Astellas Institute for Regenerative Medicine appealed against the Assistant Controller of Patents and Designs' order dated March 23, 2022, rejecting their national phase patent application No. 1547/KOLNP/2010 titled "Improved Methods of Producing RPE Cells and Compositions of RPE Cells," which involves a method for differentiating retinal pigment epithelial (RPE) cells from human pluripotent stem cells like embryonic and induced ones for screening and therapeutic uses, on the ground that it falls under Section 3(b) of the Patents Act, 1970, as potentially contrary to morality and prejudicial to human life due to ethical concerns in deriving stem cells from single blastomeres that may harm embryo implantation and survival.
Procedurally, the application was filed, a First Examination Report issued on May 25, 2017, responses and amended claims submitted, hearings conducted with written arguments, and fresh objections under Section 59(1) addressed before the impugned rejection. The appellant contended the method uses pre-established cell lines without new embryo destruction and sources stem cells solely from umbilical cord or biological waste, but the court reasoned that this claim was not borne out from the pleadings, specifications, or amended claims, which do not limit the stem cell source and treat parthenogenesis as optional, rendering the invention ethically challenging as per evidence cited; the impugned order was found adequately reasoned without infirmity, illegality, or perversity, leading to dismissal of the appeal without costs.
- An invention whose primary or intended use or commercial exploitation is contrary to public order or morality or causes serious prejudice to human, animal, or plant life or health or to the environment is not patentable under Section 3(b) of the Patents Act, 1970 [Astellas Institute for Regenerative Medicine vs The Controller of Patents and Designs, IPDAID/41/2024, Para 8].
- Arguments raised in appeal must be supported by the pleadings, amended claims, and specifications filed with the patent application; contentions introduced for the first time from the bar, such as limiting stem cell sources to umbilical cord, cannot be entertained if not reflected in the application documents [Astellas Institute for Regenerative Medicine vs The Controller of Patents and Designs, IPDAID/41/2024, Paras 5, 10].
- Rejection of a patent on ethical grounds under Section 3(b) is justified if the order is reasoned, considers all submissions, and relies on evidence showing the invention's process is ethically challenging and not embryo-saving, such as potential detrimental effects on embryo survival [Astellas Institute for Regenerative Medicine vs The Controller of Patents and Designs, IPDAID/41/2024, Paras 7, 12].
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