Patents: Isolated DNA Held Not to be a “Product of Nature”

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[author: Kirsten Anderson]

Start-up biotechnology companies often seek patent protection for inventions related to their genetic discoveries and genetic testing methods. A recent United States patent case, The Association for Molecular Pathology v. United States Patent and Trademark Office (“AMP v. USPTO”),1 illustrates two issues facing biotechnology companies in showing that their claims are patentable: demonstrating that the invention is not a “product of nature” and demonstrating that a patent method claim for genetic testing is based on more than mere abstract thought processes.

Background

In AMP v. PTO, several medical organizations, researchers, genetic counselors and patients (the “Plaintiffs”) sued Myriad Genetics, Inc. as well as other defendants for declaratory relief related to Myriad’s patent composition claims and patent method claims concerning two human genes known as BRCA1 and BRCA2. Myriad had filed patent composition claims claiming to identify and isolate the BRCA1/BRCA2 genes and patent methods for genetic testing to look for the mutations associated with a higher risk of breast cancer. The Plaintiffs asserted that the isolated DNA created by Myriad was not an invention but a “product of nature” already existing in nature and therefore ineligible for patent protection. On summary judgment, the trial court (the court of first instance) agreed with the Plaintiffs, finding that the subject of each of Myriad’s patent composition claims was a “product of nature”. It also found that Myriad’s patent method claims did not demonstrate anything more than abstract thought processes for which a patent cannot be granted.

Court of Appeals Decision

In Myriad’s appeal, the United States Court of Appeals for the Federal Circuit reversed the trial court’s ruling that Myriad’s patent composition claims were invalid. The Court of Appeals affirmed the trial court’s ruling regarding Myriad’s patent method claims concerning comparing or analyzing sequences but reversed the trial court’s ruling regarding Myriad’s method claim directed to screening potential cancer therapeutics. Demonstrating the complexity of the issues involved, in addition to the majority opinion, a concurring opinion and a dissenting opinion were issued on the issue of the patent composition claims.

In the majority opinion, the Court of Appeals held that the isolated DNA molecules that were the subject of Myriad BRCA1/BRCA2 patent composition claims, were “markedly different” from the natural DNA because the isolated DNA molecules have a different chemical structure than native DNA molecules and were the isolated DNA for the BRCA1/BRCA2 were the result of human intervention and not a “product of nature”. The majority opinion held that the chemical composition of the isolated DNA was different from that of the natural DNA and that the isolated DNA did not exist independently in nature because it had to be cleaved. The concurring opinion further relied on the differing chemical composition of the isolated DNA to the native DNA.

The majority opinion also rejected the U.S. government’s argument that the isolated DNA was a product of nature because if an extremely powerful imaginary microscope existed, it would be possible to see the molecules in question. In rejecting the argument, the majority opinion reiterated that the isolated DNA did not exist independently and therefore it could not be seen even if such an imaginary microscope existed.2

The Court of Appeals affirmed the trial court with regard to Myriad’s patent method claims comparing or analyzing sequences because the court found that they claimed only abstract mental processes rather than transformative steps as Myriad would essentially compare one genetic sequence to another genetic sequence. However, the Court of Appeals reversed the trial court with regard to Myriad’s patent claim for a method to screen potential cancer therapeutics. The Court found that the claim included transformative steps such as growing transformed cells in the absence or presence of potential cancer therapeutics and measuring growth rate and thus did not involve solely abstract mental processes.

Conclusion

As some of the parties in AMP v. USPTO have indicated an intention to petition the United States Supreme Court for review, the case serves as a reminder for start-up biotechnology companies to keep these issues in mind when considering patent composition and patent method claims related to human genes.




1 2011 U.S. App. LEXIS 15649; 99 U.S.P.Q.2D (BNA) 1398
2 The United States government appeared as amicus curiae in support of the Plaintiffs’ position that the subject of the patent claims involved products of nature.


Kirsten Anderson is an associate in FMC's Vancouver office. She advises clients in general corporate and commercial transactions and also acts for clients in venture capital transactions.