[Ip-health] KOLKATA PATENT OFFICE CLARIFIES ITS DECISION ON DIVISIONAL APPLICATIONS OF HERCEPTIN (Press Release)

leena menghaney leenamenghaney at gmail.com
Mon Aug 5 04:32:36 PDT 2013


PRESS INFORMATION BUREAU

GOVERNMENT OF INDIA
******
KOLKATA PATENT OFFICE CLARIFIES ITS DECISION ON DIVISIONAL
APPLICATIONS OF HERCEPTIN

New Delhi, August 5, 2013

This has a reference to the above-mentioned matter published today.
The response of the Kolkata Patent Office vis-à-vis the news item is
given herein below:

A.    India has partly revoked patents granted to Roche Holding AG for
its breast cancer drug Herceptin, a spokesman for the drugmaker
confirmed on Sunday. Swiss newspaper Schweiz am Sonntag reported that
the Kolkata Patent Office had lifted divisional patents for Herceptin
on July 17 on the grounds they had not been properly submitted. "I can
confirm that the Assistant Controller of Patents at the Kolkata Patent
Office has revoked divisional patents of Herceptin and that we are now
considering the further course of action," a spokesman for Roche said.

Response of the Office: The news item does not fully reflect and
appreciate the situation under which the Patent Office has disposed of
the said divisional applications. A synopsis of the patent/
applications for patent related to Herceptin is given herein below:

1.    An application for patent IN/PCT/2000/391/KOL was filed on
11‐10‐2000 and was later granted a patent with a title “A composition
comprising a mixture of anti-HER2 antibody”. The grant of the patent
was published on 06.04.2007. It may be noted that after the grant of a
patent, the said grant may be opposed by an interested member of the
public. In the instant case, the grant of the said patent has been
challenged through this post-grant opposition procedure.

2.    As per the Indian Patents Act, a patent is granted for one
invention only [Section 46 of the Patents Act]. If the claims of an
application relate to more than one application, such application can
be divided and further applications (called divisional applications,
please see Section 16 of the Act) can be filed. A divisional
application has to be filed before the date of grant of the first
application (usually referred as   mother application). Let it be
noted that after the filing of the application, the application is
duly published in the Official journal. An applicant has to file a
request for examination for an application within forty eight months
from the date of priority of the application (other than divisional
applications) and within forty eight months from the date of priority
or within six months from the date of filing in the case of divisional
applications. If the requests are not filed within time they are
treated as withdrawn under section IIB(4) of the Act

3.     Three divisional applications were filed out of this
application, namely :

a.    1638/KOLNP/2005, divisional application out of
IN/PCT/2000/391/KOL date of filing: 16-08-2005. Date of filing of
request: 17‐03‐2006

b.    3272/KOLNP/2008 divisional application out of 1638/KOLNP/2005
Date of filing of request: 12‐02‐2009

c.    3273/KOLNP/2008 divisional application out of 1638/KOLNP/2005
Date of filing of request: 12‐02‐2009

4.    In all these cases, the Controllers of the Patent Office offered
the applicant, opportunity of being heard before the final disposal of
these cases.

5.    In  1638/KOLNP/2005, the Controller found that the Request for
Examination had been filed on 17.03.2006, i.e., beyond the prescribed
period (which was due on 16.02.2006) according to Rule 24(B)(iv) of
the Patents Rules. An opportunity of hearing was offered on 18.06.2013
before exercising any discretion vested in the controller by or under
this Act adversely to the applicant. At the request of the applicant’s
newly appointed agent the hearing was rescheduled on 23.07.2013. The
agent of the applicant did not appear in the hearing and even did not
submit any notes of argument. Under these circumstances, the
Controller ordered that the application should be treated as withdrawn
by the applicant under section 11B(4) of the Act.

6.    In the matter of 3272/KOLNP/2008, the Controller found that the
instant application was divisional to a divisional application, which
in his opinion was not permissible. As the present application was to
be construed as the divisional application of the first filed
application (IN/PCT/2000/391/KOL), the said divisional application was
filed after the grant of the first filed application and was not
permissible under the ‘Act. The Controller gave due opportunity of
hearing to the agent on 31/05/2013. After the first hearing, the
Controller fixed another date of hearing in the subject matter on
15/07/2013, which was not attended by the applicant. In the operative
part of the decision the Controller said “the application no.
3273/KOLNP/2008 is not considered to be a divisional application at
all within the meaning of section 16 of the ‘Act. The application has
not been properly filed complying with the requirements of the ‘Act
and therefore, treated as abandoned”.

7.    In the matter of 3273/KOLNP/2008 also, similar decision was
arrived at by the Controller and in the instant case also, the
applicant’s agent did not turn up on the date of the hearing.

8.    It is submitted that the said divisional applications have not
been revoked but were treated as withdrawn due to non-filing of
Request for Examination within prescribed time or abandoned due to
incorrect filing. Before the Controllers issued their decisions, the
applicants were given due opportunity of being heard but the
applicants have chosen not to attend.

9.    Still thereafter, the applicant may explore further legal
possibilities, as they so desire.

B.   The decision is the latest in a series of rulings on intellectual
property and pricing in India that have frustrated attempts by Western
drug makers to sell their medicines in India's fast-growing drugs
market.

Response of the Office: Regarding this paragraph, it is submitted that
in the instant cases, the Patent Office has followed the due course of
principle of natural justice, gave the applicant the opportunity of
being heard and then only finally disposed of the matter. In the
instant cases, it is found that proper steps for filing request or
filing divisional applications were not followed by the applicants.

C. On Friday, India revoked a patent granted to GlaxoSmithKline's for
breast cancer drug Tykerb, following on from a landmark court ruling
in April disallowing patents for incremental innovations.

Response of the Office: Perhaps the news item refers to a decision of
the Intellectual Property Appellate Board. The IPAB, is an independent
judicial authority.

D.   Roche has already adapted its business model in India to increase
affordable access to drugs and try to stave off trouble from India's
patent authorities. In August 2012, it introduced cut-price versions
of Herceptin and another cancer drug MabThera, under an alliance with
Indian generics firm Emcure Pharmaceutics.

Response of the Office: The present abandonment or rejection of the
divisional applications related to Herceptin has no nexus with the
pricing of the drug. The news item failed to appreciate this fact.
Once again, it is submitted that the instant divisional applications
were not filed in proper manner.

E.    Last year, India revoked patents granted to Roche's hepatitis C
drug Pegasys, Pfizer Inc's cancer drug Sutent, and Merck & Co's asthma
treatment aerosol suspension formulation. All were revoked on grounds
that included lack of innovation.

Response of the Office: Except for Pfizer Inc’s drug Sutent, the
rejections or revocations of were made by independent judicial
authorities. The revocation of Sutent was done after following due
process of law under post-grant opposition. However, the revocation
has been set aside by the Intellectual Property Appellate Board on a
procedural issue and the matter has been remanded back.
-- 
Leena Menghaney
Tel: 46573730/1, 9811365412




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