캐나다 ‘특허강제실시’ 제도의 진화와 그 경제적 함의
Evolution of Patent Compulsory Licensing in Canada and Its Economic Implications
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캐나다는 특허강제실시 허여요건의 강화와 완화가 뚜렷하게 구분되는 역사를 가지고 있다. 캐나다는 1903년 개정 특허법에서 일반적인 강제실시조항을 처음으로 도입한 후, 1923년 의약품 및 식품에 특정한 강제실시 조항을추가하였다. 1969년 개정법에서는 의약품의 강제실시허여 요건을 크게 완화하였다. 국제협약상의 제약이 없던 이 시기에, 캐나다는 자유롭게 특허 강제실시제도를 설계하였다. 그러나, 미국의 경제적 압력으로 인해 의약품 특유의 강제실시규정은 1987년 특허법 개정 시점부터 현저히 약화되었다. 캐나다에서의 ‘특허강제실시’ 제도에 대한 ‘사회실험’은 특허강제실시 허여 요건의 강화가 외국 기업의 R&D 투자를 증가시킨다고 단정할 수 없다는 것을 보여 주고 있다. 또한 특허강제실시 허여 요건의 약화가 이루어졌던 시기에 캐나다에서의 의약품의 가격이 낮았으며, 캐나다 제네릭 의약산업이 크게 성장하였다는 것을 보여 주고 있다. 캐나다의 경험은 TRIPs 제31조의 강제실시허여 요건이 보다 완화되어, 회원국들이 창의적으로 강제실시권 제도를설계할 수 있도록 재량권을 넓혀 줄 필요가 있음을 보여 주고 있다.
Abstract
Canada has experienced a period of strengthened requirement for patent compulsory licensing after a period of mitigated requirement. Canada introduced a general patent compulsory licensing provisions relating to patent abuse in the amended Patent Act of 1903. Specific compulsory licensing provisions for medicines and food were introduced in 1923 according to the British precedent. The compulsory licensing of medicines was reinforced in 1969. Like this, compulsory licensing regime had been flexibly designed by the Canadian government until the WTO and other international agreements restricted it. However, compulsory provisions for the Medicines were significantly weakened in 1987 due to economic pressure from the US. Canada found that the strengthening of the patent compulsory licensing stabilized the price of medicines, and brought the growth of generic pharmaceutical industry. Canada also also saw that weakening of compulsory licensing did not necessarily caused to increase R&D investment of multinational corporations. ‘Social experiment’ of Canada shows that Article 31 of TRIPs of requirement for granting patent compulsory licensing needs to be more lenient than the current version.
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