Over the course of 2012, the patent law landscape for life science companies in Australia has the potential to change quite significantly, with a number of major legislative amendments to come before Federal Parliament during this period. We discuss the most significant of these proposed changes in this article.
Raising the Bar Bill
The broadest area of change to the patent law landscape so far as life sciences companies are concerned is likely to come about as a result of the Intellectual Property Laws Amendment (Raising the Bar) Bill (Raising the Bar Bill). As we reported here more fully in September 2011, the Raising the Bar Bill, if enacted in its current form, will amend Australia's patent laws in a number of ways that are of key relevance to companies in the life sciences industries, including the below.
Experimental and regulatory exemptions to
The Patents Act 1990 (Cth) (Patents Act) currently includes a 'springboarding' provision that provides that a pharmaceutical patent is not infringed by exploitation of an invention for purposes solely in connection with obtaining regulatory approval in Australia or overseas of goods intended for therapeutic use. However, where foreign regulatory approval is sought, the pharmaceutical product cannot be exported from Australia for regulatory purposes unless the relevant patent has been granted an extension of term.
The Raising the Bar Bill proposes two new exemptions from patent infringement, which are of particular relevance to companies in the life sciences industries. Firstly, it proposes an amendment that effectively broadens the 'springboarding' provision referred to above to exempt from infringement of patents other than pharmaceutical patents the exploitation of an invention for purposes solely in connection with obtaining regulatory approval in Australia or overseas. Secondly, it proposes an experimental exemption that exempts from infringement acts done for experimental purposes relating to the subject matter of the invention. 'Experimental purposes' are defined to include determining the properties of the invention, determining the scope of a claim relating to the invention, improving or modifying the invention, determining the validity of the patent or of a claim relating to the invention, and determining whether the patent for the invention would be, or has been, infringed by the doing of an act.
Inventive step (non-obviousness)
One of the requirements for an invention to be protectable by a standard patent in Australia is that it possess an inventive step. An invention will satisfy this requirement if a person skilled in the relevant art would not, at the priority date, have considered it obvious in light of the common general knowledge in the field, together with pertinent publicly-available information. Under current law, the relevant common general knowledge is limited to that which exists in Australia and publicly available information is limited to information that the skilled person could be reasonably expected to have ascertained, understood and regarded as relevant. The Raising the Bar Bill proposes the removal of these limitations.
To be patentable in Australia, an invention must also be useful. Under current law, an invention will not satisfy this requirement if it does not work, or if it fails to deliver on the promises made in the patent specification. The Raising the Bar Bill proposes an amendment that specifies that an invention is taken not to be useful unless a specific, substantial and credible use for the invention (so far as claimed) is disclosed in the complete specification.
At present, the Patents Act requires that a complete specification 'describe the invention fully, including the best method known to the applicant of performing the invention'. The full description requirement will be met if the description enables the skilled person to produce anything falling within the scope of each claim without exercise of inventive ingenuity or undue experimentation. The Raising the Bar Bill proposes to amend the Patents Act in a manner that is intended to require the specification to enable the skilled person to produce inventions across the full scope of each claim.
Australian patent law currently requires that each claim be 'fairly based' on the matter disclosed in the specification. This requirement is satisfied if the scope of the claims is consistent with 'what the body of the specification read as a whole discloses as the invention'. The Raising the Bar Bill proposes replacing the fair basis requirement with a 'support' requirement, which is intended, in addition to requiring that there be appropriate 'basis' in the body of the specification for each claim, that the scope of the claim not exceed that which is justified by the extent of the disclosure and the technical contribution to the art that the inventor has made.
The Raising the Bar Bill was passed by the Senate on 27 February 2012 and is likely to be enacted later this year.
Implementing the Doha Declaration on compulsory licensing
At present, the Patents Act grants the Federal Court of Australia the power to grant a compulsory licence to work a patented invention in limited circumstances.
In March 2011, the Federal Government announced its intention to implement measures consistent with the Doha Declaration on a Protocol under the Agreement on Trade-Related Intellectual Property (TRIPS). Pursuant to those measures, the Federal Court of Australia will be able to grant compulsory licenses for the manufacture and export of generic copies of patented medicines to the world's least developed countries that are facing specific and prolonged health emergencies.
The Intellectual Property Laws Amendment (TRIPS Protocol Implementation) Bill implementing these measures is expected to be introduced in the 2012 autumn sitting of Federal Parliament.
Patenting biological materials
At present, the Patents Act bans the patenting of human beings and the biological processes for their generation. The Patent Amendment (Human Genes and Biological Materials) Bill initially proposed to broaden this ban to exclude the patenting of "biological materials, including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to, such materials as they exist in nature". 'Biological material' was defined to include DNA, RNA, proteins, cells and fluids.
In September 2011, the Senate Committee (Committee) reviewing these proposed amendments recommended that the Senate not pass the Bill. A number of Senators dissented from the Committee's report and recommended that the Senate pass an amended version of the Bill that would seek to ban the patenting of "biological materials, whether isolated or not and however made, which are identical to such materials as they exist in nature". 'Identical' was defined to mean structurally and functionally identical.
The Patent Amendment (Human Genes and Biological Materials) Bill is due to come back before Federal Parliament later this year.
We will continue to monitor the progress of, and report on, these, and any other, Bills that may potentially alter the patent law landscape for life science companies in a significant way.
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