**Case 4: Patent application entitled "Gene Family (LBFL313) Associated with Pancreatic Cancer"**

Patent application detail of case 4 is given in **Table 4**.

The invention relates generally to the changes in gene expression in human pancreatic adenocarcinoma. The invention relates specifically to a human gene

#### *Intellectual Property Rights - Patent*

family which is differentially expressed in cancerous pancreatic tissues compared to corresponding non-cancerous pancreatic tissues.

The hearing was offered on 10th April, 2014 intimating the following outstanding objections:


Section 3(d). Section 3(d) of the Patents Act 1970 was as follows: The simple discovery of any new attributes or new utility for a known substance or of the mere utilization of a known method, machine or apparatus except if such known method results in a new product or employs at least one new reactant;

Section 3(d) of the Patents Act 1970 was amended in 2005 as follows: the simple discovery of a new form of a known substance which fails to result in the improvement of the known efficacy of that substance or the simple discovery of

**39**

20/01/2014.

such substance [16];

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

**mesylate salt" by Novartis**

legislations enacted by the Parliament [33].

any new attribute or new utility for a known substance or of the mere application of a known method, machine or apparatus unless such known method results in a new product or employs at least one new reactant. Explanation—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be anticipated to be the same substance, unless they vary

**Case 5: Patent application for the "beta crystallineform of the imatinib** 

In 2015, the patent of BoehringerIngelheim Pharma GmbH & Co for drug "Spiriva®" was granted even after pre-grant opposition by one domestic firm. Cipla

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

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

**Case 6: Patent application entitled "Sterile Pharmaceutical Composition"**

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

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

proceeded for post grant approval and the patent was revoked [34].

delivery systems, or new pharmaceutical mixtures, etc.) [36, 37].

Patent application detail of case 6 is given in **Table 5**.

were dependent claims which depend on claim 1.

the Patents Act, 1970 on 24/07/2009.

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

significantly in properties with consideration to efficacy [26, 27].

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

*Intellectual Property Rights - Patent*

objections:

of the Act.

corresponding non-cancerous pancreatic tissues.

family which is differentially expressed in cancerous pancreatic tissues compared to

1.The applicant used 777 base pairs and in prior art it was 764 base pairs. The claimed sequence ID having extra 13 base pairs but the applicant does not show any advantages due to these extra 13 nucleotide base pairs. Further, it is very much possible that the 764 base pairs may retain the natural property.

2.Objection 2 of FER is not met as amended claim 6(Production of Polyclonal Anti-LBFL313 Antibody) is directed to a host cell, which is not allowable u/s 3 (j)

3.Objection 3 of FER is not met as the amended claims 1–4 & 7–8 are not patentable as the subject matter of claim 1–4 are directed to isolated nucleic acid/PP sequence from human genomic DNA, which is considered to be an isolated nonliving substance occurring in nature, is not allowable to be patented under the provision of Section 3(c) of the Act in the absence of any clear cut recombination in these molecules. The same observation applies to the subject-matter of claim 7–8, which encodes polypeptides from the isolated nucleic acid of claims 1 i.e. sequence ID No-2.It already stated that said nucleotide sequence is isolated from nature, the polypeptide, which encodes by them, would be available in the source from which the said nucleic acid is isolated. Consequently, the subject-matter of

claims 7–8 also falls within the scope of Section 3 (c) of the Act. 3.

wise it is not acceptable in the present form.

of the application as originally filed.

4.Amended claims 7 and 8 does not sufficiently define the invention, Claims should contain all the essential feature of the polypeptide which refers by its amino acid sequence ID, not by its nucleotide sequence ID. As stated above the said claim should be defined by its essential technical features, if any, other-

5.While filing amended claims the applicant should at the same time bring the description into conformity with the amended claims. Care should be taken during revision, not to add subject matter, which extends beyond the content

6.In reply to the hearing notice, the Applicant's agent submitted a faxed letter dated 9th April, 2014 with the following statement: "We have been informed by our client that they are not interested in pursuing this application further and accordingly we will not be attending the hearing scheduled for April 10, 2014". Considering the Applicant's interest of not to pursue the instant application, it is hereby decided that the requirements communicated in the hearing notice are still outstanding and hence, the application was refused for grant of

Section 3(d). Section 3(d) of the Patents Act 1970 was as follows: The simple discovery of any new attributes or new utility for a known substance or of the mere utilization of a known method, machine or apparatus except if such known method

Section 3(d) of the Patents Act 1970 was amended in 2005 as follows: the simple discovery of a new form of a known substance which fails to result in the improvement of the known efficacy of that substance or the simple discovery of

results in a new product or employs at least one new reactant;

The hearing was offered on 10th April, 2014 intimating the following outstanding

**38**

a patent [17].

any new attribute or new utility for a known substance or of the mere application of a known method, machine or apparatus unless such known method results in a new product or employs at least one new reactant. Explanation—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be anticipated to be the same substance, unless they vary significantly in properties with consideration to efficacy [26, 27].
