Delhi High Court – Orders
Scipharm Sarl vs Assistant Controller Of Patents And … on 27 March, 2026
Author: Tushar Rao Gedela
Bench: Tushar Rao Gedela
$~1
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ C.A.(COMM.IPD-PAT) 159/2022
SCIPHARM SARL .....Appellant
Through: Ms. Naina Gupta, Mr. Anshul Saurastri
and Mr. Jay Shah, Advocates.
versus
ASSISTANT CONTROLLER OF PATENTS AND DESIGNS AND
ANR .....Respondents
Through: Mr. Mukul Singh, CGSC with Mr.
Aryan Dhaka and Ms. Sunidhi Tyagi,
Advocates.
CORAM:
HON'BLE MR. JUSTICE TUSHAR RAO GEDELA
ORDER
% 27.03.2026
1. The present appeal was filed against the rejection of the Indian Patent
Application No. 6771/DELNP/2013 titled “Method For Enhancing
Engraftment Of Haematopoetic Stem Cells” vide the order dated 29.05.2020 on
the ground of non patentability under Section 3 (i) of the Patents Act, 1970
(hereinafter referred to as “the Act”). The impugned order is extracted
hereunder:
“DECISION
An application for a patent bearing number 6771/DELNP/2013 was filed on
30/07/2013 entitled “”METHOD FOR ENHANCING ENGRAFTMENT OF
HAEMATOPOETIC STEM CELLS”. As per the provision under Section 11A
of Patents Act, the said application was published on 23/01/2015. A request
for examination under Section 11-B was filed on 12/01/2015.
The said application was examined under Section 12 and 13 of Patents Act
and First Examination Report containing a statement of objections was
forwarded on 05/07/2018 and the applicant’s agent filed response to First
Examination Report on 5/11/2018. As per the provisions under Section 13 (3)
of Patents Act, the said amended case after reply to Examination Report, was
examined and investigated in like manner as the original specification. TheC.A.(COMM.IPD-PAT) 159/2022 Page 1 of 7
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applicant was offered a hearing on 11/03/2020 with the following objections.
Other Requirement(s)
1. The submissions in your letter dated November 5, 2018 have been
considered carefully. However, the requirements of head Inventive step,
Non-Patentability, Sufficiency of disclosure and clarity and conciseness of
First Examination Report dated 05/07/2018 have not been met.
Invention u/s 2(1)(j)
1. The amended claims 1-7 cannot be acknowledged with an inventive step u/s
2(l)(j)(a) of the Patents Act, 1970 in view of the disclosures of D4, 05
-W02008070310A2 and 06 – Mubarak: A review of prostaglandin analogs in
the management of patients with pulmonary arterial hypertension.
Respiratory medicine, January 2010, Volume 104, Issue 1, Pages9-21D4 discloses he enhancement of engraftment of HSCs using prostaglandin E2
(a prostacyclin analogue).
D5 discloses method/composition of promoting tissue growth or regeneration
by contacting said tissue (specifically HSCs) with a modulator that
up-regulates the prostaglandin signaling pathway or downstream mediators
of prostaglandin signaling. Forskolin was shown to enhance the effects of
dmPGE2 which creates a reaction in which the result may be increased cell
proliferation.
D6 states that a “small number of preclinical studies have directly compared
the effects of several prostaglandin analogs on different physiological
systems.” Iloprost, treprostinil, and beraprost were examined with regard to
smooth muscle proliferation and cAMP generation in the human pulmonary
artery. Serum-induced proliferation produced by a number of prostacyclin
analogs acting on pulmonary smooth muscle cells was assessed, with
intracellular cAMP being elevated by all analogs. It was determined that
prostacyclin has desirable effects on pulmonary vasculature and make it
effective in the treatment of PAH. Fig. 3 within D6 shows that increasing
cAMP can have significant effects increasing the effect of the prostaglandin
on its receptors and on G protein activities. Using forskolin to enhance PGE2
activity on EP4 receptors can assist the EP4 receptor to induce bone
formation, mediate joint inflammation in collagen-induced arthritis, protect
against inflammatory bowel disease and facilitate Langerhans cell migration
and maturation.
It would be obvious for a person skilled in art to use the cAMP enhancer
forskolin (D5), with the prostacyclin analogs (D6), in the method of D4. D5
teaches that the result would likely lead to increased cell proliferation as part
of the prostaglandin pathway of which is the purpose of D4, the increase
proliferation of HSCs. D6 teaches that the various prostacyclin analogs areC.A.(COMM.IPD-PAT) 159/2022 Page 2 of 7
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in active clinical use to promote the effects of prostaglandins. Person skilled
in art would have a reasonable expectation of success of using the cAMP
enhancer forskolin (D5) and the prostacyclin analogs as (D6) in the method
of D4 as D5 and D6 teach that the result would likely lead to increased cell
proliferation as part of the prostaglandin pathway of which is the purpose of
04, the increase proliferation of HSCs.
Non-Patentability u/s 3
The method claims 1 and 2 still fall within the purview of section 3(i) of the
Act as the HSC used in the first step can be only obtained via surgical method.
Hearing was held on 11/03/2020 and written submission filed on
24/03/2020My inference from the above arguments with respect to amended claims are
as follows:
Regarding inventive step
The reply filed by the applicant has been considered and found persuasive.
The explanation provided by the applicant with regard to prior art
documents and figure 4 have been considered and found satisfactory and
hence the objection is considered as met.
Regarding Non- Patentability
3(i)
The explanation given by the applicant has not been found persuasive. The
applicant has amended the claims by deleting subsection (a) of the original
method claims, which refers toobtaining a sample containing haematopoetic stem cells.
This step is an essential essence for properly carrying out the invention. It
should be noted that the exclusion from the surgical method cannot be
avoided merely by drafting claims that omit one step of such method. Even
though it is pretreatment method, it is an essential step which involves
surgical method . Hence the amended claims are not allowable u/s 3(1) of the
Patent Act, 1970.
3(e)
Fig 4 has been considered with regard to 3(e) and has been found
persuasive. Hence the objection is considered as met.
Regarding Sufficiency of Disclosure u/s 10(4) and Clarity and Conciseness
C.A.(COMM.IPD-PAT) 159/2022 Page 3 of 7
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The applicant has met the objection amendment of claims.
Since, the applicant has failed to meet the requirements of outstanding
objection u/s 3(i) of the hearing letter, I refuse to proceed further with this
application for patent No. 6771/DELNP/2013 under Section 15 of the Act.”
[Emphasis Supplied]
2. So far as the objection regarding the lack of inventive step under Section
2(1)(ja) of the Act is concerned, essentially the learned Controller in his
inference records that the explanation provided by the appellant with regard to
the prior art documents and having regard to the figure 4, have been considered,
which were found satisfactory, and concluded that the objection under Section
2(1)(ja) of the Act was met. In other words, the objection regarding lack of
inventive step was met with, by the appellant.
3. So far as the objection regarding Section 3(e) of the Act is concerned, the
learned Controller has also found the submissions to be persuasive and has on
that account, noted that the objection has been met with by the appellant.
Additionally, the learned Controller also noted that the objection regarding
Sufficiency of Disclosure under Section 10(4) of the Act and Clarity and
Conciseness has been met by the appellant.
4. What remains for consideration is only the objection about
non-patentability under Section 3(i) of the Act. The learned Controller has not
found the submissions of the appellant persuasive on account of the fact that
though the appellant had amended the claims by deleting sub-section (a) of the
original method claims referring to “obtaining the sample containing
Haematopoetic Stem Cells”, yet that step was an essential essence for properly
carrying out the invention. The learned Controller had noted that the exclusion
from the surgical method cannot be avoided merely by drafting claim which
would emit one step of such method. The learned Controller was of the opinion
that the said step is an essential one, which would involve surgical methods and
C.A.(COMM.IPD-PAT) 159/2022 Page 4 of 7
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since the application pertaining to surgical method itself would be violative of
the prohibition or proscription under Section 3(i) of the Act, the patent
application was rejected.
5. It appears that during the subsistence of the present appeal, the appellant
vide the e-mail letter dated 10.02.2026, through its counsel, communicated to
the respondent that in order to bring quietus to the issue, the appellant would
amend its claims by deleting claim 1, however, retaining claims 2 to 5. On that
account, an additional affidavit has been filed on behalf of the
respondents/Controller who in para 5 of the said additional affidavit has stated
as under:
“5. That in light of the abovementioned letter of the Appellant dated
10.02.2026, it is most humbly submitted that the application was
JB/refused because the applicant failed to meet the requirements relating
to the outstanding objection under Section 3(i) of the Patents INVAct
1970, which applies only to Claim 1. As per the contents of the letter dated
10.02.2026, if Claim 1 is deleted as proposed by the Appellant, the
objection may be considered as resolved. It is most humbly submitted that
there are no further objections with respect to the composition claims.
Accordingly, the respondent most humbly submits that the matter may be
remanded back for grant of the application with the amended claims as
proposed by the Appellant vide letter dated 10.02.2026.
True copy of the communication by way of Email dated 06.03.2026 is
annexed hereto and marked as Document 2.”
6. In effect, the learned Controller has stated that the patent application of
the appellant was refused on account of the fact that the appellant failed to meet
the requirements relating to the objection under Section 3(i) of the Act which
applied only to claim no.1. In such circumstances, it has been stated that if the
appellant is willing to amend its claim by deleting claim no.1, the objection
may be considered as resolved and further states that in case such construction
is agreed to, the matter can be remanded for consideration of the application
with the amended claims as proposed by the appellant vide the letter dated
10.02.2026.
C.A.(COMM.IPD-PAT) 159/2022 Page 5 of 7
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7. This Court in C.A.(COMM.IPD-PAT) 20/2023 titled “M/S Coral Drugs
Private Limited vs. The Assistant Controller Of Patents” dated 29.01.2026
and in C.A.(COMM.IPD-PAT) 302/2022 titled “Fresenius Medical Care
Deutschland GmbH vs. Controller General of Patents” dated 16.04.2025 has
permitted amendment of claims before this Court and further remanded the
matter back to the learned Controller for consideration of the applications,
which were the subject matter of the appeals therein. The relevant paras of the
judgment Fresenius Medical Care (supra) are reproduced hereunder:
“14. In my considered view, the proposed amendments are in the nature of
an explanation and disclaimer. They are not broadening the scope of
unamended claims in any manner and the subject matter of the amendment
has also been disclosed in the specification.
15. Therefore, the proposed amendments fall within the scope of Section
58(1), 59 of the Patents Act, 1970.”
8. Having regard to the aforesaid as also the additional affidavit enclosing
relevant communications between the appellant and the Controller’s Office,
this Court deems it appropriate to permit the appellant to amend its patent
application by deleting claim no.1, however, retaining claims 2 to 5.
9. In that view of the matter, the appeal is allowed limited to the aforesaid
extent, remanding the matter back to the Controller’s office for a consideration
of the patent application in terms of the directions noted above.
10. The additional affidavit, enclosing all the documents dated 25.03.2026 is
taken on record.
11. The learned Controller is requested to process the subject patent
application after affording an opportunity to the appellant of hearing within
three months from date. Notice of such hearing shall be issued to the appellant
by the learned Controller.
12. It is important to note that this order is passed without going into merits
of the appeal and therefore the learned Controller is directed to decide the
C.A.(COMM.IPD-PAT) 159/2022 Page 6 of 7
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matter on merits uninfluenced by any observations made in this order.
13. The appeal is disposed of in above terms without any orders as to costs.
TUSHAR RAO GEDELA, J
MARCH 27, 2026/anj
C.A.(COMM.IPD-PAT) 159/2022 Page 7 of 7
This is a digitally signed order.
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The Order is downloaded from the DHC Server on 31/03/2026 at 20:41:17
