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It is important that the thresholds for these criteria are set at levels where the scope of protection given by xanax online rx a patent is commensurate with that which is disclosed to the public and that patents are not granted for trivial or obvious improvements. The GMiA submission provides a summary of the effect of the granting of low- quality patents: When a "bad" patent (i.e. one which on a robust assessment is not valid) is granted by the APO, the following occurs: •a bayview pharmacy online tramadol generic medicine supplier bears the burden of correcting the patent landscape by commencing re-examination or the anybody have hydrocodone Courts (usually the latter); •that burden is significant given the costs (time, resources and legal) of patent litigation in Australia; •where proceedings have not concluded prior to proposed generic launch xanax online rx date, interlocutory relief (by way of an injunction) is routinely sought, and routinely obtained on that "bad" patent. •the Federal Court of Australia is influenced at the interlocutory stage by the mere fact that the APO has granted the patent, considering this to be relevant to a prima facie assessment of patent validity184.

Where appropriate rigour is not applied at the APO level, the public health consequences are very xanax online rx significant. The supply of generic medicines is wrongly delayed in Australia, and the cost to the PBS and the public is very significant.185 7.1.1. Raising the bar The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) makes significant amendments to the Patents Act to raise the thresholds for the grant of patents in Australia. These changes are also intended to better align Australian standards with standards elsewhere. These amendments are the result of extensive consultation with stakeholders and applicable to all technologies, including pharmaceuticals. The higher thresholds commence in April 2013 and xanax online rx generally apply to patent applications for which a request for examination is made after commencement. The Act raises patent standards in three important areas: 1.disclosure and utility - there must be sufficient information disclosed for the public to make and use the invention.

In addition, a specific, substantial and credible use for the invention must be disclosed. 2.inventive step - all published information is taken into account during the examination of a patent and is assessed against background knowledge of a skilled person, regardless of where that person resides. 3.standard of proof - a consistent standard of proof is applied in all decisions. The Commissioner must be satisfied, on the 'balance of probabilities', that a patent, if granted, will be valid. These changes will make it harder for applicants to obtain patents for trivial advances or obvious variations, thereby limiting the opportunities for patent portfolio-type evergreening. Submissions received in relation to the Raising the Bar amendments are generally positive. Originator pharmaceutical companies welcome moves to provide strong and valid IP protection for their property.186 Similarly, generic companies acknowledge attempts to achieve the right balance between strong IP rights, the encouragement of innovation and the interests of both patentees and society as a whole.187 However, a further consensus is that these higher thresholds will need to be in place for a significant period of time before their effect can be determined.



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