The Regents Of The University Of California vs Controller General Of Patents, Designs &Trademarks & Anr.

Anish Dayal, J.

This appeal under Section 117A of the Patents Act, 1970 (“the Act”) assails order dated 18^th February, 2021 passed by the Assistant Controller of Patents and Designs (“respondent No.2”) in Patent Application No.10336/DELNP/2013 dated 29^th November, 2013 (“impugned order”). By the said impugned order, the patent application of the appellant was rejected primarily under Section 15 read with Section 59(1) of the Act. The background facts are as under:-

Subject application at the time of National Phase entry in India was filed with 33 claims of which Claims No. 1 and 24 were independent claims, Claims No. 2 to 23 were dependent on Claim No. 1, and Claims No. 25 to 33 were dependent on Claim No. 24.

The claims of subject application were then amended while filing reply to FER on October 31, 2019 (“first amendment”), wherein preamble of Claim 1 was restricted by substituting expression “marketing” with “testing”. Collectively technical features disclosed in Claims No. 5, 6, 8, 9, 15, 16, 24 and 28 were incorporated into Claim 1 to address objections related with clarity, conciseness, definitiveness. Further, Claims No. 3-6, 8, 9, 11-13, 15, 16, 18-22, and 24-33 were cancelled.

The claims of subject application were further amended by the applicant at the time of filing written submission post-hearing held on August 10, 2020 (“second amendment”). The applicant amended the claims in view of the primary objection in the hearing notice raised under Section 59 (1) of the Act. The applicant restored the preamble of Claim 1 by retaining the original expression “marketing” to address the objection raised on account of substituting the expression “marketing” with “testing” in the first amendment. Collectively, technical features disclosed in Claims No. 5, 6, 8, 9, 15, 16, 24 and 28 were incorporated into Claim No. 1 to address objections related to clarity, conciseness, definiteness (same as in first amendment). Claim No. 1 was also appended with a disclaimer- “wherein said method of marketing does not comprise any steps related with transaction of goods or services and wherein said method is restricted to evaluating synthetic cyclic tetradecapeptide mini-θ-defensins for their potential to treat chronic inflammatory condition” for imparting clarity on non-applicability of Section 3(k) of the Act. Claims No. 3-6, 8, 9, 11-13, 15, 16, and 18-33 have been cancelled.

The appellant provided a table for comparing the claims filed through the entire prosecution (the original claim, the first amendment and the second amendment) which is as under:-

(Claim 10) The method of claim 1, wherein the anti-inflammatory effect comprises clinically relevant inhibition of a sheddase.(Claim 104) The method of as claimed in any of the preceding claims 1-3, wherein the anti-inflammatory effect comprises clinically relevant inhibition of a sheddase or of Cathepsin-C.(Claim 104) The method of as claimed in any of the claims 1-3, wherein the anti-inflammatory effect comprises clinically relevant inhibition of a sheddase or of Cathepsin-C. (Claim 11) The method of claim 1, wherein the anti-inflammatory effect comprises clinically relevant inhibition of Cathepsin-C.(Claim 11) The method of claim 1, wherein the anti-inflammatory effect comprises clinically relevant inhibition of Cathepsin-C.(Claim 11) The method of claim 1, wherein the anti-inflammatory effect comprises clinically relevant inhibition of Cathepsin-C. (Claim 12) The method of claim 1, wherein the step of providing the drug composition to the marketplace comprises producing for sale at least one kilogram of the drug composition.(Claim 12) The method of claim 1, wherein the step of providing the drug composition to the marketplace comprises producing for sale at least one kilogram of the drug composition.(Claim 12) The method of claim 1, wherein the step of providing the drug composition to the marketplace comprises producing for sale at least one kilogram of the drug composition. (Claim 13) The method of claim 12, wherein the step of producing comprises manufacturing the at least one kilogram of the drug composition.(Claim 13) The method of claim 12, wherein the step of producing comprises manufacturing the at least one kilogram of the drug composition.(Claim 13) The method of claim 12, wherein the step of producing comprises manufacturing the at least one kilogram of the drug composition. (Claim 14) The method of claim 1, further comprising packaging the drug composition in an oral formulation.(Claim 14 5) The method of as claimed in any of the preceding claims 1-4, further comprising packaging wherein the drug composition in(Claim 14 5) The method of as claimed in any of the claims 1-4, further comprising packaging wherein the drug composition in comprises an oral formulation. comprises an oral formulation. (Claim 15) The method of claim 1, wherein the inflammatory condition is a proteolytic-mediated disease.(Claim 15) The method of claim 1, wherein the inflammatory condition is a proteolytic-mediated disease.(Claim 15) The method of claim 1, wherein the inflammatory condition is a proteolytic-mediated disease. (Claim 16) The method of claim 1, wherein the inflammatory condition comprises rheumatoid arthritis.(Claim 16) The method of claim 1, wherein the inflammatory condition comprises rheumatoid arthritis.(Claim 16) The method of claim 1, wherein the inflammatory condition comprises rheumatoid arthritis. (Claim 17) The method of claim 1, wherein the inflammatory condition comprises an autoimmune disease.(Claim 17 6) The method of as claimed in any of the preceding claims 1-5, wherein the chronic inflammatory condition is selected from the group consisting of comprises an autoimmune disease, proteolytic mediated disease, and rheumatoid arthritis.(Claim 17 6) The method of as claimed in any of the claims 1-5, wherein the chronic inflammatory condition is selected from the group consisting of comprises an autoimmune disease proteolytic mediated disease, and rheumatoid arthritis and wherein the chronic inflammatory condition is associated with cancer, a neurodegenerative disease, an inflammatory bowel disease, Alzheimer's disease, osteoarthritis, or to treat persons who are non-responders to an anti-TNF-α treatment. (Claim 18) The method of claim 1, further comprising marketing the drug composition as a treatment for a cancer.(Claim 18) The method of claim 1, further comprising marketing the drug composition as a treatment for a cancer.(Claim 18) The method of claim 1, further comprising marketing the drug composition as a treatment for a cancer. (Claim 19) The method of claim 1, further comprising marketing the drug composition as a treatment for a neurodegenerative disease.(Claim 19) The method of claim 1, further comprising marketing the drug composition as a treatment for a neurodegenerative disease.(Claim 19) The method of claim 1, further comprising marketing the drug composition as a treatment for a neurodegenerative disease. (Claim 20) The method of claim 1, further comprising marketing the drug composition as a treatment for an inflammatory bowel disease.(Claim 20) The method of claim 1, further comprising marketing the drug composition as a treatment for an inflammatory bowel disease.(Claim 20) The method of claim 1, further comprising marketing the drug composition as a treatment for an inflammatory bowel disease. (Claim 21) The method of claim 1, further comprising marketing the drug composition as a treatment for Alzheimer's disease.(Claim 21) The method of claim 1, further comprising marketing the drug composition as a treatment for Alzheimer's disease.(Claim 21) The method of claim 1, further comprising marketing the drug composition as a treatment for Alzheimer's disease. (Claim 22) The method of claim 1, further comprising marketing the drug composition as a treatment for osteoarthritis.(Claim 22) The method of claim 1, further comprising marketing the drug composition as a treatment for osteoarthritis.(Claim 22) The method of claim 1, further comprising marketing the drug composition as a treatment for osteoarthritis. (Claim 23) The method of claim 1, further comprising marketing the drug composition to treat(Claim 23 7) The method of as claimed in any of the preceding claims 1-6, wherein the chronic(Claim 23) The method of claim 1, further comprising marketing the drug composition to treat persons who are non-responders to an anti-TNF-α treatment.inflammatory condition is associated with cancer, a neurodegenerative disease, an inflammatory bowel disease, Alzheimer's disease, osteoarthritis, or further comprising marketing the drug composition to treat persons who are non-responders to an anti-TNF-α treatment.persons who are non-responders to an anti-TNF-α treatment. (Claim 8) A 0-defensin or analog thereof as and when used in treatment of a chronic inflammatory condition in an animal. (Claim 24) A method of manufacturing a medicament for administration to an animal to treat an inflammatory condition, wherein the medicament includes at least one of a 0-defensin, analog or derivative thereof.(Claim 24) A method of manufacturing a medicament for administration to an animal to treat an inflammatory condition, wherein the medicament includes at least one of a 0-defensin, analog or derivative thereof.(Claim 24) A method of manufacturing a medicament for administration to an animal to treat an inflammatory condition, wherein the medicament includes at least one of a 0-defensin, analog or derivative thereof. (Claim 25) The method of claim 24, wherein the medicament includes at least one of RTD-1-27, RTD-1-28 and RTD-1-29.(Claim 25) The method of claim 24, wherein the medicament includes at least one of RTD-1-27, RTD-1-28 and RTD-1-29.(Claim 25) The method of claim 24, wherein the medicament includes at least one of RTD-1-27, RTD-1-28 and RTD-1-29. (Claim 26) The method of claim 24, wherein the(Claim 26) The method of claim 24, wherein the(Claim 26) The method of claim 24, wherein the medicament is effective to produce a clinically relevant inhibition of a proinflammatory protease.medicament is effective to produce a clinically relevant inhibition of a proinflammatory protease.medicament is effective to produce a clinically relevant inhibition of a proinflammatory protease. (Claim 27) The method of claim 26, wherein the proinflammatory protease is tumor necrosis factor alpha (TNF-a)-converting enzyme (TACE).(Claim 27) The method of claim 26, wherein the proinflammatory protease is tumor necrosis factor alpha (TNF-a)-converting enzyme (TACE).(Claim 27) The method of claim 26, wherein the proinflammatory protease is tumor necrosis factor alpha (TNF-a)-converting enzyme (TACE). (Claim 28) The method of claim 24, wherein the medicament is effective to produce a clinically relevant inhibition of a proinflammatory protease.(Claim 28) The method of claim 24, wherein the medicament is effective to produce a clinically relevant inhibition of a proinflammatory protease.(Claim 28) The method of claim 24, wherein the medicament is effective to produce a clinically relevant inhibition of a proinflammatory protease. (Claim 29) The method of claim 24, wherein the medicament is effective to produce a clinically relevant inhibition of a sheddase.(Claim 29) The method of claim 24, wherein the medicament is effective to produce a clinically relevant inhibition of a sheddase.(Claim 29) The method of claim 24, wherein the medicament is effective to produce a clinically relevant inhibition of a sheddase. (Claim 30) The method of claim 24, wherein the inflammatory condition comprises rheumatoid arthritis.(Claim 30) The method of claim 24, wherein the inflammatory condition comprises rheumatoid arthritis.(Claim 30) The method of claim 24, wherein the inflammatory condition comprises rheumatoid arthritis. (Claim 31) The method of claim 24, wherein the inflammatory(Claim 31) The method of claim 24, wherein the inflammatory(Claim 31) The method of claim 24, wherein the inflammatory

Appellant’s counsel submitted that the impugned order passed by respondent No.2 was arbitrary and arose out of a wrong and incorrect interpretation of the provisions of Section 59(1) of the Act, inter alia on the following grounds:-

In the context of the submissions, the appellant focused essentially on following aspects of the amendment of claims:-

Mr. Harish Vaidyanathan Shankar, CGSC appearing for the Controller General of Patents, Designs and Trademarks submitted in support of the impugned order firstly, reference in the claims to “a method of marketing” was non-specific and could not have been acceptable; secondly, use of the word “obtaining” as part of para (a) of Claim No.1 did not emanate from the original claim and, therefore, could not be allowed under Section 59(1) of the Act; thirdly, para (b) of Claim No.1 which reads as “ receiving evidence that the synthetic tetradecapeptide mini-θ-defensin has a tumour necrosis factor alpha (TNF-α)-converting enzyme (TACE) inhibiting activity in a living cell” added additional specification which was not found in the initially filed claim; fourthly, the expression “synthetic cyclic tetradecapeptide mini--defensins” in para (c) of Claim No.1 was also beyond the scope of the initially filed claim. Thus, he justified the reasoning in the impugned order which is extracted as under:

Although Applicant is saying that features of dependent claims 5, 6, 8, 9, 15, 16, 24 and 28 have been incorporated into principal claim 1, however same is not the case. Although the preamble of claims is same, however the steps (a), (b) and (c) as incorporated in amended claim 1 are not disclosed in the originally filed claims and also are not as such disclosed anywhere in specification. As the scope of amended claims are beyond the scope of claims as originally filed and also it describes matter not in substance disclosed or shown in the specification, thus the amendments cannot be allowed u/s 59(1) of the Act.”

(emphasis added)

Since the controversy revolves around acceptance of refusal of amendment of claims under Section 59 (1) of the Act, it would be useful first to extract the provision for ease of reference:

It is, therefore, evident that amendments to the original application can be made only by way of the following:-

What needs to be, therefore, assessed is whether the Controller was correct in its assessment of the amended claims on these six benchmarks and parameters. For this purpose, the Court must systematically assess the amendments, in particular, amendments to Claim No.1, whether they fall within the rubric of Section 59(1) of the Act or not.

Firstly, reference to “method of marketing” may not, in the opinion of this Court, non-suit the patent applicant considering that the expression used in original Claim No.1 was “method of marketing a drug composition”, which was changed to “method of testing a drug composition” when the amended claims were filed with reply to the FER. However, this was subsequently reverted to the expression “method of marketing a drug composition” in the second amendment filed with the written submission. Therefore, in essence, the appellant was merely reverting to the original expression used in the original claims and not outside the scope of the original claims, but quite within it and mirroring the same. In any event, the appellant provided a sufficient explanation for why the expression was changed from “marketing” to “testing” in the first amendment. Since an objection was raised in response to the FER, the appellant in its reply to the FER amended Claim No.1 to revise the preamble to “a method of testing a drug composition”. The basis was to be found, inter alia, in para [0010] which discloses that the aim of the invention is a medicament that treats inflammatory and inflammation related condition and methods of the same, and in para [0012] which discloses that invention involves toxicity, efficacy and dose response studies and determining efficacy of the drug composition. It was, therefore, clear that the scope of the claim involved the method of determining the efficacy of the said compound.

However, pursuant to the clarification provided in the first amendment, the expression was changed back to “marketing”, in response to the hearing notice. In para 1 of “Other Requirements” of the hearing notice the following was stated by respondent No.2 - “As filed claims 1-23 for instant application were directed to “method of marketing a drug composition” and claims 24-33 to “method of manufacturing a medicament …” respectively. After amendment new claims have been filed wherein claims 1-7 are directed to “A method of testing a drug composition”…” This objection being taken in the hearing notice, the appellant, therefore, in order to address this suitably and out of abundant caution, reverted back to the original expression “method of marketing a drug composition”. Even at this stage, there was no doubt that the claim related to testing the inhibitory effect of TACE (Tumour Necrosis Factor Alpha Converting Enzyme). For this purpose, it would be useful to extract relevant portions of the specification along with Example 5 as under:-

In the opinion of this Court, therefore, the use of the expression “method of marketing” was clearly mirroring the original claim and, therefore, could not be considered, in any manner whatsoever, to be outside the scope and purview of Section 59(1) of the Act.

Secondly, as regards objection taken qua para (a), (b) and (c) of Claim No.1 being not reflected in the original claim, it is quite clear that the same detail was provided in the dependent claims in particular Claim Nos.7 and 8 which are extracted as under:-

A perusal of Claim No. 7 would bear out that the method of Claim No.1 was to measure the anti-inflammatory effect of a pro-inflammatory protease, which in turn was further clarified in dependent Claim No.8 as being TACE [Tumour Necrosis Factor Alpha (TNF- α) Converting Enzyme].

As regards dependent claims and their scope, reference may be made to a decision by a Division Bench of this Court in F. Hoffmann-La Roche Ltd. v. Cipla Ltd. 2015 SCC OnLine Del 13619, relevant portion of which is extracted as under:

Thirdly, as regards objection to the phrase “obtain” by the respondent, it was usefully clarified by the counsel for the appellant, that it was not meant to state that they would be manufacturing the same but was only meant in terms of procuring the said compound from existing sources and finally testing the same.

Succinctly stated, para (a), (b) and (c) of the amended Claim No. 1, in other words claim that firstly, the compound (synthetic cyclic tetradecapeptide mini--defensins) would be procured; secondly, the said compound had a TACE inhibiting activity in a living cell and evidence of the same would be obtained; and thirdly, is to determine the efficacy of the said compound with respect to the anti-inflammatory effect in a chronic inflammatory condition. It was further clarified in para (c) of Claim No.1 that “the said method of marketing” does not comprise any steps related with transaction of goods or services and said method is restricted to evaluating “synthetic cyclic tetradecapeptide mini--defensins” for their potential to treat chronic inflammatory condition.

These aspects already formed part of the original claims and specifications in that the composition was explained in Example 5, the pro-inflammatory protease TACE formed part of the dependent Claim No.8, and the issue of the anti-inflammatory effect was stated in dependent Claim No.7.

Moreover, substantial part of para (c) was already part of Claim No.1 in terms of the process of “determining efficacy of the composition” with respect to an anti-inflammatory effect in a human. The explanation for “marketing” is also quite sufficiently provided in the expression used in original Claim No.1 “providing the drug composition to a marketplace to treat a chronic inflammatory condition”.

Thus, in the opinion of this Court, the amendments serve only as an explanation to the original claims, amount to incorporation of actual facts, and do not disclose any matter which was not originally disclosed in the claims of specification filed before the amendment. Therefore, the impugned order would not be sustainable in that it seeks to disallow the amendments carried out on 10^th August, 2020 under Section 59(1) of the Act. The specific observation in the impugned order that para (a), (b) and (c) as incorporated in the amended claim No.1 “are not disclosed in the originally filed claims and are also not disclosed anywhere in specification” is not an accurate analysis nor a correct conclusion by respondent No.2, in view of what has been detailed above.

Therefore, the impugned order is set aside, the appeal is allowed, and the Patent Application of the appellant is remanded back for fresh consideration of the claims as amended, to be assessed on their own merits.

Subject Patent Application of the appellant shall now be examined afresh along with the amendment. Considering that time has already lapsed since filing of the present Patent Application, it is directed that the application shall be examined within three months from the date of the receipt of the order. A hearing would be provided to the appellant within the said period.

Registry is directed to supply a copy of the order to the Office of the Controller General of Patents, Designs and Trademarks of India on the email [email protected] for compliance.

The Office of the CGSC may also communicate the order to the Office of the Controller General of Patents, Designs and Trade Marks, for compliance.

Judgment be uploaded on the website of this Court.