By Wolfgang Klietman
Some Ivy League scholars have recently outlined ways they believe the Biden administration can intervene, under current law, to reduce prescription drug costs.
All the Biden team has to do is ignore the plain meaning, text, and legislative history of the law at issue, as well as numerous court rulings that explicitly run counter to the professors’ opinion. . Oh, one more thing. President Biden will have to unilaterally gut the US patent system. What could go wrong?
Activists touted the letter as something like holy scripture – the combined judgment of two of America’s most prestigious institutions of higher learning, Harvard and Yale.
As a former lecturer at Harvard Medical School myself, I can assure you that the letter is no such thing. The authors speak only for themselves.
The substance of the letter is also not new.
This is exactly the same argument that has been circulating for 20 years now, rejected by the administrations of both parties.
The importance of patent protection has been well understood in this country since its founding. Article 1, Section 8 of the Constitution empowers Congress to “promote the progress of science and useful arts, by securing for a limited time to authors and inventors the exclusive right to their respective writings and discoveries“.
This is exactly what Congress did. One such landmark piece of legislation is the Bayh-Dole Act of 1980.
Prior to Bayh-Dole, patent rights to all taxpayer-funded inventions became the property of the federal government. But the government is not responsible for developing commercial applications for scientific discoveries. Nearly 30,000 government-patented discoveries were dormant before Bayh-Dole. Bayh-Dole solved this problem by letting universities own the patents, allowing them to license their discoveries for commercial development – a powerful incentive that opened up a flood of innovation.
The law does, however, contain a protection clause to ensure that patented discoveries are made available to the public. If they are not, the government reserves the right to step in and issue a patent license to a third party who will make the product available.
This is where the Ivy League professors themselves come into play.
They want the government to use this provision to allow cheap generic copies whenever authorities deem the price of a drug to be too high – especially in cases where the government has made even a small financial contribution to research. preliminary.
This gross misinterpretation makes a mockery of the intent of the law.
Senators Birch Bayh and Bob Dole, the authors of the legislation, wrote in 2002 that “Bayh-Dole did not intend for the government to fix the prices of the resulting products”. But what would they know?
Legal debates aside, twisting Bayh-Dole to achieve the admittedly popular political goal of lower drug prices would spell disaster for future innovation.
This is not a speculative conclusion. In 1989, the National Institutes of Health tried to impose a “reasonable price” rule for products resulting from public-private cooperation. As soon as the rule came into effect, collaboration between private developers and the government collapsed. The NIH repealed the rule in 1995. A year later, such collaborations were strong again.
Bayh-Dole alone has stimulated approximately $1.7 trillion in additional economic output and fostered the creation of over 15,000 startups.
This progress would be reversed if the federal government followed the professors’ advice.
Dr. Wolfgang Klietmann is a former clinical pathologist and medical microbiologist at Harvard Medical School. This play originally aired in Boston