Chugai Pharmaceutical Co., Ltd. (Chugai) is a drug manufacturer operating in Japan. The company is headquartered in Tokyo. Historically stating, in the year – 1925, Juzo Ueno founded ‘Chugai Shinyaku Co. Ltd.’ and started importing and selling medicines. In 1927 the company started of the first own production. Following which, in the year 1943 name of the company was changed to Chugai Pharmaceutical Co., Ltd. based in Tokyo.
Chugai’s patent titled ‘Solid Preparation Containing Tofogliflozin and Process for Producing Same’ (hereinafter “subject patent”) bearing Patent Application No. 201617023236 dated 6th July, 2016 provides a novel production method of solid preparations of the compound, the International Non-proprietary Name (INN) or generic name of which is Tofogliflozin compound. Tofogliflozin is used in the treatment of diabetes mellitus. The subject patent 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.
While the subject patent was in the National Phase of Application in the PCT Application in India, Chugai sought to seek priority for its Japanese Application dated 27th December, 2013 following which, the application was published on 31st August, 2016. As a result of which, the First Examination Report was received on 8th March, 2019 in which, to state very briefly, the Controller objected to the claims of Chugai stating that those claims ought to be rejected because of their lack of novelty and inventive step along with industrial application under section 2(1)(j) [which states that "invention" means a new product or process involving an inventive step and capable of industrial application;] of the Patents Act, 1970 (“Act”).
Their claims were also rejected due to non-patentability under section 3[which enlists what are not inventions] of the Act and the lack of clarity and consciousness and definitiveness under section 10(5) and 10(4)(c) of the Act. Along with the objections, the FER also cited three documents pertaining to prior arts with respect to the claims made out in the above-mentioned application. After denying all the objections raised by the Controller, the matter was heard wherein; the Controller enlisted the reasons for its objections.
Chugai filed an appeal in the Delhi High Court challenging the order passed by the Assistant Controller of Patents and Designs, New Delhi (hereinafter ‘Controller’ rejecting the patent application filed by Chugai.
The Court upheld the reason stated by the Controller that the present invention is "A method for producing a pharmaceutical composition which is a tablet comprising tofogliflozin as an active ingredient, wherein the tofogliflozin is present in a form of monohydrate crystal "tofogliflozin is a pre-existing drug in prior art. Inventor has used its monohydrate crystal form to prepare compositions. In which tofogliflozin is an active ingredient, which is already used in prior art as cited documents.”
The claims also could not see the light of success because they were very obviously hit by section 3(d) of the Act which states that inventions which are mere discovery of a new form of a known substance or the process related to the substance which does not result in enhancement of the efficacy of the already known efficacy are not patentable. Therefore, the Court opined that Chugai is attempting to evergreen the earlier patent. The mere method for preparation of a tablet form of Tofogliflozin by direct compression method would not be patentable as the same would not constitute enhancement in therapeutic efficacy of the drug.
Lastly, even after reviewing all the data, there was nothing on record that could show as to what would be the effect of early or shorter duration of disintegration, what would be the extent of the said shorter duration of disintegration as also what would be the effect of the same on the treatment of a patient.
Based on the above reasons, the Court held that the subject patent application was nothing but an attempt to increase the term of the earlier patent for Tofogliflozin, which would not be permissible without a significant enhancement in therapeutic efficacy. Accordingly, the Patent Application No.201617023236 dated 6th July, 2016 filed by Chugai in respect of the subject patent has been rejected the Court.
