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20 October 2020Big PharmaSarah Morgan

MSD secures victory before English court

The English High Court has concluded that Merck Sharp Dohme (MSD) is not infringing a patent owned by Pfizer through the sale of its pneumococcal conjugate vaccine.

In a decision issued Thursday, October 15, Justice Richard Meade held that MSD didn’t infringe European patent (UK) 2,676,679—which is owned by Wyeth, a subsidiary of Pfizer—and that all of the patent claims were obvious in light of prior art.

The ‘679 covers a 13-valent pneumococcal vaccine which, according to Pfizer, was infringed by MSD’s 15-valent vaccine.

At issue was whether the patent was limited to vaccines having polysaccharides of precisely the 13 specified serotypes, or whether it covered vaccines with those 13 and more (such as MSD’s).

Siding with MSD, Meade said that whether Integer F of claim 1 requires precisely 13 specified serotypes or permits more hinges on the word “are”.

Integer F doesn’t use the word “comprises” which, according to the court, is conventionally in patent claim drafting to indicate "includes", so that those things that follow must be present, but others are allowed in addition.

Instead, Integer F uses “are”, which Meade claimed was an “obvious and powerful” contrast.

“It is hard to see how else, realistically, following conventional drafting, the patentee would have phrased the claim if it had intended to specify precisely the 13 pneumococcal saccharides,” he added.

Taking into account the textual and scientific context, the court sided with MSD and found the company did not infringe Pfizer’s patent.

MSD had also presented a number of different arguments, including anticipation, obviousness in light of prior art, and insufficiency.

While its insufficiency attack failed and the anticipation argument was partially successful, the court did find that all claims of the patent were obvious over one of the prior arts, a publication called “Present and Future of the Vaccination against Pneumonia”, written by Coniic Conny De Peña.

Pfizer said it was disappointed with the decision and will be seeking to appeal against it.

“We believe that the patent is valid and would be infringed by MSD’s proposed pneumococcal conjugate vaccine. As this is an ongoing case, we are not commenting further at this time,” said a spokesperson for Pfizer.

A spokesperson for MSD said it was pleased with the court’s judgment of invalidity and non-infringement. 

“We look forward to continuing our work toward marketing approval for MSD’s investigational pneumococcal vaccines,” they added.

Last week, the Federal Court of Australia issued a decision involving the same parties, on the same vaccine. While the court concluded that MSD was infringing one patent owned by Wyeth, it also found that two other Wyeth patents were invalid.

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More on this story

Asia-Pacific
15 October 2020   In a mixed decision for Merck Sharp Dohme, 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.
Americas
29 September 2020   The US Court of Appeals for the Federal Circuit has sided with EMD Serono and Pfizer over the invalidation of a multiple sclerosis drug patent, in a defeat for biotech company Biogen.
Asia-Pacific
30 November 2020   The Federal Court of Australia has granted Pfizer subsidiary Wyeth’s bid for an injunction against Merck Sharp Dohme in a dispute over vaccine patents.