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Department Of Justice Weighs In On Myriad DNA Claims

In an Amicus Brief dated October 29, 2010, (link at the end of this post) the U.S. Department of Justice (not the Solicitor’s Office of the PTO or the NIH) filed an amicus brief urging the Federal Circuit to affirm the decision that genes (and presumably any other DNA sequences) isolated directly from genomic DNA are not patentable subject matter, but simply purified products of nature: “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.’” [Brief at page 32]. Most interestingly, the DOJ accepted and would reverse the district court’s ruling that DNA’s involving a heavier application of the hand of man (such as cDNA (often made from RNA), plasmids, etc) are products of nature:

“[T]he district court erroneously cast doubt on the patent-eligibility of a broad range of man-made compositions of matter whose value derives from the information-encoding capacity of DNA. Such compositions –e.g., vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and this qualify as ‘human-made inventions’, eligible for patent protection under s. 101….The district court erred in invalidating the challenged composition claims, such as claim 2 of the ‘282 patent, that are directed solely to cDNA.”

This seems like an odd attempt to reach a middle ground. The brief says nothing directly about whether or not the cancer screening (“comparing and identifying”) method claims are patentable subject matter. On one hand, it says that the fact that mutations in the BRCA 1 and 2 gene may predispose a women to develop breast cancer are simply “products of evolution….Such basic natural relationships may not be the subject of a patent.”  On the other hand, it says:

“New and useful methods of identifying, extracting, or using genes and genetic information may be patented (subject to the prohibition against patenting abstract ideas)[Eds. Note: whatever they are], as may nearly any man-made transformation or manipulation of the raw materials of the genome, such as cDNAs. …Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult [to make] or useful that discovery may be.” [Brief at page 11.]

“A person who invents a new and useful industrial application for isolated genomic DNA [Ed. Note: Like an assay for cancer?] –or any other product of nature—[Ed. Note: Like PSA?], is entitled to seek a process patent for that application. But the underlying natural compound itself is not patentable.” [Brief at page 34.]

Where the brief falters is in its attempt to take a hard line position that “Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it [from extraneous matter].” Justifying this position on precedent requires the DOJ to ignore or re-write major decisions like In re Bergy and In re Bergstrom. Bergy is cited, not as affirming that pure strain microorganisms are as patentable as small molecule drugs (which it holds), but merely as a novelty (102) decision. But how did the Bergstrom court reach novelty if it was aware that the purified prostaglandin existed in semen in tiny but discrete amounts? The DOJ has the legal nerve to assert that Bergstrom did not overrule two 1930’s decisions – In re King and In re Merz – but completely ignores the fact that Bergy, a 1979 case decided in tandem with Chakrabarty, certainly cast doubt on any earlier decisions by predecessor courts that isolation and purification could not render a natural product patent-eligible.

The DOJ deals with the numerous decisions granting patents on purified natural products by waffling on the purification issue the authors found so compelling when dealing with genomic DNA:

“Patent eligibility may arise when a natural compound has been so refined and purified through human intervention as to become a substance different in kind from the natural product…It may be that ‘purification’ —depending on what is meant by that term—can in some cases transform a natural substance into a new compound sufficiently different in kind from its natural ancestor to cross the threshold of section 101. But this case involves no such transformation.” [Brief at pages 30-31.]

The distinction that the DOJ is trying to draw here is legally one “without a difference.” After 37 pages, I have had enough of borax-treated fruit, pine fibers and adrenal gland extracts. The Supreme Court and the Bilski guidelines have raised much more intriguing questions about the patentability of diagnostic genetic-based assays. Such tests will necessarily be dependent on the application of algorithms by computers and that may work by comparing public databases of genomic data with your genome that you carry around on your iPad. BIO’s brief did not discuss the method claims at all, but at least contained the type of policy-based arguments I think judges like to see in amicus briefs (“But it will save many lives!”). I am still waiting for the brief that explains why the Myriad method claims are not abstract ideas, even if they are interpreted to fail the M or T test. I may have a while to wait.



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