The Good Oil: Patentability of Inventions using Genetic Resources and Traditional Knowledge Considered in Hood v Bush Pharmacy Pty Ltd

KunzeaKendrick Nguyen - Unsplash

Genetic and other biological resources derived from plant and animal sources have been the subject of particularly intensive research in the life sciences for the last few decades to identify innovations such as new pharmaceuticals and therapies, agriculture and industrial processes.  

The exploitation of these resources can disregard protection of traditional knowledge of the Australian Indigenous people.  In Australia, there have been no laws for the protection of traditional knowledge relating to genetic resources, indigenous skills, techniques and other indigenous knowledge relating to bush foods, medicinal plants and other genetic resources.

The Australian Patent Law generally only affords protection for information that is documented and published and to whom can be associated a particular inventor or proprietor.  This is problematic when considering the traditional knowledge of the Australian Aboriginal people who have a tradition of passing on knowledge orally between generations.

A recent decision of the Australian Federal Court in Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686 considered a patent for an essential oil derived from a type of native Australian “Tea Tree” shrub Kunzea ambigua and therapeutic uses of the oil.  

This case considered some fundamental issues such as whether an essential oil derived from a naturally occurring plant can be patented and whether therapeutic uses of the oil are subject matter for which patent protection is available.  

The Court considered evidence of the use of native plants by Australian Aboriginal people for therapeutic purposes for thousands of years.  As will be discussed in further detail below,the lack of specific evidence of Australian Aboriginal people extracting the essential oil of the particularly claimed species or of the use of the oil by them for the claimed therapeutic purposes resulted in a finding that the patent was valid.

Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686

This decision relates to patent infringement proceedings brought by Mr. Hood against numerous alleged infringers.  The infringement proceedings were combined and were heard together in 2018.

The patent claimed an invention in an essential oil derived from the native Australian shrub of the genus Kunzea (claim 1) and, in particular the species Kunzea ambigua (claim 2).

The patentee, Mr. Hood, was a farmer in north eastern Tasmania.  In 1995 he collected samples of some native shrubs growing on his farm and had them analysed by researchers at the Queen Victoria Museum in Launceston and at the University of Tasmania to determine if their essential oils may have commercial application.  

Some samples were identified as being a genus of native Australian shrub known as Kunzea ambigua, a plant in the myrtle family, Myrtaceae.  The plant is one of many that are commonly referred to as species of “Tea Tree”.  The analysis identified that the plant contained compounds including 1-8-cineole in relatively high concentrations.

The patent contained broad claims to an essential oil derived from the shrub as well as method of treatment claims in relation to the use of such an oil for various therapeutic purposes.

Mr Hood had obtained a listing on the Australian Register of Therapeutic Goods (“ARTG”) for “DUCANE KUNZEA OIL Kunzea ambigua” in 1mL/ml liquid multipurpose bottles for the following indications:

Relief of the symptoms of influenza/flu.

Temporary relief of the pain of arthritis. (or) Temporary relief of arthritic pain.

Helps relieve nervous tension,stress and mild anxiety.

Relief of muscular aches and pains.

Temporary relief of the pain of rheumatism. [or] Temporary relief of rheumatic pain.

There were multiple alleged infringers that were producing and selling Kunzea ambigua essential oils products.  One defendant, Bush Pharmacy, was a company operating on Flinders Island off the north eastern coast of Tasmania.  The company had sold Kunzea ambigua essential oil to commercial customers in Australia and overseas since about April 2016.  It did not sell product directly to consumers.

There were several other alleged infringers namely Down Under Enterprises International Pty Limited, New Directions Australia Pty Limited, Native Oils Australia Pty Ltd, Heritage Oils Pty Ltd and Julia Gay Levinson that had also been supplying Kunzea ambigua essential oil products.

The Patent

The court noted that the Mr Hood did not assert in his patent that he was the first to “discover” Kunzea ambigua.  The evidence clearly indicated that this species of plant was known.

The specification mentioned the chemical composition of the oil obtained from Kunzea ambigua based on gas chromatograph analysis with reference to examples.  The specification also discussed “trials” conducted by Mr Hood that were essentially anecdotal in nature.  There was no suggestion of any scientific trials being conducted, such as any form of randomised trial.

Novelty

The respondents produced documentary evidence that prior to Mr Hood filing his patent application essential oil had been extracted from shrubs of the genus Kunzea.  Mr Hood conceded that this evidence meant the broad essential oil claims were invalid for lack of novelty.  Nevertheless, the patentability of the method of treatment claims in relation to the use of such an oil remained a live issue.  

Manner of Manufacture

One of the main challenges to the validity of the patent was that the invention was not a manner of manufacture pursuant to Section 18(1)(a) of the Patents Act and therefore did not constitute patent eligible subject matter.  The Act does not provide a definition of manner of manufacture and so guidance on this issue is found in case law.

The Essential Oil Claims

The respondents argued that the essential oil claims did not relate to a manner of manufacture because:

a) they were “naturally occurring” and were not “made”; and

b) were for “the use of a known material in the manufacture of known articles for the purpose which its known properties make that material suitable”.  That is, at the priority date of the Patent the processes of distillation and steam distillation were known processes by which essential oils could be, or were, derived from native Australian shrubs.

In relation to the method of treatment claims, the Respondents argued that these related to a known use of a known material.  Specifically, evidence of an expert witness suggested that it was known before the priority date of the patent that essential oils obtained from various native Australian shrubs had, amongst other potential uses and applications, medicinal and therapeutic applications, including those mentioned in the claims.

Furthermore, the Respondents argued that no manner of manufacture resides in a purported invention to a mere discovery that an essential oil derived from an Australian native shrub, such as the Kunzea ambigua, may be a product and/or used in a method of treatment involving medicinal or therapeutic applications such as those mentioned in the claims.

It was acknowledged by Mr Hood that the claims to an essential oil derived from shrubs of the genus Kunzea, as claimed claims 1 to 4 of the Patent, lacked novelty and for this reason were invalid.  

Although the Court acknowledged that it was unnecessary to reach a conclusion on manner of manufacture in relation to the essential oil claims, the Court noted that the difference between the raw oil extracted from the Kunzea ambigua shrub was insufficiently artificial or different from nature then it may not qualify as patentable subject matter.  

The Method of Treatment Claims

The court affirmed the proposition enunciated by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 that methods of treatment can be patentable subject matter in Australia.

The Respondents argued that the method of treatment claims did not relate to a manner of manufacture because they were for a known use of a known material which the High Court in Commissioner of Patents v Microcell Ltd [1959] HCA 71 had stated would not qualify as eligible subject matter.

Expert evidence was adduced that essential oils are derived from between 20 to 50 native Australian plant and that about 70% of essential oils are derived from about 12 families. The evidence further suggested that prior to Mr Hood’s patent application, the genera of plants from Australia which were commonly and generally known for producing oils with therapeutic uses included a variety of native specifies including, Eucalyptus/Corymbia – Myrtaceae family, Melaleuca(“tea tree”) – Myrtaceae family and Kunzea (“tea tree”) – Myrtaceae family, to name but a few.  

However, the Court was not convinced that the evidence indicated that the essential oil derived from Kunzea ambigua had been used previously for therapeutic purposes.  Although the expert evidence showed that Australian Aboriginal people had used native plants for therapeutic purposes for thousands of years, it did not suggest that any of those treatments involved extracting the essential oil of the plants or that Kunzea ambigua had been used by them for therapeutic purposes.

Furthermore, although the essential oil of Kunzea ambigua had previously been extracted there was no evidence to suggest that there was any prior knowledge, including indigenous knowledge, that it had properties making it suitable for use in relation to ailments mentioned in Mr Hood’s patent claims.

Inventive Step

The court summarised the evidence in relation to the common general knowledge that existed before Mr Hood filed his patent application.  Essential oils from various native Australian plants, including those commonly referred to as tea tree, had been extracted and sold for claimed medical uses.

The evidence also indicated a very long history of Australian Aboriginal people using native plants for medicinal purposes.  For example, Australian Aboriginal people used tea tree by crushing the leaves to make poultices, and reports of use of species closely related to Melaleuca alternifolia for the treatment of headaches, aches and pains, colds, skin conditions and as an insect repellent.  

The traditional methods of use included crushing leaves and small branches to inhale the vapour, and soaking bruised leaves in water and then drinking it or pouring it over the body. Crushed leaves of tea trees were inhaled to treat coughs and colds or were sprinkled on wounds, after which a poultice was applied.  In addition, tea tree leaves were soaked to make an infusion to treat sore throats or skin ailments.

The Respondents noted that the expert evidence indicated extensive use of tea-tree oil for the treatment of various ailments over many decades commercially and over thousands of years of Australian Aboriginal history.  Furthermore, the evidence suggested there had been extensive research conducted on the constituents of tea-tree oil and the activity of its constituent compounds for various medical purposes.  

The Respondents argued that in light of the evidence it would have been “very plain” to a person skilled in the art that an essential oil derived from Kunzea ambigua would be likely to be suitable for use in the treatment of a range of conditions described in the method of treatment claims.

It was suggested that if a sample of the Kunzea ambigua shrub were received in a laboratory for analysis and the analysis were conducted it would be immediately apparent from its constituents that an essential oil derived from the shrub would have various therapeutic uses.  However, the Court observed that this argument by the Respondent ignored the act of Mr Hood in collecting a sample and procuring an analysis of its properties in the inventive process.  

The Court concluded that essential oil extracted from a number of plant species have been used to treat various conditions.  It was well-known that tea tree oil products produced from Melaleuca alternifolia could be used for therapeutic purposes and as a treatment for cuts and bruises, congestion, insect bites and various other ailments.  But this is not a sufficient basis for concluding that a person skilled in the art would be sufficiently motivated to analyse the essential oil derived from Kunzea ambigua in the expectation that it might well provide a useful treatment for such ailments.

Infringement  

As only the method treatment claims were found to be valid it would be necessary for Mr Hood to rely on a claim of contributory infringement pursuant to Section 117(2).  This would require Mr. Hood to establish that the various alleged infringers has supplied product to a recipient who then uses the product in a manner that infringes the patent.  

Furthermore, Mr. Hood would need to demonstrate that either the supplier had reason to believe that the recipient would put it to the claimed use, as long as the product is “not a staple commercial product”, or that the supplier has provided instructions or an inducement to use the product in an infringing manner.

The Court agreed with the respondents contention that Kunzea ambigua oil is a staple commercial product because the evidence shows it is used in the manufacture of a range of products including hair and skin care products, massage oils and for therapeutic purposes.  

Accordingly, the only option left for Mr Hood would be to establish that the alleged infringers had provided instructions or an inducement to use the essential oil in an infringing manner.

The court determined that some of the alleged infringers that supplied the essential oil to customers with advertisements or other marketing material that suggested usefulness in relation to one of the claimed methods of treatment infringed one of the method of use claims of the patent.  In particular, claim 5 which called for a method of treatment in which the essential oil is applied topically as a treatment to relieve pain, minimize bruising, or to assist in healing.

Conclusions

This decision confirms that compositions derived from indigenous species of flora or fauna can be eligible for patent protection if they are sufficiently artificial or different from nature to qualify as patentable subject matter.  Simply extracting an essential oil from a native shrub by a well known process such as steam distillation is unlikely to satisfy this requirement.  

On the other hand, methods of treatment using known compositions derived from indigenous plant species are unlikely to be considered invalid for failing to satisfy the manner of manufacture requirement.  These types of inventions are more likely to encounter a validity challenge for lack of novelty or an inventive step.

It is well known that Australian Aboriginal people have been creating and using compositions derived from indigenous species of plants for the treatment of various ailments for millennia.  Such traditional knowledge may be a relevant consideration in relation to novelty and inventive step.  

However, evidence of the specific use of a product, such as an essential oil derived from a native plant, for a particularly claimed purpose will be required for it to deprive the invention of novelty and perhaps an inventive step.  

Of course, this present a challenge where much of the knowledge and practices of Australian Aboriginal people is unrecorded and is passed on by oral tradition.

If you would like to know more about this decision or about the patentability in Australia of inventions derived from genetic resources then contact Daniel McKinley.

Further reading
About Time | TradeMark non-use dates Australia
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Are we there yet? Expediting Examination of Patents in Australia
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