‘Linkage’ & other TRIPS+ provisions: a public health perspective Karin Timmermans World Health Organization Seminar “Data exclusivity and patent Bangkok.

‘Linkage’ & other TRIPS+ provisions:

a public health perspective

Karin Timmermans

World Health Organization

Seminar “Data exclusivity and patent BangkokLinkage in free trade agreements” 25 Aug. 2006

Patents are a public policy tool:

• to promote and reward innovation

• to disclose the invention,and make it available to society

TRIPS has harmonized standards for patents:

• all fields of technology

• product and process inventions

• minimum standards: 20 years

• effective enforcement

For most developing countries, the new standards are higher than their previous standards.

Introduction of TRIPS standards will delay the introduction of generic versions of new drugs

TRIPS contains some safeguards, that can be used to mitigate its potential negative effects on access to medicines

This is a problem, since:

• It turns the DRA into a ‘patent police’;

• But patents may be invalid or not infringed;

• The DRA does not have the capacity to assess the validity of a patent – thus there is a risk that it will ‘enforce’ any and all patents, and hence create an additional barrier to access to medicines.

‘Linkage’

‘Linkage’ means that the Drug Regulatory Authority (DRA) is not allowed to register a generic version of a medicine that is still protected by a patent.

‘Linkage’

Unfortunately, many recent Free Trade Agreements (FTAs) concluded by the US impose ‘linkage’.

The health sector should be vigilant,

and sensitize the trade officials

Where a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting safety or efficacy information, to rely on evidence of safety or efficacy information of a product that was previously approved, such as evidence of prior marketing approval in the territory of the Party or in another territory, that Party shall:

‘Linkage’ in FTAs:

US-Peru FTA, 2006

a) implement measures in its marketing approval process to prevent such other persons from marketing a product covered by a patent claiming the product or its approved method of use during the term of that patent, unless by consent or acquiescence of the patent owner; and

a) provide that the patent owner shall be informed of the identity of any such other person who requests marketing approval to enter the market during the term of a patent identified to the approving authority as covering that product.

Regulatory Agencies in Europe

refuse any and all type of linkage

between registration and patents

‘Linkage’

Regulatory Agencies in Europe

refuse any and all type of linkage

between registration and patents

‘Linkage’

Other countries may wish to follow the same approach …

Other ‘TRIPS+’ provisions

Broadening the scope of patentability

‘Evergreening’ refers to the practice of filing additional patents on minor modifications or trivial improvements of known/existing medicines, in an effort to keep generic competition at bay.

Explicit demands that patents are granted for the ‘new use’ of a known substance have been incorporated in several US-FTAs; this will facilitate ‘evergreening’.

Broadening the scope of patentability

Explicit demands that patents are granted for the ‘new use’ of a known substance have been incorporated in several US-FTAs; this will facilitate ‘evergreening’.

And while generic versions could be marketed for the first indication (the ‘old’ use) without infringing the patent for the new use, patent holders could use these patents to threaten generic competitors with lawsuits.

Broadening the scope of patentability

Subject to paragraph 2, each Party:

(a) shall make patents available for any invention, whether product or process, in all fields of technology, provided that it is new, involves an inventive step, and is capable of industrial application; and

(b) confirms that it shall make patents available for any new uses for, or new methods of using, a known product, including new uses and new methods for the treatment of particular medical conditions.

US-Oman FTA, 2006

Patent term extensions in FTAs:

(a) Each Party shall provide the means to and shall, at the request of the patent owner, compensate for unreasonable delays in the issuance of the patent by restoring patent term or patent rights.

… …

(b) With respect to any pharmaceutical product that is covered by a patent, each Party shall make available a restoration of the patent term or patent rights to compensate the patent owner for unreasonable curtailment of the effective patent term resulting from the marketing approval process related to the first commercial marketing of the product in that Party. Any such restoration shall confer all of the exclusive rights of a patent subject to the same limitations and exceptions applicable to the original patent.

US-Peru FTA, 2006

Patent term extensions

Demands that the patent is extended beyond the

TRIPS-minimum of 20 years, in case:

• there has been a delay in granting the patent, or

• there has been a delay in registration of a medicine.

For most developing countries, the TRIPS-minimum of 20 years is already a significant increase of patent protection; it seems much better to first gain experience with the TRIPS standards and to analyze their implications, before granting even longer patent terms

Patent term extensions

Demands that the patent is extended beyond the

TRIPS-minimum of 20 years, in case:

• there has been a delay in granting the patent, or

• there has been a delay in registration of a medicine.

It would be important to look at the reasons for the delay …

- questions about quality, safety or efficacy?

- who/what is causing the delay?

0 20 40 60 80 100

Philippines

Thailand

Nepal

Egypt

J amaica

Tunisia

Malaysia

Yemen

Antigua and Barbuda

Greece

Canada

Australia

Belgium

Italy

Ireland

Portugal

Spain

Luxembourg

Developing countries(5-50%)

Developed countries(50-90%)

Public spending as % of total spending on pharmaceuticals

Source: WHO/DAP

Limitations on compulsory licensing

Some FTAs also impose restrictions on the grounds (reasons) for issuing a compulsory license.

For example, the US-Jordan FTA specifies that a compulsory license only can be issued:

• to remedy anti-competitive behavior,

• for public non-commercial use,

• in case of emergency or extreme urgency,

• in case of insufficient supply.

In conclusion, the health sector should be vigilant and sensitize trade officials and negotiators about the possible implications of their negotiations on public health and access to medicines.

In conclusion, the health sector should be vigilant and sensitize trade officials and negotiators about the possible implications of their negotiations on public health and access to medicines.

Thank you