Australia revokes Myriad’s three patent claims on isolated BRCA1 DNA

genome sequenceIn a decision issued on October 7, 2015, the High Court of Australia (High Court) ruled unanimously in D’Arcy v. Myriad Genetics Inc., [2015] HCA 35, that three BRCA1 patent claims held by Myriad Genetics, Inc. under Australian Patent 686,004 were invalid. While Myriad’s patent had actually expired on August 11, 2015, the court decision set important precedent relevant to intellectual property in genetics/omics and precision medicine.

The D’Arcy case itself, along with other litigation in the U.S. involving Myriad’s gene patents, has been discussed previously on Genomics Law Report (See generally here). Mutations in the BRCA1 gene confer increased risk of breast and ovarian cancer. The Myriad scientists were first to clone and sequence BRCA1, the gene that Mary-Claire King had linked to cancer susceptibility in a landmark paper in Science in 1990. Myriad identified several BRCA1 mutations. Myriad’s Australian Patent 686,004 contains 30 separate claims. Yvonne D’Arcy challenged the validity of the first three claims in Myriad’s patent, which claimed the isolated BRCA1 sequences with mutations conferring increased risk of breast and ovarian cancer.

At Issue
Only one patentability criterion of Section 18(1) of the Patents Act 1990 (Cth) was at issue in this case: whether Myriad’s patent claims satisfied the requirement that the invention be a “manner of manufacture within the meaning of section 6 of the Statute of Monopolies” (Patents Act 1990, S. 18(1)(a)). The other elements for patentability (i.e., novelty, inventive step, usefulness, and no secret user before priority date) were not at issue in the case. An overview of the Australian patent system is available here.

Summary of Decision
All seven justices agreed to revoke Myriad’s patent claims 1-3 for the specific isolated nucleic acids. The way they arrived at that conclusion varied, however, and there were three separate opinions. The majority focused on the specific isolated nucleic acid sequences not as compounds but as information. Two justices focused on the claims as having been drafted in a sly way such that a monopoly could be gained by disguising a process as a product. In a third opinion, the seventh justice focused on the claims being drawn not to one product but in actuality to multiple products that could not be adequately defined; thus, the claims failed as overly broad.

In the majority opinion, four justices wrestled with the court’s role in government and the appropriateness of a court weighing public policy considerations when determining whether isolated DNA is patentable subject matter under Patents Act 1990, S. 18(1)(a). According to the majority, the Full Court of the Federal Court (i.e., the intermediate appellate court) had answered the wrong question when it had sided with Myriad, intentionally excluded public policy considerations, and dismissed D’Arcy’s challenge to Myriad’s patent claims. According to the majority (¶24), the question “was not whether a claimed invention, prima facie patentable, should be denied patentability by judicial fiat” but, rather, whether a claimed invention that fell outside of the established “concept of a manner of manufacture…should nevertheless be included in the class of patentable inventions” defined by the statute.

When the Full Court had sided with Myriad and dismissed D’Arcy’s challenge Myriad’s patent claims in September 2014, it had intentionally avoided public policy reasons for the exclusion of patents for gene sequences. The High Court majority indicated that public policy considerations would have to be taken into account by the court in some instances—namely, those instances when the patent application at issue was for “unimagined technologies with unimagined characteristics and implications” (¶23). This consideration of policy would be necessary precisely because the courts are tasked by Parliament with developing patentability on a case-by-case basis using a “broad statutory concept.” (¶25) Moreover, the landmark Australian patentability case (National Research Development Corp v. Commissioner of Patents (1959) 102 CLR 252) “emphatically” rejected the establishment of an “exact verbal formula” for courts to use when determining what constitutes a “manner of manufacture” (¶20).

The High Court then enumerated six factors relevant in determining patentability in cases of novel technology(¶28). Those factors, closely paraphrased, are:

1. Whether the invention as claimed is for a product made, or a process producing an outcome, as the result of human action.
2. Whether the invention as claimed has economic utility.
3. Whether attributing patentability would be consistent with the purposes of the Patents Act 1990.
4. Whether attributing patentability to the invention as claimed would enhance or detract from the coherence of the law.
5. Whether attributing patentability would affect compliance with international law or would enhance or detract from harmonization with the patent law of other countries.
6. Whether attributing patentability to the class of invention claimed would involve law-making of a kind which should be done by the legislature.

In its analysis, the majority of the High Court bolstered its position by distinguishing what is permissible from what is mandated as patentable subject matter under the Patents Act 1990. It dismissed legislative history cited by Myriad to show that Parliament had declined opportunities to create an exclusion for gene patenting (¶36-37). The majority stated simply, “This Court is not concerned in this appeal with ‘gene patenting’ generally…The legislative history does not assist the Court in answering the question posed in this appeal” (¶37).

After providing an overview of the science and the patent specification, the High Court reviewed the primary (trial) judge’s decision (¶74-76; See (2013) 99 IPR 567) and the Full Court’s (appellate court) decision ((¶78-85; See (2014) 224 FCR 479). The majority rejected the characterization of Myriad’s patent claims 1-3 for BRCA1 isolated nucleic acid sequences as an invented product in the form of chemical compounds. Instead, the justices recognized that the “sequence can properly be described as ‘information’” (¶89) and the claimed invented product is merely “the medium in which that information resides” (¶90). By examining the “the role of genetic information in characterizing the subject matter of the claims” (¶92) and rejecting the claims as a product, the majority easily decided, citing a myriad of reasons, that the patent claim was not a “manner of manufacture.”

Justices Gageler and Nettle authored a second opinion, expressing discomfort with the Full Court’s emphasis on the patent claims’ language that treated the isolated nucleic acids for BRCA1 as chemical compounds. If the claimed sequences were viewed as chemical compounds—products—infringement could not be determined until after the accused compound had been analyzed and the specific mutations or polymorphisms subject to the patent claims were found to be present. For these two justices, this meant that the claimed invention could not be treated plausibly as a product. The justices remarked, “The way in which a claim is drafted cannot, however, transcend the reality of what is in suit…If a claim drafted as a product claim is in truth a “‘disguised’ process claim”, it will be treated as such” (¶144-145). According to these justices, “Parity of reasoning dictates that application of a method of detecting the increased likelihood of certain kinds of cancer by isolating the BRCA1 gene and comparing it to the reference sequence does not confer a monopoly over the mutated BRCA1 gene” (¶148). The justices exposed Myriad’s patent claim 1 as simply an attempted “monopoly over the right to apply long-established methods for the isolation and amplification of specific nucleotide fragments to the isolation and amplification of a patient’s naturally occurring BRCA1 gene, where and if it is found upon subsequent examination that the patient’s BRCA1 gene happened to be afflicted by any of the specified mutations and polymorphisms” (¶160).

Finally, the third opinion by Justice Gordon honed in on the patent claims as being drawn to “any and every” isolated example of the BRCA1 gene in whole or in part that contains one or more specific mutations (¶178). The opinion went back to fundamentals and focused its analysis on whether the subject matter identified in the claim was an invention at all (¶219). Justice Gordon concluded that the subject matter—the isolation of the nucleic acid along with the identified characteristic mutation or polymorphism therein—was not patentable. He advanced five reasons for this conclusion: (1) the claim is to multiple products; (2) the bounds of the claim cannot be delineated effectively by reference to chemical composition; (3) Myriad did not create or alter the identifying characteristic or code; (4) there is no idea, concept, or principle embodied in a manner of new manufacture; and (5) the claim is too broad (¶230). He was specifically troubled by the fact that there would be patent infringement if genetic sequencing or testing of any kind—even testing not directed at the BRCA1 gene or specific variants—identified a BRCA1 mutation or polymorphism included in Myriad’s Claim 1.

Implications
What is the significance of the case, given that Myriad’s Australian Patent 686,004 actually expired on August 11, 2015? Well, the case sets legal precedent that specific isolated nucleic acids are not patentable. The Australian courts will continue to develop law under the Patents Act 1990 using a case-by-case methodology. For claims involving new disruptive innovations (i.e., those “unimagined technologies with unimagined characteristics and implications”) that don’t fall squarely into an established class of products or processes, the court is likely to weigh public interests and consider the state of intellectual property law outside of Australia.

The BRCA1 gene continues to prompt public interest in genetics, and breast and ovarian cancer remains a key early target for the coming wave of precision medicine initiatives. It will be important to watch how the changed intellectual property landscape affects access to genomic information, diagnostics, and therapeutics and how the legal changes spur development of different business models.

Filed under: Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP