Delhi High Court challenges Indian Patent Office’s refusal order in landmark pharma ruling

In Allergan Inc v The Controller of Patents, the Delhi High Court has ruled on the allowability of claim amendments under Section 59 of the Patents Act. The court set aside the Indian Patent Office’s refusal order, which rejected a patent application on the grounds that the amended claims did not fall wholly within the scope of the originally filed claims. The amendment related to converting claims directed to a method for treating an ocular condition using an intracameral implant, to the intracameral implant itself.

Allergan assailed the refusal order, arguing that the office had failed to provide sufficient and proper reasoning for rejecting the amendments and, therefore, the application. It maintained that there was overwhelming support in the specification and original claims for the intracameral implant aspect of the invention. Allergan emphasised that while the claims’ preamble was directed to a method of treatment, that by itself could not be the basis of the office’s position with regard to the scope of the amendments. Since the original claims recited a method of treating an ocular condition using an implant, the amendments to claim itself could not be construed as claiming an invention, which was beyond the scope of the claims as originally applied for.

However, the Indian Patent Office’s position was that the provision governing amendments – Section 59 – should be interpreted narrowly; amendments should be construed within the confines of the original claims. The description cannot be relied upon for the purposes of establishing support for any amendments. It argued that since the original claims were directed to a process (ie, a method of treating an ocular condition), the applicant should not be permitted to amend them so as to claim exclusivity over a product (namely, an intracameral implant) – only amendments relating to a process should fall within the scope of the original claims.

The court’s ruling

The court disagreed with this position and espoused the view that patent law is intended to foster innovation, research, technology and industrial progress. Accordingly, the Patents Act’s provisions should not be interpreted in an unduly restricted manner, as that would discourage innovation and entrepreneurship. In the court’s considered opinion, the claims and specification should be read as a whole when evaluating the scope of the amendments. 

Going a step further, the court observed that in arriving at any decision, it “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”. Therefore, if the patent office’s interpretation was accepted, then:

the result would be that [Allergan] would be foreclosed from seeking a patent in respect of the implants which, according to it, are a result of the [Allergan’s] own inventiveness and which are intended to cure a wide variety of ocular ailments.

The court also opined that the amendments sought by the applicant were based on restrictions mandated by the Patents Act. Since a condition’s treatment method is non-patentable in India (under Section 3(i)), amending such claims to a product claim was not improper. Further, after exhaustive analysis, the court held that the applicant set out sufficient proof to establish that the amendments were supported by the originally filed description and were encompassed by the scope of the original claims. Therefore, the amendments fell adequately within the confines of Section 59. Rejecting the application based only on the allowability of the proposed amendments was considered erroneous.

The matter has now been remanded back to the Indian Patent Office to accept the amendments and pronounce a decision on the merits.