Oramed Ltd. Vs The Controller General of Patents:

Oramed Ltd. Vs The Controller General of Patents:04.07.2025:IPDPTA/8/2022: High Court at Calcutta : Hon’ble Justice Ravi Krishan Kapur

The appeal challenged the order dated 5th June 2020, passed in Patent Application No. 3996/KOLNP/2010, which had refused grant of a patent for Oramed’s oral insulin composition.

The facts of the case revolve around Oramed Ltd.'s invention concerning an oral pharmaceutical composition aimed at administering insulin without injection. The invention comprises a protein (insulin), two protease inhibitors—Aprotinin and SBTI (Soybean Trypsin Inhibitor)—along with optional components like EDTA and Omega-3 fatty acids. The claimed invention addresses the challenges of injectable insulin, such as lipodystrophy, hypoglycemia, and lack of fine metabolic control, and seeks to enable oral insulin delivery by preventing enzymatic breakdown of insulin in the gastrointestinal tract.

The procedural background traces back to Oramed’s patent journey starting from its US priority application filed on 26th March 2008, followed by a PCT application on 26th February 2009, and subsequent national phase entry in India on 25th October 2010. After the request for examination in 2012, a First Examination Report (FER) was issued on 22nd December 2015. Oramed responded and participated in hearings; however, the Deputy Controller of Patents refused the application on 18th April 2017, citing lack of inventive step. The refusal order was challenged in a writ petition before the Calcutta High Court due to the non-functioning of the Intellectual Property Appellate Board (IPAB). On 18th June 2019, the High Court remanded the matter back to the Patent Office for reconsideration. Despite fresh hearings in 2019, the Deputy Controller passed a similar refusal order on 5th June 2020, leading to the present appeal.

The core dispute centers around whether the claimed invention involved an inventive step under Section 2(1)(ja) of the Patents Act and whether the composition was excluded under Section 3(e) as a mere admixture of known substances. The appellant contended that the Deputy Controller failed to consider the expert evidence and scientific data submitted, especially regarding the enhanced bioavailability and surprising synergistic effects of the invention.

The appellant also argued that the Deputy Controller shifted the reasoning without due notice by initially referring to prior arts D1 to D4 in the hearing notice but basing the final decision solely on D1 and D4, ignoring D2 and D3. This deprived the appellant of a fair opportunity to respond.

In its discussion, the Court noted the procedural lapses in the patent office’s order. The Court relied on Guangdong Oppo Mobile Telecommunications Corp. Ltd. vs The Controller of Patents and Designs (Unreported decision dated 13.06.2023, AID No. 20 of 2022), which held that if multiple prior arts are to be combined for assessing obviousness, there must be a common thread linking the claims to those prior arts. 

The mosaicing of prior arts without a clear rationale is impermissible. The Court also cited Enercon (India) Ltd. v. Aloys Wobben (ORA/08/2009/PT/CH, Order No. 123 of 2013, dated 13.06.2013), where it was held that mere existence of individual components in prior art does not automatically lead to a conclusion of obviousness unless a clear and obvious path connects the prior art to the invention.

The Court found that the Deputy Controller failed to consider expert affidavits, including that of Miriam Kidron, who was not only the inventor of the present invention but also the inventor of cited prior art D1. The order also incorrectly applied the principles of Section 3(d) of the Patents Act—relating to therapeutic efficacy—while adjudicating under Section 3(e), which concerns mere admixtures. This conflation of legal provisions was deemed a serious error.

The Court reasoned that the Deputy Controller’s omission of relevant scientific data, failure to consider granted patents in other jurisdictions, and misapplication of statutory provisions vitiated the decision-making process. The impugned order neither reflected a fair assessment of inventive step nor properly addressed the evidence presented.

In its decision, the Court set aside the order dated 5th June 2020 and remanded the matter for fresh consideration by a different Deputy Controller. The Court directed that all materials, including expert affidavits and technical data, be duly considered. The Controller was instructed to furnish detailed reasons for any inferences drawn while adjudicating the matter afresh.