Different Types of Insufficiency Considered in Assistant Commissioner's Decision
In 2018 NZIPOPAT 18 Bayer New Zealand Ltd v Zoetis LLC the Assistant Commissioner distinguished between three different types of insufficiency and upheld the opposition principally on the basis of insufficiency by ambiguity.
On the basis of the advantages thereof Bayer sought to patent the combination of antibiotic and NSAID as a composition in the form of a stable solution, whereas previously the combination was known and used in the form of a suspension formulation. However, Bayer’s claims to the composition were found to be ambiguously stated. Claim 1, as amended, reads as follows:
1. An injectable non-aqueous composition for the treatment of a microbial infection in a mammary gland of an animal,
wherein the composition includes
(a) a non-steroidal anti-inflammatory drug (NSAID);
(b) an antibiotic selected from the group consisting of a beta lactam antibiotic and macrolide antibiotic;
(c) a carrier
characterised in that
the composition includes at least two non-aqueous solvents,
wherein at least one non-aqueous solvent is a solubilising agent; and
at least one non-aqueous solvent is a carrier,
wherein the amount of carrier in the composition is more than the amount of solubilising agent in the composition;
wherein the solubilising agent has the property of dissolving the NSAID and/or antibiotic more readily than the carrier; and
wherein the NSAID and antibiotic are dissolved in the at least two non-aqueous solvents.
The Assistant Commissioner noted that claim 1 provides that the composition includes at least two non-aqueous solvents, where at least one non-aqueous solvent is a solubilising agent, and at least one non-aqueous solvent is a carrier. The Assistant Commissioner also noted the expert evidence that any one of the identified solvents could be the carrier or the solubilising agent, and further that use of each of the solvents with antibiotics and NSAID’s was known. Given that the carrier is described as a solvent the Assistant Commissioner agreed with the contention of one of the experts that the carrier solvent will also dissolve, degrade or precipitate the actives, and can only be described as a carrier if it does not contribute to any significant dissolution of the actives. The Assistant Commissioner agreed with Zoetis’ contentions that the skilled person would not know whether a given formulation infringes the claims as it would not be clear:
- whether the solvent is acting as a solubilizing agent or as a carrier; or
- whether the solvent needs to be the solubilizing agent in respect of both the NSAID and the antibiotic or whether each solvent can be the solubilizing agent in respect of either the NSAID or antibiotic; or
- which solvent is doing more solubilizing given that the solvents can interact and affect the others functions; or
and further noted that infringement could not be avoided by lowering the concentration of the carrier solvent as doing so could make that solvent become the solubilizing agent.
The Assistant Commissioner quickly established that there was sufficient teaching in the specification to enable a skilled person to perform activity within the scope of the claims without undue effort or further invention and so held that classical insufficiency was not established. The Assistant Commissioner also considered Biogen-type insufficiency which is characterised by claims that encompass products or processes owing nothing to the teaching of the patent and that are not enabled. After noting that at least one product formulation was enabled and that the evidence of both sides experts pointed away from all formulations falling within the claims working, the Assistant Commissioner resisted making a finding of Biogen-type insufficiency on the basis that the applicant was allowed the benefit of the doubt given that the proceedings were under the Patents Act 1953. If the proceedings had qualified as being under the Patents Act 2013 it is likely that a finding of Biogen-type insufficiency would also have been made.
2. Trade Marks
Date Set for Overhaul of Canada's Trade Mark Legislation
On 17th June 2019 Canada’s overhauled Trade Mark legislation will take effect. Notable changes are:
- A date of first use either in Canada or abroad will no longer be required. This is balanced out by adding bad faith as a ground for opposition and invalidity.
- A declaration of use will no longer be required for new applications and applications that are still pending.
- Anything that functions as an indicator of source can qualify as a trade mark. Hence the range of allowable non-traditional trade marks will expand to include colour per se, holograms, moving images, sounds, scents, tastes and textures.
- The Nice Classification of goods and services will be adopted with fees being paid per class and it will be possible to divide and merge applications. Pending applications and prior registrations will need to be grouped into Nice classes (of the current version).
- Pending applications that were not allowed by 17th June 2019 will need to be grouped prior to allowance and will have a 10 year term. Pending applications allowed before 17th June 2019 will need to be grouped within 6-months of being requested to do so following registration. Such applications will have an initial term of 15 years if the payment of the registration fee is processed by the Registrar prior to 17th June 2019 or will otherwise have a 10 year term.
- Registrations with a renewal due date prior to 17th June 2019 but which are renewed on or after that date will have a 15 year term and will need to be grouped within a short period of time of being requested to do so following renewal. Registrations with a renewal due date on or after 17th June 2019 but which are renewed before that date will have a 10 year term and will need to be grouped within a short period of time of being requested to do so following renewal. Registrations with a renewal date on or after 17th June 2019 and which are renewed on or after that date will have a 10 year term and will need to be grouped prior to renewal. Where the 10 year term applies to a prior registration the initial renewal fee due will be the renewal fee for one class.
- Canada will become a member of the Madrid Protocol. It is not yet clear whether a 12 month or 18 month refusal period will apply.
- The government registration fee will be eliminated for new applications, but will still be due for applications made before 17th June 2019 which subsequently proceed to acceptance.
Samoa Soon to Join Madrid Protocol
On the 4th March 2019 Samoa (WS) will be a member of the Madrid Protocol, having deposited their instrument of accession on 4th December 2018. Samoa will apply a refusal period of 18 months.
Significant Amendments to UK Trade Mark Legislation
On the 14th January 2019 the following notable changes take effect:
- Trade marks will no longer be required to be represented graphically, but nonetheless still need to be represented in a way that is clear, precise, self-contained, easily accessible, intelligible, durable and objective. Consequently, more sound, motion, multimedia and hologram marks will qualify for protection. Such non-graphically represented marks will be acceptable before the UKIPO and EUIPO, but cannot be used as base registrations for Madrid Protocol applications.
- The technical function prohibition that had applied only to shape marks will be extended to cover any characteristic that is intrinsic to the goods being applied for.
- The UKIPO will no longer cite marks in search reports or at examination that are expired but restorable (but such marks can still be cited if subsequently restored).
- In oppositions the relevant 5-year period for which the opponent needs to provide evidence of use changes from the 5-year period ending on the date of publication of the application under opposition to the 5- year period preceding the filing (or priority) date of the opposed mark.
- Invalidation-related issues will be considered during the course of infringement proceedings and so such proceedings will no longer need to be commenced before or alongside infringement proceedings.
- The use of a trade or company name (or part of that name) will be specified as an infringing act.
- The ‘own name’ defence will only apply to personal names and not to the use of company names.
- Exclusive licensees will not require the owner’s permission to take legal action against an infringer.
- Both exclusive and non-exclusive licensees will be able to intervene in infringement proceedings to obtain damages.
- The licensing provisions will apply to pending applications in addition to registrations.
- The provisions regarding division of marks will be extended so as to include registrations.
- In order to late renew a registration it will be necessary to demonstrate that the failure to renew was ‘unintentional’ (replacing the current test of whether it was ‘just’ to allow late renewal).