Indian generic manufacturer Lupin is sued by Genzyme for infringing patents on an earlier version of the drug – sevelamer hydrochloride (Renagal) – in March 2008.
India’ generic maker Lupin is being sued by Genzyme Corporation of UK for alleged infringement of its patent in the United States District Court of Maryland on kidney disease drug Renvela.
Renvela pills which contains sevelamer carbonate – the new general version of sevelamer hydrochloride – as active ingredient was approved by US FDA on October 9,2007 for the control of serum phospherous in patients with chronic kidney disease on dialysis.
This follows Genzyme’s litigation against Lupin on the infringement of Renagal-sevelamer hydrochloride 400 and 800 mg tablets in March this year.
The Mumbai-based Lupin, through filing an abbreviated new drug application (ANDA) for Para IV certification sought approval to commercially manufacture, use, sell of the generic 800 mg of sevelamer tablets in US.
Genzyme, on its petition filed on May 14, 2009, has alleged that if approved for sale in US, Lupin would be infringing Genzyme’s one or more claims of valid patents viz. 545,’775,’013,’203,’846 and ‘151 prior to their expiration.
However, Lupin in a Notice Letter informed Genzyme that none of the above-said patents will be infringed by the ANDA as they are invalid and unenforceable in the manufacture and sales of sevelamer pills in US.
Renvela was originally developed by GelTex Pharmaceuticals Inc which was acquired by Genzyme in the year 2000.
The patents under dispute were issued in US on patent nos. 5,496,545 (“Phosphate-Binding Polymers for Oral Administration,” issued March 5, 1996), 5,667,775 (same title, issued on September 16, 1997), 6,509,013 (“Method of Making Phosphate-Binding Polymers for Oral Administration,” issued January 21, 2003), 6,858,203 (same title, issued February 22, 2009), 7,014,846 (“Phosphate-Binding Polymers For Oral Administration,” issued on March 21, 2006), and 7,459,151 (same title, issued December 2, 2008).
Genzyme had sales last year of $678 million for Renvela the company said.
Renvela is a next-generation version of sevelamer hydrochloride, which is sold under the brand name Renagel. Renvela is a calcium-free, metal-free, non-absorbed phosphate binder, and has the added benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within recommended KDOQI range.
Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride) are currently the only phosphate binders available that do not contain either calcium or a metal. Sevelamer, the active moiety in both Renagel and Renvela, has an established safety profile and is not systematically absorbed. It is used by more than 350,000 patients worldwide.
Renvela and Renagel are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction.
In April, Elan Pharma International and Fournier Laboratories Ireland have filed a lawsuit against Lupin Pharmaceuticals for infringing two patents covering TriCor (fenofibrate), 48 and 145 mg, a drug used to reduce cholesterol levels.
Similarly in another case Lupin, along with other Indian peers Sun Pharma, Wockhardt, were sued Pfizer, the world’s largest pharmaceutical company, alleging infringement alleging patent violation for seeking marketing approvals for the generic equivalents of its high-selling neuropathic pain management drug Lyrica in the United States.
Genzyme is one of the world’s leading biotechnology companies, with revenues of $4.6 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. Genzyme’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing.