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IN RE BRISTOL-MYERS SQUIBB COMPANY - FTC LITIGATION Click to find out why . . .



Keywords & Phrases
CaseNo: IRBMSCFL258627, CourtCode: FED, CourtName: FEDERAL TRADE COMMISSION II, State: DE Delaware, UniqueCaseRef: LCD>IRBMSCFL258627, Bms, Patent, Drug, Competition, Agreement, Taxol, Respondent Bms, Commission, Complaint, Entry, Act, Fda, Federal Trade Commission, Buspar, Orange Book, Platinol, Anda, Branded Drug, Listing, Buspirone, Settlement, Pto, Market, Anda Filer, Complaint Charges, Nda Holder, Patent Infringement, Drug Product, Matter, United States, Consent Agreement, Bristol-myers Squibb, Trade Commission Act, Pharmaceuticals, Proposed Consent Order, District Court, Generic Applicant, Certification, Nda , ContentID: 120254686

Case Documents
1   DECISION AND ORDER
[ see first page and extracted highlights below  ] ItemID: 131745
13 pages
PDF
2   COMPLAINT
[ see first page and extracted highlights below  ] ItemID: 131744
25 pages
PDF
3   AGREEMENT CONTAINING CONSENT
[ see first page and extracted highlights below  ] ItemID: 131742
3 pages
PDF
4 2000-05 ANALYSIS
[ see first page and extracted highlights below  ] ItemID: 131743
21 pages
HTML
Total Documents: 4 documents , 62 pages
Price: $ 34.95


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1 . DECISION AND ORDER

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.

SNIPPETS:
  • BEFORE FEDERAL TRADE COMMISSION
  • BRISTOL-MYERS SQUIBB COMPANY,
  • The Commission, having thereafter considered the matter and having determined that it had 16 C.F.R. § 2.34, the Commission hereby issues its Complaint, makes the following jurisdictional
  • Respondent BMS is a corporation organized, existing, and doing business under and by virtue
  • "Respondent BMS" means Bristol-Myers Squibb Company, its directors, officers,
  • F. "AB-rated Generic Version" means an ANDA found by the FDA to be bioequivalent
  • to the Referenced Drug Product, as defined under 21 U.S.C. § 355.
  • Sherman Act, 15 U.S.C. § 1, or Section 5 of the Federal Trade Commission Act, 15
  • K. "ANDA Product" means the product to be manufactured under the ANDA that is the subject of
  • L. "Applicable Law" means the statutes and regulations governing Orange Book listings,
  • P. "Expiration Date" means 180 days after the date that the ANDA First Filer commences
  • R. "Listing Information" means any statement or information of any type provided to the FDA
  • T. "NDA" means a New Drug Application, as defined under 21 U.S.C. § 355, including all
  • "Patent Infringement Claim" means any allegation, whether threatened or included in a
  • "Reference Drug Product" means the Drug Product identified by the ANDA Filer as the Drug
  • IT IS FURTHER ORDERED that Respondent BMS shall not seek, maintain, certify to, or take any
  • PROVIDED, HOWEVER, nothing in this paragraph shall preclude BMS from engaging in the conduct
  • it had a reasonable belief that the Material Patent Information
  • A violation of this subparagraph VII.D
  • A resolution or settlement of a Patent Infringement Claim in which:
  • A statement that the purpose of the Notification Letter is to give the

  • 2 . COMPLAINT

    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
    
    
    SNIPPETS:
  • BEFORE FEDERAL TRADE COMMISSION
  • Pursuant to the provisions of the Federal Trade Commission Act, 15 U.S.C. § 45, and by virtue ect as follows:
  • This matter concerns BMS's continuing pattern of anticompetitive conduct that delayed the
  • When threatened with imminent generic competition to these branded drug franchises ­ which
  • paid a would-be generic competitor millions of dollars to abandon its patent challenge and ly baseless patent infringement lawsuits in federal court against would-be generic competitors.
  • BuSpar is a brand-name prescription drug containing buspirone hydrochloride as its active
  • BMS obtained FDA approval to market BuSpar for the management of anxiety disorders or
  • With entry of generic buspirone in the U.S. market in late March 2001, BMS's U.S. BuSpar
  • Taxol is a brand-name prescription drug containing paclitaxel as its active pharmaceutical
  • It also establishes a process for a branded-drug company to address potential claims of
  • The FDA views its role in listing patents in the Orange Book as purely ministerial, because
  • With its ANDA, the generic drug applicant must provide certification to the FDA with respect
  • Upon making a Paragraph IV Certification, the generic applicant must provide notice of that
  • If, however, the patent owner or branded drug company files a patent infringement suit
  • The first ANDA filer to submit a Paragraph IV Certification for a branded drug product
  • BMS sued Schein and its subsidiary, Danbury, for patent infringement in the United States
  • BMS sought issuance from the PTO of a new patent, and obtained the patent just as ANDA filers
  • Schein (which Watson Pharmaceuticals, Inc. ("Watson") acquired in August 2000) was the first
  • The relevant product market in which to assess the anticompetitive effects of BMS's conduct
  • At all times relevant to this complaint, and until March 2001, when generic buspirone

  • 3 . AGREEMENT CONTAINING CONSENT

    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
    
    
    SNIPPETS:
  • BEFORE FEDERAL TRADE COMMISSION
  • The Federal Trade Commission, having initiated an investigation of certain acts and practices
  • Proposed Respondent BMS is a corporation organized, existing, and doing business
  • If this Consent Agreement is accepted by the Commission it, together with the draft of
  • The Commission thereafter may either withdraw its acceptance of this Consent Agreement and so
  • This Consent Agreement is for settlement purposes only and does not constitute an admission
  • This Consent Agreement contemplates that, if it is accepted by the Commission, and if such to.
  • When so entered, the Decision and Order shall have the same force and effect, and may be
  • Proposed Respondent waives any right it may have to any other manner of service.
  • Proposed Respondent has read the draft of Complaint and the Decision and Order contemplated
  • it will be required to file one or more compliance reports showing that
  • each violation of the Decision and Order after the Decision and Order becomes final.

  • 4 . ANALYSIS

    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
    
    SNIPPETS:
  • The Federal Trade Commission has accepted for public comment an agreement and proposed
  • The proposed consent order would settle charges that BMS engaged in a series of unlawful acts
  • The proposed consent order has been entered into for settlement purposes only and does not
  • The complaint charges that BMS engaged in a series of anticompetitive acts over the past
  • According to the complaint, when confronted with imminent competition to these drugs through efore the U.S. Patent and Trademark Office to obtain patents; and filing baseless patent
  • As a result, the complaint alleges, consumers were forced to incur hundreds of millions of
  • Restoration Act of 1984, commonly referred to as the "Hatch-Waxman Act," to facilitate the
  • The FDA lists the approved drug and its related patents in a publication entitled "Approved
  • If the PTO grants a patent relating to an approved drug after the NDA has been approved, and
  • As part of the ANDA process, the ANDA filer must certify to the FDA regarding its generic
  • If the holder of patent rights files a patent infringement suit within 45 days of the
  • In the case of patents not eligible for listing in the Orange Book, a branded firm still can
  • The data received by the Commission showed that brand-name companies are increasingly listing
  • If patents issued to the brand-name company are listed before the generic applicant files its
  • The complaint charges that BMS first entered into an unlawful patent settlement agreement, in
  • the complaint alleges that BMS filed baseless patent infringement suits against generic
  • According to the complaint, the relevant geographic market in which to assess the competitive
  • The NDA holder can exploit the listing scheme by obtaining patents and listing them in the
  • The proposed order has been placed on the public record for 30 days in order to receive
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