Gene patents, an amicus curiae

By Grant Jacobs 01/11/2010 7


Some readers may recall earlier in the year I wrote about Myriad Genetics facing a judicial ruling against their patent of the BRAC1 and BRAC2 genes.

This ruling had implications as if genes were patentable[1] in the USA, as the judge queried the validity of patenting genes merely because they had been isolated.

In a new development, a brief (PDF file) for the United States as amicus curiae[2] in support of neither party has been presented, in which

[…] the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.

We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA. The district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature. For the reasons below, the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.

The document starts by raising two questions to be addressed:

1. Whether human-engineered DNA molecules, such as cDNAs, are patent-eligible subject matter under 35 U.S.C. § 101.

2. Whether isolated but otherwise unmodified genomic DNA is patent-eligible subject matter under section 10

then laying out an argument addressing them (from the table of contents):

A. Section 101 Embraces Only ’Human-Made Inventions’.

B. Engineered DNA Molecules, Including cDNAs, Are Human-Made Inventions Eligible For Patent Protection.

C. Isolated But Otherwise Unmodified Genomic DNA Is Not A Human-Made Invention.

1. Unmodified Genomic DNA Is A Product Of Nature.

2. ’Isolation’ Does Not Transform A Product Of Nature Into A Man-Made Invention.

3. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is A Literal Composition Of Matter.

4. Isolated Genomic DNA Is Not Rendered Patentable On The Theory That It Is ’Pure’.

5. Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify.

This argument outline seems very straight-forward, but I’m a little surprised at one or two of the statements made.

Firstly, their definition of a gene is badly wrong for this purpose to my thinking, in considering only protein-coding genes:

With qualifications not relevant here, a ’gene’ is any section of DNA that, through its nucleotide sequence, governs the expression of a particular protein.

There are, of course, functional RNAs and presumably there are people with an interest in patenting them.

I have to admit I can’t understand their decision to limit themselves in this way, as those presenting this document are very well aware of functional RNAs, unless perhaps it is the line of reasoning that they are interested in presenting, not if their line of reasoning covers all molecules that might be considered.

Secondly, I feel that in trying to argue for allowing patents on all cDNAs in the midst of this document, they have muddied an otherwise clear argument with what could be viewed in some ways as a sideline distraction.[3]

I personally think they might have been better to sidestep this. Acknowledge that this an area of interest (which it is no doubt is), note that is differs from the central claim the amicus curiae wishes to address, then set it aside for another time (and, perhaps, encourage the court to do the same).

Footnotes

[1] The document uses the no-doubt more correct patent-eligible, but I’m going to stay with the more compact patentable.

[2] The highlighting in this document is presumably that of the NYT journalist. It is not mine.

[3] My initial thoughts on this are that the nature of the cDNA matters. Isolated DNA by it’s nature is the natural thing – as the word ‘isolated’ implies – whereas cDNAs can variously be the same as, or very similar to, something that might be directly isolated, or put to a purpose in lieu of something that might be directly isolated.


Other articles in Code for life:

Myriad Genetics patent of BRCA (breast cancer) genes denied

What is your relationship with your research notebook?

Testing common ancestry to all modern-day life

I remember because my DNA was methylated


7 Responses to “Gene patents, an amicus curiae”

  • I have to admit I can’t understand their decision to limit themselves in this way, as those presenting this document are very well aware of functional RNAs, unless perhaps it is the line of reasoning that they are interested in presenting, not if their line of reasoning covers all molecules that might be considered.

    IANAL, but my guess is that they wanted to side-step the “what is a gene” question by limiting themselves somewhat, hence the “With qualifications not relevant here”. The case is specific to BRCA1 and BRCA2, so the judge only has to rule on them. I don’t know how far this would go to setting a precedent, but if the judge makes a distinction between altered and unaltered DNA in his ruling, then I guess it would be pretty clear that functional RNAs would be included (as well, possibly, as non-coding DNA).

  • Hi Bob,

    (Readers should note Bob’s first paragraph is quoting me: I’m a bit lazy to edit it into a blockquote just now!)

    (IANAL either…)

    I get what you mean — it’s why I wrote the latter portion of that quote re reasoning vs. the specific molecules named — but I’m still not sure it was the best approach. The case itself about the BRCA1/2 genes, but judge to a more general underlying principle in his earlier ruling – that merely isolating a gene didn’t make it patentable. Given that you’d think it’s unavoidable his ruling will have wider implications. (Remember this principle hasn’t been tested in court before.*)

    I seems to me that if it weren’t for the cases they use as background in the amicus curiae they could have dropped the explanation of introns/exons/etc and simply referred to the natural DNA sequence, which is the key element after all.

    In the end I still have two minds about. Given that the case is likely to lay out the principles, I personally would have liked to have seen them explicitly point to the wider story, rather than the narrower one. But then that’s me, I guess!

    I had meant to mention non-coding DNA and damn-well forgot and left it out. Sigh. (It was in my notes, too.)

    * There’s a nice quote explaining this, but I left it out as I didn’t want to crowd the post with too many legal-minded quotes!

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