221. The representative of India said that the issue of Members' experiences using alternatives to the Paragraph 6 System to achieve the objective of access to medicines had been raised and discussed for several years, but Members were still short of inputs. He therefore reiterated his delegation's demand for a dedicated workshop that would, as the delegation of Ecuador had mentioned, help strengthen the Paragraph 6 System and where Members would have an opportunity to discuss other experiences. The workshop would also help those delegations develop faith in the System who had cited a lack of faith as the reason for not accepting the Protocol Amending the TRIPS Agreement.
222. Turning to the role of compulsory licensing to provide access to medicines, he recalled that Articles 30 and 31 of the TRIPS Agreement provided a mechanism to that extent. Article 30 was a substantive exception which detailed three criteria to be met for any exception to apply to exclusive patent rights. Article 31, in contrast, was primarily procedural in nature, detailing a list of requirements that applied to other uses without authorization by the patent right holder. Both provisions taken together defined the scope of limitations to exclusive patent rights available under the TRIPS Agreement. Additionally, Article 44 outlined flexibilities with respect to the right to provide permanent injunctions.
223. He drew Members' attention to two particular cases in the United States. Shedding light on those cases could help address the problem of providing access to medicines without recurring to the complicated Paragraph 6 System. In eBay v. MercExchange, the US Supreme Court had determined that the plaintiff in infringement cases had to satisfy a four-factor test before a court could issue a permanent injunction. This four-factor test included demonstration of the following elements by the plaintiff, i.e. that: (i) he had suffered full and irreparable injury; (ii) remedies available at law such as monetary damages were inadequate to compensate for that injury; (iii) considering the balance of hardships between the plaintiff and defendant, a remedy in equity was warranted; and (iv) public interest would not be disserved by a permanent injunction. In Edwards Lifesciences v. CoreValve, a compulsory licence had been granted for manufacturing a medical device in the United States exclusively for exportation. He requested that the United States and other countries where similar judgments had occurred explain to Members why the restrictions on exports under compulsory licences as established by Article 31 of the TRIPS Agreement did not apply in those cases.
