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

Patent

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Patent ActComplete

Specification with

SampleAnirban SahaM.Pharm (Pharmaceutics)Year- 2nd , Semester- 3Amity University .

AMITY INSTITUTE OF PHARMACY

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CONTENTS

What is a Patent ?Indian Patent ActPatent Law- Salient FeaturesWhat does Patent System Do?How To Apply?Types of PatentsPersons entitled for patent in INDIAChecklist for Filing PatentSample patentConclusion

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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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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.

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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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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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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.

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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 obtainthe 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.

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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.

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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 inrespect of the same invention

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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 specification1) 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

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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 includedAlong with any picturisation during experiment.

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0.0

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0 10 20 30 40 50 60 70

Time (in minutes)

% d

rug

diss

olve

d

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)

% d

rug

diss

olve

d

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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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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