Patent applications must demonstrate novelty and inventive step; mere new uses of known substances fail under Section 3(d) without showing significant enhancement in therapeutic efficacy.

JUDGMENT

Prathiba M. Singh, J. (Oral)--This hearing has been done through hybrid mode.

2. The present appeal has been filed challenging the order dated 23rd February, 2021 passed by the Assistant Controller of Patents and Designs, New Delhi (hereinafter, "Controller"). By the impugned order, the patent application No.201617023236 dated 6th July, 2016 filed by the Appellant/Applicant - Chugai Seiyaku Kabushiki Kaisha (hereinafter the `Appellant') has been rejected by the Controller.

3. The said patent application relates to an invention titled `Solid Preparation Containing Tofogliflozin and Process for Producing Same' (hereinafter "subject patent"). The case of the Appellant is that the subject invention provides a novel production method of solid preparations of the compound, the International Nonproprietary Name (INN) or generic name of which is Tofogliflozin (chemical name: 1,1-Anhydro-1-C-[5-(4-ethylphenyl)methyl-2-(hydroxymethyl)phenyl]-_-D-glucopyranose). The compound Tofogliflozin is used in the treatment of diabetes mellitus. The compound Tofogliflozin is represented by the following chemical formula:

4. The subject invention specifically provides a method for preparation of a tablet comprising Tofogliflozin from the powder mixture by direct compression. The Appellant submits that its invention provides a tablet comprising Tofoglifozin with improved disintegration and dissolution properties as compared to the conventional production methods and is hence entitled to grant of a patent.

5. The National Phase Application was based on the PCT Application No. PCT/JP2014/084561 dated 26th December, 2014 in India in the name of `Chugai Seiyaku Kabushiki Kaisha' and claimed priority from Japanese Application No.JP 273060/2013 dated 27th December, 2013. The application was published on 31st August, 2016 and request for examination was filed by the Appellant on 1st December, 2017. The First Examination Report (hereinafter "FER") was issued by the Patent Office on 8th March, 2019. The following objections were taken under the FER:

(a) Claims 1 to 15 were hit by Section 2(1)(j) of the Patents Act, 1970 (hereinafter "Act") for lack of novelty and inventive step as also industrial applicability.

(b) Claims were also non-patentable under Section 3 of the Act.

(c) Claims were hit by Section 10(5) and 10(4)(c) of the Act for lack of clarity and conciseness as also definitiveness.

6. The summary of the FER dated 8th March, 2019 is extracted below:

7. In the FER, the Patent office cited the following three documents of the Appellant itself, as the prior arts in respect of the Claims 1-15:

"1. WO 2006/080421 A1 (Chugai Pharmaceutical Co., Ltd) published on 3rd August, 2006.

2. WO 2012/115249 A1 (Chugai Pharmaceutical Co., Ltd) published on 30th August, 2012.

3. WO 2009/154276 A1 (Chugai Pharmaceutical Co., Ltd) published on 13th December, 2009."

8. In response to the FER, the Appellant filed a Reply dated 6th September, 2019 amending the Claims as set out below:

"At the outset, we humbly bring to the Ld. Controller's notice that claims of present invention have been suitably amended as indicated below. The presently amended Claims 1 to 5 and 7 to 9 basically relate to Claims 1 to 8 of the corresponding US Patent No. 10,398,653 B2.

-Claim 1 is amended by introducing the limitations of current Claims 5, 7, 10 and 11 and a limitation that the tofogliflozin is present in a form of monohydrate crystal.

-Claims 5, 7, 9 to 11, and 15 are cancelled

-Claims 6, 8, and 12 to 15 are renumbered as amended Claim 5 to 9.

-Minor revisions are made on current Claims 6 and 8 (amended Claims 5 and 6)."

9. In respect of the