In the increasingly complex pharmaceutical supply chain, the new regulations to combat the entry of fake or counterfeit medicinal products need to be observed
UK trademarks are regulated under the Trademarks Act 1994. Further guidance and regulation for pharmaceutical products are provided by the Medicines and Healthcare Products Regulatory Agency (MHRA), while the European regulator is the European Medicines Agency.
The EU Falsified Medicines Directive (2001/62/EC) was transposed into UK law by the Human Medicines (Amendment) Regulations 2013, which came into force on August 20 2013. These amended the Human Medicines Regulations 2012. In the increasingly complex pharmaceutical supply chain, the new regulations aim to combat the entry of fake or counterfeit medicinal products.
The United Kingdom currently operates a scheme under the General Pharmaceutical Council (GPhC), the independent regulator for pharmacists, pharmacy technicians and pharmacy premises, in which legitimate online pharmacies linked to licensed pharmacies with physical premises can display a logo directing users to the GPhC’s website confirming their status. While this scheme was previously voluntary, under the Falsified Medicines Directive distance sellers of medicinal products must now be registered with a national body and must display a common EU logo and a link to the national body’s website. The logo and link must appear on every page relating to the distance selling of medicines. It is hoped that this will discourage consumers from purchasing falsified medicinal products and counterfeits from illegitimate sites.
The Falsified Medicines Directive also introduced safety requirements for the packaging of certain categories of medicine, aimed at combating counterfeits. These will apply to all prescription-only medicines and any other medicines that are at risk of counterfeiting. The specific requirements will be set out in later delegated legislation (expected by 2014), and include tamperevident seals and unique identifier references on each individual pack.
Also of relevance is the new EU Customs Enforcement Regulation (608/2013), which will come into effect on January 1 2014. This regulation aims to increase cross-border protection against the traffic in counterfeit goods, including pharmaceuticals, between member states or into the European Union. The regulation will implement the simplified procedure for dealing with suspected counterfeit goods without a court order across all member states. It also allows for rights holders to apply for certain small consignments to be dealt with automatically by Customs ex officio.
However, the new regulation has failed to resolve the issues raised by cases such as Koninklijke Philips Electronics NV and Nokia Corporation, in which the European Court of Justice (ECJ) limited the abilities of customs authorities to detain goods entering the European Union in transit. The ECJ held that goods intended for onward shipping transported into the European Union under customs supervision or stored in customs warehouses were not infringing, and so could not be seized unless the rights holders could show sufficient proof of intent to sell on the EU market. However, the European Commission has made proposals for a new directive which would enable counterfeit goods to infringe merely by virtue of entering the European Union “in the context of commercial activity”.
Developments in case law
It is well established following Armour Pharmaceutical Co v Office for Harmonisation in the Internal Market (Trademarks and Designs) (OHIM) (Case T-483/04) that for pharmaceutical goods, the level of attention of the average consumer in the context of assessing the likelihood of confusion “must be determined on a case-by-case basis, according to the facts in the case file, especially the therapeutic indications of the goods”, and that this level of attention will generally be higher with prescription pharmaceuticals. This principle was expanded in 2013 by Ferring v Medreich (UK-IPO-O-216-13) and Boehringer Ingelheim International v Glaxo (UK-IPO-O-015-13), which stated respectively that prescriptiononly goods will bring “an enhanced level of attention, but it is still unlikely to be of the highest level”, and that “pharmaceutical products sold without prescription, even where they are low cost, will require at least a reasonable level of attention to be paid to their selection”.
At the opposite end of the spectrum from prescription drugs, in First Choice Pharma v Synergy Pharmaceuticals (UK-IPO-O-264-13), the UK Intellectual Property Office (UK IPO) held that vitamin supplements could be classed as medicines as they would “be used to treat a deficiency of a particular vitamin in the body”. Since ‘medicine’ was held to be a broad enough term to include both the applicant’s vitamin supplements and the opponent’s drugs, following the principles set out in Meric v OHIM (Case T-133/05), the hearing officer found that the goods were identical. However, the hearing officer allowed that this definition might be considered too broad, and found in the alternative that the goods were highly similar due to their mode of use and physical similarity.
Perhaps less surprising was the UKIPO’s finding in Premier Foods Group v Reckitt Benckiser Healthcare UK (UK-IPO-O-158-13) that an opposition to HUG IN A MUG under Section 5(4)(a) of the Trademarks Act (passing off) based on the earlier mark A GREAT BIG HUG IN A MUG failed in relation to Class 5 because, despite the argued common belief in the restorative qualities of soup, there was not a common field of activity between producers of soup and producers of pharmaceuticals.
In consultation with the MHRA, the public and various scientific and industry bodies, the UK government intends to regulate nicotine-containing products as medicines. This is in line with the proposed revisions to the EU Tobacco Products Directive (2001/37/ EC), and will bring electronic cigarettes and other nicotine delivery systems within the scope of medical regulations and the pharmaceutical trademark regime.