Context: Lawsuits over mRNA patents allegedly infringed by COVID-19 vaccines have previously been brought, most notably by Moderna and CureVac, rather unsuccessfully so far.
What’s new: With GlaxoSmithKline, one of the world’s largest pharmaceutical companies has now thrown its hat in the ring. GSK is suing Pfizer and BioNTech over the latter’s COVID-19 vaccine in the District of Delaware, seeking damages for the alleged infringement of five patents.
Here’s the complaint:
It’s unclear why GSK waited so long to bring its claims. The company may have deemed it prudent to await developments in other litigations involving COVID-19 vaccines in general and BioNTech’s Cominaty in particular, and/or it may have wanted to wait for political reasons.
These are the five patents-in-suit:
- U.S. Patent No. 11,638,693 on a “vaccine for eliciting immune response comprising RNA encoding an immunogen and lipid formulations comprising mole percentage of lipids”
- U.S. Patent No. 11,638,694 on a “vaccine for eliciting immune response comprising lipid formulations and RNA encoding multiple immunogens”
- U.S. Patent No. 11,666,534 on “methods of administering lipid formulations with viral immunogens”
- U.S. Patent No. 11,766,401 on “methods of administering lipid formulations with immunogens”
- U.S. Patent No. 11,786,467 on “lipid formulations with immunogens”
This is what the complaint says about the history of GSK’s innovation in mRNA:
2. In 2008, more than a decade before the SARS-CoV-2 (2019) coronavirus disease (COVID-19) pandemic, Andrew Geall, an accomplished formulation scientist and the named inventor of the Patents-in-Suit, joined a team of talented researchers working under the leadership of vaccinologist Christian Mandl (the “Mandl team”) focused on developing mRNA vaccines. These individuals discovered formulations comprising lipids and mRNA molecules encoding a viral immunogen that provide protection from viral infection. The Mandl team described the inventions now claimed in the Patents-in-Suit, in patent applications filed in 2010.
3. The Mandl team’s innovation has been revolutionary for vaccine development. A significant advantage over other approaches to vaccine design is the ability to employ the technology as a platform to formulate and administer mRNA encoding a wide range of immunogens. The prestigious science journal Nature noted in 2021 that “[e]very mRNA company now uses some variation of [the Mandl team’s] delivery platform and manufacturing system[.]” Exhibit 6 (Dolgin, “The Tangled History of mRNA Vaccines,” Nature 597, 318 (2021)) at 323.
4. Another major advance of the Mandl team’s inventions over preexisting vaccine technologies is the speed with which a new vaccine candidate can be made and tested. Indeed, in response to the 2013 influenza outbreak in China, the Mandl team created a new mRNA vaccine candidate in just eight days—“in real time the moment that sequence was available.” Exhibit 7 (Dolgin, “Injection of Hope,” Nature 574, S10 (2019)) at S11. Nature recognized this achievement as “[t]he current speed record” of vaccine development. Id.
This is obviously a multi-billion-dollar case. GSK is being represented by local Delaware law firm Richards, Layton & Finger, with most of the work apparently being done by Desmarais.