Intellectual Property Rights (IPR) Recordation of Pharmaceuticals: The Underlying Trademark Issues

Intellectual Property Rights (IPR) Recordation of Pharmaceuticals: The Underlying Trademark Issues

The Anti-counterfeit Authority (ACA) announced, through Public Notice No.1/2022, the commencement of the implementation of the recordation of Intellectual Property Rights (IPR), which was to come into effect from 1st July 2022. According to the notice, recorded IPRs would be accorded ‘proactive protection against counterfeit imports.’1 However, Public Notice No.2/2022 announced the deadline extension from 1st July 2022 to 1st January 2023. Once the deadline was over, section 34 B of the Anti-counterfeit Act would come into effect. This section of the Act deals with the recordation of trademarks.2

According to the ACA, generic pharmaceutical products that are legitimately manufactured and well labelled are not counterfeit.3 It further states that recordation requirements benefit trademark owners since they protect registered marks from infringement and consumers from consuming counterfeit drugs.4 ACA also states that ‘it is an offense to import goods that have not been recorded with ACA.’5 This move has, however, been challenged by the Kenya Pharmaceutical Distributors Association (KPDA) who claim that it will criminalise the importation of generic medicine.6

The World Health Organisation (WHO) has defined generic medicine as ‘a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.’7 The Anti-Counterfeit Act 2019 defines counterfeiting in relation to medicine as ‘the deliberate and fraudulent mislabeling of medicine with respect to identity or source, whether or not such products have correct ingredients, wrong ingredients, have sufficient active ingredients or have fake packaging.’8

Generic medicines are made using similar active ingredients as the innovator company’s medicine, but are sold under a different brand ‘from the innovator company’s brand for the particular medicine.’9 They are equally safe and efficient as the original brand name product since they undergo thorough scrutiny before they are licensed and approved by the appropriate national medicines authority.10

Intellectual Property Rights Recordation

The ACA defines IPR recordation as ‘the process of collecting and entering into an electronic database, information from Intellectual Property Right owners regarding their registered IPRs irrespective of their place of registration, for all goods to be imported into Kenya.’11 The legal basis for IPR recordation can be found in section 34B12 of the Anti-counterfeit Act, Anti-counterfeit (Recordation) Regulations and Anti-Counterfeit (Amendment) Regulations.

According to the ACA, IPR Recordation aims to prevent the importation of counterfeit goods into Kenya.13 IPR Recordation differs from IPR registration in that IPR registration entails filing intellectual property rights with the appropriate registering body to be ‘granted exclusive rights with respect to ownership and use.’14 Registered names or logos eliminate the possibility of confusion arising from similar goods or services thus causing dilution of the owner’s brand.15 However, trademark registration is insufficient to offer protection and compliance when importing goods into Kenya.16 Among the harms caused by counterfeit goods are that they deny consumers the ability to enjoy the benefits of genuine products and they lead to unfair commercial competition.17 Counterfeiting also undermines intellectual property rights and ‘restricts innovation and skills development.’18 This is why IP recordation is important.

Notably, counterfeit and imitation drugs were distinguished in the case of United States vs Articles of Drugs19 where the court noted that the Federal Food, Drug and Cosmetic Act (FDCA) was designed to protect public health and consumers. It also noted that an imitation drug passes off one substance ‘in imitation of another.’20 On the other hand, a counterfeit drug is one that ‘simulates another’s label, container or identifying marks.’21

Trademark issues in branded and generic drugs

Three names designate drugs: the chemical name, generic and brand names. Since chemical names are complex, generic names were introduced.22 The generic name refers to the active ingredient used,23 while generic drugs are ‘copies of brand-name drugs that have exactly same dosage.24 Brand names are protected as exclusive private property rights.25 The brand name of a drug is also referred to as the trade name, and it is the name given by the company that makes it.26 The trade name of a drug can be registered as a trademark as long as it complies with the relevant trademark law provisions.27 The trademark of a drug may also contain words, graphics, letters and other elements.28 Also, the marks on the drug packages can be registered as trademarks.29

Although a patent can protect a drug, the originator can advertise the drug through the brand name, or trademark ‘to create brand-name recognition that continues to exist after the patent expires.’30 Once a patent expires, competitors manufacture generic equivalents that are usually sold at a lower price than originator brands.31 In a nutshell, generic medicines are those whose patent protection has expired and may be produced by manufacturers different from the innovator company.32

Brand-name drug companies manufacture drugs in specific shapes or colours for certain reasons.33 Some of the reasons include that they may be easier to swallow, are cost-effective, or for no specific reason at all.34 The trademark issue that arises with this is whether generic medicine companies can manufacture generic medicine using the same shape and colour as the brand name drug while avoiding trademark liability.35 In this case, if the drug’s colour or shape is functional, or is non-functional and has not acquired secondary meaning, then the drug is not protected as a trademark, and therefore the generic drug may be manufactured in the same shape or colour.36

A functional feature is one which serves other purposes other than identifying the source of the product. These features enable competitors achieve commercial success. Where the shape and colour are functional, trademark protection will not be granted and therefore generic manufacturers can use them.37 A case which illustrates this is Smith, Kline & French v Clark & Clark38 where the defendant manufactured generic medicine that was almost identical to the brand name drug. The plaintiffs sought an injunction against the manufacture and sale of the defendant’s patent-infringing amphetamine tablets. The court, in this case, found that the infringing tablets closely resembled those produced by the plaintiffs and that the two tablets were only distinguishable upon close examination. The court further refused to grant an injunction beyond the life of the plaintiff’s patent and also held that the various features of the amphetamine tablets were functional. This is because the scoring of the white tablets allowed the tablets to be broken into smaller dosages and the beveled and concave edges prevented crumbling and aided breakage. The court instead upheld the district court’s findings of unfair trade practices and required the defendant’s tablets to be stamped with a distinguishing mark such as C&C.

In some jurisdictions like the United States, shape and colour are protected as trade dress and, therefore, not available for generic use if they are non-functional and have ‘acquired secondary meaning.’39 Secondary meaning establishes ‘sufficient consumer recognition of the mark or dress as a source indicator.’40 Trade dress is a type of trademark law that protects the ‘look and feel of a product’,41 distinguishing it from similar products. Trade dress entails product packaging and product design and helps in the identification of a product’s source.42 The shape and colour of a pill are regarded as product design. An illustration of this is the case of Norwich Pharmacal Co. v Sterling Drug, Inc,43 where the defendant used the same pink colour for a generic liquid medicine that the plaintiff had used for the brand name. The court did not issue an injunction even though the colour was non-functional. This is because it had not acquired secondary meaning as a source indicator and was not entitled to trade dress protection.

Finally, although the IP recordation requirement is a welcome move meant to curb the importation of counterfeit goods, it is fundamental to consider the repercussions of such a move on Kenyans’ general well-being. This is because the Constitution provides that ‘every person has the right to the highest attainable standard of health…’44 The case of Patricia Asero Ochieng, Maurice Atieno and Joseph Munyi v The Republic45 illustrates this point. In this case, the petitioners argued that sections 2, 32 and 34 of the Anti-Counterfeit Act,46 at the time, denied individuals infected with HIV/AIDS the right to access affordable and essential drugs. Therefore, this would endanger the availability of generic medicine, and its overall effect would infringe on the right to life enshrined in the constitution. In the judgement, the judge held that failure to access affordable generic medicine would significantly affect people infected with HIV and AIDS, and many may risk losing their lives.47 To facilitate the recordation of IPR, the ACA has established the Anti-Counterfeit Authority Integrated Management System (AIMS) portal which can be accessed through the ACA Public System.

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1 Anti-Counterfeit Authority, Commencement of Recordation of IPR (26 April 2022) < > accessed 6 February 2023

2 The Anti-Counterfeit Act 2019, section 34B (1) provides that, ‘Trademarks relating to goods to be imported in Kenya, irrespective of the place of registration, shall be recorded with the Agency, in the prescribed manner if the registration is current.’

3 Anti-Counterfeit Authority, FAQs-Intellectual Property Rights Recordation < > accessed 6 February 2023

4 ibid

5 ibid

6 Wainaina Wambu, Drug Suppliers sue State over looming ban on generic medicine (14 December 2022) < > accessed 6 February 2023

7 Rafael Alfonso-Cristancho, Definition and Classification of Generic Drugs across the World(20 June 2015) <> accessed 6 February 2023

8 Anti-Counterfeit Act 2019, section 2 (d)

9 Bowmans, The sale of generic medicine in Kenya:Are they counterfeits under the Law? (23 April 2012) < >accessed 9 February 2023

10 ibid

11 Anti-Counterfeit Authority ( n 3)

12 Section 34B (1) provides that, ‘Trademarks relating to goods to be imported in Kenya, irrespective of the place of registration, shall be recorded with the Agency, in the prescribed manner if the registration is current.’

13 ibid

14 ibid

15 ibid

16 Victor Orandi, Recordation of Trademarks on Imported Goods <> accessed 9 February 2023

17 ibid

18 ibid

19 United States vs Articles of Drugs 601 F. Supp. 392, 398 (D. Neb. 1984)

20 Roseann B. Termini and Amy Miele, Copyright and Trademark Issues In the Pharmaceutical Industry-Generic Compliance or Brand Drug Imitating-“Copycat or Compliance” (6 February 2013) <> accessed 9 February 2023

21 ibid

22 Roger Feldman and Felix Lobo, Competition in prescription drug markets: The role of trademarks, advertising and generic names<> accessed 9 February 2023

23 The generic name (non-proprietary name) is determined by the pharmaceutical company while the chemical name refers to the molecular structure which distinguishes it from other drugs. For instance N-acetyl-p-aminophenol is the chemical name of Paracetamol (generic name)

24 Dr. Deng, Drug names: brand name, proprietary name, trade name, generic name and sponsor’s drug code(29 August 2021)<,be%20called%20the%20trade%20name.> accessed 9 February 2023

25 Feldman(n 22)

26Deng ( n 24)

27 Linda Liu, A brief introduction to the relationship between a drug’s generic name, trade name and trademark(14 June 2022)<> accessed 9 February 2023

28 ibid

29 ibid

30 Feldman (n 22)

31 ibid

32 Suzanne Dunne and others, A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study <> accessed 9 February 2023

33 Termini (n 20)

34 ibid

35 ibid

36 ibid

37 ibid

38 Smith, Kline & French v Clark & Clark 157 F. 2d at 727

39 Termini (n 20)

40 ibid

41 Red Points, What is trade dress and how it can protect your product <> accessed 9 February 2023.

42 ibid

43 Norwich Pharmacal Co. v Sterling Drug, Inc 271 F.2d 569

44 Constitution of Kenya 2010, Article 43(1)

45 High Court Civil Suit No. 409 of 2009.

46 The Kenya Anti-Counterfeit Act 2008 applicable at that time in section 2 of the Act failed to provide a clear definition of what counterfeit is and therefore generic medicine could be regarded as counterfeit. Section 32 of the Act made it a criminal offence to possess, make or sell counterfeit goods while section 34 enabled intellectual property rights holders to request seizure and detention of counterfeit goods.

47 Bowmans ( n 9)

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