Federal Circuit Holds Isolated Genes to be Patentable Subject Matter – Again

I honestly had to check the date on this opinion because it is so similar to the earlier–now vacated–decision from July 2011.  Despite the Supreme Court’s admonition to reconsider its holding in light of Prometheus (Mayo), the court again held that isolated genes constitute patentable subject matter, but that the method claims directed to comparing or analyzing gene sequences do not.  Association for Molecular Pathology v. Myriad Genetics, Inc.

Given that the court basically reiterated its earlier opinion, it is worth noting only how the court viewed the Prometheus decision and its effect on the claims at issue in this case. 

The court noted that the principal claims that it was asked to consider relate to isolated DNA molecules.  “Mayo does not control the question of patent-eligibility of such claims.”  Instead, these claims are directed to compositions of matter that are expressly authorized by § 101 of the Patent Act.  While Mayo and other Supreme Court cases provide valuable insights into the patent eligibility of method claims, the earlier decisions of Chakraborty and Funk Bros. set out the primary framework for determining patent eligibility for composition of matter claims.

The plaintiffs in this case focused on the Supreme Court concern of preemption, where use a law of nature is entirely preempted by the patent method claims.  The court denied this concern.  “A composition of matter is not a law of nature.”  Every one and every thing comes from nature and follows its laws.  This does not render man-made compositions to be natural products.  Creating a new chemical entity requires exactly the type of human transformation, skill, knowledge, and effort that the Supreme Court indicated would render an invention patentable.

The court reaffirmed its decision regarding the patent ineligibility of the claims related to methods of comparing or analyzing gene sequences.  These claims are indistinguishable from the claims struck down by the Supreme Court in Prometheus.

Finally, the court also again found the claim directed to a method of screening potential cancer therapeutics to be patent eligible.  Here, the court spent a great deal of time subtly pointing out flaws in the Supreme Court’s Prometheus opinion. 

Of course, all activity, whether chemical, biological, or physical, relies on natural laws. But, more to the point here is that claim 20 applies certain steps to transformed cells that, as has been pointed out above, are a product of man, not of nature. The Court, in its evaluation of the Mayo method claims, found that the additional steps of those claims were not sufficient to “transform” the nature of the claims from mere expression of natural laws to patent-eligible subject matter. By definition, however, performing operations, even known types of steps, on, or to create, novel, i.e., transformed subject matter is the stuff of which most process or method invention consists. All chemical processes, for example, consist of hydrolyzing, hydrogenating, reacting, etc. In situations where the objects or results of such steps are novel and nonobvious, they should be patent-eligible. It is rare that a new reaction or method is invented; much process activity is to make new compounds or products using established processes. Thus, once one has determined that a claimed composition of matter is patent-eligible subject matter, applying various known types of procedures to it is not merely applying conventional steps to a law of nature. The transformed, man-made nature of the underlying subject matter in claim 20 makes the claim patent-eligible. The fact that the claim also includes the steps of determining the cells’ growth rates and comparing growth rates does not change the fact that the claim is based on a man-made, non-naturally occurring transformed cell—patent-eligible subject matter.

Judge Moore once more issued her lengthy concurrence.  When addressing the Prometheus opinion, she did provide her insight.  First, she believes the the Supreme Court opinion applies to composition as well as method claims.  Because it did not overrule Chakraborty and Funk Bros., however, those cases control the present appeal.  In proceeding under the rubric of those two cases, she was easily able to distinguish the isolated gene sequences from the subject matter at issue in Prometheus.

Judge Bryson reiterated his dissent that the isolated DNA sequences are not patent eligible.  He does agree, however, that he Prometheus opinion does not decide this case.

What’s Next?

Another cert. petition is almost undoubtedly in the cards as the ACLU is seeking a definitive ruling from the Supreme Court that isolated genes are not patent eligible.  Judge Lourie’s opinion was certainly a repudiation fo the Supreme Court’s unintelligible Prometheus opinion where it continued the confusion between patent eligibility and the other aspects of patentability.  It is likely that this case is heading back to the High Court for a ruling on the merits.

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6 Responses to “Federal Circuit Holds Isolated Genes to be Patentable Subject Matter – Again”

  1. silver account Says:

    Worthy of note is the Supreme Court’s rejection of the arguments by the U.S. Government. The Government argued that the claims at issue comply with §101, but may be invalid in view of §102, §103 and §112. It urged that many processes, such as igniting wood for heat, would be patent eligible in view of §101, since they involve the hand of man. However, processes like this could not actually be patented, since they would be anticipated by previous human activity. This is similar to the position of Judge Rader of the CAFC.

  2. dieta Says:

    On July 9, 2012, the US Court of Appeals for the Federal Circuit decided CLS Bank v. Alice Corp. This decision allows district courts to sidestep patent challenges based on patent eligible subject matter in favor of other patent validity challeges. The decision also prevents a computer related invention from being invalidated under Section 101 unless it is manifestly evident that the patent claims are directed to an abstract idea.

  3. Global Week in Review 22 August 2012 from IP Think Tank Says:

    [...] (Patent Docs) (Holman’s Biotech IP Blog) (Kluwer Patent Blog) (Out-Law) (IP Watch) (KEI) (Inventive Step) (Patently-O) [...]

  4. Inventive step | Platformblog Says:

    [...] Federal Circuit Holds Isolated Genes to be Patentable – Inventive Step [...]

  5. Gene Patent Fight Continues « INVENTIVE STEP Says:

    [...] Federal Circuit to reconsider the issues in light of Prometheus.  The Federal Circuit did so, but reached the same conclusion that the claims to isolated genes are patentable, claims to methods of screening cancer patients [...]

  6. Supreme Court to Review Myriad Case Again « INVENTIVE STEP Says:

    [...] Federal Circuit for reconsideration in light of that decision.  After reviewing the case again, the Federal Circuit reached the same conclusion that the isolated DNA claims are [...]

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