Delhi High Court directs re-examination of Harvard’s patent application on lab-engineered insulin cells

The Delhi High Court recently set aside a 2022 order that refused a patent to the President and Fellows of Harvard College for their invention of "SC-β cells", which are specialised, lab-engineered cells designed to produce insulin [President & Fellows of Harvard College Vs Controller of Patent].

Justice Tejas Karia ruled that the Patent Office committed a glaring error by failing to consider amended claims submitted by the University during the original proceedings.

"The Impugned Order is hereby set aside, and the matter is remanded back to the learned Controller for fresh consideration of the Subject Application in view of the amended claims submitted along with post-hearing Written Submissions. This learned Controller shall pass a detailed order on the Subject Application after considering the amended Claims within six months from the date of communication of this Judgment after giving opportunity of hearing to the Appellant (Harvard)," the Court said.

Harvard had filed the patent application in 2016 for an invention titled “SC-β Cells and Compositions and Methods for Generating the Same,” relating to stem cell-derived pancreatic β cells for potential use in diabetes treatment.

The application went through examination, following which the Patent Office issued objections relating to lack of clarity, insufficient disclosure and non-patentability. After a hearing in 2021, Harvard filed written submissions along with amended claims.

However, by an order dated August 25, 2022, the Controller refused the application on the ground that it did not satisfy the requirements under the Patent Act's Section 3(j) (no patents for plants/animals or their parts), Section 3(e) (mere mixtures are not patentable), 10(4) (invention must be fully explained) and Section 10(5) (claims must be clear).

Before the High Court, Harvard argued that its amended claims materially changed the scope of the invention. While the original claims were directed at a composition containing such cells, the amended claims focused on the non-native pancreatic β cells themselves.

The Court accepted this contention and found that the Controller had proceeded only on the basis of the original claims, without evaluating the amended claims at all.

It held that this was a fundamental error, as the nature of the invention, and the objections to it could change once the claims were amended.

Accordingly, the Court set aside the refusal order and directed the Controller to reconsider the application afresh, after giving Harvard an opportunity of hearing, and to pass a reasoned order within six months.

The Court clarified that it had not examined the merits of the invention and left all issues open.

Harvard was represented by Advocates Satyapal Arora, Ashish Sharma, Kuldeep Kumar Singh and Nitin Sharma.

The Indian patent authorities was represented by Advocates Balendu Shekhar (CGSC), Krishna Chaitanya, Rajkumar Maurya, Divyansh Singh Dev and Tanisha Samanta.

[Read Judgment]