The Delhi High Court clarified Section 59(1) of the Patents Act, 1970 in their judgment in The Regents of the University of California Address for service in India Lexorbis vs Controller General of Patents, Designs & Trademarks & Anr. [C.A.(COMM.IPD-PAT) 143/2022].

Section 59(1) of the Patents Act reads as follows.

No amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.

The Appellant’s PCT national phase application number 10336/DELNP/2013, entitled “Blockade of Inflammatory Proteases with Theta Defensins”, covered through claim 1

A method of marketing a drug composition, wherein the drug composition includes a θ-defensin, analog or derivative thereof, the method comprising: determining efficacy of the drug composition with respect to an anti-inflammatory effect in a human; and providing the drug composition to a marketplace to treat a chronic inflammatory condition.

In the first examination report, the subject invention was objected for lack of novelty and inventive step, and for patent ineligibility under Section 3(i) and 3(k) of the Patents Act. To overcome the objections of the Controller and to make the claims more definitive, the Appellant made a first amendment to the claims by incorporating technical features implicitly covered by the dependent claims. Amended claim 1 read as follows:

A method of testing a drug composition intended for treating humans presenting with a chronic inflammatory condition, the method comprising: obtaining a synthetic cyclic tetradecapeptide mini-θ-defensin, receiving evidence that the synthetic tetradecapeptide mini-θ-defensin has a tumor necrosis factor alpha (TNF-α)- converting enzyme (TACE) inhibiting activity in a living cell; and determining efficacy of the synthetic cyclic tetradecapeptide mini-θ-defensin with respect to an anti-inflammatory effect in a model of a chronic inflammatory condition.

The Controller then issued a hearing notice maintaining all the objections that were raised in the first examination report (FER). In response to the hearing notice, the applicant amended the claims a second time, primarily to address the concern of the Controller that the amended claims filed with the reply to FER which related to a method of testing were not within the scope of the original claims that related to a method of marketing. Claim 1 that was refused by the Controller for non-compliance of section 59 of the Patents Act, reads as follows:

A method of marketing a drug composition useful for treating chronic inflammatory conditions, the method comprising: (a) obtaining a synthetic cyclic tetradecapeptide mini-θ-defensin, (b) receiving evidence that the synthetic tetradecapeptide mini-θ-defensin has a tumor necrosis factor alpha (TNF-α)- converting enzyme (TACE) inhibiting activity in a living cell; and (c) determining efficacy of the synthetic cyclic tetradecapeptide mini-θ-defensin with respect to an anti-inflammatory effect in a model of a chronic inflammatory condition wherein said method of marketing does not comprise any steps related with transaction of goods or services.

The Appellant contended that the Controller had erred in their assessment of the amended claims. The amended claims were argued to be within the scope of the original claims and specification, both implicitly and explicitly and were asserted to have been derived by merging features of multiple dependent claims.

It was clarified by the Appellant that the expression “useful for treating chronic inflammatory conditions” in the refused claim was merely descriptive and was part of original claim 1. It was further clarified that the expression “obtaining a synthetic cyclic tetradecapeptide mini-θ-defensin” only clarified that the compound is procured and not manufactured. The Appellant also argued that since explanation is permitted under section 59 introduction of additional words to explain the invention more clearly is permitted.

The Controller tried to justify the refusal based on the reasoning that the expression “method of marketing” was non-specific and therefore, could not be allowed. It was further reasoned that the expressions “obtaining”, “receiving evidence that the synthetic tetradecapeptide mini-θ-defensin has a tumor necrosis alpha (TNF-α)-converting enzyme inhibiting activity in a living cell” and “synthetic tetradecapeptide mini-θ-defensin” in claim 1 were not part of the originally filed claim in view of which the amendments filed by the Appellant did not comply with section 59(1) of the Patents Act.

The Court noted that amendments under Section 59 can be made only by way of disclaimer, correction, or explanation and that the proposed amendments should be tested for the following parameters:

 (i) the amendment should serve the purpose of incorporation of actual facts;

(ii) the amendment should not allow matter not in substance, disclosed originally or shown in the specification; and

(iii) the amended claim should fall within the scope of the original claim.

After a detailed analysis, the Court held that the amendments filed by the Appellant were not outside the purview of Section 59(1) and arrived at the following conclusions:

• The restoration of an amended claim to the original claim is not disallowed under Section 59(1). The Court even noted that as per the summary and examples of the invention, the scope of the claim involved a method of determining the efficacy of the mentioned compound. Therefore, the substitution of the expression “marketing” by “testing” in the first amendment was within the scope of the original claims and the further reversion from “testing” to “marketing” in the second amendment only aided to mirror the claims of the second amendment with the original claims, which was permitted.
• Since dependent claims add further statements, limitations or restrictions in the parent claim, the incorporation of the technical features disclosed in the dependent claims into the independent claim is permitted by Section 59(1).
• The addition of a disclaimer stating information already disclosed in the original claims and specification falls within the scope of Section 59(1).

In view of the foregoing, the Court set aside the impugned order and remanded the matter to the Patent Office for fresh consideration of the claims as amended.