Biochemist calls for 'open-source' R&D revolution

Aled is completely correct, and we all know this; output from research organizations of all types is not rising at the same rate as the amount of money being spent, and by some measures, is actually decreasing.
There are several reasons for this and without addressing all of them, it is unlikely that the situation will improve. But one point tracks the drop in productivity far better than other economic or demographic forces; this is the Bayh-Dole Act. This act, although only in the US, has seriously damaged the pool of publicly available basic research throught the world; there is no more "open-source" basic science to use Aled's phrase. Repealing the Bayh-Dole Act in the US (and corresponding legislation elsewhere), and requiring the results of any research performed with public money to be placed freely in the public domain would be a major boost to overall research productivity. The existing encumbrances on basic science would be removed (allowing further research to progress without concern for patent issues) and would give back the university research environment its real purpose in society, the advancement of science for public good, while leaving the necessary commercialization and development work clearly in the domain of business - which should be writing patents to cover products and their methods of production, rather than tying up basic science.
As a scientist trying to commercialize basic research, I am spending essentially all my time (and money) protecting or licensing basic science, rather than developing new commercial processes and building plants to make product.

How naive! The Bayh-Dole Act was passed specifically to promote the development of new drugs for the public good, rather than letting promsiing discoveries lie fallow because no one was going to spend the billion dollars or so necessary to take them through clinical studies and hopefully on to the market if they couldn't obtain exclusive rights via patents and licenses. Unless you are willing to substantially relax the regulatory requirements and/or fund clinical studies with public money you have to bite the bullet and learn to deal with it. In an environment where it takes an investment of upwards of ten years and hundreds of millions of dollars to possibly get a drug approved, repealing Bayh-Dole and making publicly-funded R&D "open source" will decrease the availability of new drugs, not increase it.

Get real, people.

I am flattered that my earlier comment was not only read but drew a response, and I will readily admit to being naive. But I also try to make decisions based on observed data, rather than on what I think things should be. No doubt, the Bayh-Dole Act was well-intentioned and designed to serve the public good, but nearly 30 yeas of data are less convincing.

All of my corporate experience as a chemist (who has defended his own patents) indicates increasing amounts of total resources - time, people, money - are spent trying to remove all competition at the earliest possible source, i.e. the most basic piece of identifiable technology, rather than on developing and appropriately patenting the ultimate marketable products themselves. The problem is not the concept of patents; a complete lack of patents would not be in the public interest. However, the Bayh-Dole Act badly exacerbated (and I believed even caused) the current trend by companies to pursue exclusivity at ever more basic levels of technology. It is this trend – the result of human behavior and not of patents per se – that is one of the problems that has lead to the diminished pool of publicly available science and the resulting problems.

A forgotten but relevant bit of history is the attempt by a university to defend its patent claiming the use of inhibition of cyclooxygenase to cover all possible anti-inflammatory drugs of the cox-inhibitor class. The patent was not allowed on the basis that merely claiming a basic piece of science did not teach others which molecules would be good drugs. And despite the threat of the litigation of this major, dominating patent and known competition, multiple cox-inhibitors were marketed contemporaneously to each other, and at sufficient profit to justify all risk and effort. (The subsequent Vioxx troubles meant that this incident has been completely forgotten.) Yes, this is a single data point but it clearly questions the value of exclusive ownership of basic science. Further, if one requires total exclusivity of all the technology in order to make any investment at all, then one is forced to ask why multiple ACE inhibitors, statins, H3-inhibitors, etc etc have been simultaneously on the market as branded, profitable drugs.

Perhaps the best example of the lack of “utility of exclusivity” is the Boyer-Cohen patent of 1980 (US4237224) and the two subsequent patents. These pioneering patents truly dominated the field of what is now called biotechnology. And yet, over 450 licenses were let to companies from three patents in total (CURRENT SCIENCE, VOL. 96, NO. 6, 25 MARCH 2009). The subsequent quarter-century suggest that neither the public interest nor the interest of Stanford University were negatively affected by this lack of exclusivity. And if all of the technology covered by these patents had been placed in the public domain and not patented, the public interest would not have been diminished; only Stanford would have suffered. (To its considerable credit, Stanford understood this, and its actions should serve as a model to others.)

My conclusion from this admittedly small set of data is that patenting to enforce an exclusive position on increasingly earlier and more basic pieces of technology is not useful; it does not serve the public interest in any manner (and certainly not in the manner that patents were intended) nor does it offer generally useful protection to the ultimate commercialization of the technology. I understand that patent portfolios are used to make investment decisions, and that it is easier to defend a decision to invest in a company with a larger portfolio. But this simply substitutes patent quantity for patent quality, and suggests the that investment decisions are made without proper diligence on the technology, but rather post facto reliance on a legal strategy to defeat competition.

While not the only problem, the Bayh-Dole Act is at least mainly responsible for driving the use of patents to extreme efforts to claim exclusivity at levels of basic science removed from what should be legitimate efforts of for-profit commercialization. The current pursuit of exclusivity is now damaging to such enterprise.