WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20071 Dr. Felix Addor...

WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 2007 1

Dr. Felix Addor

Deputy Director General, Swiss Federal Institute of Intellectual Property

Lecturer on International Intellectual Property Law, World Trade Institute and University of St.Gallen

WIPO Life Science Symposium on IP and BioethicsGeneva, September 4, 2007

Adressing bioethics issues :A Swiss – EC Perspective


„Considering the exclusive right to invention as given for the benefit of society, I know well the difficulty of drawing a line between the things which are worth to the public the embarrassment of an exclusive patent, and those which are not.“(Thomas Jefferson, 1813)

“As the value that society places

on intellectual property has increased,

that line has become murkier.”(The Economist, 2004)


Patenting of life forms:

Patent examiners playing God?


Misconceptions about patents

A patent is not a permission to use an invention (not a

marketing authorization).

A patent is not an approval of an invention or of the possible

exploitation of an invention.

The patent system is not a tool to guide the research

and technical development or to prevent abuses of new

technologies!


What can be protected by a patent?

1. Inventionproduct or process

that offers a new technical solution to a problem

3. Novelty not comprised in the state of the art = unavailable to the public

4. Inventive stepnot obvious for the person skilled in the art

5. Industrial applicationcommercially exploitable

2. No exclusion


What is an invention in the biotech field?

Discovery

= Description of something

existing

= Extension of human knowledge

Invention

= Instruction how to solve a problem

with technical means

= Extension of human abilities

Penicillin

Penicillium notatum


The human body = patentable subject matter?

“The human body, at the various

stages of its formation and

development, and the simple

discovery of one of its elements, […],

cannot constitute patentable

inventions.”

(Article 5(1) EU-Directive)

“The human body as such, at all

phases of his formation and

development, including the embryo, is

not patentable.”

(Article 1a(1) new Swiss Patent Law)


Elements of the human body: patentable subject matter?

“An element isolated from the human

body or otherwise produced by means

of a technical process, […], may

constitute a patentable invention,

even if the structure of that element is

identical to that of a natural element.”


“Elements of the human body in their

natural surrounding are not patentable.

Such elements are patentable as

invention if they are produced by means

of a technical process, if a technical

utility is indicated and if the other criteria

of article 1 (novelty, inventive step,

industrial applicability) are fulfilled.”

(Article 1a(2) new Swiss Patent Law)


Gene sequences = patentable subject matter?

“… a mere DNA sequence without

indication of function does not contain

any technical information [teaching]

and is therefore not a patentable

invention.”

(Recital 23 EU-Directive)

“A naturally occurring sequence or

partial sequence of a gene as such is

not patentable.”

(Article 1b(1) new Swiss Patent Law)

Isolated genes

=

as a tiger in a cage!


Gene sequences = patentable subject matter?

“An element isolated from the human

body or otherwise produced by means

of a technical process, including the

sequence or partial sequence of a

gene, may constitute a patentable

invention, even if the structure of that

element is identical to that of a natural

element.”


“Sequences deriving from a naturally

occurring sequence or partial sequence

of a gene are patentable as inventions,

if they are produced by means of a

technical process, if their function is

concretely disclosed and if the other

criteria of article 1 (novelty, inventive

step, industrial applicability) are

fulfilled.”

(Article 1b(2) new Swiss Patent Law)


1 2 3 4 5

Dependency on previous patents (crow ded art) (n = 29)

Dif f iculties to enter a technological f ield because of too many patents (n = 29)

Patents, blocking access to technologies (n = 28)

Conf licting and overlapping patents (n = 29)

Unaw areness of research staf f about patenting (n = 29)

Patents, impeding further R&D (n = 28)

Submarine patents in the f ield (n = 24)

Over-complex patent licensing negotiations (n = 29)

Individual royalties are too high (n = 28)

Accumulation of too many royalties for too many dif ferent patent holders (n = 27)

Patents hampering research co-operations (n = 29)

Break dow n of patent rights negotiations (n = 28)

Proliferation of legal patenting disputes (n = 28)

Ethical problems (n = 27)

Main problems with gene patents (acc. to participants of CH empirical survey)

CH Survey: 8.2 Extent of Experience of Problems with DNA Patents, Fig. 34 (1=never, 5=very often) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)


Possible remedies

0 5 10 15 20 25 30 35 40 45 50

Consortia

Introduction of provisionalapplications

Maximum royalty fees

Introduction of a graceperiod

Cross licensing

Patent pools

Protection limited to concretedisclosure functions of DNA

Broad research exemption

CH Survey: 8.2 Remedies, Fig. 35 (named as many times as effectively to ...) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)


Assessment of a protection limited to the concrete disclosed functions of DNA?

1 2 3 4 5

The absolute protection of DNApatents is hampering researchand further development (n=25)

A concrete disclosure of thefunction enables the restriction

of patent claims (n=24)

Limited protection of DNApatents is for our purpose more

important than absoluteprotection (n=23)

A limitation of the scope ofprotection should be providedfor in patent legislation (n=22)

CH Survey: 8.2 Extent of Experience of Problems with DNA Patents, Fig. 39 (1=no agreement, 5=total agreement) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)


Gene

F

Uses

B

A

C

D

E

ProteinsDerivedSequences

Reasoning: Is the absolute protection a too generous reward for the patent owner ?


Gene

F

Uses

B

A

C

D

E


Alternative: Purpose-limited product claims ?


Gene

F

Uses

B

A

C

D

E


The approach of the new Swiss Patent Law


The approach of the new Swiss Patent Law (2):

Absolute product claims on restricted sequences

Article 8c new Swiss Patent Law :

(DNA sequences: Scope of protection)

The protection of a claim, containing a nucleotide sequence, which is derived from a naturally occurring sequence or partial sequence of a gene, is restricted to those parts of the sequence, which is performing the concretely described function.


Ethical limits to patentability:Inventions contrary to ordre public or morality

Some subject matter is excluded from patentability even

if it constitutes an invention:

Inventions shall be considered unpatentable where their

commercial exploitation would be contrary to ordre

public or morality; however, exploitation shall not be

deemed to be so contrary merely because it is

prohibited by law or regulation.

(Article 6(1) EU-Directive / Article 2(1) new Swiss Patent Law)


How to deal with the human embryo?

Ethical controversy

Source: University of Wisconsin-Madison

The issue of human stem-cells


Ethical limits to patentability:Human embryonic stem-cells Adult, foetal and embryonic human stem-cells are elements

of the human body Adult and foetal human stem-cells are patentable in

principle no specific ethical issues But: Embryonic human stem-cells are obtained from an

human embryo that has to be destroyed controversial situation in Europe

Decisions by EPO: Edinburgh patent (EP 0 695 351) partly revoked Thomson patent (EP 0 770 125) refused (appeals are pending in both cases)


Ethical limits to human embryonic stem-cells

Subject matter EPO EGE CH

Unmodified ES Excluded from patentability

Rule 23 d (c) EPC

Excluded from patentability

Excluded from patentability

Art. 2(1)(e) PatG

Modified ES Excluded from patentability (?)Rule 23 d (c) EPC

Patentable Patentable

Procedures to obtain ES

Excluded from patentability (?)

Rule 23 d (c) EPC

Patentable Patentable


AssessmentArt. 5(1) EU-Directive

Art. 1a(1) new Swiss Patent Law

Art. 6(2)(a) EU-Directive

Art. 2(1)(a) new Swiss Patent Law

(incl. the clones thus obtained)

Recital 38 EU-Directive (transgenic

animals?)

Art. 2(1)(b) new Swiss Patent Law

(transgenic animals not excluded)

Invention concernshuman body/human genome

(reproductive and therapeutic)

cloning of human beings

processes for producing chimeras

or hybrids

Ethical limits to patentability


AssessmentEU-Directive unclearArt. 2(1)(c) new Swiss Patent Law

Art. 6(2)(b) EU-DirectiveArt. 2(1)(d) new Swiss Patent Law (incl. germ line cells thus obtained. Somatic gene therapy not excluded)

EU-Directive unclearArt. 2(1)(d) new Swiss Patent Law (only non modified ESC)

Art. 6(2)(c) EU-Directive (for industrial or commercial uses)Art. 2(1)(f) new Swiss Patent Law (for non medical uses)

Invention concernsprocesses for human parthenogenesis

germ line therapy

human embryonic stem- cells

use of human embryos

?

?


Assessmentnot contrary to ordre public/morality

not contrary to ordre public/morality



Art. 6(2)(d) EU-DirectiveArt. 2(1)(g) new Swiss Patent Law

Invention concernsdiagnostic processes involving genes

organs

somatic cells

genes

processes for genetic modification of animals likely to cause unjustified suffering


Assessing the ‚morality‘ of claimed inventions

Post grant opposition procedure (Art. 59c new Swiss Patent Law)

Any person may file an opposition against a granted patent if the ethical limits

seem not to be respected, in particular with regard to patents: of the human body of elements of the human body in their natural surrounding of naturally occurring sequence / partial sequence of a gene as such of inventions where their exploitation would violate human dignity, or would

disregard the dignity of plants and animals of inventions where their commercial exploitation would be contrary to

ordre public or morality


Biotechnology Patents – Access and Benefit Sharing

What role can patent system play?

Focus of international discussions: New disclosure requirements


Approach of the new Swiss Patent Law

Requirement to declare the source

of genetic resources and traditional knowledge

in the patent application (Art. 49a)

Sanctions for wrongful declaration (Art. 81a):

fines up to CHF 100,000

publication of ruling


Research/experimental use exemption (Art. 9.1b new Swiss Patent Law) When do you need a license to use patented inventions for research purposes?

All research (commercial or not) = free – if aimed at gaining new knowledge about subject matter of the invention

Introduction of “bolar exemption”: Use of the invention to obtain the authorisation of a pharmaceutical product = free use of invention e.g. through

Clinical trials = possible

Even production of specimens = possible

BUT

Production of the new drug only after expiration of

the patent (= no stockpiling)


Limits of research exemption: The issue of research tools

Research exemption: the used invention must be the object and not the instrument of research:

Problem: no free use of „research tools“, (such as polymerase chain reaction)

if instrument = license needed

Solution: Access guaranteed through legal licence (Art. 40b new Swiss Patent Law):

= right to use the research tool for everybody

+ obligation to pay licence fee

no agreement = fee fixed by a court

no “reach through” licence fees


Compulsory licence for diagnostic testing

Access to reliable diagnostic methods may be hampered if

disease caused by specific gene sequence or single nucleotide polymorphisms (SNPs),

and

diagnostic method based on the relevant nucleotide sequence patented

Art. 40c new Swiss Patent Law provides for a compulsory licence

in case of Anticompetitive behaviour = breach of antitrust law/abuse of dominant

position/agreement restricting competition/abusive behaviour (e.g.

BRCA1- breast cancer gene)


Transparency

Knowledge

Research & Private Use Exemption

PublicPatent Owner

Innovation

Exclusive Right

Incentive

Protection of Investments

Goal = Balancing of Interests

Date post:	27-Mar-2015
Category:	Documents
Upload:	dominic-webb
View:	214 times
Download:	0 times

WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20071 Dr. Felix Addor...

Documents