**3. Case studies of rejected patents as per Section 2 of the Indian patent act**

Section 2 describes the patentability criteria of inventions.

Section 2(j) Inventions means a new product or process which involves an inventing step and having industrial applicability;

Section 2(ja) Inventive step means invention should show technical advancement in comparison with the existing knowledge or having economic significance or both and invention must not be obvious to a person skilled in the art;

Section 2(1)(ac) "capable of industrial application", in relation to an invention, means that the invention is capable of being made or used in an industry [15, 16].

**Case 1: Patent application entitled "Powder Formulation for Valganciclovir"**

Patent application detail of case 1 is given in **Table 1**. The solid-state of valganciclovir hydrochloride exhibits acceptable physical, chemical, and light stability when stored under ambient conditions. The applicant prepared a liquid dosage form of valganciclovir hydrochloride for the pediatric patient as well as for patients who require flexibility. However, short-term stability data indicated that a liquid dosage form would be unstable for the anticipated shelf life of the product.

The applicants, therefore, focused on powder dosage forms, for later constitution with water, to provide reasonable shelf life for valganciclovir hydrochloride and the resulting (constituted) liquid dosage form. The formulation procedure was changed from a dry mix granulation to a wet mix granulation. Because valganciclovir hydrochloride is readily soluble under acidic conditions, a solid pharmaceutical dosage form must contain an organic acid present in an amount sufficient to solubilize and stabilize the valganciclovir hydrochloride in a predetermined amount of water for the proposed shelf life of the resulting (constituted) liquid dosage form. Hygroscopic organic acids were found to degrade the solid valganciclovir hydrochloride pharmaceutical dosage forms. Therefore, the applicant's claimed for a solid pharmaceutical dosage form which needs to be reconstituted in water before giving by the oral route. The product contained a therapeutically effective amount of drug (valganciclovir hydrochloride) and non-hygroscopic organic acid present in an amount sufficient to stabilize the drug in a predetermined amount of water. They claimed non-hygroscopic organic acid from the group consisting of fumaric acid, succinic acid, and adipic acid and amount of that acid was selected such to lower the pH of the constituted solution of valganciclovir hydrochloride to 3.8 or below.

The patent examiner argued that stability of valganciclovir below pH 3.8, using organic acid i.e. citric acid, is already reported in the prior art. Thus, there is no technical advancement achieved from the present invention. As the patent did not involve any inventive step, it was refused as per Section 15 on the ground of Section 2(1)(ja) of the Patent Act [17]. Examination report of the case can be studied in detail from Dynamic Patent Utilities: The Controller's Decision mentioned on website of Indian patent.

**35**

**patent act**

**Table 1.**

**machine"**

is given in **Table 2** [17–19].

*Case Study on Rejected Patents in India DOI: http://dx.doi.org/10.5772/intechopen.92356*

**4. Case studies of rejected patents as per Section 3 of the Indian** 

*Patent application detail for case 1 entitled powder formulation for valganciclovir.*

Section 3 of Indian Patent Act describes non-patentable inventions.

ously contrary to well established natural laws [16];

Section 3(a). An invention which is frivolous or which claims anything obvi-

Example: Machine that gives more than 100% performance, A perpetual motion machine of the first generation which claimed to produce work without energy input which is contrary to law of thermodynamics (law of conservation of energy - energy can be neither created nor destroyed. It simply changes from one form to another). **Case 2: Patent application entitled "Gravity wheel–a perpetual motion** 

This invention claimed to produce a powder delivery wheel, which is a perpetual motion machine working by gravitational force. This machine was claimed to be never stopped except human means. The claimed machine was a stationary engine of the unlimited size which was capable of continuous power output from gravity force and the gravity force can be universally available in any planet. The patent was abandoned under Section 21(1)on the ground of **Section 3(a)**as its performance was contrary to the law of thermodynamics. The patent application detail of case 2

Section 3(b). An invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment [16];


#### **Table 1.**

*Intellectual Property Rights - Patent*

to 2016–2017 [14].

**patent act**

and January 2017. Among them, 945, 466 and 1113 patents were rejected based on Sections 2(1)(j), 2(1)(ja) and Section 3, respectively. Ground for patents rejection may be one or more for one case [13]. As per Annual report of IPR 2017–2018 in India, number of patent applications examined, number of grant of patents and disposal of applications increased by 108.2, 32.5 and 57.6%, respectively as compared

Sections 2 and 3 were the major reasons for the rejection of patents filled in India

hence some case studies related to rejected patents are discussed in this chapter.

Section 2(j) Inventions means a new product or process which involves an

Section 2(ja) Inventive step means invention should show technical advancement in comparison with the existing knowledge or having economic significance

Section 2(1)(ac) "capable of industrial application", in relation to an invention, means that the invention is capable of being made or used in an industry [15, 16]. **Case 1: Patent application entitled "Powder Formulation for Valganciclovir"** Patent application detail of case 1 is given in **Table 1**. The solid-state of valganciclovir hydrochloride exhibits acceptable physical, chemical, and light stability when stored under ambient conditions. The applicant prepared a liquid dosage form of valganciclovir hydrochloride for the pediatric patient as well as for patients who require flexibility. However, short-term stability data indicated that a liquid dosage

The applicants, therefore, focused on powder dosage forms, for later constitution with water, to provide reasonable shelf life for valganciclovir hydrochloride and the resulting (constituted) liquid dosage form. The formulation procedure was changed from a dry mix granulation to a wet mix granulation. Because valganciclovir hydrochloride is readily soluble under acidic conditions, a solid pharmaceutical dosage form must contain an organic acid present in an amount sufficient to solubilize and stabilize the valganciclovir hydrochloride in a predetermined amount of water for the proposed shelf life of the resulting (constituted) liquid dosage form. Hygroscopic organic acids were found to degrade the solid valganciclovir hydrochloride pharmaceutical dosage forms. Therefore, the applicant's claimed for a solid pharmaceutical dosage form which needs to be reconstituted in water before giving by the oral route. The product contained a therapeutically effective amount of drug (valganciclovir hydrochloride) and non-hygroscopic organic acid present in an amount sufficient to stabilize the drug in a predetermined amount of water. They claimed non-hygroscopic organic acid from the group consisting of fumaric acid, succinic acid, and adipic acid and amount of that acid was selected such to lower the pH of the constituted solution of valganciclovir

The patent examiner argued that stability of valganciclovir below pH 3.8, using organic acid i.e. citric acid, is already reported in the prior art. Thus, there is no technical advancement achieved from the present invention. As the patent did not involve any inventive step, it was refused as per Section 15 on the ground of Section 2(1)(ja) of the Patent Act [17]. Examination report of the case can be studied in detail from Dynamic Patent Utilities: The Controller's Decision mentioned on

**3. Case studies of rejected patents as per Section 2 of the Indian** 

or both and invention must not be obvious to a person skilled in the art;

form would be unstable for the anticipated shelf life of the product.

Section 2 describes the patentability criteria of inventions.

inventing step and having industrial applicability;

**34**

hydrochloride to 3.8 or below.

website of Indian patent.

*Patent application detail for case 1 entitled powder formulation for valganciclovir.*
