In Myriad Genetics, Inc., (decided June 13, 2013), the Supreme Court held that genes and the information that they encode are not patent subject matter under section 101, even when such genes have been isolated from the surrounding genetic material.  The claims at issue were the following:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.

The Court construed this claim to mean to mean the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO: 2. 

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO: 1.

The Court construed this claim to mean the isolated DNA of claim 1 which has the nuecleotide sequence of SEQ ID NO: 1 which in theis instance was the sequence of cDNA that codes for the BRCA1 mino acids listed in claim 1. Important, SEQ ID NO:1 lists only the cDNA exons in the BRCA1 gene, rather than a full DNA sequence containing both exons and introns. This was a very important point according to the Court.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

The Court construed this claim to mean a subset of data in claim 1. In particular, it claims an isolated DNA having at least 15 nucleotides of the DNA of claim 1. The Court stated that the practical effect of claim 5 is to assert a patent on any series of 15 nucleotides that exists in the typical BRCA1 gene. and that because the BRCA1 gene is thousands of nuceotides long, even BRCA1 genes with substantial mutations are likely to contain at least one segment of 15 nucleotides that correspond to the typical BRCA1 gene.

6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2. 

In formulating its decision, the Court noted that groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the section 101 inquiry. 

Importantly and as noted above with respect to claim 2, the Court states that cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments because a cDNA sequence from mRNA results in an exons only molecule that is not naturally occurring. 

The Court also emphasized that the decision did not effect claims to DNA in which the order of the naturally occurring nucleotides has been altered. 

Method Claims

The Court noted that its decision did not apply to the method claims in the patent.  Accordingly, one needs to look to the earlier Federal Court of August 16, 2013 decision on the method claims. The Federal Court in that earlier decision held two of Myriad claims invalid but one valid. I will now turn to a short analysis of these calims. 

The key words which appear to be prohibited by the Federal Court according to the Myriad decision of the Federal Court are Analyzing or Comparing. This is pointed out by the court from the representative claims (claim 1) below from of the ’999 and ’001 patents.

1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set froth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made form mRNA form said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-487 of SEQ ID NO: 1″

1. A method for screening a tumor sample form a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises comparing a first sequence selected from the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made form mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene form a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made form mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample form the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic lateration in the BRCA1 gene in said tumor sample.

In holding the first claim above patent ineligible, the Court noted that the claim recites nothing more than the abstract mental steps necessary to compare 2 different nucleotide sequences: one looks at the first position in a first sequence; determines the nucleotide sequence at that first position; looks at the first position in a 2nd sequence; determines the nucleotide sequence at that first position; determines 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 alteration; and repeats the process for the next position. The step of comparing 2 DNA sequences is the entire process that is claimed and is invalid under section 101 according to the Supreme Court’s Mayo decision.

The second representative claim 1 above was even worse according to the court in that it did not even contain a step of “determining” the sequence of BRCA genes by, e.g., isolating the genes form a blood sample and sequencing them or any other putatively transformative step. Rather, the comparison between the two sequences can be accomplished by mere inspection alone.

The final representative method claim (claim 20) from the ’282 patent, however, was different.

20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

In holding claim 20 patent eligible, the Court pointed out that the claim does more than simply apply a law of nature. It applies certain steps to transformed cells which are a product of man, not of nature. Additionally, the claim does not cover all cells, all compounds, or all methods of determining the therapeutic effect of a compound. Rather, it is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic.