Creating a patent clearinghouse in Canada: a solution to problems of equity and access.

• Author: Sheremeta, Lorraine

Two of the most pressing normative questions surrounding biotechnology patenting today relate to the equitable distribution of the products of biotechnological research and ensuring fair access to those products. Often discussed under the heading "benefit sharing", the problem of the equitable distribution of biotechnology's advances is a mixture of two normative concerns: whether there is a universal right to benefit from scientific progress and whether particular research subjects have a right to share in the benefits of research using their tissues. The question of access is similarly twofold. On one hand, researchers are concerned that patent rights may block second generation innovation by placing licensing and monetary roadblocks in the way of research. This is the so-called "anticommons" problems that has been discussed theoretically but has yet to be demonstrated or disproved empirically. The second aspect of this question is patient access to new technologies, such as new screening tests or potential treatments based on the use of stem-cells.

This poster focuses on a few legal mechanisms that may facilitate both access to biotechnology's products and the equitable distribution of the benefits arising from those products. In particular, we suggest the creation of an independent and non-profit patent clearinghouse. This clearinghouse would administer patents in a particular field of study (e.g., all stem cell related patents) and would distribute income to patent holders arising from that administration. Specifically, the clearinghouse would charge a fixed fee for use of patent rights that would be distributed to patent owners. At the same time, the clearinghouse would hold back a certain percentage of profits (the HUGO Ethics Committee recommends, for example, between 1 and 3%) for redistribution to health care infrastructure in low-income countries. The clearinghouse would ensure that all researchers have fair access to innovations in the field while ensuring a fair economic return to patentees.

What is a Patent?

A patent is a government grant of a time-limited legal monopoly given to an inventor in exchange for the public disclosure of an invention. It can be thought of as a veto over the activities of others in respect of making, using, selling or importing an invention.

It permits the inventor or an assignee (often a corporation) to commercially exploit the invention.

What are the Criteria for Patentability in Canada?

An invention, to be patentable, must be "new", "useful" and "non-obvious". These are legal terms that have been defined in Canadian case law as follows:

New--the invention must not have been previously disclosed in a single source more than 12 months prior to the filing of the patent application.

Useful--the invention must work and must be of industrial interest.

Non-obvious--To be patentable, an invention must be a development or an improvement that would not have been obvious beforehand to persons skilled in the art.

The Current International Trend

To mitigate the anticommons effect that patents have on access to novel biotechnological applications, mechanisms to promote "benefit-sharing" and to facilitate access to medicine have been suggested by the Human Genome Organization, The United...