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Judgment
Prabha Sridevan, J
1 . This appeal has been filed against order dated 27/01/2009 (Application No. 3498/DELNP/2005) by the appellant herein. The invention relates to "The use of Lupin Conglutin for the treatment of Type II Diabetes". The priority date of the application is 11/02/2003 and the PCT application dated 06/02/2004. The Deputy Controller refused grant of patent, against which this appeal has been filed. The Learned Counsel for the appellant submitted that the impugned order suffers from several infirmities. The examiner had not gone beyond ISR and IPER and the Controller had restricted himself to the ISR and not looked at the IPER. The Learned Counsel submitted that Rule 23 of the Patent Rules provide that the requirements in Chapter 3 of the Patent Rules are supplementary to the PCT and the regulation and the administration instructions made there under. This was over looked by the Controller. The Learned Counsel submitted that the order seems to indicate that with regard to the objection under section 3(e) no data was provided regarding novelty and inventive step. The Learned Counsel submitted that section 3(e) has nothing to do with the inventive step or novelty and the Controller's approach was wrong. The Learned Counsel submitted that reading of para 3 and 5 of the impugned order will show that it has to be set aside. The Learned Counsel submitted that when the only active ingredient was lupin conglutin gamma it was not necessary for the inventor to add any other excipient.
2 . We called for the records and we also considered the submissions made by the Learned Counsel for the appellants.
3 . On receipt of request for examination, the respondents First Examination Report was sent and it is dated 31/12/2007. It contains several objections including lack of clarity, insufficiency of definition, inconsistency between title, description and place, absence of novelty, section 3(e) objection etc. It was re-submitted deleting the initial claim 1 to 7 and rewording claim 6. The claims as amended according to the Learned Counsel for the appellant are contained in Annexure 'C' and reads as follows:-
(1) The pharmaceutical compositions comprising from 150 to 750 mg of lupin conglutin gamma or a lupin protein mixture or extract containing lupin conglutin gamma.
(2) The composition as claimed in claim 1, the said lupin conglutin gamma is used as hypoglycemizing agent.
(3) The pharmaceutical composition substantially as herein described with reference to the foregoing description, examples and the drawings.
The original claims submitted are as under:-
1 . The use of lupin conglutin gamma or of proteins showing homology, higher than 50% with lupin conglutin gamma, for the preparation of a medicament, food supplements or foods for the treatment of type II diabetes.
The use according to claim I of lupin conglutin gamma.
3 . The use according to claim I, wherein said proteins showing homology higher than 50% with lupin conglutin gamma are selected from soy BG7S or carrot EDGP.
4 . The use according to claims 1 or 2 of a lupin protein mixture or extract containing said conglutin gamma.
5 . Pharmaceutical or nutritional compositions containing lupin conglutin gamma or proteins showing homology higher than 50% with lupin conglutin gamma, as active ingredient.
6 . Pharmaceutical or nutritional compositions according to claim 5, comprising a lupin protein mixture or extract containing lupin conglutin gamma.
Lupin conglutin gamma as therapeutical agent.
Lupin conglutin gamma as hypoglycemizing agent.
9 . The use of lupin conglutin gamma substantially as herein described with reference to the foregoing description and the accompanying drawings.
1 0 . Pharmaceutical or nutritional compositions substantially as herein described with reference to the foregoing description and the accompanying drawings.
Lupin conglutin gamma substantially as herein described with reference to the foregoing description and the accompanying drawings.
5 . The International Search Report dated 8th July, 2004 held that claims 1 to 4, 7 and 8 had novelty. But claims 5 to 6 are not novel. Claims 1 to 8 have no inventive step.
6 . The IPER dated 17th January, 2005 accepted novelty of claims 1 to 8 and the inventive step of claim 2, 4 and 6 & 8. The Learned Counsel pointed out that this report clearly shows that the prior art D1 is not considered to be novelty destroying and that preferred embodiment namely lupin conglutin gamma is considered inventive and not obvious. The comparison of claims as originally filed and as finally amended shows that the original claims 1 to 4 have been deleted, the original claims 5 and 6 have been merged and reworded by deleting the words "or nutritional or proteins showing homology higher than 50% with lupin conglutin gamma, as active ingredient" and inserting the words "comprising from 150 to 750 mg of lupin conglutin gamma or a lupin protein mixture or extract containing lupin conglutin gamma". Claim 7 has also been deleted. Claim 8 with suitable modification is presented as claim 2 and claim 9 is presented with suitable modification as claim 3, and claims 10 to 11 have been removed.
7 . The Controller has come to the conclusion that invention lacks inventive step because the inventor has not provided data for comparing the fact of invention with respect to prior art. It is open to the Controller to raise such objections as he deems fit before granting the patent, but he should afford adequate opportunity to the inventor. Therefore, if the Controller had found that S. 3(d) objection should be raised and the Examination Report does not refer to it, the Controller must in his intimation of date of hearing also indicate that the inventor will have to prove increased efficacy as per S. 3(d). The Controller must give the patentee the opportunity to deal both the objection under each head. The impugned order states that no documents were given regarding the inventive step. But it is seen from the reply dated 17th November, 2008 that the appellant has given his reasons why there is inventive step. It is open to the Controller to reject the contentions but when a specific case has been projected regarding inventive step, it is not open to him to say that no submission was in fact made. In the First Examination Report, in objection No. 5, it is stated that the claims are not inventive in view of citations cited in ISR. The ISR only refers to D1 for inventive step and D2 to D4 for novelty. The IPER also in its report has referred to D1 alone both for novelty and for inventive step. But the order does not indicate why the Controller held that the invention lacks inventive step on the basis of D1 or D2 to D4. We repeat again that as we have done in our judgment in Sankalp Rehabilitation Trust, Mumbai Vs. F. Hoffmann-La Roche AG, Switzerland in OA/8/2009/PT/CH (IPAB Order No. 250/2012) that it is better to describe fully the documents cited before the Controller, at least once in the order that is passed. The IPER, in the body of the report refers to D1, D2 or D4. But it contains a paragraph titled "Cited Documents", where the documents are described in detail. This is absolutely essential. It is also better to have a heading for each ground on which the patentability is decided, for example, novelty, obviousness, S. 3(e) and so on and a finding given with regard to each heading and the finding given against each head, which is dealt in the order. This will go a great deal towards clarity of the order.
Now we come to the merits.
In Merrel Dow Pharmaceuticals Inc and Another v. H.N. Norton & Co. Ltd and Others reported in (1996) R.P.C. P.76, the appellant had patented terfenadine, then they did some research into the way it worked. They found that when it passed through the stomach it was metabolised in the liver. They analysed the acid metabolite so formed, and patented it. Then they claimed that anyone supplying terfenadine would infringe their metabolite patent since on intake the terfenadine will metabolise, and the acid metabolite would be made in the human body. The Patents Court revoked the patent. The House of Lords took the example of quinine and said that the "Amazonian Indians have known for centuries that cinchona bark can be used to treat malaria and other fevers.......... In 1820 French scientists discovered that the active ingredient, an alkaloid called quinine could be extracted.........". Then they compared the quinine example with terfenadine, and said that "The quinine example shows that there are descriptions under which something may in a relevant sense be known without anyone being aware of its chemical composition or even that it has an identifiable molecular structure. This proposition is unaffected by whether the substance is natural or artificial."
D1 is Pereira, Frederico et.al "Insulinotropic action of white lupine seeds (Lupinus Albus L) Effects on Ion Fluxes and Insulin Secretion from Isolated Pancreatic Islets". The Abstract says that Debittered seeds of Lupus albus L are generally considered to have antidiabetic properties and are prescribed to counter hypoglycemia...White lupines represent therefore an hitherto unexplored source for the isolation of new oral hypoglycemic agents, potentially useful for the treatment of type 2 diabetes.
1 0 . The appellant relied on a J. Agri Food Chem 2000 1118-1123, "Thermal Stabilities of Lupin Seeds Conglutin Y Promoters and tetramers" Duranti et al. to show that "the skilled person would not have ascribed the hypoglycemic effect of D1 extracts to gamma conglutin. It will be appreciated that the present invention, on the contrary teaches to isolate gamma conglutin through a process wherein temperature never raise beyond 40 degrees Centigrade to avoid protein de-naturation."
In the instant case, Lupin seeds are known to treat diabetics. Lupin seed extract and powder have also been used for treatment of diabetics. The active constituents of lupin seed extract were known including Lupin protein (Globulins). a, 'á' & '?' conglutin were also identified. Various users of Lupin proteins were known including as dietary supplements. The case of the appellant is not that he claims '?' conglutin as a chemical compound as isolated from lupin extract that had not been previously identified, as the presence of '?' conglutin in pure lupin seeds extract was already known and it was part of the state of art. The extract of lupin seed decoction/powder was known to cure diabetics as a traditional medicine. D1 also suggest that debittered lupin seed extract contains water soluble substances with capacity to potentiate glucose-induced insulin release. It was known that 90% of protein released from lupin albus seeds incubated in water at 60ø C for about 3 hours was conglutin gamma, a putative storage glycoprotein already present in the protein bodies of native seeds.
But the invention is not the process of isolation or the method of isolation of gamma conglutin. The invention is the use of this conglutin which was contained in Lupus seeds according to Duranti. The patentee says that Duranti did not identify that the hypoglycemic effect of lupus albinus was attributable to gamma conglutin. But it need not. Duranti tells us that lupus albinus are considered to have anti diabetic properties and that it is an unexplored source for isolation of new oral hypoglycemic agents especially for type 2 diabetes. This is enough. The patent is for the use of gamma conglutin which is found in lupus albus which was known to be antidiabetic. So the use of gamma conglutin was, to quote Merrell Dow" known without anyone being aware of its chemical composition or even that it has an identifiable molecular structure." The fact that it was not known that this particular globulin had the hypoglycemic effect and not an alkaloid does not matter, because the patentee is not claiming a patent for identifying and isolating this globulin by a process which does not raise the heat above 40 degrees Centigrade. Further the patentee admits that the other ingredients in the composition are not important since they are excipients and the like. Therefore the active ingredient in the composition is only this and it is the use of this which is claimed as an invention. Though the claims have been worded, since it is only the conglutin which is the active ingredient in the composition, it is really the use of a particular dosage of this conglutin. To find the suitable dose for administration does not qualify as an inventive step. The Controller was correct in holding that this is a mere use of known substances of which the properties are known. Since we confirm this finding of the Controller it is not necessary to go into any other observations or findings in the impugned order. The appeal No. OA/16/2009/PT/DEL is dismissed. The Miscellaneous Petition No. 119/2012 is allowed.