[Ip-health] Sorin Biomedica/Chiron Italian compulsory license request

[James Love]

Also from Chiron's 10k report is this note that mentions among other things
a request by Sorin Biomedica to the Italian Ministry of Industry, Commerce
and Artisanship ("ICA") for compulsory license to the Chiron '216 patent.
Jamie

http://www.chiron.com/investor/annual/10k.htm

Even if the Company is successful in obtaining and defending patents, there
can be no assurance that these patents will provide substantial protection.
Third parties may be able to design around the patents and develop
competitive products that do not use the inventions covered by the patents.
Many countries, including certain countries in Europe, have compulsory
licensing laws under which a patent owner may be compelled to grant licenses
to third parties (for example, the third party's product is needed to meet a
threat to public health or safety in that country, or the patent owner has
failed to "work" the invention in that country, or the third party has
patented improvements), and most countries limit the enforceability of
patents against government agencies or government contractors. In these
countries, the patent owner may be limited to monetary relief and may be
unable to enjoin infringement, which could materially diminish the value of
the patent. Furthermore, most countries do not provide discovery so the
Company may not be able to meet its burden of proving infringement; nor can
it be guaranteed that the Company will even become aware of infringement of
its patents.

  [snip]

In connection with the settlement of litigation in the U.S. and certain
other countries in October 2000, Chiron granted a license to F. Hoffman
La-Roche Limited and Roche Molecular Systems, Inc. ("Roche") under its HCV
and HIV patents for use in nucleic acid amplification in clinical
diagnostics, and a limited license under these patents in blood screening.

Sorin Biomedica/Snia

    On June 14, 1994, Sorin Biomedica S.p.A. filed a lawsuit with the Court
of Milan, Italy against Chiron Corporation and Ortho Diagnostic Systems
S.p.A. for a declaration of nullity and noninfringement of the

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Italian counterpart to Chiron's European Patent 0 318 216 (the " '216
patent"). Sorin additionally filed a request with the Italian Ministry of
Industry, Commerce and Artisanship ("ICA") for compulsory license to the
'216 patent. Chiron filed a counterclaim and sought a finding that the
patent is valid and infringed by Sorin. The ICA suspended Sorin's request
for compulsory license pending the outcome of the litigation. On February
10, 1997, the Court enjoined Sorin from manufacturing or selling HCV
immunoassay kits in Italy. Subsequent to the Milan court's ruling, Sorin
introduced new claims of nullity of the '216 patent resting on inventorship
allegations. Sorin has appealed to Italy's Counsel of State for
reconsideration of the findings of the court of Milan and the ICA. On
October 17, 1999, the Court issued a ruling, which, among other things,
upheld the validity of certain of the claims. As of June 29, 2000 the
European Patent Office Technical Board Of Appeals upheld the validity of the
'216 patent in an amended form which deleted the claims that Chiron alleged
to have been infringed by Sorin. In December 2000, Snia S.p.A., Sorin's
parent company, filed an appeal in the Corte D'Apello Di Milano asking the
Court to declare the Italian portion of the '216 patent null and void and to
award Snia damages. It is not known when nor on what basis this matter will
be resolved.

   [snip]

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James Love, mailto:love@cptech.org, http://www.cptech.org
voice +1.202.387.8030, mobile +1.202.361.3040, fax +1.202.234.5176