Myriad Beyond The US: Patent Eligibility Of Genes In Australia, New Zealand And South East Asia

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This article was first published in the September/October 2013 issue of The Patent Lawyer Magazine http://www.patentlawyermagazine.com/myriad-beyond-united-states/

This article discusses the patent protection of isolated, naturally occurring nucleic acids in Australia, NZ and a number of South East Asian countries. In these jurisdictions there is no express exclusion of these molecules as patent eligible subject matter. This suggests that patent strategy for the protection of these molecules commonly implemented before the US Supreme Court in Myriad, should remain applicable in these countries.

Background

On June 13, 2013, Jim Greenwood, CEO of BIO stated in relation to the Supreme Court decision regarding Myriad’s patents: “The United States is now the only developed country to take such a restrictive view of patent eligibility, signalling an unjustified indifference towards our global economic and scientific leadership in the life sciences”.

So what is the legal position in developed countries other than the US? Is a naturally occurring gene, whether isolated or not, patentable eligible? That’s the question that we consider here, at least insofar as Australia, New Zealand and South East Asian countries are concerned.

Australia

The relevant legal principle regarding patentable subject matter is that subject matter that arises from artificial intervention, and that has utility in an economic state of affairs is patent eligible. 

This principle was recently applied by the Federal Court in the Australian Myriad trial1 in which the plaintiff alleged that isolated BRCA1 & BRCA2 genes are not patent eligible. The Court held to the contrary: the genes existing in isolated form were found to be patentable subject matter. The isolation of the genes was seen to be a relevant artificial intervention, and the fact that the genes were claimed in isolated form meant that what was claimed was something more than a discovery or law of nature.

The Australian Myriad decision has now been appealed, submissions have been filed by the parties and we await the outcome of the hearing. The Myriad decision of the US Supreme Court will undoubtedly be considered in the Australian appeal proceedings. However, while potentially persuasive, the Court will not be bound by the US decision.    

Speculation as to the outcome of the Australian appeal can be nothing more than that. On the one hand, apart from an exclusion of human beings and biological processes for production of them from patent eligibility (and plant and animal varieties in respect of innovation patents), there has never been an express exclusion of subject matter from patent protection in the Australian statute. On the other hand, it is clear from the recent Raising the Bar legislation that there is an intention to bring threshold for patentability more in line with the US. We see this in the context of the US -type utility test now in the Australian statute, and we wonder whether the same could be expected on the patentable subject matter ground.

New Zealand

Unlike Australia, New Zealand patent law has carved out certain types of technology that involve methods of medical treatment from patent eligibility. The most recent expression from the New Zealand Patent Office suggests that methods of diagnosis are also likely to be considered patent eligible2

Regarding the question of patent eligibility of naturally occurring nucleic acid molecules, while the relevant facts have not been considered in New Zealand, the decisions of the Australian Courts are influential in New Zealand. In the circumstances, and unless there is further amendment to the New Zealand patents Bill, it is possible that the outcome of the Australian Myriad appeal noted above will apply in New Zealand.

In the meantime, the New Zealand Patent Office will happily allow a claim directed to an isolated nucleic acid, whether or not that molecule is otherwise naturally occurring.

Singapore

The Singapore patents legislation does not expressly exclude gene related inventions from patent protection. A claim to an isolated nucleic acid having a sequence occurring in nature must otherwise be novel, non obvious, industrially applicable, not immoral and something more than a discovery.

The Patent Office explains in the examination manual that the ground of morality (an invention the publication or exploitation of which would be generally expected to encourage offensive immoral, or anti-social behaviour is not a patentable invention) is to be dealt with as it has been by the European Patent Office. In the relevant decision3, the EPO considered that while patenting human life would fall foul of the morality standard, a claim covering an isolated gene did not cover human life. It seems therefore that if the Singapore Court applies the same approach as the Patent Office, a claim to an isolated gene having a naturally occurring sequence is patent eligible subject matter.

The Singapore legislation does not exclude discoveries from patent protection although a decision of the Singapore Court of Appeal4 stated "the fact that a discovery is made does not mean there is invention". The examination manual refers to 19th century UK litigation as potentially explaining the meaning of 'discovery' likely to be applied by the Court.

In conclusion, currently there is no legal decision on patent eligibility of isolated naturally occurring nucleic acids, although it seems that the Patent Office will continue to allow these claims and there is some indication as to why the Singapore Court would follow this practice.

Malaysia, Philippines, Vietnam, Thailand & Indonesia

These countries are all signatories to the TRIPS agreement, and a close inspection of the relevant statutory provisions will reveal that each more or less contains some elements of the wording of Art. 27.3 of the TRIPS agreement, which allows signatories to the agreement to exclude patents in specific technical fields:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals, (other than non-biological and micro-biological processes).

Importantly, there are some differences in the wording of the relevant provisions in relation to exclusion of diagnostic methods. As explained in the Table below, for some countries the exclusion seems to be for a diagnostic method, (ie no matter how applied), whereas for others, diagnostic methods practiced on the human body are excluded.

Country

Provision

Text

Malaysia

s. 13(1) (d)

The following shall not be patentable: methods for the treatment of human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body. Provided that this paragraph shall not apply to products used in any such methods.

Indonesia

Art. 7 b.

A patent shall not be granted to an invention regarding: any method of examination, treatment, medication, and/or surgery applied to humans and/or animals.

Philippines

s. 22 (3)

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. This provisional shall not apply to products and composition for use in any of these methods.

Thailand

s.9 (4)

The following inventions are not protected under this Act: methods of diagnosis, treatment or cure of human and animal diseases.

Vietnam

Art. 59 (7)

The following subject matter shall not be protected as inventions: Human and animal disease prevention, diagnostic and treatment methods.

What becomes clear is that the exclusion of various forms of diagnostic methods (and as stated, therapeutic methods) from patent protection, highlights the importance of obtaining patent protection to the products of diagnostic processes, or the reagents that are used in these processes or therapeutic methods. This would seem to be the only way to monopolise a diagnostic or therapeutic method where the relevant method itself cannot be protected by patent. 

It is clear in the above Table that the relevant Malaysian and Philippine provisions do not preclude patenting of products used in diagnostic and therapeutic methods (which would seemingly leave open the potential to obtain patent protection for isolated naturally occurring gene sequences), and none of the statutes expressly state that an isolated naturally occurring gene sequences is patent ineligible. 

Having said this, many of these statutes preclude patenting of ‘discoveries’ and many contain the wording of TRIPS Art 27.2. The latter enables signatories to exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment.

Presently there is no case law on whether a claim to an isolated form of a nucleic acid is likely to take the relevant molecule outside the realm of discovery. There is an indication in the Malaysian Patent Examination Manual5 that this is likely to be so. 

Further, there is no case law on the likelihood of patent protection for an isolated form of a naturally occurring gene sequence being considered contrary to the ordre public. The Malaysian Patent Examination Manual6 identifies various examples of such subject matter, but none relate to biotechnology innovations. Further, according to the Manual: “this provision is likely to be invoked only in rare and extreme cases”.

Finally, presently  the relevant patent offices continue to allow claims directed to isolated nucleic acids having naturally occurring sequences. Given the paucity of litigation, it is too early to know whether this subject matter is patent eligible in these countries, but there are some indications that that this may be so.

  1. Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65
  2. Biosite Incorporated’s Application 532625 (P31/2007)
  3. Howard Florey Institute [Relaxin], V8/94 Relaxin, OJ EPO 6/1995
  4. Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] SGCA 39
  5. MyIPO Guidelines for Patent Examination, paragraph 3.1
  6. MyIPO Guidelines for Patent Examination, paragraph 4.1