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Wednesday, September 21, 2011

New law prevents patenting human organisms

This good news just in from a pro-life Congressional colleague:

Today, President Obama signed into law the America Invents Act, H.R. 1249 which contains a provision that codifies an existing pro-life policy rider included in the CJS Appropriations bill since FY2004 [See Section 33 of H.R. 1249].  This provision, commonly known as the Weldon amendment, ensures the US Patent and Trade Office (USPTO) does not issues patents that are directed to or encompassing a human organism.

The provision reads as follows:
(a) LIMITATION.—Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
(1) IN GENERAL.—Subsection (a) shall apply to any application for patent that is pending on, or filed on or after, the date of the enactment of this Act.
(2) PRIOR APPLICATIONS.—Subsection (a) shall not affect the validity of any patent issued on an application to which paragraph (1) does not apply.

This provision reflects a common-sense understanding that no member of the human species is an "invention," or property to be licensed for financial gain. Patents on human organisms commodify life and allow profiteers to financially gain from the biology and life of another human person.

Rep. Dave Weldon (R-FL) offered the current policy provision banning the patenting of human organisms during House consideration of the FY04 Commerce, Justice, State Appropriations bill.  The amendment was approved by the House of Representatives on July 23, 2003 by voice vote, without objection from either side of the aisle. The Weldon amendment was then included in the conferenced bill that became law on January 23, 2004 and has consistently remained in the CJS bill since then.

Since 1987, the United States Patent and Trademark Office (USPTO) had an internal policy that human beings at any stage of development are not patentable subject matter under 35 U.S.C. Section 101.  To ensure the policy was not vulnerable to legal challenge, the Weldon amendment put the weight of Congress behind the USPTO policy. 

The text of the Weldon amendment has been included in the relevant appropriations act since FY04 without challenge, most recently in the FY2010 Omnibus and extended by the FY2011 Omnibus spending bill.  The Weldon amendment was codified into law on September 16, 2011 in H.R. 1249, the America Invents Act.

Before the Weldon amendment, efforts to evade the internal policy at USPTO or have it reversed were underway and some researchers had already said that they wanted to patent and market human embryos with certain genetic profiles as "models" for studying diseases with genetic roots (see N. Munro, "The New Patent Puzzle," National Journal, March 2, 2002 pp. 628-9).

For example, in 2001 the University of Missouri at Columbia requested and received a patent on a method for producing cloned mammals, which failed to exclude humans (see A. Pollack, "Debate on Human Cloning Turns to Patents," The New York Times, May 17, 2002, p. A12).

Thus, because the 1987 USPTO rules were not explicitly stated in law, it became clear that the Weldon amendment was necessary to ensure the courts would not overturn the USPTO’s policy. Codifying the Weldon amendment in H.R. 1249 is consistent with current law and current USPTO policy, ensuring human beings at any state of development are not considered property to be licensed for financial gain.

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