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Official Citation: 2024 IHC 196978
Court / Jurisdiction: Islamabad High Court
Parties: M/s Vifor International AG vs Drugs Appellate Board etc.
Ruling Summary: This decision was rendered by the Islamabad High Court, officially reported as 2024 IHC 196978. In this matter between M/s Vifor International AG and Drugs Appellate Board etc., the court adjudicated key questions of statutory construction, procedural regularity, and legal precedent under Pakistani law.
Core Holding: The honorable bench evaluated governing statutory provisions and judicial authorities to establish the rights of the parties, delivering the binding reasoning set out below.
COURT: Islamabad High Court (Honourable Mr. Justice Babar Sattar) AUTHOR JUDGE: Honourable Mr. Justice Babar Sattar DECISION DATE: 27-DEC-2024 CASE NO: Writ Petition-3227-2022 CITATION: 2024 IHC 196978 PARTIES: M/s Vifor International AG VS Drugs Appellate Board etc. LAW / SECTION: - SUBJECT: Drugs Case, REMARKS: The petitioner is a pharmaceutical company. It applied for the cancellation of certain drug licenses so launched by a "Competing Company". The Appellate Board of DRAP has refused its application for cancellation. The cancellation sought was on a trademark violation. ============================================================ JUDGEMENT SHEET
IN THE ISLAMABAD HIGH COURT, ISLAMABAD JUDICIAL DEPARTMENT
Writ Petition No. 3227/2022 Vifor (International) AG, Vifor (International) Ltd. and Vifor (International) Inc. through Authorized Signatory Vs. Drugs Appellate Board through its Chairman/Secretary, Islamabad & others
PETITIONER BY: M/s Hasan Irfan Khan and Saqib Asghar Baig, Advocates. RESPONDENTS BY: Syed Muhammad Ghazanfar and Mr. Asad Ali Khan, Advocates, along with Hafiz Bilal Bin Akbar, Deputy Director (Lega l Affairs), and Mr. Shoaib Khan, Assistant Director (Legal Affairs), DRAP. Mr. Akhtar Aziz Khan, Advocate for respondent No.4. Mr. Aqeel Akhtar Raja and Raja Muhammad Jawad Arslan, Assistant Attorney General. Mr. Shoaib Ali Khan, Deputy Director (Legal), Ministry of National Health Service Regulation & Coordination, Islamabad.
DATE OF HEARING: 31.10.2024. ======================================= BABAR SATTAR, J.- The petitioner is aggrieved by the order of the Drug Registration Board (respondent No.2 ) dated 29.07.2021 pursuant to which an application filed by the petitioner for cancellation of the registration of a drug produced by respondent No.4 was dismissed, and the appeal against such dismissal order was also dismissed by the Drugs Appellate Boar d (respondent No.1) in its meeting held on 23.06.2022 as communicated to the petitioner by reasoning dated 18.07.2022. 2. The l earned counsel for the petitioner submitted that respondent No.4 sought the registration of a drug called FERIJET which was regis tered by the Drug Registration Board on W.P. No.3227 of 2022 P a g e | 2
31.01.2005. The trademark of FERIJET being used by respondent No.4 to manufacture and market its drug was deceptively similar to that of the petitioner’s drug called FERINJECT, which was registered as a trademark with registration No.214400 dated 12.10.2005. The petitioner filed a suit for trademark infringement against respondent No.4 on 25.03.2010. The suit was decreed on 13.04.2018 and the Intellectual Property Tribunal restrained respondent No.4 from manufacturing, marketing and selling the pharmaceutical product under the trademark FERIJET , while also directing it to recall all stock of the product. He submitted that respondent No.4 did not challenge the judgment and decree of the Intellectual Property Tribunal da ted 13.04.2018, which had attained finality. The petitioner was seeking execution of the decree in which various directions had been issued by the Intellectual Property Tribunal but respondent No.4 was yet to implement the judgment and was refusing to appe ar before the Intellectual Property Tribunal. He submitted that in its judgment the Intellectual Property Tribunal noted that FERIJET has been registered by the Drug Registratio n Board but rejected that as a defence on part of respondent No.4 on the basis that the registration of a drug or its name was no basis to assert that such trademark or tradename did not infringe the intellectual property rights of another person. 3. Respondent No.4 had appeared before the Intellectual Property Tribunal and had filed a written statement. Subsequently, it chose not to appear before the Intellectual Property Tribunal due to which an ultimate judgment was ex- parte. The Intellectual Property Tribunal held that there w ere W.P. No.3227 of 2022 P a g e | 3
“graphic, phonetic, visual and structural similarities” between the two drugs and respondent No.4 was manufacturing and marketing FERIJET , which was deceptively similar to the petitioner’s drug FERINJECT and was likely to call confusion with regard to the source of these products. The Intellectual Property Tribunal concluded that respondent No.4 had “dishonestly adopted deceptively similar mark FERIJET in respect of the same product”. He submitted that the petitioner filed an application dated 23.06.2024 before the Drug Regulatory Authority of Pakistan (“DRAP”) seeking cancellation of respondent No.4’s drug FERIJET and the application was not decided. The petitioner then filed Writ Petition No.1483/2021 aggrieved by the inaction of DRAP and Drug Registration Board. During the pendency of said petition by ord er dated 17.06.2021 this Court directed that the petitioner’s application be decided , which was then decided by impugned order dated 29.07.2021 passed by the Drug Registration Board. The said order was challenged before the Drugs Appellate Board , which appeal was dismissed by impugned order dated 18.07.2022. Both the orders have been impugned in the instant petition. He submitted that the order of the Intellectual Property Tribunal, being a Court of competent jurisdiction established to adjudicate disputes with intellectual property infringement including trademark infringement , had been disregarded by DRAP through orders dated 29.07.2021 and 18.07.2022. DRAP and the Drug Registration Board were executive authorities and could not sit in judgment over a ruling and decree issued by the Intellectual Property Tribunal setting its determination at naught. He submitted that the registration of a certain drug with a certain name could not be pleaded as a W.P. No.3227 of 2022 P a g e | 4
defense in a trademark infringement dispute as held by the Sindh High Court in Novartis AG through Authorized Signatory vs. Nabiqasim Industries (Private ) L imited through Chief Executive/Director/Company Secretary and another (2017 CLD 1136) and The Welcome Foundation Limited vs. Messrs Karachi Chemical Industries ( Private) Limited (2000 YLR 1376) . The Courts had deprecated the tendency of the parties to use registration under various other laws as a basis to deliberately infringe the rights of a counterparty protected through trademark registration. For this proposition he relied on M/s Farooq Ghee and Oils Mills (Pvt.) Ltd. Vs. Registrar of Trade Mark Registry and others (2015 CLD 1245), Pakistan Drug House (Pvt.) Ltd. Vs. Rio Chemical Company and another (2003 CLD 1531) and M/s ADT Services AG through Attorney and another Vs. M/s ADT Pakistan (Pvt.) Ltd. (2005 CLD 1546) . He submitted that in case of trademarks related to pharmaceutical products any confusion caused due to similarity of the trademark/trade name under which the drug was manufactured and distributed could have fatal consequences , and consequently in such cases trademark rights had to be strictly enforced. He finally submitted that DRAP was an executive body which could not undo or override a determination of infringement made by the Intellectual Property Tribunal as a Court of law and was bound to give effect to the judgment of the Intellectual Property Tribunal. He submitted that the Drug Registration Board had erred in interpreting the provisions of the Drugs Act, 1976 (“Drugs Act”), and the Drug Regulatory Authority of Pakistan Act, 2012 (“DRAP Act”) , without taking into consideration the fact that W.P. No.3227 of 2022 P a g e | 5
the production, import and marketing of a counterfeit drug and/or a spurious drug was prohibited being an offence under Section 27 read with Section 23 of t he Drugs Act. And as FERIJET had been declared to be deceptively similar to FERINJECT for which the petitioner had a registered trademark, the Drug Registration Board could not disregard the judgment of the Intellectual Property Tribunal and hold to the co ntrary that FERIJET was not a counterfeit drug within the meaning of Section 3(f) of the Drugs Act or that such counterfeit drug was not liable to cancellation in terms of Section 7(11) of the Drugs Act. 4. The l earned counsel for respondents No.1, 2 and 3 submitted that the Drug Registration Board had registered FERIJET in terms of the Drugs Act and DRAP Act read with the Drugs (Licensing, Registering and Advertising) Rules, 1976 (“Drugs Registration Rules”) on 31.01.2005, which was prior to the trademark registration of FERINJECT later in 2005. He submitted that DRAP was not party to the suit filed by the petitioner against respondent No.4 and in the judgm ent and decree issued by the Intellectual Property Tribunal no direction had been issued to the DRAP t o execute the judgment and decree. He submitted that the petitioner could also not use the constitutional jurisdiction of this Court as a means to seek the execution of the judgment and decree passed in its favor by the Intellectual Property Tribunal. He s ubmitted that the Drug Registration Board in its order dated 29.07.2021 had correctly appreciated that the Drugs Act and the DRAP Act operated in their own domain and were to be given effect independently without being influenced by any proceedings or dete rminations W.P. No.3227 of 2022 P a g e | 6
made under the Trade Marks Ordinance , 2001 (Trade Marks Ordinance”). For purposes of registration of drugs and regulating their production , import, marketing and sale, the Drugs Act and DRAP Act were special laws whose provisions were to be give n overriding effect over the Trade Marks Ordinance. And the registration of a drug could not be cancelled merely on the basis that it has been found by a Tribunal under provisions of the Trade Marks Ordinance that the name of such drug infringes a register ed trademark. He submitted that for purpose of a registration of a drug, the Drug Registration Board focused exclusively on therapeutic quality, safety and efficacy of the drug and not on related intellectual property rights. He submitted that the composit ion of respondent No.4’s drug FERIJET was different from the composition of the petitioner’s drug FERINJECT, which reduced the possibility of any conf usion. He submitted that FERINJEC T had been registered by the Drug Registration Board on 12.02.2013 and su ch registration certificate stated that in the event that there was any similarity with the name of another drug, the manufacturer would be obliged to change the name of its drug. He submitted that FERINJECT was registered as a drug on 12.02.2013 and FERIJ ET was registered as a drug on 31.01.2005, it was the petitioner that was obliged to change the name of its drug in the event of any confusion between its drug and not that produced by respondent No.4. He submitted that in view of these facts the Drug Registration Board had correctly dismissed the application seeking cancellation of the drug of respondent No.4. As doing so was neither in public interest nor had it been found that there was any misrepresentation on part of respondent No.4 in W.P. No.3227 of 2022 P a g e | 7
seeking the registration of its drug. Further the circumstances in which respondent No.4’s drug had been registered had not changed significantly in terms of Section 7(11)(b) of the Drugs Act and consequently no ground was made out to cancel the drug FERIJET. 5. The counsel for respondent No.4 defended the orders of the Drug Registration Board and the Drugs Appellate Board. He submitted that there was no warrant for cancelling the registration of its drug FERIJET , which was registered with the Drug Registration Board prior in time to the petitioner’s drug FERINJECT. He adopted the legal arguments made by the learned counsel for DRAP. 6. The questions that arise in the instant petition are the manner in which provisions of the Drugs Act and DRAP Act are to be read with provi sions of the Trade Marks Ordinance . And whether the provisions of the drug -related laws and the intellectual property laws can be read harmoniously to give effect to their respective provisions without concluding that there exists a conflict between them. The second question that arises is whether a judgment of the Intellectual Property Tribunal vested with jurisdiction over the question of trademark infringement, declaring that a trademark being used by a drug manufacturer infringes the trademark of anothe r drug manufacturer, is conclusive and binding for purposes of the Drug Registration Board in determining that the infringing drug, as declared by the Intellectual Property Tribunal, is to be treated as a counterfeit drug within the meaning of Section 3(f) of the Drugs Act. W.P. No.3227 of 2022 P a g e | 8
7. It is not contested that using a counterfeit trademark is prohibited under the Trade Marks Ordinance and manufacturing the counterfeit drug is prohibited and declared to be an offence under the Drugs Act. Further the use of a false tr ademark has also been declared to be an offence under the Pakistan Penal Code, 1860 (“PPC”). 8. Let us state the relevant definitions from the Trade Marks Ordinance, the Drugs Act and the Pakistan Penal Code. Section 2(xlvii) of the Trade Marks Ordinance.
“Trade mark” means any mark capable of being represented graphically which is capable of distinguishing goods or services of one undertaking from those of other undertakings.
Section 2(ix) of the Trade Marks Ordinance.
“Counterfeit trade mark goods” me ans any goods including packaging bearing without authorization a trade mark which is identical or deceptively similar to the trade mark validly registered in respect of such goods or which cannot be distinguished in its essential aspects from such a trade mark and infringes rights of the owner of the trade mark under this Ordinance.
Section 2(xii) of the Trade Marks Ordinance. “deceptively similar” in relation to a trade mark, means such near resemblance between it and another trade mark that it is likely to deceive or cause confusion.
Section 3(f) of the Drugs Act
"Counterfeit drug" means a drug the label or outer -packing of which is an imitation of, or resembles or so nearly resembles as to be calculated to deceive the label or outer - packing of a drug of another manufacture.
Section 28 of PPC
"Counterfeit". A person is said to “counterfeit” who causes one thing to resemble another thing, intending by means of that resemblance to practice deception, or knowing it to be likely that deception will thereby be practiced.
9. Let us also reproduce for convenience provisions from the Trade Marks Ordinance , the Drugs Act and PPC relevant for our purposes. W.P. No.3227 of 2022 P a g e | 9
Section 39 of the Trade Mark s Ordinance: Rights conferred by registration.-
(1) A registered trade mark shall be a personal property.
(2) The proprietor of a registered trade mark shall have exclusive rights in the trade mark which are infringed by use of the trade mark in Pakistan without his consent.
(3) Without prejudice to the rights of the proprietor of a registered trade mark to obtain any relief under any other law for the time being in force, the proprietor shall also have the right to obtain relief under this Ordinance if the trade mark is infringed.
Section 40 of the Trade Mark s Ordinance: Infringement of registered trade mark.-
(1) A person shall infringe a registered trade mark if such person uses in the course of trade a mark which is identical with the trade mark in relation to goods or services which are identical with those for which it is registered.
(2) A person shall infringe a registered trade mark if such person uses in the course of trade a mark where because-
(a) the mark is identical with the trade mark and is used in relation to goods or services similar to the goods or services for which the trade mark is registered; or
(b) the mark is deceptively similar to the trade mark and is used in relation to goods or services identical with or similar to the goods or services for which the trade mark is registered, there exists a likelihood of confusion on t he part of public, which includes the likelihood of association with the trade mark.
Section 7 of the Drugs Act: Registration of drugs-
(11) If the Registration Board, on the basis of information received or an f inquiry conducted by it, is of opinion that-
(a) the registration of a drug was procured by fraud or misrepresentation; or
(b) the circumstances in which a drug was registered no longer exist; or
(c) there has been a violation of the conditions subject to which a drug was registered; or
(d) it is necessary in the public interest so to do;
W.P. No.3227 of 2022 P a g e | 10
Section 23 of the Drugs Act: Import, manufacture and sale of drugs.
(1) No person shall himself or by any other person on his behalf:-
(a) export, import or manufacture for sale or sell:
(i) any spurious drug; (ii) any counterfeit drug; (iii) any misbranded drug; (iv) any adulterated drug; (v) any substandard drug; (vi) any drug after its expiry date; (vii) any drug which is not registered or is not in accordance with the conditions of registration; (viii) any drug which, by means of any statement, design or devi ce accompanying it or by other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed; (ix) any drug if it is dangerous to health when used in the dosage or with the frequency, or for th e duration specified, recommended or suggested in the labelling thereof; or (x) any drug in contravention of any of the provisions of this Act or any rule; (2) Nothing in sub -section (1) shall apply to the manufacture or import, subject to prescribed conditions, of small quantities of any drug for the purpose of clinical trial, examination, test, analysis or personal use.
Section 27 of the Drugs Act: Penalties.-
(1) Whoever himself or by any other person on his behalf:-
(a) exports, imports, manufactures for sale or sells any spurious drug or any drug which is not registered;
(b) manufactures for sale any drug without a licence; or
(c) imports without licence any drug for the import of which a licence is required;
shall be punishable with imprisonment for a term which shall not be less than three years or more than ten years and with fine which may extend to one lakh rupees:
Provided that the Drug Court may, for any special reasons to be recorded, award a sentence of imprisonment for a term of less than three years.
W.P. No.3227 of 2022 P a g e | 11
Section 478 of the PPC: Trade Mark.
A mark used for denoting that goods are the manufacture or merchandise of a particular person is called a trade mark, and for the purpose of this Code the expression “trade mark” includes any trade mark which is registered in the register of trademarks kept under the Trade Marks Act, 1940 (V of 1940).
Section 480 of PPC: Using a false Trade Mark.
Whoever marks any goods or any case, package or other receptacle containing goods, or uses any case, package or other receptacle with any mark thereon, in a manner reasonably calculated to cause it to be believed that the goods so marked, or any goods contained in any such receptacle so marked, are the manufacture or merchandise of a person whose manufacture or merchandise they are not, is said to use a false trade mark.
Section 482 of PPC: Punishment for using a false trade mark or property mark.
Whoever uses any false trade mark or any false property mark shall, unless he proves that he acted without intent to defraud, be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
Section 483 of PPC: Counterfeiting a trade mark or property mark used by another.
Whoever counterfeits any trade mark or property mark used by any other person shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
10. The Trade Marks Ordinance was enacted to “amend and consolidate the law relating to trademarks ” in Pakistan in terms of determining the rights of a trademark owner and infringement of a trademark. The Trade Marks Ordinance is a special law that will trump other laws in case of conflict when it comes to determination of trademark infringement or enforcement of the rights of a trademark owner . The history of enactment of the Trade Marks Ordinance was enumerated by the Division Bench of the Sindh High Court in Soneri Travel and Tours Ltd. vs. Soneri Bank Limited (2011 CLD 193) in the following terms: W.P. No.3227 of 2022 P a g e | 12
“Along with the Marrakesh Agreement, the states party to the same (known as member states, and including Pakistan) also entered into a number of other agreements, one of the most important of which (and of particular relevance for present purposes) was the Agreement on Trade -related Aspects of Intellectual Property Rights (commonly known as TRIPS). As its name suggests, TRIPS relates to intellectual property rights including patents, trade marks and designs. Developed countries had to bring their national legislation i n conformity with the WTO and other related agreements, including TRIPS, more or less immediately, but developing countries like Pakistan were given certain grace periods in this regard, which in the case of TRIPS extended up to 5 years.” 11. The provisions of the Trade Marks Ordinance give effect to the rights of registered trademark owners articulated in Articles 15 to 21 of the Agreement on Trade -Related Aspects of Intellectual Property Rights (“TRIPS”). In the impugned order passed by the Drugs Appellat e Board, it has misapplied itself to the origin of trademark rights protection and the evolution of intellectual property protection regime within the realm of international law as well as within Pakistan , by holding that the legislature sought to create n o linkage between registration of drugs and intellectual property rights being “cognizant of the hard-won victories by the developing world in the international regime of intellectual property laws. ” Pakistan is a signatory to TRIPS and as underscored by t he Sin dh High Court in Soneri Travel and Tours Ltd. the provisions of the Trade Marks Ordinance are to be interpreted such that they give effect to provisions of TRIPS. Article 17 of TRIPS provides as an exception that, “members may provide limited excepti ons to the rights conferred by a trademark, such as fair use of descriptive terms, provided that such exceptions take account of the legitimate W.P. No.3227 of 2022 P a g e | 13
interests of the owner of the trademark and third parties. ” The only occasion to conclude that trademark infring ement would be of no consequence in the realm of drug registration would have arisen had the legislature provided for such exception by a clear statutory provision as contemplated by Article 17 of the TRIPS Agreement. Any such exception would also need to be narrowly tailored to protect the legitimate interests of owners of trademark, and also third parties, which in case of drug registration would be the consumers of drugs. No such exception has been provided under the Drugs Act or the DRAP Act. To the contrary, in terms of Section 3(f) of the Drugs Act that defines counterfeit drugs, together with Sections 23 and 27 of the…
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