intellectual property rights, innovation and public health · property rights, innovation and...

April 19, 2005 1

Meeting between the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) and interested Federal Offices of the Swiss Government at the Swiss Federal Institute of Intellectual PropertyEinsteinstrasse 2, CH-3003 Bern

Bern, 19 April 2005

Intellectual Property Rights, Innovation and Public Health

April 19, 2005 2

Felix AddorDeputy Director GeneralSwiss Federal Institute of Intellectual Property

Bern, 19 April 2005

Some relevant aspectsof the on-going revision of the Swiss Patent Law

April 19, 2005 3

Principal topics

Protection of biotechnological

inventions

Ratification of the 2000 Act Revising the European Patent

Convention

Ratification of the Patent Law Treaty

(PLT)

Compulsory license for the export of pharmaceutical

products

Miscellaneous:parallel imports

counterfeiting and piracyetc.

Swiss Federal Patent Court

Patent attorney

Ratification of the London Agreement of the European Patent

Convention

Protection (P) vs. Innovation (I)

Minimal protection level

I

P

Maximal innovationlevel

Optimal protection level

April 19, 2005 5

Exclusions: Ordre Public and MoralityArt. 2(3) of the draft CH patent law :

refers to the violation of human dignity and the disregard of the dignity of plants and animalsincludes an illustrative list of inventions contrary to ordre public(in force since 1 March 2005 / proposed amendments):

processes for cloning human beingsprocesses for producing hybrids or chimerasprocesses for human parthenogenesisgerm line therapyunmodified human embryonic stem cellsuses of human embryos (non-medical uses)processes for genetic modification of animals likely to cause suffering

April 19, 2005 6

1 2 3 4 5

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

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

Patents, blocking access to technologies (n = 28)

Conflicting and overlapping patents (n = 29)

Unaw areness of research stuff 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 different 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)

DNA Patents

CH Survey: Extent of Experience of Problems with DNA Patents (1=never, 5=very often)

Quelle: http://www.ige.ch/E/jurinfo/documents/j10005e.pdf

April 19, 2005 7

Concrete Disclosure Functions1 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: Extent of Experience of Problems with DNA Patents (1=never, 5=very often)


April 19, 2005 8

DNA Patents: 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: Remedies (named as many times as effectively to ...)


April 19, 2005 9

Scope of protection for genes

Art. 8c of the draft CH patent law intends to introduce a „function-limited“ protection:

All processes to make the product are protected (even if unknown to the inventor and not disclosed in the application)Only the specific functions (uses) disclosed in the patent application are protectedPatents for new uses or medical indications are still possible and independent of the product patent

April 19, 2005 10

gene

F

Possible uses

B

A

CD

E

proteins

Absolute protection

Function-limited

possible uses

BA

C

chemical compound

April 19, 2005 11

Research/experimental use exemptionUse of the invention for research purposes

every act is exempted that aims at elaborating new knowledge about the subject matter of the inventionClinical trials in view of the submission for a market authorisation

The invention must be the object and not the instrument of research

there is no free use of „research tools“but the draft bill proposes a legal license

April 19, 2005 12

Genetic Testing1 2 3 4 5

Patents on genetic tests can lead to abusive monopoly positions. (n = 9/5/6)

Patents increase costs of genetic testing. (n = 9/5/6)

Tests w ere not developed due to the existence of patents. (n = 9/5/6)

Patents have a negative impact on access to genetic testing. (n = 9/5/6)

Patents increase the quality of genetic testing. (n = 9/5/6)

Patent ow ners or licensees prevent laboratories from continuing testingservices. (n = 9/5/6)

Patents improve the information sharing betw een researchers. (n = 9/5/6)

Our research staff is unaw are of the legal implications of using patentedresearch tools. (n = 9/5/6)

<50

50-250

>250

Persons/ company

April 19, 2005 13

Remedies1 2 3 4 5

Clinical use exceptions (n = 22)

Offering clinical laboratories non-exclusive licenses to range apatented genetic test on reasonable terms (n = 23)

Anti-trust law s (n = 21)

Public pressure (n = 23)

Compulsory licenses (n = 22)

Change of patentability criteria (n = 22)

April 19, 2005 14

Compulsory license for diagnostic testing

Bottleneck situations are likely in case of diseases

that are caused by a defect of a single gene or few genes

Abusive behaviour: e.g. BRCA1-gene (breast cancer)

Compulsory license in case of breach of antitrust law

(abuse of dominant position/agreement restricting competition)

April 19, 2005 15

Mathias SchaeliHead Legal Services International Trade RelationsSwiss Federal Institute of Intellectual Property

Bern, 19 April 2005

The Discussion about IP and Patents at the WTO and National Implications

April 19, 2005 16

TRIPS Agreement and Public HealthWTO Declaration on TRIPS and Public Health(‘Declaration’, Doha,14 November 2001)

Clarification of the relationship between theTRIPS Agreement and public health policies of WTO Members

«Recognition» of key TRIPS flexibilities

All WTO Members have the right to use, to the full, the provisions in the TRIPS Agreement which provide flexibility for this purpose!

TRIPS reconciles IP with public health policies

April 19, 2005 17

TRIPS Agreement and Public Health

Paragraph 6: The Gordian knot

in the Doha Declaration:

How can WTO Members without or

with insufficient manufacturing

capacities in the pharmaceutical

sector make effective use of

compulsory licenses ?

April 19, 2005 18

Para. 6 of the WTO Doha Declarationon TRIPS Agreement and Public Health

Position of Switzerland in the negotiating process

• Pinpointed approach => effective solution for the real problem:ACCESS TO DRUGS FOR THE POOR -without undermining the TRIPS patent protection in general

• Importance of IP protection for R&D of new pharmaceuticals

• Solution must not be abused for the sake of commercial/competitive interests of generics manufacturers to the detriment of R&D ofinnovative pharmaceuticals!

• «Yes, drugs for the poor - but patents as well»(Mike Moore, International Herald Tribune, 22.02.2001)

April 19, 2005 19

Tasks still to be accomplished:

1. Implementation of the para. 6 solution in the TRIPS Agreement:Deadline of March 2005 missed => ongoing consultations in the TRIPS Council

2. Implementation of the WTO Para. 6 Decision by Members at the national level

Follow-up to WTO’s Decision of 30 August 2003

April 19, 2005 20

Follow-up to WTO’s Decision of 30 August 2003

Swiss Government proposes to implement WTO’s Para. 6Decision as part of the ongoing revision of its Patent Law:

Coherent step following its position in WTO discussion

Switzerland: Opted out as a beneficiary country!

National implementation to put Swiss manufacturing capacity in the pharmaceutical factor at the disposal of developing countries in a Para. 6 situation

April 19, 2005 21

WTO Para. 6 Decision of 30 August 2003 Switzerland‘s implementation at the national level

Results of the Swiss internal consultation procedure

Proposal to implement WTO Decision at the national levelis non-controversial

Pharmaceutical industry emphasizes need to ensuresafeguards against diversion of such pharmaceuticals

NGOs urge not to limit scope of diseases; emphasize need forsimple administrative procedures and moderate remunerationto patent holder to keep prices low

April 19, 2005 22


Article 40c of draft proposal for Patent Law RevisionScope of diseases = WTO Decision of 30 August 2003, i.e. public health problemssuch as those resulting from HIV/AIDS, tuberculosis, malaria and other epidemicsScope of products = All pharmaceuticals, active substances, diagnostic kits AND vaccinesEligible beneficiary countries = Any country without or insufficient manufacturingcapacity in the pharmaceutical sector in a para. 6 Decision situation, includingnon-WTO Members! (Exclusion of WTO Members which declared opt out)Safeguards against diversion = Licensee must ensure product differentiation fromoriginal productFederal Council will specify more detailed conditions for the grant of such licences in the Patent Ordinance

April 19, 2005 23


Timetable / state of play of revision of Swiss Patent Law:

October 31, 2004: End of 2nd round of national consultation (start July 1, 2004)

March 11, 2005: Report of results of national consultation process publishedMandate by Federal Council to work out proposal for revised Patent Law

Before end of 2005: Draft revised Patent Law scheduled to be presented to Parliament

?Entry into force of revised Patent Law (including revised Patent Ordinance)

April 19, 2005 24


Full text of the draft amendment proposal of the Swiss Patent Law at:

http://www.ige.ch/D/jurinfo/documents/j10013d.pdf (German) http://www.ige.ch/F/jurinfo/documents/j10013f.pdf (French)

Documents on the Swiss internal consultation procedcure at:

http://www.ige.ch/D/jurinfo/documents/j10014d.pdf (German) (Implementation of WTO Decision: p. 31 and pp 129-132)http://www.ige.ch/F/jurinfo/documents/j10014f.pdf (French) (Implementation of WTO Decision: p. 32 and pp. 133-135)

April 19, 2005 25

„The patent system adds the fuel of interest

to the fire of genius“

Abraham Lincoln