Friday, 11 March 2011

Never ending patents?

Some interesting “pills”
Monday The New York Times published Drug Firms Face Billions in Losses in ’11 as Patents End.

"At the end of November, Pfizer stands to lose a $10-billion-a-year revenue stream when the patent on its blockbuster cholesterol drug Lipitor expires and cheaper generics begin to cut into the company’s huge sales".

"The loss poses a daunting challenge for Pfizer, one shared by nearly every major pharmaceutical company. This year alone, because of patent expirations, the drug industry will lose control over more than 10 megamedicines whose combined annual sales have neared $50 billion".

"... the industry faces intense pressure from generic competition and has tried every tactic to ward it off, including extended-release versions of the same medicine and new pills that combine two ingredients".
Reading the reference to expiration this year of Lipitor patent, the actions started against Dr Reddy (the last one at the beginning of the year) came to my mind. As announced for example in ibtimes on January 4, 2011, “Pfizer moves court against Dr Reddy's launch of Lipitor in US market”. As there reported, "The drug maker, which rakes in over $12 billion in global sales from Lipitor, has asked the court to withhold approval of the drug until one of its patents for Lipitor expires in January 2017".

On January 5, 2011, Claire Bowie wrote on Pharma Times:
"Though Pfizer’s central patent for the crystalline form of atorvastatin expires in July 2016, and it retains paediatric exclusivity through to January 2017, it came to an out of court agreement with Ranbaxy in 2008 that will see the Indian firm sell a low priced version of the enantiomer version of the drug from November this year.

The two firms have been fighting over the validity of patents covering Lipitor all over the world since 2003 and a number of analysts thought that Ranbaxy could possibly launch its generic version of the drug as soon as March 2010 in the USA, when Pfizer’s basic patent was set to expire. The enantiomer patent expires in the USA in 2011, while various process and crystalline form patents are valid until 2016 and 2017".
Bringing our attention back to the days when the agreement was signed, we find Release of Generic Lipitor Is Delayed, published on June 19, 2008, where we read:
"For people with high cholesterol, the wait for a cheaper version of Lipitor just got longer. Pfizer announced an agreement Wednesday to head off generic competition for its flagship drug until November 2011 — up to 20 months later than many analysts had been expecting.

By delaying Ranbaxy’s generic version of Lipitor, which might have been sold as early as March 2010, Pfizer has won extra time for exclusive sales of Lipitor, potentially totaling billions of additional dollars.

As part of the agreement, Pfizer granted licenses to Ranbaxy authorizing the company to sell generic Lipitor in seven other important pharmaceutical markets: Australia, Canada, Belgium, Germany, Italy, the Netherlands and Sweden.

The deal will let Ranbaxy sell its drug in those seven countries two to four months before patents expire, according to Chuck Caprariello, a spokesman for Ranbaxy".
Will the actions started against Dr Reddy end with an agreement? When will this company start selling its product? Which product will it finally sale? Will we get answers to these and many other questions before first patent expires?.

1 comment:

Antonio Selas said...

It didn’t take much. On Agusut 31 Ransdell Pierson (Reuters) reported about the agreement.

Unfortunately, “Neither Pfizer nor Dr. Reddy's would comment on terms of the settlement, or whether the generics will be allowed to reach the market after Lipitor loses U.S. marketing exclusivity in November”.