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
There is presently no bar in Australia to obtaining patent claims relating to methods of medical treatment.
The Australian Patents Act does not exclude patenting methods of medical treatment. As a matter of practice, the Patent Office currently accepts claims of this type unlike, for example, the European and New Zealand Patent Offices.
Over the years, concerns have been raised as to whether it is in the public interest to potentially preclude a medical practitioner from treating a patient in the best manner available. It is also unclear whether “contributory infringement” applies to such a method which, when carried out, does not result in a “product”. However, while debates around these issues are likely to continue, there is presently no bar in Australia to obtaining patent claims directed toward methods of medical treatment.
What is evergreening? Is it allowed under the patent system?
Evergreening is a term that now includes the process by which patent protection for (typically) a pharmaceutical compound is extended by patenting improvements over the original active compound, such as new uses of the compound, methods for its production, crystalline forms, drug combinations, dosage regimes or re-formulations.
It is sometimes argued by generic manufacturers that even though these additional patents may be vulnerable to attack, challenging them can be prohibitively time-consuming and expensive, causing delays in the entry of their (cheaper) products to the market.
The innovator pharmaceutical companies argue, however, that the generic manufacturers are free to use any methods, formulations and dosage regimes disclosed in the original patent once it expires. They also emphasise that any additional patents must in any event 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.
The patent system has evolved to encourage innovators to seek patent protection on the proviso that the innovator discloses the best method of performing the invention so that others are free to fully use the invention when patent rights expire. On that basis, there is a good argument that encouraging innovators to disclose their inventions is generally desirable, as it allows others to use that information to further develop the technology.
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.
Software and pesticide have more in common than you might think, when it comes to patents.
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 is 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.
Much of the debate surrounding the patentability of software mirrors that which occurred with the protection of pesticide use by the agricultural industry. Decades later, thanks to their patentability, the agricultural chemical industry is seen as having been responsible for many breakthroughs that have (arguably) saved the agricultural industry millions of dollars via well-protected crops.
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 .
In a recent Federal Court decision, Grant v Commissioner of Patents  FCAFC 120, the patentability of business methods was considered at length. It was held that: “it is necessary that there be some ‘useful product’, some physical phenomenon or effect resulting from the working of a method for it to be properly the subject of letters patent”.
Generally speaking, the Patent Office tends to look favourably on computer implemented methods. However, methods that are carried out in absence of any particular technological framework or tangible output are more heavily scrutinised.
By way of comparison, the Australian position is similar to, although perhaps less liberal than, that of the United States of America. In contrast, the UK and Europe have generally excluded business methods from patentability.
In the US, patentable subject matter has historically included “anything under the sun made by man” and the US courts have held that business methods are not inherently unpatentable. Over the past few years, there have been an ever-increasing number of business method patents granted in the US. However, more recently, there has been growing criticism regarding some of these, and a significant court ruling on the patentability of business methods in the US is expected later in 2008.
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.