AUTHOR: Brook Baker. ABSTRACT: European Customs officials have used fictive patent rights to justify the seizure of lawful generic medicines produced in India and destined for non-European markets. Following a public outcry and initiation of two WTO complaints, the EU has proposed amendments to Border Regulations Measure 1383/2003. The Proposed Border Regulation in its current form will not adequately resolve the risk of interception in Europe of medicines lawfully manufactured and exported from India and destined for lawful import and consumption in a non-EU country.
This analysis concludes that multiple weaknesses remain in the Border Regulations, including: (1) continued coverage of alleged patent and supplemental protection certificate infringement claims that can be based on fictional patent status under national law; the addition of utility models; and continued coverage of design rights and civil trademark infringement matters that are more appropriately addressed in ordinary court proceedings; (2) inappropriate application of the law of the in-transit country instead of the law of the importing country when assessing an IP infringement claim; (3) unclear directives to “consider” the risk of diversion to EU markets with no explicit prohibition against seizing in-transit medicines in the absence of such a showing and without requirement of clear and convincing evidence of an imminent diversion by an identified party; (4) insufficient opportunities to be heard for declarants and holders of goods; and (5) insufficient remedies for declarants and holders of goods and for purchasers and consumers who are proximately harmed by unsuccessful border applications.