Validation of European Patents to be Available in Tunisia
European patent applications with a (deemed) filing date on or after 1st December 2017 can be validated in Tunisia. To clarify this, a European application that is filed after 1st December 2017 but which is based on a PCT application that is filed before 1st December 2017 does not qualify for validation in Tunisia, since the deemed filing date is before 1st December 2017. As with other states, validation needs to occur within the later of 6-months of the mention in the European Patent Bulletin of publication of the European search report or before European regional phase if Europe is entered via the PCT. A 2-month grace period is allowed upon payment of a late fee. European patent applications that are validated in Tunisia will be subject to Tunisian patent law. Tunisia will join Morocco and the Republic of Moldova as countries that allow European patents to be validated within its territory. As earlier notified Cambodia has signed an agreement with the EPO for the validation of European patents in Cambodia, but the date at which that agreement will enter into force is currently unknown.
European Supplementary Protection Certificate Consultation
A European Commission consultation on supplementary protection certificate (SPC) protection has been initiated.
Currently SPC’s are available via separate regulations for innovative pharmaceutical and plant protection products and can add up to 5-years of patent term when it has been lost on account of achieving authorisation from regulatory authorities.
The consultation is part of a single market strategy which aims to recalibrate aspects of patent and SPC protection with a view to the creation of a single SPC legislative title. A particular area of focus is on the possible extension of the ‘Bolar’ patent exemption provisions that allow the speeding up of the process of obtaining pre-market regulatory approval, which currently only applies to pharmaceuticals for human use. Options for such extension include:
- applying to any medicines (whether or not subject to marketing authorisation),
- to obtain marketing approvals anywhere in the world,
- to explicitly allow third party supply of active pharmaceutical ingredients (APIs) within the EU for purposes of tests and trials required to obtain marketing approvals.
This also considers the economic impact of allowing manufacturing of medicines for human use protected by an SPC in protected (domestic) markets for purposes of:
- exporting to third countries where the corresponding patent or SPC has expired,
- exporting to other EU Member States where the corresponding patent or SPC has expired, and
- preparing for timely entry in the domestic market subsequent to patent or SPC expiry (stockpiling).
Substitutability Key Factor in Obviousness Analysis
In 2017 NZIPOPAT 23 Merial Inc v Alleva Animal Health Limited the Assistant Commissioner declined to make a finding of obviousness even though the prior art primarily only differed in not mentioning the specific salt of levamisole used and despite allowing salts of levamisole to be used.
Allevia opposed Merial’s 1953 Act patent application for injectable parasiticidal formulations of levamisole and macrocyclic lactones, wherein the levamisole is levamisole phosphate. Allevia’s strongest ground of opposition was that Merial’s proposed invention is obvious with respect to a foreign specification published in 2002. That earlier specification claimed an injectable veterinary compound formulation containing levamisole or salts thereof and macrolide vermifuge, and the specification includes preferred formulations and examples that use levamisole hydrochloride – but not levamisole phosphate.
Amongst other things, the Assistant Commissioner held that the following were part of the common general knowledge at the priority date:
- Levamisole is typically used in a salt form since the salts tend to dissolve better in water than the base.
- The two most well-known levamisole salts are levamisole hydrochloride and levamisole phosphate.
- While levamisole is usually present as the hydrochloride salt, levamisole phosphate is known to be less irritating than levamisole hydrochloride.
- Levamisole phosphate is the preferred levamisole salt for use in preparing injectable formulations, as the hydrochloride salt of levamisole causes tissue irritation at the site of injection.
- Injectable formulations have formulating challenges and constraints (i.e. achieving shelf stable dissolved or suspended combination formulations).
Alleva argued that the skilled person would understand the prior art’s use of the term ‘salts’ to include both levamisole hydrochloride and levamisole phosphate, particularly so given that they are the two main salts of levamisole used in veterinary medicine. Merial argued that there is no motivation to substitute levamisole phosphate and that any such substitution could lead to stability, efficacy and tolerability issues.
While both specifications have overlapping ranges of levamisole concentrations, the preferred formulations and examples involving levamisole or levamisole hydrochloride in the prior art specification were lower and outside the levamisole concentration range of the opposed application. Alleva downplayed the difference, considering Merial’s higher range to be likely due to the need to accommodate the required doses of both active ingredients while maintaining a practical injection volume.
However, the Assistant Commissioner held that the differences between the specifications constitute steps which would not be obvious to a normally skilled but unimaginative addressee. In particular, the substitution of levamisole phosphate may not be a straightforward choice because the substitution could affect the overall stability and other properties of the composition. The Assistant Commissioner found support for this conclusion in a third party’s patent specification covering similar subject matter which noted the difficulty in achieving an acceptable formulation even for highly experienced formulation chemists.
Discovery of Documents for Secondary Evidence of Obviousness Considered
In ResMed Ltd v Fisher & Paykel Healthcare Ltd the Judge set out the general principles that apply to the discovery of documents that potentially comprise secondary evidence of obviousness.
The Judge initially noted from various precedents that secondary evidence of obviousness is merely an aid to the assessment of the primary evidence – the latter being the evidence of properly qualified expert witnesses. Secondary evidence is particularly useful in providing a check against hindsight reconstruction, which primary evidence can be prone to.
ResMed claimed infringement of 4 patents, some of which it had not commercialised. It sought discovery of documents showing the commercial success of Fisher & Paykel’s allegedly infringing products, arguing that such evidence of commercial success could be used as secondary evidence of the non-obviousness of the patents. The Judge generally agreed with Fisher & Paykel’s claim that such evidence would have little relevance and that their discovery would not be proportionate given that its products were launched between 4 and 8 years after the relevant priority dates.
Documents that the Judge allowed discovery of included:
- Marketing materials relating to the advantages of 3 of Fisher & Paykel’s products – to the present.
- Documents concerning the interchangeability of 3 of the Fisher & Paykel products – to the issuing of proceedings.
- Design, development and drawing files and associated reports to the Board – to the issuing of proceedings.
- Analyses, commentary or reviews by Fisher & Paykel of ResMed’s patents - up to two years after each patent’s publication date.
- Documents produced or referred to by Fisher & Paykel concerning the common general knowledge in New Zealand as at and prior to the relevant filing dates – up to the present.
- Documents confirming or disclosing the publication of the prior art relied upon by Fisher & Paykel – up to the present.
Documents that the Judge declined discovery of included:
- Documents resulting from clinical, human factor, usability, fitting and user experience evaluations or studies. In principle allowable, but the parameters of the request were too wide and ResMed’s proposed refinement was made too late, although could possibly be included at a later stage.
- Analyses, commentary, studies, trials or evaluations of ResMed masks or features or components thereof. As above in principle allowable, but parameters too wide and proposed refinement made too late.
- High level financial documents illustrating the financial performance of Fisher & Paykel’s products both in New Zealand and internationally. The broad range of this discovery was considered unjustified, especially given the significant time lapse between the deemed filing dates and the launch of Fisher & Paykel’s allegedly infringing products.
- High level financial documents illustrating Fisher & Paykel’s allocation of research and development expenditure on the relevant products. As above too broad and unjustified.
2. Trade Marks
Voluntary Description of Trade Mark Encouraged
On the 1st November 2017 several amendments were made to the Common Regulations.
This notably includes modification to International Application Forms MM2 and MM4 to allow up to two descriptions of a trade mark. This will allow the applicant to make a voluntary description of the mark at filing and this should particularly be done where the trade mark is represented in non-standard or non-Latin characters as some countries require descriptions of such marks. In particular, Madrid Protocol countries that require descriptions of the mark where the mark is in non-standard characters include India, Singapore, the United States of America and several European states. By making the voluntary description at the time of filing the applicant can remove a ground for provisional refusal and hence reduce the likelihood of incurring extra costs from being required to have local representation. Where the original application does not contain a voluntary description, then a voluntary description can and can only be added in a subsequent designation.
Madrid Protocol soon to have 100 Members
On the 2nd January 2018 the Madrid Protocol will reach 100 members. Thailand (TH) will be a member from 7th November 2017 and Indonesia will be a member on 2nd January 2018, having deposited their instrument of accession on 2nd October 2017.