Pfizer vs Moderna Legal Battle: Who Wins?

The drug manufacturer shot to worldwide fame at the end of 2020 after its mRNA-1273/Spikevax vaccine candidate was shown to be 94.1% effective in preventing COVID-19 infections in clinical trials, with some estimates suggesting that the company’s efforts might have saved up to 2 million lives.

 

Indeed, Moderna’s rapid rise to prominence was all the more impressive given the company had only started operations in 2010. Its success was a testament to the power of its innovative mRNA technology, which has gone on to revolutionize the drug development sector ever since.

Despite making billions of dollars from its invention, Moderna also demonstrated a great deal of humility in signing up to a so-called “patent pledge,” an act that enabled other companies to use its intellectual property in their own attempts to come up with a coronavirus treatment.

 

However, that humility appears to have been short-lived. Moderna recently announced its decision to sue Pfizer and BioNTech, two rival organizations that had taken up the company’s invitation to experiment with its mRNA technology.

 

In fact, the announcement has caused much consternation within the industry, with many commentators at a loss to explain why Moderna is alleging patent infringement at this particular point in time.

In a statement outlining its intention to bring suit, Moderna claimed that Pfizer and its partner BioNTech had “copied two key features of Moderna’s patented technologies.” These features include a chemical modification that helps prevent any undesirable immune reactions arising from the vaccine, as well as a method for targeting the unique spike protein associated with the virus.

 

But can Moderna win this battle, or will Pfizer/BioNTech ultimately prevail? Before answering that question, let’s take a quick look at what the companies are actually fighting over in the first place.

 

 

Proteins are an essential component necessary for the functional and structural integrity of every cell in your body. They provide the scaffolding for cell membranes, act as enzymes to catalyze reactions, and allow cells to communicate with one another.

 

But to produce proteins from their raw amino acid building blocks, cells need to manufacture them in a process that entails something known as translation. Translation involves a molecule called messenger RNA – or mRNA – which carries the genetic instructions from your DNA to the ribosomes in your cells. The ribosomes are responsible for reading the mRNA and assembling the amino acids in the correct order to create new proteins.

 

However, in the last decade or so, researchers have discovered that mRNA could also be used to create novel vaccines in the fight against stubbornly resistant viruses and even cancer cells.

 

The new technique, called in situ vaccination, directly targets virus-infected cells and cancerous tumors, offering a more specific approach to immunity than existed before.

 

In recent years, the development of mRNA-based vaccines has gained significant momentum. This is due in part to the fact that mRNA can be easily produced in large quantities and customized to target specific antigens. Additionally, mRNA is stable and can be stored for long periods without losing its potency.

 

One of the major advantages of using mRNA as a vaccine delivery platform is its safety profile. Unlike traditional live-attenuated or killed viruses – which can sometimes cause serious side effects – mRNA cannot replicate or cause infection. This makes it an ideal candidate for use in vulnerable populations such as young children, pregnant women, and the elderly.

 

In order to stimulate an immune response, most traditional vaccines work by introducing a weakened or inactivated germ into your body. The immune system then recognizes this “invader” as different from the body’s regular cells and sets out to destroy it.

 

As part of this process, the immune system “remembers” the invader so that it can more quickly destroy any future invaders of the same type in the future.

 

An mRNA vaccine, on the other hand, works on an altogether different principle. In this case, instead of using viruses or bacteria to stimulate an immune response, they use pieces of the virus’s genetic material. This means that an mRNA vaccine can be created much faster than a traditional vaccine, as it does not need to go through the process of manufacturing a live virus. The body recognizes the viral RNA as if it was the real virus and starts to produce antibodies to fight it off. These antibodies can then protect you if you are infected with the real virus.

 

Moreover, even if the virus mutates, as long as it still produces the same proteins, the vaccine will still be effective. Currently, there are mRNA vaccines in development for a range of diseases, including influenza, HIV, and cystic fibrosis.

 

At the heart of the matter is the question of how, whether, and to what degree Moderna’s original patent covenant is binding. The company had originally pledged not to enforce its intellectual property “while the pandemic continues,” but sought to update that commitment in March 2022 to apply it to only low- and middle-income countries.

 

Naturally, critics of the move will insist the pandemic is not yet over, and the initial pledge remains in place.

 

Moderna, however, probably wants to keep its options open: It wants to sell its booster shots in rich countries at a higher price point, while still providing cheap doses for those in poorer ones too.

 

The outcome of this debate has important ramifications for future access to life-saving medicines, and it’s not entirely clear how the case will pan out. If companies can simply change their minds about commitments like this, it could make it difficult for developing countries to receive vital treatments further down the line.

 

Some have speculated that Moderna may be feeling the pressure to show progress on its commercialization efforts, as it has yet to bring any non-COVID-related products to market. Others have suggested that the company may be simply trying to intimidate its competitors, or that it may be seeking to extract some sort of licensing fee from them.

 

Whatever the reason, it is clear that Moderna’s decision to go after its rivals for alleged patent infringement is a controversial one, and one that could have far-reaching consequences for the entire biotech field.