Background
Beginning in 1983, a team at Glaxo Wellcome began researching an anti-AIDS drug. The team hoped to develop a chain terminator to halt HIV in the reverse-transcription stage of its HIV life cycle. Drugs selected on the basis of their chemical structure were screened starting in 1984.
One of the drugs screened at that time is what is now known as AZT. This drug was originally synthesized by cancer researchers in 1964, in a project that was eventually abandoned. Since that time, Glaxo Wellcome had been developing AZT as an anti-bacterial.
Zidovudine (ZDV), also known as azidothymidine (AZT), is an antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used to prevent mother-to-child spread during birth or after a needlestick injury or other potential exposure. It is sold both by itself and together as lamivudine/zidovudine and abacavir/lamivudine/zidovudine. It can be used by mouth or by slow injection into a vein.
In vitro testing on mouse cells revealed that AZT was potentially effective against AIDS. Glaxo Wellcome was not equipped to do testing of the drug on human cell lines, so it contracted with the National Institutes of Health for this work. In February 1985, the NIH reported the positive results of their screening to Glaxo Wellcome, and, on March 16, 1985, Glaxo Wellcome filed a patent application for a new use of AZT in the United Kingdom.
The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1870s and is now part of the United States Department of Health and Human Services. The majority of NIH facilities are located in Bethesda, Maryland. The NIH conducts its own scientific research through its Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program.
The validity of this patent was brought into question by the appellant generic drug manufacturers.
Reasons of the Court
Utility
The generic manufacturers claimed that the patent did not satisfy the utility requirement. Justice Binnie, for the Court, considered the doctrine of sound prediction to determine whether the invention was useful. There are three elements. First, there must be a factual basis for the prediction at the date that it was filed. Second, the inventor must have a sound line of reasoning from which the desired result can be inferred from the factual basis. Third, there must be proper disclosure. As Justice Binnie believed that predictbility is a question of fact, he relied on the trial judge's findings and determined that all three requirements for sound prediction were satisfied. At the time the patent application was filed, Glaxo Wellcome knew that AZT was suitable for prolonged treatment of humans, that compounds of its class could act as chain terminators, and that in vitro efficacy had been shown in human cells.
In United States patent law, utility is a patentability requirement. As provided by 35 U.S.C. § 101, an invention is "useful" if it provides some identifiable benefit and is capable of use. The majority of inventions are usually not challenged as lacking utility, but the doctrine prevents the patenting of fantastic or hypothetical devices such as perpetual motion machines.
In Canadian patent law, inventions must be useful, in addition to novel and non-obvious, in order to be patented.
In applying the doctrine of sound prediction, Justice Binnie noted that the doctrine is can be applied generally but that steps should be taken to ensure that it is not abused by "[dilution] to include a lucky guess or mere speculation."
Covetous Claiming
The patent claimed that AZT had both prophylactic and treatment properties. The generic manufacturers attacked the patent on the grounds that there was no sound basis to predict that the drug had any prophylactic properties. The Court did not accept this argument, instead holding that the definition of "prophylaxis" includes "prevention of the development of signs and symptoms of the disease [AIDS] without necessarily eradicating the causal factor [HIV]".
Inventorship
The generic drug manufacturers also sought to have the patent declared invalid on the grounds that the NIH researchers who did the human cell screening were not identified in the patent as co-inventors. Justice Binnie concluded that, to be considered a co-inventor, a person must have participated in the inventive concept and not merely its verification.
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