TOKYO - GlaxoSmithKline is making rounds to draw big pharma partners to its patent pool and open laboratory for neglected disease research, but questions linger over what will happen if precompetitive collaboration produces technology or compounds that have use outside of the world's poorest countries.

GSK announced in January it would make available a patent pool for compounds and technologies that might be relevant for neglected diseases. In addition, the company said it would accept researchers with promising programs to an "open lab" it established at its research center in Tres Cantos, Spain.

Researchers who come to the lab and use the database of compounds will have access at no cost for projects that target neglected diseases in developing countries. Research that leads to other indications or for programs that can be applied to established markets will require additional negotiations with GSK (Also see "GlaxoSmithKline Offering Free Access to Potential Malaria Compounds" - Pink Sheet, 20 January, 2010.).

Ideally, those discussions will take place before any research collaboration begins but can be difficult to navigate, since the outcomes from a research project are far from certain, according to Lluis Ballell - principal scientist for diseases of the developing world at GSK.

"The rules are quite clear for the world's least-developed countries and disease areas that we will be working with, but there's always the possibility that the technology or molecule will end up having an interest in another therapeutic area," Ballell said in an interview.

The first step is to actually produce a compound. The GSK organizers of the open lab are currently assessing applications from researchers interested in tapping GSK's resources at Tres Cantos. GSK will handle facility costs and salaries of staff assisting research projects, and $8 million will be provided initially to fund the projects of non-GSK researchers.

Ballell expects GSK to spend about €15,000 per researcher per year, and the open lab can accommodate up to 60 researchers. Ballell stressed though that the goal is not to reach maximum capacity but rather to fund strong research projects that align with the open lab's mission. The lab's initial focus is on malaria, tuberculosis, and kinetoplastid diseases, such as Chagas' disease, leishmaniasis and sleeping sickness.

IP Feedback Loop

While GSK is making some of its own IP available for research, the open lab also accepts proposals from researchers with their own patents that do not have the resources to advance their projects. The open lab organizers hope that IP generated at the open lab will be added back to the shared knowledge pool, creating a "value-generating revolving door," Ballell said.

But GSK does not lay claim to the IP of outside researchers, and so the company has little control of what a researcher ultimately decides to do with IP developed at the Tres Cantos open lab.

"The only thing we ask, but we cannot force, is not to generate intellectual property that is not in the knowledge pool so it can be accessible for everyone else for the use of these diseases in these countries. We will protect the rights and technologies that are theirs," said GSK's David Barros, a drug discovery scientist at GSK's Tres Cantos facility.

The original idea for the open lab was to use it as a feeder to GSK's pipeline. But the organizers of the project soon realized that to draw interesting projects, they would have to relinquish some control of IP generated from the lab to convince academia and non-profit research institutes that this was not "just a GSK thing," Ballell said.

Instead, the open lab is putting viral copyrights on compounds and technology used for the program, a workaround which allows researchers to retain some copyright and restrict how their IP will be used within the open lab.

"The ideas belong to those that generate the ideas, and that will be very clear from the beginning. It takes nothing to agree on these principles," Barros said.

Additionally, the knowledge pool - currently with more than 2,300 patents - is administered by BIO Ventures For Global Health, a non-profit industry group, and not by GSK.

Finding Comfortable Ground

Ballell considers the IP structure of the open lab a hybrid idea, which aims to make pharma companies comfortable about contributing to the pre-competitive project. "It's a realistic way for companies to commit to diseases of the developing world while respecting their business strategies."

Ballell sees the project as an opportunity to tie together various pharma projects addressing neglected diseases. Novartis has an institute for tropical diseases in Singapore, Eli Lilly established the Lilly TB Drug Discovery Initiative, AstraZeneca does neglected disease research at its institute in Bangalore, and Sanofi-Aventis and Pfizer have neglected disease programs as well.

"What we are trying to do is say, look, we are all playing the same game, but we are all playing individually," Ballell said.

All major pharmas have been approached about joining the open lab, but the initial response has been one of wait-and-see. Ballell hopes to make progress with a major pharma during a joint discussion in November.

Alnylam has joined the GSK patent pool, as have South Africa's Technology Innovation Agency, MIT, Caltech, and Emory University (Also see "Pre-Competitive Collaboration Would Help Pharmaceutical Productivity Crisis - If Lawyers Could Get Out Of The Way" - Scrip, 11 May, 2010.).

- Daniel Poppy (d.poppy@elsevier.com)

[Editor's note: BIO Ventures for Global Health COO Don Joseph, Eli Lilly VP Gail Cassell, Anacor Pharmaceuticals CEO David Perry, and Pfizer Chief Scientific Officer Neil Gibson will discuss pre-competitive collaborations in Asia at the upcoming PharmAsia Summit - Oct. 25 in San Francisco. Click here for more information.]

GSK's Open Lab Looking To Synch Big Pharma Neglected Disease Initiatives

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