[Ip-health] Text of Indian Decisions on Glivec Patent Application

[heeseob nam]

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As Joana posted on Jan 26, Novartis failed to obtain patent right on
its product, Glivec. For those who are interested in the details of
the decision, I reproduce it below.

The same ruling was made to an opposition raised by Cipla. Please
refer to the attached file for the Cipla case.

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HeeSeob Nam
Patent Attorney
IPLeft (www.ipleft.or.kr)
The Korea Chamber of Commerce & Industry Bldg.
100-743, 11th Flr. 45 4-ga
Namdaemun-ro, Jung-gu
Tel.: +82 2 6050 1621 / Mobile: +82 11 470 1180
Fax: +82 2 6050 1700
hurips@gmail.com nam@horizonlaw.com


THE PATENTS ACT, 1970 SECTION-25(1)
In the matter of an application for patent No. 1602/MAS/98 filed on
July 17, 1998.
And
In the matter of a representation under Section 25(1) of the Patents
Act, 1970 as
Amended by the Patents (Amendment) Act, 2005.
And
In the matter of rule 55 of the Patents Rules, 2003 as amended by the Paten=
ts
(Amendment) Rules, 2005.

M/S. Novartis AG, Switzerland   =A1=AD=A1=AD=A1=AD=A1=AD=A1=AD=A1=AD=A1=AD.=
. The Applicant
M/S. Natco Pharma Ltd., India   =A1=AD=A1=AD=A1=AD=A1=AD=A1=AD=A1=AD=A1=AD=
=A1=AD The Opponent

HEARING HELD ON October 14, 2005

Present :
M/s. Nalini Chidambaram,
Mr. Sanjay Kumar,
Mr. Gladis Daniel, =09=09=09=09=09Agents for the Applicant
MS. Nitin Sen

Mr. D. Calab Gabriel=09=09=09=09=09Agent for the Opponent

DECISION

=09An application for patent claiming Switzerland priority date of July
18, 1997 was filed by M/s. Novartis AG on July 17, 1998 for an
invention titled "Crystal Modification of A N-Phenyl-2-Pyrimidineamine
derivative, processes for its manufacture and its use" and the same
was allotted the application no. 1602/MAS/1998.

=09A representation by way of opposition under section 25(1) of the
Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 was
filed by M/s. Natco Pharma Ltd., India, on May 26, 2005 with a request
for hearing under rule 55 of the Patents Rules, 2003 as amended by
Patents (Amendment) Rules, 2005.

=09The Applicant through their agents M/s. Remfry & Sagar, New Delhi
filed reply statement along with evidence by way of affidavit affirmed
by Dr. Paul William Manley of Switzerland on July 25, 2005. In their
reply statement, the Applicant had requested for a hearing under rule
55 of the Patents Rules, 2003. They filed another affidavit affirmed
by Giorgio Pietro Massimini of Switzerland on September 22, 2005.

=09Before discussing the grounds of opposition, it is pertinent to
briefly mention here the background of the application. The present
application claims =A6=C2-crystal form of methanesulphonic acid salt of
4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[4-pyridin-3-yl]pyrimidin-2-=
ylamino]phenyl]-benzamide
commercially called as imatinib mesylate. Invention of the base
compound, 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-[4-pyridin-3-yl]py=
rimidin-2-ylamino]phenyl]-benzamide
called as imatinib had already been disclosed in the European Patent
publication no. EP-A-056409, published on October 6, 1993, and its
equivalent US Patent no. 5521184, etc.

Anticipation by Prior publication:

The Opponent argued that imatinib mesylate is known from the US Patent
no: 5521184, hereinafter called the 1993 Patent. And cited another
prior publication, Nature Medicine(May5, 1996) whose publication date
is prior th the priority date of July 17, 1997 of the present
application wherein imatinib mesylate has been disclosed. The patent
term extension certificate granted by US Patent Office for the 1993
Patent explicitly mentions imatinib mesylate (GlveevecR)as the
product. The Opponent further argued that imatinib mesylate salt
inherently existed in the =A6=C2-crystelline form which is the most stable
form of the salt and further said that even the affidavit submitted by
the Applicant states that the =A6=C2-form is thermodynamically more stable.
In order to confirm the crystalline form in which the salt existed,
the Applicant has submitted reports based on the studies done by two
reputed government institutions namely Indian Institute of Chemical
Technology, Hyderabad and Indian Institute of Technology, Delhi. From
their studies they have found that the salt exists in the
=A6=C2-crystalline form.  They have performed the experiments not once but
at least ten times and at all times the crystals were found to exist
in the =A6=C2-form.  Hence the claims of the present application stand
anticipated by prior publication.

The Applicant argued that compared to the disclosure made in the 1993
patent, the present invention involves two fold improvement over the
prior art =A8C (i) the imatinib free base has been chemically changed
into a salt form, (ii) a particular crystal form of the salt has been
made through human intervention.  Further the Applicant said that the
1993 Patent does not disclose imatinib mesylate but merely the
corresponding free base and it may be correct to say that the claim of
the 1993 patent embrace imatinib mesylate.  There is neither an
example for the preparation of imatinib mesylate in the 1993 Patent
nor any claim therefore.

I do not agree with the contention of the Applicant that the 1993
Patent discloses only the free base.  The 1993 patent discloses
methanesulphonic acid as one of the salt forming groups and also the
1993 patent specification states that the required acid additions
salts are obtained in a customary manner.  Further, claims 6 to 23 of
the 1993 patent claim a pharmaceutically acceptable salt of the base
compound.  The patent term extension certificate for the 1993 patent
issued by the US Patent Office specifically mentions imatinib mesylate
(GleevecR) as a product.  All these points clearly prove that imatinib
mesylate is already known from the prior art publications and the
Opponent has satisfactorily proved that the salt normally exists in
the =A6=C2-form which is the most thermodynamically stable product.  Hence
I conclude that the Opponent has succeeded in proving that this
invention is anticipated by prior publication.

Obviousness:

The Opponent submitted that all the averments made in the above ground
are reiterated.  The Opponent further said that once the free base is
disclosed by the 1993 Patent, it is obvious for a person skilled in
the art to prepare corresponding pharmaceutically acceptable salts
especially in view of the disclosure provided in column 3 of the 1993
Patent specification. Further, the reports of the Indian Institute of
Technology, and Indian Institute of Chemical Technology clearly
demonstrate that the salt prepared using instructions of the 1993
Patent inherently exists in =A6=C2-form. Hence the product claims are
obvious over the aforesaid disclosures.

=09The Applicant replied that the =A6=C2-crystals are not inherently formed
when the 1993 Patent is practiced. Moreover, the 1993 Patent discloses
only the free base, not any salt of imatinib and hence not obvious to
a person skilled in the art.

=09I do not agree with the contentions of the Applicant that the 1993
Patent discloses only the free base for the reasons stated in the
grounds of previous publication and I conclude that the Opponent has
reasonably succeeded in establishing this ground of opposition too.

Section 3(d):

=09The Opponent said that the application claims only 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. As regards efficacy, the specification itself states
that where'er =A6=C2-crystals are used the imatinib free base of other
salts can be used. Even the affidavit submitted by the Applicant
states that "the proviso to the section 3(d) is unique to India and
there is no analogous provision in the law of any other country of the
world". As per the affidavit the technical expert has conducted
studies to compare the relative bioavailability of the free base with
that of =A6=C2-crystal form of imatinib mesylate and has said that the
difference in bioavailability is only 30% and also the difference in
bioavailability may be due to the difference in their solubility in
water. The present patent specification does not bring out any
improvement in the efficacy of the =A6=C2-crystal form over the known
substances rather it states the base can be used equally in the
treatment of diseases of in the preparation of pharmacological agents
wherever the =A6=C2-crystal is used. Even the affidavit submitted on behalf
of the Applicant does not prove any significant enhancement of known
efficacy.

=09Countering the arguments of the Opponent, the Applicant said that te
case does not come under the exclusion provided under section 3(d). It
is denied that it is a mere discovery of a new form of a known
substance. The =A6=C2-crystalline form of imatinib mesylate is a new
product because the crystal form is not an inherent property of
imatinib acid addition salt exhibiting polymorphism and human
intervention was necessary in order to produce the subject compound.
As regards efficacy, the Applicant relied on the affidafit by Mr.
Massimini submitted on September 22, 2005, wherein he has conducted a
study on the relative bioavailability of the free base and imatinib
mesylate in the =A6=C2-crystalline form.

=09I do not agree with the contention of the Applicant that this
application claims a net 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. Even the affidavit submitted on behalf of the Applicant
fails to prove enhanced efficacy of the =A6=C2-isomer over the known
substance. Hence I conclude that the subject matter of this
application is not patentable under section 3(d) of the Patents Act,
1970 as amended by the Patents (Amendment)Act, 2005.

Priority:

=09The Opponent said this application was filed in India on July 17,
1998 as a convention application claiming Swiss priority date of July
18, 1997 whereas Switzerland was not a convention country on that
date. Further, section 133 did not have and does not have any
retrospective effect. The Opponent cited a decision of the High Court
of Calcutta in the case of Danieli AC Officine Meccaniche SPA, Italy
in support of his argument. In the present case also, Switzerland
became convention country only in September, 1998. Hence no priority
may be claimed from Swiss application.

=09The Applicant said that priority date is only a facility provided to
the Applicant to avoid anticipation by publication of the invention
between priority date and the filing date in India. It is the
discretion of the Applicant to claim priority. I agree with the
contention of the Opponent that this application wrongly claims
priority.

=09In view of the above findings and all the circumstances of the case,
I hereby refuse to proceed with the application for Patent No.
1602/MAS/1998.

Dated this the 25th day of January, 2006.

V. RENGASAMY
Asst. Controller of Patents & Designs

Copy to:
1) M/s. Remfry & Sagar,
Remfry house at the Millenium Plaza,
Sector =A8C 27, Gurgaon -  122 002
2) M/s. Natco Pharma Ltd.,
'Natco House', Road No. 2, Banjara Hills
Hyderabad =A8C 500 033.
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X-Attachment-Id: f_ekf13146

[ Indian decision on Glivec patent Hamied.tiff of type image/tiff deleted ]