Delhi High Court Sets Aside Order Refusing Patent For Harvard's Insulin-Producing Pancreatic Cells

The Delhi High Court has set aside an order by the Controller General of Patents that refused a patent to Harvard College for its stem-cell-derived insulin-producing pancreatic cells used for diabetes treatment. 

Justice Tejas Karia held that the Patent Office committed an error by failing to consider the university's amended claims, which had significantly altered the nature of the application.

Harvard had filed an appeal under Section 117 of the Patents Act against the Controller General of Patents, Designs and Trademarks to challenge the August 25, 2022, order that refused its patent application for stem-cell-derived pancreatic cells.

The appeal sought to reverse the refusal, which was predicated on statutory exclusions for natural biological parts and insufficient disclosure, by claiming that its "non-native" SC-β cells are novel, man-made constructs resulting from deliberate human technical intervention rather than essentially biological processes.

To substantiate this, the university argued that the Controller committed a glaring error by failing to adjudicate its amended claims, which transitioned the application from a broad composition claim to a specific cell type that exhibits distinct genetic and functional characteristics not found in nature.

In its appeal, the College contended that its SC-β cells are novel, inventive, and do not occur in nature. They submitted that these non-native cells are "structurally, functionally, and genetically distinct from native β cells" and involve technical human intervention that differentiates them from mere products of nature.

On the other hand, the Controller told the court that the claimed cells fall squarely within the statutory bar under Section 3(j) of the Patents Act, which prohibits patents on “plants and animals in whole or any part thereof.”

The Controller maintained that even though the cells are cultured in a laboratory, they do not lose their essential character and continue to remain natural derivatives of natural origin.

Looking at the record, the court noted that the impugned order was largely founded on the original claims, with little to no engagement with the alternative set of claims that had been filed along with the post-hearing submissions.

The bench noted that the entire basis of the refusal may undergo change once the Patent Office examines the transition from a composition to the specific cell type.

Consequently, the court ordered that the “amended claims that significantly alter the original claims transitioning from a composition to a non-native pancreatic β cell must be duly considered by the learned Controller independently without being influenced from prior conclusions regarding the original claims in the Impugned Order.”

The court accordingly set aside the order dated August 25, 2022, and remanded the matter to the Patent Office for fresh consideration.

The controller is directed to pass a detailed order within six months after providing Harvard College an opportunity for a fresh hearing.