On the same day the U.S. Supreme Court entertained oral argument in Mayo Collaborative Services v. Prometheus Laboratories, Inc., (reported in our December 7th post) the American Civil Liberties Union Foundation (“ACLU”) and the Public Patent Foundation petitioned the U.S. Supreme Court on behalf of the plaintiffs (the Association for Molecular Pathology, et al.) for review of 1) whether human genes should be patented, and 2) whether persons who lack evidence of personal and direct threat of an infringement action lack standing to challenge a patent. A copy of the ACLU petition is attached.

Are Isolated Genes and Gene Fragments Patent-Eligible ?

The ACLU seeks review of the Federal Circuit’s decision that isolated genes are patent-eligible. (See our July 29th and July 31st, 2011 posts). The issue was posed simply: “Are human genes patentable?” 

The claims at issue cover two isolated genes in various forms that have an association with a predisposition to breast and ovarian cancers: BRCA1 and BRCA2. Claims 1, 2 and 5 of U.S. Patent No. 5,747,282, were identified as representative:

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 DAN of claim 1.

SEQ ID NO:1 is the nucleotide sequence of the BRCA1 coding region and SEQ ID NO:2 is the amino acid sequence of the BRCA1 protein. 

In presenting the issue to the Supreme Court, the ACLU first noted the statutory provision of Section 101 of the Patent Act which allows the patenting of any new and useful process, machine, manufacture, or composition of matter and the First Amendment of the United States Constitution, which prohibits the making of any law that prohibits the free exercise of religion or abridgment of the freedom of speech. The ACLU argued that the challenged patents are invalid under Section 101 of the Patent Act because they cover products and laws of nature and abstract ideas. In addition, because the effect of the challenged patents is to preempt scientific inquiry and medical care to the detriment of patients’ health and to scientific advancement, the patent claims violate both Article I, Section 8, Clause 8 and the First Amendment of the U.S. Constitution.

The ACLU explained that because Myriad and other similar situated pantentees contain control over genes once they have been “isolated” – that is removed from the body and other cellular material – the rest of the scientific community is prohibited from examining thousand of naturally-occurring human genes and to prevent patients’ access to their own genetic information. The practical consequence, it is argued, is that Myriad and other patent holders have the authority to stop standard clinical testing of and research on its genes.

The ACLU also took issue with the Federal Circuit’s decision, and in particular Judge Lourie’s opinion. Judge Lourie in determining that isolated genes are patent-eligible noted that isolated genes are distinguishable from genes in the body even though some of the claimed isolated genes were functionally identical to genes as they exist in the human body. Judge Lourie’s reasoning that the step of isolating DNA, which requires the breaking of covalent bonds (which distinguished the isolated DNA from naturally-occurring DNA) was argued to be erroneous because covalent bonds are also broken in genes in the human body.

Judge Moore’s concurrence-in-part was noted for her opinion that both structure and function were relevant in determining if a composition is markedly different from what is found in nature, even if she ultimately sided with Judge Lourie, albeit on slightly different grounds.

Judge Dyk’s dissent that genes were not patent-eligible was relied on by the ACLU as the appropriate reasoning for the issue. Judge Dyk opined that the structural differences between the isolated gene or fragment and its naturally occurring counterpart is irrelevant to: the claim limitations, to the functioning of the genes, and to their utility in their isolated forms. The ACLU also relied upon Judge Dyk’s statement that deference to the PTO and its prior practice of patenting genes should be not be entitled to significant weight because the courts, not the PTO, have ultimate authority to determine what is patentable.

Reasons for Granting the Writ

     1.  The Issue is of Importance to the Future of Patent Law and the Advancement of Science

The ACLU argued that the divergent opinions and holdings by the District Court, the Federal Circuit judges of the panel and the US PTO  indicates that the legal community needs guidance from the Supreme Court regarding the scope of Section 101 of the Patent Act as it applies to compositions of matter and DNA. Petitioners also found issue with the Federal Ciruit’s reasoning that cDNA is patent-eligible because it is mostly man-made opining that cDNA can be naturally-occurring since it can be found in the human body.

The ACLU repeated its policy argument that patients are harmed by gene patents  because patients cannot obtain second opinions. Gene patents also are alleged to prevent advances in science and medicine because further research is prevented and Myriad has not shared its research.

     2.  Patents on Isolated DNA are Invalid under Section 101 and the US Constitution

The Federal Circuit are alleged to have departed from Supreme Court jurisprudence, noting Chakrabarty, Funk Brothers, and American Fruit Growers. These cases, it is alleged, held that a claimed composition does not become patentable simply because there has been a change in its structure, as the opinion of Judge Lourie had concluded. 

Relying on language found in Chakrabarty, the ACLU stated that the proper test is whether the claimed composition has a distinctive, name, character and use, and markedly different characteristics from any found in nature. The claims themselves, the ACLU argued, define the claimed subject matter by its naturally-occurring functional characteristic – namely the coding for a naturally-occurring polypeptides. It is the function of the nucleic acid, namely to convey information, is the same whether the DNA is isolated or not. 

The ACLU also criticized Judge Lourie’s focus on the chemical nature of DNA rather than its biological characteristics. The failure to consider the biological characteristic was allegedly erroneous because the claims themselves recite biological language (coding for a polypeptide) and Supreme Court precedence that function is a critical factor for determining whether something is patentable under Section 101.

Judge Moore’s concurring opinion that for example, short sequences of DNA were patent-eligible because of their new functions as probes or primers, was also alleged to fall short because even these involve the patenting of a product of nature and therefore would preempt researchers from working with that segment of DNA.

The patenting of genes also is an alleged violation of the First Amendment because the patents block a patient’s access to their own genetic information and deprive others from examining the genes and engaging in fundamental scientific work.

     3.  The Federal Circuit’s Holding on Standing is Erroneous

The Federal Ciruit’s holding that at least Dr. Ostrer had standing to bring the suit was challenged. The Federal Circuit had held standing was present because Dr. Ostrer had alleged an intention to actually and immediately engage in allegedly infringing activity while other plaintiffs had merely alleged that they would “consider” engaging in relevant testing. This alleged “new test” warranted Supreme Court review as it is argued to be contrary to the Supreme Court’s prior MedImmune test.  Briefly, the MedImmune test is “whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. ”

What Lies Ahead ?

Per Hal Wegner, the decision whether to grant certiorari will be made by the court in Winter of 2012 and if granted, the case would be argued in the October 2012 term of the Court. TopTen2011Dec8

The issue of whether genes, and by analogy other products of nature should be patent-eligible is of great importance not only to companion diagnostic companies involved in personalized medicine like Myriad, but also to the biotechnology and pharmaceutical industry at large. Indeed, it could have a greater impact on the pharmaceutical and biotechnology industries than the Supreme Court’s Prometheus decision which is addressing the patent-eligibility of medical diagnostic methods.

Isolated genes and gene fragments are utilized for the recombinant product of biologics and therapeutic drugs. Similar to isolated genes, many isolated stem cells also exist in nature. Recombinant products such as proteins and isolated stem cells each have overlapping biological characteristics with those in the body. Taking these technologies from the lab to the patient require significant post-discovery research and investment and removing patents as a means to recoup these costs could reduce  investment to the detriment of patient health. Moreover, small businesses and start-ups could be disproportionately affected by removing patent protection from these technologies since they are more dependent on third-party investments to bring their therapies from the bench to the bedside.