EMA: Playing the percentages

In Europe, around 50% of pharmaceutical brand names are rejected by the European Medicines Agency (EMA), according to anecdotal evidence. Yes, you read that right—one in two names is dismissed, and yes, it’s the EMA that has the ultimate say.

The success of any EU trademark application depends on the European Union Intellectual Property Office (EUIPO) giving it the green light. However, given the health and safety concerns around medicinal products, the pharma industry is unusual in that there is an extra hoop to jump through before a name is ultimately approved—it’s the EMA, an EU agency.

This creates a challenging environment for applicants, not least because the EMA’s Name Review Group (NRG) looks at names from a different angle from the EUIPO.

Pharma names play a special role, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), a Brussels-based trade organisation. A spokesperson tells WIPR that such names can enhance public health by assisting health professionals reduce medication errors and providing manufacturers with an effective tool to monitor the safety of existing drugs.

According to the EFPIA, the EMA reviews various criteria to ensure that a name does not convey misleading therapeutic and/or pharma connotations with respect to the product’s composition. It must also ensure the name does not risk causing consumer confusion either with prior names or with existing international non-proprietary names (INNs). The name cannot derive from a previous name or an existing INN, or its stem.

Roger Lush, partner at Carpmaels & Ransford, notes in a blog post that there are differences in the way the IP and regulatory bodies view confusion.

While trademark confusion relates to trade origin, the key consideration from a regulatory perspective is whether there is any health and safety risk arising from confusion with an existing pharma name, he writes. “That might include a drug being administered for an incorrect therapeutic indication or being mistaken for a generic name (ie, an INN).”

The task of successfully registering a pharma name is made more difficult because the EMA takes into account not only the names of existing products on the market, but those of pending applications—and this information is not public, says Benoît Beuken, senior trademark counsel at biopharmaceutical company UCB.

“For applicants, performing a robust trademark clearance (considering the legal, the safety and the linguistic perspectives) remains critical and essential, but it’s very difficult to predict the outcome from the EMA’s assessment, notably due to the information contained in pending submissions which is not disclosed to the public.”

Let’s talk

There are also concerns over communication from the agency, as well as communication between it and the EUIPO.

Frank Meixner, head of corporate trademarks at Bayer, says the offices “don’t talk to each other” and that it’s very difficult to predict the outcome of the EMA’s review.

The company runs regulatory studies to try to better understand the EMA’s position, but “even with those, we just don’t know whether a name will be considered too close to a pre-approved name”, says Meixner.

He adds that Bayer does try to seek answers from the EMA, “but it doesn’t help”. Bayer is invited to regular meetings in London, where the EMA is currently based, at which industry stakeholders try to achieve a “mutual understanding of the issues”. However, he says, the company usually obtains clarity only on rules and procedures—such as how many names can be submitted with the EMA—rather than on why certain names are unacceptable.

Meixner doesn’t expect the lack of communication between the EMA and the EUIPO to change. And in a seemingly paradoxical fashion, he adds that he might not want them to liaise more than they currently do. “If the two offices started talking there is a risk that the trademark office all of a sudden does what the regulatory office does, and we wouldn’t like that. At least we understand one of them.”

The threat of rejection by the EMA means companies have to come up with several variations of a product name. Even if the name is then accepted in Europe, it may well be rejected in other major jurisdictions, so companies wishing to use a universal name for their product may still need to find alternatives despite a positive EMA decision.

This naming process often involves branding agencies, whose creativity may be the difference. Meixner says Bayer can end up with a shortlist of 20 options with a “tolerable risk profile” and that “sometimes you can change one syllable or the entire name”. He suggests using “coined words”, given that INN stems are unacceptable, as are promotional components.

Beuken explains that people used to ask him why pharmaceutical brand names are often “weird”—the reason being that a name for a drug must overcome many obstacles—and he used to say that it’s “better to seek a name that is hard to forget, rather than a name that is easy to remember”.

With companies filing many variations of a product’s name in view of the EMA’s high rejection rate, the result is a highly cluttered register in class 5, which covers pharmaceutical products. Lush points out that there are 55,000 registered trademarks containing the word “pharmaceutical” in the EU’s class 5.

“As a result the potential for trademark opposition and infringement is significant,” he says. “This necessitates thorough trademark searching, which will frequently uncover earlier rights that pose a risk to the use and registration of a name.”

The clutter also leads to a large number of trademark coexistence agreements between pharma companies, says Beuken.

It would be easy for IP owners to criticise the EMA for taking a seemingly too strict view in the name review but, as Meixner points out, the organisation is not an expert on trademark matters and is not supposed to be.

The agency’s website notes that the EMA protects public and animal health in the EU’s 28 member states (plus the European Economic Area countries), “by ensuring that all medicines available on the EU market are safe, effective and of high quality”. Serving a market of more than 500 million people, the EMA can’t afford to take any risks with public health, even if this comes at the expense of a narrow stratum of society: trademark owners.

Whether the 500 million figure is set to drop by around 65 million—the size of the UK’s population—depends on the looming Brexit deal. The UK’s role in and relationship with the EMA is very much uncertain, but a report in January in the Financial Times cited “three senior UK government figures” as saying that the UK hopes to continue under the EMA’s regulation.

One thing that seems to be set in stone—the EMA’s headquarters in London will be moving to Amsterdam (however, this decision has been challenged by Italian politicians). Putting aside the UK pharma industry’s dismay at this development, not to mention the worries of the 1,000 employees currently based in London, there may be questions about what it means for trademarks, if anything. But unless significant resources were either invested in or taken away from the NRG, it is likely to be business as usual.

The problem of counterfeits

Of course, registering a pharma trademark is one thing, but enforcing it is quite another. Enforcement is another area in which pharma companies face unique challenges, mainly because of the potential deadly impact of fake drugs being consumed.

According to Meixner, successfully fighting counterfeits in Europe is still “feasible to a large extent”, and will be helped by new rules under the Falsified Medicines Directive allowing pharmacists to check whether a product is original by scanning it with a barcode.

The bigger problem is posed by illegal online websites, he says, especially as the products sold on them are hard to track down because they are sent in small consignments rather than large containers, as is common in the luxury goods industry.

The trade in fake medicines has prompted a fierce response from the authorities. In September 2017, Interpol announced it had made 400 arrests worldwide and seized more than $51 million worth of potentially dangerous medicines in a crackdown on illicit online pharmacies. The organisation said it was the largest action of its kind.

An impressive feature of the sting was not just the record number of 25 million illicit and fake medicines seized, but the fact that nearly 200 police, customs and health regulators from 123 countries combined to bring down the counterfeiters. It was a show of true collaboration and unity, but it also reiterated that even though IP and regulatory agencies may lack cohesion in the naming registration framework, the same cannot be said on the enforcement front.

While there are clear challenges for pharma brands in registering their names with the EMA, they should take some succor from the fact that authorities across Europe (and elsewhere) are evidently committed to stamping out fake products. And while the registration process may be testing and frustrating at times, the stringent standards applied are ultimately in everyone’s best interests.

EMA facts