Dow Agrosciences LLC v. Controller of Patents and Designs

IMORTANT ISSUE

1. Whether the Controller erred in rejecting the patent under Section 15 of the Indian Patents Act, on the grounds of lack of inventive step under section 2(1)(j) of the Patents Act, 1970.

SUMMARY

Subject matter of patent: Subject matter is directed to include novel transformation events of cotton plants comprising one or more polynucleotide sequences, inserted into specific site(s) within the genome of a cotton cell, to protect plants from insects.

FACTUAL MATRIX

1. This application is a divisional application of Indian patent application 3542/CHENP/2006 granted as Patent number 253525 in the parent.
2. The instant application was filed as divisional to overcome the objection of lack of unity during the examination of parent application.
3. The divisional application 3542/CHENP/2006 was examined and refused based on the grounds of lack of inventive step relying on prior arts D1 (US 20040045054 A1) and D2 (WO 2002100163 A2) on 17/01/2020.

SUBMISSION BY APPELLANT

1. According to the appellants, the reason for rejection is not justified, since it address the question of inventive step regarding a claim directed at any event insertion of Cry1Ac into the cotton genome, but regarding a claim directed at a very specific insertion which is inventive over the cited prior art.
2. Starting from D1, the skilled person would not have arrived at the subject-matter of claim 1 without inventive activity. In particular, the skilled person had no reasonable expectation that the specific integration site named in present claim 1 would solve the problem of providing a cotton plant/seed with an improved agronomic performance and an increased insect resistance. D2 does not in any way cure the deficiencies of D2. Thus, the subject-matter of claim 1 is also inventive over the disclosure in document D1 and considering the disclosure of D2.
3. The Appellant submitted that the various factors were considered in selecting this single event from amongst many. These factors would include agronomics (yield, plant appearance, growth, etc.) as well as insect resistance. Although in the impugned decision, the respondents discussed many known methods for identifying a new event from the cited documents, the knowledge of those methods does not mean that expression levels for any particular event produced by using those methods would be at all expected. Thus the subject matter of invention is inventive.
4. The Appellants further submitted that the similar invention in the parent application was granted by Indian patent office.

SUBMISSIONS BY RESPONDENTS

1. The subject matter of claim lacks inventive step as the use of additional genetic elements to improve insecticidal resistance from a multitude of standard molecular biology tools is what a skilled person is aware of in view of disclosures in the prior art D1 and D2.
2. The skilled person with the ample disclosures of prior art could generate transgenic cotton plants or their seeds containing Cry1Ac genes by applying standard cloning and plant-transformation technologies would have applied a standard screening programmes to identify those plants exhibiting a desired expression level and pattern of the inserted transgenes by applying standard DNA sequencing technologies.

HELD

1. The court accepted the contention of appellants and held that the claims have technical benefits (unexpected results) over D1 and D2 when the claimed invention (containing SEQ ID No. 2) is compared directly to the Cry1Ac cotton event 531 described in D1 and D2. Importantly, the expression of Cry1Ac is increased 5-6 fold with SEQ ID No. 2 in comparison to the Cry1Ac described in D1 and D2.
2. The court further noted that not only the patent was granted in India on the parent application but all the four prior arts quoted above have been relied upon during the examination of the corresponding applications in various other jurisdictions, as informed by the appellant, and were verified to be true. The patents in all other jurisdictions have been granted on considering these prior arts.
3. Considering the above facts, the court set aside the order of the Respondent dated 17/01/2020 and directed the respondent to grant the patent on the amended set of claims within 3 weeks from the date of issuance of this order.

Citation: MANU/IC/0013/2021
IPAB order No: OA/18/2020/PT/CHN
Copy of judgement