Summary
In a unanimous decision by seven Judges of Australia’s High Court (the highest appeal court), patent claims for isolated BRCA1 nucleic acids, indicative of a predisposition to breast or ovarian cancer, were ruled not to be patentable subject matter (not directed to a “manner of manufacture”). Consequently: (1) Australian patent claims for isolated nucleic acids directed to “genetic information” found in nature are likely to be invalid (even if isolated); (2) pending Australian applications containing such claims are likely to be rejected; (3) the Australian Patent Office is now preparing new examination guidelines for gene patents; and (4) the decision sets a precedent for the courts and Patent Office to apply a new approach when considering whether a claimed invention is a “manner of manufacture”.
Any Australian gene application or patent of commercial importance should be reviewed in view of the High Court decision and, if necessary, amended to include patent eligible claims.
The High Court decision can be found here: D’Arcy v Myriad Genetics Inc [2015] HCA 35.
Background
Myriad Genetics Inc.’s Australian Patent No. 686004 (“the Patent”) has claims to isolated BRCA1 nucleic acids (claims 1 to 3), nucleic acid probes, cloning and expression vectors, transformed host cells, BRCA1 polypeptides, their preparation and uses, and methods of diagnosis. Only the claims to isolated mutant or polymorphic BRCA1 nucleic acids (“the Claims”) were challenged by Yvonne D’Arcy (a cancer survivor). Interestingly, the Patent expired earlier this year.
Claim 1 of the Patent reads as follows:
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, 12 A and 14 and the polymorphisms set forth in Tables 18 and 19.
The leading case on what constitutes patentable subject matter in Australia to date has been National Research Development Corporation v Commissioner of Patents [1959] HCA 67; (1959) 102 CLR 252 (“NRDC”).
Previously, five Judges of the Full Federal Court of Australia had applied NRDC to the Claims of the Patent and concluded that:
“The isolated nucleic acid, including cDNA, had resulted in an artificially created state of affairs for economic benefit. The claimed product is properly the subject of letters patent. The claim is to an invention within the meaning of section 18 (1) of the [Patents] Act.”
The sole issue before the High Court was whether the Claims were for a “manner of manufacture” as required under section 18(1)(a) of the Patents Act 1990.
The Decision
In the majority decision by four Judges it was stated: “This Court is not concerned in this appeal with “gene patenting” generally, but with whether the invention as claimed in claims 1 to 3 falls within established applications of the concept of manner of manufacture.”
Those Judges concluded that the essential element of the Claims was the “genetic information” rather than a nucleic acid product per se, and that the same information occurred naturally and was not something“artificially created”. In view of this, the subject matter of the Claims was found to lie outside the established NRDC-concept for “manner of manufacture” and different factors for patent eligibility applied.
Factors for patent eligibility included: 1. whether patentability would be consistent with the purposes of the Patents Act; 2. whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability; 3. relevancy to Australia’s place in the international community of nations; and, 4. 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 these factors, the Judges concluded that the subject matter of the Claims did not meet the “manner of manufacture” requirement. In particular, it was reasoned: under point 1, “It follows that the purpose of the Act would not be served by according patentability to a class of claims which by their very nature lack well-defined boundaries or have negative or chilling effects on innovation…”; under point 2, that patentability was not required to achieve coherence in Australian law; under point 3, that Australia would not breach its international legal obligations by failing to accord patentability; and, in relation to 4, “The legislative history cannot be read as impliedly mandating the patentability of claims for inventions relating to isolated nucleic acids coding for particular polypeptides.”
In the two minority decisions, the respective Judges concluded, amongst other things, that the subject matter of the Claims was not sufficiently artificial/different from nature to be regarded as patentable, particularly since gene isolation and testing methods were routine in the art. It was stated: “the BRCA1 gene is not patentable as such because it is a naturally occurring phenomena which lacks the quality of inventiveness necessary to qualify as a manner of new manufacture.”
Conclusions
1. This High Court decision sets a precedent for the courts and Australian Patent Office to apply a new approach when considering whether a claimed invention is a “manner of manufacture”.
In relation to gene patents, if genetic information is deemed to be the sole essential element of a claim to an isolated nucleic acid and that genetic information occurs naturally or, put another way, if the isolated nucleic acid has a sequence that is naturally occurring, then the claim is unlikely to be patentable/valid. According to the decision, this includes a synthetic molecule such as cDNA. The decision could equally apply to other types of nucleic acids containing “information”, such as ribonucleic acids (eg. microRNA and small interfering RNA).
Although the new approach was applied to isolated nucleic acids in this instance, the approach could possibly be applied by the courts and Patent Office to other types of inventions, including other types of natural products and natural phenomena (eg. polypeptides, antibodies, biologics, micro-organisms and stems cells) as well as non-biological inventions (eg. computer-implemented inventions and business methods).
Just possibly, “natural phenomena” could include new dosage regimes using known therapeutics for known indications. However, it is too early to tell how the courts and Patent Office will apply the High Court’s ruling.
It is unlikely that the decision will affect claims directed to novel and inventive uses of genes, gene products and other types of natural products, including diagnostic and therapeutic applications. It is also unlikely that the decision will affect “inventive” molecules that differ from nature.
Of note, the Patent did contain claims to polypeptides (which would be identical in sequence to those found in nature), but these were not challenged in the Federal nor High Courts. Also of note, in the minority decisions the Judges commented, in obiter, that diagnostic methods and probes were potentially patentable
subject matter.
2. The claims of many granted Australian gene patents are likely to be found invalid if tested in the courts or re-examined by the Australian Patent Office.
It is not known whether the Australian Patent Office will now re-examine granted gene patents of its own accord. Note that under Australian law, should one claim of a patent be revoked, it does not necessarily follow that all claims of the patent will be revoked and rendered unenforceable.
The Patent Office has begun holding applications claiming genes in abeyance. It is also likely to re-examine recently accepted applications and revoke acceptances, if necessary.
3. The Patent Office has already begun preparing new examination guidelines for gene patents. It is not known whether those guidelines will be directed to gene patents only or to claims directed more generally to natural products and natural phenomena.
Australia is now more closely aligned with the gene patenting position in the U.S. Since the High Court looked to the U.S. Supreme Court decision of Assoc. for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S. ___ (2013) for guidance and, in fact, adopted some of that Court’s reasoning, it is possible that the Australian Patent Office will also look to the USPTO for its “Myriad-Mayo Guidance”, on how examiners should analyse claims involving “Laws of Nature/Natural Principles, Natural Phenomena or Natural Products.” Having said that, the High Court did not look to Mayo v. Prometheus, 566 U.S. ___ (2012) for guidance, so that may be a long bow to draw.
Recommendations
Any Australian gene patent of commercial importance should be reviewed in view of the High Court decision. If necessary,
post-grant amendments can be made in a relatively straightforward and inexpensive manner, provided that claim broadening is not sought. That is, the amendments must fall within the scope of the claims as granted.
Pending applications containing claims to genes should be reviewed to ensure that the claim set contains claims directed to patentable subject matter. If necessary, voluntary amendments can be made in a relatively straightforward and inexpensive manner prior to or after examination has commenced. As with post-grant amendments, amendments to accepted applications cannot be claim broadening. However, in some instances a timely divisional application may be filed if claims of greater or differing scope are required.
Pending applications containing claims directed to natural products should likewise be reviewed in the event that Patent Office policy changes in due course. Such applications should, if possible, include claims directed to inventive uses.