Celgene is prepped and ready for its patent fight over the blood cancer drug Revlimid. In fact, it's been planning its strategy for years. And the battle is similar to one fought this year on a closely related drug.
The FDA recently disclosed on its website that an unnamed company, or companies, filed an application on July 12 to market a generic version of Revlimid. However, as the Wall Street Journal notes, Celgene CEO Robert Hugin already has his battle plans for Revlimid in place. He'll use the same three law firms Celgene hired to defend Thalomid (thalidomide). After all, Revlimid is a thalidomide derivative. Earlier this year, Teva Pharmaceutical's Barr unit withdrew its ANDA for thalidomide after the two companies had faced off against one another in court.
"Everything we've done is to protect Revlimid and we feel as strong as we can about the patent estate," Hugin tells the Journal. Indeed, when fighting for Thalomid's patent protection, the company told its lawyers to back off any legal strategies that might threaten their eventual fight over Revlimid.
Revlimid is covered by 12 patents, including one that expires in 2019 and another--covering the crystal polymorph form of the drug--that expires in 2026. It's this latter patent that analysts believe is most vulnerable to challenge. "Because of the types of patents that expire beyond 2019 and the mixed track record of success with crystal polymorph patents," Jeffries analyst Thomas Wei writes in an investor note, "there is uncertainty on the exclusivity period for Revlimid beyond 2019." As of yet, we don't even know the identity of the putative challenger.