Government Response to Productivity Commission Report Issued
The Australian Government recently issued its response to the Productivity Commission’s report which made a raft of recommendations in relation to Australia’s IP legislation. Notable changes which the Government agrees in principle with are as follows:
- The phasing out of the Innovation Patent system with appropriate arrangements to maintain existing rights. On balance the Innovation Patent system was found to be unlikely to provide net benefits to the Australian community or to small and medium sized enterprises.
- Inserting an object clause to the Patents Act, although the exact wording has yet to be decided.
- Bringing Australian law on inventive step in line with the European ‘obvious to try’ test. The current tests for a ‘scintilla’ of invention, or a scenario where the skilled person would not ‘directly be led as a matter of course’, are considered insufficient thresholds for meeting the inventive step.
- In addition to changing the inventive step threshold, patent claims would have to identify the technical features of the invention.
- Introducing a reporting and monitoring regime for potentially anticompetitive conduct (such as pay-for-delay) between pharmaceutical patent owners and generic pharmaceutical manufacturers.
- Reducing the non-use grace period for registered trade marks from 5-years to 3-years.
- Ensure that parallel imports of marked goods do not infringe an Australian registered trade mark when the good has been brought to market elsewhere by the owner or licensee.
Not all of the Productivity Commission’s proposed changes were accepted. Notably, the Government will:
- Not restrict patent term extensions to only being available for patents covering an active pharmaceutical ingredient; and calculated based on the time taken for regulatory approval that exceeds one year.
- Not amend patent fees.
- Not remove the presumption of registrability when assessing whether a trade mark could be misleading or confusing.
IP Australia subsequently initiated a series of public consultations, and has requested feedback by 17th November 2017.
Swiss-Style Claims Ineligible for Patent Term Extensions
In Commissioner of Patents v AbbVie Biotechnology Ltd the Full Court of the Federal Court set aside the decision of the Administrative Appeals Tribunal (AATA) and held that the earlier decision by the Deputy Commissioner of Patents was correct to find that Swiss-style claims cannot benefit from patent term extension.
Amongst the requirements for a valid extension of term claim are the conditions given in section 70(2), which states:
(2) Either or both of the following conditions must be satisfied:
(a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
The AATA held that AbbVie’s Swiss-style claim satisfied subsection 70(2)(b). The AATA considered that it could not be concluded from a plain reading of the subsection that the drafters of the legislation intended to exclude Swiss-style claims. In particular the absence of the phrase “per se” in subsection 70(2)(b) was taken to mean that the pharmaceutical substance produced in accordance with AbbVie’s Swiss-style process claim format qualified – given that the other conditions of subsection 70(2)(b) were satisfied. This construction of subsection 70(2)(b) placed emphasis on the method or process by which the pharmaceutical substance is produced.
The Full Court disagreed with the AATA’s construction of section 70(2), instead placing emphasis on it being limited to providing patent term extensions for pharmaceutical substances. While pharmaceutical substances complying with subsection 70(2)(b) are produced by a particular type of process, being a pharmaceutical substance is nonetheless the primary qualifying requirement. Given that Swiss-style claims are a process type claim, they could never satisfy that pharmaceutical substance requirement, which needs to be met by a product type claim. In giving its construction of subsection 70(2)(b) the Full Court stated:
“…even though produced by a process involving recombinant DNA technology, the pharmaceutical substance must also, in substance, fall within the scope of the claim or claims of the specification in suit. Properly construed, this means that it is the pharmaceutical substance that must be the subject matter of the claim or claims, not methods or processes (beyond recombinant DNA technology) concerning or involving the pharmaceutical substance.”
Clarification of when Exhaustive or Inclusive Interpretation Appropriate for Claim Term "Contains"
In Nichia Corporation v Arrow Electronics Australia Pty Ltd (No 4) gave the claim term “contains” an exhaustive rather than an inclusive interpretation and as a result held there had been no infringement of the relevant claim.
The particular issue of claim interpretation arose in dependant claim 3, which further specified that the phosphor used in the light emitting device contains fluorescent material represented by a given general formula. The applicant argued that the word ‘contains’ in claim 3 is used in an inclusive sense, meaning that infringement could not be avoided by adding other fluorescent material to the light emitting device. The applicant cited several authorities to the effect that the inclusion of additional integers to a claimed combination does not necessarily avoid infringement if those additional integers are properly characterised as inessential or do not make a new working of the combination. However, the Judge rejected those authorities as irrelevant on the basis that issues of construction should precede issues of infringement.
The Judge noted that the word ‘contains’ can have either an inclusive or an exclusive meaning and that which one applies depends upon the context of its use taking into account a purposive construction.
The Judge found that claim 3 claimed a light emitting device in which the phosphor is a single fluorescent material represented by the general formula and does not include the use of other fluorescent materials. The Judge found support for this finding in the consistory statements, which only refer to specific fluorescent material and describe the phosphor as a fluorescent material of the stated formula. Further, the promise of the invention also points towards the word ‘contains’ being construed in an exclusive sense.
The applicant attempted to use claim 6 to support its position on claim 3. Claim 6 is dependent upon claim 3 and specifies that the phosphor contains two or more fluorescent materials. The applicant argued that on account of being dependent on claim 3 it must also be narrower, specifically in the sense that it excludes phosphors containing only one fluorescent material. However, the Judge considered that claim 6 further confirmed that claim 3 is restricted to phosphors containing only one fluorescent material on the basis that claim 6 would be redundant if claim 3 also covered phosphors containing two or more fluorescent materials.
Criteria for Plausibility of Proposed Technical Effect further Elaborated
An EPO Boards of Appeal (BoA) decision made earlier this year has recently been published and highlights the importance of demonstrating the plausibility of the proposed inventive subject matter at the filing date.
The EPO BoA upheld the EPO Opposition division’s revocation of Bristol Myers Squibb’s patent for an anti-cancer drug. The initial application disclosed an extremely wide range of compounds, but before the EPO BoA only a single compound was in issue. While there was no challenge to the novelty or ultimate utility of the claim to the single compound dasatinib or salts thereof, the question on appeal was whether the patentee had satisfied the requirement of plausibly demonstrating the technical effect of its activity at the filing date.
According to established case law the plausibility of the technical effect cannot be established by evidence filed after the filing date, although such evidence can be used as supplementary evidence to corroborate a technical effect that was deemed to at least be plausible at the filing date.
Although the application as filed generically referred to assays that could be employed in ascertaining the degree of activity of the numerous compounds initially claimed, no experimental results were provided for any compound in any assay. Nor had any threshold level for activity been given.
“No individual values or range of values are given. No information as to whether the observed “activity” is suitable for the intended use, i.e. the treatment of a number of diseases and disorders, is provided.”
The application as filed also did not show that the skilled person was in the possession of common general knowledge which, even in the absence of data, made it plausible that the compounds of the invention, in particular dasatinib, could be expected to show the claimed activity. The EPO BoA rejected Bristol Myers Squibb’s attempt to infer such knowledge from structurally different compounds due to the absence of any correlation between structural features and function.
The EPO BoA noted that the invention relies on a technical effect which is neither self-evident nor predictable or based on a conclusive theoretical concept. In such circumstances at least some technical evidence is required to show that a technical problem has been solved. In particular, it was not considered acceptable to draw up a generic formula covering millions of compounds, vaguely indicate an activity and leave it to the imagination of the skilled reader or to future investigations to establish which compounds exhibit the activity in a way that is suitable to achieve the desired effect.
Given that in the absence of the post-filing evidence the application did not plausibly demonstrate the claimed technical effect, the only problem that could be deemed to be solved by the application was the provision of a further chemical compound. However, in line with established case law, this was held to be insufficient to satisfy the inventive step requirement.
“a chemical compound is not patentable merely because it potentially enriches chemistry …, since originality has no intrinsic value or significance for the assessment of inventive step as long as it does not manifest itself in a valuable property in the widest sense, an effect or an increase in the potency of an effect”.
First Decision on Support Requirement in Patents Act 2013
In the recent Commissioner’s Decision 2017 NZIPOPAT 16 Charles Caulder Bree the Assistant Commissioner confirmed that the test for the ‘fair basis’ requirement that applied under the Patents Act 1953 cannot be used when considering the ‘support’ requirement under the Patents Act 2013.
Bree’s patent application, entitled Modular Foundation Resistant to Ground Movement, relates to base structures for supporting buildings while also being relatively resistant to substrate movements such as arise from seismic activity or freezing. During examination an objection was raised to the effect that the two embodiments given in the specification do not provide support for the invention as claimed.
The Assistant Commissioner noted that the fair basis test under the Patents Act 1953 was well established and that its replacement with a supported by requirement in the Patents Act 2013 indicates a substantive and intended change of approach. It was also noted that the supported by requirement was substituted for the fair basis requirement during the Committee stages of the Patents Bill so as to bring New Zealand’s law in that respect into line with UK law, being part of an overall objective of attaining greater alignment with international practice.
UK case law was also considered. In the 1989 UK Patents Court decision Schering Biotech’s Application  RPC 249 it was held that the mere mentioning in the specification of features appearing in the claim will not necessarily be sufficient to establish support. Rather, the description needs to be the base which can fairly entitle the patentee to a monopoly of the width claimed. Expressed another way, the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported.
The Assistant Commissioner also distinguished the support requirement from the sufficiency of disclosure requirements. Whereas the former requires the claims to match the scope of the invention described in the specification, the latter requires the disclosure to be clear and complete enough for the invention to be performed by a person skilled in the art. Satisfaction of the sufficiency of disclosure requirement does not entail that the support requirement has been satisfied (and vice-versa).
In applying the UK Courts approach to evaluating support the Assistant Commissioner concluded that the claims are not supported by the specification because neither example discloses an invention with the same combination of features listed in claim 1. In other words, the invention described in the specification does not match the invention described in the claims.
“that these modules could be joined together or to other modules by unspecified suitable fastenings to make a single foundation owes nothing to the teaching of the patent or any principle it discloses.”