Of more interest is the clear statement by the General Court that “there is no provision in Regulation 207/2009 that provides, at least expressly, that the withdrawal of an opposition entails the renunciation of the right to file an application for a declaration of invalidity. That withdrawal does not therefore, in law, have any effect on the lawfulness of the filing of a future application of invalidity”. This is a useful confirmation of the potential ‘gap’ left by the decision in Budweiser (1645/2001), which had made clear that an unsuccessful opposition did not create res judicata on the basis that “opposition proceeding before the Office constitute a particular expression of the so called “right of opposition”… if the opponent fails in his attempt, he can nevertheless file a cancellation action before the Cancellation Division or bring a counter claim in an infringement action before a national court”. This approach was also adopted by the English Court of Appeal in L’Oreal v Special FX in 2007 in relation to oppositions in the UK IPO, which stated that “the decision of the Registry on opposition proceedings, or more generally a decision to register despite opposition, is not a final decision so as to be capable of being the basis for an issue estoppel”. In this case, at the time of withdrawing the oppositions, Ferring had expressly stated that it intended to bring an application for invalidity of the registrations at a later date, which further demonstrated a lack of express consent on the facts. PPSA also argued that Ferring had consented to the registrations by virtue of the co-existence agreement referred to above. According to the judgment, the co-existence agreement applied only to the blue logo shown above and, therefore, could not be interpreted as amounting to express consent for Article 53(3). Practice points for co-existence agreements to keep in mind include: • whether it is in the client’s interests to have a broad definition of sign in the co-existence agreement (or not); including clear expressions of consent to future applications and registrations if the agreement is intended to do that; and ensuring the marketing and branding teams are aware of any restrictions agreed to in any co-existence agreement as to use (creative freedom) and future trade marks and logos. Health Canada Guidance on Drug Brand Name Assessment: Now in Effect Jennifer McKenzie and Amy Dam, Bereskin & Parr LLP, Toronto, Canada Sponsors filing a drug submission must also provide a brand name assessment as part of the drug safety and effectiveness evaluation. The objective of this assessment is to evaluate the potential for a proposed drug name to be confused with other authorized products in Canada with the aim of preventing medication errors. The Health Canada Guidance Document for Industry – Review of Drug Brand Names1, first released on 2 July, 2014 came into effect on 13 June, 2015. The guidance replaces the 2013 Draft Revised Guidance Document for Industry – Review of Drug Names for Look-Alike Sound-alike (LASA) Attributes. Notable changes in the guidance include the following: non-prescription products and natural health products are not included in the scope of the guidance 2; raw data to be submitted is limited to database search results (although Health Canada reserves the right to request additional material when deemed necessary); the orthographic and phonetic similarity threshold is lowered from 65% to 50%; and psycholinguistic tests are no longer required. inserting it into a variety of prescribing, transcribing, dispensing and administration scenarios and documenting the resulting failures, as well as developing a process map that outlines where and how the proposed drug will be used and who in the medication use system will come into contact with the product. Finally, the Synthesize step involves synthesizing the evidence obtained from the database search results and the simulations, and completing a Failure Mode and Effects Analysis to make a decision on the likelihood of confusion with the proposed name. Health Canada will review the information submitted by the sponsor and may reject a name and request a name change if it considers that the name is likely to cause confusion with other products or is misleading. If safety concerns remain, Health Canada may refuse to issue a Notice of Compliance for new drugs or a Drug Identification Number for existing drugs. In selecting a drug brand name, sponsors must also be mindful of the trade mark registration process under the Trade Marks Act which focuses not on the confusability on a safety perspective, but on the likelihood of confusion as to the source of manufacture of the product. (1) Available at: http://www.hcsc.gc.ca/dhpmps/pubs/medeff/ _guide/2014-review-examen_drugmedicament_names-marques/indexeng.php. (2) The guidance applies to innovative and generic drugs for human use in which a brand name is proposed (pharmaceutical drugs, Schedule D and Schedule C products, behind-thecounter drugs and drugs sold directly to healthcare professionals for professional use). (3) Brand names that contain the proper of common name(s) in final dosage form in combination with a modifier, the manufacturer name or an acceptable abbreviation of the manufacturer name are exempt from the LASA Brand Name Assessment. Brand Name Assessment Process The sponsor must first carry out (1) an initial brand name review to determine whether the name is misleading with respect to the composition, effectiveness or safety, and then provide (2) a Look-alike Sound-alike (LASA) brand name assessment to determine the likelihood of confusion between the proposed name and authorized product names (3). The testing of LASA attributes involves a multi-step approach. The Search step involves searching relevant drug name and medication error databases (the Drug Product Database and the Licensed Natural Health Products Database) and identifying drug names with a combined orthographic and phonetic similarity score of 50% or more. The Simulate step involves assessing the confusability of a proposed name by • • According to Curia, the CJEU website, an appeal was filed on 12 August 2015 – it will be interesting to see which points are argued on appeal and how the CJEU responds to them. 9