The Federal Circuit Court recently decided the appeal of the The Association for Medical Pathology vs. USPTO and Myriad Genetics Inc. case regarding Myriads patent on composition and method claims relating to genetic sequences of breast and Ovarian cancer cells. The standing issues are discussed in the case, filed as a declaratory judgment against the patent holder, but the issues relating to biotech are the focus of this article. The Case is of important because the Courts opinions implies what kinds of biotech compositions and methods are patentable subject matter. Specifically relating to methods claims the case suggests how the recent Bilski Supreme Court case decision will be applied by the lower courts on questions of patentable subject matter. This case is also helpful because it shows how the Court is applying the the Machine or Transformation test, discussed in Bilski to biological and chemical substances.
The Federal Circuit Court's discussion of the composition and method claims focus on Sec. 101, Patentable Subject Matter and whether the claims in the patent are patentable subject matter. Myriads' composition claims the court finds to be patentable subject matter as distinctive chemical forms not found in nature. Association for Molecular v. Myriad at 35. The method claims are, all but one, found to be ineligible for patentabilty, failing the patentable subject matter machine or transformation test, and therefore not patentable subject matter as abstract mental processes. Id. at 48.
The Composition Claims:
The composition claims in Myriad's patent are found to be patentable. The Court referred to two seminal Supreme Court cases, Chakrabarty 447 US 305, and Funk Brothers 333 US 129. The results of their discussion are that isolated DNA sequences are distinctive chemical forms not found in nature, like the oil eating bacteria in Chakrbarty. The Court found that these isolated sequences are not the same as in nature and therefore meet the minimum requirement's of Sec. 101 of Patentable subject matter. The Court exaplained that DNA in nature is not equivalent to isolated gentics sequences because in nature you have the entire genetic sequence, and the isolated genetic sequences are extractions of DNA, or small portions of the full DNA and often have introns removed so the isolated sequences is specific to the gene. Of course after meeting Sec. 101 standards to be granted a patent all other requirements of patentability must be met including usefulness, and nonobviousness . Id. at 37 - 48.
The Court noted that "We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than their functions." Id. at 45.
Method claims:
The Court found that Myriads' claims to comparing or analyzing two gene sequences are ineligible under Sec. 101, Patentable Subject Matter as abstract mental processes. The Court concluded that these fail the Machine or Transformation Test. The Machine or Transformation Test as discussed in the Bilski case is only one of the many tests that can be used to determine if a method is patent eligible subject matter. As Bilski did not fully elucidate when a method is patentable subject matter but related several tests the application of this test in the Biotech area is important to understanding how patentable subject matter will be determined in biotech and chemical cases.
The Court stated in regards to the ineligible patent subject matter that:
"The claims recite, for example, a “method for screening a tumor sample,” by “comparing” a first BRCA1 sequence from a tumor sample and a second BRCA1 sequence from a non-tumor sample, wherein a difference in sequence indicates an alteration in the tumor sample. ’001 patent claim 1. This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position." Id. at 50.
The in depth discussion of how the Court applied evidence from both parties to the application of the Machine or Transformation test is worth a read on page 49 through 53. Id. at 49- 53.
Myriad's patentable method claim involves a screening method relating to cell growth. The Court also applies the Machine or Transformation Test to the method but in this case finds the claim contains subject matter that is patent eligible. The Court's discussion of Myriad's "screening potential cancer therapeutic" explains that it passes muster because it contains transformative steps, including growing, determining, and comparing, which the Court states are central to the claimed processes. Id. at 53. The Court states:
"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." Id. at 53.
Conclusion:
The discussions of the composition claims appear to establish a bright line test that isolated genetic sequences are patent eligible subject matter. While the method claims discussion involves a much more nuanced understanding of the changing case law in method claiming and patentable subject matter.
The case does provide some concrete examples in the biotech area of methods that meet standards of patentable subject matter and those that do not. The case can help practitioners understand the best ways to claim their inventions to meet sec. 101 standards. It is also still to be determined if en banc review at the Court of Appeals for the Federal Circuit will be requested or a petition to the Supreme Court will filed. The Federal Circuit's decision in Myriad is heavily influenced by prior Supreme Court Precedent, and the Supreme Court does not usually take cases on issues that have recently been addressed by them so these factors may marshal against a successful petition to the Supreme Court. For scientists, entrepreneurs, and patent practitioners in biotech and chemical areas the Myriad case is of great importance to understanding patentable subject matter and should be scrutinized carefully.
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