On March 29, 2010, the University of Utah and Myriad Genetics Inc. lost a U.S. court ruling over some of its patents for detecting inherited breast cancer related to the genes BRCA1 and BRCA2.  The 152-page decision, which addresses questions about whether human genes should be subject to patent protection, could have major ramifications for gene-related patents.

Earlier, the American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole gaggle of others have filed a lawsuit challenging patents cover diagnostic tests for mutations along the genes, known as BRCA1 and BRCA2, which are responsible for most cases of hereditary breast and ovarian cancers.   Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. (09 Civ. 4515)

Emphasizing that “purification of a product of nature, without more, cannot transform it into patentable subject matter” since the isolation or “purification of native DNA” did not alter the “essential characteristic- its nucleotide sequence…”, the Court held the composition of matter claims of the BRCA1 and BRCA2 patents did not meet the statutory requirements of 35 U.S.C. § 101 and were thus invalid.

The utility of purified BRCA1/2 DNA molecules as biotechnological tools relies on their ability to selectively bind to native or isolated BRCA1/2 DNA molecules, which is a function of the isolated DNA’s nucleotide sequence.

The decision mainly focused on the basic requirements of patentability set out by statute.  Section 101 of Title 35, United States Code, provides:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

While the court noted that the Supreme Court in Diamond v. Chakrabarty said that “Congress plainly contemplated that the patent laws would be given wide scope,” this broad reading of 101 and statutory patent eligibility is not without limits.  The court then looked at whether or not claims directed to isolated DNA containing naturally-occurring sequences fall within the products of nature exception to § 101.

Citing the Supreme Court:

There are many things well known and valuable in medicine or in the arts which may be extracted from divers[e] substances. But the extract is the same, no matter from what it has been taken. A process to obtain it from a subject from which it has never been taken may be the creature of invention, but the thing itself when obtained cannot be called a new manufacture.

Through a whole series of case law, the court frames the question in these other cases as one of novelty (a § 102 question), not of patentable subject matter (a § 101 question).

The question thus presented by Plaintiffs’ challenge to the composition claims is whether the isolated DNA claimed by Myriad possesses “markedly different characteristics” from a product of nature.

The central premise of Myriad’s argument that the claimed DNA is “markedly different” from DNA found in nature is the assertion that “[i]solated DNA molecules should be treated no differently than other chemical compounds for patent eligibility,” and that the alleged “difference in the structural and functional properties of isolated DNA” render the claimed DNA patentable subject matter.

The court distinguished the present invention from chemical inventions by making a big deal out of the “unique characteristics of DNA that differentiate it from other chemical compounds”:

As Myriad’s expert Dr. Joseph Straus observed: “Genes are of double nature: On the one hand, they are chemical substances or molecules. On the other hand, they are physical carriers of information, i.e., where the actual biological function of this information is coding for proteins. Thus, inherently genes are multifunctional.” This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as “no different[]” than other chemicals previously the subject of patents.

“[N]one of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.” This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form. The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

Were the isolated BRCAI/2 sequences different in any significant way, the entire point of their use – the production of BRCA1/2 proteins – would be undermined.

The court was adamant that the scientific challenges to the discovery had no bearing on the result:

The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent. Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. § 101.

But, if claims to DNA sequences are invalid under 101, what about claims for “analyzing” and “comparing”?  Myriad tried arguing that the claims incorporate a transformation step and therefore satisfy the “transformation” prong of the Bilski “machine or transformation” test. The court disagreed:

Myriad argues that just as the act of “determining” metabolite levels in Prometheus was found to involve the transformation of human blood, so too should “analyzing” or “comparing” BRCA1/2 gene sequences be construed to incorporate physically transformative steps (i.e. the isolation and sequencing of DNA) that would satisfy the Bilski “machine or transformation” test. Myriad further asserts that these transformations are “central to the purpose of the claims,” id. at 1347, because “Myriad’s method claims each require the transformation of a tissue or blood sample in order to isolate the patient’s DNA.”

The “isolation and sequencing of DNA from a human sample, even if incorporated into the method claims-in-suit, would represent nothing more than data- gathering steps to obtain the DNA sequence information on which to perform the claimed comparison or analysis. Moreover, in the absence of a specified method for isolating and sequencing DNA, u[a] requirement simply that data inputs be gathered – without specifying how – is a meaningless limit on a claim to an algorithm because every algorithm inherently requires the gathering of data inputs.”

A copy of the complaint is also available here: Myriad Decision (pdf)

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  3. Sweet’s ruling on both the “isolated” gene patent claims, as well as the “medical diagnostic” method claims is legally flawed and factually unsupportable. Regarding the former claims, Sweet misrepresent the “product of nature” doctrine, including controlling precedent (the 1977 decision of In re Bergy). Regarding the latter method claims, Sweet’s ruling inadvisably relies upon the Bilski “machine or transformation” test which will likely be overturned by SCOTUS. I predict that Sweet’s ruing with be trounced by the Federal Circuit on appeal.

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