India: Patent On Traditional Knowledge- Patent Office Decision On Development Center For Biotechnology (Taiwan) Vs CSIR

In a recent decision taken against the pre-grant opposition filed by the Council of Scientific & Industrial Research, the Patent Office granted patent rights for the invention titled "A Pharmaceutical Composition And Process Thereof For The Preparation Of Plant Extracts For Treating Skin Disorders And Enhancing Healing Of Wounds" (provisionally numbered as 1556/ KOL/2007)" filed by Development Center For Biotechnology (The Applicant), a Taiwanese company. The grounds of Opposition are lack of novelty and inventive step. A detailed analysis of the case is as follows,

The Applicant has amended the claims twice one before filing the Pre-grant opposition followed by the final amended set of claims after filing the Pre-grant opposition. The claims are processing, extraction, composition and use claims. The first 10 claims in 'as filed' format comprise of a process for the preparation of Plectanthus amboinicus extracts, a plant extract. The said process is being prepared by a stirring separation method. Further Claims 4 to 10 comprise of the step involved in stirring separation method of the extract. Claim 11 to 16 comprises of the pharmaceutical composition and amount of Centella asiatica Urban extract. Claims 17 to 20 comprise of the use of the Pharmaceutical composition extracted from Plectanthus amboinicus.

In the amended claims, claims 14, 15 and 16 were deleted by the applicant during prosecution as they were 'use' claims. Claims 11 to 16 where objected to by the opponent (CSIR).

The Opponent has quoted " the following claims are included in the third party observation." However, no arguments have been made against the remaining claims.

Claims 11 to 16 that are disputed read as follows:

"11. The pharmaceutical composition as claimed in claim 10 further comprising a therapeutically effective amount of Centella asiatica Urban extract.

12. The pharmaceutical composition as claimed in claim 11, wherein the Plectranthus amboinicus extract and the Centenella asiatica Urban extract have a weight ratio of about 1:60 to about 1:4.

13. A wound dressing comprising a pharmaceutical composition as claimed in any one of claims 10 to 12.

14. A use of the pharmaceutical composition of any one of claims 10 to 12 in the manufacture of a medicament for treating skin disorder.

15. The use as claimed in claim 14 wherein the disorder is general trauma or bedsores.

16. The use as claimed in claim 14 wherein the skin disorder is wounds in a diabetic patient."

The Opponent has filed a Pre-grant Opposition by way of representation on 19/06/2012. The Patent Office acknowledged the role of CSIR as the general opponent in the field of Traditional Knowledge based patent applications. Further, CSIR is found to file documents prepared by them under the programme of the preparation of Traditional Knowledge Digital Library ( TKDL) to prevent the persons to claim patent right over the traditional knowledge.

CSIR-TKDL practice

It was further stated that as per practice CSIR-TKDL always submitted prior-art evidences available in TKDL with respect to patent applications filed on India's Traditional knowledge at International Patent Office's but has never been a part of hearing process in patent offices. Hence there was no personal representative in any of the Pre-grant Opposition hearings. Therefore in the present case, the hearing proceeded in the presence of the applicant representative only.

The opponent had annexed 11 documents at the time of filing Pre-grant opposition in languages other than English for which the translations in English have been filed. The cited documents mainly referred to Centella asiatica and no reference was made to Plectranthus amboinicus in terms of its method of preparation, extraction, and composition as well its use in wound healing.

The Applicant's arguments:

The Applicant had primarily argued that the opponent has merely provided documents from TKDL without providing verified translation. The agent of the applicant challenged the validity of the translations by making reference to Patent Rule 61(2) that requires production of verified translations. However, the applicant did not attempt to prove that the translations are wrong. On the question of authorised translator, the Controller held that CSIR is funded by the Government and as stated by them in their annex has an agreement with Patent office to share the TKDL for the purpose of search during prosecution of the filed patent applications and disposing them on merits. Therefore translations filed by CSIR are deemed authenticated by the Government itself. Therefore the translations were considered for the disposal of the present case.

The Controller further stated that the present opposition filed by the opponent is loosely drafted and do not even set out the grounds of opposition. Further, the Controller pointed that in a contested opposition preceding the grounds ought to be pleaded and proved. In absence of pleadings such proceeding ought to be outright rejected.

As seen from above claims 11-16 are disputed. Claims 14,15 and 16 were deleted during prosecution as the said claims are 'use' claims and do not fall within the scope of Section 2(1)(j) of the Patents Act.

Claims 11 to 13:

Defending Claims 11 to 13, the Applicant stated that Claim 11 is dependant claim on the previous claim. It is noteworthy to state that claims 1 to 10 of the present invention are not opposed. Further, the annexed documents refer to Centella asiatica Urban throughout which is an optional feature of the present invention. It is admitted that though the extract of Plectranthus amboinicus is known, the existing techniques of extractions (e.g. column chromatography) are cumbersome, time consuming and do not produce large quantities. The present invention, through the stirring separation technique, provides better and faster extraction. Also better wound healing efficacy is observed in P.amboinicus and Centella asiatica combination.

Therefore, it was prayed by the Applicant that the Claims 11 to 13 are novel and inventive and hence be allowed.

Analysis and Decision of the Controller

The Controller assessed the novelty of the present invention based on the latest filed claims as well as the documents provided by the Opponent and observed that while filing opposition it is not correct to conclude that the opponent is not aware about the first 10 claims of the present specification. In the absence of any documental evidence about the extract of Plectanthus amboiinicus prepared by stirring method and its use for wound healing novelty of the first 10 claims has been upheld by the Controller.

The combination of Plectanthus amboiinicus and Centella asiatica as claimed in claim 11 is not mentioned by the opponent as either published prior to the priority date or prior claimed or been in the public domain before the priority date of the present application. Therefore, Claim 11 is considered Novel. Claim 12 is dependent on Claim 11 which defines the specific ration of the two constituents also considered as novel.

Claim 13 defines an independent claim, claiming a product that is a "wound dressing" which in turn comprises either the extract of Plectanthus amboinicus or the combined extracts of Plectranthus amboinicus and Centella asiatica. Hence Claim 13 is also novel.

The Applicant has acknowledged about the existence of the extract of Plectranthus amboinicus from US patent applications 2006/0099283 A1 and USSN 11/605,178. The extraction in the said patent documents was carried out by column chromatography. However the drawbacks of traditional column chromatography methods are cumbersome, timeconsuming, large quantity of the active ingredient is unavailable. Hence the present process that is stirring separation is superior to column chromatography or centrifugal separation because Example 1 of the specification explains that yield of the active is shown as 0.94% whereas Example 2 of the specification explains the preparation of Plectranthus amboinicus extracts by column chromatography separation method that is the process of the prior art wherein the yield of the active is shown as 0.67%. Therefore, there exists the technical advancement as compared to the existing knowledge hence satisfying the requirement of the Section 2(1)(ja) of the Patents Act, thus the "inventive step" is established.

Conclusion:

Though the opponent had pointed the lack of novelty and inventive step, but could not prove it. The opponent's main objection is for Centella asiatica which is only an option in the present invention. The Opponent had made no references to the extract of Plectranthus amboinicus nor to its method neither of preparation nor to a combination nor to its use for skin disorders. Based on the aforesaid, it has been decided to grant the patent right to the applicant.

Footnotes

1. http://164.100.176.38/decision/1556-KOL-2007-8021/PRE%20GRANT%201556%20KOL%202007.pdf

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