Capital Commentary is the weekly current-affairs publication of CPJ, written to encourage the pursuit of public justice.


Patenting of Human Organisms


John B. MacIntyre

08-12-2011


 

August 12, 2011
by John B. MacIntyre

The US Patent and Trademark Office (PTO) has traditionally followed the view that “anything under the sun that is made by man” can be patented.  A controversial area has been whether to grant patents on living organisms.  For nearly two hundred years, the PTO refused to grant patents on living organisms.  This changed in 1980, when the US Supreme Court allowed a patent on a bacterium created to break down crude oil.  The Court focused on the fact that the bacterium was non-naturally occurring.

This ruling opened the door for the first patenting of a transgenic animal, the Harvard Mouse, in 1988.  Harvard researchers were granted a patent on a mouse that had been created with oncogenes that led to rapid cancer growth, which assisted researchers in testing cancer-fighting drugs.

The PTO was now treating non-naturally occurring, non-human living organisms as patentable subject matter.  But the PTO made it clear that it would not allow patents on human beings, and this prohibition has been annually codified via the appropriations process.

The PTO currently receives funding through the annual Commerce, Justice, and Science (CJS) Appropriations bill.  Since 2004 the CJS Appropriations bill has included language called the “Weldon Amendment,” which prohibits funds from the CJS Appropriations bill from being used to issue patents relating to human organisms, effectively banning these patents.

Earlier this year, the House passed the America Invents Act, a comprehensive reform of our patent system.  Under this legislation, the PTO will no longer receive funding through the CJS appropriations bill, but instead will receive funding via user fees.  Consequently, the Weldon Amendment—and the prohibition on patenting human organisms—will no longer apply to the PTO.

Fortunately, the language of the Weldon Amendment has been included in the America Invents Act.  By including this language in the patent reform legislation, the Weldon Amendment will no longer need to be passed each year during the appropriations process but will instead become permanent law.  This is significant because the prohibition on patenting human organisms will become permanent law and will not be subject annually to modification or removal.

As the America Invents Act makes its way through the Senate, the language of the Weldon Amendment must be kept in order to prevent the filing of patents on human beings.  No person should be allowed to patent another human being, and no government should sanction such activity.  Not only would this be immoral, but it would also violate the 13th Amendment, which prohibits the ownership of another human being.

There has never been any specific definition given to the term “human organism.”  A list of inventions that various experts believe are prohibited by the term “human organisms” includes human embryos, human fetuses, and human-animal chimeras.  Items currently allowed to be patented include human cells (including adult and embryonic stem cells), tissue, organs, non-human organisms, human genes, proteins, antibodies, and hormones; methods for creating embryos through in vitro fertilization, methods for implanting embryos, methods for enhancing fertility, genetic therapies, and nonhuman organisms incorporating one or more genes taken from a human organism.

Congress and the PTO need to define more specifically what is meant by the term “human organisms.”  In spite of the long lists given above regarding what is and what is not considered patentable subject matter, there is still great ambiguity about what can be patented.  For example, in 2001 the PTO issued Patent Number 6,211,429, which includes a claim directed to a method for producing a cloned mammal.  This patent does not include any language disclaiming humans from the claim scope, so the inventors could later claim that their patent covers the cloning of human beings, particularly if they argue that cloned humans are somehow less than “human.”

Unless the definition of “human organism” is expanded and clarified, incremental changes may occur in what the PTO allows to be patented.  Patent applications have already been filed on human-animal chimeras.  How human must the hybrid organism be in order to be unpatentable?  A ban on issuing such patent applications needs to be permanently codified.  Treating human organisms as a commodity undermines human dignity.

—John B. MacIntyre is a registered patent attorney practicing patent law in the Chicago area.

 



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Capital Commentary is a weekly current-affairs publication of the Center for Public Justice. Published since 1996, it is written to encourage the pursuit of justice. Commentaries do not necessarily represent an official position of the Center for Public Justice but are intended to help advance discussion. Articles, with attribution, may be republished according to our publishing guidelines.”