Painkiller Celebrex has been an incredible moneymaker for pharmaceutical producer Pfizer Inc., partially because of patents that guaranteed Pfizer’s U.S. exclusivity of the drug. However, after a recent district court ruling, that exclusivity may be ending quicker than the company expected.
On March 12, the U.S. District Court for the Eastern District of Virginia invalidated a reissue patent that would have extended Pfizer’s exclusive rights to the drug by 18 months. The original reissue patent was granted by the U.S. Patent and Trademark Office in 2013 and covered various methods of treating osteoarthritis and other conditions through celecoxib, the drug’s active ingredient.
As a result of the court’s ruling, Pfizer’s U.S. patent protection of the drug will now expire on May 30, 2014, rather than Dec. 2, 2015. That May date is also when another patent covering the drug’s basic compound is set to expire.
“Pfizer disagrees with the ruling and will pursue all available remedies, including an immediate appeal of the court’s decision,” the company said in a statement following the ruling.
As The Wall Street Journal notes, the timing of this announcement is intriguing because of a patent trial that was due to begin next week concerning the drug. Pfizer pursued a case against six generic drug companies, including Teva Pharmaceutical Industries Ltd., Mylan Inc., and Actavis PLC, over alleged infringement of the patent.
Teva, Mylan and Activis have already received U.S. Food and Drug Administration approval to being producing the drug generically once Pfizer’s patent expires. After the court’s ruling, Mylan told the WSJ that the company found the court’s ruling “favorable” and that it plans to begin producing the drug directly after the patent expires in May.
Pfizer has recently seen some turnover at the top of its legal department. Former general counsel Amy Schulman left the company in December 2013, with former chief compliance and risk officer Douglas Lankler taking over her former position.
For more on recent patent decisions, check out these InsideCounsel articles: