Australian court rejects Boehringer opposition bid against MSD unit’s anti-parasitic drug patent
The Federal Court of Australia has refused an appeal request in a decade-long case brought by Boehringer Ingelheim Animal Health against MSD subsidiary, Intervet International.
Boehringer had opposed a patent application by Intervet for an anti-parasitic drug formulation on the grounds of non-novelty, claiming that there were similarities with a Chinese patent.
Intervet applied for the patent for the formulation—an injectable formulation of a macrocyclic lactone and levamisole—in June 2011, essentially to create a “stable mixture of two drugs and a stable injectable formulation that would have some anti-parasitic effect” (Australian Patent number AU 2011268899 C1).
The court initially found this patent application to be valid, before the Raising the Bar bill was introduced on 22 June, 2011. However the court’s decision was made under the pre-Raising the Bar Patent Act.
Boehringer argued that the primary judge’s rejection of its opposition to the patent, on the basis that the invention described and claimed did not involve an inventive step, was affected by a number of legal and factual errors.
However, the court dismissed these claims and refused Boehringer’s leave to appeal. Judges Perram, Nicholas and Burley passed their judgment on May 18, 2022, ordering that the drug manufacturer pay for Intervet’s costs of the application.
Novel anti-parasitics
In the hearing, Intervet argued that endoparasites cause disease in livestock animals and have a “significant” adverse economic effect on farming economies. It went on to say that some parasites develop resistance to antiparasitic drugs like ivermectin.
“The discovery of novel anti-parasitics with equal or better qualities than macrocyclic lactones seems to be a distant reality in the veterinary pharmaceutical industry,” Intervet claimed, adding that “there is a need for a stable suspension formulation capable of including macrocyclic lactone compounds together with levamisole”.
The judges concluded: “In our opinion Boehringer has failed to establish that any of the primary judge’s findings or conclusions with respect to the issue of inventive step was affected by any relevant error. Nor do we consider that the applicant established any clear prima facie error which, if not corrected, would result in the grant of an invalid patent.
“In those circumstances we propose to dismiss the application for leave to appeal with costs. It is therefore not necessary for us to consider various additional factual matters raised in a proposed notice of contention upon which Intervet indicated it would rely if leave to appeal was granted.”
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