Patents
Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others.
The FDA is mired in uncertainty with some staffers losing their jobs over the weekend and more potentially to come, vaccines and psychedelic therapies could be facing very different futures under newly confirmed HHS Secretary Robert F. Kennedy, Jr., Moderna continues its downward revenue slide and Merck, Regeneron, BMS and more face strong patent headwinds.
Novartis is locked in a legal back-and-forth with MSN Pharma over alleged patent infringement of its heart failure drug Entresto.
AbbVie’s blockbuster Humira held 105 patents, shielding the anti-inflammatory drug from biosimilar competition for more than 20 years. Proposed reforms could help prevent companies from extending exclusivity with such patent thickets.
Novartis is seeking to prevent the entry of generics for its blockbuster heart failure drug Entresto, its top-selling asset that brought in more than $6 billion in net global sales last year.
A judge in the U.K. last month sided with Pfizer over GSK in a respiratory syncytial virus vaccine patent lawsuit, positioning both companies to compete for that market and laying down a marker for ongoing legal clashes in other parts of the world.
Analysts are split on whether the positive trial results will help Merck stem future Keytruda losses as the mega-blockbuster goes off patent in 2028.
Suggestions that the U.S. should emulate other countries on drug price controls or patents obscure how our present policies have allowed drug development to flourish.
The lawsuits claim that Moderna used and profited from crucial mRNA technology in its COVID-19 vaccine Spikevax and respiratory syncytial virus shot mResvia.
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
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