| SooperKanoon Citation | sooperkanoon.com/1117369 |
| Court | Intellectual Property Appellate Board IPAB |
| Decided On | Nov-13-2013 |
| Case Number | ORA 28 of 2011/PT/MUM & M.P.Nos. 70 of 2012 & 34 of 2013 |
| Judge | THE HONOURABLE MS. S. USHA, VICE CHAIRMAN & THE HONOURABLE MR. D.P.S. PARMAR, TECHNICAL MEMBER(PATENTS) |
| Appellant | La Renon Health Care Pvt. Ltd. |
| Respondent | Kibow Biotech Inc., Rep. by Its Senior Vice President (Randd) and Another |
ORDER No. 261/2013
Ms. S. Usha, Vice Chairman
Application for revoking the patent No.205478 under the provisions of the Patents Act, 1970.
2. The brief facts of case are -- The 1st respondent Kibow Biotech Inc. is a foreign company and a competitor of the applicant. The 1st respondent filed a Civil Suit No.498 of 2011 before the Honble Madras High Court alleging infringement of the impugned patent No.205478 in order to curb the competition in the market from the applicant who would be the major competitor. The said suit is pending. The applicant is therefore a person interested in the filing of this revocation petition.
Applicants case:
3. The applicant contended that it has examined the complete specification and the claims and found that the grant of the impugned patent is bad in law. The patent has been obtained for the invention titled, âPrebiotic and Probiotic Compositions and Methods for their Use in Gut-Based Therapiesâ. The respondent has in the impugned patent made a claim for pharmaceutical composition and also for a method of treatment in the same application which is barred under Section 7(1) of the Act. Two separate set of claims pertaining to two different subject matters cannot be the subject of a single application for the grant of patent.
4. According to the applicant, the 1st respondent initially filed the complete specification pertaining to the impugned patent for a process of mixing with a set of six claims. But the complete specification with the claims for which the impugned patent has been granted is for a product and a method all of which are not patentable and outside the scope of the invention as originally claimed. The title of the impugned patent application given in the patent certificate mentions it as âA process of Making Pharmaceutical Compositionâ while the complete specification mentions it as âPrebiotic and Probiotic Compositions and Methods for their use in Gut-based Therapiesâ. The respondent had only intended to obtain a patent for product. The patent has been obtained on false representation.
5. In the complete specification the field of invention has been stated as relating to pharmaceutical compositions and methods of using these compositions to treat renal, hepatic and gastrointestinal diseases by eliminating toxins and other metabolic waste products and reducing or retarding undesirable bacterial over growth.
6. In one embodiment, the invention is said to comprise a prebiotic, a probiotic, an ammoniaphilic bacteria and sorbents all of which are microencapsulated and/or enteric coated. Alternatively, in the field of invention it is stated that the probiotic, prebiotic and ammoniaphilic bacteria are administered in a microencapsulated gelatine capsule while the sorbents, if needed are administered separately in a microencapsulated and/or enteric coated formulation. These pharmaceutical compositions are useful in treating the renal, hepatic diseases and bacterial growth in the gastrointestinal tract.
7. The object of the impugned invention is stated as providing for an integrated, gut-based low cost alternative treatment for renal insufficiency, liver insufficiency, inborn errors of urea metabolism and gastrointestinal disorders and diseases. The impugned invention alleviates at the same time more than one symptom. It is also stated that the invention harnesses the beneficial effects of intestinal flora in restoring normal health. There is no proof, evidence or description to support the statement that the invention alleviates at the same time more than one symptom. The specification pertains only to kidney disease and not to others. Therefore, the statement is very general and not supported by any appropriate description in the specification. The specification suffers from insufficient disclosure in this regard.
8. The impugned invention which is stated as a pharmaceutical composition comprises of the elements like (1) a probiotic to restore normal balance between beneficial bacteria and detrimental bacteria, to remove excess urea waste product of normal protein metabolism thereby reducing burden on ailing kidney and to remove ammonia to avert mental retardation and related conditions; (2) a prebiotic to stimulate beneficial bacterial population and to ensure viability of the probiotic, so that Nitrogen sources such as urea and ammonia are effectively utilised; (3) an ammoniaphilic urea degrading micro organism with high alkaline pH stability and high urease activity with no specific functions stated; (4) a water sorbent to remove water in diarrhoea and renal insufficiency; (5) a mixture of adsorbents to remove other nitrogen metabolic wastes and bacterial over growth products i.e., uric acid, creatinine and guanidines, phenols and indoles and/or (6) inorganic phosphate adsorbents to maintain phosphate balance.
9. As per the summary, some elements are non-optional and others are optional. In some embodiments the probiotic may function to restore mental balance between beneficial bacteria and detrimental bacteria to remove urea waste product of normal protein metabolism thereby reducing burden on ailing kidney and to remove ammonia to avert mental retardation and related conditions, thus performing the function of the ammoniaphilic urea degrading microorganism.
10. The summary does not mention the level of urease activity or the alkaline pH values except that the ammoniaphilic urea degrading organism should have high alkaline pH stability and high urease activity. In the preferred embodiment, activated charcoal and inorganic phosphate adsorbent are combined together in the composition for synergistic effect and to reduce the relative proposition of these two components in relation to the probiotic and prebiotic. The synergistic effect achieved is not stated. By use of a combination of activated charcoal and inorganic phosphate adsorbent, the synergistic effect is not described nor has it been claimed. The description suffers from insufficient disclosure in this regard. It is only preferred/optional embodiment and not the main embodiment and hence, no inventive step. Another aspect of the preferred embodiment is that as the probiotic and prebiotic remove most of the urea and curtail bacterial over growth, so that the normal nitrogen waste products and bacterial end products are minimal, less activated charcoal and inorganic adsorbents are required as compared to prior art composition. The existence of prior art is admitted. There is no inventive step.
11. The composition consisting of the above mentioned elements can be used prophylactically in patients with acute or chronic symptoms of uremia. Administering of water sorbent, absorbents and/or inorganic phosphate adsorbent for diarrhoea and other gastrointestinal disorders is a very vague statement unsupported by a description. Uremia, diarrhoea and gastrointestinal disorders are all different issues and they cannot be treated in a common manner. The present invention is preferably enteric coated or microencapsulated for delivery to the ileal or colonic regions of the bowel of a patient which is also an optional embodiment. The use of the pharmaceutical composition is said to be for preventing or delaying the need for dialysis in kidney patients and to reduce the frequency and/or duration of dialysis which is not supported by any description nor is there any claim to that effect.
12. Even as per the summary of the invention, the only essential non-optional elements are the combination of one probiotic, one prebiotic and an ammoniaphilic urea degrading microorganism. There is nothing novel or inventive as the use of all elements and the microencapsulation or enteric coating are all prior knowledge. Even assuming without admitting that there is no prior knowledge, still the impugned patent lacks novelty as there is no inventive step and is obvious to a person skilled in the art. The combination does not have a new function or a technical effect or advancement different from its constituents. Therefore it is not an invention within the meaning of Section 3(e) of the Act.
13. The description controverts the summary and the claims to the extent that it mentions the use of probiotics and prebiotics whereas the summary and the said claims specifically mention the use of only one probiotic and one prebiotic. Therefore, what is claimed is the use of one probiotic and one prebiotic and the rest are disclaimed. The use of ammoniaphilic urea degrading microorganism is also made an non-essential element in the impugned patent. There is nothing novel or invention involving an inventive step in the combination. It is nothing but an admixture resulting in the aggregation of the properties of its components. It is not an invention within the meaning of Section 3(e) of the Act. The impugned patent deserves to be revoked on the grounds of Section 64(1)(d)(e)(f) and (i). The patent was falsely represented to the 2nd respondent on its patentability. It is liable to be revoked under Section 64(1)(j) also.
14. There is no sufficient description on the probiotic. The probiotic can comprise of any species of bifidium or lactobacillus which is too broad. The particular strain of bacterial has not been mentioned. The claim being too broad is not supported by a sufficient description in the specification. Therefore, the patent failing on the main claim fails on all other dependent claims which are based on the main claim. The patent deserves to be revoked under Section 64(1)(i). In view of this insufficient and improper description and disclosure, the working of the composition based on the disclosed matter is not possible by a person possessing average skill and knowledge in the art. The patent offends Section 64(1)(h) of the Act.
15. On the selection of the ammoniaphilic urea degrading microorganism the summary mentions the use of a microorganism, the description mentions the use of a microorganism the description narrows it to any bacteria in particular a few and the claims still narrows it down to two specific bacteria. The description and claims as regards bacillus and lactobacillus species in general is too broad and is not supported by sufficient description in the specification. Both in the claim and the description the strain of lactobacillus has been mentioned as KB-I without mentioning the species. The description is insufficient and the claim is improper and incapable of being enforced.
16. The description on microencapsulation and enteric coating of the alleged combination are all prior arts and therefore there is nothing inventive or novel.
17. The preferred bacterial source of the probiotic is to be capable of metabolizing urea and ammonia preferably to amino acids which can be acted by the bacteria of the patient, in the prior art and obvious. The word preferably is vague and nonspecific. If the metabolization is not into ammonia acids, then what is the result and what are the consequences, have not been described. The instructions for working of the patent are insufficient.
18. The preferred bacteria are stated to be non-pethogenic safe and to grow well in high concentration of ammonium ion and alkaline pH which are present in the intestine, particularly in uremic conditions. The 1989 prior art is also stated. Even according to the description, admittedly, the action of these bacteria in relation to alkaline pH, growth in ammonium concentration are all known.
19. The description demarcates the scope of the composition to compromise of, an enteric coated and/or microencapsulated composition comprising of a probiotic and a prebiotic as the only non-optional essential elements. The claims include ammoniaphilic urea degrading microorganisms as an essential feature specifically made as an optional embodiment of the composition in the description. The claims travel beyond the scope of the description and are not based on the matter as disclosed in the specification. The complete specification no where clearly specifies or defines what the term composition at any particular place would mean.
20. The composition comprising of the said two non-optional essentials either with or without the optional essentials is nothing but an admixture resulting only in the aggregation of the properties of its components where the properties use and effects are known and is thus obvious. The invention as claimed in the complete specification pertains only to an admixture resulting only in the aggregation of the properties of the components namely the probiotic, prebiotic, ammoniaphilic bacteria, sorbents and thus microencapsulation all of which is known much prior to the filing of the patent. The invention as claimed in any of the claims of the complete specification is not new, having regard to what was publicly known or used before the priority date of the claim or what was published in any of the documents referred to in Section 13 of the Act. This is because the scientific rationale for the use of live microbes as in the impugned patent in the prevention and treatment of infections came to limelight most transparently at the beginning of the 20th Century. Much prior to the instant patent, all have proposed about the beneficially effects of probiotics and their use to maintain microbial balance and benefit of health. Even as per the complete specification the use and effects of prebiotic, ammoniaphilic bacteria, sorbents and microencapsulation or enteric coating were all known prior to the filing of this patent. Therefore there is nothing novel or inventive.
21. The other aspect of the description pertaining to the method of administering the composition is a method of treatment which is expressly barred under Section 3(i). The 1st respondent has obtained patent for an alleged composition and also for a method of treatment which is violative of Section 7(1).
22. The complete specification pertaining to the patent mentions a number of prior arts of which 9 are highly relevant as they make the impugned patent obvious to a person skilled in the art which also leads to anticipation as regards treatment of renal and hepatic diseases. They are struck by prior knowledge as regards bacterial overgrowth in the gastrointestinal track.
23. The prior art particulars as given in the complete specification of the impugned patent are â
Probiotic prior art as per the complete specification -
| 1 | 26.05.1998 â Food Microbinal | Function of same bacteria species are considered as probiotic in that they perform beneficial functions for human organisms |
| 2. | Nov.1999 â Gastro Hepatitis | Bifidobacterium species are most prominent probiotic bacteria. They stimulate the immune system and exert a competitive exclusion of pathogenic and putrefactive bacteria, reduce the amount of ammonia and cholesterol in blood |
| 3. | Feb.2001 Cummings JH | Probiotic bacteria exert that affects in a synergistic manner to curtail and retard growth of pathogenic /detrimental bacteria of the gut. |
| 4. | 2000 Drug Exp clin Res. | Intestinal bacteria can be reduced to become unbalanced or be eliminated in patients, (a)Undergoing antibiotic treatment and other therapies (b)Suffering from inflammatory intestinal diseases; (c)Kidney disease; and (d)Liver disease |
| 5 | 2001 February | A prebiotic is a non-digestible food ingredient that beneficially affects the host by selectively, stimulating the growth and/or the acting of one or limited number of bacteria in the colon. Prebiotics are typically thought of as carbohydrates or relatively short claim length. Prebiotics are like other carbohydrates that reach the cecum such as non starch polysaccharides sugar alcohols and resistant starch, in being substrates for fermentation. They are distinctive in their selective effect on the microflora. |
| 6. | 1999 July | Through stimulation of bacterial growth and fermentation prebiotics also affect bowel habit and are mildly laxative. |
| 7. | US Patent 5,733,568 | Teaches us the use of microencapsulated lactobacillus bacteria for treatment of antibiotic associated or other acute and chronic diarrhoea as well as for skin and vaginal yeast infections. The microencapsulation is said to prevent inactivation of the bacillus and to deliver it to the intestine as well as to avoid lactose intolerance seen in the said diarrhoea. |
| 8. | US Patent 5,032,399 | Teaches the use of species of lactobacillus acidophilus to adhere to intestinal mucosa and thereby reduce gastrointestinal side effects of antibiotic therapy that reduces beneficial bacterial population. |
| 9 | 1997 Nature medicine | Use of probiotics such as lactobacillus acidophilus has been suggested to curtail the bacterial overgrowth and the accumulation of uremic toxins and carcinogenic compounds. |
24. The description does not sufficiently disclose the invention and its working. In case of pharmaceutical patents accuracy and precision are required with regard to the use of an element/component in a particular quality/quantity for a particular level of infection/disease so as to get the desired result. In the instant case, the probiotic to be used is between 5-20 gms. There cannot be a range in such cases. It is not clear what amount of probiotic is to be used for what amount of prebiotic and vice versa. The quantity of the other elements for a specific quantity of probiotic is not disclosed. A broad range of other figures for the other elements also make the composition unworkable. Insufficient disclose and the patent is liable to be revoked.
25. The claim has been made for a composition comprising of (a) a probiotic, (b) a prebiotic, (c) an ammoniaphilic urea degrading microorganism with high pH stability and high urease activity and (d) the said composition being microencapsulated or enteric coated. The range or value of the pH on the high urease activity is not mentioned in the claim. Though the description mentions the pH, it does not mention high urease activity. Even if it is mentioned in the description it is not mentioned in the claim and so, the claim is incapable of enforcement and is too broad.
26. The use and effect of probiotic microorganism, prebiotic and microencapsulation or enteric coating are all prior arts. The combination of them does not produce any new result. Use for kidney and liver ailments is struck by prior arts. The usefulness of the impugned invention is not sufficiently disclosed and deserves to be revoked. The impugned claims of the complete specification are anticipated by the prior arts mentioned in the specification.
27. The applicant therefore prays that the patent No.205478 may be cancelled/revoked on the above mentioned grounds.
Respondents response:
28. The first respondent filed the counter statement stating that it is a fourteen year old biotechnology company which specialises in the development and commercialisation of scientifically formulated and clinically tested probiotic dietary supplements. The first respondent specialises in probiotic supplements for maintaining kidney health and boosting the immunity of the geriatric population by restoring their intestinal micro flora. The first respondent company was established to help fight rapidly growing health risks and in furtherance of its objective it provides the highest quality non-drug dietary supplements at affordable prices.
29. The first respondent has been at the forefront of research in the field for several years. The Managing Director of the respondent company has published numerous papers on this subject. Recently in 2009, the respondent company published a paper in the Current Research Medical and Opinion (CMRO) entitled, âprobiotic Dietary Supplementation in Patients with Stage 3 and 4 Chronic Kidney Disease: A 6 Month Pilot Scale Trial in Canadaâ and in 2010 the respondent company had a paper published in Advances in Therapy entitled, âPilot Study of Probiotic Dietary Supplementation for Promoting Healthy Kidney Function in Patients with Chronic Kidney Diseaseâ.
30. The first respondent issued a cease and desist notice upon the applicant on 05.10.2010 calling upon them to restrain from infringing the respondent patent No.205478 in their product âCUDOâ. The applicant in their reply stated that it believes that the composition and process of manufacturing of their product CUDO is unique, superior and first of its kind in India which cannot be disclosed as it is in the process of getting the patent. The respondent thereafter requested for the claimed patent application and the date of filing of the said application. The applicant did not provide with the particulars. As the applicant did not restrain itself from manufacturing and selling the product CUDO, the respondent instituted a civil suit on 20.05.2011 before the Honble High Court of Madras.
31. The Honble High Court granted leave to file the suit. The applicant filed an application to revoke the leave granted. The Honble High Court revoked the leave and rejected the plaint on 22.08.2011.
32. The applicant anticipating that the respondent would prefer an appeal against the order of rejection of the patent, have filed this application for revocation before this Board which is in abuse of the process of law.
33. The first respondents preliminary objection was that the instant application has not been filed in the manner and format prescribed under Rule 3 of the IPAB (Patents Procedure) Rules, 2010. The applicant has filed this application against the wrong set of claims. The revocation application has been filed against the claims originally filed for by the respondent and not against the final set of patent claim that was granted after due examination. The present revocation petition has been filed against the 16 original claims at the time of filing of the Indian patent application No.1029/MUMNP/2003 whereas it has not been filed against the six claims as granted in patent No.205478. Therefore, the respondent has limited to the claims as granted in the counter statement.
34. The revocation petition contains a number of blanket assertions without any substantiation. It makes vague references to prior art documents without producing any specific references. The application has been filed under Sections 64, 71, 117A and 117B of the Act. The application is not for rectification of the register under Section 71 of the Act and no evidence has been advanced in support thereof. The present application is not an appeal under Section 117A and 117B of the Act and no evidence in support has been filed. The respondent is therefore restricting its response only to the provisions under Section 64 of the Act.
35. Mr.Ankit Shyam who is the Assistant Manager, Business Development and the authorised signatory of the applicant, in his affidavit, in para 6, has referred to the patent certificate of the Indian Patent No.205478 which bears the title, âA process for making a pharmaceutical compositionâ. This proves that the applicant had the knowledge of application No.1029/MUMNP/2003 being amended during prosecution and deliberately chose to file the instant application for revocation on an entirely wrong set of claims.
36. The first respondent company was established on 01.10.1997 to help fight rapidly growing health risks and in furtherance of its objective it provides the highest quality non-drug dietary supplementary at affordable prices.
37. The focus of the first respondents research has been on the use of the probiotics and prebiotics to maintain kidney health. The human body contains several trillions of bacteria at any given point of time. These bacteria are classified as good bacteria and bad bacteria. Bad bacteria are the organism which causes diseases and infections. Good bacteria (probiotics) contribute to good health by performing functions such as digestion and the removal of toxins, without which it would not be possible to survive. Accordingly, any attempt to improve the quality of the bodys digestive process and excretive process must aim at boosting the efficiency of the good bacteria. The respondents research in maintaining kidney health is therefore critical to preventing and reducing the increasing incidences of kidney failure in India.
38. The first respondent has a number of patents covering the inventions in many countries world over including India. The key patent in India which is under dispute in the present proceedings claims in main part,
âA process of making pharmaceutical composition comprising mixing a probiotic, a prebiotic and an ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity, a water absorbent for inorganic phosphate and an adsorbent for specific uremic solute other than urea, said composition being microencapsulated or enteric coatedâ.
In human body, an equilibrium of uremic toxins normally exists between the blood and the colons lumen which is higher during diseased conditions in the bowel. The composition obtained by the method of Indian Patent No.205478 utilises these toxins to grow and a gradient concentration is generated which derives a passive difference of more toxins from the blood to the colons lumen. The actual mechanism takes place in the large intestine. As the kidney function slows down, nitrogenous wastes build up in the blood and diffuse into the intestinal fluid by natural physiological process. When the kidney becomes compromised, uremic toxins build up in the blood. Large number of these toxins diffuse into the colon because of the extensive network of the blood vessels surrounding it. Following a journey in the upper GI, the probiotic microbes are released from an enteric coated capsule and enter the large intestine into the ileo-ceacal region. Once in the colon, the microbes target and metabolize the uremic nitrogenous wastes as nutrients for its growth. The microbes which have a high affinity for the toxins then metabolise them as nutrients. As they metabolise the uremic toxins, the microbes begin to multiply and this in turn allows for even a greater diffusion of toxins into the bowel. Eventually, the metabolised toxins are carried down through the bowel and out of the body as solid waste sparing the compromised kidneys of the burden.
39. This invention has been patented in several countries including Australia (AU 2002342641), United States (US 6706287) and Republic of Korea (1020037014919).
40. The history of the patent is that the respondent filed an application No.1029/MUMNP/ 2003 bearing the title âPrebiotic and probiotic composition and Methods for their use in gut based therapiesâ on November 7, 2003 as a national phase application of PCT application No.PCT/US2002/15073 filed on May 10, 2002.
41. The Indian patent was filed with 16 claims which were identical with the PCT application as filed. Claims 1 to 10 were directed towards a composition and claims 11 to 16 were directed towards a method. After examination, only six claims were granted for a process of making pharmaceutical composition.
42. Originally, it was filed with the claim, âA pharmaceutical composition comprising a probiotic, a prebiotic and an ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity, said composition being microencapsulated or enteric coatedâ. This was narrowed down after examination to, âA process of making pharmaceutical composition comprising mixing a probiotic, a prebiotic and an ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity a water absorbent for inorganic phosphate and an adsorbent for specific uremic solute other than urea, said composition being microencapsulated or enteric coatedâ.
43. All the other claims are dependent claims which rely either directly or indirectly on the main claim.
44. The main grounds of revocation are that it is not an invention, it lacks novelty, lacks inventive step, invention is not useful, insufficiency in complete specification, insufficiency in claims, patent obtained on false suggestion or representation, subject matter of claim is not patentable and claims anticipated based on traditional knowledge.
45. The applicant has not made out their case on any one ground, but have rather loosely relied on all grounds collectively for the basis of this revocation application. The applicant has merely made blanket assertions throughout without substantiating any one of those assertions. The applicant has not proved that the patent method is anticipated in any one of the documents cited by it as prior art or it is obvious to a person skilled in art. The applicant has not demonstrated as to how the patent method does not constitute an invention. The pleadings are therefore completely groundless.
46. None of the claims amounts to mere admixture under Section 3(e). By no stretch of imagination can this unique method be labelled as a method of producing a mere admixture.
47. In order to anticipate an invention all the features of the claimed invention should be disclosed in a single document. This being the basis of the test of anticipation is conspicuous by its absence and shows the baseless allegation of the applicant. Since the applicant is unable to produce such a document, it has avoided satisfying the basic test in order to misguide and mislead the Board.
48. The applicants though have based their revocation application on various grounds, the same have not been substantiated. It is denied that the granted patent has two separate sets of claims pertaining to two different subject matters. It has six claims with a single independent claim. All six claims are directed towards a method of forming a composition. The applicants were aware of the six claims, yet chose to file a revocation against 16 claims. By virtue of the civil suit, the applicants were aware of the six claims.
49. The patent as granted comprises of the following claims â
Claim-1 : A process of making pharmaceutical composition comprising mixing a probiotic, a prebiotic and an ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity, a water absorbent for inorganic phosphate and an adsorbent for specific uremic solute other than urea, said composition being microencapsulated or enteric coated.
Claim-2 : The process of making pharmaceutical composition of claim-1 where water absorbent is selected from locust bean gum, psyllium fiber, guar gum and zeolite.
Claim-3 : The process of making pharmaceutical composition of claim-1 further comprising adding adsorbent for inorganic phosphate and an adsorbent for specific uremic solutes other than urea.
Claim-4 : The process of making pharmaceutical composition of claim-1 wherein the said inorganic phosphate adsorbent is selected from aluminium hydroxide gel, calcium hydroxide gel and magnesium hydroxide gel and the specific uremic solute adsorbent is activated charcoal.
Claim-5 : The process of making pharmaceutical composition of claim-1 where the probiotic is selected from a Bifidium or Lactobacillus species.
Claim-6 : The process of making pharmaceutical composition of claim-1 wherein the prebiotic is selected from fructan oligosaccharide and araban oligosaccharide.
50. The essential elements as from claim-1 are:
(i) A probiotic;
(ii) A prebiotic;
(iii) An ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity;
(iv) A water absorbent;
(v) A sorbent for inorganic phosphate;
(vi) An adsorbent for specific uremic solutes other than urea; and
(vii) Microencapsulating or enteric coating the composition.
51. The teachings of page-16 of the complete specification, paragraph-1 reads as â
âIn some embodiments, the probiotic may function to restore normal balance between beneficial bacteria and detrimental bacteria, to remove excess urea-waste product of normal protein metabolism thereby reducing the burden on ailing kidney and to remove ammonia to avert mental retardation and related conditions as well to act as the ammoniaphilic urea degrading microorganism. Thus, in this embodiment, a separate ammoniaphilic urea degrading organism may not be required. Instead in this embodiment, the probiotic and the ammoniaphilic urea degrading organism comprise the same species of bacteriaâ.
52. Therefore, in some embodiments separate ammoniaphilic urea degrading mircoorganism may not be required but rather the same species of bacteria may serve as both a probiotic as well as ammoniaphilic urea degrading microorganism.
53. The summary of the invention clearly describes the synergistic effect achieved by combining together the activated charcoal and inorganic adsorbents in order to reduce the relative proportion of these two components in relation to the probiotic and the prebiotic. The option taught by the invention is between an enteric coating or microemcapsulation and not on whether or not there should be any enteric coating or microencapsulation. The scope of the invention is determined from the claims and not from the summary or from selective parts of the detailed description.
54. According to the respondent, the applicant has not established how the complete specification or the claims are insufficient and therefore does not attract the provisions of Section 64(1)(i) and (h) of the Act. The applicant has not shown how the specific elements of claim-1 are disclosed in prior art.
55. The applicant has further stated that it is incorrect to take any one of the features of the claimed invention and show that it is known in the prior art and therefore lacks any novelty and inventive step. The present invention teaches a method of making a pharmaceutical composition comprising of mixing certain ingredients together followed by enteric coating or microencapsulation. The applicant has not demonstrated how any document either singly or in combination with any other document teaches the invention as claimed. The rest were denied by the respondents.
56. On completion of the pleadings, we heard Mr.G.K.Muthukumar, learned counsel for the applicant and Mr.Essenece Obhan, learned counsel for the first respondent.
Applicants arguments:
57. Learned counsel for the applicant submitted that there were 20 claims for the process patent No.205478. The patent granted was for 10 claims only. The applicant was aggrieved because of the respondents suit for infringement on the basis of the impugned patent. The claims are beyond the scope of the specification.
58. The main grounds of revocation are that there is no inventive step. The invention is a mere admixture and not patentable. The invention is obvious in view of the prior art documents. The complete specification and the claims are totally different. The specification does not mention the process. The process claims have not been clearly defined. The invention is a mere admixture and therefore, not patentable under Section 3(e).
59. The respondents initially filed a patent application in India on 10.05.2002 for the invention titled, âprobiotic and prebiotic compositions and Methods for their use in gut based therapiesâ with a set of six claims. The claims 1 to 10 pertained to pharmaceutical composition whereas claims 11-16 pertained to method claims.
60. The impugned patent as granted however had only six claims all of which pertained to a process of making a pharmaceutical composition by mixing about 5 integers. This is in substitution of all the 16 claims and not supported by any description in the specification as to the claimed process of mixing, the proportion of mixing, the manner, method and means of mixing, the product specification/concentration of the various integers during mixing or in the finished product and the sequence of mixing and the conditions in which the various integers are mixed.
61. The field of invention relates to pharmaceutical compositions and methods of using those compositions. The summary and description deal only with the said pharmaceutical composition and the process of making this composition is not disclosed. The six claims as granted pertain to only a process of making the said pharmaceutical composition by mixing the said integers. The process claims are beyond the scope of the invention.
62. The pharmaceutical composition dealt with in the specification is only a mere admixture resulting only in the proportions of its five constituents. No inter-working or inter relation between each of these products to bring out any great result. No synergistic effect by the combination as a whole. The synergistic effect of charcoal and phosphate is that for the composition as a whole but any of these integers and even this is insufficient as there is no disclosure on the relatively less amount of charcoal and phosphate to be used to a certain proposition of uremic toxins. There is no inventive step which is in the specification from these five integers together.
63. In the background of the complete specification the use of the bowel as a substitute for kidney function is stated as prior knowledge. Administration of oral sorbents and/or encapsulated urease enzyme have been known to execute urinic waste from the gastro intestinal treat. The use of activated charcoal as an oral sorbent from treatment of uremia was also known. Microencapsulation of activated charcoal has been shown to reduce the amount of charcoal required for the above purpose. Ingestion of diclolehyde starch such as oxy starch is known to result in increased excretion of non-protein nitrogen. Locust bean gum which is a naturally available carbohydrate based oral sorbent was known to remove significant amount of urea, creatinine and phosphate in uremic patients. The water absorption property of locust bean gum was also known.
64. Genetically engineered and encapsulated Ehenlicola cells have been known to convert ammonia into usable amino acids. Micro encapsulating the cells have been known to be effective in removal of urea and ammonia. Bacteria belonging to the bifide bacteria species and lacto bacillus species are known as prominent probiotic bacteria. Stereptococcus facium and streptococcus thermophilus are known probiotic. It is also known that the probiotic bacteria excert their effect in a synergistic manner to curtail and retard the growth of pathogenic/detrimental bacteria. The ability of probiotics to ferment prebiotics which are non-digestible food ingredients that beneficially affect the host by selectively stimulating growth of probiotic bacteria in the colon is also known.
65. Prebiotics are known to be relatively of short chain length and the prominent ones are non-starch poly sacaborides, sugar alcohols and resistant starch. Non-digestible oligo saccharides such as inuline type fructanes or lactobase or known to be same of the best prebiotics. Use of probiotics, in particular, lactolacillus acidophilis has been known to curtail over growth and accumulation of uremia toxins and carcinogenic compounds in uremic patients.
66. The background of the patent invention reveals that the use and action of probiotics, prebiotics, activated charcoal and sorbents were all prior known. There is nothing found as inventive in mixing all these together as in claim-1 without obtaining a synergistic effect for the composition as a whole.
67. The impugned invention tends to address elevation of multiple symptoms stating that the mentioned prior arts only tend to address individual uremic solvents or toxins. In this regard, it is submitted that this is incorrect and in the background of the invention itself it is evident that multiple symptoms were alleviated by individual integers of the said composition. From the summary of the invention, it is to provide for integrated, gut-based low cost alternate treatment for renal insufficiency, liver insufficiency inborn error of urea metabolism and gastrointestinal disorders and diseases.
68. There is no disclosure as to how this invention is an alternate treatment as well as nothing is clear on the low cost aspect.
69. A probiotic to remove excess urea which is a waste product of normal metabolism and to remove ammonia so as to avert mental retardation and a related condition. Prebiotics are added to ensure viability of the probiotics so that nitrogen sources are effectively utilised. All these aspects are known as is stated in the complete specification and from the prior arts.
70. Annexure B2, B4, B6 and B7 are PCT search reports.
B2 â teaches microencapsulation
B3 â talks of the use of probiotics and prebiotics
B4 â talks of the use of probiotics and pet foods and read to eat
B6 â talks of the use of sorbents and kidney disorders
B7 â talks of the use of probiotics
They establish prior art and obviousness.
Annexure-C series namely C3, C11, C16, C17, C22, C23 and C24 are enabled and hence, it is obvious.
Annexure D series â D1, D5, D6 and D6 are enabled based on prior art and hence, obvious.
D1 â talks about the use of the effect of probiotics
D5 â read in support of D1 shows that bacteria such as lactobacillus defido bacterium and stereptococcus are prominent probiotics.
D6- talks about the use of the lactobacillus and acidophilus and bacillus as known probiotics (Claims 1 to 5 are directly hit by this prior art)
D8 â talks of excretion and kidney diseases in uremic patients. (Claims 1 and 5 are again directly hit by this prior art)
71. The complete specification further mentions, the use of ammoniaphilic urea degrading microorganism is optional. Therefore use of ammoniaphilic urea degrading microorganism is not an essential embodiment of the invention.
72. The summary states that one embodiment of the impugned invention is a pharmaceutical composition which may comprise â
(1) water sorbent to remove water in diarrhoea and renal insufficiency;
(2) a mixture of adsorbents to remove other nitrogen metabolic wastes and bacterial growth products such as, uric acid, creatinine and guanidines, phenols and indoles,
(3) and/or an inorganic phosphate adsorbent to maintain phosphate balance
All these aspects are prior arts as disclosed in the background of the invention mentioned in the complete specification. All these are optional embodiments and not essential embodiments.
73. A preferred embodiment mentions combining together in a composition activated charcoal and inorganic phosphate adsorbent for synergistic effect. There is only a preferred embodiment and not an essential embodiment, the manner, proportion and sequence of continuing these two substances is nowhere disclosed and the synergistic effect achieved by the whole combination is not sufficiently described so as to enable the invention.
74. The summary of the complete specification mentions that less activated charcoal and inorganic phosphate adsorbent are required when compared to prior art compositions. The use of less activated charcoal and inorganic phosphate adsorbents is very wide and vague. Without mentioning the proportion of reduction in use of activated charcoal and inorganic phosphate adsorbents, the complete specification does not fairly and sufficiently describe the invention and the best method and proportion of mixing these two substances. The summary mentions use of the said pharmaceutical composition in patients with acute or chronic symptoms of uremia for which there is no claim. The pharmaceutical composition is stated to be enteric coated or microencapsulated which is also a prior art.
75. The summary of the complete specification mentions that pharmaceutical composition is useful for preventing or delaying the need for dialysis in kidney patients and to reduce the frequency and/or duration of dialysis. There is no disclosure to substantiate these aspects through appropriate facts, figures and dates. There is nothing to show the inventive step/technical advancement of this pharmaceutical composition over the existing prior art mentioned in the invention.
76. The invention is a pharmaceutical composition comprising (1) a probiatic (2) a prebiotic (3) an ammoniaphilic urea degrading microorganism with alkaline pH stability and high urease activity (4) a water absorbent for inorganic phosphate and (5) adsorbent for specific uremic solute other than urea. The said composition being microencapsulated or enteric coated.
77. The use of each of these 5 integers and micro encapsulation or enteric coating â they are already known as prior art from the background of the invention and the prior art documents. The invention is obvious based on the said prior art. It is obvious due to lack of inventive step as the composition is a admixture having no synergistic effect as a whole. There is no inter-working between the five integers to result in a synergistic effect.
78. The description does not anywhere describe the mixing of the 5 integers. The proportion of mixing, the means of mixing, concentration of each integers for purpose of mixing the sequence, method and condition of mixing have not been described in the complete specification and therefore, hit by Section 64(1)(h) for insufficient disclosure.
79. The impugned invention which is a pharmaceutical composition containing 5 integers of which 3 are optional is not novel, is not a new product, nor does the said mixing or the product is an outcome of it or a technical advancement over the existing prior art. The mixing of the 5 integers and microencapsulating or enteric coating where the use of each integer is priorly known makes the invention obvious to a person skilled in the art.
80. Mixing all the five integers and microencapsulating or enteric coating is nothing but a mere admixture. This is because the said pharmaceutical composition results only in the properties of each of the integers and no new or technically advanced results enclosed as a result of this admixture and therefore, it is not an invention and barred from being patented.
81. The description gives an account of kidney failure and talks of solute removal in the gut in vitro studies which does not describe the process, sequence, etc. of mixing or the composition of the pharmaceutical composition as a whole.
82. Example-1 shows how microencapsulation was performed that to with respect only to oxystarch, locust bean gum, water lock and activated charcoal and individual microbes. It does not talk about the other integer or the sorbents or probiotics in particular. What is the individual microbes is not stated and what proportion and concentration is also not stated. Therefore, this example is also insufficient and does not sufficiently describe the invention. The proportion/quantity or concentration of mixing or sequences and mixing the activated charcoal with inorganic phosphate adsorbent which is stated in the summary to have a synergistic effect is not disclosed. This also does not disclose the relatively low quantity and activated charcoal and inorganic adsorbent required as compared to prior art. The use of the term less is vague and wide in scope and insufficient to enable the invention by a person skilled in the art.
83. Example-2 of the description mentions only microencapsulation of a probiotic and ammoniaphilic bacteria in accordance with the procedure described by Chang and Prakash which is a prior art on the fact of it. It does not deal with the pharmaceutical composition as a whole involving all the five integers.
84. Example-3 merely mentions the probiotic and prebiotic and sorbents were mixed with various food additives to form different formations of the impugned invention. The proportion, manner and method of mixing are not disclosed. None of the food additives have been mentioned. Table-3 only states that in 6 gram dose certain amount of probiotic bacteria locust bean gum, water lock, activated charcoal and inuline are present. The particular probiotic bacteria and prebiotic water absorbent and adsorbents have not been disclosed and whether they are included or not is not known; no way supports the invention. It talks about food composition whereas the invention is for a pharmaceutical composition.
85. Examples 4 and 7 are only in vivo studies and do not support the invention on the claim. Example-5 is missing and found nowhere in the complete specification. Example-6 is only a TNO gastrointestinal model and does not support the invention or establish the aggregated effect of the pharmaceutical composition as a whole.
86. The 16 claims were applied for initially and of these, claims 1 to 10 were for pharmaceutical composition (Product) whereas claims 11 to 16 were for a method of administering this composition (method). All the 16 claims were abandoned during prosecution of the patent and substituted with an entirely different set of six claims which were not for the pharmaceutical composition as dealt with in the description but for a process of making a pharmaceutical composition comprising mixing of five integers where the said composition is microencapsulated or enteric coated. The six claims as granted are unsupported by any disclosure in the complete specification.
87. Claim-1 is the main claim and claims 2 to 6 are ancillary claims. Claim-2 deals with the prebiotic, claim-3 deals with sorbent and adsorbent. Claim-4 deals with inorganic phosphate and activated charcoal. Claim-5 deals with probiotic and claim-6 deals with prebiotic. All the six claims mention that they pertain to a process of making pharmaceutical composition of claim-1 which comprises mixing of all the five integers.
88. The six granted claims pertain to a process of making a pharmaceutical composition and are not supported by any description in the complete specification as to process. The description talks about the composition and not the process of making the composition by mixture.
89. Claims 2, 3 and 4 are vague and wide and not sufficiently defined. The proportion of the elements are not sufficiently disclosed in the specification.
90. Claims 5 and 6 are again too wide. These cannot be two entire species of probiotic bacteria i.e., bifidium and lactobacillus. This is unsupported by a description to show that each bacteria in these two species have probiotic effect.
91. The subject of claims 1 to 6 is not an invention, has no inventive step and thus liable to be revoked. The description talks about a pharmaceutical composition which is a mixture comprising of 5 integers without disclosing the enhanced result and technical advancement of the pharmaceutical composition as a whole. The invention is a mere admixture resulting only in the properties of its integers and is barred from being patented.
92. The applicant relied on the following judgments:
(1)Order of IPAB in OA/8/2009/PT/CH dated 2.11.2012 [Sankalp Rehabilitation Trust v. F.Hoffman La Roche Ag and Another]
(2)F.Hoffman La Roche Ag and Another v. Cipla Limited [2008(37) PTC 71]
(3)Order of IPAB dated 2.12.2012 in Enercon India Ltd. v. Alloys Wobben reported in [2011 (46) PTC 558]
(4)Biswanath Prasad v. Hindustan Metal Industries [(1979) 2 SCC 511]
(5)Press Metal Corporation Limited v. Noshin Sorabji Pochkhana Walla and another [AIR 1983 Bombay 144]
Respondents arguments:
93. The learned counsel for the respondent denied that the complete specification does not sufficiently and fairly describe the invention and the method by which it is performed. The patent comes as a new and inventive process of making a pharmaceutical composition which involves the following steps of mixing certain ingredients, a probiotic, a prebiotic, an ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity, a water absorbent for inorganic phosphate and an adsorbent for specific uremic solutes other than urea and enteric coating or microencapsulating the mixture.
94. The applicant has not shown how the complete specification is insufficient. The specification is meant to be read by a person skilled in the art and any insufficiency must be judged by a person skilled in the art and such person must give evidence of alleged insufficiency.
95. The process of making the pharmaceutical composition of the claims has been disclosed in the complete specification. The patent states that the pharmaceutical composition comprising a mixture of probiotics, prebiotics and ammoniaphilic bacteria with high urease activity and/or sorbents with specific adsorption affinities for uremic toxins and inorganic phosphate along with a water sorbent. Composition comprising these mixtures are enteric coated and/or microencapsulated.
96. The patent discloses examples of various ingredients of the mixture â
| 1. | Probiotic | Bifidium bacteria species, lactobacillus species. |
| 2. | Prebiotic | Inuline, fructan oligosaccharide, lactobase and other vegetable fibres. |
| 3. | Ammoniaphilic urea degrading miroorganism with high alkaline pH stability and high urease activity | Sporosarcina urea, bacillus pasteurii, trained lactobacillus and bacillus species and novel lactobacillus KB-1 or other suitable bacillus species |
| 4. | A water absorbent for inorganic phosphate | Aluminium hydroxide gel, calcium carbonate or calcium acetate, magnesium hydroxide gel, psyllium fibres, locust bean gum, guargum or modified starches.` |
| 5. | An adsorbent for specific uremic solutes other than urea | Activated charcoal. |
| 6. | Enteric coating | Material used â Zein, polyglycolactic acid, polylactic acid, polylactide-co-glycolide. |
| 7. | Microencapsulation | Material used â Alginate/alginic acid, chistosan, cellulose acilate phthalate, hydroxyethyl cellulose. |
| 8. | Method of enteric coating | Example-1 discloses the method of enteric coating of the mixtures generally and the sorbents specifically. |
| 9. | Method of microencapsulation | Example 1 and 2 disclose the method of microencapsulation of sorbents, probiotics and ammoniaphilic urea degrading microorganism. |
| SNo. | Component/ Ingredient | Claim element | Range (gms) | Most preferred amount (gms) |
| 1 | Probiotic Bacteria | Probiotic bacteria and an ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity (embodiments wherethe probiotic bacteria and ammoniaphilic urea degrading microorganism is of the same species) | 5-20 | 12.5 |
| 2. | Locust bean gum | A water sorbent for inorganic phosphate | 10-20 | 15 |
| 3. | Waterlock | Water absorbent | 1-5 | 3 |
| 4. | Activated charcoal | Adsorbent for specific uremic solutes other than urea | 0.5-2 | 1 |
| 5. | Inulin | Prebiotic | 1-10 | 5 |
99. The counsel commented on the conduct of the applicant that in spite of the requests made by the respondent for the copy of the patent application said to be filed by them, the applicant had not produced any such. In the legal notice dated 5.10.2010, they had stated about the impugned patent herein. In their reply dated 19.05.2010, the applicantshad stated that they were incorporated on 7.8.2010. They have been using the product CUDO with the present composition since 8 months. The product CUDO is a result of highly skilled research and development team. Their composition and process of manufacturing is very unique, superior and first of its kind in India and therefore, cannot be disclosed as they were in the process of getting the patent. The efficacy of their product differs and is superior to the respondents products with regard to side effects.
100. In both enteric coating and microencapsulating example 3 is not as what was claimed but also could be used. Probiotic is used in the same manner as microencapsulation.
101. Claims 1 to 10 are limited to method. Example 5 teaches of method to product. Case T-0674/02-3310 â Board of Appeal of the European Patent Offices speaks about product to method if possible.
102. The counsel also submitted that change of category from the granted product claim to the claim of auxiliary request concerning a process does not amend the patent -- T-0554/98-324 â Board of Appeal of the European Patent Office.
103. D1 filed along with the application for rectification is of the year 2007 which will not help the applicant.
104. D5 relied on by the applicant â there is nothing about the elements relied on by the patentee. Probiotics is known and nothing more and so not relevant. This document is of the year 1990. D6 is of the year 1997 which only talks of some supplement to a person undergoing dialysis. C3 document relied on by the applicant was not relevant as it was tested on broiler chicken. C-17 is also not relevant. C-23 is about Freeze Dried Loctobacillus which does not describe probiotic and also about the mixture and so not relevant. C-24 does not mention about the sorbents.
105. Application â no affidavit who is the author not known. There is no Board resolution filed.
106. The counsel relied on Sabaf SpA (a company incorporated under the laws of Italy) v. MFI Furniture Centres Limited and others [(2004) UKHL 45] for admixture. He contended that as per the EPO guidelines the invention claimed must normally be considered as a whole. Process is not a substance under Section 3(e); not a mere admixture.
107. Lallubhai Chakubhai Jarivala v. Shamaldas Sankalchand Shah [Manu/MH/0203/1934= AIR 1934 Bom 407] â A new combination may be the subject matter of a patent although every part of the combination per se is old, for here the new article is not the parts themselves, but the assembling and working them together, what exhypothesis is new. If the result produced by such a combination is either a new article or a better article, or a cheaper article then before such combination is an invention or a manufacture within the statute and may well be the subject matter of a patent.
108. B-4 does not teach about coating material. It contains the probiotics in the coating and not like the one in this case. This is different and not relevant. Probiotic is capsulated. T-1503/05 â 33.04 â With the change in the granted claim, the patent shall be maintained. Coating is only to increase the selfline. It is totally different in enriching the target. B-5 â refers to dialysis machine and not as to what has been claimed. B-7 â Here it is antibodies and probiotics which is again not relevant. Mere combination is not correct.
109. The applicants have not filed any expert evidence or affidavit to support admixture or obviousness.
110. There is no specific averment as to on what ground the prior art documents were filed. Evidence as well as clear material is missing. The counsel then relied on the judgment of IPAB dated 12.6.2012 in ORA/18/2010/PT/MUM ( Tata Chemicals Ltd. v. Hindustan Unilever Ltd. and anr.) to state the fact as to the role of an expert.
111. Next ground of insufficiency was not substantiated. The specification is meant to be read by a person skilled in the art and any insufficiency must be judged by the person skilled in the art and such a person should give evidence of the alleged insufficiency.
112. The complete specification sufficiently and fairly describes the invention and the method by which is to be performed. A person skilled in the art would understand the process claimed in Claim-1 comprised of first mixing the probiotics, prebiotics, ammoniaphilic bacteria with high urease activity water sorbent for inorganic phosphate and a sorbent for specific uremic solution other than urea and the microencapsulating or enteric coating the mixutre. The person skilled in the art would also be able to select the probiotic, the prebiotic, the ammoniaphilic bacteria with high urease activity, the water sorbent for inorganic phosphate and the sorbent for specific uremic solution other than urea that is required to be used in the claimed process for the examples given in the specification of the patent. Such a person would also, upon reading of the specification, know how to enteric coat or microencapsulate the mixture according to the claimed process.
Applicants rejoinder:
113. The applicant in the rejoinder submitted that new documents like emails exchanged between the parties cannot be filed at the final hearing stage. Moreover, the documents filed now at this stage have no relevance with respect to the instant patent revocation. The submission about Dr.Ranganathan has no relevance to the patent impugned herein as various scientists have worked on probiotics since 1970 and any work on the same cannot be a criteria to obtain a patent.
114. The documents filed by the applicant are supported by pleadings. The respondents approached the court in the suit against the applicant. In reply to the respondents submission that the wrong set of claims were challenged i.e., as filed and not as granted, the applicants stated that the claims as filed or as granted cannot go beyond the scope of the invention as disclosed. The grounds for the claims as filed hold good for the claims as granted; so it makes no difference which set of claims were challenged. The respondent is estopped from raising this issue as it was this respondent who filed the suit and this was the cause for the applicant challenging the claims as filed. Because, the respondents had relied on the claims as filed in the infringement suit filed before the Honble High Court of Madras.
115. Each capsule acting as a mini kidney is totally false because these do not do the entire functions of the kidney which apart from water and nitrogenous waste removal are to regulate blood pressure, to produce hormone erythropoietin, to maintain electrolyte balance, to involve in bone metabolism. This may prove falsity of scope of the impugned patent.
116. Prior art documents D1, D5 and D6 have been cited for the purpose of showing that use of probiotics and prebiotics in removing nitrogenous wastes including ammonia NDMA, serum cholesterol was known beforehand and not for any other purpose. These documents may deal with other issues which are not material to this case.
117. Prior art documents C3, C17, C23 and C24 have been cited for the purpose of showing that use of probiotics and prebiotics in removing nitrogenous wastes including ammonia, urea, blood cholesterol, DMA, NDMA was known beforehand.
118. The respondents made costly incurable mistakes of omitting to mention an example in the specification and state that ingredients in claims are incorrect. The respondent made an incurable defect of claiming âcalcium hydroxide gel as a phosphate absorbentâ in claim-4 as granted which instead they argued as to be a mistake. The calcium hydroxide gel should have been calcium acetate and calcium carbonate instead. Thus, the patent need to be revoked under this very fallow claims of the patentee.
119. B4, B5, B7 and B2 â these prior art documents clearly teach the invention. The respondents have just put together all information collected from various prior art documents and come up with this specification. There is no novelty, it is not new and there is no inventive step. Adding of charcoal is not sufficiently disclosed. No technical advancement is clearly demonstrated. No synergistic effect is forthcoming. The respondent claims that in the present impugned invention, less quantity of activated charcoal is required than the prior arts and this is the synergistic effect.
120. What is the quantity of charcoal reduced is not forthcoming, and even if the quantity is reduced in the present composition still that cannot be claimed to be a synergistic effect. The rationale for the same is an admixture wherein other components have the same roles as of charcoal, will understandably reduce its quantity. Reduction in the quantity of charcoal with co-administration with absorbents are already known.
121. The invention tells of a composition whereas the claim is for a process. On this preliminary ground, the patent deserves to be revoked.
122. There is no new function or effect coming out of the entire mixture of the five integers. The function of the composition is that of its constituents and it has no new function distinct and different from that of its constituents. It is therefore barred under Section 3(e).
123. Putting together all these integers is obvious to a person skilled in the art based on the prior art, it has no inventive step.
124. The reduction in the use of activated charcoal, the comparative parameters to demonstrate reduction are not forthcoming. The other elements in claim 2 to 4 are not clearly and sufficiently described in the specification. The scope of claims 5 and 6 are too broad, vague and not clearly demarcated, apart from being struck by prior art.
125. The 6 granted process claims are totally unsupported by any disclosure in the specification. The chart filed by the respondent in the written submissions does not show the inter working, interrelationship of the 5 integers forming the composition on the synergistic effect achieved by the composition as a whole.
126. The counsel for the applicant relied on the following judgments in support of his contentions:
a) Order of IPAB dated 2.11.2012 in Sankalp Rehabilitation Trust v. F.Hoffman La Roche Ag and Anr.
b) F.Hoffman La Roche Ag and Anr. v. Cipla Limited [2008 (37) PTC 71]
c) Enercon India Ltd. v. Alloys Wobben [2011 (46) PTC 558]
d) Biswanath Prasad v. Hindustan Metal Industries [(1979) 2 SCC 511]
e) Press Metal Corporation Limited v. Noshin Sorabji Pochkhana Walla and another [AIR 1983 Bombay 144]
127. We have heard and considered the arguments of both the counsel and have gone through the pleadings and documents.
Invention:
128. The invention is related to pharmaceutical composition and the method of using the composition to treat renal hepatic and gastrointestinal diseases. It only deals with the pharmaceutical composition and nothing is stated as to the making of this composition. The process of making this composition is not disclosed.
129. Example-1 talks about the performance of micro-encapsulation with respect only to oxy-starch, locust bean gum, water lock and activated charcoal and individual microbes and does not talk about the other integer or the sorbents. The example also does not describe the mixing proportion and also does not give the outcome of such mixing. The synergistic effect is therefore not outcoming. The example is therefore insufficient.
130. Example-2 describes micro-encapsulation of a probiotic and ammoniaphilic bacteria as mentioned in procedure description by Chang and Prakash which is a prior art. Here again, it does not mention the proportion of mixing.
131. Example-3 describes the mixing of probiotic and prebiotic and sorbents with various food additives which again does not disclose the proportion manner and method of mixing. None of the food additives has been mentioned. The particular probiotic bacteria and the probiotic water absorbent and adsorbent have not been disclosed. The example talks about food composition whereas the invention talks about the pharmaceutical composition.
132. The other examples do not support the claimed invention.
133. It is seen that initially there were 16 claims when application was filed, but different set of six claims were granted. This set was not for pharmaceutical composition as mentioned in the description but for a process for making the pharmaceutical composition. The said composition is micro-encapsulated or enteric coated.
134. The claim-1 is the main claim and the other claims 2 to 6 are ancillaries. The claims 2 to 6 deal with prebiotic, sorbent and adsorbent, inorganic phosphate and activated charcoal, probiotics and prebiotics. They deal with the process of making pharmaceutical composition comprising of the mixing of all five integers. This is not supported by any description which only talks about a pharmaceutical composition and not about a process of making the said pharmaceutical composition by mixing the said integers. The proportion of the mixing has not been sufficiently disclosed in the specification.
135. There is nothing described to show that the entire species of probiotic bacteria have probiotic effect as seen in the claims 5 and 6.
Lack of inventive step:
136. The respondents main contention was that though the applicants have averred that the impugned patent consists of all that was known from the prior art documents, no inventive step and that it was obvious were not substantiated by proper documents. We shall now deal with prior art citations one by one.
137. The B-series documents were relied on by the applicants to say that a probiotic to remove excess urea which is a waste product of normal protein metabolism and to remove ammonia so as to avert mental retardation and a related condition. Prebiotics are added to ensure viability of the probiotics so that nitrogen sources such as urea and ammonia are effectively utilised. These aspects were already known from the specification background and from the prior art document, when it is known that it is obvious.
138 B1 document is the international preliminary examination report of the year 1998. It refers to the US patent 569, 099, 568, 988. US patent 568 teaches that the micro encapsulated lactobacilli survive in sufficient numbers the exposure to gastric acid while travelling through the stomach and reach the lower intestines where they help establish or re-establish a healthy bacterial flora and eliminate or alleviate the symptoms of antibiotic associated diarrhoea. The claim in that document also teaches us the composition of micro encapsulated lactobacilli bacteria of the lactobacillus acidophilic species.
139. US patent 569 which is again of the year 1999 is about the pet food product containing probiotics. The probiotic microorganism is selected from bacillus coagulans, bacillus licheniformis, bacillus subtilis, bifidobacterium spp, pediococcus acidilactici, saccharomyces cerevisiae and enterococcus faecium. The food includes a component chosen from the group consisting of insulin and fructooligosaccharide, a coating containing a probiotic microorganism. The impugned invention also relates to pharmaceutical composition comprising a mixture of probiotics, prebiotics and ammoniaphilic bacteria with high urease activity and/or sorbents with specific adsorption affinities for uremic toxins such as creatinine, uric acid, phenols, indoles, middle molecular weight and inorganic phosphate along with a water sorbent for use in the alleviation of uremia. In a preferred embodiment, the composition comprises a probiotic bacteria, a prebiotic such as, insulin, a fructooligosaccharide, lactulose and other vegetable fibres, an ammoniaphilic urea degrading microorganism with high alkaline pH stability and high urease activity and adsorbents such as locust gum with a specific adsorption affinity for creatinine and urea, actiated charcoal with a specific adsorption affinity for creatinine, guanidines phenol, indicant and middle molecular weight undefined compounents and water absorbents such as psyllium fiber, guar gum and locust bean gum. All these were known in US patent 569. Although it does specifically teach, it was anticipated.
140. US 988 teaches the composition for promoting gastrointestinal health comprising an effective amount of lactobacillus and bifidobacterium, inhibit toxic activities of bacteria in patients with chronic kidney failure.
141. The impugned patent talks about alleviating multiple symptoms at the same time. The specification that the prior art addresses only intermittent uremic solutes is not correct. Urea and ammonia levels in blood are found in the patent impugned. The invention that it reduces the uremic toxins is already known and is a prior art.
142. The reducing of urea contents as a result of this probiotic composition was also known earlier. The composition of the integers in treating gastrointestinal disorders was also found in the prior art document.
143. Different probiotic species are defined for lactobacillus species in the patent. All these are known and the impugned patent is only an admixture of the known probiotics. The 3 probiotics found in the patent were already seen in the prior art document US 677504.
144. The impugned patent is for treating kidney dysfunction and hepatic patients which again is well known and is a prior art.
145. The D-series documents are dealt with about the probiotics and the effects thereof. D-5 document is of the year 1990 which speaks about the probiotics namely, lactobacillus, defido bacterium and streptococcus. Accordingly, these probiotics are prominent and the use of these was known.
146. D-8 document teaches about the use of these prominent probiotics and was already known. This teaches that patients with chronic kidney disease often suffer from small bowel bacterial overgrowth which is accompanied by production of toxic amines such as dimethylamine. These toxic amines cause general chronic renal failure symptoms as well as target organ dysfunction. The researches have concluded that NCFM changed small lower pathobiology by modifying metabolic action of SBBO, reducing generation of toxins and carcinogens with no adverse side effects. This was again known what was claimed in claims 1 and 5.
147. In one embodiment, pharmaceutical composition of the present invention may further comprise a water sorbent to remove water in diarrhoea and renal insufficiency, a mixture of adsorbents to remove other nitrogen metabolic wastes and bacterial overgrowth products such as, uric acid, creatinine and guanidines and phenols and indoles and/or an inorganic phosphate adsorbent to maintain phosphate balance. The components are only optional and not essential, whereas in a preferred embodiment, activated charcoal and inorganic phosphate adsorbent are combined together in the composition for synergistic effect and to reduce the relative proportion of these two components in relation to the probiotic and prebiotic. Further, since the probiotics and prebiotics remove most of the urea and curtail bacterial overgrowth so that the amount of other normal nitrogen waste products and bacterial end products are reduced minimal, less activated charcoal and inorganic sorbents are required as compared to prior art components.
148. The applicants in this regard submitted that the proportion of reduction in use of the components are not sufficiently described in the invention. The pharmaceutical composition is used in the patients with acute and chronic symptoms of urea is mentioned in the summary classification which is not found in the claim.
149. The specification states that the pharmaceutical composition is administered to a subject with uremia, it is meant that the composition removes sufficient levels of uremic toxins such that a patent suffering from uremia either does not require dialysis, requires dialysis less frequently or for shorter durations or does not require initiation of dialysis. This is not clearly substantiated. By what is this arrived at or by this composition is there a technical advancement has not been clearly stated in the specification.
150. The invention is obvious based on the prior art as the use of each of the integers and micro encapsulation or enteric coating are already known from the background of the invention. There is no interworking between the integers to result in a synergistic effect.
Mere admixture:
151. The claims as granted speak of the process of making the composition by mixing the integers. The five integers are known much prior to the filing of this patent. A mere admixture of such nature does not involve any inventive step. There is no mention of the working of these products so as to having any great result. So, no synergistic effect could be achieved by the combination as a whole and therefore, there is no inventive step in mere combination of known integers.
152. The pharmaceutical composition containing 5 integers is not a new product, nor the mixing of the products advance any technical effect over the existing prior art. Thus, it makes the invention obvious to a person skilled in the art.
153. The mixing of the 5 integers is only a mere admixture. There is no invention as per the provisions of the Act. The description gives an account of kidney failure and talks of solute removal in the gut in nitro studies which does not describe the process of mixing the pharmaceutical composition as a whole. There is nothing new or there is no technical advancement in the mixing of these integers and therefore, not an invention.
154. With these above mentioned observations, we think the original revocation application deserves to be allowed and the patent granted be revoked. Accordingly, the original revocation application is allowed with costs of Rs.20,000/-. M.Ps. are disposed of as the main matter itself has been decided.