On Wednesday, 5 November 2014, Pakistan delivered the following intervention on patents and health.
Agenda 7 Statement on patents and health
1. General statement
Mr. Chair,
I will make this statement in national capacity,
We appreciate the discussion on this important item which is especially important for resource constrained developing and least developed countries. This agenda item has a close link with both preceding agenda items, namely, exceptions and limitations to patent rights and quality of patents. All developing countries should benefit fully from the flexibilities available in international agreements. However in reality, the problem is that many developing countries have little capacity to practically implement and benefit from these flexibilities. We request the secretariat to provide technical assistance to developing and least developed countries in order to enable them to amend and modify their patent laws through the use of public health related flexibilities. This is in line with Article 4 of the Cooperation Agreement for Technical Assistance between WIPO and WTO which clearly gives the mandate to WIPO to offer technical assistance on IP related matters There is also a need of study to be undertaken on the impediments of practical implementation of public health related flexibilities in the member States of developing and least developed countries from technical and legal point of view. Because many such countries have incorporated health related flexibilities in their national patent legislation but they somehow failed to practically enforce and get benefit from these provisions.
Mr. Chair,
Public Health is a serious concern of developing countries which should be given utmost importance. The grant of bogus patents impedes the public health objectives of developing countries. The International Journal of Medical Marketing (2003) states that an example of the successful use of evergreening strategies to obtain extended protection is GSK’s version of the antidepressant, paroxetine. The ‘base’ patent expired in the late 1990s, but ancillary patents covering new forms, tablets, uses and processes will not expire until 2018.
Thousands of patents are granted per year on these incremental innovations, often trivial for a person skilled in pharmaceutical research and production. In fact, such patents over trivial improvements of existing or known drugs can be used strategically to block generic competition and access to affordable drugs.
My delegation believes that we cannot achieve the public health objectives unless we improve quality of patents and fully benefit from the flexibilities of the TRIPS agreement through technical and legal assistance of WIPO.
2. Specific comments on study on the role of patent systems in promoting innovative medicines
Mr. Chair,
The study uses the R&D data as indicator of innovation and technology transfer and Paragraph 6 notes that lack of reliable data may restrict research on and analysis of the influence of IPRs on pharmaceutical R&D and technology transfer. The study also regards patent data or patent activity as an indicator of pharmaceutical innovation. However, various studies have pointed out that most of the granted patents are actually not promoting real innovation. Statistical evidence shows that many patents had been granted around the world for pharmaceutical inventions that brought no significant advancement in healthcare. A survey published in April 2005 by La Revue Prescrire, concluded that 68 percent of the 3,096 new products approved in France between 1981 and 2004, brought ‘nothing new’ over previously available preparations. Similarly, the British Medical Journal (2005) published a study rating barely five percent of all newly-patented drugs in Canada as ‘breakthrough’. Furthermore, according to the National Institute for Health Care Management Research and Educational Foundation, Washington, DC (2002), a breakdown of over one thousand new drugs approved by the US FDA between 1989 and 2000 revealed that over three quarters have no therapeutic benefit over existing products.
Economists Boldrin and Levine reviewed a list of top 10 public health achievements in the 20th century compiled by the US Centers for Disease Control and Prevention and found that none of those inventions were patented. This suggests that the patent system did not play any role or has a little role in incentivizing the most significant medical and pharmaceutical innovations known to humankind. The intervention made by the representative of World Health Organization in yesterday’s session regarding treatment of Ebola virus in Africa also confirms this fact.
The WIPO study states that there is a correlation between strong patent protection and increase in pharmaceutical R&D. However, this does not explain whether the increase in pharmaceutical R&D is because of strengthened patent protection?
The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) reported that “Where the market has very limited purchasing power, as is the case for diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to market.”
Overall, the study by the WIPO Secretariat remains inconclusive about the role of the patent system in promoting innovation in the pharmaceutical sector. The study ignores the problem of the failure of the patent system to incentivize R&D on neglected diseases that dis-proportionately affects patients in developing countries.
3. Specific comments on study on the disclosure of INN in patent applications
Mr. Chair,
The objective behind the proposal by developing countries to explore the feasibility of disclosure of INNs in patent applications is to assist patent examiners to consider whether the patent application is for an absolutely novel pharmaceutical substance or whether it is for a new form of a known substance. Patent search is an expensive task and many governmental organizations cannot even do it in developing countries. Thus asking patent owners to disclose and list all of their relevant patents should be a right thing to be done.
Paragraph 27 of the study suggests that an INN may not be available at the time of filing of the patent application as request for INN is made at the beginning of the clinical trial stage. The listing and linking requirements can be submitted later on once such INNs are known. This will be similar to other reporting (such as assignment and licensing status, renewal updates etc.) requirements. This practice can play a significant role in preventing evergreening practices. The disclosure of INN in patent application also facilitates interested parties in identifying which patent they wish to be opposed. Paragraph 48 of the study states that a comprehensive INN keyword search function would facilitate a search for relevant patents and their legal status without the need for specialized skills for searching pharmaceutical substances.
Mandatory disclosure of INNs will also bring transparency in patent data as researchers will know how many relevant and irrelevant patents are filed to cover a drug and patenting practices would become eventually rationalized in this way. A mandatory requirement of INN disclosure, when known, neither violates any international rule nor constitute any burden or cost for the patentee. Therefore, to achieve the objectives of improving patent quality and promoting access to health, INN or INNM, whenever recommended by the WHO, should be communicated to the concerned patent offices.
I thank you.