Catania 2013 - Patent Scope - VU

advertisement
European IP Law (Patents),
Catania, May 29-30, 2013
Scope of Protection
Prof. Dr. Martin Senftleben
VU University Amsterdam
Bird & Bird, The Hague
Contents
• Legal sources
• Interpreting the claims
• Equivalence
• Infringement
– exclusive rights
– exceptions
– prior use
Legal sources
European patent law
European
Patent
Convention
Community
Patent
Convention
concluded in
concluded in
Munich,
Luxemburg,
October 5, 1973,
December 15, 1975,
revision: EPC 2000
not in force
Art. 1 European Patent Convention (EPC)
‘A system of law, common to the
Contracting States, for the grant of
patents for invention, is established
by this Convention.’
... 38 Contracting States, 2 extension
States
Territorial
reach of
the EPC
system
European patents (art. 2 EPC)
‘Patents granted under this Convention
shall be called European patents.’
‘The European patent shall, in each of the
Contracting States for which it is granted,
have the effect of and be subject to the
same conditions as a national patent
granted by that State, unless this
Convention provides otherwise.’
European and national phase
centralized registration
procedure at the
result:
bundle of national
patents
European Patent Office
(EPO)
(national phase)
National phase and harmonization
no full harmonization of
substantive patent law
(infringement criteria):
Community Patent
Convention
had strong influence on
national legislation, but
never entered into force!
result:
bundle of national
patents
(national phase)
Dream of a Community Patent
EU registration
procedure
carried out by an
EU Patent Office
result:
Community Patent
= unitary patent
right for the entire
EU territory
European Patent with Unitary Effect
centralized registration
procedure at the
European Patent Office
(EPO)
result:
patent governed by
only one national law
(but applicable
national law differs
from patent to patent)
Interpreting the claims
(EPC)
Art. 69(1) EPC
‘The extent of the protection conferred
by a European patent or a European
patent application shall be determined
by the claims.
Nevertheless, the description and
drawings shall be used to interpret
the claims.’
Addressee of the patent specification
• person skilled in the art
• artificial, objective standard
• (average) specialist
– skilled technician rather than leading expert
– has working experience in the relevant field
– has standard knowledge
– knows the specific, relevant state of the art
Source material for interpretation
• elements of the patent specification:
– claims
– description, drawings
• different approaches to interpretation:
– literal (wording of the claims)
– teleological (core of the inventive idea)
• in addition: application file?
Aims underlying interpretation
validity:
infringement:
narrow reading to
shield the patent
against prior art
wide construction to
obtain broad scope
of protection
Approaches in EPC countries
• EPO allows consultation of application files
• art. 69(1) EPC does not seem to preclude
use for claim construction
• rather reluctant: UK courts
– nonetheless: if narrow meaning was given to a
term to secure the patent grant, a later argument
of wide interpretation unlikely to be accepted
• more liberal approach in other countries
– additional aid to clarify meaning of the claims
– example: The Netherlands
Dutch Hoge Raad, December 22, 2006,
Dijkstra/Saier
• at issue: strength of a bucket sealing
mechanism
• use application file in favour of patent owner:
– possible, but: cautious approach required
– only if claims remain unclear after careful study of
description and drawings
• use application file against patent owner:
– no reason for restricting use of the file if this
supports position of the defendant
Protocol Concerning Art. 69 EPC
• ‘Article 69 should not be interpreted as meaning
that the extent of the protection conferred by a
European patent is to be understood as that
defined by the strict, literal meaning of the wording
used in the claims, the description and drawings
being employed only for the purpose of resolving
an ambiguity found in the claims.’
= literal interpretation (English tradition)
Protocol Concerning Art. 69 EPC
• ‘Nor should [Article 69] be taken to mean that the
claims serve only as a guideline and that the actual
protection conferred may extend to what, from a
consideration of the description and drawings by a
person skilled in the art, the patent proprietor has
contemplated.’
= teleological interpretation (German tradition)
Protocol Concerning Art. 69 EPC
‘On the contrary, [Article 69] is to be interpreted as
defining a position between these extremes which
combines a fair protection for the patent proprietor with
a reasonable degree of legal certainty for third parties.’
literal
(legal certainty)
teleological
(fair protection)
‘position between these extremes’
Dutch Hoge Raad, January 13, 1995,
Ciba Geigy/Oté Optics
• Ciba Geigy:
– has European process patent for disinfecting
and cleaning contact lenses
– according to the claims, the process is based on
a specific sodium chloride solution which is
isotonic
• Oté Optics:
– markets a cleaning product for contact lenses
with a different solution that is isotonic
Dutch Hoge Raad, January 13, 1995,
Ciba Geigy/Oté Optics
• no strict, literal interpretation
• core idea underlying the invention =
starting point of the interpretation
• but: additional test of legal certainty
• third party interests may require
correction of the interpretation
• criterion: degree of novelty
Equivalence
Doctrine of equivalence
the same function
in the same way with
the same results
Impact in practice
doctrine (+)
doctrine (-)
no need to specify
more detailed
each and every
claims advisable to
variant of the
close potential
invention in the
loopholes for
specification
competitors
Dutch Hoge Raad, October 31, 2003,
Van Bentum/Kool
• Van Bentum:
– has a product patent concerning a truck for the
transport of laden pallets
– achieves optimal use of space by combining a
movable lowest load floor with a fixed highest
load floor
• Kool:
– markets a truck that has a movable highest load
floor and a removable top
Dutch Hoge Raad, October 31, 2003,
Van Bentum/Kool
Dutch Hoge Raad, October 31, 2003,
Van Bentum/Kool
• claims not drafted carefully
• nonethelss: interpretation required that
strikes a proper balance between fair
protection for the patent owner and legal
certainty for third parties
• equivalent variant of the invention (+)
Different approaches in EPC countries
• ‘Epilady’ saga (1990-1993)
• plaintiff
– holds patent rights to ‘Epilady’, a gadget for
removing body hair with a coiled spring
• defendant
– applies same inventive idea
– but: uses a rubber tube instead of the coiled
spring
• DE and NL: infringement (+)
• UK: infringement (-)
UK approach: three questions
• variant having material effect upon the way
the invention works?
– if yes, infringement (-)
• if no: absence of material effect obvious at
the date of patent publication?
– if no, infringement (-)
• if yes: claim indicating that strict compliance
with the primary meaning of the terms
essential to the invention?
– if yes, infringement (-)
UK approach: three questions
• inherent problem: last question takes the
court back to interpretation
• critique led to departure from the test
– Kirin-Amgen vs. Hoechst Marion Roussel,
[2005] RPC (9), 169
– no mechanical application, in particular less
helpful in case of complex chemical or
biotechnological inventions
– example: claim to a whole group of chemical
compounds expected to have similar
characteristics
Protocol Concerning Art. 69 EPC,
as amended under the EPC 2000
‘For the purpose of determining the extent of
protection conferred by a European patent, due
account shall be taken of any element which is
equivalent to an element specified in the claims.’
= recognition of the doctrine of equivalence?
• guarantee of a more uniform interpretation of
patent claims in EPC countries?
Exclusive rights
(CPC)
Art. 25(a) Community Patent Convention
‘A Community patent shall confer on its
proprietor the right to prevent all third parties
not having his consent:
from making, offering, putting on the market
or using a product which is the subject-matter
of the patent, or importing or stocking the
product for these purposes;…’
Art. 25(b) Community Patent Convention
‘from using a process which is the subjectmatter of the patent or, when the third party
knows, or it is obvious in the circumstances,
that the use of the process is prohibited
without the consent of the proprietor of the
patent, from offering the process for use
within the territories of the Contracting
States;…’
Art. 25(c) Community Patent Convention
‘from offering, putting on the market, using, or
importing or stocking for these purposes the
product obtained directly by a process which
is the subject-matter of the patent.’
Overview direct infringement
product
patent
process
patent
acts relating
to the product
use of the
acts relating to
(making, offering,
process
the product
using etc.)
directly obtained
from the process
Problem 1: identical product may be
obtained with a different process
process A
process C
process B
process D
Art. 34(1) of the TRIPS Agreement
‘…if the subject matter of a patent is a process
for obtaining a product, the judicial authorities
shall have the authority to order the defendant
to prove that the process to obtain an identical
product is different from the patented process.
Therefore, Members shall provide, in at least
one of the following circumstances, that any
identical product when produced without the
consent of the patent owner shall, in the
absence of proof to the contrary,…’
Art. 34(1) of the TRIPS Agreement
‘…be deemed to have been obtained by
the patented process:
a. if the product obtained by the patented
process is new;
b. if there is a substantial likelihood that the
identical product was made by the process
and the owner of the patent has been unable
through reasonable efforts to determine the
process actually used.’
Art. 35 Community Patent Convention
‘If the subject-matter of a Community
patent is a process for obtaining a new
product, the same product when produced
by any other party shall, in the absence of
proof to the contrary, be deemed to have
been obtained by the patented process.’
‘In the adduction of proof to the contrary,
the legitimate interests of the defendant in
protecting his manufacturing and business
secrets shall be taken into account.’
Problem 2: further products may be
required to obtain the final product
father
mother
son
production of compact discs
final
Process patent infringement?
(UK: Pioneer Electronics vs. Warner Music)
A is holder of a UK
process patent for the
production of ‘father’ discs
at a particular pressure.
He wants to prevent B
from importing final discs.
father
mother
B uses the patented
process in China to obtain
father discs and carry out
the further production
steps. He offers the final
discs in the UK.
son
production of compact discs
final
Indirect infringement
Extending patent rights to preliminary acts
direct
infringement:
rights against those
who directly carry
out prohibited acts
indirect:
rights against those who
are essentially involved,
in a preliminary way, in
bringing about complete
infringement
Art. 26(1) Community Patent Convention
‘A Community patent shall also confer on its
proprietor the right to prevent all third parties not
having his consent from supplying or offering to
supply […] a person, other than a party entitled to
exploit the patented invention, with means, relating
to an essential element of that invention, for putting
it into effect...’
= supplying means for putting a patented
invention into effect to someone not
authorized to work the patent
Art. 26(1) Community Patent Convention
‘…when the third party knows, or it is obvious in
the circumstances, that these means are suitable
and intended for putting that invention into effect.’
= supplier is treated as knowing what is
obvious to a reasonable person in the
circumstances
Dutch Hoge Raad, October 31, 2003,
Sara Lee/Intergro
Dutch Hoge Raad, October 31, 2003,
Sara Lee/Intergro
• Sara Lee:
– holder of a European patent relating to an
‘assembly for use in a coffee machine for
preparing coffee, container and pouch of said
assembly’.
• Intergro:
– offers pouches (coffee pads) on the market
that can be used to prepare coffee in the way
patented by Sara Lee.
Dutch Hoge Raad, October 31, 2003,
Sara Lee/Intergro
• infringement (-) because the pouches are
not an essential part of the patent
‘It does not follow from the simple fact that a fitting
coffee pouch is necessary to apply the patented
assembly that this pouch constitutes a means
relating to an essential element of the invention…’
• fitting pouch is not an element distinguishing
the invention from prior state of the art
Art. 26(2) Community Patent Convention
‘Paragraph 1 shall not apply when the means are
staple commercial products, except when the third
party induces the person supplied to commit acts
[amounting to patent infringement].’
= recognition that mass articles may have
non-infringing as well as infringing uses
• additional requirement: supply for inducing
a person to infringe the patent
Indirect patent infringement?
A is holder of an Italian
process patent for the
production of ‘father’ discs
at a particular pressure.
He wants to prevent B
from supplying the Italian
producer C with means for
working his patent.
In India, B supplies C with
the means necessary to
work A’s patent. C brings
these means into Italy and
works A’s patent there.
Indirect patent infringement?
A is holder of a German
process patent for the
production of ‘father’ discs
at a particular pressure.
He wants to prevent B
from exporting means for
working his patent to
Canada.
In Germany, B makes up
kits of the parts needed to
operate A’s patent. He
exports these kits to
Canada where A’s
competitors use the kits to
work the patent.
Patent infringement in transit cases?
producer of
generics
in India
owner of
European
patent rights
importer of
generics
in Brazil
Art. 41(1) of the TRIPS Agreement
‘…ensure that enforcement procedures […] are
available […] to permit effective action against
any act of infringement of intellectual property
rights covered by this Agreement, including
expeditious remedies to prevent infringements
and remedies which constitute a deterrent to
further infringements.’
‘These procedures shall be applied in such a
manner as to avoid the creation of barriers to
legitimate trade and to provide for safeguards
against their abuse.’
CJEU, December 1, 2011, case C-446/09,
Philips/Nokia
• infringement (-) as long as goods are truly in
transit to another country
‘The Court has repeatedly deduced from that fact
that goods placed under a suspensive customs
procedure cannot, merely by the fact of being so
placed, infringe intellectual property rights applicable
in the European Union…’ (para. 56)
CJEU, December 1, 2011, case C-446/09,
Philips/Nokia
• infringement (+) the moment the goods may
be put on the internal market
‘On the other hand, those rights may be infringed
where, during their placement under a suspensive
procedure […], or even before their arrival […],
goods coming from non-member States are the
subject of a commercial act directed at European
Union consumers, such as a sale, offer for sale or
advertising.’ (para. 57)
World policing in transit cases?
Legitimate
trade in
generics
Illegitimate
trade in fake
drugs
Right to compensation
EPC registration procedure
publication
application examination
formal
substantive
refusal
grant
a. novelty
b. further requirements
compensation
period
opposition
Art. 32(1) Community Patent Convention
‘Compensation reasonable in the circumstances
may be claimed from a third party who, in the
period between the date of publication of a
European patent application in which the
Contracting States are designated and the date of
publication of the mention of the grant of the
European patent, has made any use of the
invention which, after that period, would be
prohibited by virtue of the Community patent.’
= compensation for use of the invention prior
to the grant
Art. 67(2) European Patent Convention
‘In any event, each State shall ensure at least that,
from the date of publication of a European patent
application, the applicant can claim compensation
reasonable in the circumstances from any person
who has used the invention in that State in
circumstances where that person would be liable
under national law for infringement of a national
patent.’
= compensation for use of the invention prior
to the grant
Exceptions
Private, non-commercial use
‘The rights conferred by a Community
Patent shall not extend to: [...] acts
done privately and for non-commercial
purposes.’
(art. 27(a) Community Patent Convention)
• cumulative requirement of private and
non-commercial nature?
• activities of governmental, educational
and charitable institutions outside the
scope of the exception?
Experimental use
‘The rights conferred by a Community
Patent shall not extend to: [...] acts done
for experimental purposes relating to the
subject-matter of the patented invention.’
(art. 27(b) Community Patent Convention)
• allows testing of claimed properties or
different indications
• requirement: experiments are directed to
the substance itself
• problematic: use as research tool
Objective underlying experimental use
disclosure
rationale:
experimental
use exception:
patent law as a means
to make technical
knowledge available
facilitates the use of
this knowledge to
advance science
German Bundesgerichtshof, July 11, 1995,
Clinical Trials I
• plaintiff:
– holds patent rights to the medicine ‘Interferongamma’.
• defendant:
– uses Interferon-gamma to produce the drug
‘Polyferon’ under a compulsory license.
– uses Interferon-gamma for clinical trials aiming
to identify new uses of the substance.
German Bundesgerichtshof, July 11, 1995,
Clinical Trials I
• scope of experimental use
– all kinds of experiments as long as the use
serves scientific research on the subject matter
of the patented invention
– covers research on applications of the invention
• not decisive whether
– the experiments are undertaken merely to review
the patent specification
– user has further intentions, such as use of the
results for commercial purposes
German Bundesgerichtshof, April 17, 1997,
Clinical Trials II
• scope in case of commercial research
– all experimental acts that relate to the subject
matter of the invention
– regardless of whether the tests produce purely
scientific or industrially exploitable results
– defence applies as long as the research does
not specifically aim at impeding or frustrating the
sale of the original product
= liberal approach to experimental use
Differences in experimental use regimes
• distinction between purely scientific and
(partly) commercial research
• distinction between research ‘on’ and
research ‘with’ the patented technology
broad scope
(Germany)
narrow scope
(USA)
position between these two poles
in many European countries
Dutch Hoge Raad, December 18, 1992,
ICI/Medicopharma
• ICI:
– is the holder of a Dutch patent on the medicine
‘Atenolol’.
– patent expires on February 20, 1990
• Medicopharma and Pharbita:
– use Atenolol to obtain regulatory approval for the
marketing of a generic version of the medicine.
Dutch Hoge Raad, December 18, 1992,
ICI/Medicopharma
• decisive: unauthorized use must be justified
by the research objective
‘This is only the case when the person carrying out
the research argues and substantiates that the
research is of an exclusively scientific nature, and
that it aims exclusively at realizing one of the
objectives underlying the Patent Act, such as the
further advancement of science and technology.’
Dutch Hoge Raad, December 18, 1992,
ICI/Medicopharma
• in the case of tests for obtainig marketing
approval for drugs (-)
‘With their research, Medicopharma and Pharbita
aimed [...] only to carry out, during the term of
patent protection, the tests [...] necessary to be able
to market themselves the already known medicine
enjoying patent protection directly after the expiry of
the patent.’
Extension of experimental use
• art. 10(6) of Directive 2001/83/EC,
as amended by Directive 2004/27/EC
‘Conducting the necessary studies and trials with a
view to the application [for marketing approval for
generic versions of patented drugs] and the
consequential practical requirements shall not be
regarded as contrary to patent rights or to
supplementary protection certificates for medicinal
products.’
= so-called ‘Bolar’ exception
‘Bolar’ exception
• exempts use of the patented invention
for tests necessary to obtain marketing
approval for generic drugs
• US: Roche Products vs. Bolar Pharma
generic version
protected medicine
expiry
Counterbalance: extended term of protection
• ‘The term of protection available shall not
end before the expiration of a period of
twenty years counted from the filing date.’
(art. 33 TRIPS)
• longer periods?
• extensions in certain technical fields?
Supplementary Protection Certificate
for Medicinal Products
‘The certificate shall take effect at the end of
the lawful term of the basic patent for a
period equal to the period which elapsed
between the date on which the application for
a basic patent was lodged and the date of
the first authorization to place the product on
the market in the Community reduced by a
period of five years.’
(art. 13(1) EC Regulation 1768/92 (1992))
Supplementary Protection Certificate
for Medicinal Products
‘Notwithstanding paragraph 1, the duration
of the certificate may not exceed five years
from the date on which it takes effect.’
(art. 13(2) EC Regulation 1768/92 (1992))
market approval
patented medicine
extension
expiry
Farmer’s exception
‘The protection conferred by a patent on a
biological material possessing specific
characteristics as a result of the invention shall
extend to any biological material derived from
that biological material through propagation or
multiplication in an identical or divergent form
and possessing those same characteristics.’
(art. 8(1) Biotech Directive 98/44/EC)
= biotech patents expanded to material
derived by propagation or multiplication
Farmer’s exception
‘By way of derogation from Articles 8 and 9, the
sale or other form of commercialisation of plant
propagating material to a farmer by the holder of
the patent or with his consent for agricultural use
implies authorisation for the farmer to use the
product of his harvest for propagation or
multiplication by him on his own farm…’
(art. 11(1) Biotech Directive 98/44/EC)
• farmer’s own use of seed exempted
• same rule for breeding of animals
Exhaustion
Partitioning markets
Netherlands:
100 EUR
Denmark:
125 EUR
Greece:
75 EUR
• patent protection as a weapon against
parallel imports?
• (+) in case of national exhaustion
• (-) in case of international exhaustion
Art. 28 Community Patent Convention
‘The rights conferred by a Community patent shall
not extend to acts concerning a product covered by
that patent which are done within the territories of
the Contracting States after that product has been
put on the market in one of these States by the
proprietor of the patent or with his express consent,
unless there are grounds which, under Community
law, would justify the extension to such acts of the
rights conferred by the patent.’
= community exhaustion
Prior use
Different know-how strategies
A
B
trade secret
protection
patent protection
(disclosure)
Determining the patent owner
• general principle:
The first applicant obtains the patent,
not the first inventor.
• exceptions:
– unfair competition (espionage)
– employed inventor
Persons eligible for prior use rights
persons who used
persons who have in
the invention prior
good faith made
to the patent grant
effective and serious
without making it
preparations to use
available to the
the invention
public
(infringing acts
about to be done)
Time scheme: EPC registration procedure
publication
application examination
formal
substantive
refusal
grant
a. novelty
b. further requirements
compensation
period
opposition
Right of prior use
• scope depends not necessarily on form and
extent at the time of acquisition
– grows together with the business
– expansion into other products problematic
• only defence against patent owner, no right
against third parties
• no licensing permitted
• assignment only together with the relevant
business
Compulsory licenses
Art. 45(1) Community Patent Convention
‘Any provision in the law of a Contracting State for
the grant of compulsory licences in respect of
national patents shall be applicable to Community
patents. The extent and effect of compulsory
licences granted in respect of Community patents
shall be restricted to the territory of the State
concerned.’
• national compulsory licensing regimes not
harmonized in CPC
• nonetheless: harmonization because of the
international TRIPS Agreement
Art. 31 of the TRIPS Agreement
• detailed list of requirements, such as
– efforts to obtain regular authorization
– national emergency
– limited scope and duration according to purpose
– non-exclusive, non-assignable
– predominantly for the domestic market
– payment of adequate remuneration
– judicial review of decisions relating to the
compulsory license
Reasons for compulsory licensing
necessitated
by public
interest
lack or
insufficiency of
exploitation
required to put into effect a
later invention that depends on
patented technology
Example: dependent patents
• specific international requirements
– ‘important technical advance of considerable
economic significance’ in relation to the patented
prior invention
– cross-license on reasonable terms for the owner of
the first patent
– use authorization with regard to the first patent is
non-assignable except with the assignment of the
second patent
(art. 31(l) TRIPS Agreement)
Appropriate standard of
‘important technical advance’?
• problematic in sectors with incremental
evolution of new technology
• example: innovation in the software industry
invention 1
invention 2
Innovation in the software industry
• ‘important
technical
advance’?
• ‘considerable
economic
significance’?
Conclusion
No unitary patent infringement
standard in Europe
• differences with regard to
– claim interpretation
– scope of exclusive rights
– scope of exceptions
• resulting in different decisions on
– patent validity
– infringing acts
• European patent ≠ uniform assessment
of the patent in European countries
The end. Thank you!
For publications, visit www.ssrn.com
and search for ‘senftleben’.
contact: m.r.f.senftleben@vu.nl
Download