[Ip-health] Valganciclovir: IPAB remands matter back to the Controller: patent to remain revoked

Geetanjali.Sharma geetanjali.sharma at lawyerscollective.org
Mon Feb 3 05:00:36 PST 2014

Date- January 30th, 2014


30th January, 2014: The Intellectual Property Appellate Board (IPAB) set
aside the Patent Controller's decision to revoke the patent relating to
valganciclovir on technical grounds and remanded it to the Controller for
re-consideration. In a significant development for patient groups, the IPAB
rejected the demand of the patentee, Hoffman La Roche, to restore the patent
while the matter was being considered by the Controller afresh.
Valganciclovir is an important drug for treatment of active cytomegalovirus
retinis (CMV) infection affecting the eye that people living with HIV are
susceptible to. 

In May 2010, accepting oppositions filed by the Indian Network of Positive
People (INP+), the Tamil Nadu Network of Positive People (TNNP+), the Delhi
Network of Positive People (DNP+) and generic companies, the Patent
Controller had revoked the patent on grounds that it was obvious and did not
satisfy the requirements of Section 3(d) of the Patents Act, 1970.  Roche
challenged the decision by way of an appeal to the IPAB. INP+ and TNNP+ also
filed an appeal against the some of the Controller's findings, which had
gone against them. Both appeals came up for hearing on 30 January, 2014
before Chairman Shri K.N. Basha (Chairman) and Shri. D.P. S. Parmar
(Technical Member).

Appearing on behalf of Roche, Mr. Rahul Balaji, Senior Counsel assailed the
order on two grounds. Firstly, he argued that the evidence of three experts
filed by the Roche was not forwarded to the Opposition Board. Secondly, he
submitted that according to a recent decision of the Supreme Court in Pfizer
v. CIPLACIPLA Ltd. V. Union of India (UOI) and Ors. 2012(11 decided on:
27.11.2012 a copy of recommendations of the Opposition Board has to be made
available to the parties. According to him the matter had to be remanded to
the Controller to be determined again and in the mean time, sought that the
patent be restored. 

Mr. Anand Grover, Senior Counsel and Director of the Lawyers Collective,
representing INP+ & TNNP+ and DNP+ clarified that there was no dispute
regarding the procedures that had to be followed however, Roche had not even
requested a copy of the recommendations of the Board. He also submitted that
this was a peculiar case where the patent had been granted without hearing
pre-grant oppositions filed by INP+ and TNNP+. In order to expedite the
proceedings, the parties had agreed to be heard as post grant opponents,
along with order. He argued that INP+ and TNNP+ would be prejudiced if the
patent were to be restored while the Patent Controller considered the matter

He further argued that even if the matter was remanded, it has to be revoked
since the main feature of the invention is increase in bioavailability as
against therapeutic efficacy which can never meet the threshold of section
3(d) after the Novartis Supreme Court decision. 

The bench remanded the patent for fresh consideration, but agreeing with the
submissions of Mr. Anand Grover, the Bench refused to restore the patent in
the meantime. 


In 2006 Indian Network for Positive people (INP+) and Tamil Nadu Network of
Positive People (TNNP+) through Lawyers Collective had filed a pre- grant
opposition against 959/MAS/1995; however the patent was granted without
hearing the pre- grant opposition. The opponents then approached the Madras
High Court against the said decision which quashed and set aside the grant
and directed the Assistant Controller to hear the opponents. The Controller
after hearing the opponents proceeded to grant the patent in January, 2009. 

The INP+ and TNNP+ then approached the Apex Court against the decision of
the Controller wherein by an order dated 02.03.2009 the Hon'ble Court
allowed a agreement between the parties according to which INP+ and TNNP+
were allowed to raise all contentions in the form of an intervention cum
affidavit before the Assistant Controller while they agreed to be heard with
other parties (DNP+, CIPLA, Matrix, Ranbaxy and Bakul Pharma) who had by
then filed post- grant oppositions. It is pertinent to note that standing
was conferred upon by the Supreme Court keeping in mind the public interest
element which directly affected the petitioner. Also, the Apex Court did not
stay the order of the Madras High Court which had quashed and set aside the
patent but directed the Controller to hear all challenges along with the
Petitioner's affidavit as post grant oppositions. 

After hearing the post grant oppositions and intervention cum affidavit by
INP+ and TNNP+, the Assistant Controller revoked the patent limiting it to
single process claims. Hoffman-La Roche had appealed the decision
(OA/28/2010/PT/CH) as well as INP+ and TNNP+ who appealed the decision on
certain findings (OA/26/2010/PT/CH). 

In solidarity, 

Geetanjali Sharma 

Lawyers Collective 


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