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BEFORE THE CONTROLLER OF PATENTS

THE PATENT OFFICE, DELHI

THE PATENTS ACT, 1970


The Patents Rules, 2003

(SECTION 25(1) and RULE 55)

In the matter of the Patent Application


No.963/DEL/2002 filed on 24th Sept, 2002
And
In the matter of representation for opposition
under section 25(1) to the grant of patent
thereto filed by CIPLA Ltd, LBS Marg,Vikhroli(W)
Mumbai,Maharasra,India

GILEAD SECIENCE INC. US………………………….The Applicant

CIPLA Ltd. INDIA…..............................................The Opponent

Present in the hearing:

Mr. G. Nataraj Agents for the Applicant

Mr. S. Majumdar Agent for the Opponent

Dr. Rachna Nandwani Examiner of Patents and Designs

DECISION

Facts of the case:

1. M/S Gilead Science, Inc. a US company through their agent M/S Remfry &
Sagar filed an application for the grant of patent No 963/Del/2002 on 24th
September 2002 for their invention entitled "Nucleotide Analogs Composition
and method for the preparation thereof." This application was filed as
divisional application to the main application No.2174/Del/98 dated 24th July

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98 which was claming a priority date of 25th July 1997 on the basis of US
parent applications No. 08/900752 and 60/053777. The main patent
application (parent application) at the time of filing claimed a composition of
formula as given below

wherein B is adenine-9-yl and R independently is –H or –CH2-O-C(O)-O-


CH(CH3)2, but at least one R is –CH2-O-C-(O)-O-CH(CH3)2 including other
dependent claims and method claims. The parent application was accepted on
30th September, 2002 and patent was granted to a process for preparation of
fumarate salt of 9-[2-(R) [[bis [[(isopropoxycarbonyl)oxy]methoxy]phosphinoyl]
methoxy]propyl]-adenine(“bis(POC)PMPA”)comprising reacting fumaric acid
with9-[2-(R)-[[bis[[isopropoxycarbonyl)oxy]methoxy]phosphinoyl]methoxy]
propyl]-adenine optionally in the presence of a solvent of the kind such as
herein described, wherein fumaric acid and 9-[2-(R)-
[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinoyl]methoxy]propyl]-adenine
are preferably taken in molar ration of 0.6:1 to 1.4:1.

2. This application was examined and First Examination Report (FER) was
issued on 23rd January 2003.The applicants were required to put the
application in order for acceptance within a period of 15 months i.e. by 23rd
April 2004 which was further extendable for another 3 months under the
provisions of law existing at that time. Since the applicants applied for
extension of time for 3 months vide their request made on 26th March 2004,the
extension was allowed and accordingly the final date to put the application in
order for acceptance was 23rd July 2004.The applicants resubmitted the
documents along with their reply on 12th July 2004 and after further
examination, the said application was put in order for acceptance on 23rd July
2004. M/S Subramanian, Nataraj & Associates replaced Remfry & Sagar as the

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applicant’s agent on 11th October 2004. However due to some administrative
reasons the application could not proceed to grant of patent. The divisional
application as originally filed contained same 29 claims as of main application
including a claim for a composition of formula as given below

Wherein B is adenine-9-yl and R independently is –H or – CH2-O-C(O)-O-


CH(CH3)2, but at least one R is –CH2-O-C-(O)-O-CH(CH3)2 and (2) the method of
claim 12 wherein the lithium alkoxide is an alkoxide selected from the group
consisting of methoxide, ethoxide, n-propoxide, i-propoxide, n-butoxide,
i=butoxide, t-butoxide, neopentoxide, n-pentoxide, i-pentoxide or n-hexoside,
n-heptoxide, 2- heptoxide, n-octoxide, 2-octoxide, typically t-butoxide or i-
propoxide. In addition to above, it also claimed various claims inter-alia for
method comprising orally administering to a patient infected with virus or at
risk to viral infection a therapeutically effective amount of composition of claim
1, a method comprising adjusting the pH of a solution, a method comprising
mixing lithium alkoxide with a 9-(2-hydroxy propyl) adenine solution, a
product produced by the process of preparing wet granules, a process for the
preparation of fumarate salt of 9-[2-(R) [[bis[[(isopropoxycarbonyl)
oxy]methoxy]phosphinoyl] methoxy]propyl]adenine, etc. However the applicants
during the examination finally amended and restricted their claim to following
4 claims;

(1) a method of making lithium salt of (R)-9-(2-hydroxypropyl)adenine comprising


the steps of mixing a lithium alkoxide of the kind such as herein described
with (R)-9-(2-hydroxypropyladenine.
(2) The method of claim 1 wherein the lithium alkoxide is an alkoxide selected
from the group consisting of methoxide, ethoxide, n-propoxide, i-propoxide,
n-butoxide, i-butoxide, neopentoxide, n-pentoxide i-pentoxide, i-pentoxide

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or n-hexoxide, n-heptoxide, 2-heptoxide, n-octoxide, 2-octoxide, typically t-
butoxide or i-propoxide.
(3) A method as claimed in claim 2, wherein the lithium alkoxide is lithium t-
butoxide or lithium i-propoxide.
(4) A method for making a lithium salt of (R)-9-(2-hydroxypropyl_adenine
substantially as herein described with reference to the foregoing examples and
the accompanying drawings.

3. M/s Cipla Limited and Indian Company of LBS Marg, Vikhroli(W), Mumbai,
Maharashtra, India filed a representation by way of an opposition under
section 25(1) of the Act to the grant of patent thereto on 17th MAY 2006. The
reply statement by the applicant to the representation was filed on 14th
September, 2006. The applicants in their support filed evidence on 15th
September, 2006. The hearing was appointed for 9th October, 2007 after
several requests from the applicants as well as the opponents to postpone the
earlier fixed hearing dates.
4. During the hearing held on 9th October, 2007,the opponent restricted their
grounds specifically to the prior publication, prior claiming, lack of inventive
step, not an invention, not compliance with the provisions of section 8 and the
convention application not filed within the period of 12 months. The opponents
also submitted their written arguments vide their letter dated 9th February
2008,a copy of which stated to have been forwarded to the agent for the
applicants.

Submissions/arguments of the opponents


5. In the representation filed by the opponents, they have stated, as a
preliminary arguments, that contents of the specification filed with the instant
application (963/Del/2002) is identical with the contents of the specification
filed with Indian patent application 2174/Del/1998 dated 24th July, 1998 and
the claims 1 to 6 of said application 2174/Del/1998 correspond to claim 21 to
26 and 28 of the instant application and therefore cannot be the subject matter

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of divisional application since a divisional application can lie under section 16
only in respect of invention which is distinct from the claims in the parent
application and accordingly cannot be afforded a priority date of parent
application and hence the claims are hit by section 25 (1)(b), 25(c) and 25(1)(i).

6. With regard to novelty, it has been stated that product of the instant
application that is BPPF and its characterization by physicochemical properties
such as crystal X ray diffraction pattern, optical purity, etc. have been
disclosed and claimed in claims 1 to 6 of the Indian Patent application
No.2076/Del/1997 bearing an earlier priority date of 26th July 2006.Further,
claims 1 to 20 of the instant applications are also disclosed in the specification
filed in respect of Indian patent application No.896/Del/2002 with filing date
of 4th September, 2002 based on the priority date of Indian patent application
2706/Del/1997 which in turn based on the US priority dated 26th July 1996
and claims 21 to 26 and 28 are identical to claims 1 to 7 of the Indian
application No 2174/DEL/1998. They have also submitted that the priority
date of present application is not 25th July 1997 but it is 24th September, 2002
on which the instant application is filed for the reasons that claim 1 to 6 are
the products leading from the process claimed in the claims of Indian Patent
application 2174/Del/1998.As the instant application cannot be considered as
divisional application, therefore claim are not novel.

7. With regard to prior claiming, the opponents have submitted that invention
has already been claimed in Indian Patent Application No.2076/Del/1997
based on priority of US Application dated 26th July 1996, which is earlier than
the priority date of the instant application. The claims are also disclosed and
claimed in Indian applications No. 2174/DEL/1998 and 896/Del/2002.

8. With regard to lack of inventive step, they have submitted that the invention
relates to a process for making known acid addition salts of known prodrug
esters of known nucleoside analogue by following known steps and/or known

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products from such known processes. These known processes and known
products were obvious to a person skilled in the art on the claimed priority
date of the Indian patent application 963/Del/2002 i.e. 25th July, 1997, as
preparation of acid addition salts of a nucleoside analogous with enhance oral
bio availability was available knowledge for persons skilled in the art
particularly in view of the evidences submitted as an exhibit I to S, for following
reasons, which are also reiterated in the affidavit of Mr. Rajendra R. Kankan.
These are, namely; -
(a) Antiviral Nucleoside analogues suffered from the disadvantage of poor oral
availability (Exhibit- L)
(b) Prodrug esters of nucleoside analogues were prepared to overcome this
disadvantage of the parent nucleoside analogues (Exhibits M. N, Q) so as to:
• Mask the negative charges present on nucleoside analogues (Exhibit L);
• Improve the enzymatic and chemical stability of parent nucleoside
analogue compound (Exhibit L);
• Improve the gastrointestinal absorption of the parent nucleoside
analogue compounds (Exhibits R, K); and
• Improve the oral bio-availability of the parent nucleoside analogues
(Exhibits O, P, R, S and I)
(c) The ester prodrugs of nucleoside analogues were preferably obtained as acid
addition salts using acids such as citric acid, fumaric acid, lactic acid, sulfuric
acid, organic sulfonic acids etc (Exhibits I, J and K);
(d) The oral bioavailability of acid salt of ester prodrugs is significantly better
(in the range of 10% to 65%) than their respective nucleoside analogue parent
compounds. (Exhibits L, P, R, S and I)
Thus, well before, the claimed priority date i.e. 25th July, 1997 of the
Indian Patent application 963/Del/2002, aforesaid approaches of preparing an
acid addition salt of a nucleoside analogue with enhanced oral bio-availability
was available knowledge for persons skilled in the art. Hence each of the above
mentioned claims lack an inventive step and are obvious. To substantiate the

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ground, the opponents have also relied upon the evidences of Mr.Kankan
Rajendra N. working as Manager, Corporate R&D (API) with the opponents.

9. With regard to patentability, particularly on the ground that the subject


matter is not an invention within the meaning of the Act under section 3(d), the
opponents have stated that it is merely a new form of a known substance,
namely PMPA and BIS (POC) PMPA. As mentioned in the complete specification
filed with Indian patent application 963/Del/2002 on page 4, lines 30 to 35,
PMPA, BIS (POC) PMPA, other salts of BIS (POC) PMPA were admittedly known
form of free base and other salts. Further, it has not been shown that the
compounds claimed in claims 1 to 6 and claims 16 to 20 differ significantly in
properties with regard to efficacy and hence these claims are hit by section
3(d). It has been stated further that claim 9 is a method for treatment of
human or animal body for rendering them free of disease and therefore it is hit
by section 3(i), claims 10, 11, 12, 13 and 14 relate to method steps of mere
addition and admixture of two known compounds and are hit by section 3(e)
and claims 16, 18, 19 and 20 relate to mere admixture of excipients with a
known active ingredient and hence are hit by section 3(e) of the Act.

10. The opponents have further relied upon the ground that the invention is hit
by the provisions of section 25(1) (h) as the applicants have not disclosed
properly and truly the details of the corresponding foreign applications as
required under section 8 of the Act. They have further alleged that BPPF is
disclosed in example 1, step 7 of the Indian patent specification
2076/Del/1997 filed on 25th July 1997, (see page 47, lines 25 to 30, and page
48, line 35) for which inventors mentioned by the applicants (Gilead Sciences,
Inc.)are namely,(a) Arimilli; Murty N.(b)Cundy; Menneth C.(c) Dougherty;
Joseph P.(d) Kim; Choung U.(e) Oliyai; Reza, and(f) Stella; Valentino J. However
BPPF is subsequently disclosed in Indian patent applications (1)2174/Del/98
filed on 24th July, 1998,(2)896/Del/2002 filed on 4th September, 2002 and(3)
963/Del/2002 filed on 24th September, 2002 filed by same applicants that is

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Gilead Sciences, Inc. However, the inventors mentioned in these patent
applications are namely (a) John Duncan Munger (b) John Christian Rohloff
and(c) Lisa Marie Schultze. Thus, for the invention of the same compound,
different inventors are mentioned in different patent applications filed at
different times in India by the same applicant. Furthermore, all the compounds
and processes for obtaining the aforesaid compounds which are repeatedly
disclosed and claimed (claims 1 to 20 of 896/Del/2002 reproduced verbatim in
963/Del/2002 and claims 1 to 7 of 2174/Del/1997 reproduced verbatim as
claims 21 to 26 and claim 28 in 963/Del/2002) in multiple Indian
applications, by the same applicant which have been claimed and covered only
by two US patents, namely US 5922695 claiming priority from US Provisional
application serial No.60/022,708 (Filing Date: 26.07.1996) and US Patent
5935946 (Date of filing 25.07.1997).Accordingly, Indian application
2076/Del/1997 filed on 25th July 1997,derives priority from the US Provisional
application serial No.:60/022,708 filed on 26th July 1996 which is also a
priority document for US Patent 5922695 whereas Indian applications
2174/Del/98 filed on 24th July, 1998, 896/Del/2002 filed on 4th September,
2002 and 963/Del/2002 filed on 24th September, 2002 all derive priority from
US Patent 5935946 filed on 25th July 1997.
It is therefore submitted that same invention has been repeatedly
claimed in different patent applications by the same applicant filed at different
times, declaring different sets of inventors. The same invention, see for
instance step 7 of example 1, is claimed to be invented by the applicant by two
different sets of inventors. One of these statements is obviously false. The
applicants are therefore guilty of submitting information which they knew to be
false and making a false declaration and therefore the invention is hit by
section 25(1)(h) as the applicants have not disclosed properly and truly the
details of the corresponding applications. Therefore, the application deserves
to be rejected under section 25(1)(h).

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11. The opponents have further relied upon the ground that the invention is hit
by the provisions of section 25(1) (h) (i) as instant application being
conventional application was filed on 24th September, 2002 whereas the
original application has been filed on 25th June 1997. It was alleged that the
applicant cannot claim priority from the original application on the basis of
divisional application since what is claimed in the present application was
essentially claimed and disclosed in the specification filed with the Indian
patent application 2174/Del/1998. Therefore all the claims are hit by section
25(1)(i).

Submissions/arguments of the applicants:


12. While replying to the representation filed by the opponents, the applicants
stated that the representation is frivolous and vexatious and has no merit. It
was further submitted that the opposition is based on grounds, which are not
available to the Representers under section 25(1) of the Patents Act, 1970. The
applicants further submitted that although the opponents have listed all
the grounds as enumerated in clauses (a) to (i) under section 25(1) of the
Patents Act, 1970, restricted to clauses (b) Prior publication, (c) Prior
claiming,(e) Absence of inventive step,(f)Absence of invention,(h) Non-
compliance with Section 8 and (i) failure to file convention application
within 12 months. It was therefore submitted that the opponents had
voluntarily withdrawn the grounds under section 25(1)(a) Wrongful
obtaining, (d)Prior public use/knowledge in India and 25(1)(g)Insufficient
description and accordingly these grounds be treated as withdrawn. It
was also submitted that the preliminary arguments of the opponents on
page 6 of their representation are denied as lacking merit, lacking any
basis and lack of knowledge of patent law and practice of the opponents.
Since preliminary arguments of the opponents are limited to product
claims 1 to 6 as well as claims relating to process for preparation of a

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fumarate salt, they do not apply to the claims as accepted by the patent
office where none of the claims are related to product claims or process
claims for preparation of fumarate salt. Accordingly, the preliminary
arguments of the opponents are liable to be dismissed on this ground
alone. Under the circumstances, on the opponents’ admission, they have
no objection to the process claims actually accepted on this application.
It was therefore submitted that the instant opposition under reply
deserves to be dismissed on this ground alone.

13. As regards novelty, the applicants denied the contention of the opponents
and submitted that the ground of ‘not entitled to divisional status’ is not
a ground under Section 25(1). It was also submitted that the ground of
apparent anticipation based on parent application 2174/DEL/1998 has no
basis as under Section 16 of the Patents Act, 1970, a divisional application can
be filed under two circumstance namely (a) to meet an objection of distinct
invention raised by the Patent Office; or (b) if the applicant so desires
and therefore there is no requirement in either the Patents Act, 1970, or
the Rules framed thereunder, or in established patent practice in India,
that an applicant can voluntarily file a divisional application only in the
event of distinct invention. To include such a reading/interpretation of
the law is to defeat both the spirit and the purpose of the legislation. It is
therefore denied that the present application has a priority date of only
the actual date of filing. It is further submitted that this divisional
application was filed to meet an objection of distinct invention on parent
application 2174/DEL/1998. This is a matter of record. However, there
is no requirement that the claims on a divisional application at the time
of filing should be different from the claims of the parent application.
It was submitted that the entire submissions of the opponents’
contained in paragraphs [I] to [IV] on the ground of lack of novelty are against

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alleged product claims and claims relating to fumarate salt preparation and not
against the claims relating to a method for preparation of a lithium salt of (R)-
9-(2-hydroxypropyl) adenine. Therefore the claims that have been allowed have
been acknowledged as novel by the opponents. It was further submitted that
the prior application of the applicants herein namely, 2076/DEL/1997 is
not relevant to the present application for reasons, that (a) the present
application relates to a process for preparing a lithium salt of (R)-9-(2-
hydroxypropyl) adenine and not to Bis (POC) PMPA or fumarate salt
thereof; (b) the present application has an effective filing date of July 24,
1998, being the filing date of parent application 2174/DEL/1998 based
on the effective priority date of July 25,1997;(c) the cited application,
2076/DEL/1997 was not published before the priority date of the
present application namely, July 25, 1997;(d) for a document to act as
prior publication in order to destroy novelty, it must be published before
the priority date of the opposed application; and must disclose the exact
invention as claimed in the opposed application. Since the cited
application 2076/DEL/1997 was not published before July 25, 1997 and
in any event, does not disclose the method of preparation of a lithium
salt of (R)-9-(2-hydroxypropyl) adenine, the objection of the opponents be
dismissed on this ground alone.
Further, the reliance of the opponents’ on Indian patent application
896/DEL/2002 is also liable to be rejected for the reasons namely:(a) the cited
document was not published before July 25, 1997, and therefore does
not constitute prior publication;(b) the cited document, in any event,
does not disclose the exact invention claimed on the present application,
and therefore cannot be held to anticipate the process for preparation of
a lithium salt of (R)-9-(2-hydroxypropyl) adenine. It was further
reiterated that entire objection was taken only to claims 21 to 26 and 28

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as originally filed. These claims are no longer the claims that have been
allowed. However, a parent application cannot be used as a citation on
ground of lack of novelty against a divisional application. The records of
the Patent Office clearly show that this divisional application was filed
due to a finding of distinct invention by the Patent Office.

14. As regards prior claiming, it was submitted that the objection under
Section 25(1)(c) was neither valid nor applicable in the present case as
the entire objection of the opponents was to product claims and to claims
relating to preparation of fumarate salt. It was also submitted that the
claims of the present application related to a method for the preparation
of a lithium salt of (R)-9-(2-hydroxypropyl) adenine whereas cited
application 2076/DEL/1997, 896/DEL/2002 or 2174/DEL/1998
neither related, nor taught or disclosed any preparation of a lithium salt
of (R)-9-(2-hydroxypropyl) adenine. Further, application No.
2174/DEL/1998 is the parent application of the present application and
cannot be relied on under the ground of prior claiming, since the priority
dates and effective filing dates of both the parent application and the
present application are the same and therefore objections under Section
25(1)(c) are untenable and liable to be rejected.

15. As regards, lack of inventive step, it was submitted that on the


opponents own admission, their objection under Section 25(1)(e) is
limited to claims numbered 1 to 6, 10, 11, 16, 20, 21 to 29 of the listing
of claims provided by them in their written representation. The aforesaid
claims related to a product and a fumarate salt of bis (POC) PMPA.
However, none of the above claims related to a process for the
preparation of a lithium salt of (R)-9-(2-hydroxypropyl) adenine. It was
therefore submitted that the ground of lack of inventive step is liable to

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be rejected as being inapplicable on the claims on file. The applicant
have further submitted that the opponents are now estopped from
relying on their submissions on this ground, or the evidence provided by
them, or any of the citations relied on by them against the claims that
have been allowed on this application. The applicants contended that
since, the entire contents of paragraphs [I] to [IV] of the opponents’
representation are towards product claims and claims that related to
fumarate salts, the opponents have admitted that claims relating to
lithium salt of (R)-9-(2-hydroxypropyl) adenine are novel and inventive. It
is therefore submitted that this ground is liable to be rejected.
The applicants have denied the alleged publications relied on by
the opponents constituting material or relevant prior art to the claims
allowed on this application and replied each of the citations relied on by
the opponents as under;
(a)Exhibit A - Indian Patent Application 2174/DEL/1998
This document is the parent application of the present application,
and is therefore not a valid citation under the ground of
obviousness or lack of inventive step.
(b)Exhibit B – US Patent 4,808,716
Although this document apparently teaches PMPA, it does not
teach or provide any guidance towards a method for the
preparation of a lithium salt of (R)-9-(2-hydroxypropyl) adenine and
therefore this document does not constitute relevant or material
prior art.
(c) Exhibit C – Proceedings of 4th conference on retroviruses,
Washington DC, 1997
This document apparently teaches Bis (POC) PMPA. However, it
does not teach or provide any guidance towards a method for the

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preparation of a lithium salt of (R)-9-(2-hydroxypropyl) adenine and
therefore does not constitute relevant or material prior art. Further
the opponents have not clearly identified which part of the citation
anticipates the claimed invention.
(d) Exhibit D – US Patent 5,922,695; Exhibit E – Indian Patent
Application 2076/DEL/1997; and Exhibit D – US Provisional
Patent Application 60/022,708
The above documents apparently teaches Bis(POC)PMPA and
various salts thereof. The opponents also restricted their challenge
based on the said documents to product claims and claims relating
to fumarate salts. Since the cited documents do not teach or
provide any guidance towards a method for the preparation of a
lithium salt of (R)-9-(2-hydroxypropyl) adenine and therefore are
not relevant or material prior art.
(e) Exhibit G – Indian Patent Application 896/DEL/2002
The cited document does not constitute prior art, being an
application with the same effective filing date and same priority
date as the present application and therefore the opponent's
reliance on such document is not valid.
(f) Exhibit H: US Patent No.1,523,865 5,075,445 and 4,355,032
The three documents although apparently teach various antiviral
nucleoside analogues, namely, acyclovir, penciclovir, and
ganciclovir, but do not teach or provide any guidance towards a
method for the preparation of a lithium salt of (R)-9-(2-
hydroxypropyl) adenine and therefore they do not constitute
relevant or material prior art.
(g) Exhibit I to Exhibit K

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The documents namely EPO published application No. 0182,024,
US Patent No.4, 957,924 and EPO Patent No.0694547 apparently
teach various antiviral nucleoside analogues. However, they do not
teach or provide any guidance towards a method for the
preparation of a lithium salt of (R)-9-(2-hydroxypropyl) adenine and
therefore these documents do not constitute relevant or material
prior art.
(h) Exhibit L – Jones et al
This document apparently teaches nucleotide pro-drugs but does
not teach or provide any guidance towards a method for the
preparation of a lithium salt of (R)-9-(2-hydroxypropyl) adenine and
therefore does not constitute relevant or material prior art.
(i) Exhibits M to S
These citations are published articles and disclose PMPA, various
prodrugs thereof, studies into their efficacy. The opponent's expert
on the basis of these documents concluded that ester prodrugs of
nucleoside analogs are preferably obtained as acid addition salts
using acids such as citric acid, fumaric acid, lactic acid, sulfuric
acid, and organic sulfonic acids.

They further concluded that oral bioavailability of ester prodrugs is


better than that of parent compounds. In view of these findings, none of the
cited documents teaches or guides towards or provide any information relating
to the novel method of making a lithium salt of (R)-9-(2-hydroxypropyl) adenine
claimed and allowed on this application. The applicants contended that the
claims as allowed on this application are inventive over each of the citations
referred to and distinguished above. Therefore, the opponents have failed to
establish the ground of lack of inventive step under Section 25(1)(e).

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The applicants further submitted that it is well established that
obviousness/lack of inventive step is best established only with reference
to expert evidence. The expert evidence filed on behalf of the opponents
does not provide any information or discussion relating to a method for
preparing a lithium salt of (R)-9-(2-hydroxypropyl) adenine as claimed
and allowed on this application. The submissions of the opponents are
mere arguments. It was further submitted that if an opponent is relying
on the ground of lack of inventive step/obviousness, the opponent must
clearly identify which parts of the cited documents are deemed to render
the claimed invention obvious. However, what all the opponents have
done is to make blanket statements that the Exhibits render the instant
application obvious to a person skilled in the art such averment of the
opponent deserves to be rejected on the ground of being a vexatious
statement without any backing by way of specific reference to disclosures
in the cited documents or by way of expert evidence.

16. With regard to non-patentable invention, the applicants contended


that the objection under Section 25(1)(f) is taken only against claims 1 to
6 of the listing of claims by the opponents in their written representation.
Claims 1 to 6 related to bis (POC) PMPA and the opponents have
therefore disclaimed any objection to the claims that have been allowed
on this application, namely a method for the preparation of lithium salt
of (R)-9-(2-hydroxypropyl) adenine. They further contended that in any
event, the ground of lack of inventive step based on Section 3(d) is not
tenable as Section 3(d) was introduced into the Act in the year 2005 that
means much after the filing date of the present application. The
applicants have denied that the instant application claims a composition
including bis (POC) PMPA fumarate or its crystalline form. In fact it

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relates to a method for making a lithium salt of (R)-9-(2-hydroxypropyl)
adenine.
Applicants therefore contended that the objection of the opponents
under Section 25(1)(f) is a deliberate attempt to confuse and cloud the
issues on this opposition or reflect a failure on the part of the opponents
to verify the facts pertaining to this application, and at best, a complete
misunderstanding by the opponents of the meaning and scope of claims
allowed on this application. For example, the opponents allege that
claims 10-15 relate to mixtures of known compounds and therefore, the
opponents representation have no meaning or relevance to the instant
application.
17. The applicants have denied the ground relied upon by the opponents
under Section 25(1)(h). The applicants have contended that Section
25(1)(h) is inapplicable in the present case insofar as the opponents rely
on the applicants’ co-pending application 2076/DEL/1997. It was
submitted by them that the claims on the present application relate to a
method for the preparation of a lithium salt of (R)-9-(2-hydroxypropyl)
adenine. However, co-pending application 2076/DEL/1997 is not a
corresponding application. The entire argument of the opponents is
specious and without any merit. It was further contended that in a large
research organization, different people work on different areas. There is
no obligation in Section 8 of the Act that details of all applications are
provided to the Controller. Only details of corresponding applications
need to be provided. It was further submitted that the US Patent Office
has considered the US applications corresponding to this application as
well as 2076/DEL/1997. The USPTO has been pleased to grant separate
patents on both applications. This clearly establishes that the two
applications are not ‘corresponding’ applications.

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The applicants further submitted that the entire arguments of the
opponent are again based on what they consider to be the listing of
claims on this application. This listing of claims is manifestly different
from what has been accepted on this application. In addition, even a
cursory reading of the claims of 2076/DEL/1997 and parent application
2174/DEL/1998 clearly show the differences in the two inventions and
therefore the objection under Section 25(1)(h) is liable to be rejected.

18. As regards, failure to file the application within 12 months from the
filing date of application in convention country, the applicants submitted
that the arguments of the opponent under Section 25(1)(i) are wholly
lacking in merit, and only establish their ignorance of patent law and
practice. They contended that the present application was properly filed
as a divisional application out of parent application 2174/DEL/1998 and
therefore also entitled to the priority date of July 25, 1997 as claimed in
the parent application. Accordingly the entire submissions of the
opponent under Section 25(1)(i) deserve to be rejected as being baseless
and without any merit.

Consideration of submissions and arguments of both parties

19. It is on the records as well as conceded during hearing that opponents have
dropped the grounds of under section 25(1)(a) Wrongful obtaining, (d) Prior
public use/knowledge in India and 25(1)(g) Insufficient description and
therefore the opponents can not insist upon these grounds which may be
treated as withdrawn. However at the same time such withdrawal cannot
affect the power of the controller to consider at the final stage of
acceptance of the application before putting the same in order for grant

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as to whether complete specification fulfils all the requirements under
section 10 of the Act.

20. As regards preliminary objection relied upon by the opponents that the
instant application can not be considered as divisional application under the
provisions of the Act, I am not inclined to agree with their arguments and
submissions simply for the reasons that (a) claims of main application (as
accepted by the patent office and are on the records) out which the instant
application has been divided out relates to a process for the preparation of
fumerate salt of 9-[2-(R) [bis [[isopropoxycarbonyl)oxy]methoxy]
phosphinoyl]methoxy]propyl]-adenine whereas the claims of the instant
application( which are now on the records after amendments during the
processing of the application at examination stage to ensure the
provisions of section 16(3)) relate to a method of making lithium salt of (R)-9-
(2-hydroxypropyl)adenine which definitely relate to a distinct invention,
although originally the applicants filed the same set of claims and (b) the
provisions of section 16 do not bar a person from filing divisional application
voluntarily(suo motto) as long as the claims of the main(first mentioned)
application relate to more than one invention( i.e. plurality of inventions as per
provisions of section 16(1)). The provisions of section16 particularly 16(2), only
prohibit that complete specification should not include any matter not in
substance disclosed in the complete specification of main (first mentioned)
application. This is not the case of the instant application since the invention
as claimed now was not only disclosed but also claimed in the main
application.

21. As regards lack of novelty due to prior publication, the opponents have
relied upon the various applications of the applicant filed in India as well as in
the United States prior to the instant application. I fully agree with opponents
that a method of making lithium salt of (R)-9-(2-hydroxypropyl) adenine has

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been disclosed in those prior filed application, for instance, 2076/DEL/1997
dated 25th July 1997 based on US Application priority date of 26th July 1996
and 896/DEL/2002 dated 4th September 2002 which is again a divisional
application to Indian co-pending application 2174/DEL/1998 dated 24th July
1998 based on US Application priority date of 25th July 1997.However the
opponents have failed to show any record even during hearing that those
applications including the US applications from which the priority dates have
been claimed, have been published any where in any form prior to priority date
of the instant application since this is a divisional application of co-pending
application 2174/DEL/1998 dated 24th July 1998 based on US Application
priority date of 25th July 1997.Apart from this, I have even considered all
those documents which have been annexed as exhibits as well as the
opponents evidence but none of them impressed upon that the invention of the
instant application has been published earlier to constitute prior publication so
as to destroy the novelty .Moreover the opponents themselves have stated in
their written submissions dated 9th February 2008 that this ground has been
withdrawn. Accordingly, this ground has not been established. The contention
of the opponents that the instant application not being the divisional
application thereby lacking novelty is also not acceptable for the reason as
explained above.

22. With regard to the ground of prior claiming, the opponents have once again
relied upon the priority dates of the same applications of the applicants. I have
analyzed the claims of all co-pending applications namely, 2076/DEL/1997,
2174/DEL/1998 and 896/DEL/2002 and found that none of these
applications claim the method of making lithium salt of (R)-9-(2-
hydroxypropyl)adenine which has been claimed in the instant application. In
view of this, the opponents have failed to establish this ground.

23. Regarding lack of inventiveness or inventive step, the opponents have relied
upon the various documents annexed as exhibit (A) to (S) as prior art

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disclosure as well as the evidence of Mr. Kankan Rajendra N. I have considered
all these documents as well as the evidences of Mr. Kankan Rajendra N
including the submissions made during the hearing. It has been observed that
none of these discloses the method of preparation of lithium salt of (R)-9-(2-
hydroxypropyl) adenine, which has been claimed in the instant application
except the applicants’ own applications that is 2076/DEL/1997,
2174/DEL/1998 and 896/DEL/2002 as well as corresponding US
Applications. Since the disclosure regarding the conversion of (R)-9-(2-
hydroxypropyl) adenine into its lithium salt in these applications has not
become public before the priority date of the instant application, the same
cannot be considered as prior art for the purpose of obviousness or lack of
inventive step. While summarizing the ground of lack of inventive step on the
basis of disclosures made in these documents as annexed as Exhibits, Mr.
Kankan Rajendra N has failed to state categorically that the invention as
claimed in the instant application is lacking inventive step or obvious to the
person skilled in the art having regard to the prior art disclosure. Since all the
submissions and arguments are related to fumarate salt of PMPA or BPPF and
none of them relates to lithium salt of (R)-9-(2-hydroxypropyl) adenine, the
opponents have failed to establish this ground as well.

24. As regards patentability ground under section 25(1) (f), the opponents have
mainly relied upon the provisions of section 3(d), (e) and (i) of the Act. At the
out set it is observed that none of the claims are related either to any method
of treatment of human beings or animals, or to any substance produced by a
mere admixture or a process to produce such substance. Therefore, in my
opinion, none of the claims attracts the provisions of section 3(e) and 3(i) of the
Act. Further, there is no evidence or submission on the records that the
formation of lithium salt of (R)-9-(2-hydroxypropyl) adenine is new form of
already known substance. Similarly, there is nothing on the records shown by
the opponents that applicant's invention is mere discovery of new property or

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new use of known substance or mere use of known process. The opponents
have submitted that fumarate salt of 9-[2-(R) [[bis [[isopropoxycarbonyl) oxy]
methoxy]phosphinoyl]methoxy]propyl]-adenine is merely a new form of a
known substance, namely PMPA and BIS (POC) PMPA but nothing has been
argued or submitted about lithium salt. Therefore the opponents have failed to
establish the ground of non-patentability under section 3(d) of the Act as well.

25. As regards the ground relied upon under section 25(1)(h), the opponents
are required to establish that the applicant has failed to disclose to the
controller the information required under section 8 or has furnished the
information which in any material particular was false to his knowledge. In
case the applicant has filed an application outside India in respect of same or
substantially the same invention, he is required under section 8 to file along
with the application or subsequently (a) a statement with detailed particulars
of such application and (b) an undertaking to keep the controller informed the
detailed particulars of all such applications filed subsequently outside India for
the same or substantially the same invention. Further, if required by the
controller, the applicant is also required to furnish the details regarding
processing of the application in a country outside India. The opponent's case is
that the applicants have filed Indian application 2076/Del/1997 dated 25th
July 1997,deriving priority from the US Provisional application serial
No.:60/022,708 filed on 26th July 1996 which is also a priority document for
US Patent 5922695 disclosing "BPPF" (fumarate salt of PMPA) for which
inventors are namely,(a) Arimilli; Murty N.(b)Cundy; Menneth C.(c) Dougherty;
Joseph P.(d) Kim; Choung U.(e) Oliyai; Reza, and(f) Stella; Valentino J.
Similarly "BPPF" has also been subsequently disclosed in Indian patent
applications 2174/Del/98 dated 24th July, 1998, 896/Del/2002 dated 4th
September, 2002 and 963/Del/2002 dated 24th September, 2002 for which the
inventors mentioned in these patent applications are namely (a) John Duncan
Munger (b) John Christian Rohloff and(c) Lisa Marie Schultze. Thus, for the
invention of the same compound, different inventors are mentioned in different

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patent applications filed at different times in India by the same applicant.
However, the applicants have denied the contention of the opponents and
submitted that there is no obligation in Section 8 of the Act, that details of all
applications be provided to the Controller. The only obligation is to provide only
details of corresponding applications. Since the invention claimed in
2076/DEL/1997 and 2174/Del/98 including the instant application are two
different and said two applications are not ‘corresponding’ applications and
therefore there is nothing wrong in mentioning two different set of inventors for
said application.
As far as other details are concerned the applicants have submitted fresh
form- 3 on 8th October 2007giving the revised details of corresponding
applications. Apparently what the applicants said is right but the case is not so
straight forward since the conversion of (R)-9-(2-hydroxypropyl) adenine into
lithium salt has been disclosed in application No. 2076/DEL/1997 at page 44,
step-4 of the process by same method as has been disclosed in 2174/Del/98
and as disclosed and claimed in the instant application but surprisingly in
both these applications including the instant application the inventors are
different!. Since, the priority of instant application No.963/Del/2002 filed on
24th September, 2002 as divisional application to co-pending Indian
application 2174/Del/98 filed on 24th July, 1998 deriving the priority of US
Patent 5935946 filed on 25th July 1997 is later than the priority date of Co-
pending Indian application No. 2076/Del/1997 filed on 25th July 1997,
deriving priority from the US Provisional application serial No.: 60/022,708
filed on 26th July 1996.Under above circumstances, it has been difficult to
ascertain which set of the inventors has invented the method of conversion of
(R)-9-(2-hydroxypropyl) adenine into lithium salt thereof who would have
rightful claim as true and first inventors.

Although, I fully agree with the applicants that US Patent Office has
granted two different patents in respect of these application as disclosed in US
Patent applications filed corresponding to Indian patent applications No.

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2076/DEL/1997 and 2174/DEL/1998 but the invention as disclosed and
claimed in the instant application has been disclosed in both the applications
and therefore the invention is substantially same in both the application. Had
the applicants claimed the priority of 2076/DEL/1997 application while
making the divisional application for the method of preparation of lithium salt
of (R)-9-(2-hydroxypropyl) adenine, the inventors claimed in that application
would have been the true and first inventors. Therefore it is hard to believe that
the inventors as mentioned in the instant application having later priority date
than priority date of 2076/DEL/1997 could have invented the invention as
disclosed and claimed in this application. However the ground for opposition
under section 25(1)(h) is available only when the applicants have 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 their
knowledge. Since the applicants have submitted the revised form-3 as mentioned
earlier the words “or has furnished the information which in any material
particular was false to their knowledge” can not be stretched to
accommodate the wrongful or false disclosure of names of the inventors within the
ground available under this provision due to the principle of Ejusdem Generis
applicable in the interpretation of statute according to which general words
follow an enumeration of persons or things, by words of a particular and
specific meaning, such general words are not to be construed in their widest
extent, but are to be held as applying only to persons or things of the same
general kind or class as those specifically mentioned. Accordingly the
contention of the opponents is not tenable and therefore the ground is not
valid.

26. With regard to ground relied upon by the opponents under section 25(1)(i)
that is the application was not filed within the twelve months from the date of
filing of convention application, the opponents have merely reiterated the same
submission that the instant application has been filed on 24th September 2002
and invention claimed therein has already been disclosed in Indian application

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1274/DEL/1998 based on priority date of 25th July 1997and not being the
divisional application under section16 of the Act, therefore the same has not
been filed within 12 months from the date of original priority date. Since I have
already rejected the submission of the opponents in considering the instant
application as proper divisional application under the provisions of the Act,
opponent's submissions have no merit and therefore this ground is not valid

After having considered all the circumstance of this case,


representation and expert evidence of opponents, reply of the applicants,
expert evidence in support of the applicant, written submissions and
arguments in the hearing made by both parties and also my discussion and
findings as mention above, I am of the opinion that the opponents have failed
to prove any of the grounds relied upon by them. In view of the above, I reject
the representation and dispose off the opposition without any cost.

Dated this 9th day of MARCH 2009

(Dr. K.S. Kardam)


Deputy Controller of Patents & Designs.
Copy to:
1. M/s Subramanian, Nataraj and Associates
E-556 GREATER KAILASH-II
NEW DELHI -110048

2. M/s Majumdar & Co.


5, Harish Mukherjee Road,
Kolkata – 700 025.

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