Moderna wins Covid jab patent dispute over Pfizer and BioNTech

Moderna has won a case at the European Patent Office in its dispute with Pfizer and BioNTech over its Covid-19 vaccine, in a boon for the mRNA-vaccine maker in its ongoing legal fight to recoup pandemic profits from its rivals.

The decision by the EPO’s Opposition Division on Thursday to uphold the validity of one of two disputed patents is a boost for Moderna, which has faced several setbacks in its legal battle over Pfizer and BioNTech’s bestselling Comirnaty vaccine.

“We are pleased to announce that the European Patent Office decided to maintain the validity of Moderna’s EP949 patent, one of the key patents currently asserted against Pfizer and BioNTech in various European national courts,” the company told the Financial Times.

Pfizer and BioNTech have two months to lodge an appeal, which Pfizer said it may do. BioNTech said the EPO decision “does not change our unwavering and unequivocal stance that this patent is invalid,” adding “we will continue to vigorously defend our innovations against all allegations of patent infringement including this case”.

The EPO handed down an oral verdict on Thursday and is expected to publish a written decision in the coming months.

Moderna is pursuing Pfizer and BioNTech for a share of their profits from the Covid-19 vaccines in several courts across Europe and the US. The company has said that the Comirnaty vaccine infringes two of its patents.

Pfizer and BioNTech have countersued, alleging that the Moderna patents, filed in 2011 and 2016, are invalid.

Between them, Moderna, Pfizer and BioNTech — the leading Covid-19 vaccine makers — have generated billions in revenues from coronavirus shots, making $73.2bn in 2022 alone.

But the share prices of all three pharma groups have been hit as the pandemic has receded and demand for vaccines has waned.

The 949 patent relates to how mRNA is tweaked in the body to lower the immune response when introduced in the form of the vaccine. While pivotal to Moderna’s Covid-19 drug, the feature could also be applied to future mRNA-based treatments.

The EPO said that Moderna’s 949 patent “was maintained in amended form”.

Moderna last year lost a validity challenge in the EPO over an alternative patent, known as 565, which covers the use of mRNA technology specifically targeted at preventing coronavirus and other respiratory diseases. Moderna is appealing that decision.

National courts will continue to make rulings on the validity of the patent and whether it was infringed by Pfizer and BioNTech. They will also decide on any penalty to be paid.

The companies are awaiting a verdict on proceedings in London, which will also assess the legal impact of a pledge made by Moderna not to enforce its intellectual property rights while the pandemic continued.

Dutch, Belgian, German and Irish courts are also among European those assessing the validity of the patents, for which the EPO ruling could prove influential.

The Netherlands declared the 949 patent invalid in December proceedings but Moderna is appealing this ruling and litigation is likely to drag on.

Moderna has previously said it is not seeking to prevent the use of the Comirnaty vaccine.

Pfizer said: “Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the BioNTech/Pfizer Covid-19 vaccine in line with our agreements and established supply schedules, in support of public health.”

This article has been corrected to say that Pfizer and BioNTech have two months to lodge an appeal, rather than nine months.