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Why Do Generic Prescription Drugs Take So Long to Hit the Market?

Ask Keith Alderman if he needs the anti-anxiety drug Buspar.

"Before the Buspar, I would not leave the house. I would be locked up for 3, 4 days," says Alderman.

Keith--on full-time disability--always hoped for a cheaper, generic version of Buspar. When he heard how Buspar's maker, Bristol-Myers Squibb, kept one off the market, he sued.

"It's not about money to me and profit margins. To me, it's about my life," says Alderman.

Buspar's patent was set to expire last November. And a generic drug company, Mylan, was waiting with approval to sell a cheaper alternative. But, according to the lawsuit, just 12 hours before the patent expired, Bristol-Myers won a new patent on Buspar--blocking Mylan from the market and consumers from a lower-cost generic.

The new patent didn't even cover the drug itself. Rather, it dealt with a chemical compound produced in the body after taking Buspar.

So the big pharmaceutical companies are now trying to patent something your body produces? "Absolutely," says Ron Pollack of Families USA. "It defies explanation."

Actually, it may be fairly simple: The 4 months it took Mylan to get a court to invalidate the new patent meant 4 more months of a Buspar monopoly for Bristol-Myers. In that time, it's estimated the company earned another $253 million.

"Even after they lose the lawsuit they've actually won because they've delayed the generic drug from going to market," says Pollack.

This practice of obtaining new patents on existing drugs is one of the drug companies' most potent weapons in the war against generics. Each time a name-brand company files a patent infringement suit, the law automatically blocks the generic competitor from market for 2_ years.

"Some of the techniques the drug companies are using to add on patent life are pretty abusive," says Carl Seiden, a pharmaceutical analyst for JP Morgan--"for things that aren't genuine patent breakthroughs."

But don't think big drug companies wait until the end to build a firewall of patent protection. For example, one antidepressant was granted one patent for its contents and then another almost immediately after for "its tablet structure"--the way it can broken into halves or thirds. Then there's the cancer drug Platinol--given a patent for the color of its bottle before being overturned.

But as the nation's top-selling prescription drug's own advertisement points out, there's plenty of incentive to extend the monopolies. Prilosec, the little purple pill, means a lot of green. Eleven million dollars every day for a AstraZeneca, which may help to explain why the company's filed 11 additional patents--everything from how it's used to how's it made--in the last 19 years.

"The pharmaceutical companies have found ways to just overwhelm the generic companies," says Senator Charles Schumer (Democrat, New York).

Senators Schumer and John McCain are pushing a bill that would rewrite the rules--including removal f that automatic 2_-year extension.

"Because they're making so much money from these patents, they want to extend them by hook or by crook," says Schumer.

Drugs worth $20 billion in sales are due to come off patent in the next 5 years. Since the pharmaceutical industry spends more on lobbying than any other, consumers can expect any fight to change the way drug companies battle--and profit--to be fierce.

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