US Government Argues in Court that Isolated Genes are Unpatentable

AMP v. Myriad (Fed. Cir. 2010)

In March, 2010, District Court Judge Robert Sweet held Myriad's gene patent claims invalid for failing to satisfy the subject matter eligibility requirements of 35 U.S.C. 101.  The ruling was directed toward claims that cover particular isolated DNA molecules (genes) and processes of detecting and screening for those genes, but was written broadly enough to essentially invalidate all patents covering genes that were isolated from an organism. 

Last month, I heard a rumor that Obama administration science and legal advisors outside of the USPTO supported Judge Sweet's ruling.  At the time I disregarded that suggestion as unlikely. I was wrong. [Andy Pollack at the NYTimes has the scoop]

The US Department of Justice (DOJ) has now filed an amicus brief supporting the lower court decision — arguing that isolated genes are unpatentable because they improperly claim a product of naturer [Link to Brief]:

The district court correctly held . . . that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.

. . . .

Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.

. . . .

A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure.”

Several other amici have filed briefs:

307 thoughts on “US Government Argues in Court that Isolated Genes are Unpatentable

  1. 307

    My pal the Noonster has done it again with additional excellence in showing just why “isolation” is indicative of the hand O man.

    First, Iza gotta be all scholarly and quote myself:

    As Dr. Noonan has painstakingly shown, the isolation process simply involves human manufacturing of an item found in nature. For a long list of such explanations, see link to

    Manufacture is nowhere limited to adding things together using the building blocks of the particular art. Manufacture can (and does) also include activity by man in reducing the building blocks found in nature, removing bits and pieces. Ya just gotta have the right mindset of building blocks and abstractions is all.

    Just an observation – feel free to draw your own answers.

    Posted by: ping | Nov 04, 2010 at 10:04 AM

    And now the Noonster’s additional link:
    link to

  2. 306

    Oh,my friend,do you want stars?If you are feeling lonely distant from home,look up in the stars within the sky, the place there may be a star for luck that I’ve ship you.

  3. 303


    I assail thee?

    give me a break. I just show that ya keep asking questions the answers of which are out there. It is my observation that this lovely habit of yours is probably what the one poster thought of as “infamous.” Your word choice is OK with me too.

    Whether you are convinced or not I really don’t care. Another observation: those that don’t want to be convinced (for their own reasons) are often the ones that cannot be convinced, even when the courts and legislature clearly state that there is no such thing as a business method patent exception. But you just keep tilting and bringing the chuckles.

  4. 302

    You assail me again ping with your “repeatedly” but I have to say in reply that I’m still not convinced.

    The word “abstract” is not in the Patents Clause or in 35 USC 101. A lot of people want to know what it means. Some people think it has quite some potential for blocking patents on such business methods as mere hedging schemes. I’m only curious how far the courts are now going to travel, with the judicially created prohibition on the patent eligibility of subject matter which, in its substance, amounts to an “abstract” idea, how to use money to make money.

Comments are closed.