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Summary Notes: Patent Law, Drug Development KU Leuven
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INHOUDSOPGAVEIntroduction to patent law ....................................................................................................................................................... 4
Organisational aspects of the course ............................................................................................................................................. 4
Intellectual property rights ............................................................................................................................................................. 4
What are intellectual property rights? ....................................................................................................................................... 4
Why are intellectual property rights important (in pharma)? .................................................................................................... 4
Types of intellectual property rights........................................................................................................................................... 5
Patents ............................................................................................................................................................................................ 6
Justification ................................................................................................................................................................................. 6
History ........................................................................................................................................................................................ 8
Summary................................................................................................................................................................................... 14
Basic requirements patents .....................................................................................................................................................14
Patentable subject matter: general .............................................................................................................................................. 14
The ‘social contract’ in the patent system ................................................................................................................................ 14
Exclusive right ........................................................................................................................................................................... 14
Patentable?............................................................................................................................................................................... 15
Inventions ................................................................................................................................................................................. 15
Inventions & exclusions (list)......................................................................................................................................................... 16
Inventions ................................................................................................................................................................................. 16
Exclusions (non-inventions) ...................................................................................................................................................... 18
Exceptions to patentability ........................................................................................................................................................... 21
Invetions contrary to ordre public and morality: general exceptions ...................................................................................... 21
List of exceptios for biotechnology inventions ......................................................................................................................... 22
Uses of human embryos for industrial or commercial purposes.............................................................................................. 22
Plant and animal varieties & essentially biological processes for production of plants and animals (exclusions) ................... 23
Surgery, therapy and diagnostic methods ................................................................................................................................ 24
Patentable subject matter: general .............................................................................................................................................. 25
Novelty .......................................................................................................................................................................................... 26
State of the art + examples on the slides ................................................................................................................................. 26
Made available to the public .................................................................................................................................................... 27
‘By means of’ ............................................................................................................................................................................ 27
European patent applications................................................................................................................................................... 27
International patent applications ............................................................................................................................................. 28
Territorial scope........................................................................................................................................................................ 28
Temporal scope ........................................................................................................................................................................ 28
Guidelines for examination of novelty ..................................................................................................................................... 29
Selection inventions ................................................................................................................................................................. 30
What not to do when considering filing a patent application: ................................................................................................. 30
Inventive step................................................................................................................................................................................ 31
State of the art.......................................................................................................................................................................... 31
Examination of the inventive step ............................................................................................................................................ 32
Industrial applicability .................................................................................................................................................................. 33
Industry ..................................................................................................................................................................................... 33
Sufficiency of disclosure ................................................................................................................................................................ 33
Patents in chemical and biological inventions..........................................................................................................................34
1
, Patentability of inventions in specific technical fields (recap last course) .................................................................................... 34
Chemical inventions.................................................................................................................................................................. 34
Biological inventions ................................................................................................................................................................. 38
Pharmaceutical inventions ....................................................................................................................................................... 40
Types of claims for pharmaceutical inventions ............................................................................................................................. 40
History of ‘second medical use claim’ ...................................................................................................................................... 41
Patents as a source of information ..........................................................................................................................................45
Context ......................................................................................................................................................................................... 45
Patents and medicinal product life cycle .................................................................................................................................. 45
Patent documents .................................................................................................................................................................... 45
Disclosure of the invention ....................................................................................................................................................... 46
Patent applications ....................................................................................................................................................................... 46
(European) Patent application .................................................................................................................................................. 46
EPO examining guidelines......................................................................................................................................................... 50
Granted patents............................................................................................................................................................................ 50
Patent classification .................................................................................................................................................................. 50
Searching for patents.................................................................................................................................................................... 51
Espacenet ................................................................................................................................................................................. 52
Search keys ............................................................................................................................................................................... 52
Legal status of a patent document ............................................................................................................................................... 53
Scope of protection .................................................................................................................................................................53
Procedural aspects of patents .................................................................................................................................................53
National procedure ....................................................................................................................................................................... 53
Belgium ..................................................................................................................................................................................... 54
European procedure (most cases) ................................................................................................................................................ 55
General features of EPC patent and grant procedure .............................................................................................................. 55
Current debate: patent quality ................................................................................................................................................. 61
International procedure ................................................................................................................................................................ 62
PCT procedure .......................................................................................................................................................................... 62
Opposition and appeal procedures ............................................................................................................................................... 66
European level – 3 possible opposition outcomes ................................................................................................................... 66
Unitary patent .......................................................................................................................................................................... 68
Rights and limiations related to patents ..................................................................................................................................69
Rights of the patentee .................................................................................................................................................................. 69
Introduction what is a patent? ................................................................................................................................................. 69
Limitations to the right of the patentee ....................................................................................................................................... 72
International level..................................................................................................................................................................... 72
European Level ......................................................................................................................................................................... 72
Private acts ............................................................................................................................................................................... 73
experimental use exemption .................................................................................................................................................... 74
Bolar exemption ....................................................................................................................................................................... 74
Exhaustion (uitputting) ............................................................................................................................................................. 75
Prior use (voorgebruik/ persoonlijk bezit) ................................................................................................................................ 76
Term of patent .......................................................................................................................................................................... 77
Property rights .............................................................................................................................................................................. 79
2
, Ownership/joint ownership ...................................................................................................................................................... 79
Assignment – transfer............................................................................................................................................................... 81
Usefruct .................................................................................................................................................................................... 82
Seizure ...................................................................................................................................................................................... 82
Licenses..................................................................................................................................................................................... 82
Compulsory licenses (dwang licenties) ..................................................................................................................................... 83
Property right agreements ........................................................................................................................................................... 84
Licenses and competition ........................................................................................................................................................84
Context & what are licenses ..................................................................................................................................................... 84
Practices of licensing ................................................................................................................................................................ 84
Limits on licensing .................................................................................................................................................................... 84
Complex licensing ..................................................................................................................................................................... 84
Regulatory exclusivities & patents ...........................................................................................................................................84
3
,INTRODUCTION TO PATENT LAW
ORGANISATIONAL ASPECTS OF THE COURSE
INTELLECTUAL PROPERTY RIGHTS
WHAT ARE INTELLECTUAL PROPERTY RIGHTS?
IP = Creative ideas or intangible assets embedded in tangible products or processes e.g. products of thoughts, industrial
inventions
IPR = Legal rights that protect the creative ideas or intangible assets embedded in tangible products or processes
WHY ARE INTELLECTUAL PROPERTY RIGHTS IMPORTANT (IN PHARMA)?
CONTEXT
• Estimated increase in cancer incidence from 2020 to 2024
• Corona pandemia
• New paradigm form traditional medicine towards precision medicine
TRADITIONAL TO PRESISION MEDICINE
Challenges:
• Accelerating technological complexity
• Patient’s heterogeneity
• Increasing regulatory hurdles
• Falling R&D budgets
• Future patent cliffs
• Increased competition
• Declining numbers of promising projects in drug pipelines
How to overcome challenges:
4
,TYPES OF INTELLECTUAL PROPERTY RIGHTS
• IPR in a mobile phone, in coca cola…
Right For what? How?
Patent Novel inventions Filing and examination
Copyright Original creative or artistic forms Automatically
Trademark Distinctive identification of products and services Use and/or registration
Registered models Appearances Registration*
Trade secrets Valuable information not known to the public Efforts to keep secret
PATENT
• Protection of inventions which are susceptible of industrial application, which are new and which involve an inventive
step
• Technical character
COPYRIGHT
• Protection of original works against copying
• Literary or artistic works
o Data sheets
o Patient information leaflets
o Advertising materials
o Records
o Audiovisual works (character merchandising)
o Databases
TRADEMARKS
• Distinctive signs capable of distinguishing goods/services of one undertaking from those of other undertakings
• Words, logos, colours, shape, sounds, smells...
• Brand name
o Risk of confusion
TRADE SECRETS
• Confidential information (commercial, technical info)
o In general, the information must be:
§ Commercially valuable because it is secret
§ Be known only to a limited group of persons, and
§ Be subject to reasonable steps taken by the rightful holder of the information to keep it secret,
including the use of confidentiality agreements for business partners and employees
• Examples: financial information, formulas and recipes and source codes
• Protection via TRIPS art. 39(2) and European Directive on Trade secrets
INDUSTRIAL DESIGN
• Appearance of the whole or part of a product
• Packaging, containers (inhalers, tablets, capsules)
5
, DATABASE RIGHTS
• Protects collection of information against extraction and reutilization
• Database = collection of independent works, data or other materials arranged in a systematic or methodological way
and individually accessible by electronic or other means
• Substantial investment iin obtaining, verifying or presenting the contents of the database
PATENTS
JUSTIFICATION
• Information, once public, can be used without being exhausted by such use
• Without protection, such information may be copied by competitors, dropping the price of it, hence decreasing its
value
• Patent contains information on a product, or on a process, ...
• Patents give exclusive (negative) right to stop copying an invention and thereby adress the problem of free use of
information on inventions, but this needs justification
THEORIES UNDERLYING PATENT PROTECTION
NATURAL RIGHTS THEORY
John Lockean labour theory of property
• An individual has a natural property right over his ideas
• Creators also have a natural right to the sole exploitation of these ideas
• The property is personal and exclusive
o Society must recognize the property
• Unauthorised use without compensation
o Theft
Problems by applying Lockean labour theory of property to patents
• Lack of consistency:
o This theory does not make any difference between intellectual property and the traditional tangible property
(intellectual rights are based on things that are not naturally appropriable and non-rival)
• Term
o If man has rights in his ideas, the term should be perpetual
• Territory
o If man has rights in his ideas, the place is linked to the place where the mixture of ideas
• occured
• Requirements for patentability
o No logic for requiring such criteria for labor before recognizing the property
• Exclusive right
o Copying forbidden, but independent development?
• List of unpatentable inventions?
No clear basis for justification of patents under the Natural Rights Theory
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