1. This is an appeal against the order passed by the Deputy Controller of
of a Solid Dispersion of the Non-crystalline Form of Rotigotine". The
2. In response to First Examination Report, the appellant has revised the
7. The solid dispersion as claimed in Claim in
5 or 6, wherein the molecular weight of
polyvinylpyrrolidone is in the range from 1,000,000
to 1,500,000 Dalton.
8. A pharmaceutical composition comprising a
solid dispersion as claimed in Claim 5, 6 or 7.
9. A transdermal therapeutic system
comprising the solid dispersion as claimed in
claims 5 to 7 comprising at least one amine-
compatible silicone pressure sensitive adhesive,
about 0.1 to about 3.15 mg/cm2 of rotigotine in the
free base form, and polyvinylpyrrolidone, wherein
the weight ratio of rotigotine to polyvinylpyrrolidone
is in a range from about 9:4 to about 9:6.
10. A transdermal therapeutic system as
claimed in Claim 9, comprising 0.1 to about 3.15
mg/cm2 of rotigotine in the free base form and
wherein the weight ratio of rotigotine to
polyvinylpyrrolidone is 9:4.
11. A transdermal therapeutic system as
claimed in Claim 10, comprising 0.2 to about 1
mg/cm2 of rotigotine in the free base form.
12. The transdermal therapeutic system as
claimed in Claim 9, 10 or 11 having a water
content of below 2 wt%.
13. The transdermal therapeutic system as
claimed in Claim 9, 10, 11 or 12 wherein the
molecular weight of polyvinylpyrrolidone is in the
range from 1,000,000 to 1,500,000 Dalton.
14. A method for preparing a transdermal
therapeutic system, the method comprising
preparing a solid dispersion comprising a
dispersing agent and a dispersed phase, said
dispersing agent comprising at least one silicon
pressure sensitive adhesive and said dispersed
phase comprising rotigotine and
polyvinylpyrrolidone, wherein the weight ratio of
rotigotine to polyvinylpyrrolidone is in a range from
about 9:4 to about 9:6."
3. The appellant revised the claims along with written submissions and
has raised only 8 claims which reads as follows:
"1. A solid dispersion comprising a dispersing
agent and a dispersed phase, said dispersing
agent comprising at least one silicone pressure
sensitive adhesive and said dispersed phase
comprising rotigotine and polyvinylpyrrolidone,
wherein the weight ratio of rotigotine to
polyvinylpyrrolidone is in a range from 9:4 to 9:6;
rotigotine is rotigotine free base ; and the solubility
of rotigotine in the dispersing agent is below 1 wt-
%.
2. The solid dispersion as claimed in Claim 1,
wherein the dispersing agent comprises a mixture
of adhesive and has a complex viscosity between 5
and 25 MP.
3. The said dispersion as claimed in Claim 1
or 2 wherein the molecular weight of
polyvinylpyrrolidone is in the range from 1,000,000
to 1,500,000 Dalton.
4. A pharmaceutical composition comprising a
solid dispersion as claimed in Claim 1, 2 or 3.
5. A transdermal therapeutic system
comprising the solid dispersion as claimed in
claims 1 to 3 comprising at least one amine-
compatible silicone pressure sensitive adhesive,
about 0.1 to about 3.15 mg/cm2 of rotigotine in the
free base form, and polyvinylpyrrolidone, wherein
the weight ratio of rotigotine to polyvinylpyrrolidone
is in a range from 9:4 to 9:6.
6. The transdermal therapeutic system as
claimed in Claim 5, comprising 0.2 to about 1
mg/cm2 of rotigotine in the free base form.
7. The transdermal therapeutic system as
claimed in Claim 5 or 6 having a water content of
below 2 wt%.
8. A method for preparing a transdermal
therapeutic system as claimed in Claims 5 to 7."
4. The respondent no.1 refused to grant patent on the following grounds:
"8. Respondent submits about what are
known in the art. First, rotigotine the active
ingredient and its use in TDS is known in the art.
Mixture of rotigotine and PVP is also disclosed in
cited document. It is also known that PVP may be
used as crystallization in inhibitor. As respondent
discussed that ratio of rotigotine and PVP can be
adjusted by skilled person. Cited document also
discloses that PVP can be used as crystallization
inhibitor. As per the appellant, finding of particular
ratio of rotigotine and PVP is very important for
stability of rotigotine and prevent crystallization of
rotigotine. But as per respondent finding out a
particular ratio of rotigotine and PVP is a routine
experimentation, because all the components and
their use are already known from cited prior art
documents. Furthermore use of PVP as
crystallization prevent is also disclosed in cited
document D4."
5. In the hearing notice, three documents were cited i.e. D1: WO
03/092677, D2: EP 1669063 and D3: WO2009006787A1 but at the
time of hearing, the respondent has raised two additional citations i.e.
D4:EP2177217 and D5:US2005/0079206. Documents D3 and D4 are
the same documents of same family but the respondent comes to the
different analysis. The respondent rejected the Claims 4 to 7 under
Section 2(1)(j) of the Patens Act, 1970 but in the hearing notice, no
such objection was raised for the claims 4 to 7. The objection raised in
the hearing notice are as follows:
"1. After going through claim 1 it is not clear
for which protection has been sought, for product or
for method. In claim 1 there is no method step,
rather this claim discloses features of solid
dispersion. So claim 1 is not allowable u/s 10(4) of
the Act. Claim 5 is redundant wrt claim 1 and so
not allowable.
2. Claims 9-14 are transdermal therapeutic
system and method for preparation of transdermal
therapeutic system. However, the claims 1-8 are
defining method for stabilizing rotigotine and
composition comprising rotigotine. Hence, these
claims 9-14 are beyond the scope of claim 1-9."
6. The commercial transdermal therapeutic system Neupro® was
approved in 2006/2007 comprising the active ingredients rotigotine.
Rotigotine is an active drug compound used for the treatment of patient
suffering from Parkinson's Disease, depression, Restless-legs syndrome
etc. In the year 2008, there was an emergence of Form II crystal as a
result of which Neupro® had to be withdrawn from the market in the
US and was only permitted in European Patent provided the
transdermal patch is maintained through cold chain. Neupro® patch is
appellants earlier TTS and has a ratio of 9:2 of Rotigotine : PVP.
7. There was long term stability problems were associated with rotigotine.
If rotigotine crystals that are formed in the self-adhesive matrix during
long term storage, crystal growth can lead to reduce release rates of
rotigotine with the risk eventually falling below the specified values.
There was a need to develop a TTS that displays an appropriate drug
release profile combined with adequate stability and should be stable at
room temperature.
8. It is found that the object of the present invention is to provide a TTS
that displays crucial pharmaceutical aspect of a TTS such as drug
release profile distribution of the drug within the patch, drug solubility
in the matrix, drug or patch stability, adhesiveness of the patch to the
skin, smooth and complete removability of the patch from the skin.
9. Figure-1 shows the influence of varying rotigotine to
polyvinylpyrrolidone weight ratios on the release of rotigotine from a
TTS. API = active pharmaceutical ingredient (rotigotine): PVP =
polyvinylpyrrolidone. "Specification" is related to the product
specification of the existing Neupro® Rotigotine patch.
10. Figure -2 shows that the physical stability of rotigotine patches
containing different amounts of PVP (rotigotine:PVP weight ratio of 9:2,
9:3 and 9:4) after 9 months at room temperature.
11. Figure -3 shows the physical stability of rotigotine patches containing
different amount of PVP (rotigotine:PVP weight ratio of 9:3 and 9:4)
after 15 months at room temperature.
12. Figure - 4 shows the physical stability of rotigotine patches containing
different amounts of PVP (rotigotine:PVP weight ratio of 9:3 and 9:4)
after 19 months at room temperature.
13. Table -3 Results from storage stability testing of sample nos. 1-9 at 25
degree Celsius/60%RH (+=crystal,-= no crystals).
14. Taking also the above discussed data from release testing into account,
optimum result could be achieved with rotigotine to
polyvinylpyrrolidone weight ratios between 9:4 and 9:6. Higher ratios
failed to sufficiently prevent rotigotine from crystallization and made
the system prone to crystal growth or were even unprocessable. Lower
ratios led to insufficient drug release by reducing the amount of
rotigotine, which is released from the patch, below those values
specified for the marketed Neupro® patch.
15. Test for inventive steps as provided under Section 2(1)(ja) which reads
as follows:
"2. Definitions and interpretation.-- (1) In
this Act, unless the context otherwise requires,- (ja)
"inventive step" means a feature of an invention
that involves technical advance as compared to the
existing knowledge or having economic significance
or both and that makes the invention not obvious to
a person skilled in the art."
16. In the case of Avery Dennison Corporation Vs. Controller of Patents
and Designs reported in 2022/DHC/004697, the Delhi High Court
decided as follows:
"10. In order to decide this issue, some of the
fundamental principles for determining the
existence of an inventive step and the lack of
obviousness need to be emphasised.
11. For determining inventive step or lack
thereof, various approaches and tests have
emerged over the years from decisions of
courts/authorities as also from examination
guidelines of patent offices from different
jurisdictions. The same include:
i. Obvious to try approach:
• This approach involves an analysis of
whether in view of the teachings/solutions
proposed in the prior art, it was obvious to
try and arrive at the subject invention.
ii. Problem/solution approach:
• This approach considers whether in the light
of the closest prior art and the objective
technical problem, the solution claimed in
the invention would be obvious to the
skilled person. If the skilled person can
decipher the solution being claimed, then
the subject matter is held to be obvious.
• This test has been discussed by the Division
Bench in F. Hoffmann-La Roche Ltd. and
Ors. v. Cipla Ltd., 2016(65) PTC 1 (Del).
iii. Could-Would Approach
• In this approach the question that is raised
is whether there is any teaching in the prior
art as a whole that would and not simply
could have prompted a skilled person, with
the knowledge of the objective technical
problem, to either modify or adapt the
closest prior art to arrive at the subject
matter of the claims.
iv. Teaching Suggestion Motivation (TSM
test)
• This test originated in the USA as per which,
if by the Teaching, Suggestion or Motivation
from the prior art, an ordinary skilled
person can modify the prior art reference or
combine prior art references to arrive at the
claimed invention, then the subject matter
being claimed is obvious.
• However, the application of this test ought
not to be done in a narrow manner as held
by the US Supreme Court in the case of
KSR International v. Teleflex, 550 U.S.
398 (2007)."
17. The documents D1 and D2 do not provide any kind of suggestion to an
artisan to the solution offered by the present invention as any cited
documents, particularly D1 or D2 as not concerned with the problem
of producing a stable transdermal therapeutic system, which prevents
the crystallization of newly described Form II of rotigotine as the said
form was only described some years after D1 and D2 for the 1st time in
WO2009/068520 that has a priority date of November 2007. The
comparative data provided in the specification which clearly shows that
the claimed ratio of rotigotine to PVP gives the best result compared to
others ratios including the ratio of D1, D3 or D4.
18. In the impugned order, the Deputy Controller of Patents and Designs
has admitted that two new documents cited at the time of hearing and
the said documents are US2005/0079206 and EP2177217. The
respondent has relied the said two documents and held that :
"Now I would like to discuss the other cited
documents which were raised at time of hearing.
Cited document EP2177217 (D4) teaches
composition containing Rotigotine and the use
thereof in the manufacture of a Rotigotine -
containing transdermal patch. Wherein said
composition is based on a matrix mixture system
formed from a combination of an acrylic pressure-
sensitive with a silicone pressure-sensitive
adhesive, and polyvinylpyrrolidone which are
present in a particular weight ratio. The Rotigotine-
containing transdermal patch of the present
invention has a multi-layer complex structure
comprising a backing layer, a drug-containing
matrix layer comprising the active ingredient
Rotigotine and a covering layer on the drug-
containing matrix layer, may further optionally
comprise auxiliaries commonly used in transdermal
drug delivery systems, such as permeation
enhancers and antioxidants. This document also
discloses that a matrix mixture system comprising
a combination of an acrylic pressure-sensitive
adhesive with a silicone pressure-sensitive
adhesive in a certain ratio improves the solubility
and skin permeability of the drug significantly, and
the addition of a small amount of
polyvinylpyrrolidone further improves the drug load
and penetration level without affecting the
mechanical properties of the patch.
The other cited document (US2005/0079206)
also teaches about improved transdermal delivery
system for rotigotine. It is disclosed that drug
release properties of a TDS having a silicone-type
adhesive matrix containing rotigotine can be
significantly enhanced by
(1) minimizing the amount of rotigotine which is
present in the protonated form (salt form);
(2) incorporating rotigotine in a multitude of
microreservoirs within the self-adhesive
matrix consisting of a solid or semi-solid
semi-permeable polymer.
This document also discloses that rotigotine
exists in various isomeric forms and any single
isomer or a mixture of different isomers may be
used in the TDS according to the invention. Hence,
the S- or R-enantiomer or the racemate or any other
enantiomer mixture of rotigotine may be used. In
such matrix type TDS the drug is dispersed in a
polymer layer. The TDS of the matrix type in their
simplest version comprise a one-phase (monolayer)
matrix. They consist of a backing layer, a self-
adhesive matrix containing the active agent and a
protective foil or sheet, which is removed before
use. This document also discloses about a mixture
of silicone adhesives comprises a blend of high tack
silicone pressure sensitive adhesive comprising
polysiloxane with a resin and a medium tack
silicone type pressure sensitive adhesive
comprising polysiloxane with a resin. The device of
this document also contains a backing layer which
is inert. This patch also contains protective foil.
So from above said discussion following points
are amply clear:
Rotigotine and its use is already known. Cited
documents also disclose about transdermal
therapeutic system, which contain rotigotine
polyvinylpyrrolidone in particular amount. Cited
document also disclose about and matrix system
which contain silicone adhesive as matrix.
Furthermore, use of polyvinylpyrrolidone as
crystallization inhibitor is also known from cited
documents. Ratio between rotigotine and PVP also
disclosed in prior art documents."
19. In the case of Guangdong Oppo Mobile Telecommunications Corp.,
Ltd. Vs. The Controller of Patents and Designs reported in
MANU/WB/ 1263/2023, the Coordinate Bench of this Court held that:
"14. On the question of issuance of the Second
Examination Report, section 13(3) of the Act makes
it apparent that upon amendment of the claims, the
amendment application ought to be examined in a
manner similar to the original application. When a
complete specification is amended, such amended
specification should be re-examined and a Report
issued in the manner stipulated under section 12 of
the Act. In passing the impugned order, there has
been a violation of the statutory provisions in
issuing the hearing notice citing additional
objections and relying on the same in without
granting an opportunity to the appellant to amend
its claim and without issuance of a Second
Examination Report."
20. In the case of Man Truck Bus Se Vs. Assistant Controller of Patents
and Designs reported in 2024 SCC OnLine Del 874 wherein the Delhi
High Court held that:
"24. A perusal of the impugned order bears
out that the paragraphs with respect to documents
D1-D4 have simply been repeated and copied.
Aside from that document D5 was not made part of
the notice of hearing and came up during the
hearing itself to which the appellant placed a
protest (but without prejudice responded to the
same in written submissions). The Controller did
advert to prior art document D5 in the following
manner:
"The D5 solves these problems
associated with prior art honeycomb
catalysts/filters so that catalytic conversion is
approximately uniform for all flow regions of
the honeycomb catalyst/filter (see col. 2 Ins.
50-59) by providing a honeycomb
catalyst/filter wherein there is a first group of
channels having a higher flow resistance and
a second group of channels having a lower
flow resistance (see col. 2 Ins.60-67). In
particular, note that figures 3 and 6 in the D5
illustrate the honeycomb wherein certain
cross-facial regions of the honeycomb
catalyst/filter have relatively smaller openings
and the other cross-facial regions of the
honeycomb have relatively larger openings, so
that this D5 honeycomb can also be said to
have different flow regions wherein each flow
region is configured to allow particles of
essentially different sizes or masses to be
separated out in the different regions (which is
required by the Applicants' independent
claims)."
21. In the case of Otsuka Pharmaceutical Co. Ltd. Vs. Controller of
Patents reported in 2022 SCC OnLine Del 4982, the Delhi High
Court held that:
"10. Perusal of the hearing notice reflects that
objection to the grant of patent was predicated on
lack of inventive step, citing prior art documents D1
and D4. There is no mention of D2 and D3 as
rightly pointed by learned counsel for the
Appellant. Relevant part of the hearing notice is
extracted hereunder:--
"The reply submission by the applicant is
not persuasive as D4 discloses a
pharmaceutical composition comprising : (i) at
least onecarbostyril derivatives (i.e. i.e.
aripiprazole) in combination with (ii) at least
one serotoninreuptake inhibitor, and (iii) a
pharmaceutically acceptable carrier (p. 6, line
6-11). It also discloses that the serotonin
reuptake inhibitor can be fluoxetine,
citalopram, fluvoxamine, paroxetine, sertraline
and escitalopram, and salts thereof (p.7, line
22-26). D4 also discloses a method for treating
major depressive disorder by administering to
a patient with major depressive disorder said
composition (p.12, line 19-25). D1 discloses a
heterocyclic compound of formula (I) or salts
thereof, which the preferable compound (I) is
7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)
butoxy]-1 H-quinolin-2-one (p.12, line 10-14 :
see Compound (1)). D1 discloses that the
above compound of formula (I) can be provided
in a pharmaceutical composition as an active
ingredient mixed with a pharmaceutically
acceptable carrier for the treatment or
prevention of central nervous system
disorders, i.e. major depression (p. 13, line 16-
23; & p. 14, line 4 ). A person skilled in the art
would have been motivated to combine the
teachings of D1 with D4 to produce a new
composition for use in the very same treatment
of major depressive disorder, and it is prima
facie obvious to combine two compositions
each of which is taught by the prior art to be
useful for the same purpose, in order to form a
third composition to be used for the very same
purpose. Hence the subject matter of claims 1-
8 lacks inventive step u/s 2(1)(ja) of
the Patents Act, 1970 in view of the prior art
D1 and D4."
19. The impugned order thus suffers from
several infirmities, including procedural. The order
is a non-speaking and unreasoned order; takes into
account prior arts D2 and D3, while finally
adjudicating on the patent application albeit they
did not form a part of the objections referred to in
the Hearing Notice and that too without giving an
opportunity to the Appellant to respond to them.
Vital issues and documents relied upon by the
Appellant have not been considered, including
applicability of Section 3(d) of the Act, seriously
contested by the Appellant."
22. In the case of Perkinelmer Health Sciences Inc and Ors. Vs.
Controller of Patents reported in 2023 SCC OnLine Del 8590
wherein the Delhi high Court held that :
"7. The hearing notice dated 12th February,
2018 makes no mention of objection under Section
3(f). Appellant ought to have been made aware of
all grounds of objection before the hearing and
afforded sufficient opportunity to contest the same
at the time of hearing. It was incumbent upon
Respondent to have raised this objection in the
notice of hearing itself. Albeit the Appellant had
submitted written submissions subsequent to the
hearing and not given any response qua Section
3(f) of the Act, that does not absolve the
Respondent of its obligations under the Circular to
communicate objections prior to the hearing and
provide reasonable opportunity to the
applicant/Appellant. Objection under Section 3(f) of
the Act has ex-facie been raised for the first time at
hearing stage as is apparent from afore-extracted
portion of the impugned order. There is thus merit
in the submission of Mr. Banerjee that Respondent
has violated the principles of natural justice."
23. The unreported judgment in case of Protean Electric Ltd. Vs. The
Controller of Patents and Designs in AID No. 15 of 2022 dated 06th
April, 2023, the Coordinate Bench of this Court held that:
"10. The primary grievance of the appellant is
that the Controller of Patents proceeded to re-
examine the application of the appellant despite the
appellant having made all necessary amendments
to the application in view of the objections raised
by the Controller of Patents. The appellant also
assails the raising of fresh citations being D2 and
D3 in the hearing notice against the amended
application.
11. Significantly, clause 9.04 of the Manual of
Patent Office Practice and Procedure, provides that
when an applicant re-files the documents post
amendment, the application must be examined in a
fresh manner by the Examiner and a Report with
his observation must be forwarded to the Controller
of Patents upon further examination of such
application. If thereafter an application is found to
comply with all the requirements of the Act and
Rules, the Controller is expected to grant the
patent.
13. I also find that the examination request
was filed on 20 September, 2014. The First
Examination Report was issued on 7 January,
2019. Despite affidavits, the respondent Controller
has taken approximately 8 years to complete the
entire process of examination. This is unacceptable
and renders nugatory the sprit and object of the
Act. There is also blatant violation of the statutory
timelines provided under Rule 24 B of the Patent
Rules 2003 for examination which has caused
inordinate delay in the entire examination process.
Moreover, the process of examination and
subsequent steps leading to disposal of the
application have been given a go-bye. The
application had been re-examined and further
examination reports were not issued to the
appellant. The two new prior art documents cited in
the hearing notice are in violation of the mandate of
section 13(3) of the Act and alters the entire
character of the examination."
24. Documents D5:US2005/0079206 (US 8246979) and D4:EP2177217
were cited by the respondent for the first time during the hearing. The
appellant was not aware of the objection of the respondent with regard
to the said two documents and the appellant was also not aware of the
teachings of the said documents according to which the respondent
considered the invention to lack inventive steps in view of the said
documents.
25. When the notice for hearing is sent, the appellant should clearly know
the objections and the prior art that the Controller will be relying on
during the hearing. The patent office while dealing with the grant of
patent, exercises quasi-judicial power and quasi-judicial authority is
not an adversary of the patent applicant. Any objection to the prior art
must be known to the applicant before the date of hearing.
26. Accordingly, the impugned order dated 16th August, 2019 passed by
the Deputy Controller of Patents and Designs is set aside and the
matter is remanded back to the respondent for fresh consideration. The
respondent other than the officer who passed the impugned order shall
hear the parties after permitting the appellant to place on record their
replies/response to the documents being D4:EP2177217 and
D5:US2005/0079206.
27. It is made clear that the Controller or any competent officer other than
the officer who passed the impugned order shall decide the matter on
merits, in accordance with law without being influenced by any
observations made by this Court in this order or in the impugned order
dated 16th August, 2019. The decision shall be taken as expeditiously
as possible, not later than six months from the date of receipt of the
copy of this Order.
28. IPDPTA No. 117 of 2023 is disposed of.
(Krishna Rao, J.)
