Pfizer and BioNTech secure PTAB victory against Moderna amid global patent disputes

Pfizer and BioNTech scored a significant win at the US Patent Trial and Appeal Board (PTAB or the Board) over COVID-19 vaccine technology. The Board invalidated all challenged claims in two of Moderna’s patents related to its Spikevax COVID-19 vaccine, citing strong evidence of obviousness. While this decision represents a pivotal moment in the ongoing legal conflict between these pharmaceutical giants, it is unlikely to mark the end of the dispute. Moderna has signaled its intent to appeal the decision.

Background

Moderna initially filed a lawsuit in the US District Court for the District of Massachusetts in August 2022, claiming Pfizer and BioNTech infringed three of its patents. The contested patents—US Patent Nos. 10,702,600, 10,933,127, and 10,898,574—cover critical aspects of Moderna’s mRNA vaccine technology. These aspects include the use of mRNA-encoding spike proteins or subunits of betacoronaviruses delivered via lipid nanoparticle formulations. Additionally, the ‘574 patent focuses on modified mRNA technology to enhance protein production and reduce immune response.

In response, Pfizer and BioNTech filed two inter partes review (IPR) petitions with the PTAB in August 2023. They challenged claims in the ‘600 and ‘127 patents on the grounds of anticipation and obviousness, asserting that the claimed technologies were already disclosed in prior art or obvious to those skilled in the field.

PTAB outcome

On March 5, 2025, the PTAB invalidated all challenged claims in the ‘600 and ‘127 patents. The PTAB concluded that Pfizer and BioNTech “made a very strong showing” that Moderna’s claimed inventions were rendered obvious by earlier patent applications and a publication.

The Board acknowledged Moderna’s secondary considerations, including the commercial success of its Spikevax vaccine, industry praise, and the long-felt need for a safe and effective coronavirus vaccine. However, it determined that these factors did not outweigh the “strong (and, in some cases, substantively unrebutted) evidence” of obviousness presented by Pfizer and BioNTech.

The PTAB found that Moderna’s 2013 patent application (US Patent No. 9,868,692) described an mRNA vaccine platform and pointed to a 2012 Novartis application (US Patent No. 8,778,905) that used similar technology against viruses. Additionally, a 2004 Nature magazine article about SARS vaccines (SARS: The First Pandemic of the 21st Century) was also cited as rendering some challenged claims obvious. The Board concluded that a person having skill in the field would have been motivated to combine these teachings with a reasonable expectation of success.

Parallels in Europe

In the US, the Board focused on the validity of the claims challenged by Pfizer and BioNTech. In Germany, the court evaluated whether Pfizer and BioNTech’s activities infringed Moderna’s European patent.

While Pfizer and BioNTech triumphed at the PTAB, their success did not carry over to Europe. The Düsseldorf Regional Court in Germany held that Pfizer and BioNTech had infringed one of Moderna’s European patents covering mRNA vaccine technology.

Pfizer and BioNTech have announced plans to appeal the German court’s decision.

Implications

The PTAB’s decision to invalidate Moderna’s patents illustrates the critical importance of ensuring patents are strategically broad but also defensible. For companies operating in rapidly advancing fields like mRNA technology, the ruling underscores the need for a dual focus: capturing innovation in a way that withstands scrutiny while anticipating potential challenges from competitors. In practice, this means assessing prior art, evaluating invalidity risks early, and continually monitoring the competitive landscape.

The case serves as a reminder that intellectual property disputes can affect market dynamics. With billions of dollars at stake in the mRNA vaccine market, such victories can influence revenue streams and competitive positioning. For example, Pfizer and BioNTech’s victory safeguards their innovation (for now, at least) and provides them with stronger leverage in negotiating future licensing agreements or cross-licensing opportunities.

The case also emphasizes the importance of preparedness and strategic adaptability in patent enforcement strategies, particularly in responding to invalidity challenges or infringement claims. The rapid evolution of mRNA technology, coupled with a surge in legal activity, has heightened the need for companies to navigate domestic and international disputes. The contrasting outcome in Germany, where the court found infringement, highlights how differing legal frameworks can lead to varied enforcement results.

Let this serve as (yet another) cautionary tale: the strength of a company’s intellectual property lies in its ability to defend that innovation under pressure, and this strength stems from a well-rounded IP strategy.

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