IP ALERT—Federal Circuit Clears Nucleic Acid Claims But Muddies Waters on Diagnostic Method Claims in Myriad Decision
July 2011
Overview
On July 29, 2011, the US Court of Appeals for the Federal Circuit (Federal Circuit) issued its much-anticipated opinion in Myriad. The decision (formally titled Association for Molecular Pathology, et al v. United States Patent and Trademark Office, et al) restores the status quo to nucleic acid claims, but confirms that diagnostic method claims are not patent-eligible if they only recite analytical mental steps.
This decision is particularly significant to the therapeutics and diagnostics industries, because it impacts the validity of certain patent claims relating to nucleic acids and diagnostic methods that are used to detect genetic diseases.
The Decision
In its opinion, the Federal Circuit addressed two important issues for the therapeutics and diagnostics industries: i) the patent eligibility of isolated nucleic acids and ii) the patent eligibility of diagnostic methods based on correlations between genetic variations and disease.
Isolated nucleic acids. The Federal Circuit reversed the district court decision and held that isolated nucleic acid molecules have markedly different chemical structures compared to products of nature and therefore are patent-eligible even if they have the same sequences as naturally occurring nucleic acids.
The court took issue with the Department of Justice's position (in an amicus brief) that isolated nucleic acids only should be patent-eligible if they include non-naturally occurring sequences or sequence configurations. The court reasoned that the term "isolated" implies the nucleic acid has been changed from its natural state-for example, due to the cleavage of covalent bonds to isolate it from its natural genomic environment-and was therefore not a product of nature.
The Federal Circuit also gave weight to US Patent and Trademark Office guidelines and the long-standing, accepted practice of claiming "isolated" nucleic acids.
Diagnostic methods. The Federal Circuit affirmed the district court decision that diagnostic methods are not patent-eligible if they only recite mental steps such as "comparing" or "analyzing".
The court referred to the recent Bilski and Prometheus decisions and discussed the requirement for additional "transformative" steps for patent eligibility. The patent eligibility of claims that recite transformative experimental steps such as isolating, sequencing, or amplifying nucleic acids was not at issue in this case. However, the court referred to the lack of such transformative steps as one of the reasons for finding the diagnostic claims in this case to be drawn to a mental analysis and therefore unpatentable.
This suggests that diagnostic claims could be patent-eligible if they recited one or more transformative steps that are central to the purpose of the diagnostic process. However, whether the inclusion of a simple preparative step in a diagnostic claim would be sufficient to confer patent eligibility remains uncertain.
In a part of the decision that has significance for the pharmaceutical industry, the court did reverse the district court decision on drug screening claims, and held that the recitation of "inherently transformative" experimental steps such as growing cells and determining cell growth rates was sufficient to confer patent eligibility on these method claims.
What This Means to You
Claims directed to isolated nucleic acids remain patent-eligible subject matter. Therefore, patents that claim isolated nucleic acids of therapeutic or diagnostic significance will not be invalidated for lack of patent eligibility.
In addition, diagnostic method claims should still be patent-eligible if they are not limited to mental analyses. However, the Federal Circuit did not provide clear guidance on what is required for the patent eligibility of diagnostic method claims, other than indicating that such claims will have at least one transformative step that is central to the purpose of the claims.
While waiting for further guidance from the US Supreme Court in Prometheus, companies should still follow the suggestions from our previous article What to Expect from the Upcoming Decision in the Myriad Gene Patent Litigation.
Further Information
Please contact your Wolf Greenfield attorney if you would like more information about how this decision might affect your patent portfolio strategy.
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