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Pushing Drug Profits To The Limit

Ask Keith Alderman if he needs the anti-anxiety drug Buspar and he'll tell you "before the Buspar, I would not leave the house. I would be locked up for three or four days."

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

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

Buspar's patent was set to expire last November and a generic drug company Mylan was waiting with approval to sell a cheaper alternative, reports CBS News Correspondent Jim Axelrod. 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, but a chemical compound produced in the body after taking Buspar.

In essence, big pharmaceutical companies try to patent something that a body produces — something that Ron Pollack of Families USA says "defies explanation."

Actually, it may be fairly simple. The four months it took Mylan to get a court to invalidate the new patent meant four 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," said Pollack.

Drug Savings
How much will a generic drug save you over a brand-name drug? Below are the average prices for a year's worth of brand-name and generic medications at the most widely prescribed dosages.
  • Problem: Arrhythmia; Brand-name drug: Lonoxin ($85.44); Generic: Digoxin($67.44); Savings: $17.80/21%.
  • Problem: Benign prostate enlargement; Brand-name drug: Hytrin ($664.30); Generic: Terazosin ($481.80); Savings: $182.50/27%.
  • Problem: High blood pressure and congestive heart failure; Brand-name drug: Vasotec ($412.45); Generic: Enalapril ($299.30); Savings: $113.15/27%.
  • Problem: Pain, inflammation; Brand-name drug: Motrin ($481.80); Generic: Ibuprofen ($240.90); Savings: $240.90/50%.
  • Problem: Thyroid insufficiency; Brand-name drug: Synthroid ($142.35); Generic: Levothyroxine ($69.35); Savings: $73.00/51%.

    Source: Consumers Union

  • This practce 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 two-and-a-half years.

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

    But don't think big drug companies wait until the end to build a firewall of patent protection. For example, an anti-depressant, 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, Prilosec, points out, there's plenty of incentive to extend the monopolies. Prilosec, the little purple pill, means a lot of green — $11 million every day for Astrazeneca. Which may help to explain why the company has 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," said Sen. Charles Schumer, D-NY.

    Schumer and Sen. John McCain are pushing a bill that would rewrite the rules, including removal of that automatic two-and-a-half year extension.

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

    ©MMI, CBS Worldwide Inc. All Rights Reserved

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