Getting a pharmaceutical product to market is a costly and lengthy process, and involves a high degree of development risk. The Australian pharmaceutical industry is subject to a high degree of government regulation, and the overlay of the Pharmaceutical Benefits Scheme (PBS) reimbursement regime adds a layer of complexity to commercial opportunities and pricing. This is especially the case in the current political environment where major reform of the PBS is being undertaken.
Our deep understanding of the highly competitive pharmaceutical industry and Australian and overseas regulatory regimes allows us to develop IP strategies that take into account your commercial objectives in what is a very patent-aware sector.
Our clients include local and overseas developers and manufacturers of small molecule and biological pharmaceuticals and research biotechnology companies.
IP rights are particularly important assets in this industry. Any gap in a patent portfolio is vulnerable to competitor exploitation and patent rights are vigorously enforced. Patent rights able to be obtained in Australia often differ from those in other jurisdictions. For example in Australia, it is possible to obtain patent protection for methods of medical treatment (which differs from the situation in Europe). In addition, Australia has a second tier patent, the innovation patent, which may be a useful tool in the pharmaceutical industry.
We are experienced in drafting and prosecuting patent applications to protect against infringement in commercial situations, especially in situations where patent protection may not be available in other countries. We develop patent filing and prosecution strategies to take advantage of our local law and the differences from the law in other major jurisdictions. In addition, we are experienced in advising on preparing and filing requests for extension of patent term which are available in Australia for some pharmaceutical inventions.
We are also experienced in providing patent landscaping, infringement and validity advice in relation to what can often be very complex patent portfolios associated with pharmaceutical compounds/products.
Our technical range of expertise includes:
FPA Patent Attorneys - our expertise in action
We act for an overseas-based multinational client and manage its Australian portfolio in an efficient manner, providing innovative filing strategies to take into account the intricacies of Australian practice. Where possible, we have taken advantage of differences between Australian patent law and that of the US and Europe to obtain broader and/or or stronger claims than in the US or Europe.
We act for a multinational client with a large local presence and provide freedom to operate advice which includes patent re-examination and opposition actions where required.