[Cites 2, Cited by 0]

Calcutta High Court

Astellas Institute For Regenerative ... vs The Controller Of Patents And Designs on 22 December, 2025

Author: Ravi Krishan Kapur

Bench: Ravi Krishan Kapur

                                                                            2025:CHC-OS:273




                      IN THE HIGH COURT AT CALCUTTA
                               ORIGINAL SIDE
                        Ordinary Original Civil Jurisdiction

  BEFORE:
  The Hon'ble JUSTICE RAVI KRISHAN KAPUR


                                    IPDAID/41/2024

              ASTELLAS INSTITUTE FOR REGENERATIVE MEDICINE
                                    VS
                 THE CONTROLLER OF PATENTS AND DESIGNS




For the appellant                      : Mr. Debnath Ghosh, Sr. Adv.
                                         Mr. Biswaroop Mukherjee, Adv.
                                         Mr. Pradipta Bose, Adv.
                                         Ms. Madhumanti Chakraborty, Adv.
                                         Mr. S. Banerjee, Adv


For the Controller                     : Mr. Swatarup Banerjee, Adv.
                                         Mr. Priti Jain, Adv.
                                         Mr. Shankharit Charkbaroty, Adv.


Heard on                               : 22.12.2025

Judgment on                            : 22.12.2025


Ravi Krishan Kapur, J.:

1. This appeal is directed against an order dated 23rd March, 2022 passed by

the Assistant Controller of Patents and Designs.

2. The primary ground urged on behalf of the petitioner is that the impugned

order has been passed mechanically ignoring the provisions of the

amended claims and does not consider the true and correct facts of the

case. It is further contended that the subject invention has been granted

in several other countries.

2025:CHC-OS:273

3. Briefly, the subject invention is titled as "IMPROVED METHODS OF

PRODUCING RPE CELLS AND COMPOSITIONS OF RPE CELLS" and

contemplates a method of producing retinal pigment epithelial cells (RPE)

cells from human pluripotent cells. The differentiated RPE cells can be

used in screening assays and as therapeutics. The Retinal Pigment

Epithelium (RPE), is a single layer of pigmented hexagonal cells behind the

retina as the outer most layer of the retina. The RPE plays an important

role in maintaining visual function and the visual cycle. RPE cells are

phagocytic, with the ability to engulf and eliminate exfoliated POS and

maintain the normal renewal of visual cells. The RPE plays a fundamental

role in both the transport and storage of retinoids essential for

maintenance of the visual cycle. RPE cell damage, in turn, causes retinal

dysfunction and even blindness.

4. It is contended on behalf of the applicant that the invention provides for

the first time, a method in which the embryonic stem cells are

commercially exploited for the production of retinal pigment epithelial cells

(RPE Cells). The embryonic stem cells recited in the claimed invention are

obtained by methods which do not require the destruction of the human

embryo. As stated in Example 1: "Two hES cell lines derived from single

blastomeres were used-MA1 and MA09". Hence, pre-established hES cell

lines were used in the claimed method. It is alleged that the claimed

method could use the cell line without the need to destroy and embryo

anew. It is submitted on behalf of the applicant that the instant stem cells

research is purely based on obtaining the human embryo from the 2025:CHC-OS:273

umbilical cord and as such, there is no ground for rejection of the

application under section 3(b) of the Act.

5. On behalf of the respondent Controller, it is submitted that the entire case

made out before this Court that the umbilical cord is the only source for

deriving the embryos is neither made out in the pleadings nor the

amended claims nor the specifications which had been filed. In such view

of the matter, there is no infirmity with the impugned order and the same

has been passed after consideration of all the facts and circumstances of

the case. As such, the rejection of the subject invention under section 3(b)

of the Patents Act, 1970 warrants no interference whatsoever. There are

sufficient and elaborate reasons provided in the impugned order. The case

made out by the appellant that stem cells would be exclusively obtained

from the umbilical cord is de hors the pleadings and specifications filed by

the appellant. This case is sought to be made out for the first time from

the Bar and warrants rejection.

6. The application was filed for grant of a patent bearing National Phase

Patent Application Number 1547/KOLNP/2010. Pursuant to the filing of

the instant application, a First Examination Report dated 25th May, 2017

was issued by the Deputy Controller of Patents. The appellant had

responded to such First Examination Report by responding to all the

substantive and formal objections. Subsequently, the appellant's agent

received the hearing notice. Written notes of arguments were also filed and

fresh hearing notice with fresh objections under section 59(1) of the Act

was also issued by the authorities. Upon completion of the proceedings, 2025:CHC-OS:273

the impugned order dated 23rd March, 2022 was passed by the Assistant

Controller.

7. A perusal of the impugned order would demonstrate that after considering

all the submissions made on behalf of both parties and discussing the

subject invention extensively, the Assistant Controller has concluded as

follows:

v. It is observed that the process of single blastomere derivation may not kill the embryos; however, may affect the successful implantation of the embryo and may cause a detrimental effect on the survival rate of cleavage-stage embryos. Thus, the process cannot be considered as an embryo-saving strategy; and the same is ethically challenging. Evidence that the process is not an embryo-saving method can be found in Heidi ET AL, "An ethical analysis of alternative methods to obtain pluripotent stem cells without destroying embryos, Human Reproduction, Volume 21, Issue 11, Nov 2006, Pages 2749-2755, https://doi.org/10.1093/humrep/de1233.

8. Section 3(b) of the Act of 1970 provides as follows:

3.(b) an invention the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.

9. On a plain reading of the above section, inventions which may violate

public order are excluded under the given section since they are concerns

about threats to environment, public security and physical integrity of

individuals.

10. The impugned order is adequately reasoned and deals with all the

objections. It has been held that the subject invention falls within the

scope of section 3(b) of the Act of 1970 and is not patentable. The entire

case made out in this appeal that the subject invention is only obtained 2025:CHC-OS:273

from biological waste and/or umbilical cord is not borne out from the

specifications and the pleadings which have been filed by the appellants.

In this context, the amended claim filed on behalf of the appellant titled

"Improved methods of producing RPE cells and compositions of RPE cells"

is to provide a method for differentiating RPE cells from human pluripotent

stem cells, such as human embryonic and human induced pluripotent

stem cells which appears from the amended claim does not disclose the

above fact. There is nothing in the amended claims which would support

the contention made by the appellant that stem cells are only to be

extracted from the umbilical cord.

11. On the contrary, the specifications which have been filed in the subject

invention would demonstrate that the present invention provides the

corresponding feature, i.e., by parthenogenesis merely optional and has no

limiting effect on the scope of the method which is used for obtaining the

embryonic stem cells.

12. In this context, the decisions cited on behalf of the appellant are all

distinguishable and inapposite. As stated above the contention on behalf

of the appellant that the stem cells were only to be obtained from the

umbilical cord does not appear from the subject application or the

specifications. The finding in the impugned order that the subject

invention was ethically prohibited is sufficiently reasoned and justifies no

interference.