The meaning of Myriad
First published in AusBiotech’s Australian Biotechnology journal, Volume 26, Number 2, Page 62-63.
Before you can qualify for patent protection in Australia, and before you need to worry about the normal requirements of novelty and inventive step, you must have an invention that falls within the categories of technology that are generally considered patentable—that is, there needs to be patentable subject matter.
The requirement for patentable subject matter is governed by subsection 18(1)(a) of the Patents Act 1990, which specifies that in order to qualify for patent protection in Australia, an invention must be a ‘manner of manufacture’ within the meaning of Section 6 of the Statute of Monopolies. The Statute of Monopolies is a United Kingdom act from 1624. While it may seem rather strange for the current Australian patent legislation to refer to a requirement under a British act from the early 17th century, this has, in fact, served Australia well because the patentable subject matter test has been flexible enough to adapt to the previously unimaginable advances in technology of the 20th and 21st centuries.
The landmark High Court of Australia decision of 1959 in National Research Development Corporation v Commissioner of Patents ( 102 CLR 252) (NRDC), which related to a method of removing weeds from a crop using a selective herbicide, gave rise to a simple test to determine when a manner of manufacture exists. In the NRDC case, the High Court determined that in order to meet the manner of manufacture requirement, an invention must relate to an artificially created state of affairs that is of economic significance. Under this test, Australia has been able to reward and incentivise innovation in a range of new areas, including internet-related technologies and biotechnology.
In October 2015, however, the High Court issued a decision in D’Arcy v Myriad Genetics Inc. ( HCA 35) (Myriad). In this dispute, breast cancer survivor Yvonne D’Arcy sought revocation of the Myriad patent claims directed to isolated nucleic acids encoding mutant or polymorphic forms of the BRCA1 polypeptide that are markers for breast cancer. The revocation action was run solely on the ground that those patent claims did not constitute a manner of manufacture and were therefore not eligible for patent protection. Ironically, other claims in the patent directed to methods of diagnosis and diagnostic kits were not challenged, with the result that whatever the outcome of the case, the commercial activities of Myriad and its licensee GTG would not be affected by the decision.
In a surprising and complex decision, the court found that although the claimed isolated nucleic acids are chemically distinct from nucleic acids that exist in nature, when properly construed, the claims in dispute related merely to information. The court went on to reason that as this information exists in nature, it was not made and therefore could not be considered a manner of manufacture. The court outlined a challenging six-step test for determining manner of manufacture in relation to new technology areas along the following lines (which unfortunately will be difficult for lower courts, practitioners and the industry to understand and apply).
Would the decision to uphold the patent to the invention as claimed:
- give rise to a large new field of monopoly protection with potentially negative effects on innovation?
- have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee?
- involve assessing important and conflicting public and private interests?
- enhance or detract from the coherence of the law relating to inherent patentability?
- be consistent or inconsistent with (1) Australia’s obligations under international law and (2) patent laws of other countries?
- best be left for the legislature?
If any of these questions are answered in the affirmative, then the claims in question do not constitute a manner of manufacture. Following the High Court decision in Myriad, IP Australia has altered its examination guidelines and has indicated that claims directed to the following subject matter will no longer be accepted:
Isolated, naturally occurring nucleic acid molecules, whether:
- DNA or RNA
- human or non-human
- coding or non-coding.
Claims to the following are excluded from patentability where they merely replicate the genetic information of a naturally occurring organism:
- complementary DNA and synthetic nucleic acids
- probes and primers
- Isolated interfering/inhibitory nucleic acids.
Claims directed to the following subject matter are still considered by IP Australia to meet the manner of manufacture requirement:
- naturally occurring isolated bacteria
- naturally occurring isolated virus
- isolated polypeptides
- synthesised or modified polypeptides
- isolated polyclonal antibodies
- monoclonal antibodies
- isolated cells
- isolated stem cells
- chemical molecules purified from natural sources
- transgene comprising naturally occurring gene sequences
- vectors, microorganisms, animals and plants comprising a transgene.
It is going to be very interesting to see how lower court judges interpret the Myriad decision. In the meantime, while the IP Australia guidelines are a relatively sensible interpretation of a very complex decision, it will take some time before the full implications of the Myriad decision are realised.