ALLERGAN INC v. The Controller of Patents – Section 59(1) Clarification by the Delhi High Court


The Indian Patents Act, 1970 (the Act) allows an applicant for a Patent or a Patentee to make amendments in the application for the Patent or the complete specification, or any document related thereto, both before the grant and after the grant of the patent in view of Section 59(1) of the Act. Section 59(1) allows amendment by way of disclaimer, correction or explanation for incorporating facts. However, there is a wide variety of interpretations of this Section among the Indian Controllers regarding the permissible scope of claim amendments prior to the grant. This Article discusses the present scenario of pre-grant claim amendments in India in light of the recent judgment of the Delhi High Court in the matter of ALLERGAN INC v. The Controller of Patents [1].

Facts of the Case

The Appellant filed a national phase patent application in India, seeking protection for “Intracameral Sustained Release Therapeutic Agent Implants”. The claims were drafted in a “method of treatment” format. However, the method of treatment claims were characterized by the steps of the method along with disclosure of the composition of intracameral implant used in the treatment.

In the First Examination Report (FER), the Controller objected to the claims and held that the “Claims in the patent application were not patentable as they related to the method of treatment of human beings/animals, in respect of which Section 3(i) of the Patents Act, 1970 forbore grant of patent .” The Appellant filed a response along with an amended set of claims claiming the intracameral implants rather than a method of treatment.

In the hearing notice, the Controller objected that the amended claims are not allowable under Section 59(1) of the Patents Act for lacking support of the composition claims in the originally filed claims and “”intracameral implants” has not been claimed either in WIPO (International) claims or while entering in the national phase.” In response, the Appellant proposed amending the claims, from ‘method of treatment’ format to ‘composition’ claims to render the claims patentable, clearer and more definite. The Appellant submitted that the amended claims were in complete compliance with the provisions of Section 59(1) of the Act.

However, the Controller of Patents rejected the patent application on the ground that the new set of claims was beyond the scope of the original claims, and did not examine the other aspects of patentability of the claims of the appellant as amended. Aggrieved by this Order, the Appellant preferred an appeal before the Delhi High Court.

Issues before the Court

The issue before the Court was, “whether the “method of treatment” claims as originally filed could have been amended into “composition” claims by the Appellant?”

Rules and/or Law

Section 59(1) of the Act provides that an amendment of an application, specification, or any document related thereto would be permissible only if the following conditions are satisfied:

  1. The amendment has to be by way of disclaimer, correction or explanation;
  2. The amendment has to be for the purpose of incorporation of actual facts; and
  • The effect of the amendment ought not to be to amend the specification to claim or describe any matter which was not disclosed in substance or shown in the originally filed specification; and
  1. The amended claims have to fall within the scope of claims as originally filed.

Thus, for an amendment to be allowed, all conditions must be satisfied. Any amendment falling foul of (i), (ii), (iii) or (iv) above cannot be allowed.

Contentions of the Appellant

The Appellant contended that the “original claims which were drafted, were “method of treatment” claims that have been amended to composition claims which should be allowed in accordance with the existing scope of the amended claims in the complete specification.”

The Applicant submitted that there are differences in the patentability regime in different countries such as in the US, where treatment claims are patentable subject matter, and in India where treatment claims are non-patentable subject matter. Therefore, it would be impractical, nay impossible, to expect that the claims in the original PCT application, as filed (in this case, in the US), would be patentable in every designated country. In view of the same, this amendment cannot be held to be beyond the scope of the original claims because the original claims as well as the complete specification contain the support for the composition claims as amended. The Appellant has only restricted the claims to claim the very implants, for the method of use of which the original claims had been filed within and it could not be considered non-permissible under Section 59 of the Act.

Contentions of the Respondent

The Respondent contended that the amendments sought by the appellant are not allowable under Section 59(1) as the scope of allowability of amendments of claims is more restricted than that of the specification itself. Section 59(1) prescribes amendment of claims where the amended claim did not fall wholly within the scope of the pre-amended claim as the examination of the permissibility of claim amendment would have to be examined vis-à-vis the original claims. The complete specifications accompanying the original claims would be considered entirely immaterial in such consideration. Further, claim amendment within the scope of the complete specification can be permissible in the cases where the amendment was by way of a correction of the claim.

Respondent further took reference of Section 10(4)(c) of the Act and submitted that complete specification should end with the actual claim or claims defining the scope of the invention and therefore, claims are only a part of, and cannot be equated with, the complete specifications. In view of the same, the decision whether amendment sought to a claim should, or should not, be allowed with reference to pre-amended complete specifications, is completely impermissible as it would conflate the claim and the specifications, which is directly in the teeth of Section 10(4) of the Patents Act.

Observation of the Court

After hearing both parties, the Court observed that the composition which is being claimed in the amended set of claims has been explicitly spelt out in the original field detailed description. In its findings, the Court observed that the original 20 claims of the appellant were for various methods of using the intraocular implants of various compositions and constitutions, claimed to have been invented by the appellant, for treating a wide variety of ocular ailments. It is only after entering the Indian National phase, that due to a change in the patentability regime, the appellant has to amend the claims to the intraocular implants so as not to claim a non-patentable subject matter as per Indian Patent Act.

It is fact that Section 59 disallows amendment of an application for a patent or the complete specification therein, where the amended claim “would not fall wholly within the scope of a claim of the specification before the amendment”. Further, the claims and complete specifications in a patent have to be read together and form an integrated whole. Therefore, the claims have to be understood in light of the complete specifications.

Further, the Court referred to the judgement from Merck Sharp & Dohme Corporation v. Glenmark Pharmaceuticals[2], and held that “dichotomizing the claims and the accompanying specifications is, contrary to the most fundamental canons of patent law.” In the present case, there is not a wide divergence between the claims for which the patent had originally been sought, and the claims as amended subsequently. Rather the amended claims were in respect of the v same implants for the method of use of which the original claims have been filed and every detail of the implants, as contained in the amended claims, was disclosed in the original claims as filed.

The Court further referred to the Ayyanagar Committee Report which states that the amendments to a patent specification or claims prior to grant ought to be construed more liberally rather than narrowly, held that the Ld. Controller ought to have allowed the amendments which the appellant sought and to have examined the claims as so amended, and their patentability, on merits, and should not have shut out the appellant merely on the somewhat tenuous ground that the appellant was not entitled to amend its claims in view of Section 59(1) of the Patents Act.

The court made its reliance upon the case of Tony Mon George v. Controller General of Patents, Designs & Trademarks[3], wherein it was held that, “the Report favours wider scope of amendment before acceptance to that after acceptance.”

Further, the legislative intent is that no new subject matter should be added to the claims and/or description, which has not been disclosed in the originally filed specification. So long as the invention is disclosed in the specification and the claims are being restricted to the disclosures already made in the specification, the amendment ought not to be rejected, especially, at the stage of examination prior to the grant.

The Decision of the Court

With regard to the issue of whether the amendments are allowable which were not claimed at the time of filing of the application under Section 59(1) of the Act, the court held, “The appellant has amended the claims at a pre-grant stage and amendment merely sought patenting of claims relating to the very same implants, for the method of use of which the claims had originally been filed. The implants sought to be claimed in the amended claims have been clearly disclosed in the patent specification. The amendment is, thus, within the scope of the patent specification and claims as originally filed.”

The Court set aside the impugned order passed by the learned Controller and allowed the appellant’s permission to amend its claims without influencing any aspects of the patentability of amended claims which would be examined by the Controller freshly thereupon. In the opinion of the Court, the amended claims of the Appellant satisfy the conditions of Section 59(1) of the Act as specified above. Thus, the objection under Section 59(1) of the Act is not sustainable”.


This case law is indeed a benchmark step with regard to amendment in claims, especially in cases of PCT Applications wherein the patentability regimes of the priority country are different than in the Indian national phase. Claim amendment within the scope of the invention at the pre-grant stage should not be outrightly rejected without examining the other aspects of patentability. We believe this case law will eventually result in a change of practice of the Indian Patent Office concerning the acceptance of amendments in claims. As of now, the Controllers interpret the provisions under Section 59 regarding amendments, very strictly and do not allow the amending the preamble of the claims even within the scope of the specification. Hopefully, this case law would result in the allowance of amendments of claims restricted to the disclosures already made in the specification more liberally.


[1] C.A.(COMM.IPD-PAT) 22/2021

[2] (2015) 63 PTC 257 (Del-DB)

[3] 2020 SCC OnLine IPAB 988

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