Rudimentary Analysis in ACLU Gene-Owning Case

Yesterday's post talked about the ACLU's big lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office. The ACLU is grounding their argument in the First Amendment, as is their style, claiming the right of an individual to know his own genetic makeup, the right of a doctor to provide his patient with critical medical information, and the right of a scientist to study the human genome precludes Myriad’s patenting of this gene (or any other gene).

This case gets at the very heart of what purpose the patent system is designed to serve. In theory, patents encourage innovation by rewarding inventors for their ingenuity and labor, protecting them from poaching. A person would only take the time to design a computer, for example, if they were assured that Microsoft wouldn’t just copy the design and mass market it without compensating the creator. This logic applies less cleanly to gene patents.

I have spent parts of the last few days perusing the internets for commentary on this case. The most interesting post is certainly this one from a corporate patent lawyer website:

http://www.patentdocs.org/2009/06/falsehoods-distortions-and-outright-lies-in-the-gene-patenting-debate.html

The author, Kevin Noonan, slams the ACLU suit in a highly readable manner. This is my favorite post on the issue because of the extremely lively comment section below the article. The cross-fire involves multiple characters, including David Koepsell, the author of “Who Owns Your Genes” (his website is linked off to the side). Noonan and Koepsell’s debate ranges from intellectually spirited to lame personal attacks. The core argument between them (in super simplified terms) turns on whether a gene, when isolated by “human hands”, is patentable. According to Noonan, this isolation would never happen in nature. This kind of isolation has only been possible in recent decades, and great research costs to big companies, and case law strongly supports this kind of patentability. Koepsell fundamentally disagrees that the genes at the heart of the BRCA debate have had sufficient human intervention to merit patenting, and grounds his arguments largely in policy, acknowledging that the law on this subject is not to his liking. If you don’t have time to read this whole piece, you could probably skip to the comments to get a sense of where the two sides stand. There is a healthy chasm between them.

The ABA Journal recently had a piece on this issue:
http://abajournal.com/magazine/wrangling_genes/

On the merits of this case itself, the ABA article adopts the ACLU’s perspective to a great extent, but when Myriad refused to comment for the article, that was bound to happen. More interesting is the ABA’s delving into some recent case history, including In re Bilski, a D.C Circuit decision requiring patent processes to involve a machine or transformation to a different state. This decision, which overturned a great deal of precedent, seemed to be taking its cue from Justice Breyer’s dissent in Laboratory Corp. of America Holdings v. Metabolite Laboratories Inc. (2006), in which he claimed that “law of nature, natural phenomena and abstract ideas” are excluded from patent protection because “sometimes too much patent protection can impede rather than ‘promote the progress of science and useful arts…’”

For another pro-Myriad perspective, you can check out this amusing rant:
http://www.ipwatchdog.com/2009/06/22/setting-the-record-straight-on-gene-patents/id=4202/
The post drips with condescension and vitriol towards the ACLU position, and at points degenerates completely into an unrelated tirades against the Obama healthcare plan and communism. Quinn compares the ACLU position to that of the Unibomber, which really turns back the clock. Sounds like someone is freaking out.

One post that delves (VERY) deeply into the case is by University of Missouri-Kansas City Law School Professor Chris Holman, who runs a blog dedicated to issues of intellectual property: http://holmansbiotechipblog.blogspot.com/2009/05/aclu-lawsuit-challenges-patenting-of.html

Holman does not believe that the ACLU’s claims are entirely frivolous, but he is skeptical of their constitutional claims, writing, “[T]o my knowledge, a patent claim has never been invalidated solely on the basis of a constitutional violation.” For those interested in the First Amendment argument, this is by far the most even-handed post I have seen on the case. It is also pretty lengthy, and cites to a number of cases that the lay reader will not be familiar with.

What I like most about Holman’s post is his analysis of the issue of standing, which he believes will be the more determinative issue in the case, noting that “[G]enerally, members of the public are not permitted to challenge the validity of issues patents, nore are they permitted to challenge the PTO’s (U.S Patent and Trademark Office) interpretation of substantive patent law.” None of the plaintiffs have actually been sued by Myriad, potentially raising case and controversy issues. However, Holman points out that in a 2007 case, MedImmune v. Genentech, the Supreme Court created a fairly low standard for standing in patent cases, demanding only that plaintiffs bringing declaratory judgments allege “actual controversy…touching the legal relations of parties having adverse legal interest.”

Though none of the plaintiffs are engaged in commercial activity, presumably at least some will be able demonstrate their fear of being sued by Myriad for continuing work on the BRCA genes. Two of the plaintiffs, University of Pennsylvania professors, have received cease and desist letters from Myriad before, albeit eleven years ago.

Given most courts’ unwillingness to plunge into issues that shake the moral foundation of our civilization, I would not be surprised at all if the lower court made this a case about standing. Should that happen, we will all live to debate this topic for another day.