Author: Anoop Dhanvijay
Talk about drug discovery and the picture that comes to mind is that of big pharma, billions of dollars in R&D, a world class team of researchers, chemists, biologists and experts from other fields, and millions spent in trials, FDA approvals and eventually marketing to doctors to cajole them to prescribe it.
The trouble with this type of innovation cum exploitation model is that very few diseases have such high prevalence to represent a market big enough to result in a drug curing the disease to be a blockbuster drug [1] (a drug generating more than $1 billion of revenue for its owner each year). A report from URCH Publishing blockbusters contribute about one third of the total value of pharma products sold. About 125 drugs are blockbusters. The top seller was Lipitor, a cholesterol-lowering medication marketed by Pfizer with sales of $12.5 billion. Secondly, the consumption and demand of drugs in very much concentrated in high-income countries particularly USA and Japan. Sixteen percent of the world’s population living in high-income countries accounts for over 78% of global expenditures on medicines.[2] Thus the consumption patterns are such that big pharmaceutical companies don’t want to invest in finding cures for diseases which are prevalent in low or middle income countries which aren’t big enough markets or where affordability, weak IP regimes and distribution become an issue. Thus very little R&D expenditure is incurred on diseases like malaria, tuberculosis and other such diseases prevalent in low-middle income countries.
One can blame the big pharma companies all they want. However, the rules of the game have been such that it makes no economic sense to put their money in such diseases. It must also be said that the companies have used all their brain and brawn to keep the rules that way because they had drugs in the pipeline. It is only in the last decade that the pipelines have started drying up and generics have made deep inroads in the western markets shaving off profits of the drug majors. This has put them in a spot of bother.
The story could have been pretty much the same for software had it not been for the open source movement. Open-source software is software whose source code is published and made available to the public, enabling anyone to copy, modify and redistribute the source code without paying royalties or fees.[3] Open source code generally evolves through community cooperation and its development, maintenance and upgrades are overseen by a few full time developers after it reaches critical mass. It is this development model that has driven innovation, availability of cheap alternatives and availability of software of myriad applications.
Although OSS has been around for more than two decades the model has only recently spread to other sectors such as computer hardware, electronics and digital arts. The model has been tried with great success by CSIR and forced critics to take notice of its spectacular success. Samir Brahmachari, Director General of India’s Council of Scientific and Industrial Research (CSIR), had announced the launch of an open source drug discovery (OSDD) initiative to accelerate development of new drugs to treat infectious diseases that plague the developing world in April 2008.
“When it comes to health, India is in a state of war. There’s a war between health as a right and health as business,” he said.
Like the original open source software that was propelled by software developers motivated to contribute to large collaborative projects, proponents of OSDD believe that the global need for new low-cost drugs, particularly for treating neglected tropical diseases, will make this model effective.[4] The open source software technologies played the role of enabling this huge and complex collaboration. The success achieved has been remarkable because it has been achieved in little over 2 years.
In 2010 OSDD launched a project which was sought to re-annotate Mtb genome. The objective was to understand Mtb in order to identify potential drug targets. The drug targets shortlisted from the interactome of Mtb are being validated and studied at molecular level.
It has also predicted and evaluated novel drug targets, 18 of which are being actively worked upon. It has two efficacious candidates in the hit to lead phase (see figure) on TB. Thus OSDD has already contributed to improving the pipeline of TB drug discovery.[5]
While the model may prove to be successful, some issues which need to be looked deeply into are:
- Commercialization of drugs discovered, – OSDD currently maintains that if these (2 TB leads) are successful, they will be licensed non-exclusively like a generic drug. This may still thwart private players to contribute to the project and prevent the experts in the field from contributing.
- Benefit sharing with all collaborators, – Currently many players have collaborated on the project. This includes CSIR labs, academic institutions and few industry players. How will the benefits and credit be shared among can become a cause of concern.
- The IP labyrinth – The ownership of all such ideas, products and innovations coming out of OSDD can prove to be a challenge in the existing legislative setup.
- Getting private players’ to adopt the model– The core funding of OSDD (headed by CSIR) comes from GoI. It has earmarked Rs 45.96 crores (about $12 million) for the project for the duration of September 2008 to March 2012[6]. However, the greater success of the model would be to make it a viable model for private players and providing them the same quality of resources. The government can do so through policy measures and incentives. Of course public research institutes would always have a great role to play. If the government can move into the role of a facilitator from that of a sponsor it would indeed be a paradigm shift.
[1] “”Blockbuster medicine” is defined as being one which achieves annual revenues of over US$ 1 billion at global level.” in European Commission, Pharmaceutical Sector Inquiry, Preliminary Report (DG Competition Staff Working Paper)
[2] The World Medicines Situation 2011 – Medicine Expenditures, published by WHO
[4] Seema Singh , India Takes an Open Source Approach to Drug Discovery, Cell,Volume 133, Issue 2, 18 April 2008, Pages 201-203, http://dx.doi.org/10.1016/j.cell.2008.04.003
[6]OSDD funding policies, http://www.osdd.net/how-does-osdd-work
Innovation and Intellectual Property 