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Section 3
(d):
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Clause
(d) of Section 3 has been amended to exclude 'the mere
discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy of that known
substance' from being patentable inventions.
Therefore, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixture of
isomers, complexes, combinations and other derivatives are
considered to be the same substance, unless they differ
significantly in properties with regard to their efficacy. It
follows that the patentability of such derivatives is now a
matter of inventive step, rather than that of novelty.
The known parameters which may prove the efficacy of a
particular derivative of a pharmaceutical substance may
be :
| (a)
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EC50 |
| (b) |
LC50 |
| (c) |
Therapeutic
index, depends upon the EC50 and the LC50. The lower
the therapeutic index, better is the efficacy of a
drug for a desire activity. |
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Complete
after Provisional:
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Conversion
of complete specification to provisional possible only upto
twelve months from the date of filing of the purported
complete specification.
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No
extension available for filing the complete specification,
which now has to be filed with in twelve months of filing the
provisional application.
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Priority
Dates:
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The
priority date of a claim is the date of the filing of the
application in which the matter was first disclosed. This is
important in cases in which a (complete) specification is
filed claiming priority of two or more (provisional)
specifications, whereby it is safer to draft claims fairly
based on one particular application to get the priority date
of that particular application. In case the subject matter of
a claim is based on disclosure in two or more prior
applications, it is always better to sub-divide the claim in
two or more parts, if possible, to get the earliest priority
date. (Thornhill claims).
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Publication:
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Provisional
specifications for which no complete specifications have been
filed within the specified period of twelve months are not to
be published. An application which has been withdrawn three
months prior to the stipulated period for publication will
also not be published.
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Deferred
Examination:
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Request
for examination to be filed after publication of the
application, but before the expiry of 36 months from the date
of filling, under the newly introduced Deferred Examination
System.
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Grant:
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Time
for putting an application in order for grant - 6 months, from
the date of issuance of the FER. The specified time limit can
be extended only once for a period not exceeding three months,
on a request made by the applicant before the expiry of the
statutory six-month period.
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Right
to Sue:
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The
applicant has like privileges and rights as if a patent for
the invention had been granted from the date of publication of
the application until the date of the grant, provided that he shall
not be entitled to institute any proceedings for infringement
until the patent has been granted. The rights of the patentees
for application filed before 1st day of January, 2005,
relating to pharmaceuticals, will accrue from the date of
grant of the patent. The patentee for such a patent shall only
be entitled to receive reasonable royalty from such
enterprises which have made significant investments and were
producing and marketing the concerned product prior to
01.01.2005, and which continue to manufacture the product
covered by the patent on the date of grant of the patent and
no infringement proceedings shall be instituted against such
enterprises.
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Pre-grant
Opposition:
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Pre-grant
opposition (after the publication but before the grant, with
in six months from the date of publication of the
application) may be filed on the ground of:
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Wrongful
obtention; |
| (b) |
Prior
Publication; |
| (c) |
Prior
claiming; |
| (d) |
Publicly
known or used (importation of the direct product of a
claimed process included within publicly known or
used, except for reasonable trial or experiment only); |
| (e) |
Lack
of inventive step; |
| (f) |
Statutory
exclusion; |
| (g) |
Insufficient
disclosure; |
| (h) |
Failure
to furnish information required under Section(8); |
| (i) |
Convention
application not filed within 12 months of the basic
application; |
| (j) |
No
disclosure or wrong mention of the source or
geographical origin of the biological material used
for the invention; and/or |
| (k) |
Anticipated
having regard to the knowledge available within any
local or indigenous community. |
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The Controller
shall consider such representation only if the request for
examination for the subject application has been filed.
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Post-grant
Opposition:
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Belated
opposition (before the expiry of one year from the date of
publication of grant of a patent). The available grounds are the
same as that available for pre-grant oppositions. Opposition
Board to be constituted only for belated oppositions.
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Grace Period:
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The 'grace
period' for filling a patent application extended upto twelve
months, where:
| 1. |
The
invention is displayed or published by the applicant in
an exhibition notified by the Government; |
| 2. |
The
invention is read in transactions before learned
society. |
| 3. |
The
invention is worked publicly for reasonable trial, where
the nature of invention is such that it is necessary to
do so. |
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Foreign Filing:
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Any application
outside India can be filed only six weeks after filing the same
invention in India or under a written permission from the
Controller, in a prescribed fee and form. The Controller may
grant such permission within three months of filing the said
request, but generally the permission is granted within seven
working days.
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Revocation:
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A patent may be
revoked either by the Appellate Board or by the High Court,
provided that revocation on a counter-claim in a suit for
infringement of the patent may be done only by the High Court.
Therefore, if a suit for infringement is pending, the defendant
has the option of seeking revocation of the patent by way of a
counter-claim in a High Court or by way of a separate and
independent application seeking revocation by the Appellate
Board, which may be a cheaper option to the costly litigation in
Court. The grounds available for revocation are as follows:
| (a) |
That
the invention claimed is a subject of prior grant. |
| (b) |
That
the patentee was not entitled to the patent. |
| (c) |
That
the patent was wrongfully obtained by a person other
than the person entitled, this ground is available only
to a person entitled to apply. |
| (d) |
That
the invention for which the patent has been granted is
not an invention, within the definition of invention
provided for in the Act. |
| (e) |
That
the invention is anticipated with regard to prior art or
prior knowledge. |
| (f) |
That
the invention is obvious over the prior art. |
| (g) |
That
the claimed invention is not useful i.e. not workable. |
| (h) |
Insufficient
disclosure. |
| (i) |
That
the claims are not clearly defined and not sufficiently
based on the disclosure. |
| (j) |
That
the patent was obtained by false suggestion or
representation. |
| (k) |
That
the claimed invention is not patentable invention in
that it is statutorily excluded by law from
patentability. |
| (l) |
Prior
art use. |
| (m) |
Failure
to disclose information regarding foreign application. |
| (n) |
Non-compliance
with any secrecy direction issued under any provision of
the Act. |
| (o) |
Leave
to amend the specification was obtained by fraud. |
| (p) |
That
the specification wrongly mentions or does not disclose
the geographical origin of any biological material used
for the invention. |
| (q) |
Anticipation
by traditional knowledge. |
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The Appellate
Board has not yet come into force, pending a notification from
the Government to such effect.
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Compulsory
License:
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Compulsory
license for manufacture and export of patented pharmaceutical
products to any country having insufficient or no manufacturing
capacity in the pharmaceutical sector in certain exceptional
circumstances has been introduced, provided such country has
allowed importation of patented pharmaceutical products from
India.
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International
Arrangements and Conventions
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India is a member
of the World Trade Organization, the Paris Convention and the
Patent Cooperation Treaty (PCT).
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Field of
invention for a patentable invention.
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A product patent
may be granted in all fields of technology including chemicals,
food, drugs and agro-chemicals.
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Filing an
infringement suit.
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The period of
limitation for bringing a suit for infringement of a patent is
three years from the date of infringement, which three years run
from the date of the infringing act and not from the date of the
grant of the patent (Section 40 of the Indian Limitations Act).
A suit for infringement must be filed in a District Court having
jurisdiction to try the suit. Where the defendant counter claims
the revocation of the patent, the suit along with the counter
claim shall be stand transferred to the High Court.
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Reversal of
the Burden of Proof.
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According to
Section 104 (A) of the Act (Article 34 of the TRIPs Agreement),
in any suit for infringement of a patent, where the subject
matter of the patent is a process for obtaining a new product,
the Court may direct the defendant to prove that the process
used by him to obtain the product, identical to the product of
the patented process, is different from the patented process,
provided there is sufficient likelihood that the identical
product is made by the patented process and the patentee could
not establish through reasonable efforts to determine the actual
process used by the alleged infringer, provided also that the
patentee first proves that the product in question is identical
to the product directly obtained by the patented process.
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Computer
implemented inventions
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A computer
program per se is not patentable.
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A
computer-readable storage medium having a program recorded
thereon may be considered to be claim to the software program
per se and are not patentable.
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A process or a
method which is carried out under the control of a program may
not be said to be related to a computer program as such, and
therefore may be patentable if it can be shown that the process
or the method makes a significant contribution to the art.
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The inventions
relating to the application of software per se may be patentable,
when claimed in combination of hardware and software components
of a computer, which provides a technical advancement over the
prior art.
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Provisions to
safeguard the public interests
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Bolar
provision: Any act of making, constructing, using, selling
or importing a patented invention solely for use reasonably
related to development and submission of information required
under a law which regulates the manufacture, construction, use,
sale or import shall not be considered as infringement of patent
rights.
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Parallel
import: may be granted to a person duly authorized under the
law in order to stabilize the price in India, and the same
importation shall not be an infringement of the patentee's
rights.
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