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Recommendation 6.4: Section direct order phentermine 117 of the Patents Act should be amended to provide that the supply of a pharmaceutical product subject to a patent which is used for a non-patented indication will not amount to infringement where reasonable steps have been taken to ensure that the product will only be used in a non-infringing manner. Policy should further impose a presumption that "reasonable steps" have been taken where the product has been labelled with indications which do not include any infringing indications. Types of pharmaceutical inventions that can be extended 6.11.1.Pharmaceutical substance per se 6.11.1.1.Current law Section 70(2) of the Patents Act provides that an extension of term can only be granted democraciavirtual org twiki pub main alexbroot tramadol for a "pharmaceutical substance per se", or for one or more "pharmaceutical substances when produced by a process involving the use of recombinant DNA technology.160 A pharmaceutical substance is defined in Schedule 1 of the Act as: A substance (including democraciavirtual org twiki pub main alexbroot tramadol a mixture or compound of substances) for therapeutic digg com health buy tramadol online here use whose application (or one of whose applications) involves: (a)a chemical interaction, or physico-chemical interaction, with a human physiological system; or (b)action on an infectious agent, or on a toxin or other poison, in a human body; but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing. The purpose of this was to limit extensions to pharmaceutical substances democraciavirtual org twiki pub main alexbroot tramadol and not hydrocodone plus delivery systems, new uses of known pharmaceutical substances, or methods of manufacturing a pharmaceutical substance.161 6.11.1.2.Submissions Concerns are raised in submissions about the meaning of the term "pharmaceutical substance per se". For example, the Law Council of Australia submits that the complexity of the provisions has led to inconsistent interpretation in the decisions of the Australian Patent Office and hydrocodone opiod the courts.162 GMIA submits that judicial interpretation of the phrase "pharmaceutical substance per se" has led to a broad definition that encompasses items which might otherwise not hcl medication tramadol be considered a pure pharmaceutical substance, such as a layered bi-phasic tablet and a thermoplastic ring adapted to the slow release of a steroidal mixture.163 6.11.2.Judicial interpretation 6.11.2.1. The meaning of substance per se The case of democraciavirtual org twiki pub main alexbroot tramadol Boehringer v Commissioner of Patents was an appeal from a single judge of the Federal Court to the Full Federal Court.164 The single judge's decision was the first to consider the construction of s.70(2)(a).165 The patent in question claimed a container comprising an aerosol or spray composition for nasal administration of a pharmaceutical substance.

The court concluded that an extension of term would only be available for new and inventive substances where the claim is for a pharmaceutical substance as such, as opposed to a substance forming part of a method or process. The court held that it was the legislative intention of the parliament to foster primary R&D in new and inventive pharmaceutical substances, and not the way democraciavirtual org twiki pub main alexbroot tramadol such substances are made or used.



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