“In our system of patent law, the identity of the inventor is, for the most part, overshadowed by the issue of invention.” (, at para. 27)

The does not define “inventorship”, but, as per of the Act, the willful omission of the name of a co-inventor on a patent application is ground for voiding the patent. Whether two (NIH) researchers should have been named as co-inventors on the anti-HIV (AZT) patent was litigated in . To resolve the issue, the Supreme Court had to divine a definition from the rest of the Act and the common law.

HIV/AIDS was first reported in 1981. Two years later, the pharmaceutical company Glaxo Inc. (now ) assembled a team of researchers to develop a drug to combat the retrovirus. The Glaxo team tested a number of compounds on mouse retroviruses. By 1984, one of the tested compounds, AZT, showed promise at wiping out mouse retroviruses in mouse cells. However, as it was only three years since the discovery of HIV, and due to the lethality of the virus, there were very few facilities in 1984 that could test AZT on HIV in human cells. Glaxo turned to outside expertise, including researchers at the NIH, to perform this screening, and it was two NIH researchers, Drs. Broder and Mitsuya, who established the utility of AZT on human cell lines. A patent was filed in the UK shortly thereafter, and a Canadian patent based on the UK filing soon followed. Neither NIH scientist was named as a co-inventor on the patent.

As part of an action to have the AZT patent declared invalid, and Novopharm Ltd. (now ) argued that the two NIH scientists were co-inventors. The trial judge concluded that the NIH scientists were co-inventors, and used a number of facts to support his conclusion, including that: 1) the NIH scientists, not the Glaxo team, established the utility of the drug; 2) correspondence from Glaxo supported the proposition that the role of the two NIH scientists was collaborative and not simply just to confirm test results; and 3) Glaxo had also sent AZT to for testing, and although ultimately unable to successfully perform the tests, the university had signed an agreement to assign Glaxo any patents derived from its work—no such agreement was ever signed by the NIH.

The Supreme Court agreed with the trial judge in that the NIH scientists established utility, but decided that establishing utility was not the test of inventorship, and that importance should be attributed instead to the development of the “inventive concept”. A party “whose ingenuity is directed to verification rather than the original inventive concept” (at para. 99) is, by the Court’s definition, not an inventor.

On the subject of inventorship, I respectfully disagree. Glaxo did not invent AZT; it was synthesized in 1964 at the Detroit Institute of Cancer Research (now the ). Few laboratories in 1984 had the requisite facilities and expertise to examine the effects of AZT on HIV-infected human cells. And without evidence of utility with respect to combating HIV, Glaxo would not have been able to patent the drug.

The Patent Act defines invention as any new and useful art, process, machine, etc. Gerard Wire Tying Machines Co. of Canada v. Cary Manufacturing Co., [1926] Ex. C.R. 170, which is cited by the Supreme Court and quotes the U.S. text Walker on Patents, iterates that a party who “contributes an independent part of the entire invention which helps to create the whole…is a joint inventor even though his contribution be of minor importance”. The two NIH scientists contributed an independent part of the invention, and that part helped to create the whole: it was they who established the utility (i.e. usefulness) of the drug. The NIH scientists proved the concept. And their contribution was hardly minor; both Glaxo and Duke University were unable to establish AZT’s usefulness. The human cell line used by the two scientists was, in the words of the Supreme Court “original and offered a testing environment that Glaxo/Wellcome could not duplicate in-house” (at para.102), and was material to establishing AZT’s effectiveness against HIV in human cells.

A better definition of inventorship would include the presumption that any party that has made a material contribution to the development of an invention is a co-inventor. If a party’s contribution to the invention was crucial, such that without the contribution by that party the patent would not have been granted, as was the case here, then that party is a co-inventor.

This presumption would afford researchers greater protection for their scientific efforts and ingenuity, and is a more equitable measure of inventorship that better accounts for the modern reality of collaboration and the cross-pollination of ideas. Armed with these rights from the beginning, scientists would be free to negotiate and bargain them away if they so choose, as was the case with Duke University and Glaxo, but was not the case with Glaxo and the NIH.

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(CAMR) is an amendment of the Patent Act following the 2003 WTO Decision to waive certain intellectual property rights, with the aim of providing low-cost generic pharmaceutical medicines to developing countries. Although it was enacted in May 2005, nearly four years later the legislation can count only one successful export of Canadian generics to a developing country: in 2008 a deal was struck to export two-years’ worth of generic anti-retroviral medicines to Rwanda to help combat HIV/AIDS.

If Canada is committed to increasing developing nations’ access to medicines, CAMR needs to be overhauled to facilitate procurement of much needed pharmaceuticals. The trick is in balancing the aim of the legislation with the rights of the patent holder. At present, the legislation appears to inadvertently favour the patent holder in the number of hoops that a developing country and generic pharmaceutical manufacturer must jump through in order to export two years supply of patented medicine.

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In his recent article published in HIV/AID Policy & Law Review, Executive Director of the Canadian HIV/AIDS Legal Network Richard Elliot summarizes the suggestions of various civil society groups for reforming CAMR. These recommendations attempt to address certain inefficiencies of the Regime by removing barriers to procurement, or the re-use of the legislation, by developing countries.

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One recommendation summarized by Elliot that is particularly ambitious in scope and far-reaching in terms of the ramifications for intellectual property rights is the ‘one-license solution’. Under this recommendation, only one compulsory license would be required per generic manufacturer, and would authorize the manufacture and export of any pharmaceutical patented in Canada. A manufacturer could obtain this license without first specifying quantity of product to be produced and without having a prior arrangement with an importing country.

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An amendment of such potency raises the question of whether there would be any purpose at all for retaining voluntary licensing under the revised Regime. Generic manufacturers would have little incentive for negotiating in good faith with the patent holder, as this more muscular compulsory license is likely to be far more profitable than any concession squeezed out of the patent holder. In fact, in this scenario Elliot states that “a [one-license solution] would also eliminate the need for any period of attempting to negotiate voluntary licences with patent-holders”.

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Whether we should bother to protect intellectual property rights under CAMR when millions of people die each year to tuberculosis, malaria, AIDS and other diseases afflicting developing countries is certainly a valid question. But a long-term view of the question could show that weak intellectual property rights will inhibit research and development of medicines most applicable to the needs of developing countries, as patent holders will have a compulsory license foisted on any relevant pharmaceutical patent the moment it is granted. With such a diminished return on their inventions, pharmaceutical development could likely shift to developing medicines targeted solely at diseases afflicting the developed world, such as obesity—inventions unlikely to be poached by generic manufacturers out to make an easy buck.

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In fact, it may be that an intellectual property regime that is stronger, at least in some respects, could actually spur the development of medicines most needed by developing countries. This is the logic behind the additional six-months of exclusivity granted to pharmaceutical patents for paediatric medicines: that pharmaceutical companies may be enticed into the noble work of developing medicines for children in exchange for an extension on their monopoly. Perhaps, then, corollary of the apparent incentives of a stronger intellectual property regime, is that a weaker regime would act as a disincentive for the development of those medicines most needed by developing countries.

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Taken in their entirety, the proposed changes summarized by Elliot would radically alter CAMR at the expense of intellectual property rights while diminishing the role of the pharmaceutical patent holder and substantially loosening regulations that ostensibly protect the end-user and country of import. While CAMR’s lack of success undoubtedly reflects inherent flaws in the legislation which require changes should Canada decide to stand by it’s commitment of increasing developing nation’s access to medicines, a balance must be struck between increasing access and maintaining intellectual property rights, lest we kill the goose that lays the golden eggs.

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