**Case 5: Patent application for the "beta crystallineform of the imatinib mesylate salt" by Novartis**

As per Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, India has started providing product patent After 1 January 1995 [28, 29]. Novartis filed patent applications of pharmaceutically acceptable salts of a drug - "imatinib" and the patents were granted in the USA. After this Novartis filled patents application which claimed for "beta crystalline" form of imatinib mesylate and a patent was granted in the USA and other countries. The Indian Patent Office rejected the patent based on the ground of failure to promise novelty and non-obviousness. They said it is a modified version of an existing drug hence on the ground of Section 3(d) the patent cannot be granted. Novartis argued that beta crystalline form is a polymorph of imatinib mesylate and it showed better flow property, improvement in thermodynamic stability, reduced hygroscopicity and augmented bioavailability. At last, the Supreme Court declared that although the beta crystalline form of imatinib mesylate enhanced the bioavailability of the drug, it did not prove enhancement of efficacy hence it was found to be nonpatentable under **Section 3(d**) in India [30, 31]. The same product patent was granted in USA but rejected in India as patentability criteria have been provided in TRIPS but their interpretation may vary from country to country [32]. In India, the many aspects of intellectual property rights are dealt with in particular legislations enacted by the Parliament [33].

In 2015, the patent of BoehringerIngelheim Pharma GmbH & Co for drug "Spiriva®" was granted even after pre-grant opposition by one domestic firm. Cipla proceeded for post grant approval and the patent was revoked [34].

Section 3(d) has created a significant impact in determining the patentability of pharmaceutical derivatives in India [35]. Indian Patent Office opposes the concept of "evergreening" which is a practice of inventors of patented products for extending their monopoly period by various strategies (for example over associated delivery systems, or new pharmaceutical mixtures, etc.) [36, 37].

Section 3(e). A product obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance [16];

### **Case 6: Patent application entitled "Sterile Pharmaceutical Composition"** Patent application detail of case 6 is given in **Table 5**.

The applicant's claim 1 includes a sterile pharmaceutical composition including a water-insoluble anticancer agent and a pharmaceutically acceptable carrier, albumin. The ratio (w/w) of albumin to the anticancer agent was 1:1 to 9:1. The applicant claimed that the size of particles was less than 200 nm. Claims 2 to 12 were dependent claims which depend on claim 1.

The opposition was filed by M/s Natco Pharma Ltd., Hyderabad. Based on submitted documents and hearing from both the parties, the patent application was refused under Section 15 based on ground section u/s 2(1)(j), u/s 3(e) and u/s 10 of the Patents Act, 1970 on 24/07/2009.

The applicant filed an appeal in 'Intellectual Property Appellate Board' (IPAB) against the said decision. The Hon'ble IPAB again reconsiders the case on dated 20/01/2014.


#### **Table 5.**

*Patent application details for case entitled Sterile Pharmaceutical Composition.*

Second representation was considered by Assistant Controller as revised fresh representation and not the continuous hearing as the applicants have amended the claims 1 day before the hearing and opponent came to know it on the day of hearing (09/04/2009).

After hearings, the patent was refused on the ground of u/s **2(1)(j), 3(d)** and **3(e)** of the Patents Act, 1970. The specifications were also insufficient so rejection was also on the ground of u/s **10** of the Patents Act, 1970 [17].

## **Case 7: Patent application entitled "Gel Useful for The Delivery of Ophthalmic Drugs"**

Patent application detail of case 7 is reported in **Table 6**. The application was rejected by Indian Patent Office of Sigma-Tau Industrie Farmaceutiche Riunite S.P.A of Italy as it does not mate the requirements of Section 2(1)(j), Section 3(d), Section 3(e) and Section 3(n) of the Patents Act, 1970. The claims were aimed at a solid powder comprising a mixture of (a) a carboxy vinyl polymer as a gelling agent; (b) a buffer; (c) a saccharide, (d) one or more drugs used for the treatment of diseases of the eye. However, the Controller was dissatisfied by applicant's reply to the FER and sustained objection therein and gave the applicant's a chance to be heard.

The Controller sustained the objections that the amendments to claim 1 did not hold as per Section 59 (1) read with Section 57(2) of the Patent Act; revised claims were not novel, obvious and did not comprise an inventive step w.r.t. cited prior art documents; the revised claims were unacceptable under Section 3(d), Section 3(e) and Section 3(n) of the Patents Act, 1970 and last of all a few of the claims were ambiguous.

After conducting trial, the Controller accepted the agent's submissions that the amended claim 1 contained by the scope of the firstly filed PCT claims and hence was in consonance with the provisions of Section 59(1) and 57(2) of the Indian Patents Act. Further, claims remonstrated under Section 3(n) were also deleted.

With reference to Section 2(1)(j), the Controller in his verdict stated that the composition of the ophthalmic preparation (solid powder) of the claimed invention was not novel since all the ingredients were unveiled in the prior art, hence, the product did not meet the criteria as a "new" product. Further, the inventive step is missing in the drug delivery system claimed as no therapeutic efficacy

**41**

**Table 6.**

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

was exhibited. Creating a drug delivery system (powder or gel) of different well known components and verifying release rate of drug (amount of drug released after 30 min to 6 h) are regular experimentation carried out by medicinal chemist or trained artisan. The rejection was on the basis of Section 2(1)(j). Merely showing enhancement in bioavailability and retention time of the drug system was not adequate to evade the requirements of Section 3(d) and data indicative of the therapeutic efficacy was needed for the product. In absence of such data, the drug

Section 3(f). The mere arrangement or re-arrangement or duplication of known

Section 3(g) was as follows: 'a method or process of testing applicable during the process of manufacture for rendering the machine, apparatus, or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture'.

Section 3(h). A method of agriculture or horticulture(Note: But Agricultural

Patent application detail of the case is given in **Table 7**. The applicant claimed that carnivorous plant can be used as a medium for the production of the protein of interest. The applicant claimed a process in which plant was genetically modified by transformation and protein was expressed in the digestive secretion of the genetically modified plant. Hence, this patent application was refused under Section

**Case 8: Patent application entitled "Process for the Production of** 

delivery system as claimed was precluded under **Section 3(d)** [17–38].

*Patent application details for case 7 – gel useful for the delivery of ophthalmic drugs.*

Omission of this section widens the scope of patentability [40].

**Recombinant Proteins Using Carnivorous Plants"**

Equipment are patentable) [16].

devices each functioning independently of one another in a known way [39]; Section 3(g). Omitted by the Patents (Amendment) Act, 2002.


#### **Table 6.**

*Intellectual Property Rights - Patent*

(09/04/2009).

**Table 5.**

**Ophthalmic Drugs"**

were ambiguous.

Second representation was considered by Assistant Controller as revised fresh representation and not the continuous hearing as the applicants have amended the claims 1 day before the hearing and opponent came to know it on the day of hearing

After hearings, the patent was refused on the ground of u/s **2(1)(j), 3(d)** and **3(e)** of the Patents Act, 1970. The specifications were also insufficient so rejection

Patent application detail of case 7 is reported in **Table 6**. The application was rejected by Indian Patent Office of Sigma-Tau Industrie Farmaceutiche Riunite S.P.A of Italy as it does not mate the requirements of Section 2(1)(j), Section 3(d), Section 3(e) and Section 3(n) of the Patents Act, 1970. The claims were aimed at a solid powder comprising a mixture of (a) a carboxy vinyl polymer as a gelling agent; (b) a buffer; (c) a saccharide, (d) one or more drugs used for the treatment of diseases of the eye. However, the Controller was dissatisfied by applicant's reply to the FER and

The Controller sustained the objections that the amendments to claim 1 did not hold as per Section 59 (1) read with Section 57(2) of the Patent Act; revised claims were not novel, obvious and did not comprise an inventive step w.r.t. cited prior art documents; the revised claims were unacceptable under Section 3(d), Section 3(e) and Section 3(n) of the Patents Act, 1970 and last of all a few of the claims

After conducting trial, the Controller accepted the agent's submissions that the amended claim 1 contained by the scope of the firstly filed PCT claims and hence was in consonance with the provisions of Section 59(1) and 57(2) of the Indian Patents Act. Further, claims remonstrated under Section 3(n) were also deleted. With reference to Section 2(1)(j), the Controller in his verdict stated that the composition of the ophthalmic preparation (solid powder) of the claimed invention was not novel since all the ingredients were unveiled in the prior art, hence, the product did not meet the criteria as a "new" product. Further, the inventive step is missing in the drug delivery system claimed as no therapeutic efficacy

**Case 7: Patent application entitled "Gel Useful for The Delivery of** 

sustained objection therein and gave the applicant's a chance to be heard.

was also on the ground of u/s **10** of the Patents Act, 1970 [17].

*Patent application details for case entitled Sterile Pharmaceutical Composition.*

**40**

*Patent application details for case 7 – gel useful for the delivery of ophthalmic drugs.*

was exhibited. Creating a drug delivery system (powder or gel) of different well known components and verifying release rate of drug (amount of drug released after 30 min to 6 h) are regular experimentation carried out by medicinal chemist or trained artisan. The rejection was on the basis of Section 2(1)(j). Merely showing enhancement in bioavailability and retention time of the drug system was not adequate to evade the requirements of Section 3(d) and data indicative of the therapeutic efficacy was needed for the product. In absence of such data, the drug delivery system as claimed was precluded under **Section 3(d)** [17–38].

Section 3(f). The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way [39];

Section 3(g). Omitted by the Patents (Amendment) Act, 2002.

Section 3(g) was as follows: 'a method or process of testing applicable during the process of manufacture for rendering the machine, apparatus, or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture'. Omission of this section widens the scope of patentability [40].

Section 3(h). A method of agriculture or horticulture(Note: But Agricultural Equipment are patentable) [16].

### **Case 8: Patent application entitled "Process for the Production of Recombinant Proteins Using Carnivorous Plants"**

Patent application detail of the case is given in **Table 7**. The applicant claimed that carnivorous plant can be used as a medium for the production of the protein of interest. The applicant claimed a process in which plant was genetically modified by transformation and protein was expressed in the digestive secretion of the genetically modified plant. Hence, this patent application was refused under Section


#### **Table 7.**

*Patent application detail for case 8 entitled "Process for the production of recombinant proteins using carnivorous plants."*

15 based on ground of **Section 3(j).** Cultivation of plant, growing of the plant, harvesting of fluid from the trap was considered as a method of agriculture hence it was also not a patentable invention as per **Section 3(h)** [17].

Section 3(i). Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products [16];
