Ethical Limits for Patentability

Tuesday, November 2, 2004
ISSN 1535-5284
News

Intellectual Property
Ethical Limits for Patentability
Need to Be Defined, Professor Says


Today's "patent first, ask questions later" system has leaves no room for an inquiry into the morality of an issued patent, a law professor said Oct. 29 at Howard University School of Law's Second Annual Institute of Intellectual Property and Social Justice in Washington, D.C.
It should not be the job of patent examiners to define the limits of patentability for such morally controversial subject matter as cloned mammals and stem cells, she maintained.

The U.S. patent system lacks a dependable system of statutory and regulatory constraints to block ethically dubious patents before they issue, according to Margo Bagley, associate professor at Emory University School of Law, Atlanta. However, the issuance of patents on inventions in biotechnology and medicine inevitably prompts moral arguments, she noted, pointing the following:


- Patenting transgenic animals devalues life itself;
- Locking up certain medical processes with patents deprives patients of life-saving treatments;

- Allowing patents on human cloning presents the notion ownership of human organisms;

- Stem cell patents may issue even if the technology involves the destruction of a human embryo; and

- Patents proposed on human/animal mixes, or "chimeras," would degrade the human species.

Issue Brewing for Over Two Decades

Public controversy about the patenting of living things (other than plants) erupted almost 25 years ago with the Supreme Court's landmark decision in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980) . That ruling overturned the PTO's refusal to grant a patent on an oil-eating bacterium used to control oil spills.
The debate picked up again in 1987 when the Board of Patent Appeals and Interferences decided Ex Parte Allen, which found claims directed to polyploid oysters to be statutory subject matter. See 2 USPQ2d 1425 (BPAI 1987). Shortly thereafter, then-PTO Commissioner Donald Quigg issued a notice that non-naturally occurring, non-human multicellular living organisms (including animals) are patentable subject matter under Section 101 of Title 35. See 1077 OG 24 (April 21, 1987). However, the Quigg notice included the following passage:

A claim directed to or including within its scope a human being will not be considered to be patentable subject matter under 35 USC 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. Accordingly, it is suggested that any claim directed to a non-plant multicellular organism which would include a human being within its scope include the limitation "non-human" to avoid this ground of rejection.
In 1988, the PTO issued a patent on a transgenic mouse that was engineered to be susceptible to cancer, and that was followed by numerous congressional hearings and proposals for a moratorium on such patents. The position of the PTO in general was that its responsibility was to determine patentability under the statute, and that the public policy issues concerning the social acceptability of certain inventions were the province of other parts of the government.
A set of three mouse patents was issued in 1993, but the calls for moratoriums and the broader ethical debate over patents on life forms subsided until the PTO in 1998 issued a media advisory explaining that the public policy and morality aspects of the requirement that patentable inventions be "useful" under 35 USC 101 will, under certain circumstances, prevent a patent from issuing on inventions directed to human/non-human chimera.

The PTO statement was prompted by news reports about a patent application claiming a technique for combining human and animal embryo cells to produce a single animal-human embryo, or chimera. The patent applicant did not intend to produce such hybrids, but filed the application to reignite debate about the ethics of genetic engineering and the patenting of life forms. The PTO ultimately disallowed the application, finding no patentable subject matter under 35 U.S.C. §101 because the invention "embraced" a human being.

In 2002, the Center for Technology Assessment charged that a patent (6,211,429) issued in 2001 to the University of Missouri provided a technique for cloning human "embryos, fetuses and children." While the '429 patent was aimed principally at the production of transgenic pigs for organ transplantation, it included a more general claim directed at "a method for producing a cloned mammal." which the CTA said could include humans.

Attempting to rein in further expansions of patentable subject matter, President Bush in January signed into law a consolidated appropriations bill (H.R. 2673, Pub. L. No. 108-199) that contained a restriction against human patents. That language--dubbed the "Weldon Amendment" after its sponsor Rep. David Weldon (R-Fla.)--provides: "None of the funds appropriated or otherwise made available ... may be used to issue patents on claims directed to or encompassing a human organism." A similar rider appears in the pending 2005 appropriations legislation.

However, the PTO last August issued a patent (6,781,030) on methods for cloning mammals, including humans. The PTO later insisted that legislative language accompanying the Weldon amendment made clear that the '030 patent did not violate the constraints of that measure.


Other Countries More Restrictive

Bagley noted that the patent systems of other major developed countries include morality-based patent restrictions. The European Patent Office, for instance, declined in 1992 to issue a patent on Harvard University's transgenic "oncomouse" as morally offensive under the principle of the "ordre publique," Bagley noted. The Canadian Supreme Court followed suit in 2002, striking down a ruling that required that country's patent commissioner to issue a patent on the oncomouse.
A 1998 European Union directive contains an explicit exclusion from patentability for chimeras, Bagley noted, adding that the multinational TRIPS accord specifically allows morality based patent exclusions.


Who Should Decide?

Some might ask why it matters whether patents issue in potentially troubling technologies, since the research in those fields will go on nonetheless, Bagley observed. However, the principal purpose of patents is to promote research and innovation, she stressed, adding that research and patents are interrelated in that regard.
While the "patent first and ask questions later" policy has been with us for a long time, there once were morality requirements that precluded patents on devices that were used for gambling, deception, and fraud, Bagley said, pointing to an 1817 Supreme Court case.

Today, there are no such inquiries at the examination level, however, she said. She noted that the Federal Circuit in 1999 reversed a ruling that invalidated for lack of utility the patent on a juice dispenser that deceptively concealed the fact the beverage was mixed from a powder (185 F. 3d 1364, 51 USPQ2d 1700 (Fed. Cir. 1999). The court there declined to follow two early 20th century cases which found deceptive inventions unpatentable.

In Bagley's view, there are serious societal implications when patents issue on immoral or deceptive inventions. Yet under today's system, an applicant is entitled to a patent unless the examiner finds a reason to reject it, she noted.

With the presumption so decidedly in favor of the applicant, Bagley suggested, it is applicants (and scientists) who effectively determine what gets patented.

There are various options for reallocating that role, Bagley said, but each has its shortcomings. A statute-based morality restriction would be too rigid because concepts of morality are not static, she suggested.

Preferable, Bagley said, might be a more intermediate approach at the PTO level, including an additional assessment period for some patents, and the type of post-grant patent opposition system currently being contemplated.

Bagley would also like to see the resurrection of a deliberative body, like the now defunct Office of Technology Assessment, that would evaluate patents independent of the PTO process.

As for the Weldon amendment, Bagley said, "I applaud the effort," but there are definite drawbacks with that approach, including the following:

- The statutory proscription doesn't define "human;"

- The amendment is an appropriations measure that does not amend the patent statute or give any basis for rejection of immoral patents; it is only a one-year prohibition against funding the issuance of such patents; and

- The PTO's recent defense of the August mammal cloning patent demonstrates that the Weldon prohibitions do not forbid such process patents.

If the Weldon amendment is not renewed in future appropriations bills, Bagley cautioned, the PTO might be free under today's law to issue a patent for a cloned human fetus. In her view, it might be better for Congress to act first to clarify the limits of patentable subject matter, instead of leaving to a patent examiner the option of issuing such a patent.

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ISSN 1535-5284
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