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Intellectual property became front page news in 2021 as the pandemic ignited a debate on the role of patents in accessing COVID-19 vaccines and therapeutics. 2022 will see a decision on the TRIPS waiver, a new USPTO director, and action on a pending march-in petition.
The vaccines segment continues to draw the interest of participants beyond those firms with a traditional core presence, with new players largely building partnered capabilities around COVID-19 inoculations. Are these merely opportunistic forays or will the competitive landscape for vaccines stand altered more widely?
While an mRNA vaccine is still missing, 2021 saw Indian companies strike alliances, battle legal action and gain funding while the regulator played a crucial enabling role in the run up to the approval of eight COVID-19 vaccines from zero in 2020.
Availability of emergency authorization route in US depends upon lack of 'adequate, approved and available alternatives,' but as more vaccines make their way through the BLA process sponsors may find the EUA door slowly closing.
- Large Molecule
- Other Names / Subsidiaries
- Bilthoven Biologicals