eyeforpharma Philadelphia 2014

Apr 15, 2014 - Apr 16, 2014, Philadelphia

Make customer centricity work: smart pharma mindsets, models and technology that will seal commercial success

Lawsuits against Generic Competition after Patent Increase for Pfizer’s Celebrex

Pfizer filed lawsuits against several US generic drug manufacturers after a patent for its drug Celebrex was reissued, thus extending its exclusivity to 18 months.



In 2008, Teva Pharmaceuticals challenged Pfizer’s original patents for Celebrex so that it could start producing a generic version of the drug. Following this, the Court of Appeals for the Federal Circuit upheld the drug’s patents expiring in May 2014 but considered Celebrex’s ‘method-of-use’ patent, expiring in December 2015, to be invalid. This was ruled on the grounds that this 2015 patent resulted in a double-patenting of claims present in the drug’s earlier patents.       

Recently, Pfizer filed an application to reissue this 2015 patent in order to correct ‘technical defects’ and other errors present in the original patent application. This 2015 patent, reinstated by the US Patent and Trademark Office, overturned the original 2008 Teva ruling and extended the drug’s US patent protection from May 30, 2014 to December 2, 2015. The reissued patent will run after the drug’s two basic patents, covering its chemical composition, expire on May 30, 2014.     

Following this reissued patent, Pfizer filed infringement-related lawsuits against generic drug makers like Apotex Inc.,Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Lupin Pharmaceuticals USA Inc., and Watson Laboratories Inc., which is now known as Actavis Inc. after a recent merger.   

Previously, all five of these companies had already applied to the US Food and Drug Administration so that they could start selling generic versions of Celebrex from May 30, 2014. Teva, Mylan and Actavis had already received tentative approval bythe FDA to start selling capsules of celecoxib in strengths ranging from 50 milligrams to 400 milligrams.       

The disease areas treated by Celebrex includerheumatoid arthritis, acute and menstrual pain, osteoarthritis as well as a painful spinal joint disorder called ankylosing spondylitis. Celebrex generated US sales of $1.75 and worldwide sales of $2.72 billion last year. It is Pfizer’s fifth-best selling drug and capsule prices vary from $90 to $160 per month, depending on its strength. Traditionally, blockbuster drugs can lose up to 80% of sales after patent expiry.  It is thought that Pfizer will gain $5 million in revenue by delaying generic competition by another 18 months.

Prior to this reissued patent, analysts expected these sales to drop after the expiry of the drug’s patents on May 30, 2014 as a result of the generic competition. For instance, Leerink Swann estimated that Celebrex’s global sales would decline to $1.85 in 2014 from a predicted $2.83 billion in sales this year.  

Pfizer’s general counsel Amy Schulman praised the ruling saying, “Continued development of new medicines that enhance patient lives is supported by protecting intellectual property. We are pleased with the reissuance of this patent.”

If this lawsuit is successful, patients will continue paying a higher, branded price for Celebrex. Pfizer has stated that if this lawsuit is not solved before May 2014, it will apply for a preliminary injunction. This will block all generic sales of Celebrex to prevent ‘irreparable and irreversible harm’. It is still unclear whether generic competition will be allowed after December 2015.



eyeforpharma Philadelphia 2014

Apr 15, 2014 - Apr 16, 2014, Philadelphia

Make customer centricity work: smart pharma mindsets, models and technology that will seal commercial success