“Moderna Wins Patent Case Against Pfizer and BioNTech Over Covid-19 Vaccine”

In a significant development in the ongoing legal battle over Covid-19 vaccine patents, Moderna has emerged victorious in a case at the European Patent Office (EPO) against Pfizer and BioNTech. The EPO’s Opposition Division upheld the validity of one of two disputed patents on Thursday, marking a significant boost for Moderna in its quest to recoup pandemic profits from its rivals.

Moderna has been embroiled in a legal dispute with Pfizer and BioNTech over their bestselling Comirnaty vaccine, alleging that it infringes two of its patents. The company expressed satisfaction with the EPO’s decision, stating, “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.”

Pfizer and BioNTech now have two months to lodge an appeal against the decision, a move Pfizer has indicated it may pursue. BioNTech, on the other hand, maintained its stance that the patent is invalid and vowed to “continue to vigorously defend our innovations against all allegations of patent infringement including this case.”

The EPO delivered an oral verdict on Thursday, with a written decision expected to be published in the coming months. The dispute extends beyond Europe, with Moderna pursuing Pfizer and BioNTech for a share of their Covid-19 vaccine profits in several courts across the US as well.

In a countermove, Pfizer and BioNTech have alleged that the Moderna patents, filed in 2011 and 2016, are invalid. The legal wrangling comes as Moderna, Pfizer, and BioNTech, the leading Covid-19 vaccine makers, have collectively generated billions in revenues from their coronavirus shots, raking in $73.2bn in 2022 alone.

The patent in question, 949, pertains to the modification of mRNA in the body to lower the immune response when introduced in the form of a vaccine. This feature, while crucial to Moderna’s Covid-19 drug, could also be applied to future mRNA-based treatments. The EPO maintained Moderna’s 949 patent “in amended form.”

However, Moderna’s legal journey has not been entirely smooth. The company lost a validity challenge in the EPO over another patent, 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. Courts in the Netherlands, Belgium, Germany, and Ireland are also assessing the validity of the patents, with the EPO ruling potentially proving influential.

The Netherlands declared the 949 patent invalid in December proceedings, but Moderna is appealing this ruling, indicating that the litigation is likely to continue. Moderna has previously stated that it is not seeking to prevent the use of the Comirnaty vaccine.

Pfizer, in response to the EPO’s decision, stated, “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.”

The ongoing legal battle underscores the high stakes in the race to develop and distribute vaccines to combat the Covid-19 pandemic, with billions in potential profits and the future of mRNA-based treatments hanging in the balance.