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1
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DECISION AND ORDER
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EXTRACTED KEY WORDS
COMMISSION AGREEMENT PATENT ANDA DRUG PRODUCT MATTER FEDERAL TRADE COMMISSION TRADE COMMISSION ACT LAW COMPLAINT NDA PURPOSE PATENT INFRINGEMENT CLAIM PARAGRAPH FDA CONSENT AGREEMENT ANDA FILER SETTLEMENT JURISDICTIONAL FACTS VIOLATION THEREAFTER BRISTOL-MYERS SQUIBB COMPANY BRISTOL-MYERS SQUIBB ORANGE BOOK REFERENCE DRUG NDA HOLDER NOTIFICATION LETTER CONNECTION MATERIAL PATENT INFORMATION |
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
COMMISSIONERS: Timothy J. Muris, Chairman
Sheila F. Anthony
Mozelle W. Thompson
Orson Swindle
Thomas B. Leary
In the Matter of
Docket No. C-
BRISTOL-MYERS SQUIBB
COMPANY,
a corporation.
DECISION AND ORDER
The Federal Trade Commission ("Commission") having initiated an investigation of certain
and practices by Respondent Bristol-Myers Squibb Company ("Respondent BMS" or "Respondent"),
and Respondent having been furnished thereafter with a copy of a draft of Complaint that the Bureau
Competition proposed to present to the Commission for its consideration and which, if issued by the
Commission, would charge Respondent with violations of Section 5 of the Federal Trade Commission
Act, as amended, 15 U.S.C. § 45; and
Respondent, its attorneys, and counsel for the Commission having thereafter executed an
Agreement Containing Consent Order ("Consent Agreement"), containing an admission by Respondent
of all the jurisdictional facts set forth in the aforesaid draft of Complaint, a statement that the
said Consent Agreement is for settlement purposes only and does not constitute an admission by
Respondent that the law has been violated as alleged in such Complaint, or that the facts as
such Complaint, other than jurisdictional facts, are true, and waivers and other provisions as
by the Commission's Rules; and
The Commission, having thereafter considered the matter and having determined that it had
reason to believe that Respondent has violated the said Act, and that a Complaint should issue
its charges in that respect, and having accepted the executed Consent Agreement and placed such
Consent Agreement on the public record for a period of thirty (30) days for the receipt and
consideration of public comments, now in further conformity with the procedure prescribed in
Commission Rule § 2.34, 16 C.F.R. § 2.34, the Commission hereby issues its Complaint, makes the
following jurisdictional findings and issues the following Decision and Order ("Order"):
1. Respondent BMS is a corporation organized, existing, and doing business under and by
virtue of the laws of the state of Delaware, with its office and principal place of business
Park Avenue, New York, N.Y. 10154.
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2
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COMPLAINT
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EXTRACTED KEY WORDS
PATENT TAXOL BMS COMPETITION BUSPAR ENTRY ACT PLATINOL FDA BRANDED DRUG BUSPIRONE MARKET FEDERAL TRADE COMMISSION ANDA PTO ORANGE BOOK UNITED STATES DISTRICT COURT CERTIFICATION PACLITAXEL EXCLUSIVITY PERIOD PHARMACEUTICALS PATENT INFRINGEMENT BRISTOL-MYERS SQUIBB GENERIC APPLICANT TIMES RELEVANT ANTICOMPETITIVE EFFECTS ANDA FILERS EXPIRATION |
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
In the Matter of
Docket No. C-
BRISTOL-MYERS SQUIBB
COMPANY,
a corporation.
COMPLAINT
Pursuant to the provisions of the Federal Trade Commission Act, 15 U.S.C. § 45, and by
virtue of the authority vested in it by said Act, the Federal Trade Commission, having reason to
that respondent Bristol-Myers Squibb Company ("BMS") has violated and violates Section 5 of the
Federal Trade Commission ("FTC") Act, 15 U.S.C. § 45, and it appearing to the Commission that a
proceeding in respect thereof would be in the public interest, hereby issues this complaint,
charges in that respect as follows:
I. Nature of the Case
1. This matter concerns BMS's continuing pattern of anticompetitive conduct that delayed the
entry of generic drugs capable of competing with BMS's lucrative branded drug monopolies:
BuSpar, Taxol, and Platinol. When threatened with imminent generic competition to these
branded drug franchises which collectively garnered nearly $2 billion a year in revenues
BMS acted in a predatory fashion to forestall those competitive threats. BMS knew that
generic entry would decimate its sales, and that any delay in such entry would be highly
profitable for BMS, but very costly for consumers.
2. Over the course of the past decade, BMS engaged in a series of anticompetitive acts across
BuSpar, Taxol, and Platinol product lines. Among other things, BMS: paid a would-be
competitor millions of dollars to abandon its patent challenge and agree to withhold
until patent expiry; misled the United States Food and Drug Administration ("FDA") about
scope, validity, and enforceability of its patents and abused FDA regulations to block
entry; breached its duty of candor and good faith before the Patent and Trademark Office
("PTO") while pursuing patent applications purportedly related to the branded BMS products;
and filed objectively baseless patent infringement lawsuits in federal court against
generic competitors. BMS's pattern of conduct evidences a scheme to abuse competitive and
government processes for the purpose of maintaining its branded drug monopolies. As a
of these anticompetitive acts, BMS thwarted low-cost generic competition to these
for many months or years, forcing consumers to overpay by hundreds of millions of dollars for
vital prescription drug products.
II. Respondent Bristol-Myers Squibb Company
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3
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AGREEMENT CONTAINING CONSENT
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EXTRACTED KEY WORDS
CONSENT AGREEMENT COMMISSION COMPLAINT DRAFT ACCEPTANCE CONTEMPLATES FACTS LAW PROCEEDING ACTS SQUIBB COMPANY VIOLATION DISPOSITION WITHDRAW RESPECT THERETO PUBLIC RECORD PURSUANT PROPOSED RESPONDENT WAIVES JURISDICTIONAL FACTS BUSINESS HEREBY RELIEF PRACTICES FEDERAL TRADE COMMISSION COMPLIANCE MANNER COMMISSION RULE ADMISSION SETTLEMENT PURPOSES |
UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
COMMISSIONERS: Timothy J. Muris, Chairman
Sheila F. Anthony
Mozelle W. Thompson
Orson Swindle
Thomas B. Leary
In the Matter of FTC File Nos. 0010221 (Taxol)
0110046 (BuSpar)
BRISTOL-MYERS SQUIBB 0210181 (Cisplatin)
COMPANY,
a corporation.
AGREEMENT CONTAINING CONSENT ORDER
The Federal Trade Commission ("Commission"), having initiated an investigation of certain
and practices by Bristol-Myers Squibb Company, a corporation, hereinafter sometimes referred to as "
Proposed Respondent," and it now appearing that Proposed Respondent is willing to enter into an
Agreement Containing Consent Order to Cease and Desist ("Consent Agreement") from certain acts
and practices, and providing for other relief,
IT IS HEREBY AGREED by and between Proposed Respondent and its attorney, and
counsel for the Commission that:
1. Proposed Respondent BMS is a corporation organized, existing, and doing business
under and by virtue of the laws of the state of Delaware, with its office and
place of business located at 345 Park Avenue, New York, N.Y. 10154.
2. Proposed Respondent admits all the jurisdictional facts set forth in the draft of
Complaint here attached.
3. Proposed Respondent waives:
a. any further procedural steps;
b. the requirement that the Commission's Decision and Order, attached hereto
and made a part hereof, contain a statement of findings of fact and
of law;
c. all rights to seek judicial review or otherwise to challenge or contest the validity
of the Decision and Order entered pursuant to this Consent Agreement; and
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4
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ANALYSIS
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EXTRACTED KEY WORDS
PATENT DRUG AGREEMENT COMPLAINT COMPETITION COMMISSION LISTING ENTRY ACT FDA ORANGE BOOK SETTLEMENT COMPLAINT CHARGES TAXOL ANDA FILER FEDERAL TRADE COMMISSION NDA HOLDER PROPOSED CONSENT ORDER PATENT INFRINGEMENT FDA APPROVALS PTO LITIGATION PATENT INFRINGEMENT SUITS COMPLAINT ALLEGES HATCH-WAXMAN ANTICOMPETITIVE ACTS PUBLIC RECORD GENERIC APPLICANT PHARMACEUTICALS |
ANALYSIS TO AID PUBLIC COMMENT
In the Matter of Bristol-Myers Squibb Company
File Nos. 001 0221, 011 0046, and 021 0181
The Federal Trade Commission has accepted for public comment an
agreement and proposed consent order with Bristol-Myers Squibb
Corporation (BMS). The proposed consent order would settle charges
that BMS engaged in a series of unlawful acts to delay competition
from generic versions of three of its major drug products. The
proposed consent order has been placed on the public record for 30
days to receive comments by interested persons. The proposed consent
order has been entered into for settlement purposes only and does not
constitute an admission by BMS that it violated the law or that the
facts alleged in the complaint, other than the jurisdictional facts,
are true.
The complaint charges that BMS engaged in a series of anticompetitive
acts over the past decade to obstruct the entry of low-cost generic
competition to three highly profitable BMS prescription drug products:
BuSpar, an anti-anxiety agent; and two anti-cancer drugs, Taxol and
Platinol. According to the complaint, when confronted with imminent
competition to these drugs through generic entry, BMS undertook a
course of conduct that includes: paying a would-be competitor $72.5
million to abandon its challenge to a BMS patent and stay off the
market until the patent expired; abusing Food and Drug Administration
(FDA) regulations to block generic entry; making false statements to
the FDA in connection with listing patents in the Orange Book;
engaging in inequitable conduct before the U.S. Patent and Trademark
Office (PTO) to obtain patents; and filing baseless patent
infringement suits. As a result, the complaint alleges, consumers were
forced to incur hundreds of millions of dollars in additional costs to
obtain vital prescription drug products.
The proposed order is designed to remedy the pattern of unlawful
conduct charged in the complaint and prevent recurrence of such
conduct, while maintaining BMS's ability to engage in legitimate
activities that may promote innovation and benefit consumers.
Background
The proposed consent order rests in substantial part on charges that
BMS abused governmental processes to delay generic competition to
three of its highly successful prescription drug products and, in
particular, that it misused the regulatory scheme established by
Congress to expedite the approval of generic drugs.
A generic drug is a pharmaceutical product that contains the same
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