Intellectual Property and Competition Law - IPRsonline.org

ICTSD Programme on IPRs and Sustainable DevelopmentxiFinally, there are a number of areas in which IPRs play an important role and where actions takenby governments decisively shape competitive relations. This is, for instance, the case of regulationsdetermining the requirements for marketing approval of pharmaceutical and agrochemical products.The sui generis system of “data exclusivity” applied in some countries – and promoted through freetrade agreements – confers a temporary right to the exclusive use of such data by the first applicant(generally the company that developed a new product), thereby excluding generic competition duringthe period of exclusivity. Restrictions to competition may also arise from the so-called “patentregistrationlinkage” under which a national health authority cannot approve a medicine, or is obligedto take other measures, when there are patents relating to the medicine and the applicant has notobtained the patent owner’s consent.In conclusion, IP law cannot be designed and applied in isolation from other legal disciplines,particularly competition law. The “competition policy” approach suggests that creating and preservingthe conditions for competition and market contestability in the area of IPRs, is not only the taskof “competition law” or “antitrust” authorities. Defining the right balance between competitionand IPRs is an objective to be achieved through a diversity of policies and regimes. A number ofrecommendations can be made to developing countries, namely:- establish or strengthen competition laws in order to control, inter alia, possible abuses emergingfrom the acquisition and exercise of IPRs;- consider the competition implications of various policies and regimes that determine marketentry, such as marketing approval of pharmaceutical and agrochemical products;- ensure an adequate coordination among the competition law agency and other agencies whosedecisions may influence market structure and operation, with the aim of maintaining a competitiveenvironment;- fully use the flexibilities allowed by the TRIPS Agreement to determine the grounds for grantingcompulsory licences to remedy anti-competitive practices relating to IPRs;- consider, in particular, the granting of compulsory licences in cases of refusals to deal;- conceptualise and apply the essential facilities doctrine as required to address situations ofcontrol of essential technologies, taking into account the relevant market conditions and publicneeds;- develop policies, including guidelines, to prevent and correct abuses in the acquisition andenforcement of IPRs;- address situations that may normally lead to anti-competitive conduct such as “package” and“thicket” patents;- adopt guidelines for use at the patent offices to prevent the granting of frivolous or low qualitypatents, as well as patents containing overly broad claims, which may be used to unduly restrainlegitimate competition and block innovation;- avoid “linkage” provisions and data exclusivity in order to promote competition in markets ofregulated products.