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>
Emla Disclaimer Emla cream contains two medicines called Lidocaine and Prilocaine. These belong to medicines called local anaesthetics. Emla cream works by numbing the surface of the skin for a short time. It is put on the skin before certain procedures which can feel uncomfortable; this helps to stop or relieves the pain on the skin. You cannot have Emla cream allied id you are allergic o
Early Communication of an Ongoing Safety Review: BisphosphonatesFDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER Early Communication of an Ongoing Safety Review Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Ti