Home > 35 USC 101 > Not a Sweet Result for Myriad Genetics

Not a Sweet Result for Myriad Genetics

In Association for Molecular Pathology v. U.S. Patent and Trademark Office [PDF], Judge Robert Sweet of the Southern District of New York was asked to rule certain claims from Myriad Genetics’s patents invalid on summary judgment.   The propriety of issuing patents to genes is often a subject of lively public debate, but the Patent and Trademark Office has had a longstanding policy of issuing patents directed to isolated and purified genes.  Here, various entities (including (and the ACLU and PubPat) sought to challenge this policy against the backdrop of what they feel is an egregious example of gene patenting.

The court gave an impressively detailed recitation of the interested parties, and of the genetic and scientific basis for using the BRCA gene and its alleles (subtypes) in diagnosing various types of cancer.   I will not repeat that background here (it is approximately 60 pages) but, in short, Myriad owns patents directed to isolated BRCA DNA sequences, and to methods of using the BRCA sequences in detecting a predisposition to breast and ovarian cancers.

Representative composition and method claims are presented below:

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.  (Claim 1 of U.S. Patent No. 5,747,282).

A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from a group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.  (Claim 1 of U.S. Patent No. 5,709,999).

In claim construction, the court quite rightly construed “DNA” as a real, tangible chemical compound, rather than as a pure sequence of information (such as a string of letters typed on a piece of paper).  The court also construed “isolated DNA” (a segment of nucleotides existing free of cellular components), and “BRCA1” and “BRCA2” (genes having alleles which cause susceptibility to breast and ovarian cancer).

Legally, Judge Sweet tested whether the subject matter of the claims is patentable under 35 USC Sec. 101.  Judge Sweet relied, appropriately, on a long line of Supreme Court cases affirming the patentability of various inventions derived from nature.  Diamond v. Chakrabarty, for example, stated that “the patent laws [should] be given wide scope” in upholding the patentability of genetically modified bacteria as “manufactures” or “compositions of matter.”  However, the scope of patentable subject matter is not unlimited, and because scientific principles and laws of nature “define the relationship of man with his environment [they] ought not to be the subject of exclusive rights to any one person.”  In re Meyer (CCPA 1982) (citing Leroy v. Tatham (1852)).

This opinion takes problematic steps, however, in reaching its holding that isolated DNA (as recited in claim 1, above) is not patentable subject matter.

First, Judge Sweet appears to stretch the “laws of nature” rule beyond the point at which it breaks.  The Supreme Court has often said that phenomena of nature are not patentable, while still allowing certain constructs derived from nature to remain patentable (such as genetically engineered bacteria).  However, it should be apparent that phenomena of nature (such as the laws of gravity, or equations of physics) are quite different from physical entities that could not have existed before someone constructed them in a laboratory, and which are derived from phenomena of nature (such as the information-encoding function of DNA).

Second, Judge Sweet takes a wrong turn when he begins his legal reasoning with a cite to Justice Breyer’s dissent from the denial of certiorari in Lab Corp. v. Metabolite Labs. [PDF] By its very nature, Justice Breyer’s dissent, though expressing an admirable concept (“too much patent protection can impede rather than promote the ‘Progress of Science and useful Arts'”) is not binding law, or even the appropriate starting point for a recitation of binding law.  Judge Sweet compounds this error by falling prey to the dreaded “cite bite”; that is, citing a case for an attractive statement that is neither its holding nor an accurate reflection of the important legal issue (for background on the perils of the cite bite, see, for example, these comments by Chief Judge Michel, at pg. 7; and these comments by Hal Wegner).  Here, Judge Sweet cites Funk Bros. Seed Co. v. Kalo Inoculant Co. for the proposition that “manifestations of laws of nature [are] free to all men and reserved exclusively to none.”  However, Funk Bros. is not widely understood to be a case about patentable subject matter; it appears, rather, to be a case about the obviousness statute in the pre-1952 Patent Act.  Thus, it should be no help to Judge Sweet’s resolution of this case, and casts a shadow over the solidity of his reasoning.

Although Judge Sweet gets on the right track when he states that the test under Sec. 101 is a) utility [conceded here], coupled with b) statutory subject matter, one cannot help but feel that Judge Sweet was swayed by possibly erroneous legal principles, such as the one from Funk Bros. (cited again on ppg. 109 and 135).

Judge Sweet addressed the statutory subject matter question by asking whether the invention recited in the claims is “a fundamentally new product”; tested by whether the manmade invention “possesses a new or distinctive form, quality, or property” compared to the naturally-occurring article.  Here, Judge Sweet performed essentially the opposite of the trick that is commonly utilized by the Supreme Court.  At the High Court, when deciding when something is a longstanding and well-recognized fundamental right, it can quite easily be shown that something is NOT a fundamental right by defining the right narrowly.  For example, “the right to marry a loved one” could be a fundamental right, being deeply rooted in American history; the “right to marry a loved one of the same sex” would not be a fundamental right, not being deeply rooted.  It’s all in the definition.

Here, Judge Sweet worked the trick by defining the claimed material’s “fundamental nature” broadly, so as to make it more difficult for the alleged invention to be different from its natural form.  For example, Judge Sweet recites many of the ways that cDNA made in the laboratory is different from chromosomal DNA found in a cell (see, e.g., Opinion at pg. 42).  But Judge Sweet then ignores these differences when he wants to discuss what DNA “is.”  (See, e.g., Opinion at pg. 132; “a nucleotide sequence” or information).  Thus, rather than an isolated DNA molecule being quite different from DNA housed in the nucleus of a cell (which it obviously is), isolated DNA becomes exactly the same as DNA in a nucleus, because in each case the DNA’s fundamental nature is to be a nucleotide sequence, or information carrier.  Since it is undifferentiated from chromosomal DNA on this broad description of its fundamental nature, the isolated DNA of the claims cannot be patentable subject matter.

I think Judge Sweet is on much firmer ground in ruling Myriad’s method claims unpatentable as being mental processes of “analyzing” or “comparing,” and not requiring something more than abstract thought, so I will not go into that reasoning here.

Suffice to say, as I touched on above, I think Judge Sweet’s reasoning in this case leaves something to be desired.  It was clear from the tone of the background discussion how the case would come out, and it only remained to be seen what path would be taken to the outcome.  It would surprise me not at all to see Myriad appeal this case and the Federal Circuit reverse the district court.

For other discussion of this case, please see:

The New York Times

The Genomics Law Report

The Prior Art blog

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Categories: 35 USC 101 Tags: , ,
  1. February 9, 2011 at 8:10 PM

    It’s a double edged sword, to allow patents or not. Seems like for the good of mankind patents should be limited. However without the greed aspect we would not have the explosive growth advances in genetics.

  1. April 19, 2010 at 9:17 PM

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