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JudgmentGALAXY PHARMACEUTICAL LIMITED VS PRISM LIFE SCIENCE LIMITED AND REDDYS PHARMA LTD AND 1 Others21 min read

GALAXY PHARMACEUTICAL LIMITED VS PRISM LIFE SCIENCE LIMITED AND REDDYS PHARMA LTD AND 1 Others

High Court at Milimani High Court · · Wananda John Robert Anuro

1. This Ruling determines two rival Applications, one seeking confirmation of the interim injunctive orders issued herein, initially ex parte but extended a number of times, and the other seeking discharge of the same orders, and for striking out, or stay of this suit in favour of another existing suit. That the matter is hotly contested is easily depicted by the unnecessarily multiple, very lengthy, verbose and irritatingly repetitive pleadings filed by both sides. In fact, the Affidavits filed sound more like final Submissions, complete with legal arguments, in total disregard to basic rules of drafting and procedure. Be that as it may, as the two Applications are no doubt related, and as agreed by the parties, I will determine them in this one Ruling.

2. The background of this matter is that by the Plaint dated 3/11/2025, filed through Messrs Miima & Co. Advocates , the Plaintiff was described as a company engaged in the importation and sale of pharmaceutical products used in the treatment of chronic illnesses, and as the registered proprietor of 14 pharmaceutical products trade marks, which it has used in the course of trade in Kenya. It was pleaded that in or about the year 2003, the Plaintiff and the 1 st Defendant entered into an agreement whereof the 1 st Defendant was to manufacture the Plaintiff’s said branded products 14 out of which the 1 st Defendant would manufacture 45 other medical products. It was pleaded further that it was subsequently also agreed that in the event the 1 st Defendant was not able to fulfil its obligations under the Agreement, the Plaintiff would be at will to source its products from another source. It was then alleged that sometime in 2014, the Plaintiff discovered inaccuracies in the 3 rd Respondent’s Register which erroneously listed the 1 st Respondent as the Marketing Authorization Holder (MAH ) which meant that the 1 st Defendant was the owner of the products. It was further claimed that the parties had agreed that they would create two divisions, namely Prism 1 for products owned by the Plaintiff and manufactured by the 1 st Defendant, and Prism 2 for brands owned and manufactured by the 1 st Defendant and distributed by the Plaintiff in order to create a clear distinction.

3. The 1 st Defendant was then accused, in the Plaint, of crafting a plan to defeat the Plaintiff’s rights to the brands by colluding with the 2 nd Defendant to lodge a malicious complaint against the Plaintiff claiming that the Plaintiff’s products were counterfeited, among other claims, the basis upon which the 3 rd Defendant, as the industry regulatory body, cancelled the Plaintiff’s Certificate of Registration. It was stated that the 1 st Defendant, without the consent, licence and authority of the Plaintiff, has now appointed the 2 nd Defendant as its Local Technical Representative (LTR) for purposes of distribution, and sale of goods bearing marks identical to, or deceptively similar to the Plaintiff’s thereby infringing the Plaintiff’s exclusive rights. Particulars of infringement by each of the 3 Defendants, respectively, were listed, and it was also pleaded that the Defendants have caused or facilitated publication of statements in the print media concerning the dispute and which are misleading, prejudicial and calculated to damage the Plaintiff’s commercial reputation. The special damages loss suffered by the Plaintiff was also listed, and it was alleged that despite demands to cease and desist, the Defendants have failed to stop the offending actions. It was also disclosed that there is in existence another suit, High Court Commercial Case No. E065 of 2025 , filed by the 1 st Defendant to restrain the Plaintiff from exercising its intellectual rights, and there were also previous proceedings in Judicial Review Application No. 113 of 2025 in which the Plaintiff challenged the 3 rd Defendant’s decision to cancel the Plaintiff’s product registration certificates. The Plaintiff then made prayers for a declaration that it is the exclusive proprietor of the subject trade marks, and that the Defendants have infringed on the same, injunction restraining the Defendants from dealing with products bearing marks identical to, or deceptively similar to the subject trade marks, an order for delivery-up for destruction or surrender of the infringing products, and injunction orders restraining the Defendants from publishing any statements that are defamatory or misleading in respect to the issues in dispute herein, and compelling them to retract such statements previously made, and to publish an apology, damages, and costs of the suit.

4. Together with the Plaint and the other usual Pleadings accompanying it, the Plaintiff also filed the Notice of Motion of the same date (the 1 st Application), seeking interlocutory injunctive orders pending hearing and determination of the suit, to restrain the Defendants from committing the alleged infringements and violations referred to above. It is that Application which is the subject of this Ruling.

5. This 1 st Application is supported by the Affidavit sworn by one Jay Hitendra Hirani , who introduced himself as a Director of the Plaintiff. He basically reiterated the matters already set out above and deponed that unless restrained by the Court, the Defendants will continue to with their infringing activities causing irreparable harm to the Plaintiff’s business, brand value, and reputation. He asserted that as a result of the actions of the 1 st Defendant, the Plaintiff has lost out on business by not being able to deliver on the orders for pharmaceutical products, which loss amounts to about USD 5,511.42 per day.

6. The 2 nd Application, on its part, is dated 25/11/2025 and is filed on behalf of the 1 st and 2 nd Defendants, through Messrs Mutuma Gichuru & Associates Advocates . As aforesaid, it seeks discharge of the interim injunctive orders issued herein, and for striking out, or in the alternative, stay of this suit.

7. This 2 nd Application is supported by the Affidavit sworn by one Ajay Joshi who introduced himself as a resident of India and a Director of the 1 st Defendant, and described the 2 nd Defendant as the 1 st Defendant’s duly appointed and authorized Local Technical Representative (LTR) in Kenya. He then contended that this suit turns on a single, pivotal issue; “ ownership of the 45 pharmaceutical products ” and that the Plaintiff’s entire claim to this ownership is exclusively anchored on two documents, namely, a purported private Agreement dated 20/08/2003, and purported minutes of an alleged meeting held on 10/09/2004, but which he termed as fraudulent and forgeries. He then explained that its appointment of a Local Technical Representative (LTR) in Kenya was in accordance with the 3 rd Defendant’s “ Guidelines for Submission of Applications for Drug Registration ” applicable to foreign manufacturers such as itself. He explained further that consequently, upon the 1 st Defendant’s entry into the Kenyan market over 20 years ago, by its letter dated 20/08/2003, it appointed the Plaintiff as its exclusive local distribution agent for over 45 of its products, which appointment explicitly designated the Plaintiff’s role as merely that of a LTR , and not as owner of the products. He asserted that the relationship was governed solely by the said letter, and not by any separate private agreement, and at no point did the 1 st Defendant surrender its intellectual property rights, trade mark or ownership of its products to the Plaintiff. He averred that notwithstanding this; the Plaintiff proceeded to register trade marks for the 1 st Defendant’s pharmaceutical products yet the Plaintiff only held those trade marks in trust for the 1 st Defendant as an agent and only a distributor. He deponed that the relationship between the parties was cordial for 20 years but deteriorated after the Plaintiff demanded an unreasonable price increase, and that it is upon such refusal that the Plaintiff initiated a systematic campaign to fraudulently appropriate the 1 st Defendant’s business. Regarding the purported private agreement and the purported minutes of the meeting referred to above, he deponed that two separate forensic examinations reports by the Directorate of Criminal Investigations (DCI) dated 6/03/2025 and 3/10/2025 have established that the documents are forgeries.

8. He added that the Plaintiff committed further acts of fraud by varying the Market Authorization Holder (MAH) with the 3 rd Defendant by using the forged documents to misrepresent itself as the owner, and by corporate impersonation by way of acquiring “ Prism Medico & Pharmacy Ltd ” to deceptively mimic the 1 st Defendant’s “ Prism ” brand and confuse the market. He also accused the Plaintiff of importing sub-standard and counterfeit drugs as confirmed by independent laboratory tests upon which the 1 st Defendant alerted the 3 rd Defendant about this health risk, which upon conducting investigations, cancelled the irregularly obtained certificates in the Plaintiff’s name, and confirming that they were procured through misrepresentation. He asserted further that the Plaintiff obtained the ex parte interim orders from this Court through deliberate and material non-disclosure by failing to disclose the true nature of a pending suit, Milimani High Court Commercial Case No. E065 of 2025 , which involves the exact same parties and the core issue of product ownership, which rendered this instant suit sub-judice. He also accused the Plaintiff of failing to disclose that it had previously sought and had been denied identical injunctive relief in two other forums, the said Milimani High Court Commercial Case No. E065 of 2025 , and also Judicial Review No. E113 of 2025 , which non-disclosure is an abuse of the Court process.

9. He also urged that the ex parte orders are being used by the Plaintiff as a shield to continue its illicit activities, including the distribution of sub-standard drugs, which poses a grave risk to public health and safety. He urged that in view of the above matters, the commercial relationship between the parties became untenable, and to protect its brand integrity, the 1 st Defendant had no choice but to terminate its association with the Plaintiff, and lodged a formal application with the 3 rd Defendant to appoint the 2 nd Defendant as its new LTR in the Kenyan market. He deponed further that shortly after the whistle-blowing, the 1 st Defendant learnt of a letter dated 31/10/2024 which issued directives to “quarantine” the 1 st Defendant’s warehoused stock containing the 45 products purportedly based on an anonymous complaint alleging that that the 1 st Defendant’s own products were sub-standard. In his view, the timing of this “quarantine’ order was highly suspect, and he termed it implausible and unfathomable, most probably a retaliatory and malicious manoeuvre designed to tarnish the 1 st Defendant’s reputation. He thus contended that the balance of convenience overwhelmingly favours the 1 st and 2 nd Defendants as the Plaintiff has no legitimate claim to the products, and also that allowing a party engaged in distributing sub-standard drugs to continue operating pending trial poses a serious risk to public health.

10. The 1 st and 2 nd Defendants also filed the Replying Affidavit again sworn by Ajay Joshi on 25/11/2025. The same is however basically a replica of his earlier Supporting Affidavit.

11. The 1 st and 2 nd Defendants also filed the Further Affidavit sworn on 2 nd March 2026 by one Uma Reddy who introduced himself as the 2 nd Defendant’s Managing Director. He, too, basically restated the matters already set out but also pointed out instances in which the 2 nd Defendant has, through its own market survey, confirmed that the Plaintiff is still importing, distributing, and selling pharmaceutical products despite its certificates of registration having been cancelled by the 3 rd Defendant for distributing sub-standard and counterfeit drugs, and wondered how the same is still continuing. He also alluded that the investigations established that even experienced medical personnel are confused as they have continued to unknowingly prescribe the Plaintiff’s counterfeit drugs for their patients. He thus deponed that it is in the best interest of public health that the ex parte orders be set aside and vacated.

12. There is also a Further Affidavit by the Plaintiff sworn on 5/05/2026 by one Jay Hitendra Hirani who, apart from denying the allegations made by the 1 st and 2 nd Defendants, and repeating the matters and arguments already advanced, asserted that the subject matter before this Court is infringement of intellectual property rights, specifically trade marks registered in the name of the Plaintiff, and also issues of infringement of patent. He also asserted that the certificates of registration exhibited by the 1 st Defendant are drug registration certificates, as opposed to trade mark certificates, and are merely generic pharmaceutical trade names, and that any patent rights that may have previously subsisted thereunder have, by operation of law, since expired, and the active ingredients and compounds that were held by the respective originator companies have now fallen into the public domain and may be manufactured, marketed and sold by any authorized manufacturer. He also contended that at the time the Plaintiff registered its products about 2005 and 2005, there was no subsisting registered trade marks capable of barring the registration, and also pointed out that product registration by the 3 rd Defendant is distinct from trade mark registration by the Kenya Intellectual Property Institute (KIPI ), and does not therefore confer trade mark rights. He also refuted the alleged determination by the DCI that the Agreement and Minutes relied on by the 1 st Defendant, terming such determination as not constituting conclusive proof of forgery, and he insisted that the documents were genuine. In respect to the allegation of subsidiaries and acquisition of “ Prism Medico & Pharmacy Ltd ”, he contended that as all those entities are based in India, and as such, the 1 st Defendant is improperly inviting the Court to determine matters outside its jurisdiction, and also that the allegations are unsubstantiated.

13. on the allegations of distribution of counterfeit drugs, he deponed that the 3 rd Defendant, as the industry regulator, subjected the drugs to laboratory tests and cleared them as compliant and fit for the market. Regarding the existence of Milimani High Court Commercial Case No. E065 of 2025 , he denied that it renders this suit sub-judice , urging that the two suits are distinct as Milimani High Court Commercial Case No. E065 of 2025 concerns the separate issue of alleged “ trust and ownership of drug registration certificates ”, and that, as such, the questions and reliefs sought in the suits are different and not determinative of each other, as this suit seeks “ injunctive relief over drug registration certificates ”. He thus contended that staying this suit would occasion prejudice by permitting the continued infringement of the Plaintiff’s trade mark without timely judicial intervention. He also contended that in light of the Judgment delivered in Judicial Review Application No. 113 of 2025 , the balance of convenience tilts in the Plaintiff’s favour. He also prayed that the 1 st and 2 nd Defendant’s Further Affidavit be struck out for introducing new issues and for attempting to improperly vary or expand the subject matter before this Court under the guise of another existing suit.

14. This 3 rd Defendant, through Messrs G&A Advocates , also filed the Replying sworn on 28/07/2026 by Dr. Ahmed I. Mohamed who introduced himself as the 3 rd Defendant’s Acting Chief Executive Officer/Registrar. He deponed that in the year 2003, the 3 rd Defendant received an Application from the 1 st Defendant for registration of pharmaceutical products, that being a foreign company, the 1 st Defendant, by its letter dated 20/08/2003, appointed the Plaintiff as its Local Technical Representative (LTR), and accompanied the Application with the commercial agreement of August 2003 entered into between the 1 st Defendant and the Plaintiff, which set out the parameters of the terms of engagement between them, with the Plaintiff named as the sole agent and legal representative of the 1 st Defendant. He deponed that upon successful evaluation, the 3 rd Defendant issued notifications and registration of the drugs through the Plaintiff. He described the 1 st Defendant as the Market Authorization Holder (MAH) under the registration arrangement, and also stated that all annual notifications were issued through the Plaintiff. He explained that the 3 rd Defendant’s mandate is limited to ensuring the quality, efficacy and safety health products, and that other issues such as commercial arrangements, intellectual property issues and disputes that may arise therefrom are issues between the parties as such matters fall outside the 3 rd Defendant’s regulatory remit. He deponed further that by the subsequent letter dated 26/04/2016, the 3 rd Defendant received an Application from the Plaintiff requesting for “variation” or “correction” of the registration certificates held in the name of the 1 st Defendant, that the request having been lodged by the Plaintiff in its capacity as the 1 st Defendant’s duly appointed LTR , the 3 rd Respondent approved the request and effected the changes requested.

15. , and that since 2016, no complaint was reported to the 3 rd Defendant regarding ownership of the products until 19/09/2024 when the 3 rd Defendant received a request from the 1 st Defendant to change its LTR from the Plaintiff to the 2 nd Defendant, and another letter dated 24/09/2024 requesting the 3 rd Defendant to confirm that the records relating to the MAH status of the 1 st Defendant had been safeguarded. He stated further that by the letter dated 27/09/2024, the Plaintiff objected to the change of the LTR claiming that the subject products belonged to it and that it held trade mark registration, drug and retention certificates in respect thereto. He stated that upon further correspondence and review of the matter, it became clear that the request for “correction” of the drug registration certificates that had been made by the Plaintiff had not been sanctioned by the 1 st Defendant, and as such, the 3 rd Defendant had acted out of misrepresentation made by the Plaintiff, and because of this, the 3 rd Defendant, on 4/03/2025, invoked its statutory powers and cancelled the certificates held by the Plaintiff. He then urged that the cancellation of the certificates by the 3 rd Respondent was simply an administrative decision, and urged that consequently, the inclusion of the 3 rd Defendant in these proceedings is misconceived, unnecessary and amounts to an improper attempt to draw it (a Regulator) into a private commercial dispute between the Plaintiff and the other Defendants. He therefore asked the Court to strike out the 3 rd Defendant’s name from this suit.

16. I then gave the parties leave to file written Submissions. However, by the time I concluded this Judgment, more than two months later, none of the parties had filed any Submissions as I have not come across any in the Judiciary Case Tracking System ( CTS ) online portal.

Determination

17. The broad issue herein is can be basically summarized as “whether the Defendants should be restrained by way of an interim injunction from infringing on, or committing other acts that may affect the Plaintiff’s alleged trademarks, pending hearing and determination of the suit”

18. Determination on whether to grant interim injunctions is governed by Order 40 Rule 1 of the Civil Procedure Rules which provides as follows;

“Where in any suit it is proved by affidavit or otherwise —

(a) that any property in dispute in a suit is in danger of being wasted, damaged, or alienated by any party to the suit, or wrongfully sold in execution of a decree; or

(b) that the defendant threatens or intends to remove or dispose of his property in circumstances affording reasonable probability that the plaintiff will or may be obstructed or delayed in the execution of any decree that may be passed against the defendant in the suit, the court may by order grant a temporary injunction to restrain such act, or make such other order for the purpose of staying and preventing the wasting, damaging, alienation, sale, removal, or disposition of the property as the court thinks fit until the disposal of the suit or until further orders.

19. The principles that apply in applications for injunctions were well settled in the case of Giella –vs-Cassman Brown and Company Limited, Civil Appeal No. 51 of 1972 , in which it was held that the Applicant must establish or demonstrate; ( i ) the existence of a prima facie case with a probability of success , ( ii ) that he will suffer irreparable injury which cannot be compensated by damages, and ( iii ) that balance of convenience tilts in its favour.

20. It is also settled that in interim applications, such as in this case, the Court should avoid making final determinations on matters of fact made on the basis of the conflicting Affidavit evidence. In connection thereto, in Mbuthia vs Jimba Credit Finance Corporation & Another [1988] KLR 1, the Court of Appeal guided as follows:

“…the correct approach in dealing with an application for an interlocutory injunction is not to decide the issues of fact, but rather to weigh up the relevant strength of each side’s propositions.”

21. The first limb that I have to therefore determine is whether the Plaintiff has established a prima facie case. What constitutes a “ prima facie ” case was discussed in the case of Mrao Ltd vs. First American Bank of Kenya Ltd & 2 Others [2003] KLR 125 , in which the Court of Appeal held as follows:

“It may not be easy to define what is meant by “ prima facie case ”, but at least it must mean one on which a reasonable tribunal, properly directing its mind to the law and the evidence could convict if no explanation is offered by the defence ... The terms “ prima facie ” case, and “ genuine and arguable ” case do not necessarily mean the same thing, for in using another term, namely a sustainable cause of action, the words “ prima facie ” are frequently used to refer to a case which shifts the evidential burden of proof, rather than as giving rise to a legal burden of proof in the manner of considering, which was in relation to the pleadings that had been put forward in the case. It would be in the appellant’s interest to adopt a genuine and arguable case standard rather than one of a prima facie case, the former being the lesser standard of the two ... In civil cases a prima facie case is a case in which on the material presented to the Court a tribunal properly directing itself will conclude that there exists a right which has apparently been infringed by the opposite party to call for an explanation or rebuttal from the latter. A prima facie case is more than an arguable case. It is not sufficient to raise issues but the evidence must show an infringement of a right, and the probability of success of the Applicant’s case upon trial. That is clearly a standard, which is higher than an arguable case.”

22. The cause of action brought out in the Plaint filed in this suit is alleged “ infringement of registered trademarks ” for 14 pharmaceutical products (drugs) used in the treatment of some chronic ailments such as heart diseases, and diabetes, which products, I understand, to have given rise to registration of another 45 product trademarks. All the 14, and 45 trademarks, respectively, are currently registered in the name of the Plaintiff. According to the 1 st Defendant however, the registration of the trade marks by the Plaintiff was procured fraudulently and, as such, is of no effect since the products that gave rise to the trademarks have always been owned and manufactured by the 1 st Defendant, an Indian based company, and that the Plaintiff only came into contact with the products by virtue of being the 1 st Defendant’s local representative, thus an agent. The 1 st Defendant therefore accuses the Plaintiff of “undercutting” the 1 st Defendant or “stealing a match” against it by secretly and without authority of the 1 st Defendant, registering the products as its own. In view thereof, although the Plaintiff denies it, the trade mark infringement fight brought in this suit is simply a “sub-fight” of the main battle between the Plaintiff and the 1 st Defendant, which is; “ ownership of the subject pharmaceutical products” . This is because the efficacy of the registration of the trade marks in the name of the Plaintiff cannot, obviously, be determined before or without the larger issue of “ ownership of the pharmaceutical products ” being first conclusively determined. The two issues clearly go hand in hand, and are as intertwined as Siamese twins.

23. Regarding the relationship between the Plaintiff and the 1 st Defendant, they are both companies operating within the pharmaceutical industry. While the Plaintiff is a locally Kenyan-based company engaged in the importation and sale of pharmaceutical products, the 1 st Defendant is based in India, and is engaged in the manufacture, distribution, and sale of pharmaceutical products. It is not in contention that at all material times, since about the year 2003, the Plaintiff has been the 1 st Defendant’s sole appointed local representative and/or agent, in other words, the sole distributor of the 1 st Defendant’s products in Kenya. The parties also agree that in registering the parties’ agreement with the 3 rd Defendant (the industry regulator), the parties listed the 1 st Defendant as the Marketing Authorization Holder (MAH ), which they agree, meant that the 1 st Defendant was the sole owner of the products. While this is a Ruling on an interlocutory injunction in which I should not make final or conclusive findings or determination, from the above facts, I believe it can be safely stated that up to this point, the identity of the owner of the products as between the Plaintiff and the 1 st Defendant was not in issue. All indication is that it was the 1 st Defendant. As aforesaid however, the final finding on this issue shall only be conclusively made at the trial.

24. As aforesaid, the Plaintiff alleges that out of 14 products, it manufactured 45 other pharmaceutical products in respect to which it also holds registered trademarks. It is also not in dispute that the partnership or agency arrangement between the parties had proceeded smoothly for about 20 years, since 2003, until about 2024 when it came to the attention of the 1 st Defendant that the Plaintiff had obtained registration at the 3 rd Defendant’s (the industry regulator) Registry as the owner of the 14 products, and that the MAH lodged by the parties at the 3 rd Defendant (industry regulator) had been changed or varied to now indicate the Plaintiff as the owner of the products, and no longer the 1 st Defendant. As observed above, the Plaintiff also obtained registration of the trademarks for the products as owner. Needless to state, a registered owner of a given trademark enjoys exclusive rights that attach to such ownership, and is entitled to protection by the law against infringement by other persons.

25. Having set the above factual foundation, it becomes clear that the bone of contention in this case is basically “ whether the 1 st Defendant, as the registered owner of the trade marks for the subject pharmaceutical products, should be protected from the Defendants against acts amounting to infringement thereof ”. Again, as observed above, hand in hand with this issue is “ whether the 1 st Defendant lawfully acquired registration by the 3 rd Defendant (the industry regulator) as owner of the products ”.

26. There is another interesting angle. According to the 3 rd Defendant, as the industry regulator, it received a complaint from the 1 st Defendant protesting about the manner in which its ownership of, and MAH status for the 14 products were “changed” and re-allocated to the Plaintiff. According to the 3 rd Defendant (industry regulator), upon receipt of a complaint from the 1 st Defendant regarding that “change” and further correspondence, it investigated and reviewed the matter and established that the request by the Plaintiff for the “change” or “correction” of the drug registration certificates was effected irregularly and/or unlawfully as the same had not been sanctioned by the 1 st Defendant, the owner thereof, and that the 3 rd Defendant had thus acted out of misrepresentation made by the Plaintiff. It is not in dispute that as such, the 3 rd Defendant, on or about 4/03/2025, invoked its statutory powers and cancelled the certificates of registration held by the Plaintiff. It is also not in dispute that the Plaintiff, upon receiving the 3 rd Defendant’s notice of intention to restore the register back to the position ante by cancelling the “change” in registration of ownership details and to cancel the Plaintiff’s registration as owner, quickly rushed to Court and filed Milimani Judicial Review Application No. 113 of 2025 but in which it did not however secure any interim orders to bar the 3 rd Defendant from cancelling the certificates. It then transpired that by the time that the Judicial Review Court was to render its decision, the case had already been overtaken by events as the 3 rd Defendant’s intention had since been actualized, the Plaintiff’s certificates having been cancelled, and the register restored back to the position ante , which means that 1 st Defendant was restored as owner of the products. As the Plaintiff never amended its pleadings in the Judicial
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    GALAXY PHARMACEUTICAL LIMITED VS PRISM LIFE SCIENCE LIMITED AND REDDYS PHARMA LTD AND 1 Others GALAXY PHARMACEUTICAL LIMITED VS PRISM LIFE SCIENCE LIMITED AND REDDYS PHARMA LTD AND 1 Others