Duplicates Discussion: Protecting Medtech Firms from Counterfeiting

To be clear from the start: Product and brand piracy is neither a compliment nor is it a harmless, trivial offense. It is a (mostly) illegal and, above all, lucrative business worth billions. The perpetrators range from unimaginative competitors to professional counterfeiting networks that could even involve organized crime. Today, counterfeit goods are sold in all price and quality gradations—from dangerous, cheaply produced replicas to high-quality plagiarisms that are barely cheaper than the original product. Experts are growing more concerned about the unscrupulousness with which counterfeiters are increasingly offering extremely low-quality versions that endanger the health or even lives of users. The VDMA—the German Engineering Federation—confirms for the B2B sector that counterfeits often pose a risk to the operators of machines and systems or a risk to the safe operation of the system.

Innovation Stands for Progress and Diversity

Innovation is not created with a “copy-paste” command. Whether an attractive design or a unique technical solution, whether film, music, fashion, or art, none of these creations can be taken for granted. The process from initial idea through design, construction, certification, and prototyping to market readiness is extremely demanding and cost-intensive. Design and engineering services require complex expertise as well as a feel for markets, trends, sustainable production, and economic feasibility. In addition, manufacturers must regularly make financial outlays in advance. Naturally, this entrepreneurial risk must be worthwhile.

Forward-looking, progressive ideas are the most important asset for companies. It is therefore fundamental to promote and protect creative achievements and technical expertise and to recognize the outstanding importance of intellectual property for securing jobs, prosperity, and competitiveness.

However, this does not work if unscrupulous parties clumsily copy successfully established products on the market and unashamedly pass them off as their own creative achievement, offer them at a much lower price, and unfairly take market share and profits from the original manufacturer. Added to this is the loss of brand credibility and the cost of combating the infringing imitations, as well as the cost of (re-)acquiring customers. Put simply, counterfeits weaken legal trade.

Is Plagiarism a Problem for Medtech?

Absolutely. Although the quantitative extent is not comparable with some other sectors, the damage to companies affected as well as to users of the imitations is immense. In the annual customs statistics, medical technology only accounts for a relatively small percentage. In contrast, the related pharmaceutical industry is alarmingly highly affected.

Bringing Offenses to Light

In recent years, numerous plagiarism cases involving the medical sector have been submitted to Aktion Plagiarius—an organization that awards an “anti-prize” for the worst violators. Among those sent in were knee bandages, urology resectoscope sets, radial shock wave therapy devices, an insect bite healer, and, particularly unscrupulous, a counterfeit product for emergency ventilation. Additional cases (e.g., counterfeit dentistry items) were reported to us. Although the work of Aktion Plagiarius is not representative and only offers a small slice of the problem, these cases reveal the medical industry is affected by brand and product piracy.

Facts and Figures

Globalization, digitalization, and an increasing focus on price are fueling the explosion in product and brand piracy. The Organization for Economic Co-operation and Development and the European Union Intellectual Property Office put the world trade in counterfeit and pirated goods at an alarming $464 billion alone in 2019, which corresponds to 2.5% of global trade. 

The U.S. Customs and Border Protection (CBP)—responsible for enforcing trade laws regarding intellectual property rights (IPR)—constantly conducts operations to seize violative merchandise before it enters the United States for public consumption. According to the CBP, from fiscal year (FY) 2020 to FY 2024, the total number of goods seized for IPR violations has more than doubled, and the total manufacturer’s suggested retail price of these goods has seen an alarming increase of 415%. 

CBP enforces IP rights, such as trademarks, design patents, patents, utility models, and copyrights, that have been recorded with the agency for border enforcement through their e-Recordation Program. The program allows IPR holders to record IPR that has been registered with either the U.S. Patent and Trademark Office or U.S. Copyright Office.

Appearance Is Deceptive

Unimaginative freeloaders and counterfeiting networks produce short-lived, sometimes dangerous imitations under ethically questionable conditions. Further, they do so without regard for human rights or applicable safety and environmental standards.

The reality is that plagiarized and counterfeit products are only deceptively similar to the original upon first glance. To maximize profits, most counterfeit products are made of inferior materials, are manufactured poorly, and have never undergone quality control. In addition, the risks should not be underestimated, ranging from combustible electronics, poor functionality, and excessive levels of harmful substances to the risk of injury. 

The Plagiarius award-winning products include underperforming electric coolant pumps that could cause the engine to overheat, counterfeit WIKA pressure gauges that are neither robust nor precise, or copied INA angular contact ball bearings (original from the Schaeffler Group in Germany) with poor material and manufacturing quality. An absolutely reckless example was counterfeit car wheel rims that broke apart only after a short time during the TÜV load test.

Plagiarism in the Medical Sector

The following examples reveal the methods of counterfeiters and demonstrate different facets of brand and product piracy.

Beurer, Insect Bite Healer: Plagiarism does not conform to medical device regulations

Immediately after a bite, the ceramic heating plate of the insect bite healer is placed on the bite area. The controlled heat development can accelerate the healing process. Not only has the design of the insect bite healer from Beurer GmbH (Germany) been copied, but misleading advertising claims were made. The plagiarized product claims to have a medical function without having passed the EU’s strict requirements and tests for medical devices. The German online retailer stopped the sale of the plagiarism and signed a cease-and-desist declaration. Also, all infringing offers were removed from Amazon.de after reference was made to the registered product design. 

Zimmer, Radial shock wave therapy device “ZWave”: Theft of concept—product, texts, photos

The radial shock wave therapy device “ZWave” from Zimmer MedizinSysteme (Germany) is used for aesthetic medical treatments. A couple of years ago, a Chinese imitator not only copied the design of the product, but also the whole website www.zimmer-aesthetic.de, including all German text, photos, and illustrations. The only thing altered was the email address to receive orders for the imitations.

Bauerfeind, Knee support “GenuTrain”: Looked good, but was ineffective or even harmful

The original knee support “GenuTrain” was created by Bauerfeind AG (Germany). The plagiarism—offered by a Chinese company for one-eighth the original price—was identified at the MEDICA trade fair in Duesseldorf, Germany, confiscated by customs, and further distribution in Germany was prohibited. The basis was Bauerfeind had obtained a temporary injunction against the imitator for “unfair competition.” Defects of the non-marketable plagiarism: The plagiarism lacked the essential product feature, namely the compression required by law, which is why the support slipped and could not have a therapeutic effect. Furthermore, the pad material was harder than the original, which is why the pad did not fit the patella as well and could not “move” with flexion movements. In addition, the ends of the lateral spiral rods were not thinned out. If these had broken out of the knitted fabric, there would have been a risk of injury. Finally, the imitator had not applied for a medical aid license in Germany.

Weinmann, Emergency Ventilators “MEDUMAT Easy“ and “MEDUMAT Transport“

The original ventilators were invented by WEINMANN Emergency Medical Technology GmbH + Co. KG (Germany). The Chinese plagiarized emergency ventilators were particularly unscrupulous: The regulator for the oxygen supply had no stop point and could be turned round and round. In the case of an emergency, the medical staff would not know for sure whether the amount of oxygen set was suitable for either an infant, small child, or adult. These plagiarisms show inferior counterfeit products can also be life-threatening, and they reveal the unscrupulousness of counterfeiters who are willing to accept health risks and danger to the lives of the users for their own profits.

Origins of the Counterfeits

The annual customs statistics show China and the Hong Kong Special Administrative Region are still the number one country of origin for plagiarisms and counterfeits. Further, typical countries of origin include India and Turkey. Meanwhile, retailers and platform operators from third-world countries are flooding the European and U.S. markets with cheap products that are often untested, falsely declared, and do not comply with Western safety standards, including IP-infringing plagiarisms and counterfeits. At the same time, however, more and more Chinese companies are developing from the West’s extended workbench into innovative competitors on the global markets (e.g., AI, robotics, and automobile). They have rapidly learned the importance of protecting their products and consistently enforcing their IPR. 

And de facto, although still many imitations are manufactured in China, they are often commissioned or distributed by companies from industrialized countries. These imitators increasingly come from the direct corporate environment (e.g., unimaginative competitors or former business partners such as suppliers, production, or sales partners). They specifically check the existence of industrial property rights for successful competitor products. If none have been registered, any sense of entitlement and moral scruples are thrown overboard, and third-party designs and technology solutions are sold as the company’s achievement. Any loophole a company leaves will be exploited. This demonstrates it is worth also keeping an eye on the domestic competition.

e-Commerce

Recently, platform operators have intensified their efforts in the fight against product and brand piracy. Nevertheless, companies continue to face massive counterfeiting. Constantly tracking down and reporting infringing products costs entrepreneurs significant time and money. Companies affected, therefore, unanimously criticize the fact that repeated uploads of infringing offers are possible, despite knowledge of the registered industrial property rights and even though an almost identical offer has already been removed. 

Another problem is missing or incorrect contact details for the seller. It is often unclear who the buyer’s contractual partner is. Platform operators appear to be negligent in checking compliance with the general terms and conditions, and there are hardly any consequences for violations. Promises must now be followed by action: Authorities and business organizations have called for more prevention, more controls, and more sanctions against violators.

First Steps After Plagiarism Is Discovered

Admittedly, it is almost impossible to prevent an imitator from producing counterfeits. However, if IPRs are registered, those affected can take various measures that enable them to stop the distribution and hold the counterfeiters accountable. Upon discovery of an infringing product, the first step is to take stock (i.e., gather facts and evidence).

• Who is the imitator: A competitor from your environment or someone unknown to you? Is it at all possible to identify and address him?
• Where does he offer the imitations: Online, offline, which markets/countries are affected?
• Do you have registered IPR where the imitations are being offered? 
• Where is the imitator located: in your country, in Asia; is it promising to take (legal) action?
• What is the dimension of the problem? What quantities does he distribute?
• How important is this specific product for your company, and how dangerous may the counterfeits be to third parties? Are unjustified liability claims likely?

Intellectual Property Rights

Have you ever heard of “Freedom of imitation”? It is not a call to imitate, but it points out the fact that without registered IPR, counterfeiting may be brazen, but legal in certain cases. However, if unfair competitive behavior can be proven, there may be a pathway to a resolution. Therefore, please note the following three IPR recommendations from Aktion Plagiarius and their international legal advisors from Maiwald Intellectual Property.

1. Register IPR in good time. Take deadlines (novelty) into account, and get ahead of an unfair imitator’s registration.
2. Register IPR in all relevant countries/markets. Consider the “territoriality principle”—a U.S. patent ends at the U.S. borders and is worth nothing in China, India, Canada, Europe, Latin America, etc.
3. Protect your technical products not only by patents and utility models, but also by registered design rights. The principle of counterfeiters is “more appearance than substance,” and the design right gives you an additional, low-cost instrument for defense.

Registered industrial property rights allow you to: 

• Assert claims for injunctive relief
• Assert claims for damages
• Assert rights to information

A Holistic Anti-Counterfeiting-Strategy

According to Europol/Interpol, counterfeit products (B2C and B2B) are increasingly being advertised and distributed via e-commerce platforms, social media, and instant messaging services. Also, the forms of digital brand infringements are becoming increasingly diverse, from classic plagiarisms, counterfeits, and copyright infringements to domain theft and brand misuse (e.g., fake AdWords) to complete identity theft (e.g., your website) and fake shops. A great deal of criminal energy is used to exploit the reputation and expertise of renowned manufacturers, which weakens their brands and credibility.

For companies, this means it is basic, but no longer sufficient, to simply register industrial property rights in all relevant markets. Digital brand infringements require digital protection strategies. For the best possible defense against product and brand piracy, Aktion Plagiarius recommends companies rely on a holistic strategy of legal, organizational, and technical measures. In addition to the previously mentioned legal measures, companies should also investigate additional options. 

• Market monitoring: Store checks, advertising of competitors, inspection tour at trade fairs.
• AI-supported online monitoring: Detect and remove infringing offers on digital channels.
• Customs as a strategic partner: On the basis of registered IPR, customs can confiscate and remove infringing goods from circulation at the external borders. Review the e-Recordation Program for border enforcement.
• Raids at counterfeiters’ factories: It is important not only to confiscate the counterfeit products, but also the tools used for the manufacture.
• A professional IT strategy: Protect the company’s expertise and the regulation of access rights—both physical and digital.
• Technical security features: Uniquely identify the original and defend yourselves against unauthorized product liability claims (serialization/traceability along the supply chain).
• Real-time seals with forgery-proof certificates: Manufacturers can identify their authorized partners as such, which also gives users security when buying online.
• Engaging in networks: With trade groups, alliances, anti-counterfeiting coalitions.

Retailers’ Inspection Obligations

Anyone wishing to sell products must ensure they comply with the health, safety, and environmental standards applicable in the sales territory and the products are free from third-party rights relating to trademarks, designs, patents, and copyrights. A careful selection and evaluation of suppliers and regular checks are therefore essential. The responsibility of the “Purchasing and Procurement” department is immense. Diligence is not only a question of respect toward competitors and customers, but also internally in order to avoid expensive product recalls, liability, and warranty cases. 

Conclusion 

In order to stem the flood of counterfeit and dangerous products and to ensure fair global trade, all stakeholders must pull together. The fact is, without demand, the business model of counterfeiters and suppliers of cheap products would be obsolete. It is the responsibility of all market participants to opt for conscious, sustainable consumption and thus strengthen creative professionals, brand manufacturers, and the legal trade. This is necessary for future growth, jobs, and prosperity.

Plagiarius: Against BrazeN Innovation Theft
The negative “Plagiarius” award is annually given to manufacturers and retailers of particularly brazen plagiarisms and counterfeits in a media-effective manner, and has been since 1977. Before the annually changing jury selects the winners, all nominees are given the opportunity to comment. The “Plagiarius” award says nothing about whether the counterfeit product is legally permitted or illegal. Aktion Plagiarius cannot pass judgment. However, it can express the opinion that crude 1:1 imitations that deliberately look deceptively similar to the original product are reckless and morally reprehensible and lead to stagnation instead of progress and diversity. 

The Aim
The aim of the Plagiarius campaign is to protect the innovative strength and intellectual property of companies and creatives. To this end, it raises public awareness of the unscrupulous business methods of counterfeiters and sensitizes industry, politicians, and consumers to the problem in a practical way.

Based on the plagiarism cases of affected companies, the organization sheds light on the extent, damage, and background, as well as the various facets and manifestations of product and brand piracy. The trophy of the negative award is a black dwarf with a golden nose. The latter symbolizes the immense profits that unimaginative counterfeiters earn at the expense of the creative sector and industry.
In its unique exhibition, the Museum Plagiarius in Solingen is showing more than 350 Plagiarius Award winners from a wide range of industries, with a direct comparison of the original product and the plagiarized product. Guided tours provide facts and background information. Exhibits can also be booked from Aktion Plagiarius for individual external exhibitions, as can lectures about brand and product piracy.

The Plagiarius Competition 2026 will start in August 2025. Affected by plagiarism? Hand in your original product and the alleged plagiarism. More information: www.plagiarius.com or contact Christine Lacroix at [email protected].

Christine Lacroix studied international business administration at Aachen University of Applied Sciences (Germany) and Coventry University (UK). Since 2001, she has been responsible for all activities related to the Plagiarius negative award at Aktion Plagiarius e.V. Her work focuses on press and public relations—from the Plagiarius competition to international exhibitions and lectures to newsletters and social media—as well as advising affected companies on combating product and brand piracy and developing intellectual property strategies. In addition, she is responsible for the concept and development of the Plagiarius Museum, which opened in 2007 in Solingen.