Anti-Cloning Patent Legislation Stifles Life-Saving Research

From the Coalition for the Advancement of Medical Research

Background: Senator Sam Brownback (R-Kan.) has offered an anti-cloning patent amendment to the terrorism insurance bill currently on the Senate floor. This amendment would preclude the U.S. Patent and Trademark Office (PTO) from granting patents for an organism of human species at any stage of development produced by any method, a living organism made by human cloning, and a process of human cloning.
This is clearly yet another attempt by Senator Brownback to halt somatic cell nuclear transfer (SCNT), also known as therapeutic cloning, in order to stop the development of cures for deadly diseases.

Key Points: 1. This amendment is a ?back door? approach to getting the U.S. to surrender its leadership in the development of life-saving cures. By removing the economic incentive to do stem cell and SCNT research, the amendment effectively stops investment and research activity in the U.S. In contrast, other countries have made it clear they will grant patents for processes to derive stem cells. Thus, these countries will take the lead in this field, and Americans will not have first access to the newest, and potentially best treatments. Further, scientists may leave the U.S. to perform research elsewhere.

2. This amendment could stop stem cell research. The amendment would appear to ban issuing patents for the process of deriving stem cells. The National Institutes of Health (NIH) has concluded that embryonic stem cells have the potential to form any cell in the body and therefore could hold the key to treatments and cures for many diseases. Given that this amendment could halt stem cell research, that translates into a death sentence for people suffering from disease.

3. This amendment is unnecessary. The Patent Trademark Office?s standing policy is to deny patents on any subject matter that encompasses a human being.Current PTO practice prohibits the granting of patents on subject matter that includes within its scope a human being. A 1987 PTO memo issued by Donald J. Quigg, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks, states, ?A claim directed to or including within its scope a human being will not be considered to be patentable subject matter.? Accordingly, since 1987, the PTO has rejected any application that encompasses a human being. The Brownback amendment is superfluous.

4. It is not clear whether the bill would seek to apply the exclusions retroactively. Patents in the areas covered by these exclusions have already been granted. The amendment is so broad as to exclude from patent eligibility products of cloning, products obtained from in-vitro fertilization and methods of human cloning to derive stem cells. If biotechnology company patents are declared invalid retroactively, these companies will lose access to private investment and, therefore, will not be able to perform research to find cures for disease.

5. Opening up the patent laws to carve out specific subject matter sets a dangerous precedent and could halt research. Revision of the patent laws to exclude one subject area from patent eligibility may lead to other types of exclusions. For example, opening up the Patent Act could open the door and create a pathway to preclude patents on virtually any item or industrial product. If opponents of particular research technologies are allowed to amend the patent laws to get them statutorily banned, research could stop. Had no patents been issued in the past for recombinant DNA or embryonic stem cell research, these research areas would not have progressed to their current form.

The Coalition for the Advancement of Medical Research (CAMR), is comprised of nationally-recognized patient organizations, universities, scientific societies, foundations, and individuals with life-threatening illnesses and disorders, advocating for the advancement of breakthrough research and technologies in regenerative medicine - including stem cell research and somatic cell nuclear transfer - in order to cure disease and alleviate suffering. For more information, visit our website: www.camradvocacy.org