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In Starpharma Pvt Ltd v. The Assistant Controller of Patents and Designs [Mad HC, (T) CMA (PT) No.22 of 2023, Decided: 12th October 2023], the Madras HC adjudicated on issues relating to Sections 57 and 59 of the Patents Act 1970.  Section 57[1] allows amendment of applications, any specifications and any document subject to Section 59[2] of the Act. Section 59 states the following for amendment of an application for a patent or the complete specification or any document relating thereto:

  • no amendment shall be made except by way of disclaimer, correction or explanation,
  • no amendment shall be allowed, except for the purpose of incorporation of actual fact,
  • no amendment 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..

In the present case, the claims as filed were directed to “Method of treatment or prophylaxis of bacterial vaginosis, including by administration of a gel formulation….”,[3] and the claims were revised to be directed to, “Gel formulation which inhibits bacterial vaginosis….”.[4] The Controller while rejecting the application and the amended claims held that the claim revisions were not as per Section 59 and the amended claims were beyond the scope of the original claims as filed.

Starpharma Pvt Ltd. filed an appeal against the rejection and contended that the limitations and specifications of the gel formulation as claimed in the revised claims were already mentioned in the original specification and hence, came under the scope of the original claim and therefore the amended claims met the requirements of Section 59 and should be allowed. The respondent on the other hand, contended that the original claim was a method claim while the amended one was a product claim and hence didn’t fall within the scope of the original claim. Accordingly, Section 59 was rightly applied to reject the application.

An important precedent in this regard is Allergan Inc. v. The Controller of Patents [2023/DHC/000515]. This case involved the filing of a patent application for a “method of treatment”, which had detailed disclosure of the method, along with the intracameral implant that was needed for the treatment. The controller on examining the application, raised an objection under Section 3(i) of the Act, which led to the claim being modified to a product, an implant. However, citing Section 59, the application was rejected, on the ground that the amended claims did not fall within the scope of the original claim. The rejection on Section 59 was, however, set aside by the Delhi High Court in an appeal, holding the following:

  1. Firstly, it was noted that the method of treatment patent application was first filed in the US and was granted there. Further, Section 138(4) of the Indian Patent Act necessitates the entirety of the international patent application to be a part of the complete specification nationalised in India. Hence, there was no scope to amend the application initially and had to be done at a later stage through Sections 57 and 59 of the Patents Act. This is particularly required in India, as method of treatment claims are not patentable here under Section 3(i) of the Patents Act.
  2. Secondly, the composition of the implant claimed in the amended claim was also explicitly mentioned in the original claim. The Court observed that the claims and the complete specifications had to be read together as a whole to determine whether an amended claim falls within the scope of the original claim or not.
  3. Finally, patent law must be interpreted liberally and not to discourage inventions. The Ayyangar Committee Report had also recommended that the amendments to a patent specification or claims prior to grant ought to be construed more liberally rather than narrowly.

Applying the above principles laid down in Allergan Inc. v. The Controller of Patents [2023/DHC/000515], the Madras HC, too, decided in favour of the appellants.

The Madras High Court allowed the appeal and observed that the composition of the gel formulation was already a part of the original claim under the complete specification and hence it fulfilled the requirement of an amended claim to be within the scope of the original claim. Hence, the Madras High Court set aside the impugned order of rejection of application and asked the patent office to re-consider the case de novo on merits. To prevent pre-determination and reduce the scope for bias, the Court directed that an officer, different from the one who had rejected the amended claims, decide on the patentability of the gel formulation.



[3] Claims 1, 5 and 10 of the original claims are set out below:

“1. A method of treatment or prophylaxis of bacterial vaginosis in a subject, said method comprising administering to the subject an effective amount of a macromolecule comprising a polylysine, polyamidoamine, poly(etherhydroxylamine) or poly(propyleneimine) dendrimer of 1 to 5 generations and one or more sulfonic acid-containing moieties attached to one or more surface amino groups of the outermost generation of the dendrimer, wherein said effective amount is 40 mg to 10 mg of macromolecule per day.

5. A method according to any one of claims 1 to 4 wherein the macromolecule is administered in a gel formulation.

10. A method according to any one of claims 6 to 9 wherein the macromolecule is administered in gel formulation.”

[4] Claim 1 of the amended claim is as under:

“1. A gel formulation inhibitory against one or more Gardnerella vaginalis, Prevotella bivia and B. ovatus comprising a macromolecule or a pharmaceutically acceptable salt thereof comprising a dendrimer with the following structure (image) and a rheology modifying agent which is Carbopol polymer in an amount of 2-10%, a chelating agent in an amount of 0.005% to 1%, a preservative selected from methyl paraben and propyl paraben, and having a pH between 4.5 and 5.5.”