Post details: The End of Gene Patents?

The End of Gene Patents?

Posted by Andrew on February 15th, 2007

There are many serious public policy objections to the patenting of DNA molecules. But the Patent Office has found it fairly easy to dismiss these objections with the response that until Congress and/or the courts change the patent laws, public policy considerations will be entitled to no weight in the patentability analysis:

"Whoever invents or discovers any new and useful ... composition of matter ... may obtain a patent therefor." 35 U.S.C. 101. Congress creates the law and the Federal judiciary interprets the law. The USPTO must administer the laws as Congress has enacted them and as the Federal courts have interpreted them. Current law provides that when the statutory patentability requirements are met, there is no basis to deny patent applications claiming DNA compositions, or to limit a patent’s scope in order to allow free access to the use of the invention during the patent term. (66 Fed. Reg. at 1095)

That's what makes this such an exciting proposal:


Chapter 10 of title 35, United States Code, is amended by adding at the end the following new section:

"Sec. 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."

Co-sponsored by Reps. Xavier Becerra (D-CA) and Dave Weldon (R-FL), the Genomic Research and Accessibility Act may finally bring the 25-year-old debate over the social costs and benefits of DNA patenting to the attention of the only people who can effectively respond to its conclusions.

In a press release announcing the legislation, Becerra and Weldon highlight the mounting evidence that DNA patents are impeding genetic and medical research (my own contribution to the pile is here). As my own pilot project (reported in another article) has demonstrated, the issuance of DNA patents may be viewed as a historical accident, contingent on a patent system that has mistakenly substituted formalistic rules for scientific standards of "skill in the art" (and, strangely enough, on the once substantial but now rapidly shrinking cost of publishing massive sequence databases on digital media).

Rep. Becerra also joins with my colleague John Conley in contending that "Genes are a product of nature," a view that will not sit well with a patent system that has viewed isolated and purified genes as distinct from their naturally occurring counterparts. While I agree with John, I've argued to him that even a revivified product-of-nature doctrine can't support a stable categorical exclusion of DNA molecules from patentable subject matter. The legislation helpfully elides what might otherwise become an unwieldy distinction by trumping the § 101 analysis with the "Notwithstanding any other provision of law" clause.

While the simplicity of the proposed § 106 leaves many details open for debate -- the "naturally occurring products" clause might need reworking, the transition to rationality is going to be a doozy for the biotech industry, and then there's this can of worms -- these are important debates to have right now, and this legislation is a masterstroke of a catalyst. If the bill passes, the Federal Circuit will have work to do in drawing the line between the "functions or correlations" of a "nucleotide sequence" and technologies that use these functions and correlations. This is basically the same question that the Supreme Court recently ducked in LabCorp v. Metabolite, so it's more than ripe for review. Bring it on.


Comment from: cyperus_papyrus [Visitor]
Thanks for your comment on my blog directing me here. Do you think there is any chance of the proposed legislation actually becoming law at this time? Patenting genes seems to me a lot like patenting physics equations, but if there is a lot of money to be made, corporate lobbyists will exert a lot of pressure.
Permalink 02/15/07 @ 20:59
Comment from: Andrew [Member]
You're right that there are powerful vested interests. So I have to concede it'll be a longshot. But it's worth noting that there are corporate interests on the other side. And the public policy debate, now no longer merely academic, will be well worth having.
Permalink 02/15/07 @ 21:06
Comment from: cyperus_papyrus [Visitor]
Hopefully there will be quite a lot of debate.

You referenced a number of articles and papers in this post. I've been looking through them, they look very interesting, but as I'm not a lawyer, I'm not sure I follow all the details. If you have any interest in adding some information to help laymen follow what the significant points are in future posts, I'd be very interesting in reading that!
Permalink 02/15/07 @ 22:20
Comment from: Chad Poirier [Visitor]
Like the other guy, thanks for commenting on my blog and pointing me toward this post. It's definitely one of the least known, yet most important issues of our current time. When my Sociology professor brought it up last semester, I had no idea that it was such a huge issue, and not until I read through your paper and the surrounding materials provided in this post did I fully realize the weight of this problem.

My only question is, why stop at human genetic material? Don't things like terminator seeds blur a similar line of morality?

One thing is for certain, any legislation passed must be well thought out and comprehensive enough to provide at least a backbone for future generations to interpret the law in a way that it will benefit the common good. After all, that's what law is for, isn't it?
Permalink 02/15/07 @ 23:07
Comment from: raaisma [Visitor]
Thank you for for your comment on my blog. I agree with what cyperus_papyrus associates with patenting physics equation. To an ordinary person's view, it seems like people who patented genes own his or her gene translates into a dilemma,"Why something in my body is not mine?"

I do not fully understand about patenting genes, but I believe we need to put a limit on how we can profit on what it is already in the nature.
Permalink 02/16/07 @ 01:17
Comment from: pagoff [Visitor]
Thanks for the detail on this issue. Our health care non-system is a mess and the gifting of advances funded by government to private business for exploitation is part of the problem.

Dole-Bayh, the legislation that facilitated this, "required" reasonable pricing. This aspect of the bill has never been enforced.
Permalink 02/16/07 @ 10:01
Comment from: bryan kennedy [Visitor]
Thanks for your comment over on our blog on this subject, Patenting human genes. I was curious if you had any perspective on the likelihood of this bill actually passing?

I can see the biomedical lobby getting behind squashing this down pretty heavily. However, I hope Becerra and Weldon have the power to push this through.
Permalink 02/16/07 @ 11:34
Comment from: An Seanchai [Visitor]
Good to see somebody keeping a close eye on developments, well done.
Permalink 02/16/07 @ 12:07
Comment from: Tessa [Visitor]
Thank you for your comment on my blog, directing me here. Until I read Crichton's op-ed, my only exposure to the inefficiencies of the patent process was the saga of the Blackberry fight with patent claims. Reading other posts on your site, I am gob-smacked by the sheer magnitude of the problem. I wish Reps. Becerra and Weldon well in their legislative tilt at this particular windmill.
Permalink 02/16/07 @ 13:57
Comment from: the_malum [Visitor]
Like the other guys, let me say thanks for pointing me to this post. As scientists (that is to say, people who try to reason from causes to effects) it behooves us to stay on top of these issues that have wider implications than most people think about, especially the lawmakers. A science or engineering degree is not necessary to be get a job in government that impacts those fields heavily -- maybe it's time that changed.
Permalink 02/17/07 @ 17:38
Comment from: anon [Visitor]
You, Weldon, Becerra, and Crighton are so incredibly misinformed about gene patents, its truly sad.
There will be few if any more gene patents granted by the USPTO because thanks to the human genome project and Celera, pretty much all of the genes for a significant number of species are known and are publically available - meaning, no more patents because of prior art.
Permalink 02/18/07 @ 13:17
Comment from: Andrew [Member]
To the anonymous commenter (should you return) -- could you please enlighten us all on why the Patent Office has issued thousands of DNA patents since February 2002; i.e., more than one year after the HGP and Celera publications to which you refer?
Permalink 02/18/07 @ 22:11

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