Government’s Rejection of call to ban patenting of genes and biological materials welcomed
Genes and Gene Technology
Avoid simple misunderstandings when it comes to the patenting DNA and their defining nucleotide sequences.
As genes are naturally occurring molecules that encode the information for producing all living organisms, their patentability has raised concerns from an ethical viewpoint. Australian patent law recognises that isolated or purified DNA and their defining nucleotide sequences are patentable inventions, which is consistent with the approach taken in many other countries. However, these purified or isolated molecules are subject to the same fundamental requirements for patentability as inventions in other areas of technology, in the sense that they must be new, non-obvious and industrially applicable. There has been excitable debate about “Gene Patenting” over the last few years – to the point where editorial and media comment has even claimed that scientists have patents covering individuals’ DNA. This is one of the many myths surrounding this topic and we urge consultation with the Institute when formulating media articles to avoid simple (but sometimes well-entrenched) misunderstandings.
Methods of Medical Treatment
Patent claims to methods of medical treatment are permitted under Australian law.
The Australian Patents Act does not exclude patenting methods of medical treatment unlike, for example, European and New Zealand Patent law. The patentability of methods of medical treatment was recently considered by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd  HCA 50 (4 December 2013). This High Court decision confirmed the patentability of methods of medical treatment of humans, in particular methods involving the administration of therapeutic drugs. The decision also provided guidance regarding contributory infringement of method of treatment claims by the supply of pharmaceutical compounds. The findings of the High Court suggest that contributory infringement may be avoided by registering pharmaceutical products for indications that are distinct to those defined in a method of treatment claim.
What is evergreening? Is it allowed under the patent system?
Evergreening is a term that describes the patenting of improvements of a previously patented pharmaceutical compound. These improvements typically involve new uses of the compound, methods for its production, crystalline forms, drug combinations, dosage regimes or re-formulations. Importantly, “evergreening” does not involve extending patent protection for a previously patented pharmaceutical compound.
Innovator pharmaceutical companies correctly point out that generic manufacturers are free to use any methods, formulations and dosage regimes disclosed in an original patent once it expires. They also emphasise that any additional” improvement patents” must meet the fundamental requirements for patentability, particularly with regard to novelty and non-obviousness, and therefore, provided these criteria are satisfied, the protection afforded to the additional inventions is warranted.
Did you hear the one about the company which patented an animal? Perhaps it wasn’t a joke after all.
Australian patent law has developed in line with some other jurisdictions, such that isolated forms of living organisms, including microorganisms, plants, fungi, animals and genetically modified organisms are patentable in Australia, subject to the usual criteria for novelty and non-obviousness. However, the Patents Act specifically prohibits the patenting of human beings and methods for their generation. Inventions that are contrary to law are also not patentable and on that basis, any invention that is contrary to legislation governing cloning, for example, would also not be entitled to patent protection.
Recent clarification by IP Australia and the courts as to the types of inventions that fall within the patentable and non-patentable categories has been helpful to practitioners but many grey areas still remain in this technologically, legally and ethically complex area.
Broadly speaking, computer software is patentable in Australia. The underlying principle is that an invention is patentable provided it results in an “artificially created state of affairs” having economic significance and it has been held that software is capable of meeting this requirement.
Software inventions are typically defined in terms of a method that can be performed by a software application, a physical system that provides the functionality of the software in question, or a medium that carries the software. There are, of course, some limitations. For example, Australian Patent Examiners tend to raise objections where an invention is thought to involve, for example, nothing more than a procedure for solving a particular type of mathematical problem.
The Australian position on patenting of software and computer implemented technology is somewhat similar to that in the United States, but is at odds with the position adopted in Europe and a number of other countries, which expressly preclude the patentability of software.
There have been two recent decisions: a Full Federal Court decision in Research Affiliates LLC v Commissioner of Patents  FCAFC 150, a single Judge decision in RPL Central Pty Ltd v Commissioner of Patents  FCA 871 (which has been appealed).
In broad terms, the Courts have identified a distinction between: (i) “computer-specific” technology (for example where an invention relates to the way in which computers are used); and (ii) cases where an invention is in substance an abstract scheme/concept which could be performed without a need for computer technology (even if that would be terribly inefficient). The former should be patentable, whereas the latter is unlikely to be patentable. Assessment is based on the substance of the invention, as opposed to the claim language itself.
When can your method of doing business be patentable?
The Australian Patents Act sets out the basic criteria that an invention must satisfy in order to be patentable. Provided a “business method” satisfies these criteria, there is no specific bar to its patentability . However, given the recent Court decisions mentioned above, patentability of business methods is limited to situations where there is an invention involving substantive use of computer technology (as opposed to an invention for which a particular implementation uses computer technology for convenience or efficiency).
Focus on the substance of an invention tends to mean that inventions relating to “business” fields (such as investment, insurance, marketing and reward programs) are heavily scrutinised, and it is crucial for a patent specification to clearly enunciate an invention in the computer technology space in addition to any novel business-level concepts.
Free Consultation Service for Aussie Inventors
Inventors and other creators of Intellectual Property are being given access to a free service involving an initial IP consultation with a Patent or Trade Mark Attorney from IPTA.