001 0221011 0046021 0181UNITED STATES OF AMERICABEFORE FEDERAL TRADE COMMISSION
COMMISSIONERS:Timothy J. Muris, ChairmanSheila F. AnthonyMozelle W. ThompsonOrson SwindleThomas B. LearyIn the Matter of
BRISTOL-MYERS SQUIBBCOMPANY,
a corporation.
Docket No. C-4076DECISION AND ORDER
The Federal Trade Commission (“Commission”) having initiated an investigation of certain actsand 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 of Competition proposed to present to the Commission for its consideration and which, if issued by theCommission, would charge Respondent with violations of Section 5 of the Federal Trade CommissionAct, as amended, 15 U.S.C. § 45; andRespondent, its attorneys, and counsel for the Commission having thereafter executed anAgreement Containing Consent Order (“Consent Agreement”), containing an admission by Respondentof all the jurisdictional facts set forth in the aforesaid draft of Complaint, a statement that the signing of said Consent Agreement is for settlement purposes only and does not constitute an admission byRespondent that the law has been violated as alleged in such Complaint, or that the facts as alleged insuch Complaint, other than jurisdictional facts, are true, and waivers and other provisions as requiredby the Commission’s Rules; andThe Commission, having thereafter considered the matter and having determined that it hadreason to believe that Respondent has violated the said Act, and that a Complaint should issue statingits charges in that respect, and having accepted the executed Consent Agreement and placed suchConsent Agreement on the public record for a period of thirty (30) days for the receipt and
2consideration of public comments, now in further conformity with the procedure prescribed inCommission Rule § 2.34, 16 C.F.R. § 2.34, the Commission hereby issues its Complaint, makes thefollowing jurisdictional findings and issues the following Decision and Order (“Order”):1.Respondent BMS is a corporation organized, existing, and doing business under and byvirtue of the laws of the state of Delaware, with its office and principal place of business located at 345Park Avenue, New York, N.Y. 10154.2.The Federal Trade Commission has jurisdiction of the subject matter of this proceedingand of Respondent, and the proceeding is in the public interest.
ORDERI.IT IS ORDERED
that for the purposes of this Order, the following definitions shall apply:A.“Respondent BMS” means Bristol-Myers Squibb Company, its directors, officers,employees, agents and representatives, predecessors, successors, and assigns; and thesubsidiaries, divisions, groups, and affiliates controlled by Bristol-Myers SquibbCompany, and the respective directors, officers, employees, agents andrepresentatives, successors, and assigns of each.B.“Commission” means the Federal Trade Commission.C.“180-day Exclusivity Period” means the period of time established by 21 U.S.C.§ 355(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355
et seq
.).D.“6-Hydroxy-Metabolite of Buspirone” means 6-hydroxy-8-[4-[4-(2- pyrimidinyl)-piperazinyl]-butyl]-8-azaspiro[4.5]-7,9-dione.E.“30-Month Stay” means the period of time, established by 21 U.S.C.§ 355(j)(5)(B)(iii), during which the FDA may not grant final approval to an ANDA.F.“AB-rated Generic Version” means an ANDA found by the FDA to be bioequivalentto the Referenced Drug Product, as defined under 21 U.S.C. § 355(j)(8)(B).
3G.“Agreement” means anything that would constitute an agreement under Section 1 of theSherman Act, 15 U.S.C. § 1, or Section 5 of the Federal Trade Commission Act, 15U.S.C. § 45.H.“ANDA” means an Abbreviated New Drug Application, as defined under 21 U.S.C. §355(j).I.“ANDA Filer” means a person who has filed or submitted an ANDA with the FDA.J.“ANDA First Filer” means the person whom the FDA determines is and remainsentitled to, or eligible for, a 180-day Exclusivity Period that has not expired.K.“ANDA Product” means the product to be manufactured under the ANDA that is thesubject of the Patent Infringement Claim.L.“Applicable Law” means the statutes and regulations governing Orange Book listings,including, but not limited to, 21 U.S.C. § 355(b)(1) and (c)(2) and 21 C.F.R.§ 314.53(b) and (c).M.“Drug Product” means a finished dosage form (e.g., tablet, capsule, or solution), asdefined in 21 C.F.R. § 314.3(b), that contains a drug substance, generally, but notnecessarily, in association with one or more other ingredients.N.“Encourage” means suggest, advise, pressure, induce, attempt to induce, prompt, orotherwise influence.O.“Exclusive License” means a license of intellectual property that (a) restricts the right of the licensor to license the intellectual property to other persons, (b) reduces theincentives of the licensor to license the intellectual property to other persons, or (c)grants to the licensee the right to enforce the intellectual property rights against otherpersons.P.“Expiration Date” means 180 days after the date that the ANDA First Filer commencescommercial marketing of (1) the ANDA Product, (2) the Reference Drug Product, or(3) any other AB-Rated Generic Version of the Reference Drug Product.Q.“FDA” means the United States Food and Drug Administration.R.“Listing Information” means any statement or information of any type provided to theFDA in furtherance of the listing or continued listing of any patent in the Orange Book,
Search History:
Result 00 of 00
00 results for result for
p.
More From This User
Notes
Load more
