Bold proposal to restructure drug development patents

Weill Cornell Medical College scientist Dr. Carl Nathan has issued a bold call for reforming the pharmaceutical development and patent systems in order to increase the number of vaccines and drugs available to combat neglected diseases that are ravaging the world's poor.

Dr. Nathan, in a commentary published in the March issue of the scientific journal Nature Medicine, proposes a two-pronged reform: first, to create "open access drug companies," where researchers can collaborate on developing drugs based on need rather than profit; and second, to establish an additional patent track that rewards innovation in proportion to its impact on global health.

"Industry has little financial incentive to develop products for diseases that mainly afflict the poor, and the poor cannot afford products that industry develops for wealthier customers," Dr. Nathan notes. "A fundamental solution to these problems requires aligning three basic processes -- innovation, incentive and access -- so that they become mutually reinforcing."

The World Health Organization (WHO) estimates that 10 million people, most of them in lower and middle-income countries, die needlessly each year because they cannot gain access to existing vaccines and medicines. A key concern are infectious diseases such as tuberculosis, which can strike everywhere but are far more prevalent in less developed countries. Millions more are killed or maimed by neglected tropical diseases -- including sleeping sickness, lymphatic filariasis and blinding trachoma. Because these diseases primarily affect the poor in the developing world, they attract little research and drug development funding.

Dr. Nathan proposes fee-for-service sites within drug companies where academic scientists could collaborate with biotechnology and pharmaceutical researchers in arrangements that could be funded by users and government. Because most researchers in private industry lack expertise in the biology of neglected diseases, Dr. Nathan suggests that bringing them together with academics who are expert in those diseases will spur innovation and improve the quality of scientific research on those diseases.

Dr. Nathan's proposed reform would also allow open access to new chemical libraries to be assembled at one or more pharmaceutical companies, designed for their particular promise for solutions to infectious disease. These libraries would feature natural products from under-explored sources, such as marine actinomycetes, plants and uncultured organisms from which operons are cloned for expression in recombinant bacteria. The libraries would also include privately held compounds donated to promote discovery of new uses.

Those using the libraries could patent their own novel derivatives of the compounds in the screening collection, but not the open source compounds themselves. Dr. Nathan points to a current example in which Pfizer is sharing 12,000 compounds with scientists affiliated with the WHO's Special Program for Research and Training in Tropical Diseases (TDR).

The second part of the reform package would be to establish a new, additional patent track for drug development. It would reward patent owners who address the most serious and widespread diseases and get their products to the largest possible number of people.

"The present patent system provides incentive for innovation by enforcing monopolies that permit sales at prices far above production cost," Nathan comments. "A patent track that rewards innovation in proportion to its impact on the global burden of disease would incent pricing near the cost of production and commit government and business to improve health care delivery."

Dr. Carl Nathan is Chairman of the Department of Microbiology and Immunology, and R.A. Rees Pritchett Professor of Microbiology at Weill Cornell Medical College in New York City.

http://www.med.cornell.edu

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