Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or ”Petitioner” or “ACLU”) filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit’s decision and the USPTO’s decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior briefings, the Petitioners argue that the patents issued to Respondent Myriad Genetics, Inc. et al. (“Myriad”) were erroneously issued because they claims products of nature. Petitioner also applied the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)(“Mayo”). A copy of the brief is attached [MyriadPetitionersMeritsBrief].

Petitioner’s Framing of the Facts

Petitioners start simply – “Human genes are, of course, products of nature.” They argue that Myriad did not invent any genes or variants or cause their significance. The ACLU also contends that because it is not possible to study or use the genes unless they are isolated, the patents preempt medical research and diagnostic testing. Petitioners contend that “even more disturbingly,” because the claims reach all possible uses of the claimed genes, Myriad is arguably authorized to block avenues of scientific inquiry.

Although the patent claims are directed to ”isolated DNA” the ACLU frames the issue (as does the Supreme Court) as whether human genes are patentable. Petitioners attempt to equate the “isolated DNA” of the claims with “human genes” by focusing on the similarities in the coding content of DNA and genes – the linear sequence of nucleotides that are converted to the amino acids that in combination, create proteins.

The ACLU also allege that Myriad’s patents have prevented others from sequencing and studying the isolated DNA of the claims and the clinical use of the information, and go one step further by claiming that women and their families are prevented from obtaining second opinions.

Petitioners further argue that the fact that the DNA is “isolated” is of no importance because isolated DNA is not markedly different in either structure or function from a gene in the body because the nucleotides that make up the DNA is the same. Isolation by separating the gene from other parts of the body to which it is normally attached does not distinguish the DNA from genes in the human body, according to petitioners. The claims are alleged by the ACLU to reach any ”isolated DNA” that will create the proteins naturally created by the BRCA1 and BRAC2 genes and other forms of genetic material. Although the claims recite a specific limitation to stated sequences, the ACLU argues that the claims are defined by function given to the genes in nature and not limited to any molecular structure or any particular use.

Petitioner’s Arguments 

Briefly, the ACLU urged reversal on the following grounds:

1. “Isolated DNA” is not patentable subject matter under Section 101, because isolated DNA does not have markedly different characteristics from any found in nature. As noted previously, Petitioners focused on the functional, informational nature of DNA, not the biochemical nature of genes as they occur in nature.

2. The challenged claims are not based on an “inventive concept” but instead claim products and laws of nature. Petitioners applied Mayo and prior Supreme Court precedent because nothing of significance was added to the law of nature (the isolated DNA).

3. The challenged claims are alleged to preempt uses of products and laws of nature. The Petitioners argue that because isolation (an element of the claims and the focus of the Federal Circuit’s opinion) is a necessary step in any serious study, research, or clinical or commercial use of the native DNA, the patents preempt research and development.

4. cDNA is not patentable subject matter because cDNA is, at its simplest level, identical to DNA except the non-coding regions have been removed. cDNA and DNA allegedly are not “markedly different” in function. Petitioners allege that nature, not the inventors, determined which non-coding regions to remove.

5. Petitioners also urge the Supreme Court to disregard the USPTO’s decades long practice of granting patents on isolated DNA because the PTO’s practice is “largely irrelevant.”

6. Patent claims on isolated DNA violate the First Amendment because they amount to a grant of exclusive control over a body of knowledge. The First Amendment is alleged to limit the reach of intellectual property laws because granting patents gives control over an entire body of knowledge.

What do the Patents Cover and Protect?

The legal and lay press is replete with opinions and analysis of the legal issue that will soon be addressed by the Supreme Court in this case. Many have opined on the issue and, following the ACLU’s lead, have framed the legal issue in terms of the allegedly broad scope of the claims and their possible impact on research and the delivery of health care. There is no doubt that there are likely issued patents that are overreaching and provide a monopoly that exceed the contribution that the patented invention provides to society. Whether or not the Myriad patents are within this class of patents is difficult to determine.  The patent claims were never construed by the courts thus allowing the ACLU (and Myriad too) to interpret and opine on what the claims do and do not cover. Are the patent claims without limit ? Are the claims limited by structure ? Do they unnecessarily preempt innovation? It is difficult to assess and therefore allows arguments based on “factual” premises that are, at this time, mere conjecture. 

Next step-Myriad’s response.