INTELLECTUAL PROPERTY APPELLATE BOARD
Guna Complex Annexe-I, 2nd Floor, 443, Anna Salai, Teynampet, Chennai-600018
CIRCUIT BENCH AT MUMBAI
ORA/29/2011/PT/MUM
AND
M.P.NO.90/2012 & 130/2012 IN ORA/29/2011/PT/MUM
WEDNESDAY, THIS THE 13TH DAY OF NOVEMBER, 2013
Hon'ble Ms. S. Usha
…Vice-Chairman
Hon'ble Shri D.P.S. Parmar
…Technical Member (Patents)
La Renon Health Care Pvt. Ltd.,
No.5, Ashwamegh Estate,
Sarkhej – Bawla Highway,
Sarkhej, Ahmedabad – 382 210,
Gujarat.
… Applicant
(Represented by – Shri G.K. Muthukumar)
Vs.
1.
2.
Kibow Biotech Inc.,
Rep by its Senior Vice President (R&D),
Dr. N. Ranganayhan,
New Town Business Centre,
4629, West Chester Pike,
Newton Square, A 19073, USA.
…Respondent No.1
The Controller of Patents
Patent Office, Government of India,
Boudhik Sampada Bhawan,
S.M. Road, Antop Hill,
Mumbai - 400 037.
…Respondent No. 2
(Represented BY – Shri Essence Obhan for R1)
ORDER (No.262 of 2013)
Hon’ble Shri D.P.S. Parmar, Technical Member (Patents)
The application for revocation of patent No.224100 granted to
Kibow Biotech Inc., for the invention “Compositions for Augmenting Kidney
Function” is filed by La Renon Health Care Pvt. Ltd.
2.
This patent application is based on PCT application claiming priority
of US application No.10.676,622 filed on 30/09/2003.
2
Preliminary objection
3.
The counsel for the respondent contended that the revocation
application has not been filed in prescribed format under rule 3 of the
IPAB (patent procedure) Rules 2010.The counsel submitted the
revocation is against the wrong set of claims. The Respondent filed a
Miscellaneous petition MP 90/2012 to dismiss the revocation application in
limine as it is struck with an infirmity which goes into the root of the matter.
The learned counsel also pointed out that Affidavit signed by Mr Ankit
Shyam is defective as pages 12 to 20 are missing. In absence of proper
affidavit no evidence can be relied on.
MP NO.130/2012
4.
The applicant filed Miscellaneous Petition No.130/2012 for taking
on record additional documents referred as X1 to X10.The applicant
contended that perusal of X1-X9 shows suppression of material facts and
status of form 3 by respondent. The respondent denied the allegations
and submitted that amendment to Form 1 and Form 3 were made by
submission of petition on Form 13 on 2.05.2006 and further amendments
of Form 1, 3 and 5 was done on 14.08.2008 in response to first
examination report of the IPO.
5.
The respondent raised the issue of large number of documents
submitted along with the reply affidavit by the applicant. The counsel for
the respondent contended that the applicant had filed only 10 documents
along with the original application for revocation and now added 33 more
prior art documents for which there are no pleadings and no grounds, thus
putting extra burden on the respondent. The counsel for the applicant
submitted that „it is for the 1st respondent to peruse, the documents filed
by the applicant and to appreciate them and it is not for the applicant to
highlight or point out in the pleadings of the applicant to the 1st
3
respondent. This is not the practice in any Court or forum in India. On the
other hand highlighting and pointing out important aspects /points in the
pleadings and documents is done by counsel during argument for
convenience of the Court and not in the pleading.‟ Here we would like to
impress upon the applicant counsel that bald assertions in pleadings and
filing of documents is not sufficient in patent in revocation if the ground
under section 64(1)(d)[Not an invention] , 64(1)(e)[ Anticipation and 64(1)
(f) [obviousness] are taken. Plain reading of these provisions suggests
that opening words ‘that the invention so far as claimed in any claim’
requires the comparison of the prior art documents with the claimed
invention to establish these grounds. The onus of establishing the
relevance of document lies on the applicant. Counsel‟s argument cannot
substitute pleadings.
6.
Reverting back to the argument of the counsel of the applicant, we
find as many as 44 prior art documents have been filed referring to as
Annex B (WO 02/091833), Annex C (IN patent 205478), D-Series D1 to
D9 along with the application. Documents referred to as B1, B2, B3, C1 to
C25, D, E, F, G, H and I were filed along with the reply affidavit .The
counsel relied on AIR 2001 SC 1158 – Bipin Shantilal Panchal vs. State
of Gujarat - relating to admissibility of evidence .
7.
The applicant sought revocation under Section 64(1)(d), (e), (f), (h),
(i), (j), (k) and (q). During the argument only the ground of obviousness
was raised by the counsel for the applicant based on documents in B(B2),
C(C3, C17 and C23), and D series (D1, D2, D5, D6 and D8) in particular
B2, C17, D5 and X10 and the IN 205478.This being the case the applicant
has abandoned most of the 44 documents filed to establish the grounds of
revocation. We find this quite burdensome on the respondent. We do not
agree with the applicant that his duty ends just by filing the documents.We
4
urge the Bar to bear this in mind that filing of large number of additional
documents with reply to counter statement is not fair. Further every prior
art citation must be dealt by the applicant in the pleadings stage itself and
it must be compared with the invention so far as claimed in any claim to
substantiate the grounds taken for revocation. If this is done it provides fair
opportunity to the respondent to present his case.
8.
It is pertinent to note that the revocation application was based on
the claims 20 in number as originally filed instead of 10 claims as granted.
The respondent raised this issue. The applicant submitted that the
patentee has sought the relief relating to infringement on the basis of
application as filed which misleads the applicant to file the revocation
application based on the claims as filed.
9.
Though both of the parties agreed to argue the case based on the
10 claims as granted we would like to point out here that the patentee
cannot claim ignorance of the claims as granted. We will keep in mind the
conduct of the patentee who sought relief in a suit on the basis of
application as filed. We have requested time and gain to the Bar that
while filing a revocation application a certified copy of the patent
specification as granted shall be filed along with the application.
We
reiterate it again. We are also directing the Registry to raise objection in
case a certified copy of the impugned patent specification is not attached
with the application for revocation. Had this been done, this confusion
could have been avoided.
10.
The applicant is marketing the product under the brand name
CUDO. A Civil Suit C.S. No.498/2011 before the Hon‟ble Madras High
Court was filed by the Respondent alleging infringement of patent
Nos.205478 and 224100. The said suit was dismissed by the Hon‟ble
5
Madras High Court vide order dated 22.08.2011 due to non-maintainability
of the suit under section 599 of the Companies Act as per the provisions
of Order 7 Rule 13 Code of Civil Procedure. The Hon‟ble Court however
said the plaintiff is entitled to bring a fresh suit after curing the defects of
Section 599 of the Companies Act.
11.
The counsel for the respondent submitted the background of the
invention as follows .
“The human body contains several trillions of bacteria at any given
point in time. These bacteria can be classified into "good" bacteria
(termed as probiotics) and "bad" bacteria (termed as pathogens).
While the "bad" bacteria (pathogens), are the organisms referred to
as "bacteria" in popular parlance, which causes diseases and
infections, the "good" bacteria (probiotics) contribute to good health
by performing functions such as digestions and the removal of
toxins, without which .it would not be possible to survive.
Accordingly, any attempt to improve the quality of the body's
digestive process and excretion process must aim at boosting the
efficiency of the "good" bacteria. The Respondent's research has
special significance for countries like India which are witnessing
increasing numbers of patients with kidney failure who cannot
afford kidney transplants. The Respondent's research in
maintaining kidney health is therefore critical to preventing and
reducing the increasing incidences of kidney failure in India.
A composition for augmenting kidney function in a subject
comprising at least one probiotic bacterium wherein said probiotic
bacterium selected from Streptococcus thermophilus at about 5
billion to about 20 billion colony forming units of said at least one
probiotic bacterium other ingredient being selected from vitamin,
mineral, carbohydrate, protein and fats."
This invention forms the core component of the Respondents best
selling probiotic, Renadyl (formerly known as Kbow Biotics). Each
capsule of Renadyl, as Presently sold, has approximately 30 billion
CPU of a blend of Streptococcus thermophilus,
Lactobacillus
acidophilus and Bifidobacterium iongum. Additionally, psyllium
husk is added as an absorbent for water and phosphate.
ln the human body, an equilibrium of urermic toxins normally exists
between blood and the colon's lumen (Gi tract) which is higher
during conditions in the bowel. The enteric probiotic composition of
Indian patent No. 224100 utilizes these toxins to grow and a
gradient concentration is generated which drives a passive diffusion
of more toxins from the blood to the colon's lumen. The actual
mechanism takes place in the large intestines. 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 numbers of these toxins diffuse into the colon
6
because of the extensive network of blood vessels surrounding it.
Following a journey in the upper Gl, the probiotic microbes are
released from an enteric coated capsule and enter the large
intestine into the ileo-caecal 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 metabolize them as nutrients. As they metabolize
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 metabolized toxins are carried down through the
bowel and out of the body as solid waste, sparing the compromised
kidneys of the burden.”
12.
If we see the complete specification the problem is stated as
follows
“In normal, healthy humans, metabolic waste nitrogen is primarily
excreted via the kidneys as urea, uric acid creatinine, etc. in the
urine. However, in individuals with kidney disease, as well as a
number of other diseases such as inborn errors in urea cycle
enzyme deficit, waste nitrogen accumulates in the body thereby
manifesting toxic symptoms. Hyperammonium can lead to mental
retardation and, in severe cases, coma.
Hemo-or peritoneal-dialysis and renal transplant are the only
treatment modalities. However, the economic costs of these
treatment modalities are extremely high. For example, in 1996 in
the United States alone, the annual cost of end stage renal disease
(ESRD) treatment was over 14 billion dollars. In developing and
underdeveloped countries with low health care budgets, ESRD
patients are deprived access to such treatments due to their high
costs.
Accordingly, there is a need for alternative modalities of
treatment for uremia.
A number of treatment attempts have been based on the use of the
bowel as a substitute for kidney function.
During a normal digestive process the gastrointestinal tract delivers
nutrients and water to the bloodstream and eliminates some waste
products and undigested materials through the bowel. The
intestinal wall regulates absorption of nutrients, electrolytes, water
and certain digestive aiding substances such as bile acids. The
intestinal wall also acts as a semi permeable membrane allowing
small molecules to pass from the intestinal tract into the
bloodstream and preventing larger molecules from entering the
circulation.
Nitrogenous wastes such as urea, uric acid, creatinine and uric
acid, along with several other small and medium molecular weight
compounds, flow into the small intestine and equilibrate across the
small intestine epithelium.”
7
The specification further disclosed
“Use of probiotics such as Lactobacillus acidophilus has been
suggested to curtail the bacterial overgrowth and the accumulation
of uremic toxins and carcinogenic compounds. Unabsorbable
carbohydrate in the diet of uremic patients has also been shown to
increase fecal nitrogen.
Use of lactulose and dietary fiber has also been shown to reduce
plasma urea 11 to 27% and increase fecal nitrogen excretion to 39
to 62% (Lange (1997) Nature Med. 3: 2-3).
One of the major deficits of these prior art approaches, however, is
that they tend to address individual uremic solutes or toxins.
However, proper clinical management of renal, hepatic and
gastrointestinal diseases or disorders actually requires alleviation of
multiple symptoms. The present invention provides compositions
and methods for augmenting kidney function.”
In summary of invention it is stated
“The present invention relates to a composition for augmenting
kidney function in a human or animal subject. The composition
contains at least one probiotic bacterium which reduces creatinine
and BUN levels in the subject. In particular embodiments, the
probiotic bacterium is a species from the genera Lactobacillus,
Bacillus, or Streptococcus, Bifidobacterium. In other embodiments,
the composition further contains at least one carbohydrate, at least
one fat ingredient, at least one protein ingredient, at least one
vitamin component, at least one mineral component, or at least one
prebiotic. In another embodiment, the composition provides about 5
billion to 20 billion colony forming units of the probiotic bacterium.
The present invention further relates to a method for augmenting
kidney function using a probiotic composition so that build up of
toxins and metabolic wastes, and overgrowth of undesirable
bacteria is reduced in the subject thereby augmenting kidney
function. In particular embodiments, the probiotic composition
alleviates the symptoms of uremia ; the increased creatinine or
BUN levels in subjects undergoing cancer, HIV or AIDS
chemotherapy treatment; the increased creatinine or BUN
levels in subjects with metabolic syndrome; or the symptoms
of increased creatinine or BUN levels in subjects consuming
high protein and low carbohydrate diets.”
Accordingly the
“The present invention provides a composition for augmenting
kidney function, particularly in subjects with renal insufficiency,
comprising at least one probiotic bacterium wherein said probiotic
bacterium reduces creatinine and BUN levels in the subject. The
composition may comprise an enteric coating so that the
composition reaches the intestines of the subject when ingested
orally.
8
Alternatively, the composition can the form of marketable
nutriceuticals, dietary supplements and powders, health bars,
yogurts, tablets, dry foods, and pet formulations.”
Further it is stated that
“Compositions of the present invention can further contain a
phosphate binding agent such as aluminum hydroxide gel, calcium
carbonate or calcium acetate, magnesium hydroxide gel and/or a
water binding agent such as psyllium fibers, naturally occurring
gums such as locust bean gum, guar gum or modified starches.
Compositions of the present invention can further contain at least
one carbohydrate, at least one fat, at least one protein, and/or at
least one prebiotic bacterium.
While such additional additives can be combined with the one or
more probiotic bacteria and administered in the form of a capsule,
gel cap, or pill, it may be desirable to formulate the composition into
a nutritional food or nutritional food product.”
It is also specified in the specification that
When a probiotic bacterium is S. thermophilus, it is desirable
that the S. thermophilus strain used is K9, K19, or K25. These
probiotic, urealytic isolates were isolated from different food
sources and characterized in vitro by assessing their ability to
catabolize urea while proliferating in simulated gastric juice (Table
1) and simulated intestinal fluid (Figures 1A-1C).
It is further disclosed that
“It has been found that probiotic bacteria are effective in ranges of
from 109 to 1011cfu (colony forming units). For instance,
Lactobacillus acidophilus is of particular useful between 10 9 to 1010
cfu, whereas B. longum is desirably used between 10 9 to 1010 cfu,
and S. thermophilus between 1010 to 1011 cfu. See Table 3 of
Example 1. In general, the composition of the present invention
provides about 5 x 109 to about 2 x 1010 cfu of viable bacteria.
In particular embodiments, the composition will contain about 5 x
109 to 9 x 109 CFU. In other embodiments, the composition will
contain about 6 x 109 to 8 x 109 CFU of viable bacteria. One skilled
in the art can routinely determine the appropriate ranges of the
probiotic bacteria based upon desired application and use.”
To illustrate effectiveness of the composition, in the specification stated
that
“To illustrate the effectiveness of using a probiotic bacterium to
reduce nitrogenous waste build up due to renal failure, probiotic
compositions were fed to uremic rats. Sprague-Daly rats weighing
281.20±41.6 gm were subjected to 5/6th nephrectomy after
measurement of baseline weight, BUN, serum creatinine, urine
volume and fecal flora composition. The study group consisted of
36 nephrectomized rats (18 male and 18 female) with sufficient
renal impairment (serum creatinine^. 0±0. 4) and 6 controls. The
rats were distributed into 6 matched groups (GP), ANOVA showed
no significant difference between groups (p=0.516) at baseline.
After a two-week post surgery stabilization, the cohorts of six rats
9
were fed standard rat chow plus one of the following regimens: 1)
placebo; 2) B. pasteurii; 3) L. sporogenes ; 4) L. acidophilus, L.
bulgaricus, B. bifidus, S. thermophilus, L. casei, and L. reuteri; 5)
L. acidophilus, L. bulgaricus, B. bifidus, S. thermophilus ; and 6) S.
boulardii. A control group of non-nephrectomized rats (n=7, serum
creatinine^. 2±0. 1) received the same food without any
supplement. All of the control rats survived and had serum
creatinine levels at the end of the study of 0. 50. 1. For the
experimental animals, blood, urine, and fecal measurements were
obtained every 30 days for a total of 120 days. Days of survival was
the primary endpoint variable (Table 2).”
Further it is stated in the specification that
“Probiotic bacteria of the present invention are living
microorganisms that are naturally present in the gastrointestinal
tract of humans and animals. They are beneficial bacteria that
enhance the body's defenses against a number of health
conditions. A probiotic bacterium useful in the present invention
includes: Lactobacillus sp. such as L. acidophilus, L. bulgaricus, L.
casei, L. rhamnosus, L. fermentum, L. salivaroes, L. brevis, L.
plantarum, L. ruteri, or L. sporogenes; Streptococcus sp. such as
S.thermophilus ; Bacillus sp. such as B. pasteurii; and
Bifidobacterium sp. such as B. adolescentis, B. infants, B. Iongum,
B. thermophilus, or B. bifidum. “
Further in particular embodiment it is stated in the specification that
“In particular embodiments, the probiotic bacterium comprises one
or more of the following : L. bulgaricus, S. thermophilus, L.
acidophilus, L. sporogenes or B. bifidum. In other embodiments, the
probiotic bacterium exhibits high urease activity (e. g., B. pasteurii
or S. thermophilus).”
13.
Before we proceed further, let us see the claims as granted.
“1. A composition for augmenting kidney function in a subject
comprising at least one probiotic bacterium wherein said probiotic
bacterium selected from Streptococcus thermophilus at about 5
billion to about 20 billion colony forming units of said at least one
probiotic bacterium other ingredient being selected from vitamin,
mineral, carbohydrate, protein and fats.
2. The composition of claim I, wherein the Streptococcus
thermophilus is strain KB4, KB19, or KB25.
3. The composition of claim I, further comprising at least one vitamin
component and at least one mineral component.
4. The composition of claim I, further comprising an enteric coating.
5. The composition of claim I, wherein said composition is a
nutritional food or nutritional food product further comprising at least
one carbohydrate/ at least one fat ingredient/ and at least one
protein ingredient.
10
6. The composition of claim 5,wherein the carbohydrate ingredient is
dextrose, sucrose, fructose, lactose, maltose, galactose, sugar
alcohols, such as sorbitol, mannitol and xylitol, invert sugar syrups,
brown sugar, corn syrup, corn syrup solids, honey, molasses, brown
sugar, maple syrup, fruit juices, stevia, or an artificial sweetener.
7. The composition of claim 5, wherein the fat ingredient is olive oil/
canola oil, palm oil, coconut oil, sunflower oil, peanut oil, vegetable
oil, lecithin, fish oil, cotton seed oil, soybean oil, lard,
monoglycerides, diglycei-ides, butter, margarine, and other animal,
vegetable, and marine fats, or milk fats.
8. The composition of claim 5, wherein the protein ingredient is
cereal proteins, milk proteins, egg proteins, animal proteins,
vegetable proteins, whey protein, bean proteins, lactalbumin-casein
co-precipitate, calcium casemate, sodium casemate, purified or
refined grades of casein and soy proteins, or peanuts.
9. The composition of claim 5, further comprising at least one
vitamin component, at least one mineral component, and at least
one prebiotic.
10. The composition of claim 9, wherein the prebiotic ingredient is a
fructo-oligosaccharide,
a
galacto-oligosaccharide,
a
soyoligosaccharide,
a
xylo-oligosaccharide,
an
isomaltooligosaccharides, Jerusalem artichoke flour, rolled oats, banana
fiber, a pectin and pectic polysaccharide, a mannan, a pentosan, a
beta-glucan, a rabinan or a galactan.”
14.
If we see the granted independent claim 1 we find it has following
elements and limitations. A composition for augmenting kidney function
comprising
(a) at least one probiotic bacterium selected from Streptococcus
thermophilus
(b) at about 5 billion to about 20 billion colony forming units of said at
least one probiotic bacterium
(c) other ingredient being selected
carbohydrate, protein and fats.
from
vitamin,
mineral,
In claim 2 limitation, the Streptococcus thermophilus strain is KB4,
KB19, or KB25.
Obviousness
15.
During the argument only the ground of obviousness was raised by
the counsel for the applicant based on documents in B(B2), C(C3, C17
11
and C23), and D series (D1, D2, D5, D6 and D8) in particular B2, C17, D5
and X10 and the IN 205478.
US Patent Application 2003/0147795 (B2)
The counsel for the applicant submitted that US Patent Application
dt. 29.8.02 (published on 7.8.2003) B2 teaches methods for preparing
nutritional frozen desserts having palatable characteristics (pg. 67 of vol
II). It further teaches that the invention is supplemented with macro- and/or
micro nutrients including, vitamins, minerals, oils, proteins, fibers,
phytonutrients, prebiotics, probiotics, botanicals and neutraceuticals which
are all palatable (eatable) (Pg. 68 of vol II). This further talks of formulating
the composition by bacterial cultures such as with lactobacills bulgaricus
and Streptococcus Thermophilus (Para 3, page 77). According to the
counsel B2 teaches the use of a composition comprising of probiotics in
particular streptococcus thermophilus, probiotics, vitamins, minerals, oils,
proteins, fibers etc., for a nutritious ice cream, i.e. nutritious food product.
Therefore, the impugned invention claiming to contain atleast one
probiotic from the three strains of streptococcus thermophilus along with
vitamin, mineral, carbohydrate, protein and fat (claim 1) and/or probiotic
(claims 9 and 10) is identical to the invention described under B2.
Therefore B2 makes the impugned invention obvious.
Dietary modulation of human colonic microbiota-introducing the
concept of prebiotic by Glenn et al.022-3166/95 American Institute of
nutrition (C17)
The counsel submitted that C17, a 1994 article, talks of the use of
the entire species of streptococcus thermophilus species (so it cover all
strains) as a probiotic which contributes to intestinal microbial balance. It
further states that administering them to humans has a positive effect in a
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number of biomedical conditions. So the entire species of streptococcus
thermophilus was known as a probiotic for its probiotic properties, which
include removal of nitrogenous wastes from the body.
So it is only
obvious that any strain of this species could be used as a probiotic for
removing nitrogenous wastes such as creatinine and BUN (pg. 244, 248
and 253 of vol. II).
According to the counsel B2 and C17 in combination with B3, talk
of;
a. Use of entire species of streptococcus thermophilus as a
probiotic for its probiotic properties which include nitrogenous waste
removal,
b. The use of particular range of CFU of the said bacterium, and
c. Use of strains of probiotic bacterium,
d. With other ingredients such as vitamin, mineral protein, fats etc.,
Therefore, by combining B2 and C17 with B3 it is easy to come up
with the impugned invention. As, any person skilled in the art can be easily
enabled to come up with the impugned invention comprising atleast one of
the three strains of these streptococcus thermophilus bacteria in 5 to 20
billion CFU along with the other ingredients. So these three documents in
combination teach the whole of the impugned invention and make it
obvious.
Probiotics in human medicines by R Fuller (1990) (D5)
The counsel submitted that D5, a 1990 talks of use of probiotics as
food supplements, and as to their contribution to intestinal microbial
balance. Strains of lactic acid bacteria such as lactobacillus acidophilus,
lactobacillus casei, bifidobacterium bifidum, labcobacillus bulgaricus and
streptococcus thermophilus are stated to be strains that are used as
probiotics (para 2, composition of probiotics, pg.120 vol. I).
13
X10
16.
The counsel for the applicant submitted that X10, a 1999
document, talks of use of Streptococcus Thermophilus strain TMC 1543,
in 10 to 20 billion colony forming units (CFU) in humans and is shown to
reduce many other nitrogenous wastes in particular creatinine and BUN
levels in humans. This is identical to the impugned patent which talks of;
a. the same result through using atleast one probiotic strain,
b. of same quantity of 5 to 20 billion CFU (claim 1),
c. of the three stains of Streptococcus thermophilus mentioned in
claim 2.
According to the counsel this prior art document clearly reveals the
use of a particular strain of Streptococcus thermophilus of same quantity
in performing nitrogenous waste removal function.
Therefore this
document renders the impugned invention obvious.
IN 205478
17.
The counsel for the applicant submitted that the patent no.205478
clearly mentions the various bacteria that are probiotic. This includes
streptococcus thermophilus (pg.39 vol.II of TS of App.). the counsel
argued that the said species of streptococcus thermophilus bacteria did
the same function of nitrogenous waste removal in particular creatinine
and BUN which the present three strains of streptococcus thermophilus
bacteria (in claim 2) of the impugned patent seek to do. So limiting the
strains of streptococcus thermophilus bacteria in the present invention in
claim 1 to 5 to 20 billion CFU, is no invention at all. The counsel submitted
that this is because, X10 talks about using 10 to 20 billion CFU in
creatinine and BUN removal (nitrogen waste removal) and B3 talks of 0.1
million to 100 billion CFU of a strain of L. casei, which make it obvious.
14
According to the counsel this is all the more, as the synergistic effect
achieved by this range of CFU and/ or by use of one or more of these
three strains of streptococcus thermophilus is not disclosed. Further non
disclosure of the gene sequence / DNA mapping renders the description
not fair and sufficient. Therefore based on the said patent specification
which is a prior air document for the impugned patent, on this ground
alone the impugned invention deserves to be revoked.
18.
The counsel for the applicant submitted that from the above
submissions on obviousness and particularly based on B2, B3, C17 and
X10 in particular, it is clear that;
Impugned Invention
Has 1 to 3 strains of
streptococcus thermophilus
Prior Art
X10 - use of strain of
streptococcus thermophilus.
B2 - use of streptococcus
thermophilus (entire species, so
includes strains also).
C17
streptococcus
thermophilus (entire species, so
includes strains also) as a
probiotic and nitrogen waste
removal.
B3 - use of strain of
Lactobacillus casei.
In a certain range of CFU i.e. 5 to
20 billion CFT
X10 - range is from 10 to 20
billion CFU of streptococcus
thermophilus.
B3 - range of strain from 0.1 to
100 billion CFU
Along with other ingredients such
as
vitamins, mineral,
carbohydrate etc.,
Function done by Impugned
patent
a. Nitrogen waste removal in
particular creatinine and
BUN (claims 1 and 2)
b. As a nutritional food or
nutritional food product
B2- composition containing a
mixture of probiotics, prebiotics,
vitamins, minerals, carbohydrates
etc.,
Prior Art documents
Same function talked on in X10,
C17, D8 for streptococcus
thermophilus in particular.
B2, B3 in particular
15
19.
The learned counsel submitted that the impugned patent having 1
to 3 strains of streptococcus thermophilus probiotic bacteria in a certain
range of CFU i.e. 5 to 20 million CFU, along with other ingredients such as
vitamin, mineral, carbohydrate etc., lacks any inventive step or technical
advancement over existing prior art as comparatively highlighted in the
table above. The impugned product is nothing but a mixture of various
components, clearly identical to B2 as both have probiotics, prebiotics,
vitamins, minerals, carbohydrates, fats, and proteins. The function of both
ought to be the same i.e probiotic to remove nitrogenous wastes and the
other ingredients as a nutritional food product. Therefore in view of B2 the
impugned patent lacks any inventive step.
20.
The counsel for the applicant submitted that, X10 comprises a strain
of streptococcus thermophilus in 10 to 20 billion CFU for nitrogenous
waste removal in particular creatinine and BUN. Similarly the impugned
invention also has a range of CFU only that here it is 5 to 20 instead of 10
to 20 in X10 to do the same function. Since details of the three strains are
not disclosed/ known no comparison can be made for them. Moreover the
claim is similar to X10. Addition of other ingredients such as vitamin,
mineral etc., has no inventive step forthcoming. They are just a mere
admixture and have no synergistic effect which is an out come of mixing/
combining all of them together. So the impugned invention as a whole is
not an invention, its lacks any inventive step and hence deserves to be
revoked.
21.
According to the learned counsel on grounds of non-inventiveness
the subject of claims 1 to 10 in particular 1 and 5 of the impugned patent
are not an invention, lack inventive step, and are a mere admixture and
hence the impugned patent is not an invention within the meaning of
16
sections 2 (1) (j) and (ja) and section 3 (e) of the act and hence deserves
to be revoked under section 64 (1) (d). For the same reasons it deserves
to be revoked under section 64 (1) (k).
22.
According to the learned counsel in view of the submissions made
in the preceding paras on obviousness based on prior art documents B2,
B3, C17, and D5 85 D8, and X10, and also in view of the submissions
made on obviousness based on lack of inventive step the impugned
patent deserves to be revoked under section 64 (1) (f).
23.
The learned counsel for the respondent in his reply differentiate the
cited documents and stated that US 2003/0147995 [B2], B3, C 17 and
X10 do not relate to augmenting kidney function. S. thermophilus is
not used in 5-20 billion CFU. According to the counsel the impugned
patent and the Indian Patent No.205478 are based on very distinct
inventions.
24.
The learned counsel for the respondent submitted that the applicant
has made no specific averments in the petition for revocation. He has
made only bald statements in respect of all the grounds.
Inventive step/obviousness
25.
The learned counsel for the respondent submitted that Applicant
has attempted to challenge the inventive step merely by making reference
to several documents without showing how these documents when
combined teach or otherwise motivate or suggest the claimed invention. It
is evident that the applicant has failed to understand the inventive
contribution of the Respondent. It is further submitted that the documents
cited by the Applicant are irrelevant in so far as the inventive concept is
concerned. It has not been established that the invention is obvious to a
17
person skilled in the art, it is stated that the question of obviousness inter
alia has to be determined with respect to 1) knowledge present in more
than one prior published document which when taken together lead one to
the invention, or 2) knowledge present in one document further
substantiated with knowledge of a person skilled in the art to testify that it
is obvious to arrive at the present invention from the knowledge available
in that one document. The Respondent states that the applicant has
neither used option 1 nor option 2 mentioned above by total failure to bring
out as to how the impugned invention suffers from obviousness. It is
further submitted that the ground of obviousness cannot be made out by
simply referencing multiple documents without demonstrating how these
documents invalidate the invention under the impugned patent.
26.
If we see claim 1 and 2 it is limited to composition comprising a
probiotic bacterium selected from Streptococcus thermophilus at about 5
billion to about 20 billion cfus of KB4, KB19 or KB25. Composition further
comprises other ingredient being selected from vitamin, mineral,
carbohydrate, protein and fats. The composition is a food and has 5-20
billion cfus. Additionally it claims that it is a composition for augmenting
kidney functions. In light of this if we see the obviousness argument of the
applicant we find he relied on mosaic of publications viz. B2, B3, C17 and
X10. We find Koss (B2) teaches composition comprising food product
supplemented with vitamins ,minerals, oils, protein, fibers, prebiotics,
probiotics, neutraceuticals
and botanicals.(0006).The probiotic is
selected from lactobacillus and Streptococcus and prebiotic is FOS
(0061). We find Naidu (B3) teaches probiotic compositions comprising
lactobacillus caise strain KL01 which has approx 105 -1011 cfus to maintain
animal health and vitality. The other ingredients in the composition being
carbohydrates, polypeptides, lipids phyto-chemicals and combination
18
thereof. We find C17 teaches dietary modulation of the human colonic
microbiota ; introducing the concept of prebiotics. It also referred to “use of
probiotics ,either as single species or in mixed culture with other bacteria
………....
and
Thermophilus,
Streptococii
Slactis.
It
has
(e.g.
been
Streptococcus
hypothesized
salivarius
that
ss.
probiotics
administered to humans can have positive beneficial effects in number of
biomedical conditions.” We find IN 205478 is for 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. This related
IN 205478 did mention the various bacteria that are probiotic. This
includes streptococcus thermophilus. It is admitted by the respondent that
streptococcus thermophilus is a probiotic. It also stated in the specification
that „It is preferred that the bacterial source for the probiotic be capable or
metabolizing urea and ammonia, preferably to amino acids which can be
used by the bacteria or the patient. Exemplary bacterial species with these
capabilities are Bifidium bacteria species and Lactobacillus species.‟ In
example 4 it stated that “Lactobacillus sporogenes, L. acidophilus, Bacillus
Pasteurii (B.p.) and Escherichia coli DH5 (E.c.) are evaluated for their
ability to eliminate urea from fortified artificial intestinal fluid (FAIF:
100/150 mg/dL urea, 15/30 mg/dL creatinine and 15/3 0 mg/dL uric acid in
aqueous pancreatin, KH2P04 and NaOH) via the enzymatic activity of
urease. Bacillus Pasteurii and Escherichia coli DH5 are assessed both in
the native state and as alginate-poly-L-lysine-alginate microcapsules.
Activated charcoal is added to the FAIF system for the removal of
creatinine and uric acid. Locust bean gum is evaluated for its uric acid and
creatinine sorbent capacity.” If we see the prosecution history of the
19
impugned patent we find that the respondent has given up claims to
mixture of probiotics as claim 2 as originally filed had been merged with
claim 1 while narrowing the scope of probiotics only to Streptococcus
thermophilus. Claim 7 is also merged with reworded claim 1 to include
about 5 billion to about 20 billion cfu of probiotic limitation in the
composition. Even the specific strains of Streptococcus thermophilus such
as KB4, KB19 or KB25 are claimed in claim 2. None of these limitations
were taught in any of the cited document either alone or in combination.
Mere speculation of a hypothesis is not enough to defeat the claimed
invention on the ground of obviousness. Therefore, this ground fails.
Mere admixture
27.
According to the learned counsel of the applicant the impugned
invention is a mixture of probiotics, prebiotics, vitamins, minerals, proteins,
fats, carbohydrate, etc., (claim 1) similar to B2 (obvious, lacking inventive
step). There is no synergistic effect achieved by this mixture. The
composition reflects only the qualities and does the function only of its
individual components i.e. the probiotic for nitrogen waste removal and
other components (vitamins, minerals etc) as a food supplement and has
no enhanced effect or does a new function different from that of its
constituents. Therefore the composition as a whole results only in the
aggregation of the properties of its components without any synergistic /
enhanced effect and hence is not patentable under section 3 (e) the act.
28.
According to the counsel of the respondent the invention covers a
new and inventive composition comprising at least one probiotics bacteria
of a certain kind ,in a certain composition and along with other
additives(such as vitamins etc) that confer synergistic impact ,enabling the
augmentation of kidney function. By no stretch of imagination can this
unique composition be labeled as mere admixture.
20
29.
We do not agree with the averments of the applicant that the
composition reflects only the qualities and does the function only of its
individual components i.e. the probiotic for nitrogen waste removal and
other components (vitamins, minerals etc) as a food supplement and has
no enhanced effect or does a new function different from that of its
constituents. We agree with the respondent that composition comprises at
least one probiotics bacteria of a certain kind, in a certain composition and
it is not a mere admixture. If we see the specification it stated that
“Streptococcus thermophilus are also probiotic. These bacteria
produce antagonist effects against pathogenic microorganisms,
stimulate the immune system, improve lactose digestion, perform a
lipolytic activity making fats more digestible, reduce plasmatic
values of cholesterol, protect the intestinal mucosa ensuring an
even assimilation of the nutritive substances, produce
polysaccharides that are active on some tumors, and reduce
viability of some enzyme-producing microorganisms catalyzing
conversion of procarcinogen substances into carcinogenic
substances.”
It also stated that
“The present invention provides a formulation of commensal and
food grade bacteria known as probiotic bacteria, that when ingested
become intestinal or gut flora and are capable of metabolizing urea
and ammonia, preferably to amino acids which can be used by the
bacteria or the patient. Instillation of such probiotic bacteria permits
a reduction in frequency and even elimination of the need for
dialysis.”
Further it is disclosed that
The present invention provides a composition for augmenting
kidney function, particularly in subjects with renal insufficiency,
comprising at least one probiotic bacterium wherein said probiotic
bacterium reduces creatinine and BUN levels in the subject. The
composition may comprise an enteric coating so that the
composition reaches the intestines of the subject when ingested
orally.
The composition with other ingredient is given only as an
alternative as seen from disclosure in specification
“Alternatively, the composition can the form of marketable
nutriceuticals, dietary supplements and powders, health bars,
yogurts, tablets, dry foods, and pet formulations.”
21
The advantageous effect of S. thermophilus KB19 is also disclosed
in the specification as
“S. thermophilus KB19 is advantageously used in a composition of
the present invention to remove urea. In addition, strain KB19 did
not exhibit any resistance to commonly used antibiotics.”
Fig 3 also compare the various bacterial strains
“Figure 3 shows ureolysis and urea-nitrogen concentration degradation rates
for different bacterial strains. Diamonds, control ; circles, Bacillus pasteurii
ATCC 6453 triangle, Streptococcus thermophilus KB19 ; squares, E. coli
strain DH5a transformed with a multicopy plasmid bearing the Klebsiella
aerogenes urease operon.”
All the above disclosure in the specification goes against the
contention of the applicant that the claimed composition is a mere
admixture. Therefore the counsel for the applicant has failed to make out
this ground also.
False suggestion and representation
30.
The counsel for the applicant raised the ground of false suggestion
/false representation in obtaining the patent and submitted that the
impugned patent has been obtained by making a false representation to
the 2nd respondent as to its use in patients with kidney disorder. This is
because this composition as a whole cannot be used on patients with
renal problem. For, though the probiotic does the nitrogen removal
function, the other ingredients viz., protein, and fat soluble vitamins A, D,
E and K will aggravate the problem of kidney patients by adding /
increasing the nitrogenous waste in the body. Therefore, this products
cannot be taken by them.
31.
In respect of the objection on false suggestion and representation
the respondent submitted that the applicant makes a blanket frivolous
assertion without substantiating it in any way. Counsel for the respondent
22
submitted that the composition of the impugned patent aids in carrying out
the kidney function i.e. removal of waste and toxins and hence augments
the "kidney function" and not the functioning of kidney per se. It is further
clarified that the composition acts in the intestine on the unfiltered waste
and toxins present in blood and augments the function which in normal
conditions is performed by the kidney. Also, the patent nowhere in the
specification suggests augmenting the functioning of kidney by increasing
the Glomerular Filtration Rate (GFR) of the kidney, also agreed to by the
Applicant. This further proves that "Augmenting kidney function" is not the
same as augmenting the functioning of kidney. It is therefore submitted
that the respondent has not made any false suggestion in obtaining the
patent and the applicant has deliberately misconstrued the scope and
ambit of the Applicants invention.
32.
We agree with the respondent that impugned patent aids in
carrying out the kidney function i.e. removal of waste and toxins and
hence augments the "kidney function" and not the functioning of kidney
per se. This is also evident from the specification that
“In particular
embodiments, the probiotic composition alleviates the symptoms of
uremia ; the increased creatinine or BUN levels in subjects undergoing
cancer, HIV or AIDS chemotherapy treatment; the increased creatinine or
BUN levels in subjects with metabolic syndrome; or the symptoms of
increased creatinine or BUN levels in subjects consuming high protein and
low carbohydrate diets.” It not mentioned in the specification that probiotic
composition performs the kidney function. Therefore this ground also fails.
Case Law cited
35.
The learned counsel for the applicant relied on all the case laws as
covered in ORA/28/2011/PT/MUM which is also before us. They are
23
1. Intellectual Property Appellate Board Order No.250/2012 in
OA/8/2009/PT/CH and M.P. NOS.85 & 111 of 2012 in
OA/8/2009/PT/CH – Sankalp Rehabilitation Trust Vs. F.
Hoffman – La-Roche Ag and Another (PARA 15) for „trial and
error experiment‟
2. 2008 (37) PTC 71 (Del.) – High Court of Delhi – F.Hoffmann-la
Roche Ltd., and Anr. Vs. Cipla Limited. „for obviousness TEST‟
(PARA 73-74)
3. 2011 (46) PTC 558 (IPAB) – Enercon India Ltd. vs. Aloys
Wobben for „single inventive concept‟ para 67(e)
4.
(1979) 2 Supreme Court Cases 511 – M/s. Bishwanath
Prasad Radhey Shyam Vs. Hindustan Metal Industries for
‘Whether an alleged invention involves novelty and an „inventive
step‟, is a mixed question of law and fact, depending largely on the
circumstances of the case.‟(para 23 and 41)
The learned counsel for the respondent relied on decision (i) in [2004]
UKHL45 on „law of collation‟ [para 17], (ii) P&G vs Teva US Court of
Appeals for Fedral Circuit [page 5 ] [2008-1404] for „post KSR
obviousness test‟ and (iii) IPAB decision in ORA/44/2012 for „lack of
evidence‟ [para 13]. We do not find the cases cited by the applicant
relevant in view of the particular facts of this case.
36.
In
view
of
ORA/29/2011/PT/MUM
the
above
is
dismissed
analysis
with
and
costs
findings
of
the
Rs.20,000./-.
Accordingly, the M.P. No.90/2012 for early hearing is closed and M.P.
No.130/2012 for filing additional document is allowed.
(D.P.S. Parmar)
Technical Member (Patents)
(S. Usha)
Vice-Chairman
REPORTABLE : YES / NO
SRK
(Disclaimer: This order is being published for present information and should not be taken as a certified copy
issued by the Board.)