A/HRC/11/12 page 26 86. While some argue that patent linkage merely prevents governments from issuing patents while simultaneously permitting their infringement, it should be noted that patent linkage is at odds with the conception of patents as private rights.95 It imposes an obligation on a country’s DRA to prevent possible infringement of the private rights of patent holders either by denying registration or informing a patentee. 87. Further, it should be noted that the European Union (EU) does not have a system of patent linkages96 and in the United States, the Food and Drug Administration has stated that it does not have the expertise or resources to review patents.97 88. This is of particular concern as patent linkage would affect the entry of generic medicines in the case of the patents being invalidated. By delaying the process of granting marketing approval, patent linkage provides patent holders with additional opportunities to prolong their monopoly rights and delays the entry of generic medicines into the market. In fact, a United States Federal Trade Commission study showed that the United States linkage system is subject to substantial abuse by patent holders.98 The Canadian Federal Government and Supreme Court have also recognized that companies had been using the Canadian linkage system to evergreen their patents.99 89. Patent linkages, by not allowing the registration of generic versions of patented drugs can also adversely impact the early working exception, which ensures the immediate entry of generic competition after the expiry of the patent. Similarly, refusal to register also creates uncertainty in relation to compulsory licences. 4. Intellectual property (IP) enforcement mechanisms 90. The enforcement of IP claims should refrain from creating any undue barriers to access to medicines. In this respect, FTAs that impose TRIPS-plus IP enforcement measures are a 95 See TRIPS Agreement, preamble. 96 “Patent linkage is considered unlawful under Regulation (EC) No 726/2004 and Directive (EC) No. 2001/83.” See EU Directorate-General for Competition, Pharmaceutical Sector Inquiry - Preliminary Report, 28 November 2008. 97 “FDA does not have the expertise to review patent information. The agency believes that its resources would be better utilized in reviewing applications rather than reviewing patent claims.” 59 Fed. Reg. 50338, 50343 (Oct. 3, 1994). See “Generic drug entry prior to patent expiration: an FTC study”, Federal Trade Commission, July 2002, p. 44. 98 99 Ibid. T.A. Faunce and J. Lexchin, “Linkage in pharmaceutical evergreening in Canada and Australia”, Australia and New Zealand Health Policy, vol. 4, (2007), p. 8, referring to the two following sources: Government of Canada. Canada Gazette Part II Regulations amending the patented medicines (notice of compliance) regulations 2006, 140 (21): 1503-1525; AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49.