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Activery The amorphization specialist

Activery The amorphization specialist

Activery believes that amorphous drugs provide new and innovative routes to final dosage forms with differentiated pharmacokinetics

Service analyse DSC

SERVICE ANALYSE DSC ET TGA Activery offre aussi le service d analyse thermique (analyse DSC et TGA) en externalisation. Nous effectuons l analyse thermique pour différents produits chimies, polymères, cosmétiques et , spécialement, pour produits pharmaceutiques come des principes actives ou for...

Creating new paths to differentiated medicines

Creating new paths to differentiated medicines

In Activery we believe that solid state modifications may lead to a critical changes in your active pharmaceutical, thus to a differentiated drug or to a brand new innovative medicine  

Activery, the solid state specialist

Activery, the solid state specialist

Activery possess unrivalled specialist expertise about different crystallization techniques and expert knowledge in the field of solid state modulation.  

Particles and nanoparticles for special uses

Particles and nanoparticles for special uses

In Activery, we design and produce particles for special uses where size matters such as nanoparticles for cancer treatment. Through our technology you would enable new administration routes or renewed performance of your drug formulation.  

Battle Royale Between Ranbaxy and Pfizer over Lipitor PDF Print E-mail
 Battle Royale Between Ranbaxy and Pfizer over Lipitor

Sabia Tamboo from IPfrontLine.com


In August 2003 the Indian Pharmaceutiocal giant Ranbaxy decided to take a crack at Pfizer's 10 billion market by challenging the patents on its mega successful cholesterol reducing drug Lipitor. Ranbaxy challenged the patents in United Kingdom, United States, Austria, Norway, Romania and Peru.


In October 2005 the UK High Court of Justice rejected Ranbaxy's claim. Ranbaxy appealed against the decision and in June 2006 the UK Court of Appeal upheld the lower Court decision ruling that atorvastatin infringed the claims of the basic patent of Pfizer. The ruling meant that Ranbaxy would have to wait till 2011 to release its generic version in the UK market.

In November 2005 in Norway a Norwegian Court held that Pfizer's patent covering a compound used to making atorvastatin a key ingredient a Lipitor would be infringed by Ranbaxy's generic version of atorvastatin. However the Court also ruled that the Process patent for converting crystalline atorvastatin to amorphous atorvastatin was valid but was not infringed by Ranbaxy.

In April 2006 Austria's supreme patent and trade mark senate held invalid the patent covering atorvastatin calcium which was a major blow to Pfizer. However Pfizer was quick to add that the decision did not apply to any other patent litigation in relation to Lipitor taking place between Ranbaxy and Pfizer in other jurisdictions. On the other hand Malvinder Singh, Ranbaxy's CEO and managing director said "Our success further validates our strategy to successfully commercialize atorvastatin in Austria, and potentially other healthcare markets in the future,".

In December 2005 the District Court of Delaware had ruled that Ranbaxy's product infringed both the patents that Pfizer held on Lipitor. One is the patent covering the main molecule and another covers the calcium salt of Lipitor. The patent covering the main molecule expires in March 2010 and that covering the calcium salt in June 2011.

Ranbaxy appealed against this decision to the Court of Appeals For Federal Circuit and received a split decision. The Appeal court held that Ranbaxy's generic product atorvastatin infringed the basic patent which expires in 2010 but invalidated the 2011 patent.

This could mean that the generic version of Ranbaxy's product could hit the United States market by the end of March 2010.

Ranbaxy's Senior Vice President for Global Intellectual Property R Deshmukh said, "We are pleased with the Court's decision on the 995 patent and are evaluating our options with respect to the 893 patents."

On the other hand Pfizer's senior vice president of intellectual Property said, "While we are pleased that the Court has affirmed that our basic patent is valid and infringed, we are disappointed in the decision on the 995 patent."

Pfizer has successfully defended its patents in Romania and Peru. This round of litigation has thrown up a mixed bag of results for both Pfizer and Ranbaxy and now it remains to be seen what surprises come up as the Battle Royale proceeds.