Friday, November 28, 2008

European report attacks pharma patenting practices

A blog at the Wall Street Journal noted:

The report cites a number of strategies pharma uses to hold onto exclusivity.

A “patent thicket,” also known as a patent cluster, consists of hundreds of different patents filed across Europe on a single drug, with some patents coming late in the drug’s life cycle. The patent maze can make it hard for a would-be generic competitor to figure out when relevant patents have expired, and when it’s safe to bring a generic to market.

Patent litigation quadrupled between 2000 and 2007, the report found, with generic companies winning most of the cases in which a final judgment was rendered. And settlements, including those in which drug companies pay generic companies to delay market entry, totaled more than 200 million Euro, the report found.

The report doesn’t single out individual companies. But the January raid targeted big players, including Pfizer, AstraZeneca, Sanofi-Aventis and GlaxoSmithKline. And a follow-up raid earlier this week included the generics giant Teva.

The European report is available on the net, and starts with:

"Individuals and governments want a strong pharmaceuticals sector that delivers better products and value for money. But if innovative products are not being produced, and cheaper generic alternatives to existing products are being delayed, then we need to find out why and, if necessary, take action."

Neelie Kroes, European Commissioner for competition


New Jersey's MedPage Today noted:

The investigation, based partly on documents seized in raids on pharmaceutical companies' offices earlier this year, identified several practices by which the firms forestall generic competition:

Patent clustering, where a company forms a dense network of patents around a medicine
Defensive patenting, in which inventor companies patent technologies they do not seek to use, with the intention of blocking generic competition
Patent infringement litigation against generic companies that seek to market generic equivalents
Patent settlements with generic companies that limit competition
Interventions by inventor companies before regulatory bodies to prevent or delay generic approvals


The radesecretsblog reports a big loss by Pfizer related to Bextra:

A Santa Clara County jury has ordered drugmaker Pfizer to pay $38 million in compensatory damages to a leading medical research nonprofit for stealing trade secrets to develop a pain relief drug [Bextra].

The Superior Court jury reached the verdict Monday [22 Dec 08] in a 2004 lawsuit filed against Pfizer by the San Bruno nonprofit Ischemia Research and Education Foundation. The jury's foreman said after the trial that evidence showed Pfizer had conspired with a former employee of the foundation to acquire data that otherwise would have cost tens of millions of dollars.

The report mentioned issues of strategy:

The foundation's head, Dr. Dennis Mangano, said Monday that spending $15 million in legal fees instead of accepting a financial settlement was worth it.

"It's very risky going against a big company like Pfizer," Mangano said. "The right thing has been done . . . . This verdict was extremely satisfying to me, because I had felt that Pfizer had stolen the information we had gathered in order to manipulate it to keep their drug Bextra on the market. They were willing to profit at the expense of patient safety, something I have fought against my whole life."

**And on the general topic of lawsuits-->

Pfizer alone has faced more than 10,000 lawsuits in the past few years over its drugs and their alleged side effects. Waxman says the hundreds of firms representing Pfizer on product liability work were a nightmare to manage. The legal department thought that it would benefit, both operationally and financially, from working more closely with a smaller group of firms, though lawyers there refuse to put a dollar amount on any potential savings.

from Pfizer Litigators Endure Beast of a Beauty Contest


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