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“For medical purposes” – a case for unblurring the lines between pharma and nutritional products
June 2022
Food-pharma industry convergence is not a new development. In 2013, a study of the patent citation data of 274 published European patents by 5 EU Medical Nutrition companies revealed the blurring of lines between conventional food and pharmaceuticals and concluded that pharmaceutical technologies were driving medical nutrition innovation[1].
Fast forward almost a decade and the traditional silos are being disrupted at pace. In 2021, the UK’s Taskforce on Innovation, Growth and Regulatory Reform (“TIGRR”) laid down its recommendations for new regulatory regime to bridge pharma and food regulation for the emerging ‘nutraceutical’ sector[2].
Trade mark conflicts will undoubtedly continue to rise as pharma and food companies battle it out to dominate the sector. However, there remains inconsistency in the findings of the courts and registries about just how close the sectors are in purpose and in the eyes of the consumer, leading to a degree of unpredictability in proceedings concerning pharma v food goods.
Here, we take a look at court/registry interpretation of the scope of protection for products classified in class 5 (pharmaceutical products, dietetic substances for medical use) versus those found elsewhere and the case for delimiting the goods by their main purpose.
Classification guide as a tool
The Explanatory Notes to the Nice Classification are a good place to start. The Explanatory Note to Class 5 says: “Class 5 includes mainly pharmaceuticals and other preparations for medical or veterinary purposes”. This includes “meal replacements and dietetic food and beverages adapted for medical use”. However, it “does not include, in particular… meal replacements and dietetic food and beverages not specified as being for medical… use, which should be classified in the appropriate food or beverage classes”.
The Notes to Classes 29, 30 and 32 expressly exclude “dietetic food and substances adapted for medical use” (cl.29 and 30), and “dietetic beverages adapted for medical purposes”.
This sees some functional foods and drinks being classified elsewhere such as protein drinks (cl.32), nutritionally fortified beverages (cl.32), protein bars (cl.30), even dietetic foodstuffs not for medical purposes, and therein, it seems, lies the crux. How should a class 5 specification be interpreted? How far does “adapted for medical use” reach?
“For medical purposes” – a narrow interpretation
In Case T25/17, EUIPO v. Compagnie laitére européenne SA, the General Court set out distinguishing features of products in class 5, specifically pharmaceutical preparations, dietetic substances for medical purposes, dietetic preparations, dietary supplements, pharmaceutical products, all for medical purposes versus class 32, protein preparations in powder form for beverages supplemented with vitamins or minerals as well as with carbohydrates as follows:-
- The relevant distinguishing criterion is not the form of the product, i.e. whether it is a liquid or solid edible foodstuff, at [86]
- The very wording in the class 5 application shows the goods are for medical use. They are intended to be used a part of a therapeutic dietary plan, i.e. a plan to treat or relieve medical pathologies. The fact the goods are not indicated as only available by prescription, is not determinative. Nevertheless, the use of such goods presupposes intervention by a health care professional and adaptation of the composition of those goods in order to produce the desired therapeutic effects, at [97]
- Whereas the class 32 products were indicated as high in protein but low in carbohydrates and lipids, and fortified with nutritional supplements but serving no medical purpose, and the class 5 goods gave no indication as being adapted for physical conditioning or enhancing performance.
- The criterion for delimiting the goods is the use of the goods in question, i.e. their main purpose, at [87].
The Board of Appeal took the same approach in Case R 22/2019-4 MULTI-FOOD Produktions- und Handelsgesellschaft mbH v SAMI S.R.L, considering whether evidence of use on protein preparations with nutritional purposes proved use in respect of dietetic products for medical purposes. The BoA held not; the goods were essentially muscle building and protecting preparations. It said:
- “The broader category ‘dietetic products for medical purposes’ are intended to treat certain health problems, as the detail concerning ‘medical use’ indicates (26/11/2015, T-262/14, Bionecs, EU:T:2015:888, § 26)”, at [45]
- “None of the preparations that appear in the evidence of use seems to have medical purposes. They are essentially muscle building and protecting preparations without medical indications. All these products have exclusively nutritional purposes and aim to improve the athletic performance of the body”, at [46].
Taking account of Nice classifications, their explanatory notes and the findings of the courts and registries, it is apparent that class 5, particularly adapted for medical use/purposes is to be afforded a narrow interpretation, being goods to treat a deficiency or medical need, a specialised form of nutrition, which is different to products with exclusively nutritional purposes. It is the main purpose that decides. A liquid Vitamin B complex in class 5 can therefore be distinguished from a class 32 vitamin B fortified water – a court or registry may render them dissimilar – but the desire for a pharma company to be able to enforce against the latter use is understandable given the increasing convergence of industries.
Inconsistent outcomes
Yet, there appears to be an inconsistency of outcomes. In R 397/2021-5, Verla-Pharm, Arzneimittel GmbH & Co. KG v. Polski Koncern Naftowy ORLEN S.A, comparing protein and energy bars with class 5 dietetic and pharmaceutical preparations, the Board took a somewhat looser approach to assessing ‘purpose’, holding:
“…while [energy bars; protein bars] are not specifically aimed at treating, alleviating or curing illness, it is nevertheless true that they also contribute… to promoting health and that they can be administered and used, in a combined or supplementary manner, to different therapeutic ends. They are designed to respond to special dietary needs, with the aim of treating or preventing illnesses or of strengthening the organism”.
It went on at [33] to say that the conflicting goods, whether or not for medical use, are generally produced by the same pharmaceutical companies. Is this true yet or is it still the exception rather than the norm as the lines blur?
For the future
As pharma and food move out of their silos, one would expect the number of findings of similarity to increase between pharma and food categories, at least for those food/beverages drafted to ‘call out’ their nutritive benefits. As market realities develop and consumers become accustomed to pharma-food companies collaborating or becoming one through acquisition and investment, and to how functional foods and nutraceuticals are marketed and sold, it is right that the global assessment in trade mark law should shift with consumer perception. However, one anticipates that a narrow approach will (and should) remain when interpreting “for medical purposes” in the context of proof of use in opposition and cancellation proceedings.
For now, those interested in functional foods and nutraceuticals might consider:
- Whether to file in the traditionally ‘ordinary’ foodstuff/beverage classes additionally to class 5
- To ensure careful drafting so as not to limit goods to those ‘for medical purposes’ and to clearly specify if goods are not intended to be limited to this purpose
- Whether current use truly falls within class 5 for medical purposes or e.g. whether the purpose of their products is for sport/athlete enhancement and performance
- Closely scrutinising third party use to ascertain whether use is truly use in connection with registered goods in class 5 or if it displays use in other categories by virtue of the goods’ purpose.
This article was prepared by HGF’s Trade Mark Director Katie Goulding.
[1] Weenen TC, Ramezanpour B, Pronker ES, Commandeur H, Claassen E (2013) Food-Pharma Convergence in Medical Nutrition – Best of Both Worlds? PLoS ONE 8(12): e82609. doi:10.1371/journal.pone.0082609
