Biological material
- Introduction and general background of the exceptions and limitations to the principle by which patents should be granted to all inventions in all fields of technology.
When analyzing the validity element of the three tier analysis that inspired the TRIPS PLUS ULTRA proposal we´ve said that the TRIPS Agreement sets a global standard, and that this global standard admits exceptions and limitations. We’ve also say that the harmonized aspects (the uniform core or heart of the global patent) are by far more relevant than those that are not harmonized, taking as a parameter to this conclusion the patent legal institution as a whole (a legal institution is the set of rules that gives life to an abstract concept). Nonetheless, it is worth analyzing this exceptions and limitations with detail.
One of the posible limitations that countries may establish within their borders regards the patentable subject matter (exceptions to the patentability of certain products, e.i., determining certain inventions as non-patentable subject matter). According to the general principle of the TRIPS Agreement, patents should be granted to all inventions in all fields of technology. This principle admits exceptions (or leves each country liberty to regulate the issue).
2. The exception: biological material.
Taken from a “A global solution for the protection of inventions“, pp 146-148. Internal citations omitted.
“Likewise members may establish exceptions on the patentability of products and procedures related to biological material, which is one of the most sensitive issues at present time because of the ethical implications behind its protection.”
“From the economical point of view, developing countries find a restricted scope of protection convenient. Ethical implications have been used as a strong argument to dismiss its patentability. It has become the main bargaining tool for developing countries to maintain this exception. On the other hand, the potential benefits that could come from research and development in biotechnology are huge, and in that sense they deserve protection. In this regard the provisions of the TRIPS Agreement are insufficient. The agreement has remained silent concerning human genetic material and genetic structure. In terms of microorganisms, even though it stipulates that they should be protected and that they are defined implicitly, it does not provide enough regulations about them. A serious debate on this issue will be possible in a greater extent if the economic consequences of its conceptualization were to be assumed proportionally by the different countries in application of a system of differential duration of the protection granted to patents under each country’s economic capacity (as this book urges).”
(Go back to the patentable subject mater analysis for other ways the principle that state that patents should be granted to all inventions in all fields of technology could be limited.)