High Court Judgment in Favour of Generic Pharmaceutical Manufacturers a Win for Consumers

A recent High Court judgment has given the green light to three generic pharmaceutical manufacturers who supply generic alternatives to Crestor (rosuvastatin), a popular drug produced by AstraZeneca used to treat high cholesterol. A report released by the Pharmaceutical Benefits Scheme indicates that rosuvastatin is the most costly drug to the Australian Government with spending of $298.6 million in the financial year ended June 2014.

AstraZeneca commenced proceedings against the generic pharmaceutical companies in 2011 claiming that by producing a generic version of Crestor, they were infringing upon the patent held by AstraZeneca.

An injunction was obtained by AstraZeneca in 2012 preventing the generic manufacturers from entering into the market. That injunction remained in force until judgment was handed down following the hearing of the matter in the Federal Court during 2013. The Federal Court judgment found in favour of the generic manufacturers, enabling them to produce and sell their generic alternative.

AstraZeneca appealed to the Full Court of the Federal Court where they were also unsuccessful, and subsequently to the High Court.

The High Court unanimously ruled that the patent held by AstraZeneca was invalid on the basis that it lacked the inventive step within the meaning of Sections 7(2) and 7(3) of the Patents Act 1990.

The High Court ruling not only enables the generic pharmaceutical companies to sell their generic alternative, but also enables them to seek compensation from AstraZeneca for sales they would have made during the period in which the injunction was in force.

A patent is a right that is granted for any new device, substance, method or process that is new, inventive, and useful. It is legally enforceable and gives the owner exclusive rights to commercially exploit the invention for the life of the patent. There is a registration procedure in order for rights to arise under a patent. The subject matter of patent protection must be “novel” meaning that it was not previously within the public knowledge.

The length of protection given to a patent varies on the type of patent. A standard patent lasts for up to 20 years whilst an innovation patent only lasts for up to 8 years. A Pharmaceutical patent can last up to 25 years.

Rights under a patent are infringed when an unauthorised person does an act within the patent owner’s exclusive rights.

If you believe you may have an intellectual property matter and require advice, please contact our experienced team at McLaughlins Lawyers for assistance.