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Bombay High Court
Themis Medicare Limited vs The Controller General Of Patents ... on 14 July, 2026
18-COMMP-47-2025.doc

IN THE HIGH COURT OF JUDICATURE AT BOMBAY

ORDINARY ORIGINAL CIVIL JURISDICTION

COMMERCIAL MISCELLANEOUS PETITION NO. 47 OF 2025

Themis Medicare Limited                                   ...Petitioner
           Versus
 The Controller General of Patents Designs and             ...Respondent
 Trade Marks

Mr. Rashmin Khandekar, a/w Reeti Shetty i/b Ms. Charu Shukla for
     Petitioner.

Mr. Mahesh Shukla, a/w Siddhikesh Shinde & Niraj Prajapati for
     Respondent.

CORAM:       SOMASEKHAR SUNDARESAN, J.
          DATE:        JULY 14, 2026

ORDER :
1.        This Petition essentially appeals an order dated March 30, 2024, passed

under
Section 15
of the Indian Patents Act, 1970. In a nutshell, the Impugned

Order disposes of an application for patent along with objections raised

against it, for an injectable "Diclofenac Compositions", with claims to causing

minimal pain on the basis of the viscosity of the composition. While the

Impugned Order contains a detailed analysis on various facets of merits,

purely from the perspective of natural justice, the Impugned Order has been
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rendered vulnerable by reason of the following distinct and mutually

contradictory contents, extracted below:
Hence after scrutinising all examples no data could be found about the technical
               advancement contemplated by the aqueous formulation. The only thing the applicant
               is stating that the formulation can be used for alternative pathways and is stable. No
               comparative data is even produced to exhibit stability in the complete specification.
               No comparative data is produced in the complete specification to exhibit the fact
               that this particular formulation creates less pain during injection in comparison to
               other marketed similar formulations with same dosage. Alongwith the written
               submission, the applicant has also filed an affidavit wherein it is stated that the
               composition leads to a solution wherein the active is completely dissolved and
               remains stable. As far as the pain management is concerned therein, no data is
               produced in the affidavit also to substantiate the same against known formulations.
               The applicant has merely given a statement that it gives less pain at the injection
               site.
The data as available in the complete specification is duly considered. The affidavit
               as submitted voluntarily by the applicant has been also duly considered and it is
               being found that the complete specification lacks of any data to be considered as
               'enhanced therapeutic efficacy'. The affidavit also highlights the solubility of
               diclofenac sodium in diethylene glycol monoethyl ether, stability, bio-availability,
               viscosity and less pain during administration of injectable compositions. However,
               none of the above factors can even be considered as a factor of 'enhanced
               therapeutic efficacy' within framework of the Hon'ble apex court order in the matter
               of "
NOVARTIS VS. UNION of INDIA
". The same is also emphasised in the matter
               of the judgements passed by the Hon'ble Delhi High Court as stated above. Hence
               the subject matter of the claims of the instant application fails to exhibit any
               significant increase in therapeutic efficacy to be even considered under the relevant
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provision of
Section 3(d)
, and thereby the subject matter of the claims of the instant
               application is not allowable under
Section 3(d)
of the Act.
[Emphasis Supplied]
2.        I have examined the record with the assistance of Learned Advocates for

the parties.           It is apparent that the in the course of the conduct of the

proceedings, data has indeed been provided, particularly with regard to the

claims made in connection with causing less pain during injection, including

the submission of Animal Testing Laboratory Reports pursuant to animal

testing.
3.        An incoherence in the otherwise detailed order emerges from the

aforesaid extracts, which even on plain reading would show they are

inherently contradictory.
4.        The contention that no data at all has been provided in the specification

is in conflict with observation that the data provided in the specification has

been duly considered. That apart, how the data provided has been considered

is not articulated in the Impugned Order. The last of the extracted paragraphs

above obviously leads to a summary conclusion without engaging with the

data and explaining why the data would not pass muster for purposes of

assessment of the application.
5.         It is in this limited premise that it is considered appropriate to remand

the matter to the Controller with a direction to engage with the data that has
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been provided and forms part of the record, including the data contained at

Pages 840 to 842 of the Petition.
6.        Indeed, the Animal Testing Report that has been submitted to the

Controller, as also the submission dated February 5, 2020 enclosing various

findings of experiments and studies, as also the complete specification (i.e. at

Page 808 of the Petition) with data, which is placed between Pages 820 and
827. It is necessary for all such data that has been indeed provided to be dealt

with and for a reasoned order to be passed.
7.        It is made clear that nothing in this order is an expression of opinion on

the merits. It is considered appropriate to request the Controller to engage

with the data and justify how the conclusion made, particularly in the ending

of the Impugned order, that data available, was duly considered and found to

be unworthy of holding that there was enhanced therapeutic efficacy.
8.        In light of the aforesaid observations, the Impugned Order is set aside

by way of remand with the aforesaid scope of remand being made clear.
9.         The Petition is finally disposed of in the aforesaid terms.
10.       All actions required to be taken pursuant to this order shall be taken

upon receipt of a downloaded copy as available on this Court's website.
[ SOMASEKHAR SUNDARESAN, J.]
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