It's like an episode of Judge Judy. The parties enter the courtroom. The plaintiff: the Attorney General of Ohio (on behalf of Ohio and 28 other states). The defendant: the pharmaceutical giant Bristol-Myers Squibb (BMS).
The charge: BMS did fraudulently apply for a patent for a chemotherapy drug developed with taxpayers dollars.
How does the defendant plead? Innocent as a newborn lamb, of course.
On the following facts, all parties are in agreement…
The chemo drug in question is called Taxol - and maybe it's only a coincidence that the name sounds like "tax all," but the fact is that $32 million from U.S. taxpayers went into its development. The National Cancer Institute (NCI) did all of the early research and wrote all of the checks to bring this treatment along, then, in 1991, licensed Bristol-Myers to deliver the drug to market.
But there were problems. More clinical testing had to be done. Supplies of Taxol were low and slow to process. And the purity of the drug (derived from the bark of the Pacific yew tree) was inconsistent. So Bristol-Myers invested $1 billion dollars to solve the problems and conduct further testing of the drug.
In 1992, the FDA granted BMS five years of exclusive marketing rights for Taxol. The following year representatives of BMS told a congressional committee that Taxol was not patentable and that generic competition for Taxol was a "near certainty" when their marketing rights expired.
And that's where things started to go wrong.
In apparent contradiction to their statements before congress, BMS filed applications with the Patent and Trademark Office, listed the patents with the FDA, and - according to the Ohio lawsuit - withheld documents from the patent process and misrepresented information.
Uh oh. I can just imagine how Judge Judy might react to that one.
In their defense, Bristol-Myers claims that they developed a "semisynthetic" version of Taxol to solve the supply problem. So when generic companies began production of Taxol at the end of their period of exclusive rights, BMS sued their would-be competitors for patent infringement. This legal maneuver delayed generic production of Taxol for an additional 30 months.
But Betty D. Montgomery, the Attorney General of Ohio, argues that the semisynthetic Taxol was basically the same Taxol developed by NCI - making their grounds for a patent baseless. Therefore, the lawsuits launched by BMS were simply designed to keep the cheaper, generic version of Taxol off the market.
And BMS did all of this just to make an extra $4 billion.
That's the estimated profit margin that Bristol Myers enjoyed during the 30 months that their questionable actions delayed generic versions of Taxol from entering the marketplace.
As Ohio Attorney General Montgomery told NBC News, "Profit isn't a dirty word here, but violating the law is."
Or, as Judge Judy might say, "See my forehead? Stupid it doesn't say here!"
I agree with Ohio AG Montgomery. Bristol-Myers Squibb has every right to create as much profit as they possibly can - especially when they're writing checks for $1 billion dollars to make sure their product is a sure thing. After all, BMS is a public corporation, and as we've seen throughout this year of corporate hijinks, they owe it to their stockholders to work tirelessly to produce the highest possible return on any investment.
But when it came to the patent process, did they fudge? Did they try to pull a fast one? Did they attempt an end run? Did they tell lies?
And when it came to the lawsuits against the generic manufacturers, was this nothing more than a cynical maneuver designed to unfairly but legally extend their visit to the all-you-can-eat buffet?
I'm sure that each of the parties will receive a fair trial in a federal court in Ohio. But I'm going to be Judge Jenny for a moment and shoot from the hip with a well-informed opinion that would not be admissible in any court: BMS is full of bologna! Time and again we've seen the way drug giants do business. If I had to lay money on it, I'd say they did pull a fast one and their lawsuits against the generics were nothing more than a device to prolong their ability to demand and receive a premium price for their product. The fact that Taxol was discovered and developed with taxpayer dollars is beside the point really because NCI made a deal with Bristol-Myers, fair and square. But in light of their bad-faith actions which reaped billions (again - just this judge's opinion), the fact that your money and my money helped get this product started for them is just absolutely annoying.
Bristol-Myers Squibb, get out of my courtroom and I never want to see you in here again!
This court is adjourned.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
Sources:
"States Sue Maker of Breast Cancer Drug" Press Release, Attorney General, State of Ohio, 6/4/02
"Twenty-nine States File Suit Against Drug Maker Bristol-Myers Squibb" AP Online, 6/5/02 "High-cost Cancer Drug Controversy" NBC News, 7/29/02 |
