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SDNY Sides With ACLU By Limiting Gene Patenting Under 35 U.S.C. 101

By Peter Zura

Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010) (Judge Sweet)

Yesterday, the Southern District of New York issued a controversial opinion in granting partial summary judgment that the claims of several patents on BRCA1 were invalid as encompassing non-statutory subject matter.  Some of the claim language includes the following:

Claim: An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

Claim:  A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the 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.

Interestingly, before the district court dove into the substantive analysis of the claims, Judge Sweet appeared to take an opening shot at the presumption of validity for all patents:

The Federal Circuit has previously held that it owes no deference to USPTO legal determinations . . . While Congress has created a presumption of validity for issued patents, approximately 40% of patents challenged in the courts have been found invalid, demonstrating that the presumption is far from absolute . . . Moreover, the lack of Congressional action to specifically prohibit gene patents in response to the USPTO's prior grant of such patents does not preclude their review by the courts.  (pp.104-105)

Regarding the isolation (or "purification") of DNA, the court noted:

[T]he clear line of Supreme Court precedent and accompanying lower court authorities, stretching from American Wood-Paper through to Chakrabarty, establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter.  Rather, the purified product must possess 'markedly different characteristics' in order to satisfy the requirements of section 101.
 
[I]n light of DNA's unique qualities as a physical embodiment of information, none 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.
 

* * *

 
[L]ike the discovery of the mutual non-inhibition of the bacteria in Funk Brothers, discovery of the handiwork of nature - the natural effect of certain mutation in a particular segment of the human genome.  And like the aggregation of bacterial in Funk Brothers, the isolation of the BRCA1 and BRCA2 DNA, while requiring technical skill and considerable labor, was simply the application of techniques well-known to those skilled in the art . . . 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.

Regarding the method claims,

The essence of what is claimed [in the method claims] is the identification of a predisposition to breast cancer based on "analyzing" or "comparing" BRCAl/2 gene sequences . . .As in Grams, 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, "[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." Bilski, 545 F.3d at 963 (citing Grams, 888 F.2d at 839-40). Consequently, even if the method claims-in suit were construed to include the physical transformations associated with isolating and sequencing DNA, they would still fail the "machine or transformation" test under § 101 for subject matter patentability.

Read/download a copy of the opinion here (link)

See Patent Docs: "Round One Goes to the ACLU" (link)

Full post as published by Two-Seventy-One Patent Blog on March 30, 2010 (boomark / email).