PATENTS OVER PATIENTS
April 4, 2007
In the current system of drug development, if a promising compound can't be patented, it is highly unlikely ever to make it to market — no matter how well it performs in the laboratory. The development of new cancer drugs is crippled as a result, says columnist Ralph W. Moss.
The reason: bringing a new drug to market is extremely expensive. Consider:
- In 2001, the estimated cost was $802 million; today it is approximately $1 billion.
- To ensure a healthy return on such staggering investments, drug companies seek to formulate new drugs in a way that guarantees watertight patents.
As a result, drugs that can't be patented are often scrapped, says Moss. For example:
- In 2004, Johns Hopkins researchers discovered that an off-the-shelf compound called 3-bromopyruvate could arrest the growth of liver cancer in rats; with a treatment cost around 70 cents per day.
- Yet, three years later, no major drug company has shown interest in developing this drug for human use.
- Early this year, another readily available industrial chemical, dichloroacetate, was found by researchers at the University of Alberta to shrink tumors in laboratory animals by up to 75 percent.
- However, dichloroacetate is not patentable either, and the lead researcher is concerned that it may be difficult to find funding from private investors to test the chemical.
Potential anticancer drugs should be judged on their scientific merit, not on their patentability, says Moss. One solution might be for the government to enlarge the Food and Drug Administration's "orphan drug" program, which subsidizes the development of drugs for rare diseases. The definition of orphan drug could be expanded to include unpatentable agents that are scorned as unprofitable by pharmaceutical companies.
Source: Ralph W. Moss, "Patents Over Patients," New York Times, April 1, 2007.
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