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2020 Supreme(Del) 1473

IN THE HIGH COURT OF DELHI AT NEW DELHI
Mukta Gupta, J.
Astrazeneca Ab & Anr. - Appellant
Versus
Torrent Pharmaceuticals Ltd - Respondent
Interlocutory Application No. 6931 of 2020, 7399 of 2020, 9484 of 2020, 8940 of 2020, 8991 of 2020, 8997 of 2020, 9075 of 2020, 9316 of 2020, 10168 of 2020; Civil Suit (Comm) No. 323 of 2020, 346 of 2020, 414 of 2020, 418 of 2020, 419 of 2020, 426 of 2020, 323 of 2020
Decided On : 18-11-2020

Advocates Appeared:
Pravin Anand, Advocate, Vaishali Mittal, Advocate, Siddhant Chamola, Advocate, Rohin Koolwal, Advocate, Devyani Nath, Advocate, Souradeep Mukhopadhyay, Advocate, Sandeep Sethi, Advocate, Suhrita Majumdar, Advocate, Dominic Alvares, Advocate, Afzal B Khan, Advocate, Samik Mukherjee, Advocate, C.S. Vaidyanathan, Advocate, Bitika Sharma, Advocate, Adarsh Ramanujjan, Advocate, Namrita Kochar, Advocate, Nitya Sharma, Advocate, Devanshu Khanna, Advocate, Vrinda Pathak, Advocate, Akshay Nagarajan, Advocate, J. Sai Deepak, Advocate, C. Aryama Sundaram, Advocate, Lakshay Kaushik, Advocate, Rajeshwari H, Advocate, Tahir A J, Advocate, Praveen Singh, Advocate, G. Natrajan, Advocate, Avinash Sharma, Advocate, Sudhir Chandra, Advocate

Headnote:(A) Patents Act, 1970 - Sections 8, 10(4), and 64(1)(a) - Temporary injunction against defendants for allegedly infringing plaintiffs' patents on compound Dapagliflozin - Defendants challenged the validity of the suit patent IN 625, asserting it was anticipated by prior claims in genus patent IN 147 and invalid due to non-compliance with Section 8 - Court held that Dapagliflozin was not explicitly disclosed in IN 147 and the plaintiffs had not sufficiently complied with Section 8(2), leading to its vulnerability on grounds of obviousness and prior claiming. (Paras 10.1, 11.1, 12.7, 17.1, and 17.3)

Facts of the case:
Plaintiffs sought an interim injunction against the defendants for manufacturing and selling products containing Dapagliflozin, asserting infringement of their patents. The suit patent IN 625 relates specifically to Dapagliflozin, while defendants argued it was already covered under the genus patent IN 147.

Findings of Court:
Court found credible challenges to the validity of IN 625 based on non-compliance with disclosure requirements and obviousness.

Issues: The validity of the patent based on disclosure in IN 147 and compliance with Section 8.

Ratio Decidendi: The court emphasized that the validity of the suit patent was brought into question due to insufficient compliance with statutory requirements and possibility of obviousness arising from the comparison with existing patents.

Result: Interim injunctions were vacated; defendants were to maintain accounts of their sales and manufacturing activities.

JUDGMENT

Mukta Gupta, J. - Brief Facts of the Plaintiffs:

1.1 By the present suits, the plaintiffs have sought decree of permanent injunction against the defendants and their employees and agents including third parties, for restraining them from manufacturing, selling, online retailing of the products comprising of the compound Dapagliflozin thereby infringing the patent owned by the plaintiffs being IN 235625 (in short, IN 625) besides damages and rendition of accounts in respect of the infringement of the patents IN 205147 (in short, IN 147) and IN 625.

1.2 By the present applications, the plaintiffs seek a temporary injunction restraining the defendants from manufacturing, selling, retailing etc. the compound Dapagliflozin thereby infringing the plaintiffs'' patent IN 625, rendition of accounts and an ex parte relief in terms thereof. Since interim injunctions were granted in CS(COMM) 323/2020, CS(COMM) CS(COMM) 426/2020 and CS(COMM) 346/2020, applications under Order XXXIX Rule 4 CPC have been filed therein.

1.3 The defendants in the present suits are Torrent Pharmaceuticals Ltd. (in short ''Torrent''), Micro Labs Limited (in short ''Micro Labs''), Zydus Healthcare Ltd.(in short ''Zydus''), ERIS Lifesciences Ltd. (in short ''ERIS''), USV Pvt. Ltd. (in short ''USV'') and MSN Laboratories Pvt. Ltd. (in short ''MSN'').

1.4 Plaintiff No.1 Astrazeneca AB is a company organized and existing under the laws of Sweeden operating as a subsidiary of Astrazeneca PLC. Plaintiff No.2 Astrazeneca Pharma India Limited is a company incorporated under the laws of India and an Indian subsidiary of Astrazeneca marketing pharmaceutical products in the domestic market. By the suit patent IN 235625 (in short IN "625) which is the species patent of IN 205147 the genus patent, plaintiffs claim to have invented the pharmaceutical composition i.e. Dapagliflozin which is a molecule having the chemical formula (2S, 3R, 4R, 5S, 6R) -2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6- (hydroxymethyl)tetrahdro-2H-Pyran-3,4,5-triol.

1.5 According to the plaintiff Dapagliflozin has proven to be an effective Sodium-Glucose co-Transporter 2 (in short SGLT2) inhibitor indicated for managing diabetes mellitus type 2. SGLT2 protein is a transporter protein majorly responsible for the reuptake of the glucose in the proximal tubule, thus playing a crucial role in maintaining a balance between the levels of glucose excretion as well as plasma glucose level by modulating what proportion of sugar filtered by the kidneys gets reabsorbed in the blood plasma. In view of Dapagliflozin working in reduction in re-absorption of the glucose, the same has turned out to be very effective in control of diabetes and diabetic complication such as retinopathy, neuropathy, nephropathy, wound healing and related diseases. The plaintiff''s distributor in India, namely Sun Pharma Laboratories Limited and Abbott Healthcare Private Limited make drugs comprising of Dapagliflozin, such as OXRA, OXAMET, OXMET IR, OXRAMET XR and GLEDEPA, GLEDEPA MET IR and GLEDEPA MET XR.

1.6 Plaintiff No.1 is the registered holder of the patent IN ''147 having the title ''A C-ARYL GLUCOSIDE'' wherein the plaintiffs claimed the Markush structure which covered numerous compounds and based on various permutations and combination, quadrillion compounds could be prepared. The relevant bibliographic chart of the genus patent is as under:-

Application Number

IN/PCT/2002/00433/MUM

Genus Patent

Applicant Name

AstraZeneca AB

PCT International Filing Date

October 02, 2000

Priority date

October 12,1999

S.11A Publication Date

March 18, 2005

Date of Grant

March 15, 2007

Date of Patent Expiry

October 02, 2020

1.7 Plaintiff No.1 is also the registered holder of species patent IN ''625 "A COMPOUND (2S, 3R, 4R,5S,6R)-2(4-CHLORO-3(4-ETHOXYBENZYL) PHENYL)-6 (HYDROXYMETHL) TETRAHYDRO-2H-PYRAN-3, 4, 5- TRIOL AND COMPOS

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