening form of cancer that
often strikes persons with AIDS, developed and tested Paxene®, a
paclitaxel-based drug. The counterclaimants allege that through
Baker Norton's application to the NIH for a license to the Wilson
patent, Bristol improperly learned that Baker Norton was
preparing a New Drug Application to obtain "orphan drug"
exclusive marketing privileges regarding the treatment of
Kaposi's sarcoma. Countercl. ¶¶ 83-84. Orphan drug designation is
a form of non-patent marketing exclusivity granted by the FDA
pursuant to 21 U.S.C. § 360bb to encourage the development of
drugs to treat rare diseases or conditions. The counterclaimants
allege that in February 1997, with the assistance of data from
NCI researchers, Bristol submitted to the FDA its own application
for orphan drug status and a supplemental New Drug Application.
Countercl. ¶ 89. These applications were approved, and Bristol
was granted a seven-year period of marketing exclusivity. As a
result, Baker Norton's New Drug Application, submitted in March
1997, was approved, but Baker Norton was barred from marketing
Paxene® to treat patients with Kaposi's sarcoma until 2004.
Countercl. ¶¶ 92-93.
I. Standard for a Motion to Dismiss
On a motion to dismiss pursuant to Fed. R.Civ.P. 12(b)(6), the
court is required to accept as true all allegations in the
counterclaims, and all reasonable inferences that can be drawn
therefrom, and to view them in the light most favorable to the
non-moving parties. See Oshiver v. Levin, Fishbein, Sedran &
Berman, 38 F.3d 1380, 1384 (3rd Cir. 1994). The question is
whether the claimants can prove any set of facts consistent with
their allegations that will entitle them to relief, not whether
they will ultimately prevail. Hishon v. King &
Spalding, 467 U.S. 69, 73, 104 S.Ct. 2229, 81 L.Ed.2d 59
(1984). While a court will accept well-pleaded allegations as
true for the purposes of the motion, it will not accept
unsupported conclusions, unwarranted inferences, or sweeping
legal conclusions cast in the form of factual allegation. See
Miree v. DeKalb County, Ga., 433 U.S. 25, 27 n. 2, 97 S.Ct.
2490, 53 L.Ed.2d 557 (1977). The Court may consider the
allegations of the pleadings, as well as documents attached or
specifically referenced thereto, and matters of public record.
See Pittsburgh v. West Penn Power Co., 147 F.3d 256, 259 (3rd
Cir. 1998); see also 5A Charles A. Wright & Arthur R. Miller,
Federal Practice & Procedure § 1357 at 299 (2nd ed. 1990).
II. The Noerr-Pennington Doctrine
Bristol moves to dismiss certain allegations of the
counterclaims for state law unfair competition (Count I),
monopolization in violation of Section 2 of the Sherman Act,
15 U.S.C. § 2 (Count III), and attempted monopolization (Count IV).
As the counterclaim defendant, Bristol maintains that because any
injury to Baker Norton was the result of Bristol's valid efforts
to obtain government action, such efforts are immunized from
federal antitrust and state law liability by the Noerr-Pennington
According to Bristol, Zenith Goldline does not have standing to
assert counterclaim allegations that Bristol carried out a
"scheme" to monopolize profits from paclitaxel-based drugs: The
relevant counterclaims assert in part that Bristol interfered
with Baker Norton's ability to obtain a license to the Wilson
patent and secure immediate FDA approval to market paclitaxel.
Admittedly, these allegations do not concern Zenith Goldline.
However, the counterclaimants also allege that Bristol obtained
patents by fraud and inequitable conduct, illegally obtained
exclusive patent licenses and is currently asserting invalid
patents to the detriment of Zenith Goldline. The court cannot
readily disentangle the respective counterclaims of Baker Norton
and Zenith Goldline. Because Bristol has made no other arguments
concerning the standing issue, the court treats these
counterclaims as they were asserted, that is, by both
The Supreme Court in Eastern R.R. Presidents Conference v.
Noerr Motor Freight, Inc., 365 U.S. 127, 81 S.Ct. 523, 5 L.Ed.2d
464 (1961), ruled that federal antitrust liability did not arise
from a publicity campaign by railroad companies directed toward
obtaining legislation favorable to railroads and destructive of
the business interests of competitor trucking companies. The
Court held that such a result was necessary to protect the First
Amendment right to petition the government. It reasoned that such
actions are "not business activity, but political activity," and
found that while violations of the Sherman Act typically involve
"express or implied agreement or understanding that the
participants will give up their trade freedom, or help one
another to take away the trade freedom of others through the use
of such devices as price-fixing agreements, boycotts,
market-division agreements, and other similar arrangements,"
"where a restraint upon trade or monopolization is the result of
valid government action, as opposed to private action, no
violation of the Act can be made out." Id. at 136, 81 S.Ct.
The Noerr Court countenanced only one exception to immunity:
"There may be situations in which a publicity campaign,
ostensibly directed toward influencing government action, is a
mere sham to cover what is actually nothing more than an attempt
to interfere directly with the business relationships of a
competitor and the application of the Sherman Act would be
justified." Id. at 144, 81 S.Ct. 523.
The principles of Noerr and its companion, United Mine
Workers of America v. Pennington, 381 U.S. 657, 85 S.Ct. 1585,
14 L.Ed.2d 626 (1965), have since been extended to provide
immunity to private efforts to influence courts, federal and
state agencies. California Motor Transport Co. v. Trucking
Unlimited, 404 U.S.
508, 510, 92 S.Ct. 609, 30 L.Ed.2d 642 (1972).
The counterclaimants protest that this doctrine does not
immunize an entire course of wrongful acts simply because Bristol
requested government approval and licenses as part of its
allegedly tortious scheme. They rely on Allied Tube & Conduit
Corp. v. Indian Head, Inc. that the scope of antitrust
protection depends on the "source, context, and nature of the
anticompetitive restraint at issue." 486 U.S. 492, 499, 108 S.Ct.
1931, 100 L.Ed.2d 497 (1988) (holding that anticompetitive
actions of private standard-setting body could not be considered
either valid governmental action or "incidental" to a valid
effort to influence government action, and thus were subject to
antitrust scrutiny). "An anticompetitive, private tortious scheme
is not transformed into protected `political' activity simply
because a defendant submits an application to a government agency
for approval or authorization." Opp. Br. at 14; see Ticor Title
Ins. Co. v. F.T.C., 998 F.2d 1129 (3rd Cir. 1993) (refusing to
permit immunity where title insurance companies agreed
collectively to set uniform rates, though rates were subject to
approval by state-chartered rating bureaus; holding that "a
state's rubber stamp is not enough" to immunize private actions);
Litton Systems v. American Tel. and Tel. Co., 700 F.2d 785,
804-809 (2nd Cir. 1983) (rejecting NoerrPennington doctrine as
inapposite where telecommunications carrier had filed its rates
in a tariff with a federal agency because "[t]he fact that the
FCC might ultimately set aside a tariff filing does not transform
AT & T's independent decisions as to how it will conduct its
business into a `request' for governmental action or an
`expression' of political opinion.")
A. Sherman Act Counterclaims
Baker Norton and Zenith Goldline plead two counterclaims for
violations of the Sherman Act. They allege that Bristol
improperly obtained exclusive licenses to government-owned
patents and secured orphan drug exclusivity privileges: (1) to
block competition to market paclitaxel to breast cancer patients,
Bristol contracted with NCI for an exclusive license to the
Wilson patent (the '846 patent), by employing a "blatantly
incorrect" interpretation of Bristol's CRADA; and (2) once it
learned that Baker Norton was preparing to request FDA approval
of Paxene® to treat Kaposi's sarcoma, Bristol secured FDA
approval of its own supplemental NDA and request for orphan drug
exclusivity, which barred Baker Norton's ability to market
paclitaxel for that indication until 2004.
The counterclaimants also allege that Bristol secured patents
through inequitable conduct and fraud on the Patent and Trademark
Office, attempted to enforce invalid patents, and brought
litigation to exclude Baker Norton and Zenith Goldline from the
paclitaxel market. Bristol does not move to dismiss these Walker
1. Whether Bristol Engaged in Protected Petitioning Activity
Responding to Bristol's motion to dismiss, the counterclaimants
contend that Bristol's conduct did not constitute protected
political petitioning activity. Opp. Br. at 15 n. 10. The court
does not agree. "Petitioning activity takes many forms. . . .
Lobbying legislators or executive agency officials for
advantageous changes in business laws or regulations, filing suit
to enjoin an ex-employee from disseminating trade secrets,
completing a questionnaire promulgated by a judicial commission
rating candidates' fitness for judicial office, testifying at a
zoning hearing before the county commissioners, complaining to
appropriate county officials about unfit teachers or about police
misconduct, and reporting violations of environmental laws ...