Vide an order dated 14th December 2022, the Controller of Patents and Designs, allowed Indian Patent Application no. 4412/DELNP/2007, filed by Novartis AG covering its heart failure drug Vymada. Ten Pre grant Oppositions were filed during the pendency of the said application. One of the Opponents was Natco Pharma Ltd. (Natco).

A writ petition under Article 226 of the Constitution of India, filed by Natco against the order dated 14th December 2022, was allowed by the Delhi High Court.

On 25th November 2022, the Controller addressed a notice, only to Novartis. Following the issuance of the aforesaid notice and as envisaged therein, Novartis presented itself before the Controller on 2nd December 2022, and was heard. Natco was never issued notice of the said hearing appointed under Section 14 (examination proceeding) and was, therefore, unrepresented. This was one of the grounds of the Writ.

The main reason for allowing the Writ was that the Court held that Rule 55(5) does, as it is enacted, envisage participation by both sides (applicant and opponent) in the entire exercise, from the point of submission, by the patent applicant, of a reply under Rule 55(4) to the notice under Rule 55(3), till the final decision to grant or refuse the patent or require the patent specification applications to be amended. The Court held that the objector objecting to the application cannot be excluded from the examination proceedings at any point. The order of grant was set aside and matter was remanded back.

An appeal was filed by Novartis against said order of the Single bench of the Delhi High Court, setting aside of grant of patent. The Division Bench till the next date of hearing, has stayed the impugned judgment of the Single bench of the Delhi High Court and therefore the Patent reinforced.

The main issues to be decided in the appeal is whether once the pre-grant opposition is filed both examination and opposition proceedings stand merged and whether any examination of the application can be undertaken by the Controller without issuance of a Notice to the opponent, arise for consideration in the present appeal.