60271 antitrust bulletin

Hale and Dorr LLP
diseases with primary focus on women’s cancers and infectious diseases. Its core product (the only one of its kind) includes a DNA-based test for human papillomavirus (HPV), a virus believed to cause nearly all cervical cancer cases. Digene’s HPV test is a more targeted test for cervical cancer, used when Cytec’s Pap test results are ambiguous or borderline. The HPV test is most effectively performed by using residue from the original Pap test, but such reuse requires the liquid-based test manufacturer to obtain FDA approval for its samples to be later used with the Digene test.
Department of Justice Unravels
River’s MATRIXx products (with a follow-on option Obtaining such approval requires the two firms Distribution Agreement Among
to cooperate. Prior to the merger, Digene was Competitors
developing and marketing its own products.
cooperating with Cytec and Cytec’s only competitor.
MathWorks paid $11.5 million to Wind River, and Wind River Systems Inc. (Wind River) and The it effectively obtained control over the prices, According to the FTC, Digene is the only U.S.
MathWorks, Inc. (MathWorks) are competitors in marketing, support and future development of the development and sale of dynamic control the Wind River dynamic control system design Commission alleged that entry by other firms was system design software tools. These tools enable tools. Shortly after the agreement, MathWorks a remote possibility. Cytyc is one of two U.S.
engineers to develop computerized control systems announced its intention not to undertake any sources for liquid-based Pap tests and accounts for sophisticated devices, such as anti-lock brake further development of the MATRIXx products— for 93% of the market. Three other companies systems for automobiles, guidance and navigation thereby eliminating those products as a competitive have yet to begin clinical trials for their products.
control systems for unmanned spacecraft, and The FTC alleged that Cytec’s acquisition of Digene flight control systems for aircraft. By automating would result in Cytec being the only company On June 21, 2002 the Department of Justice filed the steps of modeling, analyzing, simulating, with FDA approval for sample reuse with Digene’s a civil antitrust lawsuit against MathWorks and testing and generating software code for these test. If this were true, Cytec’s competition would Wind River and simultaneously filed a proposed types of control systems, engineers can develop be substantially disadvantaged and likely driven consent decree that settled the lawsuit against For more information, contact Hale and Dorr’s them in a shorter time and at a much lower cost.
Wind River alone. The lawsuit alleged that the Antitrust and Trade Regulation Group.
MathWorks’ dynamic control system software is distribution agreement was a per se violation of Digene has also tested its HPV test as a primary called Simulink, and Wind River’s competing James C. Burling
Section 1 of the Sherman Act because it illegally screen for cervical cancer, both in conjunction product is called MATRIXx. The two product lines fixed prices and allocated and eliminated with Pap tests and as a stand-alone test, and is 617.526.6416
are reported to have competed for over 10 years.
competition in the dynamic control system design seeking FDA approval for such uses. If approved, software market. The Department alleged that the HPV test would become a direct competitor John C. Christie
River entered into a series of agreements, including the competition between MathWorks and Wind of Cytyc’s Pap tests. Therefore, the Commission a distribution agreement that gave MathWorks a River, which had existed prior to the distribution concluded that the merger would eliminate the 202.942.8403
30-month exclusive right to price and sell Wind possibility of any future competition between Michelle D. Miller
Princeton
This challenge is notable because conventional 617.526.6116
wisdom predicted that the present administration DOJ investigation unravels competitors’
FTC and GlaxoSmithKline battle over
would not likely be challenging mergers that were This publication is not intended as legal advice. Readers should not act upon distribution agreement
privileged documents
information contained in this publication without professional legal counseling. Software licensing agreement resolves
FTC enjoins medical testing merger
Washington
disputed acquisitions
Charles James on merger statistics
and new directions

Hale and Dorr. When Success Matters.
Hale and Dorr LLP Counselors at Law <haledorr.com> technological improvements and price reduction MSC, UAI and CSAR all manufactured advanced spoke to attendees about the Division’s accomplish- The district court agreed with the FTC and ordered for consumers. The complaint further alleged that Nastran software. Nastran is a computer language that all 91 documents be produced. The court in two markets, simulation software and automatic that allows structural analysis of automotive and found that GSK had not demonstrated that all of James began with some stunning statistics about code generation software, MathWorks and Wind aerospace designs during the design of products.
the recipients of all of the documents had a need the declining level of merger activity nationwide.
River had combined market shares of 84% to 95%.
In 1999, MSC acquired both UAI and CSAR. Both to know the contents, nor that each and every At the same time last year, the FTC and the DOJ transactions fell below the HSR filing threshold document contained confidential information The consent decree that settled the lawsuit against had received 2,075 pre-merger notifications. That and, therefore, there was no requirement that the directly related to giving or receiving legal advice.
Wind River required Wind River to cooperate with number plummeted to just 1,020 this year. James transactions await government review before any discovery in the case and also to cooperate blamed the economic downturn, particularly in On appeal, GSK argued that the district court closing. MSC closed the transactions and began with any future divestiture of the MATRIXx products the telecommunications and technology sectors, improperly second-guessed its corporate decision integrating UAI and CSAR technology into its new from MathWorks. Wind River remained a party to that distribution to the entire group was necessary.
Nastran product. Both existing UAI and CSAR the lawsuit, but the Department agreed to refrain The appeals court agreed with GSK and reversed.
products were essentially shelved in favor of the James reviewed some of the Division’s more from seeking civil penalties or other damages.
The court obviously wanted to avoid reviewing significant merger challenges, including General and evaluating corporate decisions to share On August 15, 2002, the Department filed a Dynamics’ failed attempt to acquire Newport In October, 2001, the FTC sued MSC to undo information with particular employees. The court proposed consent decree that settled the lawsuit News, and United Airlines’ unsuccessful bid for these two acquisitions. On the verge of trial, the reasoned that it is sufficient for distribution to be against MathWorks. MathWorks agreed to sell the USAirways. The Division deemed a total of 19 case settled and MSC agreed to license its new limited to employees whose corporate duties MATRIXx business assets and to provide the buyer transactions anticompetitive and succeeded in Nastran product to up to two new competitors.
generally relate to the contents of the documents.
with relevant patent licenses. Wind River, as its challenges to all but one of them—the The FTC maintained that the shelving of the This standard grants companies broad protection.
required by its earlier consent decree, agreed to competitors’ old products would have rendered The FTC has not yet decided whether or not to divest its remaining interest in the MATRIXx assets.
the sale of those assets meaningless relief because James suggested a few areas that will be receiving seek Supreme Court review of the decision.
The Department retains the right to approve the they had not been developed or maintained, increased attention now that mergers are no longer prospective purchaser and the terms of the sale.
FTC Vote to Enjoin Ends
and a company buying them was unlikely to put dominating the Division’s workload. These include Medical Testing Merger
The MathWorks/Wind River transaction was not any competitive pressure on MSC and its new joint venture arrangements that James believes subject to the reporting requirements of the Hart- generation product. Under the settlement, MSC are often alternatives to actual mergers.
Following the Federal Trade Commission’s Scott-Rodino Antitrust Improvements Act of 1976 can select a company to license its intellectual announcement authorizing its staff to seek a Note: Since the writing of this article, Charles because filing with respect to exclusive distribution property and, depending upon the Commission’s preliminary injunction to block Cytyc Corporation’s James unexpectedly resigned his position with agreements is not required under the Act.
view of the competitive viability of that firm, may (Cytyc) proposed $420 million acquisition of the Antitrust Division of the Department of Justice. Additionally, the consideration for the agreement be required to license to another. MSC also must He will be replaced in the coming months. was well below the Act’s $50 million minimum allow the new competitor to hire away MSC announced the termination of the agreement.
threshold. Notwithstanding the form of the FTC and GlaxoSmithKline
Cytyc first announced its intention to acquire Battle over Privileged
Digene on February 19, 2002. Following a lengthy challenge the distribution agreement as if it were Documents
Hart-Scott-Rodino Act process that included a formidable competition than existed in 1999. Both reset waiting period and a request for additional In connection with the FTC’s investigation of information, the Commission voted unanimously Dispute over Two
and accounted for only single digit market shares.
GlaxoSmithKline’s (GSK) actions related to generic Consummated Acquisitions
MSC was by far the dominant manufacturer. The competitors of its popular drug Paxil, GSK claimed Settled by Software Licensing
proposed relief is likely to create one—if not two— attorney-client privilege for 91 documents. The competitors stronger than UAI or CSAR.
FTC challenged that designation, arguing that the Agreement
documents were distributed widely within the products for medical diagnostic applications After a lengthy investigation and the initiation of Charles James Speaks
company and that GSK failed to prove that all of primarily focused on women’s health. Its core litigation, the Federal Trade Commission and on Merger Statistics
the recipients had job responsibilities that required products involve a system for liquid-based Pap MSC.Software Corp. finally settled their dispute and New Directions
them to know the information. The FTC also tests for primary screening of cervical cancer.
over MSC’s 1999 acquisition of two competitors— At the ABA Annual Meeting in August, Charles claimed GSK failed to demonstrate that each Digene develops, manufactures and markets Universal Analytics Inc. (UAI) and Computerized A. James, assistant attorney general for the document contained confidential information proprietary gene-based testing systems for the Structural Analysis and Research Corp. (CSAR).
Antitrust Division of the Department of Justice, necessary for obtaining or providing legal advice.
screening, monitoring and diagnosis of human technological improvements and price reduction MSC, UAI and CSAR all manufactured advanced spoke to attendees about the Division’s accomplish- The district court agreed with the FTC and ordered for consumers. The complaint further alleged that Nastran software. Nastran is a computer language that all 91 documents be produced. The court in two markets, simulation software and automatic that allows structural analysis of automotive and found that GSK had not demonstrated that all of James began with some stunning statistics about code generation software, MathWorks and Wind aerospace designs during the design of products.
the recipients of all of the documents had a need the declining level of merger activity nationwide.
River had combined market shares of 84% to 95%.
In 1999, MSC acquired both UAI and CSAR. Both to know the contents, nor that each and every At the same time last year, the FTC and the DOJ transactions fell below the HSR filing threshold document contained confidential information The consent decree that settled the lawsuit against had received 2,075 pre-merger notifications. That and, therefore, there was no requirement that the directly related to giving or receiving legal advice.
Wind River required Wind River to cooperate with number plummeted to just 1,020 this year. James transactions await government review before any discovery in the case and also to cooperate blamed the economic downturn, particularly in On appeal, GSK argued that the district court closing. MSC closed the transactions and began with any future divestiture of the MATRIXx products the telecommunications and technology sectors, improperly second-guessed its corporate decision integrating UAI and CSAR technology into its new from MathWorks. Wind River remained a party to that distribution to the entire group was necessary.
Nastran product. Both existing UAI and CSAR the lawsuit, but the Department agreed to refrain The appeals court agreed with GSK and reversed.
products were essentially shelved in favor of the James reviewed some of the Division’s more from seeking civil penalties or other damages.
The court obviously wanted to avoid reviewing significant merger challenges, including General and evaluating corporate decisions to share On August 15, 2002, the Department filed a Dynamics’ failed attempt to acquire Newport In October, 2001, the FTC sued MSC to undo information with particular employees. The court proposed consent decree that settled the lawsuit News, and United Airlines’ unsuccessful bid for these two acquisitions. On the verge of trial, the reasoned that it is sufficient for distribution to be against MathWorks. MathWorks agreed to sell the USAirways. The Division deemed a total of 19 case settled and MSC agreed to license its new limited to employees whose corporate duties MATRIXx business assets and to provide the buyer transactions anticompetitive and succeeded in Nastran product to up to two new competitors.
generally relate to the contents of the documents.
with relevant patent licenses. Wind River, as its challenges to all but one of them—the The FTC maintained that the shelving of the This standard grants companies broad protection.
required by its earlier consent decree, agreed to competitors’ old products would have rendered The FTC has not yet decided whether or not to divest its remaining interest in the MATRIXx assets.
the sale of those assets meaningless relief because James suggested a few areas that will be receiving seek Supreme Court review of the decision.
The Department retains the right to approve the they had not been developed or maintained, increased attention now that mergers are no longer prospective purchaser and the terms of the sale.
FTC Vote to Enjoin Ends
and a company buying them was unlikely to put dominating the Division’s workload. These include Medical Testing Merger
The MathWorks/Wind River transaction was not any competitive pressure on MSC and its new joint venture arrangements that James believes subject to the reporting requirements of the Hart- generation product. Under the settlement, MSC are often alternatives to actual mergers.
Following the Federal Trade Commission’s Scott-Rodino Antitrust Improvements Act of 1976 can select a company to license its intellectual announcement authorizing its staff to seek a Note: Since the writing of this article, Charles because filing with respect to exclusive distribution property and, depending upon the Commission’s preliminary injunction to block Cytyc Corporation’s James unexpectedly resigned his position with agreements is not required under the Act.
view of the competitive viability of that firm, may (Cytyc) proposed $420 million acquisition of the Antitrust Division of the Department of Justice. Additionally, the consideration for the agreement be required to license to another. MSC also must He will be replaced in the coming months. was well below the Act’s $50 million minimum allow the new competitor to hire away MSC announced the termination of the agreement.
threshold. Notwithstanding the form of the FTC and GlaxoSmithKline
Cytyc first announced its intention to acquire Battle over Privileged
Digene on February 19, 2002. Following a lengthy challenge the distribution agreement as if it were Documents
Hart-Scott-Rodino Act process that included a formidable competition than existed in 1999. Both reset waiting period and a request for additional In connection with the FTC’s investigation of information, the Commission voted unanimously Dispute over Two
and accounted for only single digit market shares.
GlaxoSmithKline’s (GSK) actions related to generic Consummated Acquisitions
MSC was by far the dominant manufacturer. The competitors of its popular drug Paxil, GSK claimed Settled by Software Licensing
proposed relief is likely to create one—if not two— attorney-client privilege for 91 documents. The competitors stronger than UAI or CSAR.
FTC challenged that designation, arguing that the Agreement
documents were distributed widely within the products for medical diagnostic applications After a lengthy investigation and the initiation of Charles James Speaks
company and that GSK failed to prove that all of primarily focused on women’s health. Its core litigation, the Federal Trade Commission and on Merger Statistics
the recipients had job responsibilities that required products involve a system for liquid-based Pap MSC.Software Corp. finally settled their dispute and New Directions
them to know the information. The FTC also tests for primary screening of cervical cancer.
over MSC’s 1999 acquisition of two competitors— At the ABA Annual Meeting in August, Charles claimed GSK failed to demonstrate that each Digene develops, manufactures and markets Universal Analytics Inc. (UAI) and Computerized A. James, assistant attorney general for the document contained confidential information proprietary gene-based testing systems for the Structural Analysis and Research Corp. (CSAR).
Antitrust Division of the Department of Justice, necessary for obtaining or providing legal advice.
screening, monitoring and diagnosis of human Hale and Dorr LLP
diseases with primary focus on women’s cancers and infectious diseases. Its core product (the only one of its kind) includes a DNA-based test for human papillomavirus (HPV), a virus believed to cause nearly all cervical cancer cases. Digene’s HPV test is a more targeted test for cervical cancer, used when Cytec’s Pap test results are ambiguous or borderline. The HPV test is most effectively performed by using residue from the original Pap test, but such reuse requires the liquid-based test manufacturer to obtain FDA approval for its samples to be later used with the Digene test.
Department of Justice Unravels
River’s MATRIXx products (with a follow-on option Obtaining such approval requires the two firms Distribution Agreement Among
to cooperate. Prior to the merger, Digene was Competitors
developing and marketing its own products.
cooperating with Cytec and Cytec’s only competitor.
MathWorks paid $11.5 million to Wind River, and Wind River Systems Inc. (Wind River) and The it effectively obtained control over the prices, According to the FTC, Digene is the only U.S.
MathWorks, Inc. (MathWorks) are competitors in marketing, support and future development of the development and sale of dynamic control the Wind River dynamic control system design Commission alleged that entry by other firms was system design software tools. These tools enable tools. Shortly after the agreement, MathWorks a remote possibility. Cytyc is one of two U.S.
engineers to develop computerized control systems announced its intention not to undertake any sources for liquid-based Pap tests and accounts for sophisticated devices, such as anti-lock brake further development of the MATRIXx products— for 93% of the market. Three other companies systems for automobiles, guidance and navigation thereby eliminating those products as a competitive have yet to begin clinical trials for their products.
control systems for unmanned spacecraft, and The FTC alleged that Cytec’s acquisition of Digene flight control systems for aircraft. By automating would result in Cytec being the only company On June 21, 2002 the Department of Justice filed the steps of modeling, analyzing, simulating, with FDA approval for sample reuse with Digene’s a civil antitrust lawsuit against MathWorks and testing and generating software code for these test. If this were true, Cytec’s competition would Wind River and simultaneously filed a proposed types of control systems, engineers can develop be substantially disadvantaged and likely driven consent decree that settled the lawsuit against For more information, contact Hale and Dorr’s them in a shorter time and at a much lower cost.
Wind River alone. The lawsuit alleged that the Antitrust and Trade Regulation Group.
MathWorks’ dynamic control system software is distribution agreement was a per se violation of Digene has also tested its HPV test as a primary called Simulink, and Wind River’s competing James C. Burling
Section 1 of the Sherman Act because it illegally screen for cervical cancer, both in conjunction product is called MATRIXx. The two product lines fixed prices and allocated and eliminated with Pap tests and as a stand-alone test, and is 617.526.6416
are reported to have competed for over 10 years.
competition in the dynamic control system design seeking FDA approval for such uses. If approved, software market. The Department alleged that the HPV test would become a direct competitor John C. Christie
River entered into a series of agreements, including the competition between MathWorks and Wind of Cytyc’s Pap tests. Therefore, the Commission a distribution agreement that gave MathWorks a River, which had existed prior to the distribution concluded that the merger would eliminate the 202.942.8403
30-month exclusive right to price and sell Wind possibility of any future competition between Michelle D. Miller
Princeton
This challenge is notable because conventional 617.526.6116
wisdom predicted that the present administration DOJ investigation unravels competitors’
FTC and GlaxoSmithKline battle over
would not likely be challenging mergers that were This publication is not intended as legal advice. Readers should not act upon distribution agreement
privileged documents
information contained in this publication without professional legal counseling. Software licensing agreement resolves
FTC enjoins medical testing merger
Washington
disputed acquisitions
Charles James on merger statistics
and new directions

Hale and Dorr. When Success Matters.
Hale and Dorr LLP Counselors at Law <haledorr.com>

Source: http://www.wilmerhale.de/files/Publication/02d2a107-9f2c-4ebb-9e3b-e9f66ee9941e/Presentation/PublicationAttachment/180ce45a-6246-4fba-a3c9-06fa6e458f77/NovAntitrust.pdf

Medical.indd

June 24, 2005 Contact us: [email protected] tel +61 3 9572 4700 fax +61 3 9572 4777 Emergency +61 3 9573 3112 70 Bambra Rd Caulfield North Victoria 3161 Australia Commentary: Setting aside tradition when dealing with endocrine disruptors 2005-05-18 In 1996, the US Congress directed the Environmental Protection Agency to produce screens and assays to detect

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International Consensus Study of Antipsychotic Dosingpsychotic drugs are required to guide clin-ical dosing as well as design and interpret reference, estimated clinical equivalency research studies. Available dosing guide-lines are limited by the methods and data for sulpiride to 10.0 for trifluperidol. Sev-istics, including age, hepatic and renal Method: With a two-step Delphi method, th

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