IN THE HIGH COURT OF DELHI
S. MURALIDHAR, TALWANT SINGH, JJ.
Natco Pharma Limited - Appellant
Versus
Bayer Healthcare LLC - Respondent
FAO.(OS) (COMM). No. 158 of 2019 & CM Appl. No. 30589 of 2019 (Stay)
Decided On : 11-07-2019
Patent Infringement - Pharmaceutical Patent - Indian Patent Act - Section 10, Code of Civil Procedure, 1908 - Order XXXIX Rules 1 and 2 CPC - [Indian Patent Act, Section 10, Code of Civil Procedure, 1908]
Fact of the Case:
The Respondent filed a suit against the Appellant for patent infringement, seeking to restrain the Appellant from infringing its Indian patent. The Respondent alleged that the Appellant planned to commercialize a product that infringed the patented drug Regorafenib. The court granted an interim injunction in favor of the Respondent, restraining the Appellant from infringing the patent.
Finding of the Court:
The court found that the impugned interim order did not adequately consider the elements required for granting an interim injunction, such as the existence of a prima facie case, balance of convenience, and irreparable hardship. The court set aside the interim order and directed the application for interim injunction to be heard again on merits by the learned Single Judge.
Issues: The issues included the validity of the patent, the timing of the Defendant's product launch, and the balance of convenience and irreparable hardship to the parties.
Ratio Decidendi: The court emphasized the need to consider the elements of a prima facie case, balance of convenience, and irreparable hardship when granting an interim injunction, especially in cases involving alleged infringement of pharmaceutical patents.
Final Decision: The court set aside the interim injunction and directed the application for interim injunction to be heard again on merits by the learned Single Judge. The status quo was maintained, and the parties were directed to file their respective submissions for a fresh order.
JUDGMENT :
S. MURALIDHAR, J.
1. Notice. Ms. Archana Shankar, learned counsel accepts notice on behalf the Respondent/Plaintiff. With the consent of learned counsel for the parties, the appeal has been heard finally.
2. This appeal by the Defendant in C.S. (COMM) No.343/2019 is directed against the order dated 5th July, 2019 passed by the learned Single Judge in I.A. No.8878/2019 in the said suit whereby, inter alia, the Appellant was restrained from infringing Indian patent IN No. 240207 held by the Respondent/Plaintiff.
3. The Respondent, which is part of the Bayer Groups of Companies, filed the aforementioned suit against the Appellant/Defendant for permanent injunction to restrain it from making, using, selling, distributing, advertising, exporting, offering for sale and in any other manner directly or indirectly dealing with any product that infringes the subject matter of the Plaintiff’s Indian Patent No. 240207 or any claims thereof, including Regorafenib and any forms thereof.
4. The Plaintiff averred in the plaint that it was granted the above patent on 29th April 2010 and the drug covered i.e. Regorafenib is used for treatment of metastatic colorectal cancer and advanced gastrointestinal stromal tumors. It was averred that this was a valid and subsisting patent having a term of 20 years from 22nd July, 2004. It was disclosed in the plaint that Appellant/Defendant had filed a revocation petition against the said patent before the Intellectual Property Appellate Board (IPAB) and that the said application is pending. The plaint also disclosed that another patent registered in favour of the Respondent/Plaintiff is IN 215758 which related to “Carboxyaryl Substituted Diphenyl Ureas” and that “the said patent does not cover Regorafenib”.
5. It was stated in the plaint that in the last week of June 2019, the Plaintiff became aware of the infringing activities of the Defendant when it found out from various sources that the Defendant was planning to commercialize the Regorafenib product in Indian market. It was further averred that the Defendant was planning to introduce in the market the said product under the brand name ‘Regonat’ and that the said product had not yet been commercially launched.
6. The Plaintiff referred to a photograph of the Defendant’s product obtained by its personnel which showed that the tablet strength was identical to the strength in which the Plaintiff markets its commercial Regorafenib products viz., Stivarga, Nublexa and Resihance. It was alleged therefore that the Defendant had merely copied the patented product of the Plaintiff. In Para 34 of the plaint, it was averred that the Plaintiff had recently learnt that the Defendant had filed in the City Civil Court in Hyderabad, a suit for declaration of non-infringement against the Plaintiff pertaining to the product having international non-proprietary name Regorafenib and that the said suit was listed on 28th June, 2019. It was further stated that notice appeared to have been made returnable on 8th July, 2019.
7. In para 35 (iv) of the plaint it was averred that without waiting for an injunction sought in the suit to be granted, the Defendant appeared to have “sent its infringing products to their distributors, although the infringing product has not entered the commercial and retail market as believed by the by the Plaintiff.”
8. The suit C.S.(COMM) No.343/2019 was listed first for hearing before the learned Single Judge on 5th July, 2019 along with the aforementioned I.A. 8878/2019 filed by the Plaintiff under Order XXXIX Rules 1 and 2 CPC seeking an interim injunction.
9. A perusal of the impugned order shows that the Defendant appeared on caveat and was represented by a senior counsel. Para 11 of the impugned order indicates that the learned Single Judge “straightaway asked the senior counsel for the Defendant as to why the interim order in terms of the order dated 31st May, 2019 in CS(COMM) No. 314/2019 titled as Sterlite Technologies Ltd. V. ZTT India P
Dorab Cawasji Warden v. Coomi Sorab Warden (1990) 2 SCC 117
Merck Sharp and Dohme Corporation v. Glenmark Pharmaceuticals 2015 (63) PTC 257 [Del][DB]
Shiv Kumar Chadda v. Municipal Corporation of Delhi (1993) 3 SCC 161
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