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Tuesday, August 6, 2013

Federal Court confirms new formulations are eligible for patent term extension


By Senior Associate Alison Beaumer

In its recent decision in Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658, the Federal Court held that a patent claiming a new and inventive controlled release formulation of oxycodone had been validly granted an extension of term under section 76 of the Patents Act 1990 (Cth). Oxycodone is an opioid drug used to provide pain relief and the controlled release formulation is marketed as OxyContin. Allens acted for the respondents (other than the Commissioner of Patents) in the proceedings. Spirit has now appealed the decision.

The central issue in the case was whether the controlled release formulation was 'a pharmaceutical substance per se' within the meaning of s70(2)(a) of the Patents Act. Spirit contended that only an active pharmaceutical ingredient (API), such as oxycodone itself, and not a formulation, could be 'a pharmaceutical substance per se'.




Justice Rares held that the text of s70(2) and the other relevant provisions of the Patents Act had a clear meaning and it was therefore not necessary to consider any extrinsic materials in construing those provisions. His Honour considered that the requirement that the patent must relate to a pharmaceutical substance 'per se' was connected to the altered nature of the exclusive rights that the patentee acquired pursuant to s78 under an extension of the patent. 

The inclusion of the words 'per se' did not operate to restrict s70(2)(a) to APIs alone and could extend to new formulations, provided that the patent otherwise met the requirements of s70(2)(a). Justice Rares held that the patent in suit did meet the requirements of s70(2)(a) and had been validly extended. The controlled release formulation, OxyContin, was a mixture of substances that had a 'therapeutic use' achieved by chemical interactions in the human physiological system (as required by the definition of 'pharmaceutical substance' in the Patents Act). In considering the nature of the 'therapeutic use' for the formulation, his Honour noted that the results achieved by the controlled release formulation were different to those achieved by repeated doses, over the same time period, of the API alone. 

Even if a controlled release formulation in and of itself could be eligible for an extension of term, Spirit contended that the claims of the patent in suit were not claims to the controlled release formulation 'per se'. Rather, each claim was defined by additional integers regarding, for example, dosage and the blood concentrations of oxycodone to be achieved. In this respect, Justice Rares preferred the reasoning of Justice Weinberg in Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2006) 69 IPR 1, a case which Spirit had argued was wrongly decided. In that case, Justice Weinberg held that the additional integers contained in the claims simply marked out the basis on which the new and inventive substance could be distinguished from other prior art and enabled the scope of the protection to be more accurately understood. Similarly in this case, Justice Rares held that the various claimed mixtures, including the additional integers regarding dosages, excipients and pharmacokinetic parameters, were all embodiments of the pharmaceutical substance per se, OxyContin, that met the criteria in s70(2)(a).

Australia's patent term extension regime has also been a topic of interest on the policy front. In its draft report released in April this year, the Federal Government's Pharmaceutical Patents Review Panel observed that patents with claims to APIs or new formulations of a known API are considered to be eligible for an extension in Australia, but also noted that the relevant definition of 'pharmaceutical substance' had not yet been the subject of judicial consideration. The Review Panel concluded that the current approach of allowing extensions for new formulations appeared reasonable on the basis that such inventions are desirable, require considerable R&D and are prevented from entering the market until regulatory approval is given (with a timeframe for regulatory approval similar to new APIs). The Federal Court's decision in Spirit v Mundipharma provides much needed judicial guidance on the meaning of 'pharmaceutical substance' and reaches an outcome consistent with the Review Panel's policy recommendations.

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