Australian court issues mixed vaccine patent ruling
In a mixed decision for Merck Sharp Dohme (MSD), the Federal Court of Australia has concluded that the pharmaceutical company is infringing one patent owned by Wyeth, but that two other Wyeth patents are invalid.
Yesterday, October 14, in a 959-paragraph ruling, Justice Burley concluded that MSD’s 15-valent pneumococcal conjugate vaccine would infringe one of Wyeth’s patents, Australian number 2,006,235,013.
However, the court also found that two other patents owned by Wyeth (which is a subsidiary of Pfizer) were infringed but invalid.
“It is perhaps not inappropriate that, at a time when the world is affected by the COVID-19 pandemic, the present dispute concerns attempts to improve disease immunity,” said Burley.
MSD had claimed that the three patents were invalid. Both the ‘013 and Australian patent number 2,013,206,844 concern a “multivalent immunogenic composition comprising 13 distinct polysaccharide-protein conjugates”.
The third patent, Australian number 2,012,216,628, is known as the container patent throughout the ruling and is called “Novel formulations which stabilise and inhibit precipitation of immunogenic compositions”.
Burley added: “Two pharmaceutical companies are in the race to develop better forms of immunisation against Streptococcus pneumoniae, which is a leading cause of meningitis, pneumonia and severe invasive disease in people, especially infants and young children, throughout the world. These proceedings concern an aspect of that race.”
Infringement and injunctions
Wyeth sought declaratory, injunctive and other relief against MSD in November last year, claiming that MSD would infringe the ‘013 and ‘844 patents through the launch of its 15-valent vaccine. Then, at the commencement of the trial, Wyeth also argued that MSD would infringe the claims of the container patent.
“For the reasons set out perhaps far too fully above, I have found that the asserted ‘013 patent claims are valid and will be infringed by MSD’s 15-valent vaccine,” said Burley.
Under the Patents Act 1990 (which applies to the ‘013 patent but has subsequently been amended), claims of a patent must be fairly based on the matter described in the specification.
MSD argued that the disclosure in the specification is of a composition with the 13 specified serotypes and no more, so that there is no “real and reasonably clear disclosure” of an immunogenic composition with more than 13 serotypes.
But, the court sided with Wyeth, finding that there was a “real and reasonably clear disclosure,” so MSD’s fair basis challenge failed.
MSD was also found to have infringed the other two patents, but the court found both patents invalid.
The parties have been directed to confer and propose short minutes of order giving effect to this judgment.
A spokesperson for Pfizer said it welcomed the decision that its ‘013 patent is valid and infringed by the proposed MSD vaccine. It plans to ask the court to grant an injunction preventing the launch of MSD’s proposed vaccine until expiry of the patent on March 31, 2026.
“Pfizer is additionally pleased with the Federal Court decision that another of its composition and a formulation patent relating to Prevenar 13 would be infringed by MSD’s proposed vaccine, but is disappointed with the finding that the two patents are invalid. Pfizer intends to appeal this portion of the decision,” said the spokesperson
MSD declined to comment.
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