IN THE HIGH COURT AT CALCUTTA ORIGINAL SIDE (Intellectual Property Rights Division) BEFORE: The Hon’ble Justice Ravi Krishan Kapur IPDPTA/8/2022 ORAMED LTD. (OA/14/2020/PT/KOL) VERSUS THE CONTROLLER GENERAL OF PATENTS AND DESIGNS & ANR. For the appellant : Mr. Subhatosh Majumdar, Advocate Mr. K. K. Pandey, Advocate Ms.Mitul Dasgupta, Advocate Ms. Pooja Sett, Advocate Mr. Teeshan Das, Advocate Ms. Mallika Bothra, Advocate For the Controller : Mr. Indrajeet Dasgupta, Advocate Ms. Priti Jain, Advocate Reserved on : 26.06.2025 Judgment on : 04.07.2025 Ravi Krishan Kapur J. 1. This is an appeal under section 117A of the Patents Act, 1970 against an order dated 5 June, 2020 passed in Patent Application No. 3996/KOLNP/2010. 2. Briefly, the invention is an oral pharmaceutical composition comprising of a protein (insulin) of molecular weight up to 100,000 Doltons, a first protease inhibitor and a second protease inhibitor and each of the protease inhibitors inhibits trypsin (thus preventing protein breakdown). The composition further optionally comprises of EDTA (Ethylene diamine 2 tetracaetaic acid) or a salt thereof (such as Na-EDTA), and an Omega-3 fatty acid. 3. Presently, the only route of insulin administration is injection. It is contended that daily injection of insulin has side effects such as lipodystrophy at the site of the injection, lipatrophy, lipohypertrophy and occasional hypoglycaemia. In addition, subcutaneous administration of insulin does not typically provide the fine continuous regulation of metabolism which normally occurs when insulin is secreted from the pancreas directly into the liver via the portal vein. The invention is aimed towards addressing the need for an alternate solution for administration of protein. The technical advancement which the invention seeks to achieve is due to the use of two the protease inhibitors Aprotinin and SBTI. The beneficial properties of the composition is in that substantial amount of insulin administered orally retains its activity after absorption. 4. For convenience, the relevant dates culminating in the filing of this appeal are as follows: DATES EVENTS March 26, 2008 Patent application filed in the United States of America being Patent Application Number 61/064,779 for grant of patent in respect of “Methods and Compositions for oral administration of proteins for treatment of diabetes”. February 26, 2009 International Application filed under the Patent Cooperation Treaty (PCT) serialized as PCT/IL2009/000223 October Patent application being No. 3999/KOLNO/2010 filed at the Patent office 3 25, 2010 as national Phase Entry in India from PCT/IL2009/000223 claiming priority of application filed in USA 61/064,779 dated 26/03/2008 January 7, 2011 Application published (Pre grant publication) March 12, 2012 Request for examination filed and allotted the examination request serial number RQ No. 1104/RQ-KOL 2012 December 22, 2025 First examination report (FER) being a substantive examination report issued by Patent office November 14, 2016 Reply to the First Examination Report filed December 28, 2016 Hearing notice issued January 18, 2017 Matter heard by the Deputy Controller February 2, 2017 Written notes of Arguments submitted April 18, 2017 Order passed by the Deputy Controller of Patents u/s 15 of the patents Act refusing the application February 27, 2019 The order dated 18.04.2017 received by the appellant’s agent under covering letter of Patent Office dated 25.02.2019 May 22, 2019 Writ Petition filed t the Calcutta High Court against the order dated April 18, 2017 of the Deputy Controller of Patents since as the IPAB was not functioning with appropriate quorum for hearing Patent matters. May 25, 2019 Appeal filed at the IPAB simultaneously as a matter of abundant caution, which was later withdrawn pursuant to the order of the Hon’ble Calcutta High Court June 18, 2019 Order passed the Hon’ble Calcutta High Court in Writ Petition No. WP No. 9575(W) of 2019 remanding the matter back to Patents Office for fresh hearing 4 September 25, 2019 Hearing notice issued by the Patents Office for fresh hearing on November November 20, 2019 Matter heard afresh by the Deputy Controller of Patents December 19, 2019 Fresh Written notes of arguments submitted at the Patents Office June 5, 2020 Impugned order passed by the Deputy Controller after hearing the matter afresh June 5, 2020 Order received by the appellant’s agent. 5. As mentioned above, the appellant had filed a prior writ petition, being WP/9575/2019 wherein by an order dated 18th April, 2017 matter was remanded to the Patents Office for fresh hearing with certain directions. 6. It is contended on behalf of the appellant that there are glaring infirmities in the impugned order. In particular, though the hearing notice referred to a combination of prior arts namely, D1 to D4 in determining lack of inventive steps, nevertheless, in the impugned order, the Deputy Controller has only relied on documents D1 and D4. Such a change of view of the Deputy Controller was without any notice or opportunity to the appellant. The arbitrary omission of the prior arts D2 and D3 in the impugned order is as fatal inasmuch as the same was without notice to the appellant. 7. It is also contended that the Deputy Controller has neither referred nor dealt with the data with reference to the figures and specifications which has been furnished by the appellant in their submissions. Such scientific 5 and technical data supported the technical advancement of the invention and has not even been referred to in the impugned order although the same were filed and fully elaborated upon. It is also contended that there is no reference to the expert evidence in the impugned order which dealt with both inventive steps and synergistic activities necessary in determining the patentability of the invention. In such circumstances, the impugned order is liable to be set aside and the matter be remanded to a different Deputy Controller. 8. On behalf of the respondent authorities, it is fairly submitted that the impugned order does not deal with the expert evidence or the scientific technical materials which had been furnished by the appellant. In particular, the expert evidence of Miriam Kidron has been ignored in the impugned order. 9. Admittedly, the Hearing Notice referred to prior arts i.e. D1 to D4. However, the impugned order concludes that the invention lacked inventive steps only on the basis of the prior arts D1 and D4 and ignores D2 and D3. Any such change ought to have been made known to the appellant and an opportunity ought to have been provided to the appellant to contest the new combination of documents D1 and D4 alone. The different combination of documents relied on in the impugned order would entirely change the case of obviousness which is to be answered by the appellant. In Guangdong Oppo Mobile Telecommunications Corp., Ltd. vs The Controller of Patents and Designs (Unreported decision dated 13.06.2023 in AID No. 20 of 2022) this Court had held as follows: 6 “.............If several prior art documents are to be read in combination; there must be some common thread linking the claim with the prior art documents obvious to a person skilled in the art. It must be shown that the skilled person when faced with the claim would turn to some other citation to supplement the claim. Otherwise, the combined reading of the prior art documents or mosaicing of the same is impermissible.” 10. In Enercon (India) Limited v. Aloys Wobben (ORA/08/2009/PT/CH) Order No.123 of 2013 dated 13 June 2013, it has been held as follows: 43. The mere existence in the prior arts, of each of the elements in the invention, will not ipso facto mean obviousness. For after all most inventions are built with prior known puzzle-pieces. There must be a coherent thread leading from the prior arts to the invention, the tracing of the thread must be an act which follows obviously. We must apply this reasoning to test if indeed it is obvious, or if it seems to us to be obvious to the person skilled in the art because of what we know now. If it is the latter, it is hindsight deduction and is not acceptable, but if it is the former, then the patent must go.” 11. In such circumstances, the decision to exclude of documents D2 and D3 is arbitrary, unjustified and without basis. Any common thread linking the claim with D1 and D4 and the decision to exclude D2 and D3 has not even been discussed in the impugned order. 12. In determining inventive steps, the Deputy Controller has also not referred to nor dealt with the data with reference to the figures in the specification submitted alongwith the Written Submissions. On the contrary, the Deputy Controller has proceeded to find components in the prior arts ignoring the actual technical advancement achieved by the present invention as a whole. There is also no reference to the expert 7 affidavit in the impugned order, though the same highlighted both inventive step and synergistic activity in dealing with section 3(e) of the Act. Rather, the Deputy Controller while recording the submissions of the appellant selectively and arbitrarily chose to omit portions of the same including the expert evidence of Miriam Kidron who was not only the inventor of the invention in hand but also of the cited document D1 and highlighted the surprising effects of the invention. 13. Significantly, the order of this Court dated June 19, 2019 passed in the Writ Petition No. WP (9575) of 2019 had directed the respondent to take into consideration all materials made available and filed by the appellant in deciding the application which has been ignored in passing the impugned order. On the aspect of inventive step, as well as section 3(e), the Deputy Controller has regarded pharmaceutically acceptable pH lowering agent or protease inhibitor to be present in a manner as if these in combination amount to two protease inhibitors. On that basis, the Deputy Controller held that D4 teaches the use of two protease inhibitors. The above premise is based on an erroneous interpretation of D4. D4 does not mention the presence of double or multiple protease inhibitors. Thus, the Deputy Controller erred in its finding that D4 teaches two protease inhibitors. In view of the above, the conclusion of obviousness cannot be supported. 14. The finding of the Deputy Controller that bioavailability alone does not establish synergism and requires therapeutic efficacy for the purpose of section 3(e) is incorrect and is based on a misconception of the provisions. While the latter is a criteria for adjudication under section 8 3(d) of the Act, it is wholly irrelevant for the purposes of interpreting section 3(e) of the Act. The impugned order proceeds on the basis of section 3(d) of the Act while considering the application for grant of patent. On the contrary, the hearing notice was under section 3(e) read with section 2(1)(ja) of the Act. This is a serious flaw in the impugned order inasmuch as it brings elements of section 3(d) inter-alia enhancement of therapeutic efficacy as well as bioavailability which are wholly irrelevant and immaterial insofar as section 3(e) of the Act is concerned. 15. In passing the impugned order, the Deputy Controller has also failed to appreciate that section 3(e) is only applicable if there is an admixtures of two or more substances resulting in the additive effect of the inherent properties of each of the substances. In this regard, the Deputy Controller failed to consider the description of the invention alongwith its specification as well as the affidavit of the expert, which recommended that the bioavailability of the composition was greatly enhanced, and such composition is peculiar having regard to the inherent properties of the individual components of the invention. In fact, there is sufficient guidance to be found in the Patent Office Manual with regard to the scope and applicability of sections 3(d) and 3(e) of the Act (Clauses 09.03.05.04 and 09.03.05.05 of the Patent Manual of Version 3.0 dated November 26, 2019) which has been disregarded in passing the impugned order. 16. The fact that the invention had been granted in other jurisdiction details whereof had been adduced by the appellant in the filings before the 9 Deputy Controller has also not been discussed in the impugned order. Significantly, each of the prior arts singularly and in combination were the subject matter of those proceedings. Despite the same being on record and relied on by the appellant, the same were ignored in passing the impugned order. 17. In view of the above, the following directions are passed: 1. The impugned order dated June 5, 2020, is set aside and the matter is remanded back for fresh consideration by a different officer. 2. The Controller is directed to consider all the documents including the expert affidavit with reference to the data provided in the specifications and the results thereof, while considering the application afresh. 3. The Controller is also directed to furnish reasons on the inferences drawn in arriving at any conclusion while adjudicating the issue of patentability. 18. With the above directions, IPDPTA/8/2022 stands disposed of. (RAVI KRISHAN KAPUR, J.)