Why patents matter
We have blogged quite a bit about U.S. patent reform but wanted to provide context on why patents and other forms of intellectual property are important to the biopharmaceutical industry.
First, what is a patent?
A patent provides the right to exclude others from making, using, selling, offering for sale, or importing the patented invention for the term of the patent, usually 20 years from the filing date.
Why do patents matter to our industry?
The discovery and development of a new medicine requires a significant investment of resources by research-based pharmaceutical companies over a period of 10 or more years (click here for an interactive look at the process).
Biopharmaceutical companies often file for a patent on a promising research project early on in this process, meaning that the patent term begins long before a potential new medicine gets to market. In fact, patents can be expired before drug approval, issued after drug approval, and anywhere in between.
For this to be a viable investment, the results – new medicines – must be safeguarded from being copied with a reasonable amount of certainty for a reasonable period of time so the industry can generate the revenue it needs to reinvest in new medicines.
Are patents the only form of intellectual property protection for medicines?
Regulatory Data Protection (or ‘data exclusivity’) is an important intellectual property right concerning data we are required to submit to regulatory authorities in order to obtain marketing approvals for our medicines. Significant investment is required to generate such data (for example, through conducting global clinical trials); and this proprietary data is protected from use by third parties (such as generic manufacturers) for a number of years in a limited number of countries. The period of such protection and the extent to which the right is respected differs significantly between these countries.
This FDA fact sheet on patents and data exclusivity explains that in the US, data exclusivity represents exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Data exclusivity is designed to promote a balance between new drug innovation and generic drug competition.
Where can I learn more?
For more information, visit the Coalition for 21st Century Patent Reform at http://www.patentsmatter.com.