Ranbaxy geht von einem Sieg aus und bereitet schon die Produktion der Lipitor-Generika vor. Analysten der Citibank sehen eine 50 zu 50 Chance für Pfizers Patentverlust. Die Entscheidung soll in England bereits in den nächsten Tagen fallen - in den USA kurze Zeit später. Quelle:
$12bn battle that pits an Indian upstart against the mighty PfizerFight for rights to cholesterol drug could slash £400m NHS bill
Heather Tomlinson
Monday August 29, 2005
The Guardian
The Indian drug firm Ranbaxy has launched court battles in Britain and America that could save the NHS and other healthcare providers billions of pounds a year by freeing the rights to make the cholesterol drug atorvastatin. In the process the Delhi-based drug maker could triple its own profits to about $1bn (£554m) in a year.
The battle will not be easy, as Ranbaxy is fighting for the right to produce the biggest selling drug in the world, which brought in revenues of $12bn last year alone. The drug, sold under the brand name Lipitor, is owned by the biggest and one of the most fearsome pharmaceutical companies in the world, the American firm Pfizer. Ranbaxy is trying to invalidate Pfizer's patent, taking away its exclusive right to sell the drug, and market it itself in Britain and America.
Ranbaxy is confident enough about its chances to have already started gearing up to manufacture the tablets. The judge hearing the case in the UK could rule as early as the end of this month, and an American judgment should follow shortly after. "We conclude that the chances of Pfizer prevailing are as likely as a loss," said research from investment bank Citigroup.
[Andere Analysten sehen eine 90 zu 10 bzw. 95 zu 10 Chance dafür, dass Pfizer das Patent behalten darf. Verfolgt Citibank mit dieser "Analyse" Eigeninteressen? Sind sie short Pfizer und wollen den Kurs drücken, oder wollen sie den Preis drücken, um günstig einsteigen zu können?? A. L.]
In Austria, Pfizer has already lost a similar trial and is awaiting the outcome of a second before it knows whether Ranbaxy can sell the drug. "The ruling is not relevant to litigation in other jurisdictions, there are differences in patent law from country to country," a spokesman for Pfizer said. "We believe we have presented a compelling case in the US trial and in the UK."
When drugs are "on" patent the company sets the price and the profit margins can be huge. Sales for just one year can generate well above the $1bn it can cost to develop a drug, as well as the expense of manufacturing.
The American company is known for its aggressive tactics against upstarts such as Ranbaxy, and has fought such legal cases vigorously. But the stakes are high. Pfizer stands to lose $6bn profit a year and a fifth of its sales if it loses the case. Its share price could fall by as much as a fifth,...
[also 20 % Rückschlags-Potenzial bei einem Erfolg Ranbaxys...]
according to analysts at Deutsche Bank. The company is already facing a $15bn fall in sales from the potential loss of patents on a number of other drugs.
If the biggest selling drug in the world lost its patent, the entire pharmaceutical industry would feel the repercussions, particularly manufacturers with other branded cholesterol-lowering drugs, such as Crestor, owned by the UK's second largest drugs firm, AstraZeneca.
Bestsellers
But the Lipitor patent cases are not just commercial battles for sales and profits - the outcome could have profound effects on healthcare systems around the world.
There are several similar cholesterol lowering drugs on the market, known as statins, which are the best selling class of medicines. In the 1990s their use increased from a limited market of people with heart disease or very high cholesterol and a correspondingly high risk of heart attacks and strokes to those who simply had high cholesterol levels, when trials showed that taking statins was beneficial for such people.
There are cheap, off-patent statins available where companies such as Ranbaxy compete to sell the drug at the cheapest price. However, the most popular and most effective are branded, and therefore more expensive.
For instance, an American consumer magazine, Consumer Reports, has said people with a severe cholesterol problem or those with heart disease or diabetes should take Lipitor because it is more effective, even though it can be as much as five times more expensive in the US. It is such advice that has helped Lipitor become the biggest selling drug in the world. Even the relatively parsimonious NHS prescribes Lipitor more frequently than most of its rivals.
If Ranbaxy wins the case, the savings for the NHS could be huge. Last year it spent more than £400m on Lipitor, nearly half the total it spent on cholesterol lowering drugs. Rival drug simvastatin is prescribed slightly more often. But since this has lost its patent in the UK, the NHS's annual bill has been reduced, although it still stands at £251m.
Challengers
In the US, where drug prices are much higher, the government is about to take responsibility for buying a big chunk of the drugs of the elderly, uninsured and disabled. Lipitor had sales of $8bn last year in the US. The introduction of a generic competitor could mean a fall in sales of as much as 90%, which would mean big savings for the US government and healthcare providers.
At present Judge Joseph Farnan in the US and Judge Pumfrey in Britain are mulling over the legal arguments from Pfizer and Ranbaxy. They are highly complex arguments involving the chemical structure of the drug and the legal history of all patent claims. Even if Ranbaxy loses the case, the magnitude of the savings involved mean there are other potential challengers. The Public Patent Foundation in the US is willing to take on the might of the drugs giants. It has already invalidated one patent on Lipitor by making a case to the US version of the patent office. It refuses to comment on whether it will do the same on the other, stronger patents that Ranbaxy is taking on. But if the Indian firm lost its case, the charity could take on the job.
"We find substantial merit in the invalidity arguments made by Ranbaxy against [one] patent," said Dan Ravicher, an executive at PPF. "Should the public's interests against the harms caused by wrongly issued patents not be adequately respected by the results of the litigation, we will evaluate our opportunities to do so."
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