WIPO-Pharma Patent Database Started With Industry In Early 2017

A newly announced partnership between the UN World Intellectual Property Organization and the international pharmaceutical industry to set up a database of medicines patents announced this month to the surprise of governments and civil society was an idea originally brought to WIPO by a group of companies in February of this year. Now they appear to be encouraging others to join in.

Launch of Pat-INFORMED, l-r: Tembenu, Gurry, Cueni 

WIPO Director General Francis Gurry and Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), signed an agreement establishing the Patent Information Initiative for Medicines (Pat-INFORMED) at a public event on 3 October.

Intellectual Property Watch published a prepared Q&A about the initiative with Gurry and Cueni on the day of the announcement, see (IPW, WIPO, 3 October 2017).

The announcement, made alongside the annual WIPO General Assemblies (held from 2-11 October), was promoted as the launch of a new partnership to “promote the accessibility of patent information for health agencies tasked with procurement of medicines.” It was characterised as the beginning of the process, and was said that input from other sources would be welcome.

But the announcement and “launch” of the program came as a surprise to many, including health advocates and managers of related databases, as it apparently had been developed in private between industry and WIPO staff.

The initiative had been “an idea kicking around for a while,” one industry representative told Intellectual Property Watch after the launch event. It started in February of this year, when some 17 companies wrote to WIPO, he said. Intellectual Property Watch did not request a copy of the letter.

The Pat-INFORMED online initiative is expected to be operational by mid-2018.

Another Industry Partnership for WIPO

In recent years, WIPO has stepped up its direct activities with industry, particularly in the biopharmaceutical innovator sector. The latest initiative is seen by WIPO and the industry partners as another in the line that includes WIPO Re:Search and WIPO Green, all aimed at helping patent holders put their IP to use for the benefit of developing countries. As such, it was not seen as requiring member state vetting and involvement in its development. The projects also have a function of helping clarify the IP rights ownership around innovation, which helps with enforcement.

And WIPO does recognise the sensitivity of IP and health issues.

“The question of intellectual property and innovation and health is of course one of the fundamental and one of the most difficult policy questions that occupies the international community and it occupies national governments,” Gurry said in his remarks opening the launch event.

Samuel B. Tembenu, minister for justice and constitutional affairs in Malawi, said at the launch, Since the coming into existence of the TRIPS agreement, there has been a constant tension between access to essential medicines and innovation.

For there to be access to essential medicines there has to be someone else who puts in the investment to developing these drugs, he said. Tembenu’s connection to the project was not clear, but one source indicated they may have thought it appropriate to have a government official on the podium along with the others.

Cueni said in his remarks that the initiative started as an initiative of companies. Patents are never simple, he said. And the announcement showed the private sector’s ability to propose initiatives that are constructive, he added.

Tom Bombelles, former pharma lobbyist and head of WIPO Global Health, now head of WIPO NGO and Industry Relations, demonstrated the technology. He showed searches of patents on various compounds, by International Nonproprietary Names (INN), gives dosage, how taken, company and what patents are on it. Clicking on the patent gives the patent, title, owner and more in the original patent language, and WIPO’s latest translation tool can translate it. It then offers a contact for the patent owner.

This is “real world guidance” for sourcing licensing inquiries, Bombelles said.

Bombelles made a point of saying that they are at the beginning of the process, and with this event were “putting the initiative in front of you” to “give it as high a public profile as possible.” He cited the UN Sustainable Development Goal number 17 which he said calls for public-private partnerships to further the aims of development.

He did not appear to answer a question to the panel about who has ultimate responsibility, but afterward Intellectual Property Watch was told that it will be the companies themselves. They also will be responsible for their own quality control and updating, but will use a standard form for submitting information which help with quality.

And WIPO, which will provide several staff to work on the project, will help encourage quality and updating.

Working with Others

Speaking on the panel as well was Esteban Burrone, head of policy at the Medicines Patent Pool (a UN-created organisation across the street from WIPO in Geneva), which has a related initiative called MedsPal, which was launched at the WIPO General Assemblies last year. He said the new project is a “very welcome initiative” that “went way beyond” what they would have expected. The MedsPal team was not consulted in the construction of the new Pat-INFORMED database, sources said, and does not appear to have been made a partner with WIPO.

MedsPal (Medicines Patents & Licences Database) is for developing countries, Burrone said, and described why the two databases would be complementary. Patent disclosure, which is what Pat-INFORMED offers, is “a starting point,” he said, but “not the end of the story.” For instance, if there are a number of licences granted in a country, MedsPal shows that. It also shows data exclusivity if it exists. And it takes into account information they have gathered from many national IP offices. It is important to engage with other sources, he said.

Roy Waldron, chair of the IFPMA IP and Trade Committee, and senior vice president & associate general counsel, chief intellectual property counsel, at Pfizer, said the announcement represented the first phase, and they want to see what is being used and what is not.

Bombelles noted the social bargain inherent in granting a patent to make information available to the public, said the new initiative bridges a gap between the availability of information, and what is accessible.

Waldron said this will help the user see the patent information at a glance rather than having to hire a specialist researcher to do the search. “The patent information really resides with us” he said referring to industry, so they are letting users know the information.

Burrone asked about the need for updating the database, and also asked why patent application status was not added, for instance showing if the patent is expired, withdraw, opposed and so on. A concern is that a search may indicate that a patent or patents exist, discouraging innovation or use, when in fact the patents may have expired or have other circumstances.

Peter Beyer, senior advisor, Department of Essential Medicines & Health Products, World Health Organization, also praised the initiative and asked some questions about it. He said WHO is working on a database of drug prices and he hoped industry would be helpful in providing drug pricing information.

Member-State Driven Organisation

A representative of the mission of Chile said from the audience that the country signed a memorandum of understanding with MedsPal, and that offices take responsibility for the data on that platform. Who will take responsibility for this data, will it be WIPO? the delegate asked. She suggested that the WIPO Standing Committee on the Law of Patents (SCP) could look into it.

A Brazilian government representative to WIPO said knowing the status of a patent is critical for stakeholders to make informed decisions. Brazil has been active in the SCP, he said, and in its last session, after long discussions, the committee agreed to allow [pdf] the Medicines Patent Pool to present its work at the next session of the committee.

Brazil welcomes any initiative that provides detailed information on patent status, he said, but added that it is important to include member states in initiatives from the start in order to enhance transparency, build trust, increase quality, and ensure there is enough member state support.

The 2007 WIPO Development Agenda (Recommendation 9) called for WIPO to create, in coordination with member states, a database on IP, he said. And given the scarcity of resources and the need not to duplicate effort, they should ensure coordination from the outset. Brazil raised a concern that it would be more productive to collaborate with MPP, and asked why WIPO did not involve the MPP from the beginning.

Waldron said the information is coming from the companies themselves, and that those that own the intellectual property are probably best positioned to answer questions about it. The patent offices don’t have internal knowledge of the company, he said. He said this is already done in the United States with the so-called Orange Book, which identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

This is an opportunity to expand the registry to other countries, he said.

A delegate from the United States said the initiative will be “extremely useful and helpful.” The United Kingdom also said it was positive.