Allens: Biotech News

Allens Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.

Feature article: Methods of treating humans: an overview of patentability in various jurisdictions
Company news
BioTip: Priority Dates
Upcoming AAR event
Events

Feature article: Methods of treating humans: an overview of patentability in various jurisdictions

In brief: Partner Trevor Davies(view CV) and Technical Assistant John Landells provide a jurisdictional comparison of the patentability of methods of treating humans.

Introduction
United States
Australia
New Zealand
Europe
Summary

Introduction

The scope of patentable technologies has progressively broadened over time to encompass a very broad range of applications. A patent can be obtained for an innovation providing it meets the universal validity requirements of novelty, inventive step and usefulness. However, even if these validity requirements are met, some exclusions to patentability still exist in a number of jurisdictions.

Although international agreements, such as Trade-Related Aspects of Intellectual Property Rights (TRIPS), have largely standardized the patentability requirements throughout the world, differences still exist between countries in what technologies are specifically excluded from patentability. The United States has led the world to provide almost no exclusions to what can be patented, with Australia now following close behind. However, New Zealand and Europe provide a more conservative and internationally representative example of what technologies are typically excluded from patentability. The exclusions are of relatively narrow scope and usually concern contentious subjects such as the patenting of higher life forms or establish the general patent boundary between mere information or art and its patent worthy practical application.

Patent laws attempt to provide a balance between encouraging innovation and not unduly restricting human activity. However, one field of technology that has divided the international community is that concerning methods of treating humans to alleviate pain, illness or disease. An underlying principle or belief is that the actions of physicians in alleviating human suffering does not belong to the field of economic endeavour. This principle has translated into long-established exceptions to the patentability for claims directed to methods of treating humans from disease or illness. The US, and more recently Australia, have departed from applying such exceptions to patentability.

Return to top

United States

On enactment of the 1952 US Patents Act, Congressional reports claimed that 'anything under the sun that is made by man' was patentable in the US. The US courts ran with that dictum and broadened the scope of patentability by repeatedly overturning the United States Patent and Trademark Office (USPTO) decisions to refuse patents in new fields of technology. Apart from some rare exceptions, such as to claims encompassing human beings, there are now very few restrictions to patentability in the US.

Living organisms in the form of genetically engineered micro-organisms were first held to be patentable subject matter in Diamond v Chakrabarty 447 US 303 (1980). Following this decision, there have been no exclusions in the US to the patentability of claims directed to methods of treating humans, exemplified by the AZT/AIDS patents accepted by the USPTO in the late 1980s that included method claims covering the treatment of humans suffering from AIDS with the compound AZT. The validity of these types of method claims have also been confirmed by provisions incorporated into the US Patents Act in 1996 (35 USC 271), which provide a defence to patent infringement for licensed medical practitioners (and their institutions) for operating on humans, or on animals in human-related medical research or training. This defence is of narrow scope and does not cover the use of patented machines, substances, or biotechnology processes.

Return to top

Australia

Although there are statutory provisions in Australia excluding from patentability human beings and biological processes for their generation, there are no restrictions to claims directed to methods of treating humans or animals. The Australian position on claims directed to treating humans was established by a series of decisions following the watershed decision in NRDC (1959), including Anaesthetic Supplies v Rescare (1994) and Bristol Myers Squibb v Faulding (1998).

Return to top

New Zealand

'Method' or 'use' claims relating to the treatment of humans that involve surgery or prevention or treatment of disease are excluded from patent protection in New Zealand. The New Zealand courts have continued to embrace the principle that claims that could restrict a physician's ability to treat a patient suffering from pain, injury, disease or illness, are excluded from patentability. There are some gaps in this general exclusion, for example non-invasive diagnostic or purely cosmetic methods, such as skin and nail strengthening treatments, are patentable. There are also no restrictions on claims covering animals that clearly exclude human beings. The Intellectual Property Office of New Zealand (IPONZ) will raise an objection to a patent claim if there is any doubt over its scope in relation to this exclusion. Such objections can usually be overcome by amending any claim to clearly exclude from its scope such treatment of humans, most commonly by limiting the claim to 'in vitro' or 'non-human' methods or by amending the claim into the Swiss-style format.

The Swiss-style type claim is effectively a hybrid 'use' claim that is valuable in cases where the related open 'method' or 'use' claim would fall under the exclusion from patentability for the treatment of disease in humans. An acceptable Swiss-style claim format is of the following form:

The use of 'compound X' in the manufacture of medicament for the treatment of 'disease Y'.

A first or second medical use of a known composition (eg where a drug known to relieve pain is found to be effective against cancer) can be protected in New Zealand by the Swiss-style type claim. The second (or unknown) medical use must provide an unconnected and unexpected medical activity. The limitation in the Swiss-style claim to the 'manufacture' of the medicament provides a claim scope that is intended to capture drug manufacturers only.

In regards to Swiss-style claims, IPONZ has also recently confirmed that it will maintain its practice relating to the allowability of claims in the Swiss-style format in accordance with its practice guideline issued late last year. IPONZ will object to any Swiss-style claims that attempt to incorporate method steps, such as administration steps or dosage regimes, which are restricted under the above general exclusion. Generally, IPONZ applies a rather narrow interpretation of the allowability for Swiss-style claims. Although the courts have yet to specifically address the use of administration steps or dosage regimes within Swiss-style claims, the courts have recently shown a strong preference for protecting the physician/patient relationship from the patent system, therefore its expected that, if tested, the courts would probably adopt a rather restricted interpretation of the allowable scope of Swiss-style claims (ie being consistent with the present IPONZ guidelines).

Return to top

Europe

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are excluded from patentability under European patent law, as they are specifically regarded as not being susceptible of industrial application (Article 52(4) EPC). This provision under European patent law does not apply to products, in particular substances or compositions for use in such methods.

However, a decision of the Enlarged Board of Appeal of the European Patent Office (G 5/83 [3]) in 1984 allowed the use of Swiss-style claims, which are interpreted to cover the manufacture of the substance or composition for use in the method, not the medical treatment itself. Useful protection may therefore be obtained in Europe for methods of treatment by way of first and subsequent medical use type claims in the Swiss-style format, which appear acceptable to the courts of most of the signatory states of the European Patent Convention (EPC). Such claims may also cover novel and inventive dosage regimes for known medicaments (T1020/03). A revision of the EPC has also been proposed to specifically allow protection for such claims. The precise scope of protection Swiss-style claims afford has not yet been fully clarified, and it is possible that differences may arise between countries on consideration by their national courts.

Return to top

Summary

There are no exclusions in the US or Australia to claims directed to methods of treating humans. Method claims covering the treatment of humans by surgical and therapeutic methods are generally not patentable in New Zealand or the member states of the EPC. First and subsequent medical use claims may be protected in New Zealand and the member states of the EPC in the more limited form of the Swiss-style claim. When seeking patent protection for inventions relating to medical treatment, it is important to file appropriate claims in various jurisdictions to obtain allowable protection for the invention.

For further information please contact Dr Trevor Davies on +61 2 9230 4007.

Return to top

Company news

In brief: Regular news from the biotech industry.

APO rules in Pfizer's favour
Bionomics and SAFC Pharma sign contract to manufacture BNC105
Coreg CR^TM approved for cardiovascular disease
FDA approves Januvia^TM for Diabetes
Lilly expands biotech capabilities
Lilly to buy ICOS Corporation
Needle-free psoriasis treatment outperforms competitors
Pfizer assists WHO in search for new treatments against diseases of the developing world
Phase 3 trials demonstrate positive results for influenza vaccine
Roche and InterMune to collaborate
SEROQUEL® approved for Bipolar depression
Switzerland to purchase H5N1 vaccine
WHO nominates LAIV for key role in global pandemic action plan

APO rules in Pfizer's favour

17 October - The Austrian Patent Office (APO) has ruled that a claim in the company's basic patent covering the use of atorvastatin, the active ingredient in Lipitor, would be infringed by generic manufacturer Ranbaxy. The decision will allow Pfizer to take further legal action to prevent Ranbaxy from launching a competitor product before the expiration of Lipitor's basic patent in November 2001. Ranbaxy still has a right of appeal.