By Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization
Question from a Reader:
Heather: Whether Jonas Salk believed in patenting research or not isn’t important, at least not to me. What I do find important, and hadn’t realized until reading this article, is that the polio vaccine was extremely successful despite the fact that it wasn’t patented. That sounds like an interesting story because it goes against the current dogma of ‘we won’t invest in it if it’s not patent protected’. I’m curious to know if there have been other vaccines/drugs that have bucked the patent system but remain successful.
Heather, thank you for your interest in this important issue.
Unfortunately, it’s not so much a question of bucking the patent system as it is a question of who steps up to the plate if there are no incentives to invest. Usually, nobody does. There are literally hundreds (if not thousands) of examples of promising drug molecules which are not being developed because they are owned by no one. The polio vaccine is actually a good, and unusual, example of a tremendously important product that, for various reasons, lacked commercial incentives for it to be developed by private companies – maybe the absence of patent protection had something to do with that. Ultimately, developing the polio vaccine required such a big societal effort, requiring field trials on millions of children, that it would have been impossible for a single company to handle (and so expensive that it would have amounted to corporate suicide). Instead, the development of the vaccine required an unusual, coordinated effort by charitable foundations, the U.S. government, and many other entities.
Penicillin is another example. It was discovered in the 1920s and languished for many years in the public domain. The molecule wasn’t owned by anyone, and there was no commercial incentive to invest in its development. It was only during World War II that penicillin became strategically important to the U.S. and British governments. It was developed through a process of compulsory government contracting, as part of the wartime effort. Notably, while penicillin itself was not patentable because it had already been known for a long time, the government contract lab did obtain a patent on the method for mass-producing it.
These two success stories are neither typical nor a realistic model for the development of new medicines. It is true that sometimes a government and charitable foundations must step up and support the development of exceptionally important drugs for which there is no other commercial incentive. The drug molecule may be long-known and unpatented. Or it may be useful only for a medical condition that is so rare that a drug company could not recoup its investment. When the government or charitable foundations fund the development of such drugs, they often do so in partnership with drug companies – think of it as the public sector “splitting the risk” with private companies. But it is rare indeed for a drug to be developed by a government alone, absent a commercial incentive for private investment. For one, governments are not particularly good at developing drugs. We know this from experience with former socialist countries, which produced Nobel Prize-winning chemists and physiologists but no drugs. Even our own government-funded researchers prefer to do what they do best: studying the molecular basis of diseases and understanding the biological mechanisms and interactions that keep us healthy or make us sick. Biotech companies, on the other hand, are good at the tedious and lengthy task of developing medicines. Think of it as two sides of an equation, where public research often provides the “science” and the private sector contributes the “engineering.” So the typical situation today in the U.S. is that generous public funding is used to support basic biological research at government laboratories and research universities, and that private companies shoulder the task, at staggering cost, of translating these basic discoveries into real-world solutions for disease.
According to the Tufts Center for the Study of Drug Development, the total capitalized cost of developing the average biopharmaceutical requires nearly a decade of work and an investment of $ 1.2 billion. Patents can provide some assurance to the investors who are considering whether to invest in a biotech company to help it fund the lengthy and expensive drug development process necessary to produce a new life-enhancing, and in some cases life-saving, medical therapy. Without a patent, there is limited opportunity for a return on that significant investment.
It is important to remember that patents are granted for a fixed period of time. During that time, the patent owner has exclusive rights to the patented invention (that he or she has the option to license to others). After the patent expires, the invention is in the public domain and everyone can access it. In the biopharmaceutical world, this is often when generic drugs become available.