Thursday, January 27, 2005

More on Pfizer v. Ranbaxy on Lipitor

In the report below, the text --Ranbaxy charged that Pfizer withheld crucial scientific data that may have influenced the patent-review board's decision to grant an extension on the original patent and award the second patent.-- sounds more like an inequitable conduct defense than the previously discussed noninfringement/invalidity defense.

Reuters via Hindustan Times,00020013.htm

Ranbaxy chief executive Brian Tempest told Reuters on the sidelines of the World Economic Forum that he would await the outcome of any appeal before introducing a copycat version of the cholesterol-lowering medicine in the United States.

He expects a ruling in the US patent case to come around July this year. If it loses, Pfizer, the world's largest pharmaceuticals maker, will certainly appeal -- a process which could take about 12 months.

"We wouldn't launch at risk. We are a conservative company. We will wait until the appeal at the federal level," Tempest said.

Overturning Pfizer's patents on Lipitor, which sells $10 billion a year, would be a transforming event for Ranbaxy which, even as India's largest drugmaker, currently has revenues of only around $1.2 billion.

Ranbaxy put its case at a two-week trial in the US District Court of Delaware last month. It is trying to break two patents that currently protect Lipitor from generic competition until 2009 and 2011.

Ranbaxy charged that Pfizer withheld crucial scientific data that may have influenced the patent-review board's decision to grant an extension on the original patent and award the second patent.

Until recently, most commentators thought Ranbaxy had little chance of success. But Tempest said attitudes had started to change.

"A number analysts originally said we had the flimsiest of cases. I think now they see that this is a serious case," he said.

Ranbaxy is busy getting ready for a generic Lipitor launch ahead of the legal ruling, something it has already warned shareholders will weigh on earnings in 2005.

"We've already started to buy raw materials, so we are already on the track and we think that is the right thing to do for our investors," Tempest said.

The Indian company is also challenging patents on Lipitor in around a dozen other countries, with a decision expected in a case in Austria in April, he added.

Ranbaxy and other generic drug companies have enjoyed a boom in the United States as healthcare providers try to cut escalating costs. A public outcry for access to cheaper prescription drugs has also emboldened many generic companies to pursue high-stakes patent cases.

The Lipitor case is a "big deal" to Pfizer. From Bloomberg (19 Jan 05):

Revenue from two of Pfizer's biggest drugs, Lipitor and the Celebrex painkiller, jumped as much as 24 percent as the company took market share from rivals such as Merck & Co. The gains may slow after a study linked Celebrex to heart attacks and caused a year-end drop in prescriptions, and as generic competition damps demand for drugs such as the Neurontin epilepsy pill.

Sales of Lipitor, the world's best-selling drug, jumped 23 percent to $3.26 billion in the fourth quarter. Full-year sales increased 18 percent to $10.9 billion.

Lipitor has about 40 percent of the worldwide cholesterol market and more than 42 percent of the U.S. market in total prescriptions, Pfizer said today.

Doctors including Ira Nash, the associate director of the Cardiovascular Institute of the Mount Sinai Medical Center in New York, and Dr. William James Howard, vice president for academic affairs at Washington Hospital Center in Washington, said doctors are prescribing drugs such as Lipitor more widely because recent clinical trials have shown that it's beneficial to lower cholesterol aggressively.


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