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The Delhi High Court has quashed an order by the Controller of Patents against US-based Allergan denying patent for an intracameral sustained release implant for ocular ailment and remanded the application back to the Controller for fresh consideration.
The Controller of Patent refused the patent application by Allergan for its intracameral sustained release therapeutic agent implants through an order on March 30, 2020, observing that the amended claims does not have support in the originally filed claims and the intracameral implants has not been claimed either in the WIPO (International) claims or while entering in the national phase. The application is thus not allowable under Section 59(1) of the Patents Act.
The company explained that the issue related to the amended claim is owing to a difference in the patentability regime in the US and in India. Method claims are patentable in the US, whereas they are not patentable in India, by virtue of Section 3(i) of the Patents Act.
Allergan's original patent claim, as filed in the US, was for methods for treating ocular ailments using the intracameral implants, but it would not have been patentable in India. Since the national phase applications are filed only after the original patent application is filed. In terms of filing the national phase application, the Patents Act requires the title, description, alcim and abstracted drawings filed in the international application to be taken as the complete specification for the purposes of the Act and there could be no occasion for the company to amend the claims as originally filed the PCT application in the US. However, the company amended its claim in India to a product patent following a First Examination Report (FER) from the patent authority and this has caused the refusal of the application.
The Counsel appearing for the Patent Office argued that the Controller was justified and correct in law in holding that the company was not entitled to amend its claims in the manner in which it had chosen to do, as such amendment was specifically debarred under the Section 59(1) of the Patents Act.
The Section 59(1) on the supplementary provisions as to amendment of application or specification, states, "No amendment of an application for a patent or a complete specification or any document related 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."
Hearing both sides, Justice C Hari Shankar in his order observed that the Controller's interpretation of Section 59 (1) is not correct and if it is accepted, the result would be that the company would be foreclosed from seeking a patent in respect of the implants, which according to it, are a result of its own inventiveness and which are intended to cure a wide variety of ocular ailments.
"In such circumstances, the Court is also required to keep in mind public interest, being one of the cardinal aims of patent law, especially where the patent is pharmaceutical or therapeutic in nature," said the order.
A large part of the complete specifications in the subject patent is dealt with the implants themselves, and their peculiar compositional constitution, he observed. The claims and complete specifications in a patent have to be read together and as a whole. The claims have to be understood in the light of the complete specifications. They form an integrated whole, and cannot be treated as two distinct parts of one document, added the Judge.
The Court, concluding the analysis, ordered that the order passed by the Controller refusing the patent is quashed and set aside. Allowing the company's prayer to amend its claims, the Order remanded the amended claims to the Controller for consideration of their patentability afresh, keeping in mind the Patents Act and its principles applicable in relation thereto.
The decision would be taken by the Controller in keeping with the principles of natural justice and following due procedure in that regard as also after grant of an opportunity of hearing to the company.
"It is clarified that the present judgement is restricted to the aspect of permissibility of the amendments which were sought by the appellant in the original claims. This Court has not expressed any view on the patentability of the amended claims. The learned Controller would examine the patentability of the amended claims uninfluenced by any of the observations contained in this judgment," added the Order.
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