Case Study of a Pre-Grant Patent Opposition, involving a Dipeptidyl Peptidase-IV inhibitor, Linagliptin
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Mar 09, 2025
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About This Presentation
Intellectual Property Rights(IPR) are becoming increasingly important, in this age of connectivity. The formation of the IP Divisions, at the High Court level, beginning 2021, is another indication of importance of IPR and our government's commitment to resolve the disputes therein. Being easily...
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1
Case Study of a Pre-Grant Patent Opposition, involving a Dipeptidyl Peptidase-IV
inhibitor, Linagliptin
by
Sankar Sundaram
¶
& Srivathsan Ramakrishnan
¥
9
th
March, 2025
¶Sankar Sundaram had taught Pharmaceutical Chemistry for 30 years and later on
served as a DPIIT IPR-CHAIR professor for 2 years.
¥ Srivathsan Ramakrishnan is a Lawyer.
Case Study of a Pre-Grant Patent Opposition, involving a Dipeptidyl Peptidase-IV
inhibitor, Linagliptin
by
Sankar Sundaram
¶
& Srivathsan Ramakrishnan
¥
9
th
March, 2025
¶Sankar Sundaram had taught Pharmaceutical Chemistry for 30 years and later on
served as a DPIIT IPR-CHAIR professor for 2 years.
¥ Srivathsan Ramakrishnan is a Lawyer.
2
Case Study Of a Pre-Grant Patent Opposition, Involving A Dipeptidyl Peptidase-IV(DPP-IV) Inhibitor, Linagliptin
Synopsis:
Boehringer Ingelheim International GmbH filed a Parent Patent Application, numbered 9501/DELNP/2008, at the
Indian Patent Office. During the course of its patent-grant process, Boehringer modified, its Claims, to comply with
the patentability requirements. As the Patent Office did not find, among other criteria, the novelty and non-
obviousness aspect of this patent application claims to be persuasive, the Controller refused this Parent Patent
Application’s grant. Subsequently, Boehringer filed a Divisional Patent Application numbered 201718031279. A pre-
grant Opposition was filed against this Divisional Patent Application on the grounds of Sections 25(1)(f) and 25(1)(h) of
the Patent Act, 1970. This Divisional Patent Application’s grant too was refused by the Controller, citing the reasons of
the divisional application’s claims not being under the scope of the parent patent application and also the legend of
the divisional application’s claims being similar to the already refused claims of the parent Patent Application. So now,
when Boehringer appealed the Controller’s refusal decision, to the Hon’ble High Court of New Delhi, the Hon’ble High
Court held that as there was no plurality of inventions in the original Parent Patent Application, another Divisional
Patent Application, based on this original Parent Patent Application, cannot be filed, by the Applicant. Thus, the
Hon’ble High Court’s Judgment was not in favor of Boehringer Ingelheim International GmbH.
= = = = = = = = = = = = = = = = = = = = = = =
a)About the Parent Patent Application
The parent Patent Application, numbered 9501/DELNP/2008 was filed by Boehringer Ingelheim International GmbH on 14
th
November 2008, for
their invention entitled, “Uses of DPP IV INHIBITORS” at the Patent Office. DPP-IV inhibitors, downregulate the enzyme Dipeptidyl Peptidase-IV.
Dipeptidyl Peptidase-IV, degrades the good hormones, glucose-dependent insulinotropic polypeptide(GIP) and Glucagon-like peptide-1(GLP-1). GIP
and GLP-1 hormones, when present in the human blood stream, cause a decrease in the body’s blood-glucose level. So, by inhibiting DPP-IV, the
degradation of GLP-1 and GIP is slowed down.
Case Study Of a Pre-Grant Patent Opposition, Involving A Dipeptidyl Peptidase-IV(DPP-IV) Inhibitor, Linagliptin
Synopsis:
Boehringer Ingelheim International GmbH filed a Parent Patent Application, numbered 9501/DELNP/2008, at the
Indian Patent Office. During the course of its patent-grant process, Boehringer modified, its Claims, to comply with
the patentability requirements. As the Patent Office did not find, among other criteria, the novelty and non-
obviousness aspect of this patent application claims to be persuasive, the Controller refused this Parent Patent
Application’s grant. Subsequently, Boehringer filed a Divisional Patent Application numbered 201718031279. A pre-
grant Opposition was filed against this Divisional Patent Application on the grounds of Sections 25(1)(f) and 25(1)(h) of
the Patent Act, 1970. This Divisional Patent Application’s grant too was refused by the Controller, citing the reasons of
the divisional application’s claims not being under the scope of the parent patent application and also the legend of
the divisional application’s claims being similar to the already refused claims of the parent Patent Application. So now,
when Boehringer appealed the Controller’s refusal decision, to the Hon’ble High Court of New Delhi, the Hon’ble High
Court held that as there was no plurality of inventions in the original Parent Patent Application, another Divisional
Patent Application, based on this original Parent Patent Application, cannot be filed, by the Applicant. Thus, the
Hon’ble High Court’s Judgment was not in favor of Boehringer Ingelheim International GmbH.
= = = = = = = = = = = = = = = = = = = = = = =
a)About the Parent Patent Application
The parent Patent Application, numbered 9501/DELNP/2008 was filed by Boehringer Ingelheim International GmbH on 14
th
November 2008, for
their invention entitled, “Uses of DPP IV INHIBITORS” at the Patent Office. DPP-IV inhibitors, downregulate the enzyme Dipeptidyl Peptidase-IV.
Dipeptidyl Peptidase-IV, degrades the good hormones, glucose-dependent insulinotropic polypeptide(GIP) and Glucagon-like peptide-1(GLP-1). GIP
and GLP-1 hormones, when present in the human blood stream, cause a decrease in the body’s blood-glucose level. So, by inhibiting DPP-IV, the
degradation of GLP-1 and GIP is slowed down.
3
Generally, the DPP IV inhibitors may be used to lower, a type-2 diabetic patient’s, elevated blood glucose levels. Linagliptin drug-molecule, which is a
DPP-IV inhibitor was discovered by Boehringer Ingelheim Pharma GmbH scientists, earlier and bears the chemical name of 1-[(4-methyl-quinazolin-
2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine. The Parent Patent Application of Boehringer Ingelheim International
GmbH, encompasses eighteen claims which generally relate to the uses of Linagliptin and its analogues, solo or in combination with other
medicaments.
THE FOLLOWING FLOWCHART POINTS TO THE TIMELINE OF THE PARENT PATENT APPLICATION #9501/DELNP/2008 PROSECUTION:
Parent Application No.
9501/DELNP/2008 titled : “USES
OF DPP-IV INHIBITORS" filed on
14
th
November, 2008
First Exam
Report(FER) from
Patent Office on
24
th
March, 2014
Boehringer’s
response to the
Objections on 24
th
October, 2014
Boehringer’s further response
to the FER on 23
rd
March 2015
& on 19
th
February 2016
Controller’s 5
th
July, 2017 Hearing-
Notice & the subsequent In-
person Hearing held on 28
th
August 2017
Boehringer’s Written
Submission reply for
the Hearing on 5
th
September 2017
Controller’s Decision refusing the grant, under
Sec. 15 of the Patent Act, on 4
th
January 2018
Generally, the DPP IV inhibitors may be used to lower, a type-2 diabetic patient’s, elevated blood glucose levels. Linagliptin drug-molecule, which is a
DPP-IV inhibitor was discovered by Boehringer Ingelheim Pharma GmbH scientists, earlier and bears the chemical name of 1-[(4-methyl-quinazolin-
2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine. The Parent Patent Application of Boehringer Ingelheim International
GmbH, encompasses eighteen claims which generally relate to the uses of Linagliptin and its analogues, solo or in combination with other
medicaments.
THE FOLLOWING FLOWCHART POINTS TO THE TIMELINE OF THE PARENT PATENT APPLICATION #9501/DELNP/2008 PROSECUTION:
Parent Application No.
9501/DELNP/2008 titled : “USES
OF DPP-IV INHIBITORS" filed on
14
th
November, 2008
First Exam
Report(FER) from
Patent Office on
24
th
March, 2014
Boehringer’s
response to the
Objections on 24
th
October, 2014
Boehringer’s further response
to the FER on 23
rd
March 2015
& on 19
th
February 2016
Controller’s 5
th
July, 2017 Hearing-
Notice & the subsequent In-
person Hearing held on 28
th
August 2017
Boehringer’s Written
Submission reply for
the Hearing on 5
th
September 2017
Controller’s Decision refusing the grant, under
Sec. 15 of the Patent Act, on 4
th
January 2018
4
b)Boehringer’s Claims and the Controller of Patent’s First Examination Report (FER)
After the Publication of this Parent Patent Application in the Patent Journal of the Indian Patent Office, the Patent Application was Examined by the
Patent Office for its suitability of a patent grant and the Patent Office’s Objection to the same, after Examination, was communicated to Boehringer,
in the form of a First Examination Report . Boehringer’s Parent Patent Application had the following Claims:
Parent Application No. 9501/DELNP/2008 title : “USES OF DPP-IV INHIBITORS" filed on 14
th
November, 2008
CLAIMS:
1. Use of a DPP IV inhibitor of formula (I) (Formula Removed) and one of the salts thereof, characterised in that R1 denotes
([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl], (quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-
cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, or (4,6-dimethyl-pyrimidin-2-yl)methyl and
R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino or 2-(S)-amino-propyl)-methylamino,
for preparing a medicament for the therapeutic treatment of a patient who has been diagnosed with a physiological functional disorder
selected from among pre-diabetes, glucose intolerance, pathological fasting glucose, diabetic foot, diabetes-associated ulcer, diabetic
hyperlipidaemia, diabetic dyslipidaemia, newly diagnosed type 1 diabetes, gestational diabetes, hyperglycaemia, adrenergic postprandial
syndrome and heart failure, or for the therapeutic treatment of a patient with transplanted islets of Langerhans or beta cells.
2. Use of a DPP IV inhibitor of formula (I) (Formula Removed) and one of the salts thereof, characterised in that R1 denotes
([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl, (quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-
cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, OR (4,6-dimethyl-pyrimidin-2-yl)methyl and
R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino OR (2-(S)-amino-propyl)-methylamino, for preparing a
medicament for the treatment of patients who have been diagnosed with pre-diabetes or manifest type 2 diabetes, characterised in that
by using the pharmaceutical composition the risk of impaired glucose metabolism despite treatment, an elevated HbA1c value despite
treatment, an impaired fasting glucose value despite treatment, the need for insulin treatment, manifest type 2 diabetes, a diabetic foot,
a diabetes-associated ulcer, diabetic hyperlipidaemia, diabetic dyslipidaemia or a macrovascular complication is reduced.
3. Use according to claim 2, characterised in that the macrovascular complication is selected from among myocardial infarct, acute
coronary syndrome, unstable angina pectoris, stable angina pectoris, haemorrhagic or ischaemic stroke, right heart insufficiency, global
heart failure, heart rhythm disorders and vascular restenosis.
4. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a patient
in whom pre-diabetes, glucose intolerance or pathological fasting glucose has been diagnosed.
5. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a patient
in whom diabetic hyperlipidaemia or diabetic dyslipidaemia has been diagnosed.
6. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a
b)Boehringer’s Claims and the Controller of Patent’s First Examination Report (FER)
After the Publication of this Parent Patent Application in the Patent Journal of the Indian Patent Office, the Patent Application was Examined by the
Patent Office for its suitability of a patent grant and the Patent Office’s Objection to the same, after Examination, was communicated to Boehringer,
in the form of a First Examination Report . Boehringer’s Parent Patent Application had the following Claims:
Parent Application No. 9501/DELNP/2008 title : “USES OF DPP-IV INHIBITORS" filed on 14
th
November, 2008
CLAIMS:
1. Use of a DPP IV inhibitor of formula (I) (Formula Removed) and one of the salts thereof, characterised in that R1 denotes
([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl], (quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-
cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, or (4,6-dimethyl-pyrimidin-2-yl)methyl and
R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino or 2-(S)-amino-propyl)-methylamino,
for preparing a medicament for the therapeutic treatment of a patient who has been diagnosed with a physiological functional disorder
selected from among pre-diabetes, glucose intolerance, pathological fasting glucose, diabetic foot, diabetes-associated ulcer, diabetic
hyperlipidaemia, diabetic dyslipidaemia, newly diagnosed type 1 diabetes, gestational diabetes, hyperglycaemia, adrenergic postprandial
syndrome and heart failure, or for the therapeutic treatment of a patient with transplanted islets of Langerhans or beta cells.
2. Use of a DPP IV inhibitor of formula (I) (Formula Removed) and one of the salts thereof, characterised in that R1 denotes
([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl, (quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-
cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, OR (4,6-dimethyl-pyrimidin-2-yl)methyl and
R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino OR (2-(S)-amino-propyl)-methylamino, for preparing a
medicament for the treatment of patients who have been diagnosed with pre-diabetes or manifest type 2 diabetes, characterised in that
by using the pharmaceutical composition the risk of impaired glucose metabolism despite treatment, an elevated HbA1c value despite
treatment, an impaired fasting glucose value despite treatment, the need for insulin treatment, manifest type 2 diabetes, a diabetic foot,
a diabetes-associated ulcer, diabetic hyperlipidaemia, diabetic dyslipidaemia or a macrovascular complication is reduced.
3. Use according to claim 2, characterised in that the macrovascular complication is selected from among myocardial infarct, acute
coronary syndrome, unstable angina pectoris, stable angina pectoris, haemorrhagic or ischaemic stroke, right heart insufficiency, global
heart failure, heart rhythm disorders and vascular restenosis.
4. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a patient
in whom pre-diabetes, glucose intolerance or pathological fasting glucose has been diagnosed.
5. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a patient
in whom diabetic hyperlipidaemia or diabetic dyslipidaemia has been diagnosed.
6. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a
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gestational diabetes.
7. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a
hyperglycaemia or an adrenergic postprandial syndrome.
8. Use according to claim 1, characterised in that pharmaceutical composition is used for the therapeutic treatment of heart failure.
9. Use according to claim 2, characterised in that by using the pharmaceutical composition the risk of a further rise in the HbA1c
value, a deterioration in the fasting glucose and the need for insulin treatment is reduced.
10.Use of a DPP IV inhibitor of formula (I) (Formula Removed) and one of the salts thereof, characterised in that R1 denotes
([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl, (quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-
cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, or (4,6-dimethyl-pyrimidin-2-yl)methyl and R2
denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino OR (2-(S)-amino-propyl)-methylamino, for preparing a
medicament combination with an active substance selected from among the other antidiabetics; active substances that lower the blood
sugar level; active substances that lower the lipid level in the blood; active substances that raise the HDL level in the blood; active
substances that lower blood pressure; and active substances that are indicated in the treatment of atherosclerosis or obesity.
11.Use according to claim 10, characterised in that a medicament combination of a DPP IV inhibitors with another antidiabetic or a
blood pressure-lowering active substance is prepared.
12.Use according to claim 10, characterised in that a medicament combination of a DPP IV inhibitor with metformin, miglitol,
atorvastatin, valsartan or telmisartan is prepared.
13.Use according to claim 10, characterised in that the medicament combination is used for the therapeutic treatment of a patient in
whom a physiological functional disorder has been diagnosed, selected from among pre-diabetes, glucose intolerance, pathological
fasting glucose, diabetic foot, diabetes-associated ulcer, diabetic hyperlipidaemia, diabetic dyslipidaemia, newly diagnosed type-1
diabetes, gestational diabetes, heart failure, hyperglycaemia and adrenergic postprandial syndrome.
14.Isolation or storage medium for islets of Langerhans or beta cells, characterised in that the medium contains 1 nmol/l to 1 µmol/l
of a DPP IV inhibitor for enhancing the vitality and secretion capacity of the cells.
15.Medium according to claim 14, characterised in that the structure of the DPP IV inhibitor is described by the formula (I)
(Formula Removed) and one of the salts thereof, characterised in that R1 denotes ([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl,
(quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl,
(4-methyl-pyrimidin-2-yl)methyl, OR (4,6-dimethyl-pyrimidin-2-yl)methyl and R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-
propyl)-methylamino OR (2-(S)-amino-propyl)-methylamino.
15A.Method of enhancing the vitality and secretion capacity of islets of Langerhans or beta cells, characterised in that during the
isolation and transplantation phase of the islets of Langerhans or beta cells a DPP IV inhibitor is added to the isolation and storage
medium in a concentration of between 1 nmol/l and 1 µmol/l.
16.Method of treating a patient with a DPP IV inhibitor, characterised in that the patient has been diagnosed with a physiological
functional disorder selected from among pre-diabetes, glucose intolerance, pathological fasting glucose, diabetic foot, diabetes-
gestational diabetes.
7. Use according to claim 1, characterised in that the pharmaceutical composition is used for the therapeutic treatment of a
hyperglycaemia or an adrenergic postprandial syndrome.
8. Use according to claim 1, characterised in that pharmaceutical composition is used for the therapeutic treatment of heart failure.
9. Use according to claim 2, characterised in that by using the pharmaceutical composition the risk of a further rise in the HbA1c
value, a deterioration in the fasting glucose and the need for insulin treatment is reduced.
10.Use of a DPP IV inhibitor of formula (I) (Formula Removed) and one of the salts thereof, characterised in that R1 denotes
([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl, (quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-
cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, or (4,6-dimethyl-pyrimidin-2-yl)methyl and R2
denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino OR (2-(S)-amino-propyl)-methylamino, for preparing a
medicament combination with an active substance selected from among the other antidiabetics; active substances that lower the blood
sugar level; active substances that lower the lipid level in the blood; active substances that raise the HDL level in the blood; active
substances that lower blood pressure; and active substances that are indicated in the treatment of atherosclerosis or obesity.
11.Use according to claim 10, characterised in that a medicament combination of a DPP IV inhibitors with another antidiabetic or a
blood pressure-lowering active substance is prepared.
12.Use according to claim 10, characterised in that a medicament combination of a DPP IV inhibitor with metformin, miglitol,
atorvastatin, valsartan or telmisartan is prepared.
13.Use according to claim 10, characterised in that the medicament combination is used for the therapeutic treatment of a patient in
whom a physiological functional disorder has been diagnosed, selected from among pre-diabetes, glucose intolerance, pathological
fasting glucose, diabetic foot, diabetes-associated ulcer, diabetic hyperlipidaemia, diabetic dyslipidaemia, newly diagnosed type-1
diabetes, gestational diabetes, heart failure, hyperglycaemia and adrenergic postprandial syndrome.
14.Isolation or storage medium for islets of Langerhans or beta cells, characterised in that the medium contains 1 nmol/l to 1 µmol/l
of a DPP IV inhibitor for enhancing the vitality and secretion capacity of the cells.
15.Medium according to claim 14, characterised in that the structure of the DPP IV inhibitor is described by the formula (I)
(Formula Removed) and one of the salts thereof, characterised in that R1 denotes ([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl,
(quinoxalin-6-yl)methyl, (4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl,
(4-methyl-pyrimidin-2-yl)methyl, OR (4,6-dimethyl-pyrimidin-2-yl)methyl and R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-
propyl)-methylamino OR (2-(S)-amino-propyl)-methylamino.
15A.Method of enhancing the vitality and secretion capacity of islets of Langerhans or beta cells, characterised in that during the
isolation and transplantation phase of the islets of Langerhans or beta cells a DPP IV inhibitor is added to the isolation and storage
medium in a concentration of between 1 nmol/l and 1 µmol/l.
16.Method of treating a patient with a DPP IV inhibitor, characterised in that the patient has been diagnosed with a physiological
functional disorder selected from among pre-diabetes, glucose intolerance, pathological fasting glucose, diabetic foot, diabetes-
6
associated ulcer, diabetic hyperlipidaemia, diabetic dyslipidaemia, newly diagnosed type-1 diabetes, gestational diabetes, heart failure,
hyperglycaemia and adrenergic postprandial syndrome, or of treating a patient with transplanted islets of Langerhans or beta cells.
17.Method of treating a pre-diabetes or type 2 diabetes patient with a DPP IV inhibitor, characterised in that the treatment reduces
the risk of impaired glucose metabolism despite treatment, an elevated HbA1c value despite treatment, an impaired fasting glucose value
despite treatment, the need for insulin treatment, manifest type 2 diabetes, a diabetic foot, a diabetes-associated ulcer, diabetic
hyperlipidaemia, diabetic dyslipidaemia or a macrovascular complication.
18. Method of treating a patient with a DPP IV inhibitor, characterised in that the patient is suffering from heart failure.
For the Parent Application No. 9501/DELNP/2008, the First Examination Report (FER), was issued from the Patent Office dated 24
th
March, 2014.
Objections raised by the Office of the Controller in its FER :
1.The present set of claims lack novelty and inventive step under section 2(1)(j) of Patents Act,1970,The following documents are considered
for the examination.
D1: WO 2004/018468 A (2004-03-04)
D2: WO 2004/050658 A (2004-06-17)
D3: WO 2005/085246 A (2005-09-15)
D4: WO 2006/029769 A (2006-03-23)
D1, D2, D3 and D4 disclose the use of specific DPP-IV inhibitors which in each case fall under the Markush formula of the present
application, for the treatment of, inter alia, diabetes mellitus type 1 and type 2, prediabetes, reduction of the glucose tolerance or changes
in the fasting blood sugar, diabetic complications, insulin resistance, metabolic syndrome or dyslipidaemia. The use of the DPP-IV inhibitors
as combination medicament with other antidiabetics (including metformin), with antilipemics (including atorvastatin) or with agents which
lower blood pressure is also disclosed.
So novelty cannot be acknowledged for the present set of claims 1-17
Inventive step under section 2(1)(ja) of Patents Act,1970.
Each of the documents D1-D4 represents per se the closest prior art, since the use of specific DPP-IV inhibitors for the treatment of diabetes
mellitus in various facets is disclosed and it appears that there is no technical advancement achieved with the compounds of the present
application with respect to its closest prior art documents.
So inventive step cannot be acknowledged for the present set of claims 1-17.
associated ulcer, diabetic hyperlipidaemia, diabetic dyslipidaemia, newly diagnosed type-1 diabetes, gestational diabetes, heart failure,
hyperglycaemia and adrenergic postprandial syndrome, or of treating a patient with transplanted islets of Langerhans or beta cells.
17.Method of treating a pre-diabetes or type 2 diabetes patient with a DPP IV inhibitor, characterised in that the treatment reduces
the risk of impaired glucose metabolism despite treatment, an elevated HbA1c value despite treatment, an impaired fasting glucose value
despite treatment, the need for insulin treatment, manifest type 2 diabetes, a diabetic foot, a diabetes-associated ulcer, diabetic
hyperlipidaemia, diabetic dyslipidaemia or a macrovascular complication.
18. Method of treating a patient with a DPP IV inhibitor, characterised in that the patient is suffering from heart failure.
For the Parent Application No. 9501/DELNP/2008, the First Examination Report (FER), was issued from the Patent Office dated 24
th
March, 2014.
Objections raised by the Office of the Controller in its FER :
1.The present set of claims lack novelty and inventive step under section 2(1)(j) of Patents Act,1970,The following documents are considered
for the examination.
D1: WO 2004/018468 A (2004-03-04)
D2: WO 2004/050658 A (2004-06-17)
D3: WO 2005/085246 A (2005-09-15)
D4: WO 2006/029769 A (2006-03-23)
D1, D2, D3 and D4 disclose the use of specific DPP-IV inhibitors which in each case fall under the Markush formula of the present
application, for the treatment of, inter alia, diabetes mellitus type 1 and type 2, prediabetes, reduction of the glucose tolerance or changes
in the fasting blood sugar, diabetic complications, insulin resistance, metabolic syndrome or dyslipidaemia. The use of the DPP-IV inhibitors
as combination medicament with other antidiabetics (including metformin), with antilipemics (including atorvastatin) or with agents which
lower blood pressure is also disclosed.
So novelty cannot be acknowledged for the present set of claims 1-17
Inventive step under section 2(1)(ja) of Patents Act,1970.
Each of the documents D1-D4 represents per se the closest prior art, since the use of specific DPP-IV inhibitors for the treatment of diabetes
mellitus in various facets is disclosed and it appears that there is no technical advancement achieved with the compounds of the present
application with respect to its closest prior art documents.
So inventive step cannot be acknowledged for the present set of claims 1-17.
7
2.1)Claims 1-13 do not constitute an invention under section 2(1)(j),since it does not constitute a product or a process.
2)The claim part of the complete specification should commence with the phrase;" I/We claim".
3) The expression "according to claim" as used in claims should be replaced "as claimed in “appropriately"
4)Extraneous matter should be deleted from the complete specification.
3.Claims 15-18 fall within the scope of such clause (i)of section 3.
4.Proof of right or assignment from the inventor to the applicant should be filed to this office in the prescribed manner asap.
5.Details regarding the search and/or examination report including claims of the application allowed, as referred to in Rule 12(3) of the Patent
Rule, 2003, in respect of same or substantially the same invention filed in all the major Patent offices along with appropriate translation
where applicable, should be submitted within a period of Six months from the date of receipt of this communication as provided under
section 8(2) of the Indian Patents Act.
6.Details regarding application for Patents which may be filed outside India from time to time for the same or substantially the same invention
should be furnished within Six months from the date of filing of the said application under clause(b) of sub section(1) of section 8 and rule
12(1) of Indian Patent Act.
c)Behringer’s response to the FER Objections on 24
th
October, 2014 via Amendment No.1
Boehringer restricted / narrowed down its original 18 Claims, into the below mentioned 3 Claims.
Amended Claims in Behringer’s Parent Application No. 9501/DELNP/2008 filed on 24
th
October, 2014
We Claim
1.Isolation or storage medium for islets of Langerhans or beta cells, characterized in that the medium contains 1 nmol/l to 1 µmol/l of a
DPP-IV inhibitor for enhancing the vitality and secretion capacity of the cells.
2.Medium as claimed in claim 1, wherein the structure of the DPP IV inhibitor is described by the formula (I) or the formula (II) [both
formulas are omitted by this compiler], R1 denotes ([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl], (quinoxalin-6-yl)methyl, (4-
methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-
yl)methyl, or (4,6-dimethyl-pyrimidin-2-yl)methyl and R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino or
2-(S)-amino-propyl)-methylamino.
3.Method of enhancing the vitality and secretion capacity of islets of Langerhans or beta cells, wherein during the isolation and
transplantation phase of the islets of Langerhans or beta cells a DPP IV inhibitor is added to the isolation and storage medium in a
concentration of between 1 nmol/l and 1 µmol/l.
2.1)Claims 1-13 do not constitute an invention under section 2(1)(j),since it does not constitute a product or a process.
2)The claim part of the complete specification should commence with the phrase;" I/We claim".
3) The expression "according to claim" as used in claims should be replaced "as claimed in “appropriately"
4)Extraneous matter should be deleted from the complete specification.
3.Claims 15-18 fall within the scope of such clause (i)of section 3.
4.Proof of right or assignment from the inventor to the applicant should be filed to this office in the prescribed manner asap.
5.Details regarding the search and/or examination report including claims of the application allowed, as referred to in Rule 12(3) of the Patent
Rule, 2003, in respect of same or substantially the same invention filed in all the major Patent offices along with appropriate translation
where applicable, should be submitted within a period of Six months from the date of receipt of this communication as provided under
section 8(2) of the Indian Patents Act.
6.Details regarding application for Patents which may be filed outside India from time to time for the same or substantially the same invention
should be furnished within Six months from the date of filing of the said application under clause(b) of sub section(1) of section 8 and rule
12(1) of Indian Patent Act.
c)Behringer’s response to the FER Objections on 24
th
October, 2014 via Amendment No.1
Boehringer restricted / narrowed down its original 18 Claims, into the below mentioned 3 Claims.
Amended Claims in Behringer’s Parent Application No. 9501/DELNP/2008 filed on 24
th
October, 2014
We Claim
1.Isolation or storage medium for islets of Langerhans or beta cells, characterized in that the medium contains 1 nmol/l to 1 µmol/l of a
DPP-IV inhibitor for enhancing the vitality and secretion capacity of the cells.
2.Medium as claimed in claim 1, wherein the structure of the DPP IV inhibitor is described by the formula (I) or the formula (II) [both
formulas are omitted by this compiler], R1 denotes ([1,5]naphthyridin-2-yl)methyl, (quinazolin-2-yl)methyl], (quinoxalin-6-yl)methyl, (4-
methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl, (3-cyano-quinolin-2-yl)methyl, (3-cyano-pyridin-2-yl)methyl, (4-methyl-pyrimidin-2-
yl)methyl, or (4,6-dimethyl-pyrimidin-2-yl)methyl and R2 denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-methyl-propyl)-methylamino or
2-(S)-amino-propyl)-methylamino.
3.Method of enhancing the vitality and secretion capacity of islets of Langerhans or beta cells, wherein during the isolation and
transplantation phase of the islets of Langerhans or beta cells a DPP IV inhibitor is added to the isolation and storage medium in a
concentration of between 1 nmol/l and 1 µmol/l.
8
d)Boehringer’s further response to the FER of the Parent Patent Application No. 9501/DELNP/2008 on 23
rd
March 2015
In rebutting the Novelty and Inventiveness Objections raised in the FER, Boehringer did an Amendment No 2 to its previous Claims into a set of 11
Claims. Behringer now stated that, its now-disavowed Claims, were reserved by Behringer, to be either recited on a Divisional Application or to be
included in this same Patent Application, on a later date. Boehringer had also on July 2, 2014 replied back to the Patent Office, regarding the Search
and/ or Examination Reports of Boehringer’s foreign-filed Patent Applications, as required by the Patent Office. Boehringer in response to the FER
Objections, adduced the relevant prosecution details outside of India. Boehringer stated that, these Amended Claims were based on the original
claims 10-12 and on the Description contained in that part. Boehringer stated that, the DPP IV inhibitors as included in the new Claim Set are
distinct from structurally comparable DPP IV inhibitors, as they combine exceptional potency and a long-lasting effect with favorable
pharmacological properties, receptor selectivity and a favorable side-effect profile or that they bring about unexpected therapeutic advantages or
improvements when combined with other pharmaceutical active substances. Boehringer further stated that, as these Amended Claims are directed
to a combination, these Amended Claims, do not fall under the purview of Section 3(i) of the Patent Act. Section 3(i) of the Patent Act, under the
excluding section of the Patent Act, reads that any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other
treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or
that of their products, is not an invention.
A Request for Hearing with the Controller’s Office was also requested by Boehringer.
Boehringer’s Amended Claims (by filing the First Form - 13) in the Parent Application No. 9501/DELNP/2008 filed on 23
rd
March 2015
We Claim
1.A medicament combination of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine, or one of the therapeutically active salts thereof, in a dosage of 2.5 mg to 10 mg for oral administration, with
metformin.
2. The medicament combination as claimed in claim 1 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, either in a free
combination or in a fixed combination.
3.The medicament combination as claimed in claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, in a fixed
combination, which is a tablet or capsule.
4.The medicament combination as claimed in claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
5.The medicament combination as claimed in claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
d)Boehringer’s further response to the FER of the Parent Patent Application No. 9501/DELNP/2008 on 23
rd
March 2015
In rebutting the Novelty and Inventiveness Objections raised in the FER, Boehringer did an Amendment No 2 to its previous Claims into a set of 11
Claims. Behringer now stated that, its now-disavowed Claims, were reserved by Behringer, to be either recited on a Divisional Application or to be
included in this same Patent Application, on a later date. Boehringer had also on July 2, 2014 replied back to the Patent Office, regarding the Search
and/ or Examination Reports of Boehringer’s foreign-filed Patent Applications, as required by the Patent Office. Boehringer in response to the FER
Objections, adduced the relevant prosecution details outside of India. Boehringer stated that, these Amended Claims were based on the original
claims 10-12 and on the Description contained in that part. Boehringer stated that, the DPP IV inhibitors as included in the new Claim Set are
distinct from structurally comparable DPP IV inhibitors, as they combine exceptional potency and a long-lasting effect with favorable
pharmacological properties, receptor selectivity and a favorable side-effect profile or that they bring about unexpected therapeutic advantages or
improvements when combined with other pharmaceutical active substances. Boehringer further stated that, as these Amended Claims are directed
to a combination, these Amended Claims, do not fall under the purview of Section 3(i) of the Patent Act. Section 3(i) of the Patent Act, under the
excluding section of the Patent Act, reads that any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other
treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or
that of their products, is not an invention.
A Request for Hearing with the Controller’s Office was also requested by Boehringer.
Boehringer’s Amended Claims (by filing the First Form - 13) in the Parent Application No. 9501/DELNP/2008 filed on 23
rd
March 2015
We Claim
1.A medicament combination of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine, or one of the therapeutically active salts thereof, in a dosage of 2.5 mg to 10 mg for oral administration, with
metformin.
2. The medicament combination as claimed in claim 1 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, either in a free
combination or in a fixed combination.
3.The medicament combination as claimed in claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, in a fixed
combination, which is a tablet or capsule.
4.The medicament combination as claimed in claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
5.The medicament combination as claimed in claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
9
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
6.The medicament combination as claimed in claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a free combination.
7.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is 500-2850 mg.
8.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is 500 mg, 850 mg or 1000 mg.
9.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is from 300 mg to 1000 mg once
or twice a day, or delayed-release metformin in a dose of 500 mg to 1000 mg once or twice a day or 500 mg to 2000 mg once a day.
10.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is 500 mg, 850 mg or 1000 mg
metformin as a single dose with a total daily dose of metformin of 500-2850 mg, or 500 mg, 1000 mg, 1500 mg or 2000 mg metformin in
delayed release form.
11.The medicament combination as claimed in any one of the preceding claims, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
In order to ascertain the invention better, in its Application No 9501/DELNP/2008 Boehringer did an Amendment No 3 to its previous Claims.
Boehringer’s Amended Claims (by filing the second Form - 13) as provided in its “Marked Copy” on 19
th
February 2016
New Claims 12 to 15:
12.A medicament combination of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine, or one of the therapeutically active salts thereof, with telmisartan.
13.The medicament combination as claimed in claim 12, wherein the dosage of the DPP IV inhibitor is 2.5 mg or 5 mg for oral administration.
14.The medicament combination as claimed in claim 12 or 13, wherein the dosage of telmisartan is 20 mg to 320 mg or 40 mg to 160 mg per
day.
15. The medicament combination as claimed in claim 12, 13 or 14, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
e)Controller’s response to Boehringer’s Amended Claims
On 5
th
July, 2017 the Patent Office had informed Boehringer regarding the Hearing, at its Kolkata Office, which was then held on 28
th
August 2017.
f)Behringer’s Written Submissions of the Kolkata Patent Office Hearing dated 5
th
September 2017
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
6.The medicament combination as claimed in claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a free combination.
7.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is 500-2850 mg.
8.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is 500 mg, 850 mg or 1000 mg.
9.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is from 300 mg to 1000 mg once
or twice a day, or delayed-release metformin in a dose of 500 mg to 1000 mg once or twice a day or 500 mg to 2000 mg once a day.
10.The medicament combination as claimed in any one of the claims 1 to 6, wherein the dose of metformin is 500 mg, 850 mg or 1000 mg
metformin as a single dose with a total daily dose of metformin of 500-2850 mg, or 500 mg, 1000 mg, 1500 mg or 2000 mg metformin in
delayed release form.
11.The medicament combination as claimed in any one of the preceding claims, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
In order to ascertain the invention better, in its Application No 9501/DELNP/2008 Boehringer did an Amendment No 3 to its previous Claims.
Boehringer’s Amended Claims (by filing the second Form - 13) as provided in its “Marked Copy” on 19
th
February 2016
New Claims 12 to 15:
12.A medicament combination of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine, or one of the therapeutically active salts thereof, with telmisartan.
13.The medicament combination as claimed in claim 12, wherein the dosage of the DPP IV inhibitor is 2.5 mg or 5 mg for oral administration.
14.The medicament combination as claimed in claim 12 or 13, wherein the dosage of telmisartan is 20 mg to 320 mg or 40 mg to 160 mg per
day.
15. The medicament combination as claimed in claim 12, 13 or 14, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
e)Controller’s response to Boehringer’s Amended Claims
On 5
th
July, 2017 the Patent Office had informed Boehringer regarding the Hearing, at its Kolkata Office, which was then held on 28
th
August 2017.
f)Behringer’s Written Submissions of the Kolkata Patent Office Hearing dated 5
th
September 2017
10
Behringer had stated that its amended claims, including those Boehringer Claims of 23
rd
March 2015 and 19
th
February 2016, fell within the Scope of
its Original Claims 10, 11 and 12 as filed by Boehringer on 14
th
November, 2008. Section 59(1) of the Patent Act, is the governing section regarding
the allowance/disallowance of amendments in a patent application and reads as follows:
Section 59(1): No amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by
way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact,
and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or
describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended
would not fall wholly within the scope of a claim of the specification before the amendment.
Boehringer states that its amended claims are novel and inventive and do not fall under the purview of Section 3(e) of the Patent Act. Section 3(e)
of the Patent Act, is the excluding section and reads that a substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance, is not an invention.
Boehringer adds that the First Exam Report’s, Section 3(i) objection, is not relevant to its amended claims.
g)The Controller’s Decision of 4
th
January 2018
The Controller’s Decision explained that the scope of protection of the original filed claims on 14
th
November, 2008, which are for the use of DPP IV
inhibitor of formula I or formula II alone or in combination with other active substances, could not be extended to the protection of a medicament
combination of a DIPP IV inhibitor with metformin / telmisartan, as such a change in the contents of amended claims did not wholly fall within the
scope of the originally filed claims. The Controller’s Decision further explained that the above amendments (filed on 23
rd
March 2015 and 19
th
February 2016) could not be considered to be done by way of a disclaimer, correction, clarification or explanation as there was a clear change in
category of claims wherein the “use claims” of 14
th
November, 2008 were amended to “product claims” of 23
rd
March 2015 / 19
th
February 2016.
So, Boehringer’s amended 3-count Claims of 24
th
October, 2014 were only considered. The Novelty and Inventiveness Objections, which were
raised in the FER, were once again maintained against Boehringer’s amended 3-count Claims of 24
th
October, 2014 too. As, all the objections raised
during the Hearing Notice, could not be met by Behringer, within the permissible time, Boehringer’s 9501/DELNP/2008 Patent Application was
refused for the grant of a patent under Section 15 of the Patents Act, 1970. Section 15 is titled as POWER OF CONTROLLER TO REFUSE OR REQUIRE
AMENDED APPLICATIONS, ETC., IN CERTAIN CASE. Section 15 reads as follows:
Section 15: Where the Controller is satisfied that the application or any specification or any other document filed in pursuance thereof does not
comply with the requirements of this Act or of any rules made thereunder, the Controller may refuse the application or may require the application,
specification or the other documents, as the case may be, to be amended to his satisfaction before he proceeds with the application and refuse the
application on failure to do so.
Behringer had stated that its amended claims, including those Boehringer Claims of 23
rd
March 2015 and 19
th
February 2016, fell within the Scope of
its Original Claims 10, 11 and 12 as filed by Boehringer on 14
th
November, 2008. Section 59(1) of the Patent Act, is the governing section regarding
the allowance/disallowance of amendments in a patent application and reads as follows:
Section 59(1): No amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by
way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact,
and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or
describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended
would not fall wholly within the scope of a claim of the specification before the amendment.
Boehringer states that its amended claims are novel and inventive and do not fall under the purview of Section 3(e) of the Patent Act. Section 3(e)
of the Patent Act, is the excluding section and reads that a substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance, is not an invention.
Boehringer adds that the First Exam Report’s, Section 3(i) objection, is not relevant to its amended claims.
g)The Controller’s Decision of 4
th
January 2018
The Controller’s Decision explained that the scope of protection of the original filed claims on 14
th
November, 2008, which are for the use of DPP IV
inhibitor of formula I or formula II alone or in combination with other active substances, could not be extended to the protection of a medicament
combination of a DIPP IV inhibitor with metformin / telmisartan, as such a change in the contents of amended claims did not wholly fall within the
scope of the originally filed claims. The Controller’s Decision further explained that the above amendments (filed on 23
rd
March 2015 and 19
th
February 2016) could not be considered to be done by way of a disclaimer, correction, clarification or explanation as there was a clear change in
category of claims wherein the “use claims” of 14
th
November, 2008 were amended to “product claims” of 23
rd
March 2015 / 19
th
February 2016.
So, Boehringer’s amended 3-count Claims of 24
th
October, 2014 were only considered. The Novelty and Inventiveness Objections, which were
raised in the FER, were once again maintained against Boehringer’s amended 3-count Claims of 24
th
October, 2014 too. As, all the objections raised
during the Hearing Notice, could not be met by Behringer, within the permissible time, Boehringer’s 9501/DELNP/2008 Patent Application was
refused for the grant of a patent under Section 15 of the Patents Act, 1970. Section 15 is titled as POWER OF CONTROLLER TO REFUSE OR REQUIRE
AMENDED APPLICATIONS, ETC., IN CERTAIN CASE. Section 15 reads as follows:
Section 15: Where the Controller is satisfied that the application or any specification or any other document filed in pursuance thereof does not
comply with the requirements of this Act or of any rules made thereunder, the Controller may refuse the application or may require the application,
specification or the other documents, as the case may be, to be amended to his satisfaction before he proceeds with the application and refuse the
application on failure to do so.
11
= = = = = = = = = = = = = = = = = = = = = = = = = =
h)AND A DAUGHTER PATENT APPLICATION CONTINUES IN THE FORM OF A DIVISIONAL PATENT APPLICATION
Boehringer’s Divisional Patent Application No. 201718031279 titled, “USES OF DPP-IV INHIBITORS” was filed at the Patent Office on 4
th
September
2017. It may be recalled that 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is the
Linagliptin drug molecule. The Divisional Patent Application had the following 25 claims:
Boehringer’s Divisional Application No. 201718031279 titled, “USES OF DPP-IV INHIBITORS” filed on 4
th
September 2017
1.A medicament of DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-
xanthine, or one of therapeutically active salts thereof, in a dosage of 2.5 mg to 10 mg for oral administration, optionally in combination
with another antidiabetic or a blood pressure-lowering active substance.
2.The medicament combination according to claim 1 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, either in a free
combination or in a fixed combination.
3. The medicament combination according to claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, in a fixed
combination, which is a tablet or capsule.
4.The medicament combination according to claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
5.The medicament combination according to claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
6.The medicament combination according to claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a free combination.
7.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is 500-2850 mg.
8.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is 500 mg, 850 mg, or 1000 mg.
9.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is from 300 mg to 1000 mg once
or twice a day, or delayed-release metformin in a dose of 500 mg to 1000 mg once or twice a day or 500 mg to 2000 mg once a day.
10.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is 500 mg, 850 mg, or 1000 mg
= = = = = = = = = = = = = = = = = = = = = = = = = =
h)AND A DAUGHTER PATENT APPLICATION CONTINUES IN THE FORM OF A DIVISIONAL PATENT APPLICATION
Boehringer’s Divisional Patent Application No. 201718031279 titled, “USES OF DPP-IV INHIBITORS” was filed at the Patent Office on 4
th
September
2017. It may be recalled that 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine is the
Linagliptin drug molecule. The Divisional Patent Application had the following 25 claims:
Boehringer’s Divisional Application No. 201718031279 titled, “USES OF DPP-IV INHIBITORS” filed on 4
th
September 2017
1.A medicament of DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-
xanthine, or one of therapeutically active salts thereof, in a dosage of 2.5 mg to 10 mg for oral administration, optionally in combination
with another antidiabetic or a blood pressure-lowering active substance.
2.The medicament combination according to claim 1 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, either in a free
combination or in a fixed combination.
3. The medicament combination according to claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg or 5 mg for oral administration, with metformin, in a fixed
combination, which is a tablet or capsule.
4.The medicament combination according to claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
5.The medicament combination according to claim 3 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a fixed combination,
which is a tablet.
6.The medicament combination according to claim 2 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 5 mg for oral administration, with metformin, in a free combination.
7.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is 500-2850 mg.
8.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is 500 mg, 850 mg, or 1000 mg.
9.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is from 300 mg to 1000 mg once
or twice a day, or delayed-release metformin in a dose of 500 mg to 1000 mg once or twice a day or 500 mg to 2000 mg once a day.
10.The medicament combination according to any one of the claims 1 to 6 wherein the dose of metformin is 500 mg, 850 mg, or 1000 mg
12
metformin as a single dose with a total daily dose of metformin of 500-2850 mg, or 500 mg, 1000 mg, 1500 mg, or 2000 mg metformin in
delayed release form.
11.The medicament combination according to any one of the claims 1 to 10, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
12.A method of preparing a combination of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-
(R)-amino-piperidin-1-yl)-xanthine, or one of the therapeutically active salts thereof, with metformin, said method is characterized by
combining the DPP IV inhibitor in a dosage of 2.5 mg or 5 mg with metformin in a dosage of 500 mg, 850 mg, or 1000 mg.
13.The method according to claim 12, wherein the daily oral dose of metformin is 500-2850 mg and the daily oral dose of the DPP IV
inhibitor is 5 mg.
14.The medicament combination according to claim 1 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg to 10 mg for oral administration, with telmisartan, either in a
free combination or in a fixed combination.
15. The medicament combination according to claim 14, wherein the dosage of the DPP IV inhibitor is 2.5 mg or 5 mg for oral administration.
16.The medicament combination according to claim 14 or 15, wherein the dosage of telmisartan is 20 mg to 320 mg or 40 mg to 160 mg per
day.
17.The medicament combination according to claim 14, 15 or 16, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
18.A medicament of DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-
xanthine, or one of therapeutically active salts thereof, wherein the medicament is for oral administration and contains a dosage of 2.5
mg to 10 mg (such as e.g. 2.5 mg, 5 mg or 10 mg) of 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine.
19.A method of preparing a DPP IV inhibitor, which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine, wherein the medicament is for oral administration, said method is characterized in that the DPP IV inhibitor in a
dosage of 2.5 mg to 10 mg (such as e.g. 2.5 mg, 5 mg or 10 mg) is formulated together with one or more inert carrier and/or diluents.
20.The medicament according to claim 18 or the method according to claim 19, wherein a medicament is formed which is a galenic
preparation selected from a tablet or coated tablet.
21.The medicament or method according to any one of claims 18 to 20, wherein the DPP IV inhibitor is formulated together with mannitol,
pregelatinized starch, maize starch, copovidone and magnesium stearate.
22.The medicament or method according to any one of claims 18 to 21, wherein the medicament is in the form of a film-coated tablet,
wherein 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, mannitol, pregelatinized
starch, maize starch, copovidone and magnesium stearate are present in the tablet core coated with a film-coating of hydroxypropyl
methyl-cellulose, polyethylene glycol, talc, titanium dioxide and iron oxide.
23.The medicament or method according to any one of claims 18 to 22, wherein 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-
yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, mannitol, pregelatinized starch, maize starch and copovidone are wet granulated.
24.The medicament or method according to any one of claims 18 to 23, wherein the dosage of the DPP IV inhibitor is 2.5 mg or 5 mg.
metformin as a single dose with a total daily dose of metformin of 500-2850 mg, or 500 mg, 1000 mg, 1500 mg, or 2000 mg metformin in
delayed release form.
11.The medicament combination according to any one of the claims 1 to 10, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
12.A method of preparing a combination of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-
(R)-amino-piperidin-1-yl)-xanthine, or one of the therapeutically active salts thereof, with metformin, said method is characterized by
combining the DPP IV inhibitor in a dosage of 2.5 mg or 5 mg with metformin in a dosage of 500 mg, 850 mg, or 1000 mg.
13.The method according to claim 12, wherein the daily oral dose of metformin is 500-2850 mg and the daily oral dose of the DPP IV
inhibitor is 5 mg.
14.The medicament combination according to claim 1 of a DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, in a dosage of 2.5 mg to 10 mg for oral administration, with telmisartan, either in a
free combination or in a fixed combination.
15. The medicament combination according to claim 14, wherein the dosage of the DPP IV inhibitor is 2.5 mg or 5 mg for oral administration.
16.The medicament combination according to claim 14 or 15, wherein the dosage of telmisartan is 20 mg to 320 mg or 40 mg to 160 mg per
day.
17.The medicament combination according to claim 14, 15 or 16, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
18.A medicament of DPP IV inhibitor which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-
xanthine, or one of therapeutically active salts thereof, wherein the medicament is for oral administration and contains a dosage of 2.5
mg to 10 mg (such as e.g. 2.5 mg, 5 mg or 10 mg) of 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine.
19.A method of preparing a DPP IV inhibitor, which is 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine, wherein the medicament is for oral administration, said method is characterized in that the DPP IV inhibitor in a
dosage of 2.5 mg to 10 mg (such as e.g. 2.5 mg, 5 mg or 10 mg) is formulated together with one or more inert carrier and/or diluents.
20.The medicament according to claim 18 or the method according to claim 19, wherein a medicament is formed which is a galenic
preparation selected from a tablet or coated tablet.
21.The medicament or method according to any one of claims 18 to 20, wherein the DPP IV inhibitor is formulated together with mannitol,
pregelatinized starch, maize starch, copovidone and magnesium stearate.
22.The medicament or method according to any one of claims 18 to 21, wherein the medicament is in the form of a film-coated tablet,
wherein 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, mannitol, pregelatinized
starch, maize starch, copovidone and magnesium stearate are present in the tablet core coated with a film-coating of hydroxypropyl
methyl-cellulose, polyethylene glycol, talc, titanium dioxide and iron oxide.
23.The medicament or method according to any one of claims 18 to 22, wherein 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-
yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine, mannitol, pregelatinized starch, maize starch and copovidone are wet granulated.
24.The medicament or method according to any one of claims 18 to 23, wherein the dosage of the DPP IV inhibitor is 2.5 mg or 5 mg.
13
25.The medicament or method according to any one of the claims 18 to 24, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
i)The Controller’s First Examination Report for Boehringer’s Divisional Application No: 201718031279 on 16
th
July 2019
This Divisional Application with Application No: 201718031279 was filed by Boehringer, based on its Parent Application No:9501/DELNP/2008. But
the Controller’s Office states that Boehringer’s Parent Application No:9501/DELNP/2008 itself did not contain any plurality of inventions. So,
Boehringer’s Divisional Application itself stood as baseless. So, the patent office stated that, it had not examined the Novelty-aspect and
Inventiveness-aspect of Boehringer’s Divisional Application No: 201718031279. The Controller’s Office had further stated in its FER that, all these 25
recited claims in Boehringer’s Divisional Application No: 201718031279 were already examined by the Patent Office and therefore the same set of
Claims could not be allowed in another patent application.
j)Boehringer’s response to the FER (as verbatim reproduced underneath) of its Application No: 201718031279 on 31
st
December, 2019
REPLY TO TECHNICAL OBJECTIONS-PART I AND Part II
With respect to serial numbers 1 and 2 of the Summary (sub-paragraph number 2 of paragraph B of PART-II of the FER), it is respectfully
submitted that the learned Controller's refusal to consider the amendments of 23 February 2015 and 19 February 2016 in the parent case (as
"going beyond the scope of claims as on record before the amendments") implies that he/she has considered the subject-matter after the
amendment as being distinct from the subject-matter on-record before the amendments. Consequentially. such subject-matter, which the
Learned Controller has held to be distinct, is proper subject-matter for a divisional application.
Furthermore, the first examination report in the parent case referred to claims 1-17 only, however in fact there has been originally claims 1-18
present. Therefore, the learned Controller himself/herself has not addressed/examined the entire original claim set 1-18 within one and the
same Office Action, which implies that the original claim set 1-18 has been considered non-unitary by the learned Controller and has not been
fully examined (and consequentially not fully refused at least in this regard) during examination. Thus, examination of the parent case was
incomplete and non-unitary, at least from this reason.
Moreover. the learned Controller is clearly erroneous in his/her statement that 'the present divisional claims 1-25 were already examined and
refused in the parent application", which is factually not true here, because the present divisional claims 1-25 are directed to a medicament
(combination) whereas the original claims of the parent were directed to medical use, isolation/storage medium or medical method of
treatment, and the refused claims of the parent were directed to isolation/storage medium only.
It may be noted that the novelty and inventive step for the present medicament (combination) claims has never been (substantially) examined
by the learned Controller, neither from formal reasons nor from material reasons, at least because the learned Controller has expressly refused
to consider just these requested amendments in the parent application. At least in this regard, learned Controller's objection seems to be
25.The medicament or method according to any one of the claims 18 to 24, wherein the oral daily dose of the DPP IV inhibitor is 5 mg.
i)The Controller’s First Examination Report for Boehringer’s Divisional Application No: 201718031279 on 16
th
July 2019
This Divisional Application with Application No: 201718031279 was filed by Boehringer, based on its Parent Application No:9501/DELNP/2008. But
the Controller’s Office states that Boehringer’s Parent Application No:9501/DELNP/2008 itself did not contain any plurality of inventions. So,
Boehringer’s Divisional Application itself stood as baseless. So, the patent office stated that, it had not examined the Novelty-aspect and
Inventiveness-aspect of Boehringer’s Divisional Application No: 201718031279. The Controller’s Office had further stated in its FER that, all these 25
recited claims in Boehringer’s Divisional Application No: 201718031279 were already examined by the Patent Office and therefore the same set of
Claims could not be allowed in another patent application.
j)Boehringer’s response to the FER (as verbatim reproduced underneath) of its Application No: 201718031279 on 31
st
December, 2019
REPLY TO TECHNICAL OBJECTIONS-PART I AND Part II
With respect to serial numbers 1 and 2 of the Summary (sub-paragraph number 2 of paragraph B of PART-II of the FER), it is respectfully
submitted that the learned Controller's refusal to consider the amendments of 23 February 2015 and 19 February 2016 in the parent case (as
"going beyond the scope of claims as on record before the amendments") implies that he/she has considered the subject-matter after the
amendment as being distinct from the subject-matter on-record before the amendments. Consequentially. such subject-matter, which the
Learned Controller has held to be distinct, is proper subject-matter for a divisional application.
Furthermore, the first examination report in the parent case referred to claims 1-17 only, however in fact there has been originally claims 1-18
present. Therefore, the learned Controller himself/herself has not addressed/examined the entire original claim set 1-18 within one and the
same Office Action, which implies that the original claim set 1-18 has been considered non-unitary by the learned Controller and has not been
fully examined (and consequentially not fully refused at least in this regard) during examination. Thus, examination of the parent case was
incomplete and non-unitary, at least from this reason.
Moreover. the learned Controller is clearly erroneous in his/her statement that 'the present divisional claims 1-25 were already examined and
refused in the parent application", which is factually not true here, because the present divisional claims 1-25 are directed to a medicament
(combination) whereas the original claims of the parent were directed to medical use, isolation/storage medium or medical method of
treatment, and the refused claims of the parent were directed to isolation/storage medium only.
It may be noted that the novelty and inventive step for the present medicament (combination) claims has never been (substantially) examined
by the learned Controller, neither from formal reasons nor from material reasons, at least because the learned Controller has expressly refused
to consider just these requested amendments in the parent application. At least in this regard, learned Controller's objection seems to be
14
inconsistent, arbitrary, and frivolous.
It may further be noted that - at utmost - any rejection decision is only pertinent to the very claimed subject-matter of the request that has been
subject of the rejection (here: only the parent claims directed to isolation/storage medium).
Without prejudice, it is submitted that even if there is no explicit invitation by the learned Controller to file a divisional (or no explicit finding of
plurality of distinct inventions), a divisional application can be filed voluntarily by the applicant.
With regard to the Section 16, it is submitted that it is possible to voluntarily file a divisional application, even without previous unity/plurality
objection and without plurality/distinction requirement as applied by the learned Controller (as long as the "disclosure" requirement Of Section
16(2), i.e. ‘shall not include any matter not in substance disclosed in the complete specification", and the 'double patenting" requirement of
Section 16(3) are fulfilled, i.e. "no claim for any matter claimed in the other").
This is reaffirmed by Explanation to this Section clearly stating that the divisional application is to be treated as a substantive and independent
application. Also, the divisional application is mandatorily published subjecting its claims to the public scrutiny of pre-grant representation, thus
there is none "uncertainty" for the public by a voluntary divisional application.
In addition, in fact, the presently claimed subject-matter is clearly not the same as/not identical with the parent claims, at least because of
different category and/or different scope, i.e. different claimed subject-matter and different material content. Furthermore, the parent claims
have not been granted/patented, i.e. no double patenting can occur by matter of principle.
Accordingly, the present divisional claims do not include any claim for any matter claimed in the parent. i.e. the present divisional claims fulfill
the requirements of Section 16(3). The disclosure requirements of Section 16(2) have never been objected in the present divisional application.
Notably, Section 16(1) clearly and expressly allows at any time before grant to voluntarily ("if he so desires") to file a divisional application in
respect of any invention disclosed in the specification:
(l) A person who has made an application for a patent under this Act may, at any time before the grant of the patent. if he so desires, or with a
view to remedy the objection raised by the Controller on the ground that the claims of the complete specification relate to more than one
invention, file a further application in respect of an invention disclosed in the provisional or complete Specification already filed in respect of the
first mentioned application.
Thus, according to Section 16(1) basis för a divisional application is the disclosure in the specification of the parent application, but not only the
inconsistent, arbitrary, and frivolous.
It may further be noted that - at utmost - any rejection decision is only pertinent to the very claimed subject-matter of the request that has been
subject of the rejection (here: only the parent claims directed to isolation/storage medium).
Without prejudice, it is submitted that even if there is no explicit invitation by the learned Controller to file a divisional (or no explicit finding of
plurality of distinct inventions), a divisional application can be filed voluntarily by the applicant.
With regard to the Section 16, it is submitted that it is possible to voluntarily file a divisional application, even without previous unity/plurality
objection and without plurality/distinction requirement as applied by the learned Controller (as long as the "disclosure" requirement Of Section
16(2), i.e. ‘shall not include any matter not in substance disclosed in the complete specification", and the 'double patenting" requirement of
Section 16(3) are fulfilled, i.e. "no claim for any matter claimed in the other").
This is reaffirmed by Explanation to this Section clearly stating that the divisional application is to be treated as a substantive and independent
application. Also, the divisional application is mandatorily published subjecting its claims to the public scrutiny of pre-grant representation, thus
there is none "uncertainty" for the public by a voluntary divisional application.
In addition, in fact, the presently claimed subject-matter is clearly not the same as/not identical with the parent claims, at least because of
different category and/or different scope, i.e. different claimed subject-matter and different material content. Furthermore, the parent claims
have not been granted/patented, i.e. no double patenting can occur by matter of principle.
Accordingly, the present divisional claims do not include any claim for any matter claimed in the parent. i.e. the present divisional claims fulfill
the requirements of Section 16(3). The disclosure requirements of Section 16(2) have never been objected in the present divisional application.
Notably, Section 16(1) clearly and expressly allows at any time before grant to voluntarily ("if he so desires") to file a divisional application in
respect of any invention disclosed in the specification:
(l) A person who has made an application for a patent under this Act may, at any time before the grant of the patent. if he so desires, or with a
view to remedy the objection raised by the Controller on the ground that the claims of the complete specification relate to more than one
invention, file a further application in respect of an invention disclosed in the provisional or complete Specification already filed in respect of the
first mentioned application.
Thus, according to Section 16(1) basis för a divisional application is the disclosure in the specification of the parent application, but not only the
15
claims of the parent application.
In this regard, the present divisional concerning a further invention (i.e. a further contribution over the art) disclosed in the parent fulfills the
requirements of Section 16(1), even if filed upon desire by the applicant.
Further indications for more clarity in relation to filing of Suo moto divisional application may be found in IPAB decision, particularly in Milliken
& Company v Union of India (OA/61/2012/PT/MUM). A copy of the decision is enclosed. In this case it was held that the second divisional
application, which was filed voluntarily without receiving an objection on lack of unity in the first divisional application, was valid. The IPAB
upheld the validity of the voluntary second-generation divisional application, even without looking into presence of multiple/plurality of
inventions.
The Controller is therefore requested to withdraw this objection.
REPLY TO FORMAL REOUIREMENTS - PART III
Date and Signature of Applicant: It is respectfully submitted that Form 18 was executed electronically with digital signature in accordance with
the prescribed procedure. The learned Controller is therefore requested to withdraw this objection.
Statement & Undertaking (Form 3 details): We have the honor to submit herewith the updated details of corresponding foreign applications on
a statement and undertaking on Form 3. Further, we have filed a petition under Rule 137, via e-filing, for obviating the irregularity in filing the
details of corresponding applications on Form 3. We enclose herewith a copy of the CBR reflecting payment of the official fee for said petition.
The learned Controller is requested to withdraw the objection.
With the submission of the revised documents and the detailed response, it is believed that this application is in order. Accordingly, allowance
and grant of this application by the in-extendible period expiring on January 16, 2020, is respectfully requested.
In any case before taking an adverse decision on this matter the learned Controller is respectfully requested to afford an opportunity to the
Applicant to be heard officially in this matter. The learned Controller is also requested to appoint such hearing, if necessitated, via Video
Conferencing.
k)Patent Office intimation to Boehringer regarding a pre-grant Opposition filed against Divisional Application No: 201718031279 on 27
th
January, 2021:
The Patent Office made it known that a pre-grant opposition representation was filed in Form-7A, citing Section 25(1)(f) and 25(1)(h) grounds of the
Patent Act, as the basis of opposition, on 27
th
January, 2021.
claims of the parent application.
In this regard, the present divisional concerning a further invention (i.e. a further contribution over the art) disclosed in the parent fulfills the
requirements of Section 16(1), even if filed upon desire by the applicant.
Further indications for more clarity in relation to filing of Suo moto divisional application may be found in IPAB decision, particularly in Milliken
& Company v Union of India (OA/61/2012/PT/MUM). A copy of the decision is enclosed. In this case it was held that the second divisional
application, which was filed voluntarily without receiving an objection on lack of unity in the first divisional application, was valid. The IPAB
upheld the validity of the voluntary second-generation divisional application, even without looking into presence of multiple/plurality of
inventions.
The Controller is therefore requested to withdraw this objection.
REPLY TO FORMAL REOUIREMENTS - PART III
Date and Signature of Applicant: It is respectfully submitted that Form 18 was executed electronically with digital signature in accordance with
the prescribed procedure. The learned Controller is therefore requested to withdraw this objection.
Statement & Undertaking (Form 3 details): We have the honor to submit herewith the updated details of corresponding foreign applications on
a statement and undertaking on Form 3. Further, we have filed a petition under Rule 137, via e-filing, for obviating the irregularity in filing the
details of corresponding applications on Form 3. We enclose herewith a copy of the CBR reflecting payment of the official fee for said petition.
The learned Controller is requested to withdraw the objection.
With the submission of the revised documents and the detailed response, it is believed that this application is in order. Accordingly, allowance
and grant of this application by the in-extendible period expiring on January 16, 2020, is respectfully requested.
In any case before taking an adverse decision on this matter the learned Controller is respectfully requested to afford an opportunity to the
Applicant to be heard officially in this matter. The learned Controller is also requested to appoint such hearing, if necessitated, via Video
Conferencing.
k)Patent Office intimation to Boehringer regarding a pre-grant Opposition filed against Divisional Application No: 201718031279 on 27
th
January, 2021:
The Patent Office made it known that a pre-grant opposition representation was filed in Form-7A, citing Section 25(1)(f) and 25(1)(h) grounds of the
Patent Act, as the basis of opposition, on 27
th
January, 2021.
16
Section 25(1)(f) reads as follows:
Section 25(1)(f): Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by
way of opposition to the Controller against the grant of patent on the ground that the subject of any claim of the complete specification is not an
invention within the meaning of this Act, or is not patentable under this Act.
Section 25(1)(h) reads as follows:
Section 25(1)(h): Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by
way of opposition to the Controller against the grant of patent on the ground that the applicant has failed to disclose to the Controller the
information required by section 8 or has furnished the information which in any material particular was false to his knowledge.
l)Boehringer’s Reply Statement to the above pre-grant opposition of its Divisional Application No: 201718031279 on 20
th
May, 2021
One aspect of Boehringer’s reply, counters the opposition, by stating that, “the opposition largely rests on whether the present application is a valid
divisional application under the Indian patent law. It is submitted that the opponent cannot be allowed to raise this issue as there is no such ground
under Section 25(1)”. Boehringer, further requests the Patent Office to dismiss the pre-grant opposition and to allow the application to proceed for
the grant of a patent, among Boehringer’s other prayers to the Patent Office.
m)Written Submissions by both parties, regarding the Patent Office Hearing which was held on 28
th
July, 2021
The Opposition, vide its communication dated 5
th
of August 2021, among other aspects submitted that the Indian Patent Act provides under the
aegis of Public Interest, to apply the provision of Section 15 of the Act, to overcome the limiting 11 grounds [from clause (a) to clause (k)] of Section
25(1) pre-grant opposition. So, it is possible to contest the eligibility of the impugned Boehringer’s Divisional Patent Application, filed for a grant of
the patent, under Section 15 too, as per the Opposition.
Boehringer, vide its communication dated 10
th
of August 2021, cited various aspects of the Controller’s FER, among other arguments as a support to
Boehringer’s stance for the grant of its Divisional Application for a patent.
n)The Controller’s Decision regarding the Divisional Patent Application on 25
th
March 2022
The Joint Controller of Patents and Designs, did not find the Divisional Patent Application No: 201718031279 of the refused-Parent Patent
Application numbered 9501/DELNP/2008, from Boehringer, persuasive, for its grant, vide Section 15 of the Patent Act, 1970. The Patent Office
stated that the 201718031279 numbered Divisional Application’s scope was not within the ambit of the parent patent application and that it had
claims similar to that of the Parent Patent Application numbered 9501/DELNP/2008. Thus, the Pre-grant Opposition-party was favored by this Joint
Controller’s decision dated 25
th
March 2022.
Section 25(1)(f) reads as follows:
Section 25(1)(f): Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by
way of opposition to the Controller against the grant of patent on the ground that the subject of any claim of the complete specification is not an
invention within the meaning of this Act, or is not patentable under this Act.
Section 25(1)(h) reads as follows:
Section 25(1)(h): Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by
way of opposition to the Controller against the grant of patent on the ground that the applicant has failed to disclose to the Controller the
information required by section 8 or has furnished the information which in any material particular was false to his knowledge.
l)Boehringer’s Reply Statement to the above pre-grant opposition of its Divisional Application No: 201718031279 on 20
th
May, 2021
One aspect of Boehringer’s reply, counters the opposition, by stating that, “the opposition largely rests on whether the present application is a valid
divisional application under the Indian patent law. It is submitted that the opponent cannot be allowed to raise this issue as there is no such ground
under Section 25(1)”. Boehringer, further requests the Patent Office to dismiss the pre-grant opposition and to allow the application to proceed for
the grant of a patent, among Boehringer’s other prayers to the Patent Office.
m)Written Submissions by both parties, regarding the Patent Office Hearing which was held on 28
th
July, 2021
The Opposition, vide its communication dated 5
th
of August 2021, among other aspects submitted that the Indian Patent Act provides under the
aegis of Public Interest, to apply the provision of Section 15 of the Act, to overcome the limiting 11 grounds [from clause (a) to clause (k)] of Section
25(1) pre-grant opposition. So, it is possible to contest the eligibility of the impugned Boehringer’s Divisional Patent Application, filed for a grant of
the patent, under Section 15 too, as per the Opposition.
Boehringer, vide its communication dated 10
th
of August 2021, cited various aspects of the Controller’s FER, among other arguments as a support to
Boehringer’s stance for the grant of its Divisional Application for a patent.
n)The Controller’s Decision regarding the Divisional Patent Application on 25
th
March 2022
The Joint Controller of Patents and Designs, did not find the Divisional Patent Application No: 201718031279 of the refused-Parent Patent
Application numbered 9501/DELNP/2008, from Boehringer, persuasive, for its grant, vide Section 15 of the Patent Act, 1970. The Patent Office
stated that the 201718031279 numbered Divisional Application’s scope was not within the ambit of the parent patent application and that it had
claims similar to that of the Parent Patent Application numbered 9501/DELNP/2008. Thus, the Pre-grant Opposition-party was favored by this Joint
Controller’s decision dated 25
th
March 2022.
17
THE FOLLOWING FLOWCHART POINTS TO THE TIMELINE OF THE DIVISIONAL PATENT APPLICATION #201718031279 PROSECUTION:
= = = = = = = = = = = = = = = = = = = = = = = = =
=
o)Boehringer’s Appeal, against the Controller’s decision on Boehringer’s Divisional Patent Application
Divisional Application No.
201718031279 titled, “USES OF
DPP-IV INHIBITORS” filed on
4.09.2017
First Exam
Report(FER) from
Patent Office on
16.07.2019
Boehringer’s
response to the
Objections on
31.12.2019
pre-grant opposition citing Sec
25(1)(f) and 25(1)(h) grounds
filed on 27.01.2021
Boehringer’s Reply Statement to
the pre-grant opposition on
20.05.2021
Hearing held on 28
th
July, 2021
with Written Submissions from
Opposition: 5.08.2021
Boehringer: 10.08.2021
The Controller’s Decision refusing
Boehringer’s Divisional Application
request on 25.03.2022
THE FOLLOWING FLOWCHART POINTS TO THE TIMELINE OF THE DIVISIONAL PATENT APPLICATION #201718031279 PROSECUTION:
= = = = = = = = = = = = = = = = = = = = = = = = =
=
o)Boehringer’s Appeal, against the Controller’s decision on Boehringer’s Divisional Patent Application
Divisional Application No.
201718031279 titled, “USES OF
DPP-IV INHIBITORS” filed on
4.09.2017
First Exam
Report(FER) from
Patent Office on
16.07.2019
Boehringer’s
response to the
Objections on
31.12.2019
pre-grant opposition citing Sec
25(1)(f) and 25(1)(h) grounds
filed on 27.01.2021
Boehringer’s Reply Statement to
the pre-grant opposition on
20.05.2021
Hearing held on 28
th
July, 2021
with Written Submissions from
Opposition: 5.08.2021
Boehringer: 10.08.2021
The Controller’s Decision refusing
Boehringer’s Divisional Application
request on 25.03.2022
18
Boehringer preferred an Appeal to the Hon’ble High Court of Delhi in connection with the above Controller’s decision of 25
th
March, 2022 refusing
Boehringer’s Divisional Application bearing the number No. 201718031279, request. Boehringer submitted to the Hon’ble High Court that Claims 1
to 25 of the Divisional Patent Application, are based out of the original patent Specification in No.9501/DELNP/2008 and thus, since the scope of the
parent specification includes the claimed products and formulations, the same could be the subject matter of the Divisional Application in terms of
the Section 16 of the Patent Act.
Section 16 is entitled, “Power of Controller to make orders respecting division of application”.
The Opposition Party’s counsel had submitted to the Hon’ble High Court that the subject matter of the Parent Application No.9501/DELNP/2008 was
regarding the use of DPP-IV inhibitors and not for the inhibitor/medicament itself. The Opposition Party further contended that the manner in
which the relevant Amendments were sought to be made for seeking exclusivity qua the inhibitor was contrary to Section 10(4) of the Patent Act.
Section 10 of the Patent Act 1970 is entitled as, “Contents of Specification” and in the relevant part, reads as follows:
Section 10(4): Every complete specification shall-
(a)Fully and particularly describe the invention and its operation or use and the method by which it is to be performed.
(b)Disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim
protection: and
(c)End with a claim or claims defining the scope of the invention for which protection is claimed;
(d)Be accompanied by an abstract to provide technical information on the invention;
The Opposition Party’s counsel had submitted to the Hon’ble High Court that if the amendments were once refused by the Controller, as being
beyond the scope of the Claims, Section 16 could not be invoked.
The Hon’ble High Court citing Amendments Nos.2 and 3, of the 9501/DELNP/2008 application, held that those Boehringer’s amended claims, were
product-Claims, which were not contained in the 18-count claims of the 14
th
November, 2008 application at all, which were either Use-claims or
Method-claims. The Hon’ble High Court further held that Claim Numbers 1 to 17, of the 201718031279 application (Boehringer’s Divisional
Application) were reflected in some form in Boehringer’s Amendment Nos. 2 and 3, made in its 9501/DELNP/2008 application. Also, the Hon’ble
High Court noted that Claims 18 to 25 of the Divisional Application appeared to be completely new claims.
The Hon’ble High Court’s Verdict, in its conclusion stage, is verbatim reproduced here:
35. In view of the above discussed settled position in law, this Court is clearly of the opinion that a divisional application in
the present case cannot be filed since there was no “plurality of inventions” in the parent application. In the present case, the
original ‘DPP IV inhibitor’ arising out of a Markush formula, in various permutations and combinations describing its use and
Boehringer preferred an Appeal to the Hon’ble High Court of Delhi in connection with the above Controller’s decision of 25
th
March, 2022 refusing
Boehringer’s Divisional Application bearing the number No. 201718031279, request. Boehringer submitted to the Hon’ble High Court that Claims 1
to 25 of the Divisional Patent Application, are based out of the original patent Specification in No.9501/DELNP/2008 and thus, since the scope of the
parent specification includes the claimed products and formulations, the same could be the subject matter of the Divisional Application in terms of
the Section 16 of the Patent Act.
Section 16 is entitled, “Power of Controller to make orders respecting division of application”.
The Opposition Party’s counsel had submitted to the Hon’ble High Court that the subject matter of the Parent Application No.9501/DELNP/2008 was
regarding the use of DPP-IV inhibitors and not for the inhibitor/medicament itself. The Opposition Party further contended that the manner in
which the relevant Amendments were sought to be made for seeking exclusivity qua the inhibitor was contrary to Section 10(4) of the Patent Act.
Section 10 of the Patent Act 1970 is entitled as, “Contents of Specification” and in the relevant part, reads as follows:
Section 10(4): Every complete specification shall-
(a)Fully and particularly describe the invention and its operation or use and the method by which it is to be performed.
(b)Disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim
protection: and
(c)End with a claim or claims defining the scope of the invention for which protection is claimed;
(d)Be accompanied by an abstract to provide technical information on the invention;
The Opposition Party’s counsel had submitted to the Hon’ble High Court that if the amendments were once refused by the Controller, as being
beyond the scope of the Claims, Section 16 could not be invoked.
The Hon’ble High Court citing Amendments Nos.2 and 3, of the 9501/DELNP/2008 application, held that those Boehringer’s amended claims, were
product-Claims, which were not contained in the 18-count claims of the 14
th
November, 2008 application at all, which were either Use-claims or
Method-claims. The Hon’ble High Court further held that Claim Numbers 1 to 17, of the 201718031279 application (Boehringer’s Divisional
Application) were reflected in some form in Boehringer’s Amendment Nos. 2 and 3, made in its 9501/DELNP/2008 application. Also, the Hon’ble
High Court noted that Claims 18 to 25 of the Divisional Application appeared to be completely new claims.
The Hon’ble High Court’s Verdict, in its conclusion stage, is verbatim reproduced here:
35. In view of the above discussed settled position in law, this Court is clearly of the opinion that a divisional application in
the present case cannot be filed since there was no “plurality of inventions” in the parent application. In the present case, the
original ‘DPP IV inhibitor’ arising out of a Markush formula, in various permutations and combinations describing its use and
19
method for treatment, which is only mentioned in the examples in the specification, cannot be permitted to be claimed as separate
product Claims in a divisional application, as there were no product Claims in the parent application. Clearly, the Claims in the
parent application only related to method or use claims whereas, the Claims in the divisional application concern “products” i.e.
medicaments or their combinations. Once the product Claims were not sought in the original application and the said products were
clearly disclosed in the content of the complete specification, the products ought to be treated as having been disclaimed. Thus, the
parent application cannot be interpreted to have included a “plurality of inventions,” i.e., completely new product Claims, patentable
by way of a divisional application.
Thus, the Appeal Suit was resolved, in favor of the Respondents.
Reference:
Boehringer Ingelheim International GmbH (Appellant) Vs. The Controller of Patents & Anr. (Respondents), The High Court of Delhi at New Delhi, Case
No. C.A.(COMM.IPD-PAT) 295/2022 & I.As. 10369-70/2022 dated 12
th
July, 2022.
method for treatment, which is only mentioned in the examples in the specification, cannot be permitted to be claimed as separate
product Claims in a divisional application, as there were no product Claims in the parent application. Clearly, the Claims in the
parent application only related to method or use claims whereas, the Claims in the divisional application concern “products” i.e.
medicaments or their combinations. Once the product Claims were not sought in the original application and the said products were
clearly disclosed in the content of the complete specification, the products ought to be treated as having been disclaimed. Thus, the
parent application cannot be interpreted to have included a “plurality of inventions,” i.e., completely new product Claims, patentable
by way of a divisional application.
Thus, the Appeal Suit was resolved, in favor of the Respondents.
Reference:
Boehringer Ingelheim International GmbH (Appellant) Vs. The Controller of Patents & Anr. (Respondents), The High Court of Delhi at New Delhi, Case
No. C.A.(COMM.IPD-PAT) 295/2022 & I.As. 10369-70/2022 dated 12
th
July, 2022.
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