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March 01, 2010 (Vol. 30, No. 5)

ACLU Takes on Patent Office & Myriad Genetics

Federal Judge Hears Arguments about Gene Patents for BRCA

  • Myriad Replies

    Brian Poissant, counsel for Myriad Genetics, took the podium and began by noting that history has a tendency to repeat itself. He elaborated, saying that the same level of controversy and media attention around this case also occurred 30 years ago when the Supreme Court considered the Chakrabarty case.

    Poissant said that then, as now, some members of the public proclaimed that a “gruesome parade of horribles” would result if the Court were to decide that claims involving genetic technology could be patented. He added that the Court in 1980 wisely deferred these public policy issues to Congress, urging that Judge Sweet interpret the claims in question in light of the law as written.

    Poissant invoked the language of section 101 of the patent law, directing the court’s attention to two of the four categories of patentable-eligible subject matter: processes and compositions of matter, and to the qualifier that they be “new and useful.” Focusing on “new,” Poissant said that the isolated nucleic acids recited in the patent claims to compositions of matter simply do not exist in nature. And an “isolated” polynucleotide having a particular sequence that’s “useful” takes a lot of work to come up with.

    A critical portion of the cell’s undifferentiated DNA must be identified by the scientist. Such isolated nucleic acids are useful because they can be used as probes that find and attach to complementary sequences in a subject’s DNA, such as in diagnostic tests. The claimed nucleic acids may also potentially be used for gene therapy.

    Poissant cast doubt on the ACLU’s contention that Parke-Davis was impliedly overruled by later case law and added that the patent-eligibility of isolated DNA sequences has long been recognized in the law and in USPTO rules and procedures. Poissant also urged the court to take the approach of the Supreme Court in J.E.M. Ag Supply v. Pioneer Hi-Bred and look to whether Congress has passed legislation that renders subject matter patent-ineligible when it otherwise appears to be patent-eligible. Now, as then, Poissant said, such legislation is absent.

    Poissant also argued that many of the cases that the ACLU relies on are off-topic. He said that Funk Brothers dealt with anticipation under section 102, not patent-eligible subject matter under section 101. He also noted that American Food Growers was about whether the claimed subject matter was an “article of manufacture,” not involving either a process or a composition of matter, as here.

    Applying the “machine or transformation test” for method claims stated in the Bilski decision of the CAFC, Poissant asserted that, as in the Prometheus case, the method claims of the patents at issue do involve a transformation. Elaborating on this, Poissant said that cells are taken from the body and are opened up; probes having the recited BRCA sequences are introduced; the probes traverse the DNA from the cell; and, if the DNA from the cell contains a sequence complementary to a probe, the probe attaches to the complement.

    Poissant said that the claims are not about intangible information but about physical molecules. He added that thinking or talking about the DNA sequences are not precluded by the patents, despite what the ACLU would have the court believe.

    Counsel for the USPTO, Ross Morrison, spoke briefly to state that under the Doctrine of Constitutional Avoidance, the court should decide the case on the basis of the ACLU’s Constitutional arguments only if it first finds that the patent claims are valid under section 101 of the patent statute. Morrison then said that the applicable test for a Constitutional challenge is whether Congress had a rational basis for establishing the patent system and that the rational basis was clearly to “Promote the Progress of Science and the useful Arts” as stated in the IP Clause of the Constitution.

    In response to the First Amendment claim made by the ACLU, Morrison said that the patent system promotes the sharing of information under the “written description and enablement” requirements of section 112 of the patent law. Furthermore, when the first Patent Act was being passed by Congress in 1790, the First Amendment to the Constitution was in the process of being ratified, so that Congress at the time would have taken into consideration the interplay between the two.

    Judge Sweet said that he wouldn’t issue his decision immediately, noting that the importance and complexity of the subject matter justifies careful deliberation.

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