Compulsory license actions in Germany - HOFFMANN EITLE · 2017-07-25 · Life Science IP Seminar...
Transcript of Compulsory license actions in Germany - HOFFMANN EITLE · 2017-07-25 · Life Science IP Seminar...
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Mike Gruber, LL.M. IP (GWU)
Compulsory license actions in Germany:
The Shionogi/Merck-case
Attorney at Law
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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Introduction
Requirements
Procedure
The Shionogi/Merck-case
Future developments
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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Introduction
“After the grant of a compulsory license in
the Shionogi/Merck-case the interest in
this patent infringement defense
strategy has increased substantially.”
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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4 Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
Introduction
Requirements
Procedure
The Shionogi/Merck-case
Future developments
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Requirements
Main requirements:
1. (failed) attempt to obtain a license to
use the invention under appropriate
terms during an appropriate length of
time and
2. grant of a compulsory license is in the
public interest
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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Requirements
attempt to obtain a license
appropriate terms = what a reasonable
third party would be willing to agree to in
that situation
appropriate length of time = start and end
of negotiations before request is filed
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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Requirements
attempt to obtain a license
• willingness to take a reasonable license
sufficient; license proposal not required
• (future) licensee's perspective relevant
• royalty deductions due to uncertainties
of the patent’s validity may be allowed
• fake licensing attempts are insufficient,
e.g. delaying/stalling tactics
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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Requirements
public interest
• e.g. needed to provide general health
care, particularly in the treatment of
deadly or infectious diseases
• no “more or less” equally effective
alternatives available
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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9 Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
Introduction
Requirements
Procedure
The Shionogi/Merck-case
Future developments
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Procedural aspects
• request for compulsory license filed at
the Federal Patent Court
• appeals to the Federal Court of Justice
• (additional) preliminary proceedings if
grant of compulsory license is “urgent”,
i.e. compulsory licenses needed until
the decision in main proceedings; no
urgency for filing of the request needed
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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Procedural aspects
• royalty setting can be deferred to main
proceedings
• security is set for patentee’s potential
damages until the decision in main
proceedings plus legal costs
• no limitation of compulsory license to
certain patient groups if they cannot be
defined
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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12 Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
Introduction
Requirements
Procedure
The Shionogi/Merck-case
Future developments
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The Shionogi/Merck-case
• patent owner of EP 1 422 218 (EP’218)
covering the use of raltegravir in a drug
for preventing/treating a viral disease,
granted in 2012
• opposition proceedings against EP’218
pending on appeal (hearing Oct. 2017)
• does not sell its own raltegravir drug
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The Shionogi/Merck-case
• manufacturer of the antiretroviral drug
Isentress® (API: raltegravir) marketed
since 2007
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The Shionogi/Merck-case
History
• 6/2014: Shionogi notifies the Japanese
Merck subsidiary of patent infringement
of the Japanese counterpart of EP‘218
• Shionogi makes two offers: one time
payment for past sales, running royalty
• Merck makes a counter-offer with lump
sum of $10M for a world-wide license
• 8/2015: Shionogi files infringement
actions in Germany and the UK
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The Shionogi/Merck-case
Expert opinion
• two alternative integrase inhibitor APIs
dolutegravir and elvitegravir available
• Isentress® is more effective for certain
patient groups, i.e. pregnant women,
infants, children, and patients treated
for HIV already for several years
• increased infection risk for the general
population if Isentress® is unavailable
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The Shionogi/Merck-case
Decision
• preliminary compulsory license granted
to use EP’218 for offering, selling, etc.
current versions of Isentress® until the
decision in main proceedings
• no compulsory license for versions that
are still under development
• security of €6.5M by Merck required
• no royalty setting (→main proceedings)
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
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18 Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany
Introduction
Requirements
Procedure
The Shionogi/Merck-case
Future developments
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Future developments
• there will be more cases!
• limitations/non-assertion of injunction
claim in certain infringement situations
• implications for negotiation strategy in
certain patent infringement cases
• devaluation of patents in certain fields?
• open issue: license fee calculation?
Life Science IP Seminar 2017 - Compulsory l icense act ions in Germany