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IN THE HIGH COURT OF DELHI AT NEW DELHI
Navin Chawla, J.
Bayer Healthcare Llc – Appellant
Versus
Natco Pharma Limited – Respondent
CS(COMM) 343 of 2019 & I.As. 8878 of 2019, 9685 of 2019, 1178 of 2022 with CS(COMM) 660 of 2022 & I.As. 15573 of 2022, 15574 of 2022,
Decided On : 05-07-2023
| Table of Content |
|---|
| 1. details on the suit patent and its validity. (Para 1 , 2 , 3 , 4 , 5 , 6 , 7) |
| 2. plaintiff's claims about regorafenib. (Para 8 , 9 , 10 , 11 , 12 , 13) |
| 3. defendants' arguments against the suit patent. (Para 14 , 15 , 16 , 17 , 18 , 19) |
| 4. defendants' claims regarding lack of novelty and inventive step. (Para 20 , 21 , 22 , 23 , 24) |
| 5. plaintiff's counterarguments regarding the patent. (Para 25 , 26 , 27 , 28 , 29) |
| 6. discussion on coverage vs disclosure in patents. (Para 30 , 31 , 32 , 33) |
| 7. discussion on the implications of evergreening patents. (Para 34 , 35 , 36 , 37) |
| 8. court observations on the application of law. (Para 38 , 39 , 40 , 41 , 42) |
| 9. previous judgments referenced regarding patent law. (Para 43 , 44 , 45 , 46) |
| 10. prosecution history and the court's interim order. (Para 47 , 48 , 49) |
| 11. updates on other actions related to the patent. (Para 50 , 51) |
| 12. court's decision-making criteria for interim injunction. (Para 52 , 53 , 54 , 55) |
| 13. legal standards set for interim relief in patent matters. (Para 56 , 58 , 59 , 60) |
| 14. discussion about markush claims in patents. (Para 61 , 62 , 63) |
| 15. clarification of terms under patent law. (Para 64 , 65 , 66) |
| 16. determinations regarding patent claims. (Para 67 , 68) |
| 17. analysis of inventive step in the context of patent. (Para 69 , 70 , 71 , 72) |
| 18. implications of international patent coverage. (Para 73 , 74 , 75 , 76 , 77) |
| 19. court's final observations regarding the case. (Para 78 , 79 , 80) |
| 20. essentials for granting interim injunction. (Para 81 , 82 , 83 , 84 , 85) |
| 21. final judgment and directions from the court. (Para 86 , 87 , 88 , 89 , 90) |
| 22. court's order for further proceedings. (Para 91 , 92) |
JUDGMENT
I.A. 8878/2019 in CS(COMM) 343/2019
I.A. 15573/022 in CS(COMM) 660/2022
1. The present applications are being taken up together for consideration as they relate to the claim of the plaintiff to an order of interim injunction against the defendants based on the same patent, being Indian Patent No.240207 (hereinafter referred to as the `Suit Patent'), that covers and claims a molecule, which is claimed to be a new chemical entity, 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide, which has been assigned an International Non-proprietary Name (`INN'), REGORAFENIB.
CASE OF THE PLAINTIFF
2. The plaintiff is a part of the Bayer Group of Companies ('the Group'), the Holding Company being Bayer AG. The Group conducts its business in the healthcare sector through the plaintiff, which is involved in research, development, manufacturing and marketing products for the prevention, diagnosis and treatment of diseases.
3. As mentioned hereinabove, the plaintiff claims that the suit patent covers and claims a molecule, being a new chemical entity, that is, 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide, which has been granted INN, REGORAFENIB.
4. The bibliographic details of the suit patent are given below:
"a) Indian Patent No.: 240207
b) Patentee: Bayer HealthCare LLC
c) Indian Application No.: 402/DELNP/2006
d) Date of filing in India: 23rd January, 2006
e) Date of publication u/s 11A: 24th August, 2007
f) Date of filing of international application: 22nd July, 2004
g) PCT Application No.: PCT/US04/023500
h) Priority application nos. and dates:
US 60/489,102 (23-Jul-2003)
US 60/540,326 (02-Feb-2004)
i) Date of grant: 29th April, 2010
j) Title: A FLUORO SUBSTITUTED OMEGA-CARBOXYARYL DIPHENYL UREA COMPOUND OR A SALT, OR AN ISOLATED STEREOISOMER THEREOF
k) Drug covered: REGORAFENIB (WHO INN Nomenclature)-used for treatment of Metastatic colorectal cancer and advanced gastrointestinal stromal tumors.
l) No. of claims: 9
m) Claims claiming/covering Regorafenib: Specifically claimed in Claims 1 and 3.
n) The suit patent discloses the compound REGORAFENIB, its preparation and characterization in Example 1, The HCl salt of Regorafenib is exemplified in Example 2, the Mesylate salt
Validity of specific patents is upheld while assessing distinctions between coverage and disclosure, emphasizing protection of intellectual property rights against infringement.
Intellectual Property right - Infringement of Indian patents - It is also a well settled position in law that damages are entirely insufficient as panacea for holder of a valid patent, which is infri....
The main legal point established in the judgment is the exclusive rights of the patent holder to prevent infringement under Section 48 of the Patents Act.
Patent is prima facie invalid due to prior claiming and non-working, infringing on patent system integrity by prolonging monopoly post-expiration.
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