DECEMBER 2008 / JANUARY 2009
Pharmaceutical patents need a new lease of life
Managing Intellectual Property
Patrick Duxbury and Emma Tuck ask whether the increasing cost of drug development, and the declining numbers of drugs being approved, mean that IP protection for life science products should be reevaluated
| One-minute read |
| The cost of R&D for new drugs is climbing substantially – thanks to increasing regulation, price control, competition and generic challenges – while the number of drugs being approved is falling. Existing systems provide for a 20-year patent term, with further protection available in some territories (such as the EU) through SPCs and data protection. This system has worked well for a number of years, providing pharmaceutical companies with an incentive for the high costs of research. But the growing expense of development, the challenges of researching new blockbusters, the impact of government price controls and regulatory intervention highlight the limits of the protection available. This is particularly true in the field of biologics. The industry has responded by filing follow-on patents, generating patent thickets. But perhaps a better solution would be to have longer patents for truly innovative products with real social value. It may be time to reevaluate IP protection in the sector. |
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), by 2006 the cost of researching and developing a new chemical or biological product had reached on average €1,059 million ($1,318 million). Increasing regulation, price control, competition and challenges from generics are often cited as contributory reasons for the continuous and substantial increase in development costs. When you add to this the decreasing number of drugs being approved today, perhaps it's time to take a fresh look at the IP protection (in particular the duration of protection) given to pharmaceutical products.
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