He's Baaack!

Congressman Becerra Once Again Tries to Ban Gene Patenting by Statute

    By Kevin E. Noonan --

When last we encountered Congressman Xavier Becerra (D-CA), he was rumored to be headed for a post as U.S. Trade Representative (see "Proponent of Gene Patent Ban to Leave Congress").  That seems to have fallen through, because the Congressman remains as the chief legislative threat to gene patenting.  He has introduced anti-gene patenting legislation in the past (see "The Continuing Threat to Human Gene Patenting"), spurred on by the late Michael Crichton's unrealistic warnings about the purported "threat" (see "Science Fiction in The New York Times").  His latest bill that he is planning to introduce is even broader (and ironically itself imposes a greater threat to "the progress of science and the useful arts" than the gene patents is seeks to ban).

The proposed bill goes even further than his earlier bill by banning ­patenting of all genes (animal, vegetable, and from microorganisms).  The text, under the innocuous title "The Genomic Research and Accessibility Act" (also the title of the bill he introduced in the 110th Congress), is simple:

SEC. 2. PROHIBITION ON PATENT ON 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 on genetic material
    "Notwithstanding any other provision of law, no patent may be obtained for—
        ''(1) a nucleotide sequence or its complementary sequence;
        "(2) any function or correlation of any nucleotide sequence or its complementary sequence; or
        ''(3) the naturally-occurring products that any nucleotide sequence or its complementary sequence specifies.''

Fortunately, there is a savings provision for patents already granted (no doubt based on fears of the lawsuits over governmental takings that might ensue without it; see "'Takings' by Congress and the Courts"):

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

While similar in format, the earlier bill was specifically directed towards human genetic material.  But like the earlier bill, 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.)

The expansion of the scope of this bill is troubling, since it would not only ban human gene patenting but all gene patenting.  Such a ban would preclude from patentability a wide array of biologic products, including vaccines, as well as genes for beneficial improvement in crops such as resistance to insect predators.  The ban on patenting "the naturally-occurring products that any nucleotide sequence or its complementary sequence specifies" would also preclude protection for any genetically-engineered crop or foodstuff.

No doubt emboldened by the recent District Court decision in AMP v. USPTO on the Myriad patents (see "Round One Goes to the ACLU"), Congressman Becerra has sent a letter to his colleagues to garner support (and co-sponsors) of his bill.  The letter is the same recitation of half-truths and falsehoods that have characterized this debate for years, but the Congressman and his friends never tire of reciting them.  These include:

That proprietary rights over the most basic element of an individual's genetic identity should not be enforceable.

And they are not.  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.  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.  In addition, the genes encompassed by these patents are structurally altered compared with their existence within an individual's chromosomes, and are in a form not produced other than by the hand of man.

Allowing patents on natural human biology and natural human medical phenomena imposes real and severe limits on scientific research, learning and the free flow of information.

The letter references "studies" that have "demonstrated that research has been delayed, limited, or even stopped due to concerns about gene patents."  Actually, no.  Study after study intending to show a widespread negative effect of gene patents on basic research have consistently found little or no effect.  Indeed, a PubMed search for scientific journal articles reciting "BRCA1" or "BRCA2" uncovers more than 7,000 such publications.  There is no evidence that basic scientific research is impeded; patent infringement by hospitals and physicians (i.e., commercial use rather than basic research) is what has been impeded, as it should be.

Gene patents have an equally harmful effect on the practice of medicine by granting exclusivity of practice to medical procedures or clinical diagnostic tests.

The issue is what is the alternative?  What Congressman Becerra doesn't appreciate, or chooses to ignore, is that patents have finite terms, a requirement for an enabling disclosure coincident with the scope of the claims, and (for now) the best mode of practicing the invention.  Banning diagnostic tests doesn't require a gene patenting ban, after all:  as shown in Bilski, the law is capable of distinguishing between a method claim and a composition claim.  And whether the ban encompasses isolated nucleic acids or not, banning genetic diagnostics isn't going to liberate them for general public use, it will drive the technology and the information to be protected as a trade secret -- which never expires, never gets into the public domain, and (if done correctly) is resistant to reverse engineering.

The letter even cites the recent SACGHS (Secretary's Advisory Committee on Genetics, Health and Society) Report for the Department of Health and Human Services (HHS) entitled "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests" in favor of its position, citing one of the main passages regarding what the committee expected to find:

Trends in patent law appear . . . to pose serious obstacles to the promise of these developments [in genetic research and clinical practice].  Patenting has moved upstream; instead of covering only commercial products, patents can now control foundational research discoveries, claiming the purified form of genes.  Fragmented ownership of these patents on genes by multiple competing entities substantially threatens clinical and research use.

Despite these sentiments (alternatively, prejudices), as with most studies, the reality and experience of the research community does not support the presumption that non-commercial use has been impeded to any significant extent by permitting genes to be patented.

The Congressman has been unsuccessful before, and despite Judge Sweet's decision there is no general ban on gene patenting today.  And unless and until the Federal Circuit or the Supreme Court so rules, there is no such prospect for a ban; perhaps that is why this otherwise undistinguished Congressman is again pushing his radical agenda.  As we have said before, political Cassandras and opportunists do us no service with their misinformed cries that the sky is falling; we listen to them at our peril.

Comments

[EG]

Kevin,

O joy, we have the return of the anti-gene patent Prince of Darkness. Doesn't Becerra have something better to do? Like encouraging business and job growth in America. Once he's destroyed the American biotech industry with this mis-guided bill, how does he plan retrain all those unemployed biotech folks? Becerra needs to go away and get a life.

[Dan Feigelson]

Kevin, after reading your post, at first I thought there might be an IQ cap on representatives from Mr. Becerra's district. Then I found that he hails from the CA 31st district, which encompasses Hollywood. So while there may or may not be a maximum intelligence limitation in play, Mr. Becerra clearly had to meet a "divorced from reality" requirement to be elected. That helps explain his behavior, but doesn't make the behavior less dangerous. Do you know which committee this bill has to get out of before reaching the floor? Perhaps the committee chairman has both feet on the ground and would be receptive to arguments based in fact and reason rather than a bestselling work of fiction.

[Oskar]

Kevin,
Does the bill incorrectly presume that all nucleotide sequences are naturally occurring? It seems that this bill's prohibition would extend to even non-naturally occurring nucleotide sequences. Is that right or did I miss something? In other words, if I conceive of a non-naturally occurring protein and also a nucleotide sequence that codes for that protein, then it appears this bill would try to prevent a claim to that nucleotide sequence. Though there would still be other issues to debate about gene patents, without limiting the bill to naturally occurring nucleotide sequences, this bill's prohibition appears to be way too broad.

[EG]

Oskar,

Your point about this oxymoronic bill likely prohibiting the patenting of "synthetic" nucleotides is well-taken. Like the earlier version of this bill which misrepresented in its title what the bill covered, this bill too has extremely troubling language. Beceera needs to focus his attention on more important matters, like how we're going to pay for this mind-boggling health care package that he and his Democratic cronies just passed without imposing on America a tax-burden which will simply stiffle all economic growth, including in the biotech sector.

[EG]

Kevin,

One suggestion I have which isn't the "all or nothing" approach of the Becerra bill is to provide the US government with something similar to the "march-in" provision that exists in Bayh-Dole. Such a provision should also provide the patent owner with the ability to secure "reasonable compensation" for what would likely amount to a "compulsory license" in the Court of Claims, similar to an action under 28 USC 1498. They could even put in a "research exemption" provision that would allow academia and other non-profits to do basic gene research without fear of a patent infringement suit. Anything is better than this oxymoronic Becerra bill. In other words, the basic gene research could proceed uninhibited, but the patent owner wouldn't be completely deprived of any ROI just because some take the extreme view that patenting gene technology is simply a "morality" issue.

[6]

Seems reasonable to me.

[max]

The Congressman has a BA in Economics from Stanford and a JD from the same institution. How strange that someone with this background would sponsor legislation like this...poorly written and economically devastating. Until you consider that the US Congress has evolved into a stupendous protection racket: "Nice business youse got dere. Sure would be sad if someone passed some legislation that hurts it." The Congressman is a senior member of Ways and Means, where this art is practiced with aplomb. Better, the racket will yield double dividends. The Democrats in the SF Bay Area (there are no Republicans) will have to be bought off to lean on this guy. What a great business state intervention is! There's pie for all the politicians.

[Geoff Karny]

What a moron! Making policy on the basis of a science fiction novel? The book was the worst piece of trash I ever tried to read. (I gave up when I got to the talking parrot that did math.) This guy isn’t qualified to be a dog catcher let alone a congressman.

[EG]

Geoff,

I understand your sentiments, but I prefer to refer to Becerra bill itself as moronic. As noted above, the language is poorly drafted and would have an impact on the American biotech industry that would anything but positive.

The Becerra bill also continues to foster the sense of "entitlement" to whatever technology is developed, even when it costs significant money and time to develop that technology. That attitude is depressing innovation and economic growth in the private sector, especially for small businesses. At the moment, the only job growth we've got is in government (especially federal). Unless we want to follow the awful economically depressing path in Europe, we need to move towards initiatives that foster growth in the private sector (especially those fostering small business growth) and away from government. That includes avoiding "entitlement" initiatives like the Becerra bill which could kill American job growth in the biotech sector.

[Geoff Karny]

EG,

In theory, I agree with you. Your assessment of the Becerra bill is certainly more rational and analytical than mine. But I've been hearing the anti-patent propaganda for 30 years, and I'm sick of it. I and many members of the patent bar have been trying to explain the patent system to the anti-patent folks for many years and getting nowhere. Not only do they choose not to understand, they twist the facts and manipulate emotions. The Big Lie propagated by the ACLU in the AMP case finally put me over the edge. I think it is time for patent lawyers to speak out forcefully and directly against the propaganda of the anti-patent cabal.

By the way, try reading Crichton's book (Next) some day when your stomach is strong and your toleration of idiocy is high. Even then, I'd be surprised if you got through it.