Quasi-judicial authorities must provide reasoned, speaking orders when refusing patent applications. They are obligated to apply established multi-step tests for inventive steps and must explicitly address technical data and specific arguments raised by applicants to avoid the order being deemed perverse or non-compliant.

JUDGMENT :

JYOTI SINGH, J.

1. This appeal is filed on behalf of the Appellant under Section 117A of the Patents Act, 1970 (‘1970 Act’) challenging order dated 31.01.2020 passed by the Respondent refusing Indian Patent Application No. 3029/DELNP/2015 and for a direction to the Respondent to grant the patent.

2. To the extent necessary, the facts are that the subject invention relates to ‘STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTION FOR INJECTION’. Appellant filed a PCT International Application on 23.10.2013 bearing No. PCT/US2013/066349, claiming priority from US Application No. 61/718,026 dated 24.10.2012 and US Application No. 61/736,179 dated 12.12.2012. Appellant filed Indian Patent Application No. 3029/DELNP/2015 on 10.04.2015 with complete specification comprising claims 1-27 and drawings.

3. It is stated in the appeal that Request for Examination by way of Form-18 was made on 27.05.2015 and Form-13 was filed on 02.07.2015 requesting to place on record amended set of claims 1-13 by way of correction and explanation. First Examination Report (‘FER’) was issued by the Respondent on 09.03.2018, to which Appellant filed a response on 07.12.2018 along with amended set of claims 1-9. Hearing was conducted on 25.09.2019, whereafter post-hearing written submissions were filed by the Appellant on 04.10.2019. On 31.01.2020, Respondent passed the impugned order and refused the application on ground of lack of inventive step under Section 2(1)(ja) of 1970 Act and non-patentability under Section 3(e).

4. Learned counsel for the Appellant submits that present invention relates to a stable, preservative-free and antioxidant-free liquid pharmaceutical formulation of Ketorolac and Phenylephrine for injection into intraocular ophthalmologic irrigation solutions. Claimed invention recites a sterile liquid pharmaceutical formulation comprising Phenylephrine, Ketorolac and a 20mM sodium citrate buffer system in an aqueous carrier, wherein the formulation is preservative free and antioxidant free, which is claim 1. Further, the formulation is a solution which is free of solubilizing agents and free of visible precipitation and crystallization and is stable for 6 months when stored at a temperature from 5+/-3° C to 25+/-2° C. The formulation can be suitably injected into an intraocular irrigation carrier and is used to irrigate ocular tissues during surgery. Additionally, this formulation avoids the potential toxicity that may be associated with preservatives and antioxidants and still has stability.

5. It is submitted that present invention provides a solution to the problem as to how to maintain long-term stability for a liquid intracameral ophthalmic solution, which is a mixer of two disparate active pharmaceutical ingredients (APIs), one of which is a weak aromatic base (Phenylephrine) and one of which is a weak aromatic acid (Ketorolac) without use of either antioxidant or preservatives, that are typically required for stability but can be injurious to intracameral tissues. Therefore, the invention provides a sterile formulation of irrigation solutions for perioperative local application to ocular tissues, including intraocular and topical application, where Phenylephrine is used as a mydriatic agent and Ketorolac as an anti-inflammatory and both are free of preservatives and antioxidants and yet document unexpected good stability. They are preferably packaged in single-use containers for injection and can be injected into a larger volume of intraocular irrigation carrier prior to and during intra