Health

Ethical Pharmaceutical Collaboration: A Catch-22 for Patent Law

The Guardian is reporting that British scientists have found ways to create drugs at a fraction of the cost of big pharma’s development costs:

Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model “ethical pharmaceuticals”.

Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.

On the face of it, however, this development does not appear to be about creating new drugs, but about modifying existing drugs and selling them cheaper for a new disease. The Innovation Blog condemns the method thus:

This effectively amounts to a sophisticated form of reverse engineering that skirts patent laws and this is not the same as conducting original drug development.

Further, it sees the problem of expensive drug R&D as one of collaboration:

I would much rather see companies, non-profit agencies, governments, and universities strike up new partnerships aimed at lowering the cost and spreading the risk of original drug development. A number of people are currently exploring the potential for open-sourcing drug discovery. There’s also the potential to expose biological research problems to much larger communities of scientists using new Web-based collaboration tools.

The blog seems correct in explaining how the British method works and in its limitations. Yet, it is ironic that it presents the virtues of open-source collaboration but condemns a method that is a natural extension of such collaboration – building on the R&D of others for new research.

Collaboration is only part of the solution. Success in drug development is, essentially, a fixed probability. The only way to increase the chances of finding an effective drug are to increase the number of experiments being conducted.

Collaboration does nothing to reduce the cost of drug development (yes, it spreads risk). Rather, if partnerships must pay for R&D from scratch they will be financial non-starters. To reducing the cost of R&D, building on existing molecules is critical. That requires allowing researches to build on any existing molecules – even the ones under patent, so long as the new developments don’t threaten the profits of existing patented medicines.

By doing just that this method of drug ‘development’ seems to step on two sensitive issues of patent law – incrementally modified drugs (IMDs) and new use. Big pharma, in strengthening patent legislation has always argued that IMDs and new use of an existing drug should qualify for patent protection.

This method turns that argument on its head – or against big pharma and in favor of ‘ethical pharmaceuticals’. Its success rests on changing existing drugs at the molecular level and presenting them for new diseases.

Yet, it also presents a catch-22 for both big pharma and proponents of weaker patent legislation. It is best illustrated by Novartis’ challenge to India’s new patent law. Uphold the legality of this new method, and you allow Novartis’ cancer drug Gleevec exclusive marketing rights in India, banning its many generic cousins. Disallow this new method, and you disallow drug development built upon existing molecules.

I’d welcome input to understand this method, particularly with perspectives on implications for public health and patent legislation.