On 21st September 2013, Samoa will become bound by the Paris Convention.
Patentable Subject Matter Consultation
Following on from the implementation of the Raising the Bar legislation and the Intellectual Property Laws Amendment Bill 2013, IP Australia has now released a consultation paper that seeks to bring further clarity to the determination of patentable subject matter and the exclusions to patentability. While the recent IP legislative program has or is in the process of implementing many of the recommendations of the Advisory Council on Intellectual Property (ACIP) 2010 Patentable Subject Matter report, there are still several recommendations to address. The consultation paper concerns two of the recommendations.
Firstly, it seeks to introduce an Objects clause that outlines the purpose of the patent system in a way that indicates the various parties whose rights, interests and expectations need to be considered. Two options are given for an Objects clause, with the main differences being whether the promotion of Australia’s national interest or the promotion of innovation and the dissemination of technology should be recognised.
Secondly, it seeks to introduce an explicit exclusion from patentability for inventions the commercialisation of which society finds offensive or morally objectionable. For standard patents the current exclusions relate to the patenting of human beings and inventions the use of which would be contrary to law. However, the consultation paper notes that there may be a lawful use for the invention, but society may object to its commercialisation. The consultation paper also notes that while the TRIPs agreement allows inventions that are contrary to morality to be excluded from patentability, it prohibits exclusion merely because the exploitation is prohibited by law. Hence, it recommends replacing the contrary to law exclusion with exclusion for an invention the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public. It further recommends that the Commissioner be given the power to seek non-binding advice about such matters. Submissions are required by 27 September 2013.
Extension of Term
In Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd the Federal Court upheld the granting of an extension of term for a pharmaceutical formulation, even though the pharmaceutical formulation was claimed by result rather than by proportions required to achieve controlled release.
Section 70 of the Patents Act 1990 allows the granting of extensions of term for pharmaceutical substances. The Patents Act also defines “pharmaceutical substance” as follows:
pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic 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 patent concerns controlled release oral dosage formulations of oxycodone. The claims specified the amount of oxycodone contained within the formulations, but they did not specify the amounts and proportions of excipients required to achieve the controlled release. Rather, the claims defined the pharmacokinetic parameters to be achieved upon administration of the formulation.
Spirit argued that the skilled addressee would understand that the achievement of the result was not limited by any particular dosage or choice of excipients or their quantities in the mixture, and that in the absence of any such limitation the controlled release formulation was not a pharmaceutical substance per se. Rather, Spirit contended, the only pharmaceutical substance that Mundipharma could point to was oxycodone, but this was not the subject of the claims.
The Judge noted that a decision of the Full Court had held that:
“... for a substance to fall within s 70(2)(a) it must itself be the subject of a claim in the relevant patent. It is not enough that the substance appears in a claim in combination with other integers or as part of the description of a method (or process) that is the subject of a claim. The policy adopted in s 70 was to confine extensions to patents that claim invention of the substance itself.”
However, it was also noted that a subsequent decision of the Full Court held that a pharmaceutical substance per se need not equate with the subject matter of the claim in patent terms.
“For example, a chemical compound claimed in a patent may not have the necessary therapeutic use or enable the required physico-chemical interaction unless formulated. It is sufficient if the pharmaceutical substance is in substance disclosed in the specification and in substance falls within the scope of the claim or claims. At that point in the scheme of s 70, the satisfaction of s 70(2), the necessary definition of the pharmaceutical substance by reference to the patent ceases.”
That judgement went on to hold that the definition of pharmaceutical substance focused on the ingredient for therapeutic use that involves the relevant type of interaction.
“However, the pharmaceutical substance per se is the molecule, the (+)-enantiomer. The racemic mixture is a solution that contains both (+) and (-) enantiomers in equal proportions. [The] (+)-enantiomer molecule per se fulfils the requirements of s 70(2). It is the molecule that “works” as a pharmaceutical substance alone, or together with other substances, in goods listed on the ARTG. These other substances may be components of a formulation or may otherwise be described as impurities, such as the (-)-enantiomer.”
The Judge noted that the controlled two-stage release achieved by the (parameter defined) formulations gave improved results compared to repeated doses of the prior art immediate release formulations. The Judge then reasoned that the therapeutic use of such controlled release formulations was sufficient for the various mixtures of substances to qualify as pharmaceutical substances per se.
Late Entry to PCT National Phase in Australia
Where the 31-month time limit for entering national phase in Australia either by chapter I or chapter II has passed, it is possible to have the time limit extended upon payment of a fee. This can apply where the failure to meet the time limit is:
(i) due to an error or omission on the part of the applicant, their agent or attorney; or
(ii) due to circumstances beyond the control of the person concerned; or
(iii) in spite of due care as required by the circumstances (to the Commissioner’s satisfaction).
United States of America
Claim Term Construction
In Aventis Pharmaceuticals Inc v Amino Chemicals Ltd the Court of Appeal for the Federal Circuit (CAFC) considered whether the same claim term can have a different construction depending on how the term is used in the claims and specification. Aventis, as licensee of the patent, appealed after a District Court construed the term “substantially pure” to have the same meaning throughout the specification, thereby making Amino’s actions fall outside the claim scope.
The patent in question concerns methods for making purer forms of piperidine derivatives, and covers a method used to produce fexofenadine. The claims and specification use the term “substantially pure” both when characterizing an intermediate compound formed during the process and when describing the piperidine end product. The specification does not define substantially nor does it give a numerical value. However, the District Court gave it a uniform value of 98% on the basis of statements in the prosecution history regarding pharmaceutical grade purity, which requires an impurity level of no greater than 2%.
The CAFC reversed and remanded the District Court’s finding on the basis that a uniform construction of the term “substantially pure” was not justified when the term was read in context. While the end product does need to be pharmaceutical grade, the same is not required of an intermediate compound. The District Court was found to have erred in applying a ‘one construction throughout the patent’ rule, since there is no requirement that a claim term be construed uniformly, particularly if it would lead to a nonsensical reading. In construing the term in relation to the intermediate compound the CAFC noted that in other contexts the CAFC has interpreted “substantially” as a non-specific term of approximation that avoids a numerical boundary. The CAFC accepted Aventis’s construction of “substantially” as “largely but not wholly”.
3. Trade Marks
NZ Acceeds to Nice Agreement
Recently the voluntary and mandatory conversion of old 3rd schedule trade mark registrations to Nice classifications was completed. Subsequently, with all ‘live’ marks classified according to the Nice classification, on 16th July 2013 New Zealand deposited its Instrument of Accession to the Nice Agreement with the World Intellectual Property Organization. The Nice Agreement will come into force in New Zealand on 16 October 2013.
Extension of Short Term Prohibition on Parallel Importation of Films
The Copyright (Parallel Importing of Films) Amendment Bill is set to extend for a further 3-years the prohibition on the immediate parallel importation of films into New Zealand. Currently there is a prohibition on the parallel importation of films into New Zealand within a period of 9-months from the international release date, with the prohibition set to expire on 31st October 2013.
However, when enacted, the Bill will change the prohibition period to 5-months from the international release date, with the prohibition to expire on 31st October 2016. After that date cinemas will have to compete directly with other exhibition formats such as DVD, Pay-Per-View and Free-To-Air.