[Ip-health] Compulsory cross-license of Immunex TNF patents to Serono

[James Love]

Given the interest in US compulsory licensing practices, I'll post a
few more.  The following documents concern the US FTC's 2002
compulsory cross-license of Immunex patents tumor necrosis factor
(=93TNF=94) patent, to Serono.   The license allows Serono the "freedom
to practice in the research, development, manufacture, use, import,
export, distribution and sale of TNFbp-I Products and certain
glycosylated and nonglycosylated fragments, derivatives and analogs
thereof in the United States."    Note the permission to export,
which is anticipated by Article 31.k of the TRIPS.   In this case,
the compulsory cross-license allows a Swiss firm to compete with the
US patent owner.    Jamie

http://www.ftc.gov/opa/2002/07/amgen.htm
July 12, 2002

Resolving Anticompetitive Concerns, FTC Clears $16 Billion
Acquisition of Immunex Corp. By Amgen Inc., Companies Required to
Implement Divestiture and Licensing Remedies in Three
Biopharmaceutical Markets

    [snip]

The FTC alleges that the market for TNF inhibitors is highly
concentrated. Immunex, which makes Enbrel, and Johnson & Johnson
Company, which makes Remicade, are the only companies with TNF
inhibitors on the market. In 2001, Immunex sold over $760 million of
Enbrel in the U.S. and Canada, while Remicade accounted for the rest
of the market in the U.S. There are only three other companies with
TNF inhibitors in clinical development in the United States. Amgen
has a TNF inhibitor similar to Enbrel in clinical development that it
expects to launch in 2005. Abbott Laboratories recently submitted a
Biologic License Application to the FDA for its D2E7 product.
Pharmacia Corporation and Celltech plc are jointly in Phase II trials
for their TNF inhibitor, CDP870. Additionally, Serono, a Swiss
biotechnology company, is developing a TNF inhibitor for use in
Europe, but it does not possess the patent rights necessary to market
its product in the United States.

According to the FTC, new entry into the research, development,
production, and sale of TNF inhibitors is difficult, expensive, and
time-consuming. New entry - which likely would take eight to ten
years - would not be timely enough to counteract the alleged
anticompetitive impacts of the proposed merger in this market.

The proposed merger of Amgen and Immunex allegedly would eliminate
competition from Amgen's TNF inhibitor in development. To remedy the
potential anticompetitive effects in the TNF inhibitor market, Amgen
would be required to license certain patent rights to Serono. This
license would give Serono the ability to market its TNF inhibitor
product in the United States, while allowing Amgen to continue the
development of its own TNF inhibitor.

     [snip]

http://www.ftc.gov/os/caselist/c4056.htm

Amgen Inc. and Immunex Corporation, File No. 021 0059, Docket No. C-4056


UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION
COMMISSIONERS: Timothy J. Muris, Chairman
Sheila F. Anthony
Mozelle W. Thompson
Orson Swindle
Thomas B. Leary

Docket No. C-4056

In the Matter of AMGEN INC., and IMMUNEX CORPORATION

DECISION AND ORDER

ISSUED: September 3, 2002

BBB. =93TNFbp-I=94 means a molecule capable of binding to tumor necrosis
factor (=93TNF=94), thereby reducing the binding of TNF to target cell
membrane receptors, which molecule is comprised of the soluble
portion of TNF Receptor Type-I, and which is also known as soluble
TNF Receptor Type-I.

CCC. =93TNF Settlement and Cross-License Agreement=94 means the license
agreement between Serono and Amgen dated June 28, 2002, attached
hereto as non-public Appendix III.
     [snipp]

A.  Not later than ten (10) Business Days after the Effective Date,
Respondents shall grant to Serono rights and immunities under certain
Patents controlled by Respondents sufficient to
allow Serono freedom to practice in the research, development,
manufacture, use, import, export, distribution and sale of TNFbp-I
Products and certain glycosylated and nonglycosylated fragments,
derivatives and analogs thereof in the United States in accordance
with the TNF Settlement and Cross-License Agreement (which agreement
shall not vary or contradict, or be construed to vary or contradict,
the terms of this Order), which is incorporated by reference into
this Order and made part hereof as non-public Appendix III.

B. The purpose of the requirements in Paragraph III.A. is to ensure
the continuation of TNFbp-I research and development for additional
TNFbp-I Products to be approved by the FDA for
sale in the United States and to remedy the lessening of competition
resulting from the Merger as alleged in the Commission=92s Complaint.

APPENDIX III (non-public)
TNF Settlement and Cross-License Agreement
[Redacted From Public Record Version]


---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton"