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Background:
Senator Sam Brownback (R-Kan.) had offered an anti-cloning patent amendment to the terrorism insurance bill was on the Senate floor. This amendment would have precluded 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.

Role of the PTO:
Current PTO practice prohibits patents on subject matter that includes within its scope a human being. In 1987, Donald J. Quigg, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks issued a memo stating, "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 claim that encompasses a human being. The statutory basis for the PTO's rejection of patents encompassing a human being is found in title 35 U.S.C. 101, which delineates patent-eligible subject matter. To date, such patent rejections have generally applied to actual products and not to the process of making the product. The PTO has the expertise to make these patentability determinations on a case-by-case basis.

Key Points:

• 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.
• Opening up the patent laws to carve out specific subject matter sets a dangerous precedent. 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. Opening the Patent Act could have long-term implications for all industry sectors.
• This amendment is a "back door" way of stopping stem cell research and regenerative medicine in the US. By removing the economic incentive to do this research, the amendment effectively stops investment and research activity in the United States. 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.
• This amendment could stop stem cell research. The amendment would appear to ban issuing patents for the process of deriving stem cells. The 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.
• Specific exclusions from patent eligibility are inconsistent with the U.S. positions in the international arena. The Word Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement allows countries to deny patents on plants and animals, which has been a source of U.S. concern for many years. At the international level, the United States has consistently fought to provide broad patent coverage for transgenic plants and animals and other key biotechnology sectors. Carving out technology areas, such as cloning, from the U.S. patent system would be inconsistent with long-standing U.S. trade and IP policy and would set a dangerous precedent internationally.
• 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.

For more information, please contact Michael Werner at (202) 962-9200 or mwerner@bio.org.