SCP 24 - A fruitful discussion?

30 June 2016

By Sophia Simon

The World Intellectual Property Organization’s (WIPO) Standing Committee on the Law of Patents (SCP) plays a significant role as the United Nation’s only dedicated, multilateral forum for the discussion on patents. The WIPO SCP convened for its 24th session in Geneva from 27 June 2016 to 30 June 2016.

After years of debate, dissent prevails among Member States. While developing and least developed countries have pushed WIPO to embark on a more robust work program on exceptions and limitations along with patents and health, developed countries have endeavored to steer discussions towards work sharing (between patent authorities) and the harmonization of international standards for client attorney privilege.

By the end of the SCP’s 23rd session in December 2015, no consensus had been reached, so the agenda for SCP 24 consisted of the same five main substantive topics, which have been on the table since SCP 16: (1) exceptions and limitations of patent rights, (2) the quality of patents, (3) patents and health, (4) confidentiality between clients and patent advisors, and (5) the transfer of technology. An additional agenda item on the revision of the 1979 WIPO Model Law for Developing Countries on Inventions, tabled by the Group of Latin American and Caribbean Countries (GRULAC), will be considered. Although discussions are mainly based upon old proposals, several other documents were presented this week, including a proposal from Spain on the assessment of inventive step and a revised proposal from the African Group for a WIPO work program on Patents and Health.

Exceptions and Limitations to Patent Rights

First introduced in the 14th session as SCP/14/7, Brazil’s revised proposal from February 2013 on exceptions and limitations, SCP/19/6, was the primary document of discussion.

To follow up on their proposal, Brazil emphasized that it is time for the WIPO Secretariat to provide an analysis of exceptions and limitations used for development concerns, along with a non-exhaustive reference guide for member states, inviting submissions from all stakeholders. Additional stakeholders would include civil societies, industries, and research institutions. The delegation also pointed out that a compilation of relevant court cases could be made, which would help all member states to better understand existing legislation.

The Group of Latin American Countries (GRULAC) spoke to support Brazil, as did Iran, the Bahamas, Pakistan, India, the African Group and South Africa. Even the EU said it was “essential to learn from practical experiences on the effectiveness and challenges of exceptions and limitations to patent rights to address development issues,” mentioned the topic should be considered as a part of future work program. China, Russia, and Latvia on behalf of the Central European and Baltic States (CEBS) also expressed their view that it would be beneficial to share experiences on exceptions and limitations, demonstrating an unexpected yet welcome area of consensus between diverse Member States.

On the other hand, the United States did not support any analysis of commonly used exceptions and limitations. They noted that further study on the subject would be a waste of time and effort, as there had already been an extensive amount of information presented by the committee, including studies during SCP 21 and 22 and numerous seminars. The delegates also stated they believe that socioeconomic analysis of the effectiveness of exceptions and limitations would fall outside the scope of the SCP and WIPO as a whole. In their view, it is not within the secretariat’s competency to evaluate a topic where countries have such divergence in objectives.

Third World Network (TWN) stressed the importance of limitations and exceptions to safeguard public interest. After stating that many member states face difficulties while using flexibilities, TWN explicitly called out Switzerland and the US. TWN contended that when the US and Switzerland pressured Colombia against using a compulsory license for the drug imatinib, the nations had violated their international human rights obligations to respect the sovereignty of states.

Quality of Patents (including Opposition Systems)

At the end of the last session, the Committee agreed the Secretariat should improve the Patent Cooperation Treaty (PCT) and Patent Prosecution Highway Pilot web page on work sharing and collaborative activities in order to be able to better explore bilateral or multilateral programs at different phases of the search and examination process.

Along with the work sharing website, WIPO also gave a presentation regarding WIPO CASE, an initiative between 24 patent offices to facilitate file sharing. Another program, CADOPAT, was presented by Mexico to demonstrate their first hand experience with work sharing, which they claimed was successful. The US delegation also elaborated upon the Global Dossier with the ‘IP 5’ - the USA, Korea, Japan, China and the European Patent Office, noting that work sharing provided a “bold, brave new wonderful world for patent examiners.”

Many nations went on to express their support and even dire need for work sharing. The Irish delegation pointed out that his patent office “has only three patent examiners, expected to examine patent applications from across the spectrum,” creating unmanageable workloads which work sharing with larger nations could potentially mitigate. Many developed countries pointed out that work sharing would help to reduce the time of the application process, save resources, and diminish the duplication of work. On the other hand, developing nations called on the committee to first reach a common understanding of “quality of patents.” The Indian delegation expressed concerns that open databases could increase biopiracy and cause harmonization of sovereign patent laws, while also noting that in their opinion, work sharing does not relate to high quality patents. Iran further commented that work sharing not only does not fall within the SCP’s mandate, but “is a bilateral issue and could undermine autonomy of national offices to ensure patent application meets the substantive requirements of its national law.”

Another discussion point under the agenda item on quality of patents was the Spanish proposal in document SCP/24/3, suggesting that studies should be conducted to determine how different regions and nations define inventive step. It was met with high levels of support from member states, although developing nations such as Brazil and India reiterated that the study should not be used as a mechanism to harmonize patent laws.

Patents and Health

Much to the delight of many developing nations and NGOs, the African Group tabled a proposal on patents and health (SCP/24/4) which updated their previous proposal (SCP/16/7). The proposal introduced a comprehensive work program consisting of multiple studies, an exchange of information between Member States and experts in the field, and the provision of technical assistance to Member States. In particular, it intends to focus WIPO's attention on new challenges and developments in public health including the Zika and Ebola viruses, Anti-Microbial Resistance (AMR), new funding sources for research and development, the revisions to the WHO Model List of Essential Medicines, the United Nations High-Level Panel on Access to Medicines, the adoption of the Sustainable Development Goals (SDGs) (particularly the third goal) and the WTO extension of the transition period under Article 66.1 of the TRIPS agreement.

Many developing nations such as Brazil, Pakistan, South Africa and Iran discussed how patents and health is a matter of critical concern for all member states regardless of development, and how health is one of the UN Sustainable Development Goals. The Pakistani delegation noted that “the basic human right to health is denied to populations globally as they are being denied treatment for hepatitis C, cancer, and multi-drug resistant tuberculosis only because treatment is unaffordable.”

Iran, Brazil, India, South Africa, Nigeria and Pakistan spoke out to support the African Group proposal. Iran further commented that full use of TRIPS flexibilities should be encouraged to promote public policy and health objectives, which South Africa echoed. India emphasized that the patent health system had a responsibility to ensure access to medicines. The Indian delegation also noted that Markush claims face problems for meaningful search and examination in patent applications, and therefore requested a study be conducted on the costs and benefits of patenting Markush formulas.

Some developed nations, including Group B, urged member states to consider incentives other than patent flexibilities to help R&D reach smaller markets and increase innovation. They pointed out that patents are not the only factor affecting access to healthcare and technology, which the EU and US reiterated. The US delegation commented that by only focusing on patents affecting access to healthcare, the African Group was oversimplifying a complex and multifaceted problem.

The disclosure of International Nonproprietary Names (INN) in patent applications was also discussed under this agenda item. Group B and Japan noted that often INN is only filed years after a patent application, and therefore would be almost impossible to include in the initial filing. On the other hand, some nations such as India and Oman commented that it could facilitate the granting of patents.

KEI's statement highlighted the high-cost T-DM1 drug for breast cancer in the UK and the unaffordable leukemia medicine, imatinib, in Colombia.

On 8 August 2014, the National Institute for Health and Care Excellence (NICE) decided that T-DM1 should not be made available on the National Health Service (NHS), citing its extraordinarily high cost. NHS patients in England continued to get access to T-DM1 through the Cancer Drug Fund (CDF). The Cancer Drug Fund, however, does not extend to patients living in Northern Ireland, Scotland and Wales, demonstrating the disparity in access to high-cost medicines that exists even within one nation.

Turning now to Colombia, in November 2014, civil society groups in Colombia petitioned the Colombian government to issue a compulsory license on the expensive anti-leukemia medicine, imatinib (marketed as Gleevec by the Swiss company, Novartis). The process for a compulsory license is specified in Colombian law, and the right is preserved through numerous well-known international trade agreements, including the TRIPS Agreement, the Doha Declaration on the TRIPS Agreement and Public Health, and the U.S.-Colombia Free Trade Agreement. In spite of this, there has been well-documented pressure on the Colombian government not to use TRIPS flexibilities by the Swiss government, the pharmaceutical industry, the USTR, the United States Senate Finance Committee, and the United States Chamber of Commerce. The Minister of Health recently did take the commendable step of issuing a public interest declaration-a prerequisite under Colombian law before a compulsory license may be issued.

In light of the current conditions regarding extremely high prices for drugs, KEI encouraged the SCP to do the following:

“In terms of the Committee’s work program on patents and health, we urge the WIPO SCP to commission a framework study by leading independent experts to examine the implications of international trade agreements on access to medicines including norms on the evergreening of patents, mandatory patent extension, sui generis exclusivity, damages and the investor state dispute system (ISDS). The study should examine the impact of patent monopolies on the prices of, inter alia, hepatitis C medicines and cancer medicines. The study should also examine limitations and exceptions to remedies for infringement contained in Part III of the TRIPS Agreement, the very area that is facing new challenges from the new norms on remedies for infringement included in the TPP.”

Other issues on the table

The report on certain aspects of national/regional patent laws had received no updates from member states since the previous session, so the study remained the same.

Regarding confidentiality of communications between clients and patent advisors, most developed nations underscored the need to establish an international privilege by working towards a soft-law approach. Alternatively, other Member States argued that this topic fell under national legislation, transparency should be encouraged, and harmonization should be avoided. Iran commented that harmonization would be “unworkable and inappropriate.”

Many members of the SCP supported the GRULAC proposal to revise the 1979 WIPO Model Law, including the African Group, the Asia Pacific Group, Pakistan, Oman, Iran, Senegal, South Africa, India and KEI. Others, such as Group B and the EU, contended that discussion on this subject would lead farther away from a balanced work program. Despite the controversy, this agenda item has remained on the table.