shutterstock_1197728128_photobyphm-jpg
photobyphm / Shutterstock.com
15 March 2019Big Pharma

Senior counsel at Bayer highlights pharmaceutical TM challenges

Doctors’ handwriting poses a significant challenge to the registration of pharmaceutical trademarks, according to a senior counsel at German pharmaceutical company Bayer.

Speaking yesterday, March 14 at the Chartered Institute of Trademark Attorneys spring conference in London, Christian Schalk said trademark risk assessments must include a test of how a potential trademark will be handwritten by different people.

According to Schalk, 40% of all trademarks are rejected by health authorities for not meeting regulatory requirements.

The European Medicines Agency ( EMA) rejects 46% of all trademarks. Although the US Food and Drug Administration officially only rejects 15%, it has a high rate of informal rejection, Schalk said.

An informal rejection is when the FDA will inform an applicant that its mark will be rejected, and on which grounds, and advises it to refile its application.

One major drawback for pharmaceutical trademark registrations is the fact that physicians often hand-write prescriptions for drugs.

This means trademarks must be distinguishable to an extent that they will not be confused even when written in a number of different ways, Schalk said.

He added that before applying for a mark, attorneys should carry out risk assessments to determine how the proposed mark will be perceived when written by different people.

“There is no regulatory body to tell doctors how to fix their handwriting,” Schalk said.

This is echoed by the EMA. In its 2014 guidelines for trademarks, it said trademarks “should not cause confusion in print, handwriting or speech”.

Additionally, Schalk highlighted the importance of registering pharmaceutical trademarks.

He said many pharmaceutical companies had adopted the strategy of combining International Nonproprietary Names (INN) with their company names, in place of using product-specific trademarks.

“The INN is the active ingredient of a drug. It is extremely important because it facilitates the identification of a drug worldwide,” Schalk said.

For example, if a consumer is on holiday in another country but runs out of a  certain medicine, that INN will allow them, and pharmacists, to identify that same drug despite it being sold under a different label.

But, Schalk highlighted a number of benefits of marketing a product under a pharmaceutical  trademark rather than taking this approach.

“For as long as a product has patent protection, a company has exclusive rights to the product, and can defend it against anyone who infringes that patent,” Schalk said.

But, when the patent expires, someone else may also market a version of the same drug. This is when companies benefit from having a trademark.

“After a patent expires, the only differentiator between one company’s product and another’s is the trademark,” he said.

He said trademarks are also useful when large companies divest. If all of the company’s products were previously marketed with its name, when those products then become property of a new company, the old packaging is useless.

This means that essentially, the new owner has to build a market reputation of a drug from scratch. If a pharmaceutical trademark for the drug was already in place, the new company would not face this issue.

Schalk said the strongest type of trademarks for pharmaceutical products are coined names, or newly-invented words.

“Names which have no meaning are highly distinctive and the chances of getting them registered are high,” he said.

Schalk added: “For me, only three things matter. Is the name pronounceable, is it free from cultural connotations and is it registrable worldwide?”

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.


More on this story

Biotechnology
9 November 2018   The European Patent Office has revoked a Bayer-owned patent which covers a type of broccoli adapted to make their harvesting easier.
Big Pharma
13 August 2020   Bayer has settled a patent infringement suit with generics manufacturer Apotex, after claiming that its version of a cancer treatment infringed two patents.

More on this story

Biotechnology
9 November 2018   The European Patent Office has revoked a Bayer-owned patent which covers a type of broccoli adapted to make their harvesting easier.
Big Pharma
13 August 2020   Bayer has settled a patent infringement suit with generics manufacturer Apotex, after claiming that its version of a cancer treatment infringed two patents.