Wockhardt Ltd v Hetero Drugs Ltd (2005)

Summary

The Court recorded that “Prior to India becoming a signatory to the TRIPS agreement, the Patents Act, 1970, as it stood originally, contemplated only a process patent in respect of medicinal preparations” and that “In the interregnum period, a transitory provision in Chapter IV-A was introduced whereby an exclusive marketing right (EMR) was granted to an applicant” (p 2). “On 8.5.2000, the applicant applied for process patent for benoquinilozines on the ground that the applicant had invented the admixture composition” and “the applicant was granted EMR for a period of five years on 15.12.2003 upto 16.7.2008” (para 2). “The Drugs Controller General granted manufacturing and marketing licence to the first respondent company for Nadifloxation 1% cream based on US patent by an order dated 14.9.2004” (para 3). The applicant sued for “permanent injunction restraining the respondents from in any way infringing the Patent No. 188847” and “the EMR granted to the applicant” (para 4).

Recalling that in Intas Laboratories Private Limited, Ahmedabad and Anr. v. Novartis A.G. (2005) 1 MLJ 309, the appeal from Novartis v Adarsh Pharma (2004), the Division Bench “directed that the issue should be decided only within the parameters of the balance of convenience and public interest in question” (para 6), the Court held that “this Court would also be competent to find out a prima facie case for grant of interim order” (para 7). It found that “All the above three conditions are satisfied by the applicant” (para 7), but that “it would not be proper to restrain the first respondent company from manufacturing and marketing the NADIDERM on the strength of the order on the Drugs Controller General dated 14.9.2004” (para 8). “Accordingly, the interim order of injunction is vacated and the O.A. Nos. 544 and 545 of 2005 are dismissed. For the same reason, O.A. No. 546 of 2005 is also dismissed.” (para 9)

What the court decided

1. The interim stage after Intas. “Though the original applications for injunction are to be considered on the basis of the balance of convenience as well the public interest in question, this Court would also be competent to find out a prima facie case for grant of interim order.” (para 7)
2. Validity of the exclusive marketing right. “Whether the EMR” (“exclusive marketing right”) “granted to the applicant is valid or not is not a matter for this Court to adjudicate and decide, as the grant of EMR is not questioned before this Court by the first respondent company.” “Hence, the EMR granted in favour of the applicant is still in force.” (para 7)
3. Conditions for the grant. “For the grant of EMR, as already referred to, an applicant should have a process patent, should have filed a product patent application and should have a valid manufacturing licence. All the above three conditions are satisfied by the applicant.” “From the above it is seen that the applicant, by virtue of the grant of EMR coupled with the grant of manufacturing and marketing licence, is entitled to manufacture and market Nadifloxacin 1% cream.” (para 7)
4. The rival’s drug licence. “It is also relevant to note that the challenge to the manufacturing licence given to the first respondent company by the Drugs Controller General is questioned by the applicant before the Delhi High Court and the said order has not been stayed. In the circumstances, it would not be proper to restrain the first respondent company from manufacturing and marketing the NADIDERM on the strength of the order on the Drugs Controller General dated 14.9.2004.” (para 8)
5. A prima facie view. “I am convinced that the first respondent cannot be injuncted from manufacturing and marketing the NADIDERM on the strength of the manufacturing licence given by the Drugs Controller General on 14.9.2004.” (para 8)
6. Balance of convenience. “Insofar as the balance of convenience as well having obtained the manufacturing licence, the first respondent company is entitled to manufacture and sell the NADIDERM cream” and “no order restraining the first respondent company from manufacturing NADIDERM cream on the basis of the manufacturing licence was passed.” (para 8)
7. Disposition. “For all the above reasons, I am of the considered view that the injunction granted should be vacated. Accordingly, the interim order of injunction is vacated and the O.A. Nos. 544 and 545 of 2005 are dismissed. For the same reason, O.A. No. 546 of 2005 is also dismissed.” (para 9)

What the court did not decide

“Whether the Nadifloxacin 1% cream is an invention as defined under Section 2(1) or is not an invention under Section 3(d) & (e) is not a matter to be decided by this Court at this stage as it should be decided at the time of trial. Any finding on the said issue will have a direct effect in the trial.” (para 7) “Whether the first respondent company are manufacturing the Nadifloxacin 1% cream by copying the composition contained in the applicant’s patent and EMR” (“exclusive marketing right”) “cannot also be gone into in detail at this stage, as it would be determining the claims of the parties, which should be done only in the trial.” (para 8)

Subsequent treatment

• Appealed — Set aside by the Division Bench of the Madras High Court on 25 November 2005 in Wockhardt v Hetero Drugs (Madras, 25 November 2005), which held that “the learned single Judge’s order is set aside. The appellant/plaintiff would be entitled to injunction in the applications, filed in the suit.” (para 48)