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March 14, 2016 Articles

International Conflicts over Patenting Human DNA

The High Court of Australia recently emphasized the public policy issues concerning gene patents

By Alyson L. Wooten

In D'Arcy v Myriad Genetics Inc. [2015] HCA 35, the High Court of Australia (High Court) found an isolated nucleic acid coding for specified mutations or polymorphisms of the BRCA1 gene is not patent-eligible subject matter. The case in Australia, widely viewed as the counterpart to the U.S. case Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), in which the U.S. Supreme Court also found that isolated nucleic acids are not patentable, is the subject of heated policy debate. The D'Arcy majority's heavy emphasis on public policy arguments highlights the tension between protecting and rewarding advances in biotechnology, without constraining development of new diagnostic techniques.

Issue Before the High Court

Myriad was responsible for locating the BRCA1 gene in the human genome and identifying certain mutations or polymorphisms in the BRCA1 gene indicative of a predisposition to breast cancer and ovarian cancer. Myriad's worldwide patent portfolio covered various aspects of this finding, including the isolated nucleic acid itself, probes, vectors, methods of producing mutant BRCA1 polypeptides, and various methods of diagnosis. Myriad claims that these patents cover a screening test—a blood test—to check for specific changes in genes that can help predict or determine chances of developing associated types of cancer.

This decision was on appeal from the Full Federal Court decision handed down in September 2014, which upheld the claims on isolated DNA from the BRCA1 gene. The only claims at issue were directed to the isolated nucleic acid (claims 1 to 3 of Australian Patent 686004). Claim 1 of the Myriad patent provided:

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

The only patentability criterion of section 18(1) of the Patents Act 1990 (Cth) at issue in this case was 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." The High Court made explicit that it was not considering other requirements of section 18(1), namely "novelty, inventive step, usefulness and no secret user before the priority date," but was reviewing only the Full Federal Court's decision to uphold the claims of the patent for the isolated nucleic acid.

Summary of Decision

On appeal, all seven justices of the High Court agreed to overturn the Full Federal Court's decision, and to revoke Myriad's patent claims 1 to 3 directed to specific isolated nucleic acids.

In the majority opinion, four justices of the High Court analyzed not only the science behind the patent, but also the court's role in government and the role of public policy considerations when determining patent-eligible subject matter. According to the majority, the Full Federal Court considered the wrong question in determining "whether a claimed invention, prima facie patentable, should be denied patentability by judicial fiat." Instead, the High Court found that the relevant question is whether a claimed invention that falls outside of the established "concept of a manner of manufacturer . . . should nevertheless be included in the class of patentable inventions" defined by the statute.

The leading case defining patentable subject matter in Australia is National Research Development Corp. v Commissioner of Patents, (1959) 102 CLR 252 (NRDC). In NRDC, the Full Federal Court upheld the validity of a patent for the use of previously unknown properties of a known chemical to effect a new purpose. The Full Federal Court stated that an invention is not a "manner of manufacture" unless it results in an "artificially created state of affairs" and provides a new and useful effect that is of economic significance.

The majority in D'Arcy found that although the requirements of NRDC were met, NRDC was not a formulaic test and other relevant factors must be considered. The High Court enumerated six factors relevant to determining patentability:

1. Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action.

2. Whether the invention as claimed has economic utility.

. . . .

3. Whether patentability would be consistent with the purposes of the Act[.]

. . . .

4. Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability.

5. [Whether according patentability would be consistent with]:

5.1. Australia's obligations under international law;

5.2. the patent laws of other countries.

6. Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature.

After considering the Myriad claims in light of NRDC and these factors, the majority characterized the claimed invention as "information" rather than a chemical product. The majority narrowly defined the invention as the code for the BRCA1 gene, which can be stored in various products, such as isolated DNA or cDNA. Myriad had argued that the isolation of a nucleotide sequence with the specific BRCA1 gene or mutation indicative of susceptibility to cancer gave rise to a patentable invention. The majority, however, rejected this argument, and explicitly found that none of the described differences between isolated nucleic acids and nucleic acids as present in the cell played any part in the definition of the claimed invention. While the High Court was careful to state that its decision was limited to the facts of the case, and it was not providing a broad opinion on the patentability of all isolated nucleic acids, the decision provides a framework for evaluating patentability of isolated nucleic acids and precedent for holding that specific isolated nucleic acids are not patentable in Australia.

Public Policy Considerations

The High Court's majority opinion that isolated nucleic acids are not patentable is especially noteworthy because it was driven by public policy considerations associated with allowing a patent over a gene. The Full Federal Court below had intentionally avoided public policy considerations for rejecting patents directed to gene sequences. The High Court majority, on the other hand, found this approach was erroneous, and indicated that public policy considerations must be taken into account in some circumstances, including specifically when the patent application at issue is for "unimagined technologies with unimagined characteristics and implications." The High Court found that Parliament's instruction to the courts to determine patentability on a case-by-case basis using a "broad statutory concept" mandated weighing questions of public policy:

Where an affirmative application of the concept is likely to result in the creation of important rights as against the world, to involve far-reaching questions of public policy and to affect the balance of important conflicting interest, the question must be asked whether that application is best left for legislative determination. The patentability of nucleotide sequences derived from human DNA is in that category.

In considering Myriad's claims relating to the BRCA1 gene, the High Court found that there was a real risk that the chilling effect of a patent over the gene "would lead to the creation of an exorbitant and unwarranted de facto monopoly on all methods of isolating nucleic acids containing [the gene]."

The High Court's majority opinion unmistakably signals (indeed, requires) that the courts and patent office must examine broad public policy issues when considering the limits on patent protection. This free rein to consider wide-ranging policy considerations in assessing patentable subject matter, however, introduces subjectivity and thus potential uncertainty into the law. For example, cases involving genetic material other than human DNA, or issues less emotionally fraught than cancer screening, may be weighed differently within these public policy considerations, and thus lead to arguably inconsistent results.

The High Court's analysis highlights the ongoing debate over the advisability of permitting genes used in diagnostics to be patented, for fear that such patents may constrain new diagnostic methods. In general, proponents of the validity of gene patents argue that such patents encourage investment in biotechnology and promote innovation by publicizing technological advances. Opponents argue that these patents stifle innovation by preventing others from conducting cancer research and limit options for cancer patients in seeking genetic testing. With nearly 30,000 human genes patented in the United States, this debate is by no means over, and will continue to play out in Australia and around the world.

The Myriad line of cases, which courts have addressed in the United States, Europe, and Australia, raises concerns about the potentially limiting effects of patents on further research, on the development of new tests and diagnostic methods, and on access to testing. While the considerable medical benefits of the cancer screening technology are not in dispute, views differ about how the patent system should treat such technology, if at all, and about how patents on such technology, once granted, should be exercised.

Little is known about how gene patents are being used and whether they are having a net beneficial or detrimental effect on scientific research and commercial product development. There is general agreement that patents are necessary to attract venture and risk capital, but the role of patents as a motivator for academic research is less clear. Strategies to avoid patents, such as a license, design around, or relocation of R&D offshore, are well known and commonly used. Nonetheless, the effect of these practices on research and competition are not well understood.

Time will tell how courts around the world will rise to the challenge of dealing with these issues. Very likely, the High Court of Australia's emphasis on policy concerns as an "international community" will be debated around the globe.

Keywords: litigation, intellectual property, Australia, DNA, patentable subject matter

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