As a preview to some of the issues that will be discussed in our upcoming 9th Annual Pharmaceutical Law, Reform & Regulation Conference, we spoke with Grant Shoebridge, a Principal with Shelston IP to discuss the current issues surrounding patent law and the pharmaceutical industry.
As a Principal with Shelston IP with a decade of experience in pharmaceutical and biotechnology-related intellectual property, can you tell us about your work?
I specialise in drafting patent specifications, prosecution and patent opposition matters relating to molecular biology, cell biology, immunology, pharmaceuticals, medical devices, agricultural technology, and diagnostic technology. I also have particular expertise in securing extensions of term on pharmaceutical patents, advising on patent validity and infringement, and Federal Court litigation matters.
An issue that I am passionate about is the patentability of subject matter derived from the natural world. This type of technology is typically covered in so-called “gene patents”. I have followed and been involved in the gene patent debate since about 2008 when a Senate Inquiry was set up to investigate the patentability of genes and other biological material. Since that time I have made numerous TV, radio and print media appearances. I was also involved in the Institute of Patent and Trademark Attorneys of Australia application to be heard as amicus curiae in the High Court appeal in D’Arcy v Myriad Genetics.
I also enjoy teaching and from 2010 to 2013, I was a lecturer for “Interpretation and Validity of Patent Specifications” which is part of the University of Technology, Sydney postgraduate law program, and the Masters in Intellectual Property, which provides a pathway to registration for Australian patent attorneys. I am currently a lecturer for the University of NSW course “Myths and Realities of Personalised Medicine: The Genetic Revolution”.
At the upcoming Summit you are planning to discuss the implications that could arise from the Myriad High Court “Gene Patent” Decision. Could you tell us about the case, and it’s significance to the patentability of pharmaceutical compositions?
In the Myriad decision, (D’Arcy v Myriad Genetics Inc. & Anor  HCA35) the High Court ruled against the patentability of isolated naturally-occurring genes, useful for determining susceptibility to breast and ovarian cancer. This decision was interpreted by the Patent Office narrowly, in their revised examination practice guidelines, as applying only to isolated naturally-occurring nucleic acid sequences or isolated nucleic acid sequences that convey or embody the same “genetic information” as naturally-occurring nucleic acid sequences, for example cDNA. Those opposed to “gene patents” were surprised and disappointed that the Patent Office did not interpret the Myriad decision as excluding from patentability all isolated naturally-occurring molecules/materials, such as proteins and micro-organisms. This was the result in the corresponding US Myriad decision.
The Myriad decision is relevant for the pharmaceutical industry in Australia because it is currently impacting the patentability of pharmaceutical compositions comprising nucleic acid sequences. These compositions include DNA vaccines and interfering RNA molecules, capable of attenuating the expression of a target protein. As pharmaceuticals, interfering RNA molecules are capable of treating diseases such as inflammation and cancer. Relevantly, the Patent Office recently held a hearing in relation to the patentability of interfering RNA pharmaceutical compositions. A decision is expected within three months and will determine whether interfering RNA pharmaceutical compositions are patentable in Australia.
The other important aspect of the Myriad decision for the pharmaceutical industry in Australia is that at some point claims defining isolated naturally-occurring material other than a nucleic acid sequence will be challenged on the basis of the Myriad decision. Because the Myriad decision is somewhat ambiguous, it will be interesting to see how the Federal Court interprets the decision. As such, it will be some time before the full ramifications of the Myriad decision for pharmaceutical patentability are known.
The Productivity Commission recently released a draft report on intellectual property arrangements. What are your thoughts on this report’s potential impact on pharmaceutical patents?
The draft report recognises that research and development costs and times in relation to bringing pharmaceutical products to market are significant. This clearly supports a case for the patent protection of pharmaceuticals to attract investor funds. In this regard, the costs and times for pharmaceutical development are so significant that Australian firms and research institutes carrying out research in connection with pharmaceutical-related inventions currently require the support of large pharmaceutical companies in order to bring their products to the market. Notwithstanding, the relevant recommendations of the Productivity Commission’s draft report appear to relate to eroding a patentee’s rights for pharmaceutical inventions. For example, currently patents that cover pharmaceuticals can be entitled to a term extension because of delays in obtaining marketing approval. Importantly, if a pharmaceutical patent receives the benefit of a full term extension period under the current provisions, the effective term of the patent will only be 15 years – that is 5 years less than the standard term of a patent. Accordingly, there is an argument that patentees of pharmaceutical patents are disadvantaged compared to patentees in other areas of technology. Despite this, the draft report makes a recommendation to significantly reduce the term that a pharmaceutical patent can be extended. This would further disadvantage owners of patents covering pharmaceutical compositions.
Relevantly, the Productivity Commission’s draft report makes numerous references to the Pharmaceutical Patents Review Report 2013 – a report that has been criticised because the makeup of the panel conducting the review was not considered to be balanced, but rather biased towards the generics industry.
Overall, the recommendations of the Productivity Commission’s draft report have been viewed as detrimental to the pharmaceutical industry in Australia and there have been a number of submissions, for example by the Institute of Patent and Trade Mark Attorneys Australia and my firm Shelston IP, that provide constructive comments and criticisms of the draft recommendations. It will be interesting to read the final report that is due out in August 2016.
Are there any presentations at the upcoming Pharmaceutical Law, Reform & Regulation Summit that you are looking forward to seeing and why?
The program for the summit looks compelling because the presentations cover topics that are currently critical to the pharmaceuticals industry. In particular, I am looking forward to the presentations on the Productivity Commission’s report and the presentation by Prof. Andrew Christie on evergreening. I am also looking forward to the presentation on biosimilars, which is currently a very hot topic in the pharmaceutical space.
Grant Shoebridge will be discussing the Myriad High Court “Gene Patent” decision and its impact on the patentability of pharmaceuticals at the 9th Annual Pharmaceutical Law, Reform & Regulation Conference. For more information, including our current agenda, please head to our website.