WIPO Re:Search Celebrates 3 Years, Looks To The Future

Several years ago, the World Intellectual Property Organization set up a project aimed at helping bring together those with intellectual property rights and those with ideas for research to develop medical products for people in need. The project, WIPO Re:Search, has gathered numerous partners and is beginning to look ahead to its next phases, including the possible eventuality of drug development, according to the WIPO secretariat.

Intellectual Property Watch‘s William New sat down recently with WIPO officials in charge of the Re:Search project: Anatole Krattiger, director of the Global Challenges Division, and Tom Bombelles, who is head of Global Health at WIPO.

WIPO Re:Search has three activities: a database managed by the WIPO secretariat, a ‘Partnership Hub’ managed by BIO Ventures for Global Health (BVGH) – a non-governmental group based in Seattle led by Jennifer Dent – and supporting services.

The Partnership Hub represents the “heart” of the project because it is “where the deals are made,” according to Bombelles.

After three years since launch (and even longer since the concept emerged), what they have determined is that “the IP of companies can be shared very successfully for research and product development in the neglected tropical diseases space,” said Krattiger.

Companies that are party to many arrangements are sharing and hosting arrangements, he said, adding that public sector companies in developing countries are “extremely happy and eager” to participate in neglected tropical disease (NTD) R&D.

“We’ve gone beyond proof of concept, have a track record, have a volume of activity,” Krattiger said. Now they want to look at how the environment has evolved. For this, they have hired an outside consultant.

Krattiger said there are two key questions to ask:

– How do we continue to deliver real value in the space? What is our niche?

– How does that evolve now? How does the focus change if at all in order to have more impact? How do we move forward with collaborations that are successful?

For example, he said, “some of our pharmaceutical company members can screen products for our smaller members, but if there is something promising … [we need to ask] how to take it forward to the next stage where more funding is needed.”

“We don’t have to solve the problem yet, but we need to think about it,” said Krattiger. “We believe we will have plenty of candidates in the future to hand over to product development partnerships (PDPs).”

A third question, eventually, he said, is what will be the best structure to enable that new phase to flourish.

‘Interesting and Positive Stage’

“We’re in an interesting and positive stage” in the evolution of the project, said Bombelles. It has been three years since the launch at the end of 2011.

During the first three years, the project focused on building membership, and through the Partnership Hub and BVGH, on establishing research partnerships between members.

The first years of infancy focused on research, he said, and more than tripled membership in that time. BVGH has brokered more than 81 deals, recently adding a new pharma member, Merck Serono.

“The project is going well,” Bombelles said. “We’ve shown proof of concept.”

Now they are looking at the work plan going forward with BVGH, what has worked, what hasn’t worked.

As is normal in the evolution of a project, it is appropriate to look at the structure, he said. This project started with 31 members, and now has almost 100. So, Bombelles said, it may be time to ask questions like: “What is our administrative capacity to interact with and provide services to so many members? Do we need a new governing structure?”

“These are some of the questions that we ask ourselves, but also remembering that this is a ‘good news’ story,” he said.

In the first 2-3 years, the emphasis was on connecting researchers, and making the connection between members. “Let’s say a researcher in Africa sends material to a university in the US. If the project progresses, where will the funding come from for additional pre-clinical work, and eventually clinical research?” he said. “This is another question we have to ask ourselves and our members. If these things progress, we didn’t address money for funding development.”

“It’s [sort of] like a date: what if it gets serious, goes to clinical development. Who funds that?” he commented.

Capacity Building

Part of what WIPO Re:Search does is that capacity-building, providing IP training to scientists and R&D managers in developing countries.

WIPO Re:Search held its annual meeting in New York in November, and brought 15 African scientists to New York for a two-day workshop for the benefit of developing country members. They came from Cameroon, Egypt, Ghana, Kenya, Mali, Mauritius, Nigeria and Tunisia. The cost of the workshop and the participation of the developing country scientists was underwritten by the government of Australia.

The Australian government provides a “Funds-In-Trust” (FIT) grant to WIPO for its development work, said Bombelles. Some of the funds were used to target research institutions to develop IP management capacity within the institution. This helps them in their collaborations, such as material transfer agreements with appropriate IP clauses, when they negotiate agreements with other WIPO Re:Search members, or any outside institution, Bombelles said.

“We don’t even have an IP policy,” one of the scientists was quoted as saying at the workshop. “If someone asks us to send a sample of, say, fauna from our country, we don’t even know what terms to include with the transfer.”

The workshop is put forward as a good example of the capacity-building activities undertaken by WIPO, in this case within the context of the Supporting Services of WIPO Re:Search.

Every university in developed countries, and most of Asia, has a technology transfer office, Bombelles noted, adding that this is not the case in many African research institutions, hence the value of the IP training provided by WIPO for WIPO Re:Search members.

External Consultant

Meanwhile, to help with the process of looking ahead, WIPO retained the services of an external consultant who interviewed many members and drew on his own extensive experience in research, PDPs, and direct research in neglected tropical diseases in order to evaluate the progress and what can be a way forward for the future, Krattiger said.

The external consultant, Richard Mahoney, has been meeting with members of WIPO Re:Search, providers, and supporters, he said.

Mahoney is an expert in institution-building, Krattiger said. He has set up non-profits, fundraising, and product development, created seven non-profits, including PATH. The timeline for the review is the first half of 2015.

But, the officials noted, he is “not telling WIPO Re:Search what to do,” just surveying the landscape and providing input.

The officials said the transactional work of the project has demonstrated that lots of collaborators can be developed.

“The review helps us answer questions about how we might catalyse many of these early stage collaborations into a product pipeline,” said Krattiger. “How with that strength we have can we contribute to that?”

The project has 82 members, which means more actors working together, and more opportunities, he said. There is “more buy-in by industry to share without reservation, with BVGH as ‘honest broker’.”

As to budget, WIPO provides the secretariat, and operations of the project is in the WIPO budget. The project leverages FIT resources, which depend on governments. It also helps BVGH with its funding strategy, as “they do work we as a UN agency couldn’t be doing.”

Company Incentives

WIPO Re:Search has eight leading companies as members, and is continuing to encourage others to join. “We appreciate especially our “founding” members, for the faith they showed in the potential of WIPO Re:Search at the beginning,” Krattiger said.

The value proposition for companies is to catalyse research into neglected tropical diseases (NTDs). Pharmaceutical companies have large libraries of thousands of compounds. Many have therapeutic value, but maybe not in an area that the company is focused on,” he said. But those assets can be productively used by others, and the companies are “very happy” to contribute these assets.

“We are the one avenue to help them contribute in this field,” he said, adding that they are working on a range of diseases and other issues.

The project makes it possible to use IP for public sector objectives using private sector incentives, he said.

Products on the Horizon?

The project is still a long way from delivering products, the officials emphasised. “We’re far from products. Let’s have that conversation in seven years,” Krattiger said. “But it’s the access to research, not just drug access.”

As to the specification of neglected tropical diseases, these are a subgroup of diseases predominantly affecting developing countries, which have suffered from underinvestment and market failure.

The focus of WIPO Re:Search is on least-developed countries (LDCs). Middle-income countries (MICs), home to large numbers of poor patients, may not be the beneficiaries. “We can’t be everything to everyone,” he said. They are working on 21 diseases already, and added malaria and tuberculosis.

Bombelles explained that for MICs from the R&D aspect, assets are transferred between members on a royalty-free basis anywhere in the world. “When we get to the day when a product is developed under WIPO RS, whoever makes that is bound to sell it royalty-free in all LDCs,” he said. Examples are that malaria is global, schistosomiasis in LDCs.

“There is no reason to sell to middle-income countries royalty-free,” he said.

Krattiger said WIPO Re:Search “will, we are confident, make product available to all on a reasonable basis, royalty-free in LDCs,” giving an example that for Dengue, there might be a market, while for Chagas, it is not likely)

The project can help achieve maximum impact and lowest cost, driving down the price if there is high volume.

“There are plenty of sweet spots and win-win propositions, but without IP you have nothing to structure the development of the product on,” he said.

The Value Proposition

The WIPO officials touted the success of the project to date (a “very interesting stage,” Bombelles repeated), citing its various contributions. These include: the Partnership Hub, and supporting services such the IP management workshop, hosting agreements, funding sabbaticals for developing country scientists to pharma companies, accomplished with funding from IP Australia and support from the government of Japan.

“All these are markers of success,” he said, and Krattiger added that the value proposition is to “leverage, unleash this tremendous IP, establish and enhance the pipeline of candidates that enter product development.”

He said it “reduces risk substantially when you have done research in other places.”

WIPO Re:Search, by virtue of the fact that it brings together major pharmaceutical companies and a wide range of developed and developing country researchers, has a “particular, and rare, value proposition,” he said.

“That’s really a central value that WIPO RS can really deliver,” said Krattiger. “Nobody else is doing that.”

Press Event Announces Merck’s Joining WIPO Re:Search

By Catherine Saez

During a press event on 24 November, WIPO Director General Francis Gurry, announcing that Merck (Germany) is joining WIPO Re:Search, said the project has been steadily growing since its launch three years ago. This growth, he said, is the result of efforts by members of the platform and the energy put into the platform by BIO Ventures for Global Health (BVGH), which role is to bring together partners in the platform in practical collaborations.

WIPO Re:Search had 31 participating members at its beginning, he said, while today the platform counts 94 members, and thanks to BVGH, some 81 collaborations were concluded in various fields.

Stefan Oschmann, CEO of Merck and newly appointed president of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), said Merck is at the same time the newest member of WIPO Re:Search, and the oldest pharmaceutical and chemical company, founded in 1668.

Access to health is a key objective of the company, he said. “We believe there is a tremendous opportunity in practical partnerships,” he said, adding “we need to make sure that market failure does not result in moral failure.”

He applauded the work done by WIPO Re:Search but also all stakeholders working in public health for the last thirty years who have allowed substantial improvements in areas such as the fight against poverty, and infant and maternal mortality, although much still needs to be done.

It does not make any sense to lament this situation and fight between sectors, he said. “We need to work together.”

He said the company has a particular focus on schistosomiasis. According to Merck’s website over 200 million people in Africa suffer from this illness caused by flatworms which spread through stagnant water. “People become infected by the worm larvae while doing activities such as swimming, fishing, playing, or washing their clothes,” he noted.

BVGH President Jennifer Dent said of Merck joining WIPO Re:Search: “It is critically important to have pharmaceutical companies on board in this effort.”

Pharmaceutical companies bring IP assets such as compounds and compound libraries that they might have developed for other diseases such as cardiovascular diseases and some of those compounds can be repurposed.

“Being able to tap into those libraries is really critical” to develop new products, she said. “Having Merck come on board is a very important milestone.”

Dent explained that the IP assets shared by companies were shared under a set of guiding principles. Those guiding principles state, for example:

“For products resulting from licenses through the Consortium, all Providers of Intellectual Property agree to:

Provide licenses for these products on a royalty-free basis for use and sale in all LDCs.

Consider in good faith the issue of access to these products for all developing countries, including those which do not qualify as LDCs. This includes considering in good faith the granting of a license under any relevant Intellectual Property on a case-by-case basis, taking into account the economic development of the countries and the need to facilitate access to disadvantaged populations.”

They also state that “Providers agree to grant Users royalty-free licenses to this Intellectual Property for research and development, anywhere in the world, of products, technologies or services, for the sole purpose of addressing public health needs for any or all NTDs in LDCs.”

Oschmann said that some 90 percent of essential drugs are off patents and still not accessible in some developing countries. He said Merck does not even file patents in low-income countries.

A list of collaborative agreements is available on the WIPO website.

Dent said no discussions have happened so far in WIPO Re:Search about the possibility of including the Ebola virus in the work of the platform. Oschmann added that in the Ebola crisis, the main challenge is the weakness of health systems in affected countries.

On local production of medicines, Oschmann said that governments should have a balanced approach and consider cases when it is better for them to import cheap drugs and when it would be more interesting to produce the drugs. “This is not a black and white situation,” he said.