Pfizer sues Sun, Wockhardt, Lupin on Lyrica (pregabalin) patents

Sun and Wockhardt have breached one patent each while Lupin three, of its valid patents on Lyrica, alleges Pfizer.

Pfizer has filed a complaint against generic makers including Indian companies like Sun Pharma, Wockhardt and Lupin for infringing its patent on Lyrica (pregabalin), in the US district Court of Delaware.

Pfizer approached the court alleging that  Sun Pharma, Wockhardt and Lupin are violating its valid patents on Lyrica as these companies filed abbreviated new drug application (ANDA) seeking approval to market a generic version of Lyrica.

Among Pfizer’s patents the ones currently in dispute are: patent no.6,197,819 (’819) refers Gamma Amino Butyric Acid Analogs and Optical Isomers for the treatment of fibromyalgia,” issued March 6, 2001. Patent no.6,001,876 (’876) refers to Isobutylgaba and Its Derivatives for the Treatment of Pain,” issued December 14, 1999 and No.5,563,175 (’175) GABA and L-glutamic Acid Analogs for Antiseizure Treatment,” issued October 8, 1996.

Some of these patents are expected to expire by March 6, 2018 .

While Pfizer has accused Lupin for the alleged infringing of its valid patents Nos. ’819, ’876 and ’175, the world’s largest drug maker, accused Sun and Wockhardt for violating patent no.’819 which cover Lyrica in US, in their filing  to US FDA seeking para IV certification for generic versions.  

While Sun Pharma in a response letter argued that its para IV filing for pregabalin strengths 25, 50, 75, 100, 150, 200, 225, 300mg that ’819 patent is invalid, unenforceable and will not be infringed by the commercial manufacture use, or Sale of the generic product.

Teva, Sandoz, Actavis, Cobalt Laboratories, Alphapharm Pty Ltd are the other generic companies being sued by Pfizer on Lyrica patent violations in US.

Lyrica (pregabalin) is an oral pill that is chemically related to the other gabapentin grugs like Neurontin and Gabarone. It is used for treating pain caused by neurologic diseases such as postherpetic neuralgia as well as seizures.

The mechanism of action of pregabalin is unknown. Pregabalin binds to calcium channels on nerves and may modify the release of neurotransmitters (chemicals that nerves use to communicate with each other). Reducing communication between nerves may contribute to pregabalin’s effect on pain and seizures. The FDA approved pregabalin in December 2004.

The US FDA approved pregabalin in December 2004. for use in treating epilepsy, diabetic neuropathy pain and post-herpetic neuralgia> Pfizer started selling it on the US market in fall 2005.

In June 2007 the FDA approved Lyrica as a treatment for fibromyalgia. Fibromyalgia is a disorder classified by the presence of chronic widespread pain and a heightened and painful response to gentle touch. Fibromyalgia also include debilitating fatigue, sleep disturbance, and joint stiffness. 

Global sales of Lyrica is estimated to be around 1.2 billion. Lyrica sales jumped 45% last year to $675 million, majorly offsetting Pfizer’s losses from dropping revenues from its leading block-buster drug Lipitor. Analyst estimates that Lyric could continue to be blockbuster that can spin more earnings for Pfizer in the coming years as well.

Teva is a unit of Petah Tikva, Israel-based Teva Pharmaceutical Industries Ltd., the world’s largest generic drugmaker. Cobalt is based in Bonita Springs, Florida. Wockhardt and Lupin are based in Mumbai. Sandoz is a unit of Basel, Switzerland-based Novartis AG. Alphapharm is a unit of Canonsburg, Pennsylvania-based Mylan Inc.

Founded in 1849, Pfizer is the world’s largest comapny in terms of drug sales. Pfizer makes the number-one selling drug Lipitor (atorvastatin, used to lower blood cholesterol); the neuropathic pain/fibromyalgia drug Lyrica (pregabalin); the oral antifungal medication Diflucan (fluconazole), the long-acting antibiotic Zithromax (azithromycin), the well-known erectile dysfunction drug Viagra (sildenafil citrate), and the anti inflammatory Celebrex (celecoxib) (also known as Celebra in some countries outside USA and Canada, mainly in South America).

On January 26, 2009, Pfizer agreed to buy pharmaceutical giant Wyeth for US$68 billion, a deal financed with cash, shares and loans. Pfizer cloaked an annual revenue of $48.418 billion (2007).