Supreme Court to answer whether human genes are patentable

The Supreme Court recently granted certiorari to the highly contentious patent case focusing on the patentability of human genes. The case, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., combines challenges regarding a patent originally developed at the University of Utah. The Supreme Court unanimously disallowed a patent for evaluating a patient’s response to a drug in March 2012 in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1794 (2012). The Supreme Court has asked the Federal Circuit to review Myriad in light of Prometheus, but the Federal Circuit re-affirmed its decision upholding the patentability of the genes in dispute.

In 2009, WIPO Magazine provided this very helpful explanation of the patents under review:

BRCA-1 and BRCA-2 are two genes linked to susceptibility for breast and ovarian cancer (hence their acronyms). The risk of falling ill increases if these genes show certain mutations. Identifying the mutations is therefore important for diagnosis and for monitoring higher-risk women. Myriad Genetics Inc., in collaboration with the University of Utah, were the first to sequence the BRCA-1 gene, and applied for patent protection in 1994. Together with the University of Utah Research Foundation and the United States of America, Myriad holds U.S. patents 5747282 and 5710001 on the isolated DNA coding for a BRCA-1 polypeptide and on a screening method. In 1997, together with the Centre de Recherche du Chul in Canada and the Cancer Institute of Japan, they received patent protection on an isolated DNA sequence, asserting rights over a number of mutations in the gene (U.S. Patent 5693473). Further patent applications were filed on the second gene, BRCA-2, in the U.S. and in other countries (US Patents 5837492 and 6033857).

The Supreme Court accepted certiorari on one question: Are human genes patentable?

In framing the question, the Petitioners seeking to overturn the Federal Circuit decision introduced the issue as follows:

Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent eligible simply by removing (“isolating”) the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own.

The medical professionals pressing the case have been supported by public advocacy organizations. Among them, the ACLU has been a leader among the parties fighting the validity of the BRCA gene patents. Petitioners argue that human genes cannot be eligible for patentability because genes are ‘products of nature’ and therefore can’t be patented.” This question represents a traditional patent challenge to any gene which is merely isolated, when the patent provides no use for that isolation.

At the same time, however, many of the objections to the patent have been triggered by public frustration at the cost and restrictions on testing labs. To the extent that women are seeking to identify these markers, the Federal Circuit concluded that there is a therapeutic value in the information, which can be used for preventive surgery.

At the trial court level, the ACLU also made a First Amendment claim on the basis that genetic patents prevent research and discussion of the patented subject matter. This claim has not received support in any of the lengthy judicial proceedings.

The Supreme Court petition does not necessarily invite a discussion of the appropriateness of a patent’s role in limiting treatment resources and it is highly unlikely to delve into any First Amendment discussion. But the question whether the isolation of a human gene represents a legitimate invention rather than the identification of a product of nature will have significant implications for the pharmaceutical and bio-tech industries.

The ACLU reports that the PTO “has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented.” The Supreme Court could set significant limits on patent eligibility for human genomes or it could invite Congress to set those limits.

Congress has already taken some action. As reflected in the PTO Manual of Examining Procedure, the recent amendments to the Patent Act limit the scope of human patentability somewhat:

The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33(a), 125 Stat. 284, states:

Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.

The legislative history of the AIA includes the following statement, which sheds light on the meaning of this provision:

[T]he U.S. Patent Office has already issued patents on genes, stems cells, animals with human genes, and a host of non-biologic products used by humans, but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former, but would simply affirm the latter.[1]

The legislative history both suggests that Congress was aware of the scope of patent eligibility and expressed a desire to draw a line regarding the expansion of patent eligibility rather than to restrict that eligibility. If the Supreme Courts accepts this view, then the case will be focused squarely on the transformation of the gene from something found in nature to an invention made by the inventor.

As the Supreme Court explained, “[t]he laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.” So perhaps the simpler question could have been whether an isolated gene is closer to a newly discovered species than a newly created species. But the Supreme Court accepted the question regarding patentability of Human genes not isolated genes. So the seminal decision of Diamond v. Chakrabarty, 447 U.S. 303 (1980) which set out the current test may soon receive a new judicial gloss.

At a time when the scope of intellectual property protection is facing great political pressure, the Supreme Court action to revisit this question could have profound effects – even beyond patents to the role and scope of intellectual property more generally.

[1] 157 Cong. Rec. E1177-04 (testimony of Representative Dave Weldon previously presented in connection with the Consolidated Appropriations Act, 2004, Pub. L. No. 108-199, ‘ 634, 118 Stat. 3, 101, and later resubmitted with regard to the AIA; see 149 Cong. Rec. E2417-01). Thus, section 33(a) of the AIA codifies existing Office policy that human organisms are not patent-eligible subject matter. [Text in original MPEP Section.]


Patent Rules Being Revealed

The USPTO announced that on Tuesday, August 14, 2012, it will publish in the Federal Register final rules implementing a number of key provisions for the American Invents Act (AIA). These include

  • the inventor’s oath/declaration,
  • supplemental examination,
  • post-grant review,
  • inter partes review, and
  • covered business method review provisions.

The final rules will be available for public inspection in the Federal Register Reading Room on Monday, August 13, 2012 and available online. The inventor’s oath/declaration, supplemental examination, post-grant review, inter partes review, and covered business method review provisions become effective on September 16, 2012.

In addition, rules relating to section 6, regarding the new post-grant review proceedings affecting both ex parte and inter partes  review. Those final rules are now available here.

The USPTO authors an implementation blog which provides a great amount of information. Janet Gongola, Patent Reform Coordinator, authors the blog and most of the notices regarding the new rules.

Earlier, On July 31, 2012, the USPTO published final rules in the Federal Register implementing the statute of limitations provision for Office disciplinary actions. These final rules as seen in the Federal Register are available here: OED Statute of Limitations Final Rules.

As these regulations are published, the details of the impact of AIA begin to take shape.