Counsel at European pharma companies have described a “vicious circle” in which brands are over-crowding the EU trademark system in their attempts to have product names approved for medicinal use.
Counsel at Bayer, Sanofi, UCB Pharma, Insud Pharma and another company tell Managing IP they often apply for more than one trademark for a proposed product in the hope that one will pass the subsequent approval tests carried out by regulators.
Regulators have the final say over whether a trademarked name can be approved for use, irrespective of the determination from the relevant intellectual property office. The regulatory bodies undertake strict safety tests to ensure there is no possible confusion with existing medicines and no danger to patients.
“It’s a numbers game,” says one counsel, who adds that it is common for drug companies to apply for five to 10 trademark variations for just one product because the regulatory outcome is so uncertain.
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Earlier this week, Managing IP spoke to primarily US-based pharma companies that said winning approval for a new name from the US Food and Drug Administration (FDA) was one of the biggest challenges they are gearing up for this year.
The situation, it seems, is no different in Europe, where counsel say they have additional unique hurdles to overcome such as language barriers and the fact that each applied-for name must be assessed by both local regulators and the supranational European Medicines Agency (EMA).
File, file, file
Frank Meixner, head of corporate trademarks at Bayer in Germany, says regulatory approval – whether approved or denied – is “very complex and unpredictable”.
“The outcome for pharma companies is to file for as many trademarks as possible: a preferred mark and a group of alternatives,” he says.
He adds that it is common for companies to file five to ten trademarks for one product in the hope that one may clear both hurdles – legal and regulatory.
Joëlle Sanit-Hugot, principal counsel and lead trademark attorney for vaccines at Sanofi in France, says this would be her advice too. “When developing names for a pharmaceutical product, always develop several trademarks: two main trademarks, and back-ups,” she says.
Benoit Beuken, senior trademark counsel at UCB Pharma in Belgium, says he too advises having back-up names up your sleeve, adding that companies should proactively provide documents and reports to support their submission.
Vicious circle
However, counsel note that the need for multiple applications can create an ‘over-cluttering’ problem in the trademark register, where class 5 (which covers pharmaceutical products) is already very crowded.
“It’s a vicious circle,” one source notes. They add that this also opens them up to opposition and infringement proceedings.
However, Sanit-Hugot says the registers are already clogged in many countries and that class 5 does not contain only pharmaceutical preparations.
“Other items in class 5 include disinfectants, preparations for destroying vermin, fungicides and herbicides, which are totally different from pharmaceuticals and related goods,” she notes.
Meixner at Bayer adds that the over-filing tactic also disproportionately affects smaller companies, which perhaps have the resources to apply for just one or two marks.
He speculates that smaller companies may face a rejection rate of around 50% from regulatory agencies but larger companies [which can file more trademarks] have a better chance.
Sources add that because they have to file multiple applications, they are able to recycle some trademarks at a later date. However, they also have a higher number of unused trademarks as a consequence.
Meixner at Bayer notes that this could be a problem if the EU were to shift towards a system similar to that deployed in the US, where trademark owners have to prove use of a mark every five years by providing material evidence and statements of use, therefore facing an additional administrative burden.
At the moment, EU law provides trademark owners with a five-year grace period in which to use a mark.
Comprehensive checks
Sanit-Hugot at Sanofi says companies can get a head start by performing ‘pharma in use’ searches – comprehensive checks of relevant databases of pharmaceutical names that are actually in use.
“They should also be aware of the criteria applied by the regulators,” she says, adding that relevant information is provided in the EMA’s guidelines on acceptable names.
In addition, Sanit-Hugot recommends engaging brand agencies, some of which offer regulatory and name testing.
“The agencies apply the regulatory criteria defined by regulatory bodies to test the trademarks for the pharmaceutical product,” she adds.
Beuken adds that robust legal trademark clearance followed by safety research on desired candidate names (performed by specialist agencies) is essential to limit the risks of rejection.
Pedro Román Goicoechea, IP counsel at Insud Pharma in Madrid, says it is imperative to make sure counsel strike the right balance between the legal and marketing teams.
“You have to find the right balance between what legally works (under trademark law), what marketing want and what will meet regulatory requirements,” he says.
Lost in translation
Turning briefly to the US, Meixner at Bayer notes that there are handwriting and verbal analyses tests carried out by the FDA to determine whether a proposed name is confusingly similar to another drug name.
During this phase, nurses, pharmacists and physicians are asked to participate in a mock simulation of the prescription ordering process. Meixner notes that the notion that doctors have messy handwriting can be a factor here if their notes are hard to read.
Although sources say a final decision from one regulator is no easier to predict than any other, counsel in Europe note that the variety of languages and cultures across the bloc poses a unique challenge.
Sanit-Hugot says: “Compared to the FDA, the situation in the EU is more complex: the trademarks are reviewed by each member state by the local regulators prior to final review by the EMA. The number of languages in the EU renders the assessment of similarity more complicated.”
She adds: “A consensus is reached at the EMA level to accept or reject an objection raised from a local regulator. The companies only receive the final decision: either approval or rejection for the entire EU (with grounds for rejection).”
Goicoechea at Insud Pharma says it’s important to make linguistic assessments early in the process – ideally before submitting any name for approval.
“What sounds fine in French could mean something totally different or have different connotations in German,” he says, adding that the company once had a proposed name rejected by authorities in Norway and the Czech Republic – but nowhere else – because of its connotations in those languages.
If the ‘lucky dip’ approach of filing multiple marks does not work then a comprehensive language check may be in order first.
