NEWS Australia’s highest court to hear Myriad gene patent case


Te High Court of Australia is set to consider the Myriad Genetics case concerning whether isolated genetic material is patentable subject matter. On February 13, the Full Federal Court of


Australia granted a request by Yvonne D’Arcy, the plaintiff in the case, for special leave to appeal to the High Court. It means the High Court, the country’s most senior, will hear the case in April 2015. Special leave is granted in cases where there is


a question of law that is of public importance. Te decision to grant it is determined by one or more justices of the Federal Court. Te case, D’Arcy v Myriad Genetics, which was


filed by breast cancer survivor D’Arcy, centres on whether isolating a DNA sequence from a gene’s surrounding genetic material involves structural and functional changes that create a new composition—and can therefore be patented. D’Arcy filed the case in partnership with the


Cancer Voices Australia organisation against Myriad in 2010. In February 2013 a judge at the Federal Court


of Australia ruled in favour of Myriad, finding that isolated gene sequences are patentable as they are the product of human intervention. D’Arcy appealed against the decision to the


Federal Court in August 2013, and in September 2014 the court upheld the validity of the patent.


Te plaintiff later sought special leave to appeal. Te patent is related to the BRCA1 gene,


mutations of which can increase an individual’s chance of developing breast or ovarian cancer. Myriad offers tests that examine the BRCA1 gene. Australian law defines patentable subject matter


as a “manner of manufacture”. D’Arcy argued that gene patents are not a manner of manufacture, as isolating a gene does not make a difference to it—the resulting product is identical to that found in nature. In 2013, the US Supreme Court found that


genes are not patentable subject matter simply because they have been isolated. Rebecca Gilsenan, a principal at Australian


law firm Maurice Blackburn, who is representing D’Arcy in the case, said that the matter has “enormous significance” for access to genetic testing, as well as for research and development into treatments for disease. “It raises a number of ethical, philosophical


and legal questions about the commercialisation of the human body. It is important that there is legal certainty to allow scientists and others the freedom to study genes without fear of a patent holder taking legal action against them,” she added. Myriad did not respond to a request for


comment.  US district court strikes down AstraZeneca’s Pulmicort patent


A US court has ruled that an AstraZeneca patent covering asthma inhaler Pulmicort Respules (budesonide inhalation suspension) is invalid, allowing generic drug makers to enter the market with their own versions. In a judgment issued on February 13, the US District Court for the District of New Jersey found that US patent 7,524,834, called “sterile powders, formulations, and methods for producing the same”, was obvious. Te patent was due to expire in 2018, with


paediatric exclusivity extending that protection by six months to 2019. In a statement Paul Hudson, president of


AstraZeneca US, said the company “strongly disagrees” with the court’s decision. Hudson said that the company is considering


its legal options, including filing an appeal against the court’s decision. AstraZeneca sued Apotex in 2009 (and later


Watson Laboratories, now Actavis, Breath Limited, and Sandoz) for infringing patents directed to methods of the use and formulation of Pulmicort’s active ingredient. In April 2013, in a consolidated action, the New


Jersey court ruled that an AstraZeneca patent, US number 6,598,603, which also covers Pulmicort


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and protects a “method for treating respiratory diseases”, was invalid. Te court ruled that the generic makers did not infringe the ‘834 patent. In October that year, following AstraZeneca’s


appeal, the US Court of Appeals for the Federal Circuit reversed and remanded for further proceedings the lower court’s decision that


the


defendants did not infringe the ‘834 patent, but upheld the court’s decision on the ‘603 patent’s invalidity.


But the district court has now invalidated the


‘834 patent. On the day of


the district court’s latest


decision, Actavis announced that it had launched a generic version of Pulmicort Respules. Generic drug maker Teva is already licensed to market a generic version of the drug. Pulmicort Respules helps to manage asthma


symptoms in children aged between 12 months and eight years. 


IMAGE POINT FR / SHUTTERSTOCK.COM


PHILLIP MINNIS / SHUTTERSTOCK.COM


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