Global differences on patents lead WIPO patent law committee to stumble on future work
Once again, differences over the role of a World Intellectual Property Organization committee last week came in the way of consensus and prevented delegates from agreeing on future work. At the heart of the discontent was the perceived imbalance of the proposed programme of work, which some said disregarded the interests of developing countries. A speaker for the African region gave a striking speech on the Ebola crisis as an example of the failure of the patent system.
The Ebola crisis is an example of the failure of the patent system, a delegate from Kenya said, “Thousands of people are dying, yet this patent system, this organisation who is supposed to cater for our interests does not seem to care.”
“If we cannot have a patent system and pharmaceutical industries work for all of us, then let’s not pretend and use the word ‘balance’,” he said.
The Standing Committee on the Law of Patents (SCP), which held its 21st session from 3-7 November, deals with substantial issues concerning “the progressive international development of patent law,” according to WIPO.
After a week of discussions on topics such as patents and health, the confidentiality of clients/IP attorneys, and patent quality showed divided opinions brought by different perspectives on the patent system, the meeting closed with no approval on the programme of work of the next session.
Developed countries are keen to work on patent quality, including the sharing of work between IP offices so they can build on work previously carried out by other offices, in particular on prior art searches. Developing countries have shown strong interest in exploring the relationship between patents and health, and how patents possibly impact assess to medicines.
The summary of the session [pdf] issued on the last day by SCP Chair Mokhtar Warida of Egypt, was intended to be noted rather than approved to avoid lengthy discussions on the way the week-long meeting was summarised. It did not contain a future work programme, which was the subject of a separate document, as the work programme of the next session needs approval by delegates.
A second version [pdf] of the summary was released later as some member states found a shorter description of discussions was preferable so that some positions are not better reflected than others. Examples are agenda item 6 (quality of patents), and the seminar on work-sharing. This second version includes a minimal work programme: two studies that were previously approved at the previous session of the SCP, relating to the quality of patents.
A summary [pdf] of the work-sharing session regarding experiences on international work-sharing and collaboration was issued by the secretariat on 6 November listing interventions made by four countries which presented their national experiences and further comments by member states (IPW, WIPO, 5 November 2014).
No Agreement on Future Work
Victor Portelli of Australia, the ad hoc vice chair of the SCP, had been tasked with conducting informal consultations to reach agreement on a work programme for the next SCP session.
An informal non-paper [pdf] containing a draft future work proposal was proposed to the plenary on Friday afternoon after Portelli said no agreement was found with regional coordinators.
The draft work programme listed the five current issues dealt with by the SCP: exceptions and limitations to patent rights; quality of patents, including opposition systems; patents and health; confidentiality of communications between clients and their patent advisors; and transfer of technology.
Under each topic were listed the activities foreseen for the next session. That included a seminar on the quality of patents, and a seminar on work-sharing. Under limitations and exceptions, there was to be a compilation of member state experiences and case studies on the effectiveness of exceptions and limitations, in particular, in addressing development issues.
Kenya, on behalf of the African Group, said the group was concerned about balance in the draft work programme, and Brazil concurred. Paraguay, on behalf of the Group of Latin American and Caribbean countries (GRULAC), said they felt prejudiced against by the draft work programme as several of their proposals had not been reflected.
One of the concerns of developing countries is the SCP delving into work-sharing discussions, which they see as an attempt to harmonise the global patent system, a developing country source told Intellectual Property Watch.
GRULAC proposed to change the term “compilation” to “studies” on the exceptions and limitations item of the work programme. According to a developing country source, studies imply an analytical work on the findings rather that just presenting facts.
Japan for the Group B developed countries said balance is always difficult to reach but the group was ready to go along with the proposed document, so that “this organisation continues its work in line with its objectives.”
The Asia and Pacific Group said they “could live with it,” as did the Central European and Baltic States (CEBS) Group, although both said it was not really to their liking.
After another round of consultations in the early evening of Friday to try to tweak the text to agree with all, it became apparent from the conversations in the corridors that consensus remained elusive.
African Group: Too Much Patent Quality Focus, Not Enough Health
The main problem in the meeting was the amount of work envisaged on the quality of patents and work-sharing, compared to exceptions and limitations to patent rights.
Although most regional groups said they could agree to the draft work programme with a few amendments, the African Group remained firm in its request. The Kenyan delegate, on behalf of the group, delivered a vibrant speech chastising the SCP for not taking into account the plight of African countries facing major public health problems, in particular at that time, the Ebola crisis.
He said two studies on inventive step and sufficiency of disclosure had been agreed at the 20th session of the SCP, and thus would be carried out for the next session. But, he said, this should be balanced with two studies, one on limitations and exceptions to patent rights, and the other on so-called “Markush claims.”
Markush claims are defined in a May 2011 proposal [pdf] by the African Group and the Development Agenda Group as “claims that may apply to a broad range of compounds.”
In their proposal, the groups noted, “It could be worthwhile to analyze whether such claims based merely on theoretical inference can be considered to satisfy the criteria for patentability.”
The Ebola crisis is an example of the failure of the patent system, the Kenyan delegate said, “Thousands of people are dying, yet this patent system, this organisation who is supposed to cater for our interests does not seem to care.”
“If we cannot have a patent system and pharmaceutical industries work for all of us, then let’s not pretend and use the word balance,” he said.
Faced with disaster in Africa on public health, he said, “we have a problem and we need to see flexibility to ensure that the patent system does not become a hindrance.” The African Group is ready “to take the blame” for not agreeing on the draft work programme “for the sake of our people,” he said.
Meeting Chair Warida, seeking a link between Ebola and the patent system, said the world is responding to the crisis and asked Kenya which studies would help the situation. The Kenyan delegate pointed to the requested studies on INNs and Markush claims.
However, the two studies requested by the African Group could not be agreed upon. Brazil also requested studies on exceptions and limitations and on patents and health. India also supported a study on Markush claims. None of the studies was agreed.
Without consensus on future work, the agenda of the next SCP has only the two studies agreed upon at the last session of the committee.
One participant said that afterward, some felt perhaps the Kenyan statement had gone too far.
In his concluding remarks, the Czech Republic delegate noted his concern about “the attempt to divide this house between developed and developing countries,” which he qualified as “a dangerous way for all of us.”
Pakistan for the Asia and Pacific Group said the group does not want to see WIPO become deadlocked “like so many other organisations.” There is just one planet, the delegate said. “We need to live with each other’s differences.”
Patents and Health on Agenda
Earlier in the week, patents and health were discussed in the committee, and in particular the study [pdf] carried out by the WIPO secretariat on the “Role of Patent Systems in Promoting Innovative Medicines, and in Fostering the Technology Transfer necessary to Make Generic and Patented Medicines available in Developing Countries and Least Developed Countries.”
The European Union in its statement said the study reaffirms the “critical role of patent protection for pharmaceutical innovation.” They also said the study confirms that IP protection is “a requisite condition for pharmaceutical technology transfer,” while not the only factor.
Brazil proposed further studies in relation to the patent system and the availability of medicines in developing countries and least-developed countries.
Egypt pointed to the self-assessed challenges of the study, some of which are noted in paragraph 8 of the study, such as the fact that “the use of patenting activity to measure innovation may pose challenges.”
The study states that, “The value of a pharmaceutical innovation may not be captured by merely counting the patents or patent application.”
India concurred and said measuring patent activity is not a valid measurement. Algeria underlined that according to the World Health Organization, strong patent protection may not facilitate research and development (R&D) in developing countries.
Knowledge Ecology International (KEI) underlined the very high prices of new drugs, citing cancer drugs which could be priced at over US$ 100,000 per year per patient and beyond, linking those high prices to the monopoly awarded by patents.
KEI said one of the approaches worth exploring “is to delink the patent from the notion of an exclusive right, and make the patent a mechanism to establish a claim on innovation inducement prizes, and are given as a reward for innovation – as a substitute for the grant of a monopoly.” KEI suggested the SCP undertake a review or ask for a study of the provisions in national patent laws that would enable full de-linkage of drug prices and R&D costs.
KEI mentioned two research notes it published in 2014: Recent European Union Compulsory Licenses [pdf], and Recent United States Compulsory Licences [pdf].
Disclosure of International Nonproprietary Names
A feasibility study [pdf] entitled, Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents was also discussed.
According to the WHO, INN “facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.”
The EU said on 4 November in their statement that according to the preliminary findings of the study carried out by WIPO, “it is impossible to disclose, at the time of filing, the future corresponding and yet to be published INN in patent applications filed before the publication of the Recommended INN.”
Some developed country delegates said the mandatory disclosure of INNs in patent applications would be an additional burden on patents applicants and patent offices, such as Japan and the United States, who added that the time and resources to implement such procedure would be better spent on things such as increasing the quality of patent and decreasing backlogs.
Kenya on behalf of the African Group said the disclosure of INNs could prevent patents from being granted on incremental innovation, or potential attempts to extend the life of patents.
KEI delivered a statement saying that ministries of health, procurement agencies and humanitarian organisations “may be interested in knowing the patent status of medicines in order to check the validity of patents, negotiate price or license with the patent holder or to consider the possible use of compulsory licenses or governmental use.”
“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,” they said.
Client-Patent Advisor Confidentiality
A seminar [pdf] on the Confidentiality of Advice from Patent Advisors took place on 5 November and presented the perspective of patent advisors and clients.
Developed countries are keen to reach an agreement on a soft law protecting the confidentiality of communications between clients and their patent advisors, in particular in the cross-border context. Developing countries are arguing that this issue falls outside the scope of the SCP and the matter is dealt with by national legislation.
According to the presentation of Manisha Desai, assistant general patent counsel for Eli Lilly and company (speaking from the clients’ perspective), patent applications for important innovations may be filed in up to 100 countries.
Problems arise in cross-border communication, she said, as the privilege of client-attorney communication may be recognised in the originator country but not by others and communications may become public, she said, adding that communications with non-lawyer IP professionals may not be privileged and are therefore discoverable.
Steven Garland, from the International Association for the Protection of Intellectual Property (on the patent advisors’ perspective panel), in his presentation, also said cross-border communication is a problem since there is a lack of coverage domestically in certain countries. He cited Canada, which provides no protection for communications with non-lawyer IP professionals, and the US, where there is no single approach to domestic and foreign non-lawyer agents/attorney communications.
According to a source, India remarked on an Indian lawyer speaking on the panel of patent advisors as not specifically representing the perspective of the Indian government.
