State of Innovation

Patents and Innovation Economics

Association of Molecular Pathology v. USPTO

The CAFC opinion in this case was issued on July 29, 2011.  This case has alternatively been known as ACLU v. Myriad or the Myriad gene patent case.  In a 2-1 decision, the Court of Appeals for the Federal Circuit (CAFC), stated that patents to isolated genes are patentable subject matter (35 USC 101), they found the comparing and analyzing method claims were not directed to patentable subject matter, and found Myriad’s method claims to screening potential cancer therapeutics via changes in cell are patentable subject matter.

Isolated Genes Claims

The opinion explains, “It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form—as distinctive chemical molecules—from DNAs in the human body, i.e., native DNA.  Native DNA exists in the body as one of forty-six large, contiguous DNA molecules.”  p. 41  Since isolated DNA is distinct and man made, it is patentable subject matter.

Moore in his concurring opinion points out:

In contrast, mere purification of a naturally occurring element is typically insufficient to make it patentable subject matter.  For example, our predecessor court held that claims to purified vanadium and purified uranium were not patentable subject matter since these were naturally occurring elements with inherent physical properties unchanged upon purification.  See In re Marden, 47 F.2d 958, 959 (CCPA 1931)

He distinguishes these cases as, “Isolation of a DNA sequence is more than separating out impurities:  the isolated DNA is a distinct molecule with different physical characteristics than the naturally occurring polymer containing the corresponding sequence in nature.” P. 11 Moore He further states, “I decline to extend the laws of nature exception to reach entirely manmade sequences of isolated DNA, even if those sequences are inspired by a natural template.” P. 14 Moore.  He further explains the difference between this case and purified vanadium or uranium as, “Given the chemical differences highlighted by Judge Lourie’s opinion and discussed  supra, the mere fact that the larger chromosomal polymer includes the same sequence of nucleotides as the smaller isolated DNA is not enough to make it per se a law of nature and remove it from the scope of patentable  subject matter.  The actual molecules claimed in this case are therefore not squarely analogous to unpatentable minerals, created by nature without the assistance of man.” P. 15 Moore.

Moore further takes on the red herring[1] debate about whether these sort of patents result in promoting science and the useful arts.  He points to David E. Adelman & Kathryn L. DeAngelis, Patent Metrics:  The Mismeasure of Innovation in the Biotech Patent Debate, 85 Tex. L. Rev. 1677, 1681 (2007), as clearly showing biotech patents have resulted in increase innovation.

Method Claims to Comparing and Analyzing

The courts stated, “We conclude that Myriad’s claims to “comparing” or “analyzing” two gene sequences fall outside the scope of § 101 because they claim only abstract mental processes.”  p. 50  This is clearly mistaken.  The step of comparing requires a physical and transformative process.  For instance, the process of sequencing a gene is a physical and transformative process it is not a mental process.  There is no other way to compare and analyze two gene sequences without the physical process of sequencing.  As explained by Myriad:

The steps of “extracting and sequencing DNA molecules from a human sample (is necessary)—before the sequences can be compared or analyzed.  According to Myriad, the district court failed to recognize the transformative nature of the claims by (1) misconstruing the claim term “sequence” as just information, rather than a physical molecule; and (2) erroneously concluding, in the alternative, that Myriad’s proposed transformations were mere data-gathering steps, rather than central to the purpose of the claims.  p. 49.

Method Claims to screening potential cancer therapeutics

The court in analyzing these claims states:

Starting with the machine-or-transformation test, we conclude that the claim includes transformative steps, an “important clue” that it is drawn to a patent-eligible process.  Bilski, 130 S. Ct. at 3227.  Specifically, the claim recites a method that comprises the steps of (1) “growing” host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, (2) “determining” the growth rate of the host cells with or without the potential therapeutic, and (3) “comparing” the growth rate of the host cells.  The claim thus includes more than the abstract mental step of looking at two numbers and “comparing” two host cells’ growth rates. The claim includes the steps of “growing” transformed cells in the presence or absence of a potential cancer therapeutic, an inherently transformative step involving the manipulation of the cells and their growth medium.  The claim also includes the step of “determining” the cells’ growth rates, a step that also necessarily involves physical manipulation of the cells.  p. 53

The sad thing about the court’s analysis above is that it clearly applies to the method claims for comparing and analyzing.  You cannot compare and analyze without manipulating the cells.  Even if a non-mechanical method were found for sequencing a gene (e.g., an optical, x-ray of other analysis) this is clearly a physical process and transformative.  The court is being logically inconsistent between the method claims to comparing and analyzing and the method claims to screening potential cancer therapeutics.

While I do not agree with all the points made by Judge Lourie and Moore, these are thoughtful opinions by smart people who understand patent law and the underlying technology.  Note that both of these judges are patent attorneys and have advanced technical degrees.  Unfortunately, but not surprisingly, the same thing cannot be said about the dissenting opinion by Judge Byson.  Byson is neither a patent attorney and does not have a technical background.

Dissent

Judge Byson’s dissent boils the question down to, “whether an individual can obtain patent rights to a human gene.  From a common-sense point of view, most . . . observers would answer, Of course not.  Patents are for inventions.  A human gene is not an invention.”  This shows Judge Byson’s complete lack of understanding of the underlying technology.  Myriad did not patent a human gene, it patent an isolated human gene.  Isolated gene’s have value (utility) that non-isolated genes do not or the plaintiffs would not have filed this lawsuit.  Myriad did not patent a random segment of human genetic material, it patented a human gene that had diagnostic value.  Discovering that diagnostic value was the product of human intelligence.  An invention is a something created by man that has objective utility.  The isolated gene is created by man and it has objective[2] utility.  The dissent’s arguments show why the CAFC should be limited to patent attorneys.

 


[1] This is a red herring argument, because these same people do apply this standard to copyrights.  Do Disney movies really promote science and the useful arts?

[2] By “objective utility” I mean to distinguish this from a creation that only has aesthetic utility.

 

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August 5, 2011 - Posted by | -Law, Patents | , , , , , ,

2 Comments »

  1. Although a bit of trepidation is likely in order (no matter on what end of the spectrum you tend to fall), I look forward to reading what the SCOTUS has to say when the esteemed Justices opine on gene patents. Particularly since Myriad presents a bit of a chicken-and-egg question — that is thus perhaps not scientifically, definitively solvable — policy considerations will probably weigh heavily in their ultimate determination. Which also makes one wonder to what extent the Court’s new political makeup will affect the case’s outcome.

    Comment by patent litigation | August 9, 2011 | Reply

  2. The only real policy question that should be asked is whether isolating human genes for a useful purpose an invention?

    A patent is not just a right to sue any more than any other property right is just a right to sue. A patent is property right. Like other property rights it gives me the right to collateralize my property rights, subdivide my property right, sell my property right, etc.

    Comment by dbhalling | August 9, 2011 | Reply


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