Merck recently announced that it will be acquiring Verona Pharma. The deal is slated to potentially offset losses as Merck’s blockbuster Keytruda gives way to generic competition. Verona’s principle drug is Ohtuvayre, which is an inhaled treatment indicated for chronic obstructive pulmonary disease (COPD). Ohtuvayre was approved in June 2024 in the U.S., and it has received five years of NCE exclusivity. Merck has high hopes for Ohtuvayre, and some analysts have suggested the drug to reach $4 billion a year. The drug is only protected by four patents, including a polymorph patent that expires in 2031, but could receive another five years of PTE. Is that enough to protect Merck’s acquisition of Verona?
Read MorePfizer is currently attempting to fend off generics for Vyndamax and Vyndaqel. Both drugs indicated for treatment of cardiomyopathy caused by transthyretin amyloidosis. Both contain the same active ingredient, tafamidis, but one is a salt form. Vyndamax contains the free acid form of tafamidis, whereas Vyndaqel contains the meglumine salt of tafamidis. Pfizer has patents for both drugs, expiring as early as 2025 and as late as 2035. How long can Pfizer keep out generics?
Read MoreAcadia Pharmaceutical has been litigating to keep out generics for its Parkinson’s Disease drug Nuplazid®. Although Acadia initially sued five separate generics for infringement of multiple patents, all the generics settled-out except one, MSN Pharmaceuticals. And in the case against MSN, only a single patent remains at issue (U.S. Patent No. 7,601,740). MSN recently moved for summary judgment on the ground that the ‘740 patent is invalid for obviousness-type double patenting (ODP). A recent precedential Federal Circuit decision, In Re: Cellect, LLC, addressed the ODP doctrine in detail. How will Cellect affect Acadia’s defense against the last generic holdout for Nuplazid®?
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