Merck sued over expired anti-cancer patent
PDL BioPharma has sued Merck Sharp & Dohme (MSD) in a complaint that centres on a now-expired patent directed to treating melanoma.
In a lawsuit filed at the US District Court for the District of New Jersey, PDL said that anti-cancer drug Keytruda (pembrolizumab), manufactured by MSD, infringed its US patent number 5,693,761.
The patent, which was granted in 1997, is called “Polynucleotides encoding improved humanized immunoglobulins”. It expired in December 2014—shortly after Merck’s drug was approved.
According to the complaint, Keytruda was approved by the US Food and Drug Administration in September 2014. PDL’s patent, directed to a method of attacking cancerous cells during treatment, expired on December 2 that year.
In its complaint, filed on January 22, PDL claimed that MSD infringed one or more claims of the ‘761 patent by making Keytruda without a licence or authority from PDL.
The complaint added: “Merck has known about the ‘761 patent for many years prior to the expiration of the patent and was well aware long before the filing of this action that making Keytruda amounted to infringement.”
According to PDL, it agreed a licensing deal with MSD in 2005 to secure rights to the ‘761 patent for a “variety of potential products—but not Keytruda”.
PDL is seeking a judgment of wilful infringement, damages and attorneys’ fees.
