Wyeth secures Australian injunction against MSD vaccine
The Federal Court of Australia has granted Pfizer subsidiary Wyeth’s bid for an injunction against Merck Sharp Dohme (MSD) in a dispute over vaccine patents.
Today, November 30, the Australian court restrained MSD from infringing Wyeth’s patent, Australian number 2,006,235,013, through the importation of its 15-valent pneumococcal conjugate vaccine.
In mid-October, the court concluded that MSD was infringing one patent owned by Wyeth, but that two other Wyeth patents are invalid.
The infringed patent, ‘013, concerned a “multivalent immunogenic composition comprising 13 distinct polysaccharide-protein conjugates”.
While MSD argued that the disclosure in the specification is of a composition with the 13 specified serotypes and no more, the court sided with Wyeth, finding that there was a “real and reasonably clear disclosure”.
Today, Justice Stephen Burley granted Wyeth’s request for injunctive relief, rejecting MSD’s argument that the court should conduct a separate hearing on whether it is against the public interest to grant an injunction.
Burley said that Wyeth had established that MSD threatens to launch the infringing product and that the Pfizer subsidiary is prima facie entitled to an injunction as a consequence of that finding.
Second, the judge noted that there is no current evidence as to the state of MSD’s proposed 15-valent vaccine and that the company had not obtained regulatory approval in Australia.
Third, said Burley, MSD had previously contended that any relief restraining the supply of a 15-valent vaccine “would be inequitable, unconscionable and contrary to the public interest”.
Because of this, MSD was conscious of the public interest issue well before the hearing but did not adduce evidence at trial on this point or seek orders formally deferring consideration of the question of whether or not injunctive relief should be granted.
“Even if there was a present basis for declining to grant an injunction, in the absence of any evidence to explain why MSD did not either (1) lead such evidence it had available to it relevant to its public interest arguments at the trial; or (2) seek to raise the public interest point as a separate issue, I would be reluctant to permit it to, in effect, re-open its case after judgment in order to advance evidence and arguments that could have been raised then,” said the judge.
On costs, the Australian court declared that MSD should pay 85% of Wyeth’s costs in relation to the ‘013 patent and another patent (Australian number 2,013,206,844).
The court also ordered Wyeth to pay 80% of MSD’s costs of the third patent (known as the container patent) infringement and validity case.
Finally, the Australian court added that certain claims of the 844 patent and the container patent, which were previously found invalid, should be revoked. These orders were stayed for 28 days initially and, if an appeal or cross-appeal is lodged within this period, the orders will be stayed until the determination of such.
Pfizer welcomed the decision. A spokesperson for the company said: "Pfizer is proud of the significant contributions it makes to the health and wellbeing of Australians through its innovative vaccines. This decision encourages an environment that fosters innovation and manufacturing of new vaccines by companies like Pfizer."
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