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
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.