Governments everywhere trade off economic reality against long-term good, and the balance between patent protections and free markets are no different.

Patents are there to stimulate the research and development of new therapies and support enterprise, by guaranteeing the enjoyment of all the profits that good marketing of a new medicine can generate for up to 25 years.

Canny pharmaceutical companies subsequently service shareholder, rather than patient obligations by “evergreening” their products with new patent applications, usually for small changes in formulation or systems of administration.

India has recently affirmed their opposition to “evergreening” by denying patent applications for Glivec®, Sutent®, and Pegasys®. It would seem that Glivec® has no place in the Indian market where generic pharmaceutical brands supply 300,000 consumers at around one-tenth of the originator’s price.

Gardasil® is an example of the vast resources required to take a drug to market. The first patent application for Gardasil® was filed in 1991, before research findings could be safely shared with, and scrutinised by, the scientific community prior to its official release in 2006. During this period there were international patent applications and IP court battles.

In 2007 it celebrated sales of US $1.5 billion and is now approved in 121 countries.

Under the patent application system, research is driven by the achievable returns. Many medicines have multi-faceted indications, such as antiepileptics that can be used for mood stabilisation and pain management.

Pharmaceutical companies rarely invest in further research for new indications, leaving clinicians to prescribe off-label from hearsay, and restricting patient access to government subsidies for these indications.

Peter Mansfield, sceptic, recommends separation of research and distribution. He suggests that the government could afford to fully fund independent research from the savings achieved by truly competitive pricing in a patent and subsidy free environment.

References:

  1. Kulkarni K, Mohanty S. Novartis loses landmark India cancer drug patent case. Reuters 2013; Mon Apr 1.
  2. Kubler P. New drugs for old. Aust Prescr 2006; 29: 148-9.
  3. Mansfield PM. Can pharmaceutical companies contribute to the quality use of medicines? Aust Prescr 2010; 33: 98-9.