The Name Game: Pharmaceutical Trademarks

Finally, all drugs have a scientific name, which follows a standardized naming convention outlined by the International Union of Pure and Applied Chemistry (IUPAC) conventions. However, these names are normally lengthy. For example, ZAVESCA’s scientific name is “N-butyldeoxynojirimycin.”

Broadly, the brand name is the name consumers will recognize and is the same as the trademarked name in its given jurisdiction. However, if the name is rejected, pharmaceutical companies must either settle for an alternative brand name for that specific jurisdiction or go back to the drawing board to create a new marketable name for their treatment.

In his experience, Mr. Rickles has had a mark rejected because authorities said it was promotional since it started with ‘wel,’ which they thought was similar to ‘well.’ Some countries have rejected the mark because another company had apparently submitted a similar mark, but “they can’t tell you who that is and what the mark is.” In these situations, he said they generally end up rejecting both marks.

The “Big Two”

According to frequent filers, the difficulty in getting health regulators to approve a branded drug name varies substantially depending on the jurisdiction and the regulator’s guidelines, which are generally publicly available.

However, if a company wants to market its treatment internationally, chances are it will always have to submit the drug name to the “Big Two”—the EMA and FDA. Clearing this initial hurdle can mean smoother sailing later down the road.

Mr. Rickles said: “If you can get the name approved at the FDA and EMA, most other regulators are generally happy to approve the name in their jurisdiction.”

While many regulators, including the EMA and FDA, make their guidelines for pharmaceutical name analysis readily available on their websites, outcomes can still be hard to predict for pharmaceutical companies.

Charles Kohler, a spokesperson for the FDA, said: “[The] FDA considers the information and analyses about the proposed proprietary name and determinations are made on a case-by-case basis, considering the totality of the information.

“The FDA may object to a proposed proprietary name that is likely to contribute to medication errors or otherwise contributes to violations of the FD&C Act [Federal Food, Drug, and Cosmetic Act]. Attributes that FDA may find objectionable are described in detail in our ‘Guidance for Industry.’”

While these two agencies both exhibit a rigorous approval process, there are a few key differences between the two.

For one, the EMA does not provide or recommend any assessment tools, while the FDA does; its FDA’s Phonetical Orthographic Computer Analysis (POCA) system is designed to help applicants anticipate the outcome of the agency’s decision.

While this might make pinning down exactly how likely a name is to receive approval in the U.S., companies may find it easier to hedge their bets at the EMA as the agency allows applications to submit two names for review at a time.

Mr. Rickles noted: “Europe might be a little easier here as you get two bites at the apple ... EMA will also normally give an answer quicker, maybe within a couple of months whereas the FDA can take six months.”

Other Jurisdictions

The regulator’s scrutiny is sometimes at odds with the IP office’s approach to trademark registration. An example of this can be seen in Palestine, where confusion of a pharmaceutical trademark with a prior mark is not a key concern.

Firas Attereh, managing partner, Hussam Attereh Group for Legal Services (Palestine) said: “Since pharmaceutical products are not considered over-the-counter products, the customer perception of the trademark is deemed of ‘very low weight’ [by both the Trademark Registrar in Gaza and the Office of the Registrar in the West Bank]. In other words, the customer does not choose the product based on the trademark it bears—rather the products are given based on the doctor’s prescription.”

“To that effect,” he added,”the trademark may be allowed registration despite its similarity with a prior registered trademark.”

In some jurisdictions, pharmaceutical names are required to be registered as trademarks in “local transliterations,” Tapio Blanc, chief trademark officer, F. Hoffman-La Roche AG (Switzerland) explained. “And there might be more formal requirements than in others,” he said.

“For example, the trademark owner must also register not only the Latin version of the trademark but also the local transliterations, such as Cyrillic, Chinese simplified/traditional, Hindi or Katakana,” depending on the jurisdiction.

“The Chinese name and its name in its original language should be corresponding as far as possible. Therefore, transliteration is generally given priority to,” she said.

Some countries do not require national health regulators to weigh in on branded drugs when companies are bringing them to market.

India, for example, is among them. However, court precedent has mandated a general brand name confusion check by the Central Drugs Standard Control Organisation.

In India, courts “have issued multiple guidelines to regulatory authorities mandating that, before granting permission to manufacture a drug under a brand name, the authority must be satisfied that there will be no confusion or deception in the market,” according to Abhai Pandey, partner at LexOrbis (India).

The courts have also requested that authorities submit “search reports” from the trademark registry for the proposed pharma trademarks.

Despite this, “approvals are frequently granted to similarly branded medicines/drugs,” he added.

Increasing the Chances

In addition to typical due diligence prior to product launch, such as market research, legal searches, and regulatory and linguistic checks, pharmaceutical companies usually take a standard path to increase the odds that a drug name will be approved.

A company will eventually narrow down a drug name to 5 to 20 final candidates. At this point, general or in-house counsel typically steps in to flag any potential issues that IP offices or regulators might raise.

Then, the big question looms of whether to seek the approval first by the health regulators or the local IP office. Mr. Rickles recommends filing the trademark first.

“The [trademark offices] usually act a little quicker, and they can look at several marks at one time, unlike many regulators. This means you get several names secured before you approach the health authority,” he said.