Monday, June 02, 2008

Patently Immoral Genes

It is not uncommon for patent attorneys in the United States to console themselves, especially when suffering from the stress of long workdays and endless due dates, deadlines, and statutory bars, that at least their branch of legal practice avoids the minefields of morality. Even if a patent attorney's judgment fails, none of her clients will be executed, jailed, or suffer public shaming as a consequence. As one patent attorney once "boasted" to a group of non-patent attorney colleagues, "Patent law is totally amoral."

Almost 200 years ago, in Lowell v. Lewis, F. Cas. 1018, 1019 (C.C.D. Mass. 1817), Justice Story proscribed certain inventions as too immoral for patenting if they would be "injurious to the well being, good policy, or sound morals of society." However, in the ensuing years this "moral utility" requirement has waned significantly, at least in U.S. patent law. In Juicy Whip, Inc. v. Orange Bang, Inc., 98-1379, 1999 U.S. App. LEXIS 18342, 51 U.S.P.Q.2D (BNA) 1700, (Fed. Cir. Aug. 6, 1999), the Court of Appeals for the Federal Circuit appeared to dismiss moral utility as a quaint historical practice, stating that "the principle that inventions are invalid if they are principaly designed to serve immoral or illegal purposes has not been applied broadly in recent years."

However, moral concerns about the patentability of biotechnology have retained their salience in Europe. In fact, Article 53(a) of the European Patent Convention ("EPC") explicitly excludes from patentability "inventions the publication or exploitation of which would be contrary to 'ordre public' or morality..."

Gene patents have been a special lightning rod in Europe for moral qualms about patenting. Now, the European Society of Human Genetics ("ESHG") has issued recommendations that would severely limit patents on genes in the European Patent Office ("EPO") and member states of the EPC. Specifically, the ESHG recommends that the EPO establish an "ethics committee" to police the patentability of controversial technological innovations, such as genes. As its report explains,
Many disputes between supporters of the patenting system and the public revolve around ethical issues. It is also felt that attorneys, patent applicants and patentees sometimes push the ethical limits of patentability, which damages the perception of the legitimacy of the patenting system as a whole. The ESHG urges EPO to find a way, together with the scientific community and the European institutions, to ensure that a morality issue, when it cannot be addressed under the morality article of EPC, can still be taken into account.

Along the same lines, the ESHG proposes EPO to consider the benefit of having an ethics committee to consider issues of major interest, such as patents applied to genes.
Enhanced ethical scrutiny, as well as other restrictions on gene patents proposed in the ESHG report, will not be greeted warmly by European biotechnology companies. On the other hand, the ESHG proposals will be viewed with interest by those in the U.S., such as Michael Crichton ("You, or someone you love, may die because of a gene patent that should never have been granted in the first place.") and California Democrat, Xavier Becerra (whose "Genomic Research and Accessibility Act" (H.R.-977) would ban gene patents), who are also pursuing strict limitations on gene patents justified largely on moral grounds.

As more and more gene-based drugs and diagnostic tests enter the market, and genetic testing for genetic traits and family ancestry become commonplace, this debate is likely to grow in importance.


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