Delhi High Court - Orders
Eli Lilly And Company Private Limited & ... vs Eskayef Pharmaceuticals Limited & Ors. ... on 12 March, 2024
Author: Sanjeev Narula
Bench: Sanjeev Narula
$~52
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CS(COMM) 207/2024
ELI LILLY AND COMPANY PRIVATE LIMITED & ANR. &
ANR. ..... Plaintiffs
Through: Mr. Pravin Anand, Ms. Prachi
Agarwal, Ms. Ridhie Bajaj and
Ms. Kanupriya Chawla, Advocates.
versus
ESKAYEF PHARMACEUTICALS LIMITED & ORS. & ORS.
..... Defendants
Through: Mr. Naman Joshi, Mr. Rahul,
Mrs. Ayushi Bansal and Ms. Ritika
Vohra, Advocates for D-3.
CORAM:
HON'BLE MR. JUSTICE SANJEEV NARULA
ORDER
% 12.03.2024 I.A. 5474/2024 (seeking leave to file additional documents)
1. This is an application filed by Plaintiffs seeking leave to file additional documents under the Commercial Courts Act, 2015.
2. If Plaintiffs wish to file additional documents at a later stage, they shall do so strictly as per the provisions of the said Act.
3. Accordingly, the application stands disposed of. I.A. 5475/2024 (seeking exemption from pre-institution mediation)
4. As the present suit contemplates urgent interim relief, in light of the judgment of Supreme Court in Yamini Manohar v. T.K.D. Krithi,1 1 2023 SCC OnLine SC 1382.
CS(COMM) 207/2024 Page 1 of 8This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:28 exemption from attempting pre-institution mediation is granted.
5. Disposed of.
I.A. 5476/2024 (seeking exemption from filing originals, clearer copies, dim copies, translated copies and left side margins)
6. Exemption is granted, subject to all just exceptions.
7. The Plaintiffs shall file legible and clearer copies of exempted documents, compliant with practice rules, before the next date of hearing.
8. Accordingly, the application stands disposed of.
CS(COMM) 207/2024
9. Let the plaint be registered as a suit.
10. Issue summons. Mr. Naman Joshi, counsel accepts summons on behalf of Defendant No. 3. Upon filing of process fee, issue summons to the remaining Defendants by all permissible modes. Written statement(s) shall be filed by the Defendants within 30 days from the date of receipt of summons. Along with the written statement(s), the Defendants shall also file affidavit(s) of admission/denial of the documents of the Plaintiff, without which the written statement(s) shall not be taken on record.
11. Liberty is given to the Plaintiff to file replication(s) within 15 days of the receipt of the written statement(s). Along with the replication(s), if any, filed by the Plaintiff, affidavit(s) of admission/denial of documents of the Defendants be filed by the Plaintiff without which the replication(s) shall not be taken on record. If any of the parties wish to seek inspection of any documents, the same shall be sought and given within the timelines.
CS(COMM) 207/2024 Page 2 of 8This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:28
12. List before the Joint Registrar for marking of exhibits on 13th May, 2024. It is made clear that any party unjustifiably denying documents would be liable to be burdened with costs.
13. List before Court for framing of issues thereafter.
I.A. 5473/2024 (u/Order XXXIX Rules 1 & 2 r/w Section 151 of the Code of Civil Procedure, 1908)
14. Mr. Pravin Anand, counsel for Plaintiffs, has presented the following facts and contentions:
14.1. Plaintiff No. 1/ Eli Lilly and Company, conducting its business in India through its wholly owned subsidiary Plaintiff No. 2/ Eli Lilly and Company (India) Pvt. Ltd., is a leading innovation-driven global corporation engaged in the discovery, research, development, manufacture, and sale of pharmaceutical products.
14.2. The present suit concerns infringement of Plaintiffs' Indian Patent No. IN 297760, relating to "Methyl substituted Benzoimidazole compounds as Protein Kinase Inhibitors" and is titled "Protein Kinase Inhibors", useful in the treatment of cell proliferative diseases such as cancer ["Suit Patent"].
Plaintiff No. 1 is the proprietor of the Suit Patent, which is valid and subsisting till date and has not been the subject of any opposition/ rectification proceedings in India. The bibliographic details of the Suit Patent are reproduced below:
Indian Patent Number 297760
Patent Application Number 3454/CHENP/2011
Applicant/Patentee Eli Lilly And Company
Title PROTEIN KINASE INHIBITORS
National Phase entry-filing date of Indian
May 19, 2011
Application
International Application No. PCT/US2009/068030
CS(COMM) 207/2024 Page 3 of 8
This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:28 International Filing Date December 15, 2009 December 22, 2008 Date of Priority February 24, 2009 WO Publication No. WO/2010/075074 International Publication date July 1, 2010 Publication Date in India (u/s 11A) March 23, 2012 Date of Grant June 19, 2018 Publication Date in India(u/s 43(2)) June 22, 2018 Date of Expiry December 15, 2029 14.3. Claim 1 of the Suit Patent covers, inter alia, the compound having International Non-Proprietary Name (INN) 'Abemaciclib', having molecular formula C27H32F2N8 and chemical structure as depicted hereunder:
14.4. Abemaciclib is a kinase inhibitor for oral administration and is indicated for treatment of, inter alia, women with HR-Positive, HER2-
negative advanced or metastatic breast cancer. It has been designated as a Breakthrough Therapy, and has received regulatory approvals in various countries, including approval from the Food and Drug Administration in the United States of America. In India, Plaintiff No. 2 has been granted import and marketing approval for Abemaciclib (50mg, 100mg, 150mg, 200mg) by the Central Drug Standard Control Organization (CDSCO). 14.5. Abemaciclib is the active pharmaceutical ingredient (API) in the commercial product marketed and sold under the brand name 'Ramiven®' in India and 'Verzenio®' in other countries. The said products have been commercially successful worldwide, and details of sales and revenue have CS(COMM) 207/2024 Page 4 of 8 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:28 been delineated in the plaint. Plaintiffs' rights in the Suit Patent have also been recognised and protected by this Court previously, having granted an ad-interim injunction in favour of the Plaintiffs through order dated 19 th June, 2020 in CS(COMM) 183/2020.
14.6. Plaintiffs have received information that Defendant No. 1, purportedly a leading manufacturer of pharmaceuticals in Bangladesh, is producing a generic version of Abemaciclib, marketed under the brand name 'Abeclib' ["Impugned Drug"]. The Impugned Drug is listed on Defendant No. 1's websites www.skfbd.com and www.skf-oncology.com. Further, it is also listed by Defendant No. 2 as one of its products on the e-commerce website www.indiamart.com of Defendant No. 3. Moreover, Defendant No. 3 has verified Defendant No. 2 as a trusted seller on the aforenoted website, creating a false impression of authenticity. Screenshots depicting the Impugned Drug, marketed as containing Abemaciclib, have been filed along with the plaint, some of which are reproduced below:
CS(COMM) 207/2024 Page 5 of 8This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:28 14.7. Plaintiffs have also engaged an independent investigator to ascertain the scope of infringing activities. Although the market survey revealed that the Impugned Drug is not available in Kolkata or Delhi, Mr. Rabi, owner/ partner of Defendant No. 2, confirmed the availability of the Impugned Drug and indicated a willingness to deliver the same to Delhi. Details of the investigation undertaken at the behest of the Plaintiffs has also been placed on record. In such circumstances, the instant suit is filed seeking protection of the Suit Patent.
15. Issue notice. Mr. Naman Joshi, counsel for Defendant No. 3, accepts notice. Although Plaintiffs have filed an affidavit of service highlighting that advance service of the suit paper-book has already been effected on the CS(COMM) 207/2024 Page 6 of 8 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:29 remaining Defendants, there is no appearance on their behalf. Accordingly, upon payment of process fee, let notice be issued to Defendants No. 1 and 2, by all permissible modes, returnable on the next date of hearing.
16. Heard. Plaintiff No.1 is the registered owner of the Suit Patent, as established by the documents placed on record which covers the chemical compound Abemaciclib, which has received regulatory approvals in various countries, including from CDSCO in India. There has been no pre-grant or post-grant opposition or revocation proceedings challenging the Suit Patent, indicating strong presumption of its validity. Despite the subsisting validity of the Suit Patent till 15th December, 2029, the Defendants No. 1 and 2 have launched a generic version of Abemaciclib, without any permission or authorization from the Plaintiffs. The above-extracted screenshots of Indiamart website indicate that the Impugned Drug contains Abemaciclib, i.e. the API covered by the Suit Patent. Additionally, it is pertinent to note that the Impugned Drug has not been granted any regulatory approvals in India. Thus, by importing the Impugned Drug from Bangladesh, as alleged by the Plaintiffs, the Defendants would not only be prima facie violating the Plaintiffs' statutory rights in their Suit Patent, but also effectively bypassing the rigours of the regulatory mechanism for pharmaceuticals in India, which could have wide-ranging potentially detrimental consequences.
18. In view of the above, the Court prima facie finds that the Impugned Drug 'Abeclib' infringes on the Plaintiffs' Suit Patent, and in case no interim injunction is granted, irreparable harm would be caused to the Plaintiffs; balance of convenience also lies in favour of Plaintiffs and against the Defendants.
19. Accordingly, till the next date of hearing, the following directions are CS(COMM) 207/2024 Page 7 of 8 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:29 issued:
19.1. Defendants No. 1 and 2, as well as anybody acting on their behalf, are restrained from using, making, selling, distributing, advertising, marketing, exporting, offering for sale, importing or in any other manner, directly or indirectly, dealing in any product, including but not limited to a generic Abemaciclib product, including but not limited to the Impugned Drug 'Abeclib', or any other product that infringes the subject matter of the Suit Patent IN 297760.
19.2. Defendant No. 3 is directed to delist and permanently remove the following link from their website:
https://www.indiamart.com/proddetail/abeclib-150-mg- abemaciclib-2853313026730.html 19.3. In case Plaintiffs were to identify any further links/ advertisements on Defendant No. 3's platform relating to the product 'Abeclib', which is manufactured by Defendants No. 1 and 2, they will be at liberty to bring the same to the notice of Defendant No. 3, who shall take down/ de-list the said links, if found to be covered within the scope of the order.
20. Reply be filed within four weeks from today. Rejoinder thereto, if any, be filed within a period of two weeks thereafter.
21. Compliance of Order XXXIX Rule 3 of Code of Civil Procedure, 1908 be done with one week from today.
22. List before the Court on 14th August, 2024.
SANJEEV NARULA, J MARCH 12, 2024 nk CS(COMM) 207/2024 Page 8 of 8 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 14/03/2024 at 21:33:29