12 April 1955 history was made when the National Foundation for Infantile Paralysis announced: “The vaccine works. It is safe, effective and potent”.
This announcement came as a welcome relief to millions of American parents after a nationwide trial using an experimental polio vaccine was conducted. More than 1.8 million children were signed up by frantic parents to be part of the trial. Kids were injected with either the vaccine or a placebo. It was a double blind study, neither the child nor the caregiver knew who was receiving the vaccine or a placebo. A nationwide trial of an experimental vaccine using school children as virtual guinea pigs would be unthinkable today.
A polio-survivor said it shows how much people feared polio that mothers and fathers were willing to accept the word of researchers that the vaccine was safe.
One year after the trial started, the National Foundation announced that the Salk vaccine proved 80 to 90 percent effective in preventing polio. In 1961 the rate of polio had dropped by 96% in the United States.
In an interview Edward R. Murrow asked Salk who owned the patent to the polio vaccine. Salk replied “Well, the people, I would say. There is no patent. Could you patent the sun?” Over the last half-century, Salk’s rhetorical question has become the cry for those who rally against pharmaceutical patents.
Dr Salk might have believed that personal gain is secondary to helping mankind and meant every word. He did, however, not mention that the National Foundation for Infantile Paralysis looked into patenting the Salk vaccine and concluded that it could not be patented because the vaccine did not meet the novelty requirements and would not be considered a patentable invention by the standards of the day.
This raises the interesting question of the distinction between a discovery, which is not patentable, and an invention. Should a vaccine be considered a natural occurring substance i.e. a discovery, or a product of human innovation and engineering i.e. an invention?
A vaccine contains live or dead cells from a pathogen itself, or genetically modified versions of the virus or bacteria. When considering that the flu vaccine has to be made anew every year and involves months of work by highly trained scientists, it would be considered a stretch to say vaccines are naturally occurring.
The US Supreme Court in 1980 made a clear distinction between a discovery and an invention. Products of nature, like the sun, are not patentable; however isolating and purifying a product of nature may render it patentable if it fullfils all the other requirements for patentability. Despite the Supreme Court not specifically addressing the patentability of vaccines, thousands of patents relating to vaccines have been issued in the United States.
Even though the decision not to apply for a patent for the polio vaccine was a purely academic one, it might be said that morally it was the right one. The vaccine trial was made possible by volunteers. No money was received from federal grants or pharmaceutical companies. The trial was financed by donations made to the National Foundation for Infantile Paralysis. David Oshinsky wrote: “It’s the incredible organisation involved, with tens of thousands of mothers and families coming together to save their children. And it was all done privately.
It could therefore be said that Salk was correct in saying that the “patent” belongs to the people.