United States District Court, D. Maryland
L. Russell, III United States District Judge
MATTER is before the Court on Defendants Actelion
Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc., and
Janssen Research & Development LLC's(collectively,
“Actelion”) Motion to Dismiss Pursuant to
12(b)(6) for Failure to State a Claim (ECF No. 39). The
Motion is ripe for disposition, and no hearing is necessary.
See Local Rule 105.6 (D.Md. 2018). For the reasons
outlined below, the Court will grant the Motion.
is a pharmaceutical company that produces and sells Tracleer,
the brand name for the drug bosentan, which is used to treat
pulmonary artery hypertension (“PAH”). (Pls.'
Consol. Class Action Compl. & Demand for Jury Trial
[“Am. Compl.”] ¶ 1, ECF No. 34). PAH is a
disorder in which elevated blood pressure causes narrowing of
the arteries between the heart and lungs, restricting blood
flow and causing extra strain on the heart. (Id.).
PAH is relatively rare, affecting between 10, 000 and 20, 000
people in the United States, but it is chronic and
potentially fatal. (Id.).
at Hoffman-LaRoche Inc. (“Roche”) discovered and
developed bosentan in the 1990s. (Id. ¶ 92). In
1992, the co-inventors of bosentan submitted a patent
application to the U.S. Patent and Trademark Office
(“PTO”). (Id. ¶ 93). In 1994, the
PTO issued the patent for bosentan (the “Patent”)
and assigned it to Roche. (Id. ¶ 94). In 1997,
Roche assigned the Patent to Actelion-which was founded by a
small group of former Roche scientists and managers-giving
Actelion the exclusive right to develop, make, and sell
products covered by the Patent. (Id. ¶ 97).
Actelion has been the sole licensee of the Patent since 1997.
2000, Actelion sought approval from the U.S. Food and Drug
Administration (“FDA”) to sell tablets of
bosentan under the tradename Tracleer for the treatment of
PAH. (Id. ¶¶ 98-99). At the time, there
were no approved oral treatments for PAH. (Id.
¶ 101). The FDA approved Tracleer for treatment of PAH
on November 20, 2001. (Id. ¶ 107). In approving
Tracleer, the FDA granted Actelion two regulatory
exclusivities: first, because Tracleer was a new chemical
entity, Actelion would have regulatory exclusivity until
November 20, 2006; and second, the FDA deemed Tracleer an
“orphan drug, ” giving Actelion an additional two
years of market exclusivity. (Id. ¶ 108). These
regulatory exclusivities guaranteed that Actelion would not
face competition to Tracleer from generics until November 20,
2008 at the earliest. (Id. ¶¶ 108, 117).
Further, Actelion would have patent exclusivity over Tracleer
until the Patent expired on November 20, 2005. (Id.
¶¶ 96, 109).
receiving FDA approval, Actelion launched the Tracleer Access
Program (“TAP”), which limited sales of Tracleer
to purchasers who agreed to certain limitations on the use of
the drug. (Id. ¶¶ 111, 124, 126). In 2009,
the FDA approved a Risk Evaluation and Mitigation Strategy
(“REMS”) for Tracleer. (Id. ¶ 118).
The REMS provided that “Tracleer is available only
through a special restricted distribution program called
[TAP]” and “Tracleer may be dispensed only to
patients who are enrolled in and meet all conditions of
[TAP].” (Id. ¶ 120). The REMS also
explained that only prescribers and pharmacies registered
with TAP may prescribe and distribute Tracleer. (Id.
in 2009, various generic drug manufacturers-Zydus
Pharmaceuticals (USA) Inc. (“Zydus”) and its
partner Cadila Healthcare Ltd. (“Cadila”),
Apotex, Inc. (“Apotex”), Actavis, Inc.
(“Actavis”), and Roxane Laboratories, Inc.
(“Roxane”) (collectively, the
“Generics”)-sought to purchase samples of
Tracleer from Actelion's certified distributors and
wholesalers in order to conduct bioequivalence testing, which
is a prerequisite to FDA approval of the generic version of
the brand-name drug. (See id. ¶¶ 42-52,
130, 138-58, 161-72). In their requests, the Generics
indicated they would be willing to pay market price for
Tracleer and comply with any limitations in Tracleer's
TAP and REMS. (Id. ¶¶ 140, 143-44, 146,
150, 153, 162, 169). Nonetheless, Actelion and its certified
distributors and wholesalers repeatedly denied the
Generics' requests to purchase Tracleer. (Id.
¶¶ 138-39, 141, 152, 154-55, 157, 165-66). At the
time, Actelion advanced two primary reasons for its refusal
to sell Tracleer to the Generics: (1) Actelion sought to
protect its intellectual property rights; and (2) providing
Tracleer to Generics would violate the REMS' distribution
restrictions. (Id. ¶ 170; see also id.
¶¶ 152, 155, 157, 166). Without access to samples
of Tracleer, the Generics were unable to conduct
bioequivalence studies, and therefore could not seek approval
of generic bosentan from the FDA. (See id. ¶
September 2012, Actelion sued Apotex and Roxane in the U.S.
District Court for the District of New Jersey, seeking a
declaration that Actelion had no duty to supply Tracleer
samples to prospective generic competitors and that doing so
would be in violation of the REMS for Tracleer. (Id.
¶¶ 173-76). Apotex and Roxane filed counterclaims
against Actelion in November 2012, alleging that
Actelion's refusal to distribute samples of Tracleer for
bioequivalence testing constituted an abuse of monopoly power
in violation of federal and state antitrust laws and FDA
regulations. (Id. ¶¶ 177-86). The same
month, Actavis moved to intervene, complaining that Actelion
refused to sell Tracleer in order to block or delay generic
competition. (Id. ¶¶ 187-88).
January 16, 2013, Actelion moved to dismiss Apotex, Roxane,
and Actavis's counterclaims. (Id. ¶ 189).
In May 2013, while Actelion's motion to dismiss was still
pending, Apotex again requested Tracleer samples from
Actelion, this time attaching a recent letter from the FDA
approving the safety protocols used in Apotex's
bioequivalence testing. (Id. ¶ 199). As it had
done before, Actelion refused Apotex's request.
(Id.). Zydus and Cadila intervened in the litigation
on July 9, 2013 on the grounds that Actelion had also denied
them access to Tracleer samples. (Id. ¶ 200).
court denied Actelion's motion to dismiss on October 17,
2013. (Id. ¶ 206). On November 1, 2013,
Actelion settled with Apotex on undisclosed terms, and Apotex
dismissed its claims and counterclaims with prejudice.
(Id. ¶ 212). Actelion settled with the
remaining Generics on undisclosed terms in February 2014.
(Id. ¶ 213).
Patent expired on November 20, 2015, ending Actelion's
legal exclusivity over bosentan. (Id. ¶¶
1, 109). To date, there is no generic version of bosentan
available on the market. (Id. ¶ 1).
Mayor & City Council of Baltimore (the
“City”) filed its initial Complaint against
Actelion on November 19, 2018. (ECF No. 1). Upon the City and
Government Employees Health Association's
(“GEHA”) unopposed Motion for Consolidation and
Appointment of Interim Class Counsel (ECF No. 32), this Court
consolidated Government Employee Health
Association v. Actelion Pharmaceuticals, Ltd., et al.,
No. 1:18-cv-3571-GLR (D.Md. filed Nov. 20, 2018) with the
present case on January 18, 2019. (ECF No. 33). On January
25, 2019, the City and GEHA (collectively, the “Named
Plaintiffs”) filed a Consolidated Class Action
Complaint and Demand for Jury Trial (“Amended
Complaint”) on behalf of the Named Plaintiffs and
similarly situated individuals in thirty states and U.S.
territories. (ECF No. 34). In their forty-six-count
Amended Complaint, Plaintiffs allege: unlawful refusals to
deal and attempts to monopolize in violation of § 2 of
the Sherman Act, 15 U.S.C. § 2 (2018) (Count 1);
violations of various state antitrust laws (Counts 2-26);
and violations of various state consumer protections
(Counts 27-46). (Am. Compl. ¶¶ 296-659). Plaintiffs
seek declaratory, injunctive, and equitable relief.
(Id at 74-124).
February 25, 2019, Actelion moved to dismiss Plaintiffs'
Amended Complaint for failure to state a claim. (ECF No. 39).
Plaintiffs filed an Opposition on March 27, 2019. (ECF No.
44). On April 11, 2019, Actelion filed its Reply. (ECF No.