Introduction to patent law in the bio-innovation area · Introduction to patent law in the...

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Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen Institute, Norway (photo outline Regine Andersen) IP Training, Botswana, 8.-12. April 2013

Transcript of Introduction to patent law in the bio-innovation area · Introduction to patent law in the...

Page 1: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Introduction to patent law in the bio-innovation area

Morten Walløe Tvedt Senior Research Fellow, lawyer

Fridtjof Nansen Institute, Norway

(photo outline Regine Andersen)

IP Training, Botswana, 8.-12. April 2013

Page 2: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

FNI’s ABS Project Team FNI political science and law • Studied biodiversity policy and law for almost 20 years

• Private independent Norwegian research institute

• Competence center on biodiversity policy and law

• Capacity building and implementation consultations for countries: Bhutan, African, Pacific and Caribbean

• Looking at international law in a high number og foras: Patent law, IPR, WIPO, FAO, ITPGRFA, CGRFA etc

•Team of researchers: Kristin Rosendal, Morten Walløe Tvedt, Christian Prip, Leif Christian Jensen, Ane Jørem, Tone Winge, Ole Kristian Fauchald, Peter Johan Schei

Page 3: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

FNI’s ABS Project Team FNI political science and law • Studied biodiversity policy and law for almost 20 years

• Private independent Norwegian research institute

• Competence centre on biodiversity policy and law

• Capacity builiding and implementation consultations for countries: latest Bhutan and African countries

• Looking at international law in a high number og foras: Patent law, IPR, WIPO, FAO, ITPGRFA, CGRFA etc

•Team of researchers: Kristin Rosendal, Morten Walløe Tvedt, Christian Prip, Leif Christian Jensen, Ane Jørem, Tone Winge, Ole Kristian Fauchald, Peter Johan Schei

Page 4: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Relevant studies on GR Law: Bioprospecting and the Convention on Biological Diversity: Implementing the Nagoya Protocol on ABS: A Hypothetical Case Study on Enforcing Benefit Sharing in Norway (with Ole Kristian

Fauchald, forthcoming 2011) Functionality of an ABS Protocol’, with Olivier Runkundo, FNI report 9/2010 Beyond Access – Options for implementing CBD in User Countries, with Tomme R. Young, 2007 Elements for Legislation in User Countries to Meet the Fair and Equitable Benefit-Sharing Commitment (The Journal of World

Intellectual Property (2006) Vol. 9, no. 2, pp. 189–212) Animal Genetic Resources: Process Patent Protection in the Field of Animal Breeding and Farm Animal Genetic Resources (In co-operation with Magnus

Finckenhagen, Journallof world intellectual property, 2008) Animal Genetic Resources – Exchange, Conservation and Sustainable Use – Policy and Regulatory Options (January 2007 FNI-

Report); Patenting in the Field of Animal Breeding and Animal Genetic Resources (ACTA, 2008) International Patent Law and Genetic Resources: A worldwide patent system – what is in it for developing countries (Third World Quarterly, 2010) A Path to One Universal Patent (Journal of Environmental Policy and Law, 2007) How will the new WIPO draft Substantive Patent Law Treaty affect Genetic Resources? (Journal of World Intellectual Property 2005 no 3 May);

Marine and Fish Genetic Resource: Ongoing projects on Aquatic Genetic Resources (Marine Biobank, Norway and India, FUGE) Patent Protection for Inventions Related to Farmed Fish in Norway and the EPO (forthcoming in edited book 2011) A Case-Study from Norway: A Supreme Court Case in the Fish Industry and the Ethical Board of Animal Patents (forthcoming 2011) Patent Law and Bioprospecting in Antarctica (Polar record, 2010) A Study of Marine biobanks in Norway FNI-rapport 2009 Access to and Property Rights of Aquaculture Genetic Resources – Norwegian Perspectives (The Journal of World Intellectual Property (2006) Vol. 9, no. 4,

pp. 392–412)

Page 5: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

The situation in GR Policy and Law

Norway

Law of the provider country

Movement of biological material and TK

Law of user country

Botswana

International law

Regional level

Page 6: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Norway

The ‘global’ patent system

Botswana

Movement of biological material and TK

IPR regulation in the country: Domestic consideration Territoriality

International law WIPO, WTO, UPOV

Regional level • Harmonisation: EU, AU • Grant of patents: ARIPO, EPO,

Page 7: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level • Harmonisation: EU, AU • Grant of patents: ARIPO, EPO,

Search

Examination

Enforcement

Grant

Revocation

National patent system:

Page 8: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application - Written

description

- Patent claims

- Deposit of biological material

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

Page 9: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application - Written

description

- Patent claims

- Deposit of biological material

Invention/ discovery

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

ARIPO-application

Page 10: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application - Written

description

- Patent claims

- Deposit of biological material

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

ARIPO-application

Global std

Page 11: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Selection of claims in the teff patent Claims 1. A flour of a grain belonging to the genus Eragrostis, preferably Eragrostis tef, characterized in that the falling number of the grain at the moment of grinding is at least 250, preferably at least 300, more preferably at least 340,most preferably at least 380. 2. A flour according to claim 1, characterized in that the grain has after-ripened. 3. A flour according to claim 2, characterized in that the falling number of the grain at the moment of grinding is at least 1.01 times higher than at the moment of harvesting the grain, preferably at least 1.05, more preferably at least 1.20 and still more preferably at least 1.30 times higher.

Page 12: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Selection of claims in the teff patent Claims 4. A flour according to any one of the preceding claims, characterized in that the grain is gluten-free. 5. A flour according to any one of the preceding claims, wherein the grains has been ground at least 4, preferably least 6, more preferably at least 8 weeks after harvesting. 6. A flour according to any one of the preceding claims, wherein the falling number of the grain at the moment of grinding is substantially stable for at least 2-3 weeks. … 16. A dough or batter comprising flour according to any one of claims 1-15. 17. A gluten-free dough or batter comprising flour according to any one of claims 1-14. 18. A food product comprising flour according to any one of claims 1-15.

Page 13: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application

your claims

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Page 14: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

So what are they searching for?

prior art

What was known before

Published before

‘a gene hidden in a multitude of clones’

“Problems of Traditional knowledge as prior art”

Page 15: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

So what are they searching for?

prior art

What was known before

Published before

‘a gene hidden in a multitude of clones’

Page 16: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

EPO

Search

So what are they searching for?

prior art

What was known before

Published before

‘a gene hidden in a multitude of clones’

Members to the PCT:

Page 17: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Application

The ‘life span’ of a patent International law WIPO, WTO, UPOV

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

Examination

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

So what are they searching for?

prior art

What was known before

Published before

‘a gene hidden in a multitude of clones’

Page 18: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

Page 19: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

Page 20: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

NATIONAL

Page 21: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

NATIONAL

Novelty

• Absolute novel?

• Defined and operational

• Identical to the prior source

• What about TK?

Page 22: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

NATIONAL

Inventive step

• All sources of prior art

• Substantial different

• Inventive step

• Non-obvious

“A person skilled in the art”

When is an invention based on TK non-obvious

Page 23: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

NATIONAL

Industrial application

• Yes a patent has been applied for

Page 24: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

NATIONAL

Page 25: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Necessarily under national law

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

NATIONAL

ARIPO

Grant

NATIN.

Ex- boards

Regn. court patents?

Page 26: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Grant

Revocation

National patent system:

PCT Global Search

EPO

Search

Global std Global

EPO-

Examination

NATIONAL

Europ

Grant

NATIN.

EPO boards

EU court for patents?

Article 28 Rights Conferred 1. 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 not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product;

(b) where the subject matter of a patent is a process, to prevent third parties not having the owner’s consent 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.

Page 27: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

International law WIPO, WTO, UPOV

Application

your claims

The ‘life span’ of a patent

Regional level Grant of patents: ARIPO, EPO and harmonisation: EU

Search

priorart

Examination

• Novelty

• Inventive step

• Industrial appli.

Enforcement

Necessarily under national law

Grant

Revocation

National patent system:

PCT Global Search

ARIPO

Search

Global std Global

ARIPO-

Examination

NATIONAL

ARIPO

Grant

NATIN.

Ex- boards

Regn. court patents?

Page 28: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Exercise on patentability

Page 29: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Case 1 – Tunderic 1. A method of promoting healing of a wound in a patient,

which consists essentially of administering a wound-healing agent consisting of an effective amount of tunderic powder to said patient.

2. The method according to claim 1, wherein said tunderic is orally administered to said patient.

3. The method according to claim 1, wherein said tunderic is topically administered to said patient.

4. The method according to claim 1, wherein said tunderic is both orally and topically administered to said patient.

5. The method according to claim 1, wherein said wound is a surgical wound.

6. The method according to claim 1, wherein said wound is a body ulcer.

Page 30: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Case 2 – Hoodium tablets

1. Any medicinal use of Hoodium, as it is found in nature.

2. A highly compressed form of Hoodium as an extract.

3. The use of the highly compressed form of Hoodium extract as an active appetite suppressant.

4. A unique method of compressing Hoodium into a tablet.

5. The method of compressing other plants with the same method into tablets.

Page 31: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Case 3 – A blue dye made out of the juice of Azure

1. The use of Azure extract as a basis for a blue dye for the colouring of textiles.

2. The use of Azure extract as a basis for a blue dye for the production of face paint and paint to be used in tattooing.

3. A method of extracting Azure and applying it to large quantities of textiles.

4. A method of reducing the use of toxic blue agents by using Azure as a substitute.

5. The use of active ingredient x to stabilize colours in textiles, to prevent premature colour fading.

Page 32: Introduction to patent law in the bio-innovation area · Introduction to patent law in the bio-innovation area Morten Walløe Tvedt Senior Research Fellow, lawyer Fridtjof Nansen

Thank you for your attention

Morten Walløe Tvedt, [email protected], www.fni.no