Document Type : Research Paper

Authors

• Alireza Jabbari ¹
• Mohammad-Reza Parvin ²
• Shahrouz Shokraie ³

¹ LLM, Intellectual Property Law, Shahid Beheshti University, Tehran, Iran

² Assistant Professor, Intellectual Property Law, Department of Microbial Biotechnology, Agricultural Biotechnology Research Institute of Iran (ABRII), Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran

³ Ph.D. Student, Private Law, Ayatollah Amoli Branch, Islamic Azad University, Amol, Mazandaran, Iran

Abstract

Introduction

Trade dress, as an instance of nontraditional trademarks, encompasses the overall visual image of a product, including elements such as size, shape, color or combinations thereof, packaging, textures, graphics, and even specific sales techniques. However, to qualify for legal protection in many countries, trade dress must be nonfunctional. A feature is deemed functional if it is essential to the product’s use or purpose, or if it impacts the product’s cost or value. Nowadays, size, shape, color, and color combinations have emerged as crucial branding tools within the pharmaceutical industry. Indeed, the distinctive shapes, colors, and other visual characteristics of medications can be significant, especially when utilized during the patent term. Nevertheless, in certain instances, a drug’s appearance may serve functional or practical purposes, such as uniquely identifying a specific medication, preventing dosing errors through color-coded drug doses, and enhancing patient compliance. In such cases, trade dress provides an additional mechanism to establish exclusive rights over drugs and health technologies beyond the scope and term of patent protection. This can result in gratuitous and complex litigations, hindering generic companies from entering the market, impeding access to healthcare for patients, and negatively impacting patients’ health. Therefore, fundamental questions arise: When does the shape and color of drugs become functional? Do the current laws and regulations in Iran exclude functional features from the scope of registrable trademarks? What are the effects of failing to establish a clear legal barrier to registering functional trademarks on patients’ health and competition in the pharmaceuticals?
The present study aimed to review and compare the legislative approaches adopted by Iran and other selected countries regarding the registrability of trade dress in pharmaceuticals. It sought to examine the effectiveness of the functionality doctrine in preventing anti-competitive effects and risks associated with patients’ health.
First, the research provided a brief explanation of the scope of trademark protection in pharmaceuticals, followed by a discussion on the functional doctrine, conceptual requirements, and various legal approaches in select countries. Then, the functional doctrine in pharmaceuticals was examined in detail, along with the adverse effects stemming from a lack of explicit legal prohibitions against registering functional trademarks, including its impact on patients’ health, competition, and generic substitution. Then, the study analyzed the effect of alternatives on the registration of functional features as well as the admissible evidence for proving the functionality of trade dress in both courts and trademark offices.

Materials and Methods

Based on an analytical–comparative method, the present study used the library research and note-taking techniques to collect the data from various documents, books, and articles.

Results and Discussion

Concerning the functionality doctrine in the legal systems of Iran and other countries, the study found it challenging to establish clear principles for determining precisely when a feature is deemed functional. Nevertheless, a global trend and consensus exist in advocating for legal prohibitions to prevent the protection and monopolization of such features. The majority of WTO members have embraced this perspective by explicitly excluding functional features from trademark protection. They have instituted legal constraints on the registration of functional trademarks, irrespective
of whether such trademarks meet another distinctiveness requirement (Handler, 2018). However, the functionality doctrine has not been effectively integrated into Iranian trademark law for a long period. Although there is no specific provision excluding functional features from the scope of trademark protection, Articles (32) of the Act on Patents, Industrial Designs, and Trademarks Registration of 2008 (IRI), as well as Article (105) of the new Industrial Property Protection Plan, allow for the registration of trade dress for pharmaceuticals. It seems necessary to review and amend existing regulations, considering the paramount importance of patients’ health and the necessity to prevent undue hindrances to competitors in accessing and utilizing functional features such as shape, color, and other pharmaceutical signs.
According to the research findings, certain design features of pharmaceutical products (e.g., the shape, size, and color of medicines) may evolve into functional features over time. This functionality is not the traditional utilitarian type but a therapeutically-based functionality, as patients come to consider these visual cues an integral part of their treatment (Calboli, 2020). For instance, individuals taking multiple medications daily become deeply familiar with the appearance of their medicines. Particularly, elderly patients rely on the size, color, and shape of drugs to distinguish between various medications or different doses of the same medication. Moreover, patients who have grown accustomed to the appearance of their drugs over many years associate the effectiveness of the treatment with the visual characteristics of the medication. They may have doubts about the efficacy of drugs with a different appearance. In such cases, transitioning from a brand name to generic products with distinct physical features may impact patient adherence, compliance, and the acceptance of medication regimens, potentially leading to medication errors. Additionally, medical service providers may need to invest significant time reassuring patients when prescribing generic medicines with different appearances, as some patients feel doubts about the effectiveness of such medicines. On the other hand, generic producers are unable to replicate the designs of brand-name medicines after the patent expires—due to trade dress protection. They thus find themselves at a distinct competitive disadvantage compared to the original manufacturers, encountering formidable obstacles when attempting to enter the market.

Conclusion

Iran’s Act on Patents, Industrial Designs, and Trademarks of 2008, as well as the new Industrial Property Protection Plan, have embraced a broad and inclusive definition of mark. This definition notably encompasses elements such as packaging, shape, or color. However, it does not explicitly address nontraditional functional trademarks. To address concerns related to potential anti-competitive consequences and risks to patients’ health, it is recommended that signs exclusively comprised of specific qualities be considered absolute grounds for refusal or invalidity in the existing laws and regulations. The qualities are:  a) the shape or another characteristic inherently derived from the nature of the goods; b) the shape or another characteristic crucial for achieving a technical result; c) theshape or another characteristic that substantially contributes value to the goods.

Keywords

• Trademark
• Trade Dress
• Functionality Doctrine
• Generic Substitution
• Patient Adherence
• Placebo Effect

Main Subjects

• International Law