I continue reading Howard Brody's book"Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry" (Rowan & Littlefield Publishers, Inc, 2007) Dr. Brody has an MD and a PhD in Philosophy, evident in his writing, ie dense stuff at times.
He notes the passage of the Byah-Dole law in 1980. This law was passed based upon a study in the 1970's, showing that of the 2800 patents held by the US govt and its scientists, only 5% had been licensed to manufacturers. The inference was that these discoveries needed to be moved from the laboratories into industry in a more "streamlined" way (p.75). With passage of this law, universities and the NIH could patent scientific discoveries and grant exclusive manufacturing to pharmaceutical firms to produce the final products. The law included a clause for "reasonable pricing". If a pharmaceutical co developed a product from that which was developed and patented by the federal government, the price of the product must be "reasonable" or the government had the right to repossess the exclusive patent rights from the company. This was termed the "march-in rights".
Brody notes that there was not much use of the Bayh-Dole law until 1995, when the NIH "dropped the reasonable-pricing requirement altogether" (p78). In 2002, 2 Washington Post reporters, Peter Arno and Michael Davis, wrote an article noting that the Bayh-Dole provision should give govt a way to make drug pricing reasonable. Senator Bayh reported at this time that his interpretation of the "march-in-rights" was not to affect drug pricing but to force drug cos who had been given exclusive rights to manufacture a "useful" drug and then failed to bring the drug into production to give the "public access to the new drug---at whatever price the company decided to charge" (p. 79)
I assume in all the legal back and forth with Amgen, the use of the "march-in-rights" was considered....just noodling here...The author notes that the NIH dropped the "reasonable pricing" provision--he does not state that it was repealed.....Perhaps an inquiry to either or both of the Washington Post reorters might be in order. madelyn