IN THE HON’BLE HIGH COURT OF DELHI AT NEW DELHI
(Original Commercial Jurisdiction)
CS(COMM)-294/2026
IN THE MATTER OF:
NOVO NORDISK A/S & ANR. …Plaintiffs
versus
DR REDDYS LABORATORIES LIMITED …Defendant
Note of arguments for 23 March 2026
1. Background.
1.1. This present suit (hereinafter, “Commercial Suit”) has been filed seeking permanent
injunction restraining the alleged infringement of patent number 325669 (hereinafter, the
“Suit Patent”), renditions accounts/ damages, delivery up etc.
1.2. The patented composition is the active ingredient of Plaintiffs’ drug sold in India under the
brand Rybelsus (Semaglutide tablet). Plaintiff No.1 is the patentee of the Suit Patent, and
Plaintiff No.2 markets the product containing the Suit Patent in India under the brand
Rybelsus.
1.3. The present Commercial Suit is a quia timet action seeking to prevent the Defendant from
commercially manufacturing, stockpiling, exporting, etc drug products containing solid
composition for oral administration comprising Semaglutide and SNAC, wherein Semaglutide
is in the range of 0.01 mg to 100 mg and SNAC is in the range of 0.6-2.1 mmol, in the
domestic and export markets
The Plaintiffs rely on regulatory disclosures (CDSCO/SEC recommendation for oral
Semaglutide tablets of 3, 7 and 14 mg dosage), public statements, and materials from the
Defendant’s website to assert a credible and imminent launch. [Paragraphs 22 - 29 at
Pages 30-39 of the Plaint]
Prayer (a) as mentioned in the Plaint [Paragraph 91 at Page 68 of the Plaint]
1.4. This Suit Patent contains 13 granted claims. Out of which claim 1 is independent claim and 2-
13 are directly or indirectly dependent on Claim 1. The independent Claim 1 of the Suit Patent
is a composition claim defined by precise, closed quantitative ranges which relates to a
pharmaceutical composition in the form of solid dosage form comprising:
a) a GLP-1 receptor agonist namely Semaglutide and,
b) a salt of N-(8-(2-hydroxybenzoyl)amino) caprylic acid (NAC) (preferably Sodium salt)
(hereinafter, as “SNAC”),
c) wherein the amount of said salt of NAC is in the range of 0.6-2.1 mmol and the amount of
Semaglutide is in the range of 0.01 mg to 100 mg.
2. The Defendant’s Products are not infringing the Suit Patent.
2.1. The ranges claimed in the Suit Patent are essential limitation that define the claimed
invention’s alleged novelty and inventiveness. The prosecution history of the Suit Patent
unequivocally confirms the same. The Plaintiff No.1, during prosecution of the Suit Patent,
amended the claims by replacing the open-ended phrase “at least in the range of in the range
of 0.6-2.1 mmol” with the specific, closed ranges for SNAC that are present in the granted
patent.
Written submissions dated 01 November 2019 filed by Plaintiff No.1 before the Controller
of Patents. [Page 1 of the Written Submissions]
2.2. In the response to the FER dated 13 August 2018, the Plaintiff No.1 explicitly admitted that
“at least 0.6 mmol of the salt of N (8 (2 hydroxybenzoyl)amino)caprylic acid (NAC) and
semaglutide” is an important feature of the claimed invention. This position was advanced to
overcome objections relating to inventive step, Section 3(d) and Section 3(e) of the Patents
Act, 1970.
Response dated 13 August 2018 filed by Plaintiff No.1 before the Controller of Patents.
[Page 5 of the Response]
2.3. The Plaintiffs are bound by such amendments and cannot later assert a scope that was
disclaimed during prosecution. Under the principle of prosecution history estoppel, such
admissions and amendments constitute binding statements, preventing the Patentee from
claiming subject matter deliberately excluded to secure patent protection.
Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd., reported at 535 U. S.
722 (2002); at pages 727, 729, 730, 733 to 735;
Pharma Tech Sols., Inc. v. LifeScan, Inc., reported at 942 F.3d 1372, at paragraphs 5 to 10;
Jay Switches India Pvt. Ltd. vs. Sandhar Technologies Ltd. and Ors., reported at
MANU/DE/8435/2024, at paragraph 41 and 42;
Crystal Crop Protection Limited v. Safex Chemicals India Limited and Ors., reported at
2025:DHC:3382, at paragraphs 44 to 46:
R.N. Gosain v. Yashpal Dhir, reported at (1992) 4 SCC 683, at paragraph 10;
2.4. Consequently, the Suit Patent’s claims must be strictly construed as limited to formulations
containing Semaglutide in an amount from 0.01 mg to 100 mg and SNAC in the range of 0.6–
2.1 mmol (i.e., 180 – 633 mg). Thus, a composition containing Semaglutide and SNAC in any
amount outside the said range shall be outside the scope of Suit Patent, in view of the
fundamental rule of patent law i.e. what is not claimed is disclaimed.
Electric and Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23, 39
2.5. The Defendant has obtained Clinical Trial No Objection Certificate (CT NOC) vide File. No.
BIO/CT/24/000142 and conducted clinical trial registered in Clinical Trial Registry of India
under CTRI/2025/06/088110 in relation to Dr. Reddy’s Oral Semaglutide Tablets (3mg, 7 mg
and 14 mg) (hereinafter, the “Defendant’s Products”).
2.6. The Defendant’s Products contain approximately 0.398 mmol (≈120 mg) of SNAC, which
falls outside the range claimed in the Suit Patent. In addition to the NAC salt, the Defendant’s
Products composition includes sodium caprylate as an additional permeation enhancer which
is chemically distinct from a NAC Salt (it is the sodium salt of caprylic acid without the 2
hydroxybenzoyl amide substituent that characterizes NAC/SNAC), and it cannot substitute for
the claimed NAC Salt requirement. Consequently, the Defendant’s Products do not fall within
the scope of the IN 325669.
Affidavit dated ____ on behalf of Authorized Representative of Defendant
Expert Opinion dated 20 January 2026.
3. The Defendant’s Products are not bioequivalent to the Suit Patent.
3.1. Infringement under the doctrine of equivalence is made out only where the allegedly
infringing product performs substantially the same function in substantially the same way to
achieve substantially the same result without omitting or altering an essential claim element.
F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd., reported at 2015 SCC OnLine Del 13619
at paragraph 67.
Sotefin SA v. Indraprastha Cancer Society and Research Centre and Others, reported at
2022 SCC OnLine Del 516 at paragraph 19-20.
Nokia Corporation v. Bharat Bhogilal Patel, reported at 2014:DHC:2900 at paragraph 36.
Vifor International Ltd.& Anr. v. MSN Laboratories Pvt. Ltd., reported at 2023:DHC:5122
at paragraph 63.
3.2. The specification and prosecution history consistently teach that Semaglutide in an amount
from 0.01 mg to 100 mg and a salt of N-(8-(2-hydroxybenzoyl) amino)caprylic acid (NAC) in
the range of 0.6–2.1 mmol is critical for creating a localized microenvironment that facilitates
the oral bioavailability of Semaglutide. Thus, specific range for the SNAC claimed in the Suit
patent is an essential element of the Suit Patent. Accordingly, the Defendant’s Products which
contain only approximately 0.398 mmol (≈120 mg) of SNAC as sodium caprylate as an
additional permeation enhancer cannot be said to be bioequivalent to the Suit Patent.
3.3. The Plaint only provides mere allegations of functional similarity and bioequivalence through
certain extracts of the Defendant’s website and regulatory approvals and no product-to-claim
mapping has been provided by the Plaintiffs which is an essential requirement to prove a
prima facie case in cases wherein bioequivalence is claimed.
F-Hoffmann-La Roche AG & Anr. v. Zydus Lifesciences Ltd., 2024:DHC:7868 at
paragraphs 25-26;
Zydus Lifesciences Ltd. v. E.R. Squibb & Sons, LLC & Ors., 2026:DHC:178-DB at
paragraphs 26.2.5 & 26.5.7.
3.4. The Plaintiff apply the incorrect logic that Defendant’s Products would necessarily embody
the patented solid composition for oral administration comprising Semaglutide and SNAC,
wherein Semaglutide is in the range of 0.01 mg to 100 mg and SNAC is in the range of 0.6-
2.1 mmol, as claimed in the suit patent IN’669. The mere fact of applying for a similar
biologic cannot lead to a finding of patent infringement.
Zydus Lifesciences Ltd. v. E.R. Squibb & Sons, LLC & Ors., 2026:DHC:178-DB at
paragraphs 26.2.5 & 26.5.7.
4. There are gross misrepresentations in the Plaint.
4.1. The Plaint at various places provides that the Defendant’s CDSCO approval for the
Defendant’s Products is for a Subsequent New Drug (SND), this is ex facia wrong as the
Defendant’s approval is for a Biosimilar Application.
4.2. The Plaint at various places provides the Defendant’s Products are synthetic origin drugs, this
is ex facia wrong as the Defendant’s Products are made by recombinant method.
SIM AND SAN, Attorneys-at-Law,
Counsel for the Defendant
A-12, Gulmohar Park, New Delhi – 110049
Email: litigation@[Link]
aditya@[Link]
Place: New Delhi
Date: 22 March 2026