Plagiarism and counterfeiting: protecting intellectual property rights

The European Medical Device Regulation (MDR) stipulates that medical devices must be safe and effective. Counterfeit medical products and plagiarized devices often bypass the outlined standards as they are manufactured beyond legal control and without the required expert knowledge. This makes plagiarized medical devices not only detrimental to the original manufacturers but also puts patients in harm's way.

In this interview with MEDICA-tradefair.com, Christine Lacroix talks about plagiarism and how manufacturers can protect themselves from counterfeiters. She also explains why it is always a good idea to be vigilant at trade fairs like MEDICA - and reveals what you should do if you detect plagiarism.

Ms. Lacroix, do counterfeit medical devices pose a serious threat today?

Christine Lacroix: They are definitely a real problem but not to the same extent as in other industries. In customs statistics, medical technology makes up just a small percentage, unlike the escalating counterfeit problem in the related pharmaceutical industry.

We have received a number of plagiarism cases in recent years, which included complaints about knee bandages, resectoscopes used in urology or radial shockwave therapy equipment. One counterfeit mechanical ventilator included a regulator that did not stop at a fixed-flow rate, bordering on criminal activity. It shows that plagiarism can also endanger the lives of patients.

That being said, the work of Aktion Plagiarius e.V. is not representative since not all affected companies alert us or want the general public to know about their dilemma.

How can medical device manufacturers protect themselves from counterfeiters?

Lacroix: They should definitely protect their intellectual property, i.e. file a patent or utility patent application before they launch a product on the market. This allows them to protect new technology or unique solutions they use. The design also plays an increasingly important role when it comes to technology products. This is where registered design rights take effect. We often see counterfeiting that applies to branded products, which is why you should also register your trademark.

These types of property rights are always territorial in nature. Prior to market launch, you must always consider in which country you need to seek protection and where you manufacture and distribute your product.

What happens if a counterfeit device has hit the market?

Lacroix: You should act fast if you are being affected. We recommend walking around trade fairs like MEDICA right on the first day. Many companies do this anyway just to check out trends and see the innovations showcased by their competitors.

This also allows you to determine whether some products out there infringe on your property rights. Many companies actually hire lawyers to monitor and report any plagiarism. Lawyers can then team up with customs authorities or a bailiff to remove products that violate intellectual property rights from the booth and request for injunctive relief and perhaps even punitive damages. Registered trademarks and a current border seizure application submitted to customs are prerequisites for customs to be able to act and seize counterfeit products - not only at trade fairs but at borders, ports or airports as well.

What support does your association provide?

Lacroix: Our primary goal is to raise public awareness – among the industry, consumers and legislators – about product and brand piracy. We want to shine a bright light on the harmful effects for the industry and how this can potentially put consumers and users at risk.

The award winners of our anti-prize “Plagiarius” receive international publicity, with news traveling all the way to China. The plagiarism cases submitted by companies allow us to draw attention to the relevancy of this problem. The award winners showcase the wide range of industries that are affected, which enables us to call out brazen counterfeits.

Once someone has been accused of plagiarism and nominated for the award, we contact the alleged counterfeiter and allow the party to respond to these plagiarism accusations. We get different responses to these allegations, but every year we also have some cases where the counterfeiter seeks an amicable agreement with the original equipment manufacturer, signs an injunctive relief clause, and takes the remaining counterfeits off the market. This is a complete success for both the company and us.

You gave a lecture about this issue at the MEDICA TECH FORUM. How important was this event for you?

Lacroix: The forum was well attended, always turning it into a great opportunity to reach many people and network. I have also noticed that the Forums attract more and more visitors who select specific lectures and then take the time to listen, to ask questions and to exchange ideas. We can use this chance to communicate our message: Do not forget to protect your intellectual property rights and register them early. Regularly check on your competition – find out what they are doing at trade fairs, in retail settings and online.