Features
This issue of Biotech News contains two feature articles relating to biotech patent issues. The first discusses Astra's successful High Court appeal last week on the 'obviousness' of its Losec patent. The second summarises the current status of general issues arising in the patentability of medical treatments.
Australian High Court allows Astra's Losec patent appeal
In brief: Cynthia Cochrane and Michael Dowling review the recently-decided case of Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59 ('Losec').
Facts
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Aktiebolaget Hässle (Astra ) owns the patent. Astra manufactures and sells the product Losec formulated in tablet form as claimed by the patent.
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The invention involves a combination of integers that interact with each other. There is a 'core material' (the active ingredient), a 'subcoating layer' and an 'outer enteric coating'.
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The invention solves the problems of preventing the active form becoming unstable during storage and of getting the active to the site in the intestine where its activity is required. This is achieved through the combination of coatings.
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Alphapharm (a generic drug manufacturer) moved the court to revoke the patent on the ground that it was invalid for obviousness (ie no inventive step).
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Alphapharm succeeded at trial and in the Full Federal Court.
On Thursday 12 December, 2002, the High Court of Australia ruled by majority 5-2 that the courts below had asked wrong questions on obviousness. They found that if the right question was asked, the invention was not obvious.
The HCA's directions on the test of obviousness
There is no single formula for obviousness. However, 'obvious' means 'very plain' for the non-inventive Person Skilled in the Art (PSA) given the relevant prior art.
[For 1952 Act patents, obviousness is assessed against prior disclosures shown to be part of Common General Knowledge' (CGK ). This was broadened for 1990 Act patents to include single or connected documents not within the CGK but which are publicly available in Australia and which the skilled person would be reasonably expected to locate. This was further expanded by the 2001 Act to include information in written publications anywhere in the world and oral disclosures or use in Australia.]
The terms 'worth a try' or 'obvious to try' beg the question that the statute asks, as do lines of inquiry in relation to those terms (which the Federal Court took).
First step, define the invention. Here it was the combination of the three elements. The ingenuity of that combination was the issue, not whether one or more of the integers taken individually was routine. Then, the appropriate question is - given the problem and the relevant prior art, would the PSA directly be led as a matter of course to try the subject in issue in the expectation that it might well produce a solution to the problem?
Comment
To be so led to try the subject in issue, the PSA has to see the solution itself and have the requisite degree of expectation that trying that concept will succeed.
The Court put the 'trying by routine steps' approach to the sword in various ways. In one of those, it pointed out that a course of action which is complex, detailed, laborious and with a good deal of trial and error, with dead ends and retracing of steps, is not the taking of 'routine steps' to which the hypothetical PSA would be taken as a matter of course.
For further advice, please contact Michael Dowling on +61 3 9613 8743
Patentability of methods of medical treatment
In brief: Lawyer Clare Cunliffe discusses the Australian approach to the patentability of methods of medical treatment.
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History
- Judicial Consideration
- The practice of the Australian Patent Office
- Rescare
- Bristol Myers Squibb - Implications
Australian patent law provides considerable incentive for medical research and development. Like the United States but in contrast with more conservative jurisdictions such as New Zealand and Europe, Australia recognises that methods of treatment of the human body should be patentable. This move, led by the Patent Office and affirmed by the Courts, provides protection for innovators in medical research, whether their inventions relate to methods of medical treatment or products suitable for treatment regimes. Businesses and individuals engaged in medical research and development in Australia can proceed confident that valuable intellectual property can be fully protected.
History
Judicial consideration
It is now well established that products for medical treatment should be patentable. For a long time, however, the patentability of methods of medical treatment was more uncertain. Between the 1930s and 1994, Australian Courts touched on the issue, but only in passing. Some members of the legal and medical community thought methods of medical treatment should not be patentable, as this would be contrary to the public interest. It was not until recently that this issue was determined finally.
The practice of the Australian Patent Office
Despite judicial suggestion to the contrary over the years, the patentability of methods of medical treatment has been accepted by the Australian Patent Office since the early 1970s. The Manual of Practice and Procedure of the Patent Office states:
The Patent Office is obliged to accept patents unless these are clearly invalid... Since there is no clear precedent to find that methods of medical treatment are invalid, the Patent Office will continue its long standing practice of accepting claims to methods of treatment.
Rescare
The issue of whether a method of treatment of the human body was patentable was considered in 1994 by the Full Bench of the Federal Court in Anaesthetic Supplies Pty Ltd v Rescare Ltd (Rescare), a case concerning a patent for the treatment of sleep apnoea. The applicants in Rescare challenged the patent on a number of grounds, including that methods of medical treatment of the human body should not be patented.
Although the patent was found to be invalid on other grounds, the Court held that there was no justification in law, logic or principle why a method of treatment of the human body was not a manner of manufacture and therefore a proper subject for a patent. The judges were influenced by Parliament's failure to enact a legislative prohibition against patenting methods of medical treatment, although patenting human beings and the biological processes for their generation was prohibited. The Court also noted that the Patent Office as a matter of practice regularly granted patents of this kind, seemingly without detriment to the public. The Court concluded as a matter of policy that innovators of medical treatment should be rewarded for their endeavours.
Bristol Myers Squibb
As the Full Bench unanimously ruled that the patent in Rescare was invalid on other grounds, the views expressed on the patentability of methods of medical treatment were not necessarily binding on later Court decisions. The issue of the patentability of methods of medical treatment was decided in 2000 by the Full Bench of the Federal Court on appeal in Bristol-Myers Squibb v F H Faulding Co Ltd (BMS), regarding a patent for a new method of using a known anti-cancer drug, Taxol.
All judges affirmed that methods of medical treatment are not invalid as being generally inconvenient. The judges' conclusion was influenced by two considerations:
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The perceived logical inconsistency of allowing patentability of products for medical treatment but denying patentability for methods of medical treatment; and
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The fact that Parliament chose not to prohibit patents for methods of medical treatment when drafting the Patents Act 1990 .
The decision in BMS firmly established that methods of medical treatment are patentable subject matter in Australia and provided clear support for the existing practice of the Patent Office in granting these patents.
Implications
The BMS decision did not change the status quo for prospective patentees, given the Patent Office practice of granting patents of this kind. It confirmed that Australia, like the US, recognises the need to reward innovators in the medical field consistently.
Businesses and individuals in the medical field should take note of the following considerations in relation to the availability of patent protection for medical methods in Australia:
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Protect your IP: The Courts have recognised the economic value in medical treatment and the need to reward innovators. Accordingly, if you are developing new methods of medical treatment, you should take steps to protect those methods so that you can fully reap the rewards of your innovation.
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Be aware of third party rights: The field of medical research and development is moving at a rapid pace and information is readily available on new advances. If you are considering adopting methods of medical treatment developed by others, enquiries should be made as to whether those methods are subject to patent protection. If so, it is prudent to seek approval for use of those methods to prevent any risk of unauthorised use of third party rights.
For further information, please contact Trevor
Davies on
+61 2 9230 4007.
