introduction and basics

1. Patent Act
Complete
Specification
with
Sample
Anirban Saha
M.Pharm (Pharmaceutics)
Year- 2nd , Semester- 3
Amity University .
AMITY INSTITUTE
OF PHARMACY

2. CONTENTS
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What is a Patent ?
Indian Patent Act
Patent Law- Salient Features
What does Patent System Do?
How To Apply?
Types of Patents
Persons entitled for patent in INDIA
Checklist for Filing Patent
Sample patent
Conclusion

3. What is patent?
 A patent is a state grant in favor of the inventor conferring on
him a right to use the invention to the exclusion of all others.
 The fundamental Principle in awarding a patent is that the right
must be granted for an invention, which has novelty and utility.
The extent of legal protection accorded to a patent is based
upon the way the patent claim is drafted in the patent application.
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4. 4
Indian Patent Act
 A patent is an exclusive right granted by a country to the owner of
an invention to make ,use ,manufacture and market the invention,
provided the invention satisfies certain conditions stipulated in
the law.
 Exclusive rights implies that no else can make ,use, manufacture
or market the invention without the consent of the patent holder.
 A patent in the law is a property right and hence can be gifted,
inherited, assigned, licensed or sold.

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 The patent right is territorial in nature and inventors/their assignees
will have to file separate patent applications in countries of their
interest.
 There are two kinds of patents namely process and product patent.
 A product-patent system means that the end result of the product is
patented and not the process by which it is made.
 India follows both the product and process-patent systems. For the
pharmaceutical, drug, food and chemicals industries, we follow
process patents, while for all other industries the product-patent
system.
 In India grant of process patents was limited to food and drugs.
 However with effect from January 2005 the said limitation is
removed.

6. Patent Law - Salient Features
• Both product and process patent provided.
• Term of patent – 20 years.
• Examination on request.
• Both pre-grant and post-grant opposition.
• Fast track mechanism for disposal of appeals.
• Publication of applications after 18 months with
facility for early publication.
• Substantially reduced time-lines.
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7. What Does Patent System Do ?
 It encourages RESEARCH.
 Induces an inventor to disclose his inventions instead of
keeping them as secret.
 Provides inducement for capital investment Encouraging
technological development.
 It encourages establishment of new industries.
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8. 01-03-20088
 HOW TO APPLY?
For this, patentee have to give application to patent office with necessary
requirements.
TYPES OF PATENT APPLICATIONS
A. Ordinary Patent Application
It is a simple application for patent without any priority claim
and not being convention or National Phase Application. It
should be accompanied by a provisional or complete
specification at the time of filing.
B. Convention Application
An applicant who files an application (.basic application.) for
patent in a convention country can make convention
application in India within 12 months from the date of basic
application.

9. C. National Phase Application under PCT
PCT stands for the Patent Co-operation Treaty. It is a sister
treaty of the Paris Convention administered by the World
Intellectual Property Organization (WIPO).
The PCT system facilitates filing of patent applications under a
single umbrella and provides for simplified procedure for the
search and examination of such applications.
This allows a resident or national of a PCT member state to
obtain
the effect of patent filings in any or all of the PCT countries and
to defer the bulk of filing costs usually due on filing.
India became a PCT Contracting state on December 7, 1998.

10. PERSONS ENTITLED TO APPLY FOR PATENT IN
INDIA
An application for a patent for an invention may be
made by any of the following persons either alone
or jointly with another
a)True and first Inventor
b) His/her Assignee
c) Legal representative of deceased inventor or
assignee.

11. CHECK-LIST AND INFORMATION REQUIRED FOR FILING
PATENT
1.Name, Nationality and Address of the applicant
2. Name, Nationality and Address of the inventor
3. Title, Description, Drawings, Claims & Abstract of the
Invention
4. FORM 1- Application for patent to be filed in duplicate
5. FORM 2- Description, Drawings, Claims and abstracts in
duplicate
6. FORM 3- Statement and undertaking regarding foreign filing
details in
respect of the same invention

12. 9. FORM 5- Declaration as to Inventor-ship
10. Priority document (if applicable)
11. FORM 26- Power of Attorney (can be filed later,
before hearing)
12. Proof of right if the application is made by the
assignee or by way of separate assignment
deed.(proof of right may be submitted within three
months of application)

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Complete specification
1) Title of the invention
2) Field to which the invention belongs
3) Background of the invention including prior art giving
drawbacks of the known inventions and practices
4) Complete description of the invention along with
experimental results
5) Drawings (if necessary)
6) Claims, which are statements of technical facts expressed
in legal terms, related to the invention on which legal
proprietorship is being sought. therefore the claims have to
be drafted very carefully.

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Front Page

15. 15
Title Page

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Complete description of the invention along with
experimental results

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Drawings (if necessary)
Mainly Graphs are included
Along with any picturisation during
experiment.

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0.0
20.0
40.0
60.0
80.0
100.0
0 10 20 30 40 50 60 70
Time (in minutes)
%drugdissolved
Itraconazole as such ITRA : FA (1 : 1) PM ITRA : FA (1 : 1) SE
ITRA : FA (1 : 1) FD ITRA : FA (1 : 1) SD
0.0
20.0
40.0
60.0
80.0
100.0
120.0
0 10 20 30 40 50 60 70
Time (in minutes)
%drugdissolved
Itraconazole as such ITRA : FA (1 : 1) SD Sporanox Capsules 100 mg
Comparative Dissolution Profile
Dissolution Enhancement by
Complexation

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Utility of the Invention
• Can be used as a Platform technology for improving the
bioavailability of existing drugs.
• A number of New drugs discovered do not get marketed because of
their poor biopharmaceutical characteristics. The developed
technology can be used to recover such drugs from being
discarded.
Claims
• Novel complexing agents in the form of fulvic and humic acids extracted
from shilajit as bioavailability enhancers.
• Process for the extraction of fulvic and humic acids from Shilajit.
• Process for preparing of complexes of drugs with humic and fulvic acids
extracted from Shilajit.
• Complexes of problematic drugs with improved solubility, permeability
and bioavailability.
• Pharmaceutical formulations containing these complexes.

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Claims

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FORM 2

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Conclusion
 It maintain continuous stream of new ideas and experimentation
so it directly point out at growth of a country.
 The burden of duplication of the invention is avoided : it saves
further spending of time and money.
 Any interested person may buy the Patent, wherein the Patent
becomes a nice tool for the transfer of technology.
 Patent provides protection to the Patentee, wherein, if the Patent
is infringed, the Patentee may seek the legal remedies. Thus
Patent is a form of social security to an inventor.
 Once, the life of the Patent is over, any person may freely,
without paying any royalty to the Patentee, may enjoy the
invention.

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