The Development Center for Biotechnology (a Taiwanese Company) filed a patent application on 16th November 2007 for an invention titled as “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) (PRE GRANT 1556 KOL 2007. Decision by the Deputy Controller of Patent: T. V. Madhusudhan).
The invention relates to the processing, extraction, composition and use of extracts of a plant Plectranthus amboinicus (about Plectranthus amboinicus). Claims 1 to 7 are process claims wherein the Plectranthus amboinicus extract is prepared. Claims 1 to 3 refers to the methodology of the process which is a ‘stirring separation technique’. Claims 4 to 7 explain the stirring separation technique and are dependent claims. Some claims also refer to the use of Centella asiatica (another medicinal plant) as an optional ingredient. Claims 11 to 16 where objected to by the opponent (CSIR). However, claims 14, 15 and 16 were deleted by the applicant during prosecution as they were ‘use’ 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 – Council of Scientific & Industrial Research filed a pre grant opposition by way of representation on 19 June 2012. They argued lack of novelty and inventive step but failed to prove the same. The main objection of the opponent was with respect to the use of Centella asiatica and no reference was made to Plectranthus amboinicus (its method of preparation, extraction, combination ).
The patent office observed that the TKDL has a large and exhaustive database on which perhaps the entire world depends. Despite this, even though they were aware of the first 10 claims, CSIR could not retrieve any data related to the extracts of Plectranthus amboinicus. Did the CSIR somehow overlook this aspect of the invention (which is the main part)? Or are there really no prior instances related to the extraction etc of Plectranthus amboinicus? However, in the absence of any evidence about the extraction/combination etc. of Plectranthus amboinicus prepared by stirring separation method and its use for wound healing, novelty of the first 10 claims was acknowledged. Claims 11 to 13 were also upheld as novel and inventive.
There was no personal representative of the CSIR in the pre grant opposition hearings in this case. The CSIR, as per practice, only submits prior art evidence available at TKDL to patent offices but never takes part in the process of actual hearing. They play more of an enabling role by letting the patent office take a decision on the invention against the prior art evidence made available by them.
Though this logic may make sense for patent hearings in International Patent Offices, where the time and cost of such presence may outweigh the benefit of opposition, should the same logic apply to an opposition in India, why not go all the way?
11 documents were submitted at the time of pre grant opposition. These documents were in languages other than English for which translations in English were filed. The applicant challenged the validity of these translations on the ground that Patent Rule 61(2) required production of verified translations. It was contended that since the translations in this case were not verified they must not be considered at all. The controller, however, held that – first, the applicant did not contend that the translations were wrong and second, it is the government that authorizes translators and since CSIR is mainly funded by the Ministry of Science and Technology, translations filed by them are deemed authenticated by the Government itself. Therefore the translations were deemed valid and were taken on record.
The applicant contended that the opponent has simply made assertions without showing how the documents are relevant for proving lack of novelty and inventive step. An IPAB decision (IPAB order No. 262 of 2013) was cited to argue that mere assertions without sufficient comparison with prior art is not sufficient to constitute a valid opposition. In the instant case the opponent instead of referring to the specified grounds under Section 25(1) has only stated ‘traditional knowledge on the issue of novelty and inventive step concerning Section 3(p) and Section 2(1)(j) respective of Indian Patents Act.’
Further it was submitted that all the opposition documents refer to Centella asiatica Urban which is an optional feature of the present invention and no reference has been made to Plectranthus amboinicus. Since there is no indication of the use of the extract of Plectranthus amboinicus from the documents submitted by the opponent, a person skilled in the art would never be motivated to make such a combination.
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.
Hence it was submitted that claims 11 to 13 should be upheld as novel and inventive.
First, the controller held that the opposition clearly refers to lack of novelty and obviousness which relate to specific grounds of opposition under Section 25(1) of the Indian Patents Act.
With regard to claims 1 to 10, the controller observed that it cannot be assumed that the opponents were not aware of these claims while filing the opposition. Therefore, since no documents referring to Plectranthus amboinicus were submitted and only documents related to Centella asiatica Urban were produced, claims 1 to 10 were accepted as novel.
Claim 11 and 12 were also held to be novel as the opponent did not bring forth any evidence related to the combination of Plectranthus amboinicus and Cetella asiatica. Moreover, with respect to claim 11 the addition of the extract of Centella asiatica is an optional feature of the invention.
Claim 13 is an independent claim that relates to ‘wound dressing’ either with the extracts of Plectranthus amboinicus or the combined extracts of Plectranthus amboinicus and Centella asiatica. This claim was also held to be novel for the same reasons as above.
The applicant admitted that there exists a process of extracting the juice of Plectranthus amboinicus (US patent application US 2006/0099283. Where the said extract is obtained by grinding and then removing fragments by centrifugal filter devices. And other processes of extracting the leaf juice of Plectranthus amboinicus by column chromatography.) However, the present invention uses a ‘stirring separation technique’ which is less cumbersome, faster and yields more juice. Thus technical advancement as compared to the existing knowledge was held to be satisfied. Hence all the claims were upheld and the patent was granted.
Many thanks to our very own and dear Prashant Reddy for bringing this case to our notice!