Intellectual property and
biomedical sciences
Table of contents
1. Introduction............................................................................................... 1
2. Patents...................................................................................................... 2
2.1. validity..................................................................................................................... 3
2.2. Patent application procedures.................................................................................4
2.2.1. National route.................................................................................................... 4
2.2.2. European route.................................................................................................. 5
2.2.3. EU route: unitary patent....................................................................................6
2.2.4. international route............................................................................................. 7
2.3. Titularity.................................................................................................................. 8
2.4. patent databases..................................................................................................... 9
2.5. Scope of protection.................................................................................................. 9
2.6. Supplementary protection certificates...................................................................11
2.7. Trade secrets......................................................................................................... 12
3. Copyright................................................................................................. 12
3.1. Validity................................................................................................................... 12
3.2. Titularity................................................................................................................ 13
3.2.1. Copyright as an asset......................................................................................13
3.3. scope of protection................................................................................................ 14
Guest lecture 1: Protecting biomedical inventions.........................................14
Introduction.................................................................................................................. 14
What is patentable?...................................................................................................... 15
Criteria for patentability................................................................................................16
Typical claim formulations............................................................................................ 16
Freedom to operate...................................................................................................... 16
Guest lecture 2: health data.........................................................................16
Introduction.................................................................................................................. 16
health data – GDPR....................................................................................................... 17
EHDS......................................................................................................................... 17
Practice questions........................................................................................18
Answers........................................................................................................................ 22
1. Introduction
Standard regiment to answer a question:
,1: validity = is there a legal right in the first place? (are the conditions for
this right realized?)
2: titularity = who owns the rights?
3: scope of protection = what can you do with the rights?
== material law
(4: how can you enforce this law to another person?
= formal law = law about law)
Exception to freedom of commerce:
Intellectual property rights (IPRs) = negative rights (tell other people that
they cannot make and sell the same thing)
- exclusive rights to exclude
- granted by law
- granting temporary protection (monopoly)
- valid in certain territory
- for immaterial good
why do you need IPR?
- intangible object: cannot physically protect it
- to control object when made public
- stimulate creativity
- stimulate innovation
What are patents for? => technical inventions
Other IPRs: copyright, trademark and design
one product can have different types of IPRs
Complements of IPRs: unfair commercial practices, trade secrets
only apply to those that agreed to contract >< IPR to everyone
(within scope of protection, territoriality)
Databank for patents: espacenet
Also databanks for trademarks and designs (not for copyright because no
registration)
Geographical:
IPRs are only in a certain territory eg national, EU, European, international
2. Patents
Geographical levels of patents:
1. national level: individual patent in each country
2. European union
a. Biotech directive: not a European law, still has to be
transposed by member states
b. Unitary patent (enhanced cooperation): no national scope,
only in countries that decided to participate
3. International
a. Paris convention: (old) to create uniform system
2
, b. European patent convention: bundle of national patents with
harmonization for patent protection
c. TRIPS agreement: builds into Paris convention, connects
patent principles with international trade
Definition of patent:
- right to exclude:
o Prohibit third parties from producing, selling or using the
invention
o temporary
o for one or multiple specific countries
o disclosure of essential technical characteristics (made public)
>< trade secrets
- document: patent as description of invention
o person skilled in the art can understand and apply the
invention based on the document
o the patent is a source of technical knowledge and information
2.1. validity
Exclusion categories:
Category 1: no invention
- no technical character (so no invention)
- eg: discovery-, mathematical method-, aesthetic creations-,
computer programs as such
- as such: if technical step is introduced then the non-invention can
become an invention and become patentable
o discovery that DNA exists in nature is not an invention BUT
isolated DNA sequence may be patentable
Category 2: no patentability
- exclusion often on ethical grounds
- inventions contrary to public order/morality
- eg cloning people
- eg diagnostic methods and methods for treatment BUT the
substances for this can be patented
Inclusion steps: (is not excluded by categories before)
Step 1: novelty
- new = not part of the state of the art at the date of filing or not filed
by someone else before (= priority)
- content:
o state of the art = everything made to the public (in any way)
o exception if within 6 months if abuse by employee or shown at
internationally recognized exhibition
sign NDA!
o exception if within 12 months in case of own disclosure (in US)
- temporal scope:
o priority date: also if application done in other patent office
3
biomedical sciences
Table of contents
1. Introduction............................................................................................... 1
2. Patents...................................................................................................... 2
2.1. validity..................................................................................................................... 3
2.2. Patent application procedures.................................................................................4
2.2.1. National route.................................................................................................... 4
2.2.2. European route.................................................................................................. 5
2.2.3. EU route: unitary patent....................................................................................6
2.2.4. international route............................................................................................. 7
2.3. Titularity.................................................................................................................. 8
2.4. patent databases..................................................................................................... 9
2.5. Scope of protection.................................................................................................. 9
2.6. Supplementary protection certificates...................................................................11
2.7. Trade secrets......................................................................................................... 12
3. Copyright................................................................................................. 12
3.1. Validity................................................................................................................... 12
3.2. Titularity................................................................................................................ 13
3.2.1. Copyright as an asset......................................................................................13
3.3. scope of protection................................................................................................ 14
Guest lecture 1: Protecting biomedical inventions.........................................14
Introduction.................................................................................................................. 14
What is patentable?...................................................................................................... 15
Criteria for patentability................................................................................................16
Typical claim formulations............................................................................................ 16
Freedom to operate...................................................................................................... 16
Guest lecture 2: health data.........................................................................16
Introduction.................................................................................................................. 16
health data – GDPR....................................................................................................... 17
EHDS......................................................................................................................... 17
Practice questions........................................................................................18
Answers........................................................................................................................ 22
1. Introduction
Standard regiment to answer a question:
,1: validity = is there a legal right in the first place? (are the conditions for
this right realized?)
2: titularity = who owns the rights?
3: scope of protection = what can you do with the rights?
== material law
(4: how can you enforce this law to another person?
= formal law = law about law)
Exception to freedom of commerce:
Intellectual property rights (IPRs) = negative rights (tell other people that
they cannot make and sell the same thing)
- exclusive rights to exclude
- granted by law
- granting temporary protection (monopoly)
- valid in certain territory
- for immaterial good
why do you need IPR?
- intangible object: cannot physically protect it
- to control object when made public
- stimulate creativity
- stimulate innovation
What are patents for? => technical inventions
Other IPRs: copyright, trademark and design
one product can have different types of IPRs
Complements of IPRs: unfair commercial practices, trade secrets
only apply to those that agreed to contract >< IPR to everyone
(within scope of protection, territoriality)
Databank for patents: espacenet
Also databanks for trademarks and designs (not for copyright because no
registration)
Geographical:
IPRs are only in a certain territory eg national, EU, European, international
2. Patents
Geographical levels of patents:
1. national level: individual patent in each country
2. European union
a. Biotech directive: not a European law, still has to be
transposed by member states
b. Unitary patent (enhanced cooperation): no national scope,
only in countries that decided to participate
3. International
a. Paris convention: (old) to create uniform system
2
, b. European patent convention: bundle of national patents with
harmonization for patent protection
c. TRIPS agreement: builds into Paris convention, connects
patent principles with international trade
Definition of patent:
- right to exclude:
o Prohibit third parties from producing, selling or using the
invention
o temporary
o for one or multiple specific countries
o disclosure of essential technical characteristics (made public)
>< trade secrets
- document: patent as description of invention
o person skilled in the art can understand and apply the
invention based on the document
o the patent is a source of technical knowledge and information
2.1. validity
Exclusion categories:
Category 1: no invention
- no technical character (so no invention)
- eg: discovery-, mathematical method-, aesthetic creations-,
computer programs as such
- as such: if technical step is introduced then the non-invention can
become an invention and become patentable
o discovery that DNA exists in nature is not an invention BUT
isolated DNA sequence may be patentable
Category 2: no patentability
- exclusion often on ethical grounds
- inventions contrary to public order/morality
- eg cloning people
- eg diagnostic methods and methods for treatment BUT the
substances for this can be patented
Inclusion steps: (is not excluded by categories before)
Step 1: novelty
- new = not part of the state of the art at the date of filing or not filed
by someone else before (= priority)
- content:
o state of the art = everything made to the public (in any way)
o exception if within 6 months if abuse by employee or shown at
internationally recognized exhibition
sign NDA!
o exception if within 12 months in case of own disclosure (in US)
- temporal scope:
o priority date: also if application done in other patent office
3
