There are currently around 1,000 medicinal products authorised for human use in the European Union. Yet, there are 45,000 pharmaceutical trade marks protected in the UK. Clearly, there are far more pharmaceutical trade marks than there are products on the market.
| 1,039 | Medicinal products authorised for human use in the EU (by the European Commission) |
| 9,699 | International non-proprietary names (“generics”) |
| 45,526 | UK trade marks which cover “pharmaceuticals” in class 5 |
To get pharmaceuticals from the laboratory to the pharmacy is a long journey: from initial conception to the marketplace can take decades and involves the creation of three names for each product (at least):
- Chemical name
- Generic name
- Proprietary name
- Conception
Pharmaceuticals, whether this is traditional small-molecule drugs or biopharmaceuticals, start life in the lab. They might be a “simple” mix of chemicals or a concoction of components from living sources. Either way, there will be a written chemical formula, or instructions on how to get the right result.
- Approval
At the approval stage we find generic pharmaceutical names and proprietary pharmaceutical names or brand names/trade marks.
Generic pharma names
A new pharmaceutical which is to be approved for use in humans must have a generic approved name. This is so that medical practitioners and patients can easily understand what they are prescribing or taking[1]. Very often the name has a common root which refers to its chemical components (for example, the –ase suffix refers to enzymes). This is officially known as the international non-proprietary name (the INN) name and is open to all to use (for example, paracetamol).
Inventors of a new pharmaceutical product often create a generic name in parallel with a proprietary brand name. This means that legitimate third party manufacturers of the generic drug have a descriptive term to use and reduces the temptation to adopt (and infringe) the trade mark.
New INNs are considered and approved by the World Health Organisation. The process is stringent and third parties may object based on similarities with existing INNs, medical names, chemical names or trade marks.
Proprietary pharma names/brand names/trade marks
A pharmaceutical company will also want to create a trade mark to communicate the origin of the goods. This is typically an invented name, such as Calpol or Lemsip. By building a brand identity, the product will attract a premium over its identical non-branded equivalents and a revenue stream is created which will last long after the patent rights have expired.
New trade marks must be approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the UK market and the European Medicines Agency (EMA) for the EU market. They must also be cleared for use and can be registered at the relevant intellectual property offices.
The regulatory bodies have different requirements, with the MHRA and EMA adhering to Directive 2001/83/EC and the intellectual property offices adhering to the UK Trade Marks Act and Regulation (EU) 2017/1001:
| MHRA | UK IPO |
| The MHRA is concerned with protecting patients. Its assessment is detailed and specific to the product in question.
The name will be rejected if: 1. it will cause confusion with the name of an existing medicine; Once approved, the name is under continual review and can be revoked if actual or potential hazards come to light following marketing. This is time consuming and costly. |
The UK IPO is concerned with protecting consumers. Its concern is that consumers will be able to identify a trade mark as indicating the origin of the pharmaceutical goods.
Common grounds for a trade mark to be rejected are: 1. if it descriptive or non-distinctive (e.g. “drugs” or “strong stuff”). Objections on this basis are usually brought by the trade mark office; or Once approved, a trade mark is still vulnerable to third party challenges. If pre-filing searches have been done, and a mark selected, which is available for use, to register a trade mark is relatively cost effect. The UK IPO does not check a trade mark is used or approved for use in relation to the goods it is registered for. This means there may be many marks registered but not used for “pharmaceuticals”. |
- Market
The final stage is, of course, to get pharmaceuticals to the hospitals, the pharmacy shelves and to patients.
Even once there is an approved product and an approved name, there are still ongoing issues to manage, for example, parallel importers, counterfeiters and unlawful trade mark use by generics manufacturers.
Pharma naming strategy
From a branding perspective, the ultimate objective is an attractive, clear and memorable invented product name, which is consistent across all countries and has regulatory approval. However, achieving that goal is extremely challenging and strategic planning, plus a little luck, is essential.
For the greatest chance of success, the best approach is to search broadly, search early and search several marks. From there it is a funnelling process with multiple fall-back positions in case one reaches a dead end.
[1] a prescription may be for a specific brand of a pharmaceutical, for example, see Flynn Pharma Ltd v Drugsrus Ltd and anor [2017] EWCA Civ 226
