Delhi High Court Directs Fresh Review of Harvard’s Insulin Cell Patent Application

NEW DELHI – The Delhi High Court has set aside a previous order refusing a patent to Harvard University for its "SC-β cells"—lab-engineered cells designed to produce insulin. The Court found that the Patent Office failed to consider amended claims submitted by the university before the final rejection was issued.

Background of the Dispute
In 2016, the President and Fellows of Harvard College filed a patent application for an invention titled "SC-β Cells and Compositions and Methods for Generating the Same." The technology aims to provide a potential breakthrough in diabetes treatment by using stem cell-derived pancreatic cells.

The Controller of Patents initially rejected the application in August 2022, citing several grounds under the Patents Act, 1970:

• Section 3(j): Which prohibits patents on plants, animals, or parts thereof.
• Section 3(e): Relating to "mere mixtures" that do not involve an inventive step.
• Section 10: Concerns regarding the clarity and sufficiency of the invention's disclosure.

The Court’s Decision
Justice Tejas Karia, presiding over the matter, observed that Harvard had submitted amended claims during the initial proceedings which materially altered the scope of the patent. While the original claims focused on a "composition" containing the cells, the amended claims shifted focus to the non-native pancreatic β cells themselves.

The Court held that the Patent Office committed a fundamental error by failing to evaluate these updated claims. The judgment noted:
"The Impugned Order is hereby set aside, and the matter is remanded back to the learned Controller for fresh consideration... The learned Controller shall pass a detailed order after considering the amended claims within six months."

Key Takeaways

• Procedural Fairness: The ruling reinforces that the Patent Office must evaluate the most recent version of claims submitted by an applicant.
• No Ruling on Merits: The High Court did not decide whether the invention is actually patentable; it merely ordered a "re-do" of the evaluation process.
• Timeline: The Controller of Patents must now provide Harvard with a fresh hearing and issue a reasoned decision by October 2026.

This remand offers Harvard a second chance to argue that their lab-engineered cells are a patentable "man-made" invention rather than a naturally occurring biological part excluded under Indian law.

Discription: The Delhi High Court recently set aside a 2022 order rejecting Harvard University’s patent for "SC-β cells"—lab-engineered cells designed to produce insulin. Justice Tejas Karia ruled that the Patent Office committed a procedural error by ignoring Harvard's amended claims, which shifted focus from a "composition" to the specific non-native cells.

While the Patent Office originally cited exclusions under Sections 3(j) and 3(e) of the Patents Act, the Court emphasized procedural fairness over the merits of the case. The Controller must now conduct a fresh review and pass a reasoned order by October 2026.