As reported in my November 30th, 2012 post, the U.S. Supreme Court granted certiorari to review the issue “are human genes patentable?” The issue arises from the long-running dispute among a consortium of plaintiffs, led by the American Civil Liberties Union (collectively “ACLU”) who sued Myriad Genetics, Inc. and the Directors of the University of of Utah Research Foundation (collectively “Myriad”) challenging the patentability of composition and method claims related to human genetics. The Supreme Court’s opinion has the potential to overrule over 30 years USPTO practice that supported the growth of the U.S. biotechnology industry.

The Appealed Patent Claims

The case started when the ACLU sought a declaration that 15 claims from seven patents assigned to Myriad were drawn to patent-ineligible subject matter under 35 U.S.C. section 101. The challenged composition claims cover two isolated human genes, BRCA1 and BRCA2 (collectively “BRACA1/2? or “BRCA”) and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers.

Representative isolated DNA claims included claims 1, 2 ,and 5, of U.S. Patent No. 5,747,282 (the ’282 Patent):

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth 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.

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

SEQ ID NO:2 depicts the amino acid sequence of the BRCA1 protein. Thus, claim 1 covers any DNA coding for the polypeptide including DNA as it exists on the human chromosome, but in isolated form or separated from the human body. At the Federal Circuit, Judge Lourie (who authored the 3-judge panel opinion) determined that the key distinction between patent-ineligible DNA as it exists in the human body and patent-eligible subject matter is the separation of the DNA from the human body by the breaking of covalent bonds within the DNA.

Not all judges on the panel agreed with Judge Lourie. Judge Moore agreed with Judge Lourie but did so on the ground that holding otherwise would substantially undermine the position the government (the USPTO) has taken on this issue. Judge Moore also noted that Congress had implicitly approved the USPTO’s policy of rewarding patents on genes and DNA sequences, citing Consolidated Appropriations Act, 2004, Pub. L. No. 108-199, Sec. 634, 118 Stat. 3, 101.

Judge Bryson (the third member of the panel) disagreed with Judges Lourie and Moore. In his dissent, Judge Bryson opined that isolated DNA is similar to minerals extracted from the earth, which is indisputably not patent-eligible.

Claim 2 of the ’282 Patent relates to SEQ ID NO: 1, which depicts the nucleotide sequence of the BRCA1 DNA coding region. Isolated DNA containing only the coding sequence is colloquially referred to as cDNA. All members of the panel agreed that cDNA was patent-eligible because it is clearly man-made. cDNA is not found in nature as it is the pure coding sequence for a protein and omits DNA that does not non-coding DNA.

Claim 5 cover fragments of isolated DNA as well as full-length isolated DNA as described in claim 1. Isolated DNA fragments can be used diagnostically as probes or primers. Judge Lourie determined that isolated DNA fragments are patent-eligible for the same reason that claim 1 is patent-eligible. Judge Moore also concluded that the fragments are patent-eligible because the property of the fragments to perform as probes and primers is a function not found when DNA is in the human body. Judge Bryson disagreed with Judges Lourie and Moore and is unpatentable on the ground that the claim is too broad. He also did not give weight to the USPTO’s long standing practice of patenting this technology.

Looking Ahead for the Industry

For those who have been involved in the patenting of isolated DNA, this dispute has been somewhat odd from the start. Judge Lourie’s opinion likely expresses the view of many in the patent and biotech community – the challenged patent claims do not patent human genes. Human genes are found in the body and the process of identifying and isolating the genes from the body (no small undertaking at the time the DNA was first isolated) clearly distinguishes the claimed DNA from “human genes.” Others, such as Judge Bryson, have a different opinion. Isolation and characterization of the DNA, no matter how difficult it was to accomplish at the time the invention was made, are insufficient to convert patent-ineligible subject matter to patent-eligibility.

No matter how difficult the undertaking was at the time the BRCA1/2 DNA was isolated, technology now exists that has removed the barriers to isolating and characterizing human DNA. High-throughput sequencing and the collective work of The Human Genome Project has effectively removed the ability to claim isolated DNA of human origin because the technology fails the novelty and non-obvious requirements for patenting. Thus, if the Supreme Court limits its opinion to the question now before it – are human genes patentable? – its decision could effectively become a historical artifact, having little impact on the industry moving forward. Whole genome sequencing will likely soon be the norm for the diagnostic industry. Whole genome sequencing does not “isolate” the DNA and therefore is arguably outside the scope of the patents. Moreover, isolated DNA in combination with other technology not of human origin, such as vectors for recombinant expression of the DNA, are never found within the human body and therefore should be outside the scope of the Supreme Court’s review.