Transcript Patent Law - VU

EBS Law Term 2013
Intellectual Property Law
Patent Law: Introduction
Prof. Martin Senftleben
VU University Amsterdam
Bird & Bird, The Hague
Intellectual property domains
culture
copyright law
technology
patent law
commerce
trademark law
Contents
• definition
• international treaties
• criteria of protection
• exclusions from patentability
Definition
A patent is an exclusive right in an industrial
invention that is granted upon request
... great inventions:
... small inventions:
• penicillin
• post-it stickers
• transistor
• Lego bricks
International treaties
International
• WIPO: The Paris Convention for the
Protection of Industrial Property
(1886/1967)
• WTO: The Agreement on Trade-Related
Aspects of Intellectual Property Rights
(1994)
• WIPO: The Patent Cooperation Treaty
(PCT, 1970)
Criteria of protection
Art. 27(1) of the TRIPS Agreement
‘...patents shall be available for any
inventions, whether products or
processes, in all fields of technology,
provided that they are
• new,
• involve an inventive step and
• are capable of industrial application.’
Novelty
Subject matter is not new if it belongs to
the state of the art.
... to determine on the basis of the situation at
• the filing date (when applying for a patent for
the first time)
• the priority date (when subsequently filing
patent applications in further countries of the
Paris Union)
Paris Union
Priority right (art. 4 of the Paris Convention)
filing a patent
application in one
country of the Union
12 months
subsequent
filings in
other Union
countries
State of the art
= everything that is made publicly available
• decisive: can a person skilled in the art
carry out the invention on the basis of the
information made available?
• essential: keeping the invention secret
before applying for a patent
(protection of trade secrets via unfair
competition law (see art. 39 TRIPS))
Still new?
• publications in
foreign languages
• earlier, not yet
published patent
applications
• demonstration at
official or officially
recognized
international
exhibitions
• talks, presentations, ... (+) because of
product proofs
temporary protection
granted under art. 11
• demonstration to
Paris Convention
visitors
... (-)
Inventive step
... when the invention is non-obvious for a
person skilled in the art.
... to determine on the basis of the situation at
• the filing date (first application)
• the priority date (subsequent applications in
countries of the Paris Union)
The person skilled in the art
• artificial, objective standard
• (average) specialist
– has working experience in the relevant field
of technology
– has standard knowledge
– knows the specific, relevant state of the art
In practice
• contents of patent claims
– not new if all elements can be found in one
single prior source (mostly earlier patent or
earlier patent application);
– not inventive if all elements can be derived
from several prior sources, the combination of
which is obvious.
• from the perspective of a person skilled in
the art, considering that person’s standard
knowledge
Industrial application
... when the subject matter can be applied
to any field of industry.
• Industry is to be understood in a broad
sense, including not only ‘industry and
commerce proper’ but also ‘agricultural
and extractive industries’
(art. 1(3) of the Paris Convention).
The field of industry
‘Industrial property shall be understood in the
broadest sense and shall apply not only to
industry and commerce proper, but likewise to
agricultural and extractive industries and to all
manufactured or natural products, for example,
wines, grain, tobacco leaf, fruit, cattle, minerals,
mineral waters, beer, flowers, and flour.’
(art. 1(3) of the Paris Convention)
Exclusions from
patentability
Art. 27(2) of the TRIPS Agreement
Inventions may be excluded if this is
necessary to
• protect the ordre public or morality;
• protect human, animal or plant life or
health;
• avoid serious prejudice to the
environment.
Art. 27(3) of the TRIPS Agreement
Members may also exclude
• diagnostic, therapeutic and surgical
methods for the treatment of humans or
animals;
• plants and animals other than microorganisms, and essentially biological
processes for the production of plants or
animals other than non-biological and
microbiological processes.
Discussion on biotech inventions
• US: Diamond vs. Chakrabarty,
447 U.S. 303 (1980)
• lead of the US and Japan over the EU
• EU: Biotech Directive 98/44/EC (1998)
engine of
innovation
developing countries:
biodiversity
ethical
questions
Art. 3 EC Biotech Directive
• ‘... inventions ... shall be patentable even
if they concern a product consisting of or
containing biological material or a process
by means of which biological material is
produced, processed or used.’
• ‘Biological material which is isolated from its
natural environment or produced by means
of a technical process may be the subject of
an invention even if it previously occurred in
nature.’
EBS Law Term 2013
Intellectual Property Law
Patent Law: Acquisition
Prof. Martin Senftleben
VU University Amsterdam
Bird & Bird, The Hague
Contents
• registration procedure
• term of protection
• registration strategies
• portfolio management
Registration procedure
Examination systems
refusal
application examination
formal
substantive
grant
a. novelty
b. further requirements
opposition
Registration systems
(refusal)
application examination
formal
substantive
(
)
grant
a. novelty
b. further requirements
opposition
Pros and cons
Examination system
Registration system
• legal certainty high
• legal certainty low
• long procedure
• short procedure
• expensive
• cheap
• settlement of
• settlement of
disputes in the
disputes in court
framework of the
proceedings
office procedure
Term of protection
The 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)
• extensions in certain technical fields?
– pharmaceutical products requiring marketing
approval (can take several years)
– supplementary protection certificates in certain
countries (example: EU)
Registration strategies
Starting point: priority right (art. 4 PC)
filing a patent
application in one
country of the Union
12 months
subsequent
filings in
other Union
countries
Different routes of registration
national
registrations
regional:
European Patent
Convention (EPC)
bundle of rights
having the same
effect as national
patents
Patent Cooperation Treaty (PCT):
international registration
International route:
Patent Cooperation Treaty
Starting point: traditional system
(months)
0
12
File
applications
abroad
File
application
locally
Local patent application followed within 12 months by multiple
foreign applications claiming priority under Paris Convention:
- multiple formality requirements
- multiple searches
- multiple publications
- multiple examinations and prosecutions of applications
- translations and national fees required at 12 months
Some rationalization because of regional arrangements:
ARIPO, EAPO, EPO, OAPI
What is the PCT?
Overview PCT system
(months)
0
File local
application
Typically a national
patent application in
the home country of
the applicant
12
File PCT
application
International
publication
16
18
International
search report
& written
opinion
Enter
national
phase
22
28
(optional)
File
demand for
International
preliminary
examination
(optional)
International
preliminary
report on
patentability
30
What is the PCT?
Overview PCT system
(months)
0
12
File local
application
File PCT
application
International
publication
16
18
International
search report
& written
opinion
Typically filed in same
national patent office--one
set of fees, one language,
one set of formality
requirements--and legal
effect in all PCT States:
effect international
application = national
patent application
Enter
national
phase
22
28
(optional)
File
demand for
international
preliminary
examination
(optional)
International
preliminary
report on
patentability
30
What is the PCT?
Overview PCT system
International
publication
16
18
(months)
0
12
File local
application
File PCT
application
International
search report
& written
opinion
Report on state of the art
(prior art documents and
their relevance) + initial,
non-binding patentability
opinion:
applicant can evaluate the
application
Enter
national
phase
22
28
(optional)
File
demand for
International
preliminary
examination
(optional)
International
preliminary
report on
patentability
30
What is the PCT?
Overview PCT system
Disclosing to world
content of application
in standardized way
(months)
0
12
File local
application
File PCT
application
International
publication
16
18
International
search report
& written
opinion
Enter
national
phase
22
28
(optional)
File
demand for
International
preliminary
examination
(optional)
International
preliminary
report on
patentability
30
What is the PCT?
Overview PCT system
(months)
0
12
File local
application
File PCT
application
International
publication
16
18
International
search report
& written
opinion
Enter
national
phase
22
28
(optional)
File
demand for
international
preliminary
examination
(optional)
International
preliminary
report on
patentability
Request an additional
patentability analysis on basis
of amended application
30
What is the PCT?
Overview PCT system
(months)
0
12
File local
application
File PCT
application
International
publication
16
18
International
search report
& written
opinion
Enter
national
phase
22
28
30
(optional)
File
demand for
international
preliminary
examination
(optional)
International
preliminary
report on
patentability
Additional patentability
analysis, designed to assist
in national phase decisionmaking:
again a preliminary, nonbinding opinion
What is the PCT?
Overview PCT system
(months)
0
12
File local
application
File PCT
application
Express intention
and take steps to
pursue to grant in
various states
International
publication
16
18
International
search report
& written
opinion
Enter
national
phase
22
28
(optional)
File
demand for
international
preliminary
examination
(optional)
International
preliminary
report on
patentability
30
Why use the PCT?
Comparison of the systems
Fees for:
Traditional
--translations
--Office fees
--local agents
(months)
0
File
applications
abroad
12
Fees for:
File local
application
--translations
--Office fees
--local agents
Enter
national
phase
PCT
International
publication
(months)
0
File local
application
12
16
File PCT
application
International
search report &
written opinion
18
22
28
(optional)
File
demand for
international
preliminary
examination
(optional)
International
preliminary
report on
patentability
30
Success of the PCT system
• more time for decision making:
30 instead of 12 months
• PCT form accepted by any Contracting
Party = no rejection on formal grounds
• evaluation and amendment of the
invention prior to national phase
• major costs of filing in different countries
are postponed
EBS Law Term 2013
Intellectual Property Law
Patent Law: Protection
Prof. Martin Senftleben
VU University Amsterdam
Bird & Bird, The Hague
Contents
• exclusive rights
• exceptions
• other use without authorization
Exclusive rights
Art. 28(1) of the TRIPS Agreement
‘A patent shall confer on its owner the
following exclusive rights:
a. where the subject matter of a patent is a
product, to prevent third parties […] from
the acts of: making, using, offering for sale,
selling, or importing for these purposes
that product;…’
Art. 28(1) of the TRIPS Agreement
b. where the subject matter of a patent is a
process, to prevent third parties […] from
the act of using the process, and from the
acts of: using, offering for sale, selling, or
importing for these purposes at least the
product obtained directly by that 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. 34(3) of the TRIPS Agreement
‘In the adduction of proof to the contrary,
the legitimate interests of defendants in
protecting their 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
Art. 28(1) of the TRIPS Agreement
b. where the subject matter of a patent is a
process, to prevent third parties […] from
the act of using the process, and from the
acts of: using, offering for sale, selling, or
importing for these purposes at least the
product obtained directly by that process.’
• answer depends on national interpretation
of ‘obtaining directly’
Exceptions
Art. 30 of the TRIPS Agreement
‘Members may provide for limited exceptions
to the exclusive rights conferred by a patent,
provided that such exceptions do not
unreasonably conflict with a normal
exploitation of the patent and do not
unreasonably prejudice the legitimate
interests of the patent owner, taking account
of the legitimate interests of third parties.’
Example: ‘Bolar’ exception
• exempts use of the patented invention for
tests necessary to obtain marketing
approval for pharmaceutical products
• US: Roche Products vs. Bolar Pharma
generic version
protected medicine
expiry
Example: 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)
• testing claimed properties or different
indications (+)
• ...insofar as the experiments are directed
to the substance itself
• use for commercial research?
Other use without
authorization
Art. 31 of the TRIPS Agreement
• problem of compulsory licenses
• 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
Problem: flexible enough for sufficient
access to medicine?
• ‘national
emergency’?
• ‘predominantly
for the
domestic
market’?
Art. 31(l) of the TRIPS Agreement
• problem of later patents involving an important
technical advance of considerable economic
significance in relation to the prior invention
• specific requirements
– 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
Problem: flexible enough for markets with
small, incremental innovative steps?
• ‘important
technical
advance’?
• ‘considerable
economic
significance’?
The end.
contact: [email protected]
ANNEX:
Interpretation of
Patent Claims
Interpretation of Patent Claims
• central elements of a patent application:
– claims
– description, drawings
• different approaches to interpretation:
– literal (wording of the claims)
– teleological (core of the inventive idea)
• additional consideration: equivalents
Equivalents
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
Different approaches in countries of
the European Patent Convention
• ‘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