MODERNA US Inc. V. PFIZER Inc., BIONTECH SE, Manufacturing Gmbh & Biontech US Inc. : A patent lawsuit from pandemic

The COVID-19 pandemic not only hit hard on the daily lives of humans all around the world but also cause greater damage to the economies all around the world. Still many big and small businesses are struggling on their way out of the pandemic, except for one and that is the pharmaceuticals industry. As per the report of relief web these 3 big pharma giants i.e. Moderna, Pfizer and BioNTech were making a profit of $1,000 every second during the pandemic. Now a lawsuit over patent infringement is also resulting from that pandemic between these 3 companies.

MATTER OF THE SUIT
A 1046 pages long suit is filed by Moderna against Pfizer/BioNTech over alleged patent infringement of the mRNA vaccine technology developed by the 2010 established company Moderna, a platform that is essential to the development of covid jabs.
Moderna alleged 2 fold infringement of their patent: first is the chemical modification that prevents the body from attacking the vaccine before it works in the body. And the second one is a virus that the vaccines train the body to recognize coronavirus spike protein, which is a part of the virus that lets it penetrate human cells.

RELIEF CLAIMED
Keeping in line with the 2020 statement given by the Moderna company they are not seeking any injunction order against the company for making any future sale in the market because of the life-saving role they played in the pandemic.
They are planning to seek damages for the alleged infringement by filing a suit in US and German courts.
As of the year 2022, Moderna expected a turnover from its mRNA -based covid vaccine to be around $10.4 billion whereas for Pfizer it is around $22 billion.

LAWS DEALING WITH PATENTS IN THE PHARMA INDUSTRY
The company chose to wait for around 2 years for filing this lawsuit for damages. One reason could be the lifesaving role played by these industries in the pandemic or the other cone could be the BOLAR EXEMPTION. It is one of the defenses against patent infringement in this industry.
USA
It is developed in a US case under which the newly invented drug or any invention can be used or sold by a third party for further development or research purposes without any fear of legal consequences.
Roche Products V. Bolar Pharmaceuticals
The court held that Bolar’s use of a patented compound for federally mandated testing was an infringement of the patent. But it ruling was overturned by Congress by enacting a law
permitting the use of patented inventions in research work to seek approval of the Food and Drug Administration.

INDIAN LAW
The Bolar exemption is recognized in India under section 107(A) of the Indian Patent Act, 1970.
Moreover, it is also upheld by the Delhi high court in the case of Bayer corporation v. Union of India and others as well as also in the case of Bayer Intellectual Property GMBH & Anr.V. Alembic Pharmaceuticals Ltd.

In the present lawsuit of 2022, these three companies involved are already facing a series of patent infringement lawsuits from a number of small companies over the use of mRNA vaccine technology. So what is the effect of these lawsuits on this case as well as who has the actual ownership of this technology will surely add an interesting chapter to the patent law.

Daman Preet Kaur

Author

I am a final year student, pursuing law from Punjabi University Patiala. I have interned with 7 law firms and throughout these internships, I try to make sure they deal with different areas of law so that I can learn and diversity my knowledge as much as possible.

As I truly believe a great lawyer is one who knows something of everything and everything of something.

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