Fresenius Medical Care Deutschland GmbH v. Controller General of Patents, Designs and Trademarks and Anr

1. The present appeal has been filed against the order of the Respondent dated 27th February, 2020, refusing the grant of the Indian Patent Application No. 7493/DELNP/2012 (hereinafter referred to as the Subject Patent Application) dated 28th August, 2012, having priority date of 2nd March, 2010, in respect of the invention titled “Microvesicles (MVs) derived from adult stem cells for use in the therapeutic treatment of a tumor disease”.

2. The Subject Patent Application is a national phase application of PCT application no. PCT/EP2011/052945 with 20 claims with the independent claims being:

3. The Patent Application was published under Section 11A of the Patents Act, 1970 on 1st January, 2016. The First Examination Report was issued by the Respondent on 28th June, 2017, which was replied to by the Appellant on 27th December, 2017. A new set of amended claims 1-9 were filed by the Appellant along with the reply. The independent claim of the amended set of claim is reproduced below:

the patient, preferably 1-150 micrograms/kg body weight of the patient, even more preferably 3-120 micrograms/kg body weight of the patient.”

5. The Respondent vide order dated 27th February, 2020 (hereinafter referred to as the impugned order), rejected the subject patent application on the following grounds: a) Lack of Novelty u/s 2(1)(j) in claims 1-5 and 8 in view of D[1]. Claims 6 and 7 were considered Novel. b) Lack of Inventive step u/s 2(1)(ja) in view of documents D[1] and D[2]. c) Lack of Sufficiency of Disclosure and Clarity. d) Non-Patentability under Section 3(e). e) Non-Patentability under Section 3(i).

6. The Appellant preferred an appeal against the said decision of the Respondent on 15th October, 2020, before the Intellectual Property Appellate Board, which was then transferred to this Court pursuant to the abolishment of IPAB, on 12th July, 2022.

7. It was submitted by Mr. Anand that the claimed invention has been duly recognized in the corresponding patent applications in China, Europe, Japan, and USA, where the patent has been granted in each of these jurisdictions.

8. Mr. Anand further brought to the attention the set of claims presented before this Court as Auxiliary Set 2 in the written submissions filed in the appeal to overcome the objections as stated in the impugned order and the written submissions by the Respondent. The claim 1 in this auxiliary set also has the element of claim 71 incorporated within it. Accordingly, the Appellant

7. A composition as claimed in claim 6, wherein the cytotoxic and/or eytostatic agents are doxorubicin or vincristine. has proposed to amend the claim 1 in the manner below, while the claim 7 has been deleted: “Claim 1: A pharmaceutical composition for use in the therapeutic treatment of a tumour disease comprising a microvesicle (MV) derived from an adult stem cell, wherein said microvesicle inhibits tumour cell proliferation and/or induces cancer cell apoptosis and one or more cytotoxic and/or cytostatic agents, wherein the cytotoxic and/or cytostatic agents are doxorubicin or vincristine, said composition dose being between 0.[1] to 200 micrograms/kg body weight of the patient, preferably 1-150 micrograms/kg body weight of the patient, even more preferably 3-120 micrograms/kg body weight of the patient.”

9. The Appellant has placed on record amended claims. In view of the stand taken by the Respondent before this Court, the Appellant is proposing to amend Claim 1 to highlight the inventive feature of the invention.

10. Mr. Anand submits that it is a settled position of law that the amendments can be carried out at the appellate stage as well.

11. In Societe Des Produits Nestle SA v. Controller of Patents and Designs and Anr., 2023 SCC OnLine Del 582, I have held that the High Court, while hearing an appeal against a refusal order passed by the Controller, would have the same powers as given to a Controller under Section 15 of the Act, which includes the powers to require amendment. Therefore, the Court is within its power to direct the Appellant to amend the complete specification of the patent application including claims at this stage.

12. The aforesaid observations made in Nestle SA v. Controller of Patents (supra) were also relied on by another Coordinate Bench of this Court in Opentv Inc. v. Controller of Patents, 2023 SCC OnLine Del 2771 wherein it was noted that irrespective of the amendments to the claims or complete specification of a patent application being made at the behest of the applicant or the Court, amendments are allowed at the appellate stage before Court. The relevant paragraph of the said judgment is given below: “54. Thus, amendments having been held to be permissible at the appellate stage, this Court is of the opinion that irrespective of whether the amendment is directed by the Court or is at the instance of Patent Applicant, so long as the requirements as laid down under Section 59 of the Act are fulfilled such that the amended claims are within the scope of original claims, is not breached, the amendment is permissible.” *** “61. Therefore, though there is no embargo on permitting a Patent Applicant to amend claims even at the appellate stage, the amendment sought in this particular case intends to widen the scope of the original claims as filed. It is due to this reason that the same cannot be allowed.”