[Commons-Law] Novartis loses patent claim on cancer drug Patents Controller upholds Natco contention
Via: TAHIR AMIN
ALF and Lawyers Collective, on behalf of the Cancer
Patients Aid Association, also filed an opposition to
Glivec (as did CIPLA, Sun Pharma and Ranbaxy in their
own right). We have yet to receive a decision, but it
should reflect what is reported below.
Tahir
Novartis loses patent claim on cancer drug Patents
Controller upholds Natco contention
C.R. Sukumar
Hyderabad , Jan. 25
IN a major setback, the Swiss pharmaceutical giant
Novartis AG has lost a patent claim for an anti-cancer
drug Imatinib Mesylate before the office of the
Indian Controller of Patents and Designs on Wednesday.
Following serious objections raised by Natco Pharma
Ltd, a Hyderabad-based pharma company, the office of
the Controller of Patents & Designs at Chennai has
ruled against the claim of Novartis AG.
The patents office has refused to proceed further with
the application for a patent filed by Novartis AG for
Gleevec (Imatinib Mesylate), a life-saving drug used
in the treatment of chronic myeloid leukaemia, sources
told Business Line.
Novartis was earlier granted exclusive marketing
rights (EMRs) in India for Gleevac. Natco Pharma,
which launched a generic version of Gleevac under the
brand `Veenat', had challenged the grant of EMRs to
Novartis. This case is currently pending before the
Supreme Court.
Subsequently, Novartis had applied for an Indian
patent and Natco had filed pre-grant opposition
petition before the Controller of Patents & Designs,
as provided in the amended Patents Act and Rules.
According to the judgment copy available with this
newspaper, the patent application was rejected after
due hearings on three grounds anticipation by prior
publication, obviousness, priority and also on the
ground that the product was a derivative of a known
substance.
Natco has submitted to the Controller that Novartis AG
has filed claim for a polymorphic form of Imatinib
Mesylate. As per Section 3(d) of the Patents Act, any
salt, polymorph or derivative of known substance is
not patentable unless such salt, polymorph or other
substance shows enhanced efficacy of the substance.
The Controller was informed that the specification
states that wherever beta-crystals are used, the
Imatinib free base or other salts can be used.
Further, Natco has submitted that the technical expert
has conducted studies to compare the relative
bioavailability of the free base with that of
beta-crystal form of Imatinib Mesylate and has said
that the difference in bioavailability is only 30 per
cent and also the difference in bioavailability may be
due to the difference in their solubility in water.
"The present patent specification (of Novartis AG)
does not bring out any improvement in the efficacy of
the beta-crystal form over the known substances rather
it states the base can be used equally in the
treatment of diseases or in the preparation of
pharmacological agents wherever the beta-crystal is
used.
"Even the affidavit submitted on behalf of the
Applicant (Novartis AG) does not prove any significant
enhancement of known efficacy," Natco submitted to the
Controller.
Following this, the Assistant Controller of Patents &
Designs, Mr V. Rengasamy, in his ruling on Wednesday
said he was not convinced with the contentions of
Novartis AG that the patent application claims a new
substance. "It is only a new form of a known
substance. It is found that this patent application
claims only a new form of a known substance without
having any significant improvement in efficacy."
Further, stating that Novartis AG failed to prove
enhanced efficacy of the beta-isomer over the known
substance, the Assistant Controller has concluded
that, "the subject matter of this (patent) application
(filed by Novartis AG) is not patentable under Section
3(d) of the Patents Act 1970 as amended by the Patents
(Amendment) Act, 2005."
ALF and Lawyers Collective, on behalf of the Cancer
Patients Aid Association, also filed an opposition to
Glivec (as did CIPLA, Sun Pharma and Ranbaxy in their
own right). We have yet to receive a decision, but it
should reflect what is reported below.
Tahir
Novartis loses patent claim on cancer drug Patents
Controller upholds Natco contention
C.R. Sukumar
Hyderabad , Jan. 25
IN a major setback, the Swiss pharmaceutical giant
Novartis AG has lost a patent claim for an anti-cancer
drug Imatinib Mesylate before the office of the
Indian Controller of Patents and Designs on Wednesday.
Following serious objections raised by Natco Pharma
Ltd, a Hyderabad-based pharma company, the office of
the Controller of Patents & Designs at Chennai has
ruled against the claim of Novartis AG.
The patents office has refused to proceed further with
the application for a patent filed by Novartis AG for
Gleevec (Imatinib Mesylate), a life-saving drug used
in the treatment of chronic myeloid leukaemia, sources
told Business Line.
Novartis was earlier granted exclusive marketing
rights (EMRs) in India for Gleevac. Natco Pharma,
which launched a generic version of Gleevac under the
brand `Veenat', had challenged the grant of EMRs to
Novartis. This case is currently pending before the
Supreme Court.
Subsequently, Novartis had applied for an Indian
patent and Natco had filed pre-grant opposition
petition before the Controller of Patents & Designs,
as provided in the amended Patents Act and Rules.
According to the judgment copy available with this
newspaper, the patent application was rejected after
due hearings on three grounds anticipation by prior
publication, obviousness, priority and also on the
ground that the product was a derivative of a known
substance.
Natco has submitted to the Controller that Novartis AG
has filed claim for a polymorphic form of Imatinib
Mesylate. As per Section 3(d) of the Patents Act, any
salt, polymorph or derivative of known substance is
not patentable unless such salt, polymorph or other
substance shows enhanced efficacy of the substance.
The Controller was informed that the specification
states that wherever beta-crystals are used, the
Imatinib free base or other salts can be used.
Further, Natco has submitted that the technical expert
has conducted studies to compare the relative
bioavailability of the free base with that of
beta-crystal form of Imatinib Mesylate and has said
that the difference in bioavailability is only 30 per
cent and also the difference in bioavailability may be
due to the difference in their solubility in water.
"The present patent specification (of Novartis AG)
does not bring out any improvement in the efficacy of
the beta-crystal form over the known substances rather
it states the base can be used equally in the
treatment of diseases or in the preparation of
pharmacological agents wherever the beta-crystal is
used.
"Even the affidavit submitted on behalf of the
Applicant (Novartis AG) does not prove any significant
enhancement of known efficacy," Natco submitted to the
Controller.
Following this, the Assistant Controller of Patents &
Designs, Mr V. Rengasamy, in his ruling on Wednesday
said he was not convinced with the contentions of
Novartis AG that the patent application claims a new
substance. "It is only a new form of a known
substance. It is found that this patent application
claims only a new form of a known substance without
having any significant improvement in efficacy."
Further, stating that Novartis AG failed to prove
enhanced efficacy of the beta-isomer over the known
substance, the Assistant Controller has concluded
that, "the subject matter of this (patent) application
(filed by Novartis AG) is not patentable under Section
3(d) of the Patents Act 1970 as amended by the Patents
(Amendment) Act, 2005."
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