The Continuing Threat to Human Gene Patenting

    By Kevin E. Noonan --

Reliable sources inform Patent Docs that the House of Representatives, having finished its summer portion of mischief by passing H.R. 1908 "reforming" U.S. patent law into unrecognizability, is set to turn its attention to the bill, introduced by Congressman Becerra (31st Dist., Cal.) (at right), that would ban human gene patenting.  Although initially thought to be so wrong-headed that the House would not seriously consider the bill, it now appears that - like patent "reform" - the House political majority may be content in continue meddling in patent law in the absence of their ability to garner a majority (a veto-proof majority, in any event) in support of solutions to more pressing national concerns.

To review, the bill as introduced on February 7, 2007 reads as follows:

A BILL

To amend title 35, United States Code, to prohibit the patenting of human genetic material.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Genomic Research and Accessibility Act''.

SEC. 2. PROHIBITION ON PATENT OF HUMAN GENETIC MATERIAL.

(a) IN GENERAL. -- Chapter 10 of title 35, United States Code, is amended by adding at the end the following new section:

"§ 106. Prohibition on patent of human genetic material

"Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies.''.

(b) TABLE OF CONTENTS. -- The table of sections of Chapter 10 of title 35, United States Code, is amended by adding at the end the following:

"106. Prohibition on patent of human genetic material.''.

(c) APPLICABILITY. -- The amendment made by subsection (a) shall not apply to a patent issued before the date of the enactment of this Act.9

There are a number of problems with the scope of this bill.  First, it is not limited to banning DNA patenting.  The prohibition is to "a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies"  If passed, this bill would ban not only DNA patenting itself but also a patent on "the naturally-occurring products [a nucleic acid] specifies."  This would ban patenting of all naturally-occurring proteins produced by any means.  This would include proteins such as blood clotting Factor VIII, erythropoietin, hemoglobin, albumen, and human growth hormone, to name only a few.  It would also ban any diagnostic assay depending on the identification of genetic polymorphisms such as single nucleotide polymorphisms (SNPs), no matter how deduced.  This would render unpatentable not only existing polymorphism-based assays but those yet to be developed.  In short, the bill would eliminate patent protection for the molecules that are expected to provide the "pipeline" of new drugs for the next twenty years.  (It would not, paradoxically, render unpatentable recombinant cells and organisms used to produce useful quantities of these gene products that could otherwise not be obtained in useful quantities.)

In addition to these practical reasons to defeat the bill, it is based on a flawed understanding of the science underlying biotechnology.  This issue has been the subject of prior Patent Docs posts, but let's recap:

1.  No one owns "your" genes.  Indeed, no one would want to:  it has been known for more than forty years that any particular copy of a gene in an individual in a population is likely to contain at least one polymorphism that does or could (under the right environmental conditions) affect its function.  This was illustrated recently in reports of the complete diploid genomic DNA sequence of J. Craig Venter's (at right) DNA, where more than 4 million nucleotide variants were detected (see "A Complete Diploid Human Genome Reveals Some Surprises").  More importantly, claims to nucleic acids require that they are "isolated" or "isolated and purified," and thus "your" DNA is outside the scope of any such claims.

2.  There is nothing unique about DNA.  Indeed, "a gene is but a chemical, albeit a complex one."  Amgen Inc. v. Chugai Pharmaceutical Co.  Rhetoric to the contrary is nothing less than an attempt to return to vitalism, the quasi-religious notion that natural products isolated from living things are somehow different from what can be found or produced from the inorganic world.  This notion was disproven more than 100 years ago by Friedrich Wohler's demonstration that urea (produced in mammalian urine) was in fact merely a chemical compound that could be produced from non-living chemicals in a laboratory.

3.  The types of patent protection given to nucleic acids are no different than protection for other types of chemical inventions.  Indeed, there is no basis for distinguishing nucleic acid patents from any other type of chemical compound (see "A DNA Patenting Thought Experiment").

4.  DNA patents do not only claim nucleic acids but disclose them, and this aspect - the information that is the nucleotide sequence of the gene and an accurate deduced amino acid sequence - is not protected;  indeed, the information is placed in the public domain and can be used as information for database searching, interspecies comparisons, and any other academic endeavor.

5.  DNA patents have had no appreciable affect on scientific research, despite fears (ultimately shown to be baseless) that they would create a "tragedy of the anticommons" (see "The True Tragedy of the Anti-Commons").  Ironically, banning gene patenting would likely create a "tragedy of the commons" because no one would have sufficient protection for the intellectual property that would justify investment in the technology.

6.  Although the bill excludes already-issued patents from the scope of the ban, it does not exclude already-filed applications which form the bulk of the nascent patent rights of DNA patents (including the provisional rights created by publication of U.S. applications disclosing and claiming these genes).  Applicants, having had certain property rights attach by the filing and publication of these sequences (as opposed to, for example, keeping them as trade secrets), passage of the bill would violate the prohibition against ex post facto lawmaking set forth in Article I, section 9 of the Constitution and would also be a unconstitutional taking.  It might also violate the Due Process Clause of the 14th amendment.

7.  Banning gene patenting would reduce the advantages the U.S. has enjoyed for the past 20 years over the rest of the world, that was slow to permit patenting of genes and other products of biotechnology.  The U.S. biotechnology industry has resulted in U.S. dominance in the pharmaceutical industry, to the detriment of the very European and Japanese companies poised to overtake this country economically in the past (see "The Continuing Value of Biotech Patenting").  Patent policies abroad already permit those countries to "free-ride" on American innovation.  Why should we adopt their failed policies here?  And who will create the next generation of drugs based on biotechnology if we do?

We have seen ample evidence of the harm that can be wrought on the patent system when extreme policies are adopted in response to a perceived problem supported by faulty logic and incorrect "evidence:"  the recent changes in patent practice occasioned by U.S. Patent and Trademark Office rules limiting continuation applications and claims are but one example.  Twisting U.S. patent law to ban DNA patenting begs the question of when will another special interest group attempt to influence legislators into enacting their particular special interest into law so they can infringe on the intellectual property of others with impunity.  Biotech patenting has allowed a generation of (predominantly) U.S. companies to bring diagnostic tests and therapeutic agents to market and to attack diseases that were death sentences just a few short years ago.  Political Cassandras and opportunists do us no service with their misinformed cries that the sky is falling; we listen to them at our peril.

For additional information on this topic, please see:

• "The Anti-Patent Beat Goes on at The New York Times," July 1, 2007
• "The Future of DNA Patenting," February 20, 2007
• "A DNA Patenting Thought Experiment," February 16, 2007
• "Science Fiction in The New York Times," February 13, 2007
• "The Continuing Value of Biotech Patenting," February 4, 2007
• "Anti-Patent (Sullivan?) Malice by The New York Times," January 29, 2007
• "In Support of Gene Patents," December 7, 2006
• "The 'Anti-Commons' Aren't So Tragic After All," October 27, 2006
• "Gene Patenting in the News Again," December 5, 2006

Comments

[me]

Simply astounding. The lack of science knowledge even permeates the halls of Congress...

[Kevin E. Noonan]

Dear Me:

Actually, it's worse than that. I'm sure the Congressman will have testimony from a biased groups of professional nay-sayers on gene patenting (as did the panel that considered patent "reform") to get to his pre-ordained conclusion. So long as this never gets to a floor vote, they can debate it all they want. Maybe Becerra will be defeated in 2008, and then we can put this to bed permanently.

Thanks for the comment.

[anon]

Me - you are surprised at the lack of scientific knowledge in Congress? I thought this was a foregone conclusion.

It looks like Congressman Becerra is essentially trying to legislate Diamond v. Chakrabarty out of existance.

Someone better call Michael J. Fox and Nancy or Ron Reagan if this thing picks up any traction.

[Jud]

Is there a provision in the Code that makes Section titles limiting in a substantive way? I looked quickly, but couldn't find one. If not, then Sec. 106 isn't limited to human genetic material, since the word "human" or "homo sapien" is not present as a limitation on the types of DNA or proteins whose patenting is barred.

[me]

Absolutely, either drafting of this is incredibly overbroad and they are complete idiots (do they know all living things have DNA?), or, even worse, they DO mean to stop all patenting of DNA and proteins. Either way, this thing is poorly drafted and incredibly poorly thought out.