8 patent jntu pharmacy

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PATENTS

BYDr. Suman PattanayakAssociate ProfessorDepartment of Pharma Analysis & QA.

Vijaya Institute of Pharmaceutical Sciences for Women

B. Pharm IV year/ II SemDRA, IPR & Patents

Legislative Framework of IP Administration

Department of IP &P coversThe Patents Act, 1970 (as amended in 2005)

The Patents Rules, 2003 (as amended in 2006)The Designs Act, 2000

The Designs Rules, 2001 (as amended in 2008) The Trade Marks Act 1999

The Trade Marks Rules 2002The Geographical Indications of Goods (Registration & Protection) Act, 1999

The Geographical Indications of Goods (Registration & Protection) Rules, 2002,

Department of Education coversThe Copyrights Act 1957 (amended in 1999)

CONTROLLER GENERAL OF PATENTS, DESIGNS AND TRADEMARKS

(CGPDTM)

T M REGISTRY

DESIGN OFFICE

G.I. REGISTRY

Head OfficeKOLKATA

BranchDELHI

BranchCHENNAI

BranchMUMBAI

Head OfficeMUMBAI

DELHI

KOLKATA

CHENNAI

A’BAD

IPTI ,NIIPM, P.I.S. Nagpur

KOLKATA

PATENT OFFICE

CHENNAI

Law and Regulations

• Patents Act, 1970– Amended in

• 1999• 2002• 2005

• Patents Rules, 2003– Amended in

• 2005• 2006

Legislative Measures -Patents

• From 1.1.1995– Mail-Box for pharmaceutical and agrochemicals products– Exclusive Marketing Rights

• From 1.1.2000– Patent term increased to 20 years – Definition of invention – inclusion of inventive step– Reversal of burden of proof – on the infringer– Mandatory compulsory licence provision for food, drugs and

chemicals removed– Right of patentee (importation also included)

• From 1.1.2005– Product patents for food, chemical and pharmaceutical

We have met our international commitments

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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• Provision for protection of bio-diversity and

traditional knowledge• Publication of applications after 18 months with

facility for early publication• Substantially reduced time-lines

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Safeguards in the Patent Law

• Compulsory license to ensure availability of drugs at reasonable prices

• Provision to deal with public health emergency

• Revocation of patent in public interest and also on security considerations

Scope of Patentability Under The Patents Act

What is an Invention?

Sec.2(1)(J) “Invention” means a new product or

process involving an inventive step and capable of industrial application

Patentable subject matter

Invention must relates to a Process or Product or both be new (Novel) involves an inventive step be Capable of industrial application not fall under Section 3 and 4

“NEW”MEANS

Invention must not bePublished in India or elsewhere

In prior public knowledge or prior public use with in India

Claimed before in any specification in India

Inventive stepA feature of an invention that

involves technical advance as compared to the existing knowledge or have economic significance or both and makes the invention not obvious to a person skilled in the art

Industrial application means

Invention is capable of being made or used in

any kind of industry

Section 3 exclusionsSection 3(a) • Frivolous inventions• Inventions contrary to well established

natural laws

Examples Machine that gives more than 100%

performance Perpetual machine

Section 3 exclusionsSection 3(b)

Commercial exploitation or primary use of inventions, which isContrary to

public order or Morality

Examples– Gambling machine, – Device for house-breaking ,

Section 3 exclusionsSection 3(b) Commercial exploitation or primary use of inventions , which

Causes serious Prejudice to health or human, animal, plant life or to the environment

Examples Biological warfare material or device,

weapons of mass destruction Terminator gene technology, Embryonic stem cell

Checks and Balances Section 3(b)Excludes patents on

• GMOs – exploitation of which could be contrary public order or morality or prejudicial to human, animal or plant life or health or to the environment

Effect : Only genetically modified micro-organisms (GMOs) which do not fall under section 3 (b) are patentable.

Section 3 exclusions Section 3 ( c )• Mere Discovery of a Scientific Principle or• formulation of an Abstract Theory or• discovery of any living thing or • discovery of non–living substance occurring in nature

ExamplesNewton’s Laws Superconducting Phenomenon as such Property of certain material to withstand mechanical shockDiscovery of micro-organism Discovery of natural gas or a mineral

Checks and Balances Section 3(c)Excludes patents on

•Naturally occurring Micro-organisms

Effect Genetically modified microorganisms (GMOs) are however, patentable.

Section 3 exclusionsSection3 (d)

The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance

Section 3 exclusionsSection3 (d) ExplanationFor the purposes of this clause,• salts, esters, ethers, polymorphs, • metabolites, pure form, particle size,• isomers, mixture of isomers, • complexes, combinations and other derivatives of known substances

shall be considered to be the same substance, unless they differ

significantly in properties with regard to efficacy.

Examples– Crystalline forms of known substance

Checks and BalancesSection 3 (d) Explanation

Effect Salts, esters, ethers, polymorphs, metabolite, pure

forms, particle size, isomers, complexes, combinations and derivatives of a known substance with enhanced efficacy are patentable

Section 3 exclusionsSection3 (d)

Mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus, unless such known process results in a new product or employs at least one new reactant.

Examples– New use of Aspirin for heart ailments,– Mere new uses of Neem

Section 3 exclusionsSection 3(e)

Substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance

Examples Combiflam [Paracetamol (Antipyretic) + Brufen (analgesic)] Solution of sugar and color additives in water to form a soft drink

However,A mixture resulting into synergistic properties of mixture of ingredients however, may be patentable - Soap, Detergents, lubricants etc

Checks and Balances Section 3 ( e )

Effect Substance obtained by mere admixture resulting

only in the aggregation of the properties of the components thereof or

a process for producing such substanceare not patentable

However Synergistic formulations are patentable

Section 3 exclusionsSection 3 ( f )Mere arrangement or re-arrangement or duplication of known devices, each functioning independently of one another in a known way

ExamplesA Bucket fitted with torch,An Umbrella with fanA Clock and radio in a single cabinetA flour-mill provided with sieving

Section 3(h) Method of Agriculture or Horticulture

ExamplesCultivation of algae , Producing new form of a known plant, Preparation of an improved soil

However, Agricultural Equipments are patentable

Section 3 exclusions

Section 3(i) Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products

Examples Removal of cancer tumor Removal of dental plaque and carries Surgical processes Processes relating to therapy Method of vaccination, Blood transfusion


However ,Treatment performed on tissues or fluids permanently removed from the body Surgical,therapeutic or diagnostic Apparatus or instrumentsare patentable

Section3 exclusions Section 3(j) Plants & animals in whole or any part

thereof other than microorganisms, but including seeds, varieties an d species and essentially biological process for production or propagation of plants & animals

Section 3 exclusionsSection 3(j)• Plants & animals in whole• Parts of plants & animals• Seeds• Varieties & species• Essentially biological processes for

propagation or production of the animals & plants

Checks and Balances Section 3(j)Excludes patents on • Plants and animals in whole or any parts thereof,

…… including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals

Examples– Clones and new varieties of plants– A process for production of plants or animals if

it consists entirely of natural phenomena such as crossing or selection

– Essentially biological Process

Section 3(k) * mathematical method or * business method or * algorithms or * computer programme per se

Examples– Computer program by itself or as a record on a carrier

However – New calculating machine – combination of hardware and software is patentable


Section 3(l) A literary,dramatic, musical or artistic work or any other aesthetic creation including cinematographic work and television productions These subject-matters fall under the copyright protection


Section 3(m) A mere scheme or rule or method of performing mental act or method of playing game

Examples•Scheme for learning a language •Method for solving a crossword puzzle, •Method of learning a language •Method of teaching /learning

However,•Novel apparatus for playing game or carrying out a scheme is patentable


Section 3 (n)Presentation of information

Examples Any manner or method of expressing information

whether by spoken words Visual displaysymbolsdiagrams

Information recorded on a carrier


Section 3 (o)Topography of integrated circuits.

ExamplesMask works - circuits layout


Section 3 (p)Inventions which are Traditional Knowledge or an aggregation or duplication of known properties of traditionally known component or components

ExamplesTraditional Knowledge already in public domain- Wound healing property of Haldi

However, Any value-addition using Traditional Knowledge leading to a new process or product ,which is novel with inventive step and industrial applicability, gExtraction of Azadirachtin from Neem

can be patented


Section 4Inventions falling within Section 20(1) of the Atomic Energy Act, 1962 are not patentable

EffectInventions relating to compounds of Uranium, Beryllium, Thorium, Plutonium, Radium, Graphite, Lithium and more as notified by Central Govt. from time to time.

Non Patentable inventions

Stages from filing to grant of a patent

Obtaining a patent

• File an application for patent– With one of the patent offices based on territorial

jurisdiction of the place of office or residence of the applicant /agent

– Pay the required fee• Information concerning application form and details

of fee available at www.ipindia.nic.in • Guidelines for applicants also available on this

website

http://www.ipindia.nic.in/

Formality Check

• An Examiner checks the formal requirements before accepting the application and the fee – this is done immediately

• Issue of application number and the cash receipt – this is done the same day

• In case of receipt of application by post, cash receipt, application number is sent by post within 2-3 days

Publication

• Application is kept secret for a period of 18 months from the date of filing

• In 19th month, the application is published in the official journal – this journal is made available on the website weekly

• Applicant has an option to get his application published before 18 months also

• In that case, application is published within one month of the request

Request for Examination

• Application is examined on request• Request for examination can be made either

by the applicant or by a third party• A period of 48 months, from the date of filing,

is available for making request for examination

Examination

• Application is sent to an Examiner within 1 month from the date of request for examination

• Examiner undertakes examination w.r.t.– whether the claimed invention is not prohibited

for grant of patent – whether the invention meets the criteria of

patentability

Issue of FER

• A period of 1 to 3 months is available to Examiner to submit the report to the Controller

• 1 month’s time available to Controller to vet the Examiner’s report

• First Examination Report (FER) containing gist of the objections is issued within 6 months from the date of filing of request

Response from the Applicant

• 12 months’ time, from the date of issue of FER, is available to the applicant to meet the objections

• If objections are met, grant of patent is approved by the Controller – within a period of 1 month

Pre-grant Opposition

• After publication, an opposition can be filed within a period of 6 months

• Opportunity of hearing the opponent is also available

Examination of Pre-grant Opposition

• Opposition (documents) is sent to the applicant

• A period of 3 months is allowed for receipt of response

Consideration of Pre-grant Opposition

• After examining the opposition and the submissions made during the hearing, Controller may – Either reject the opposition and grant the patent – Or accept the opposition and modify/reject the

patent application • This is to be done within a period of 1 month

from the date of completion of opposition proceedings

Grant of a Patent

• A certificate of patent is issued within 7 days

• Grant of patent is published in the official journal

STAGES - FILING TO GRANT OF PATENT

PUBLICATION OF APPLICATION

REQUEST FOR EXAMINATION

GRANT OF PATENT

3rd Party Representation

Revocation/Amendment

OPPOSITION

• PROMPTLY AFTER 18 MONTHS FROM P.D.

• WITHIN 48 MONTHS FROM F.D.

• ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS

• IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS

• WITHIN 12 MONTHS

FILING OF APPLICATIONPROVNL. / COMPLETE

Decision of Controller

EXAMINATION-ISSUE OF FER

Appeal

Appellate Board

Renewal Fee

• To be paid within 3+6 months from date of recording in the register [sec 142 (4) ]

• No fee for 1st and 2nd year• Renewal fee, on yearly basis, is required to be paid

for 3rd to 20th for keeping the patent in force• Delay upto six months from due date permissible on

payment of fee for extension of time • Patent lapses if renewal fee is not paid within the

prescribed period

26th May'09 Dr.Asha Aggarwal 53

Object of patent law• The object of the patent law is to provide:

a statutory right to owner of the patent for a certain period of time to stop others from using, selling or working out his invention, and exploit it commercially

to disclose the invention and practice that invention and make it work thus encourage scientific research and new technology,

to stimulate new inventions of commercial utility and to pass invention into public domain after the expiry of the

fixed period of the monopoly.


BENEFITS

• Stop re-inventing the wheel• Know what is already patented

• Patent α Collaboration/ Money / Fame/ Name/ etc………


Grant for a patent

• To get a patent grant, the first most step is to file a patent application.

Who can file a patent application?Where to file a patent application?How to file a patent application?


Who can file Patent Application

In India [Section 6 and 134] • The application can be filed either alone or jointly:

By any person claiming to be true and first inventor(s) By any person being the assignee of person claiming to be true

and first inventor(s) ( proof of assignment has to be submitted along with the

application ) By the legal representative of any deceased person or assignee


Where to file patent application

• The appropriate office of the patent office shall be the head office of the patent office or the branch office as the case may be within whose territorial limits …

Residence of applicant or Domicile; or His the place of business; or The place where the invention actually originated.

• If the applicant has no business or domicile in India, the address for service in India is given by such applicant


Regional Patent office’s Jurisdiction

Office Territorial JurisdictionPatent Office Branch, Chennai

The States of Andhra Pradesh, Karnataka, Kerala, Tamil Nadu and the Union Territories of Pondicherry and Lakshadweep

Patent Office Branch Mumbai

The States of Maharashtra, Gujarat, Madhya Pradesh, Goa and Chhattisgarh and the Union Territories of Daman and Diu & Dadra and Nagar Haveli.

Patent Office Branch, New Delhi

The States of Haryana, Himachal Pradesh, Jammu and Kashmir, Punjab, Rajasthan, Uttar Pradesh, Uttaranchal, Delhi and the Union Territory of Chandigarh.

Patent Office, HOKolkata

The rest of India


How to file a patent application?

• Documents can be filed in the patent office

through online( e-filing) or www.ipindiaonline.gov.in/online through post or can be submitted by hand

http://www.ipindiaonline.gov.in/online


GENERAL PROCEDURE FOR OBTAINING A PATENT

• Filing of patent application• Publication after 18 months• Pre Grant Opposition /Representation by any person.• Request for examination• Examination: Grant or Refusal• Publication of Grant of patent• Post Grant Opposition to grant of patent• Decision By Controller


Pre 2005

Patent Application

Examination

Application in order for grant

Advertisement of acceptance Of Complete Specification

Opposition by Interested Person

Sealing / Grant

From 2005

Patent Application

Publication

Examination

Application in Order for Grant

Publication of Grant

Post Grant Opposition

Pre Grant opposition


Documents required for filing of A Patent Application

1. Covering letter- indicating the list of documents;2. Application for Grant of Patent in Form 1 [section 7, 54 & 135 and Rule 20(1)]

in duplicate;3. Complete/Provisional specification in Form 2 in duplicate [Section 10; Rule

13]4. Statement and Undertaking in Form 3 [Section 8; Rule 12];5. Power of Attorney in Form 26 (in original) (Rule 3.3 (a) (ii)); (if filed through

attorney)6. Declaration of Inventor-ship in Form 5 (only in case of an Indian Application; (Rule 4.17);7. Certified true copy of the Priority document (in case priority is claimed);8. Requisite Statutory fees (cheque / DD).


SPECIFICATIONS

Provisional specification -a provisional specification is usually filed to establish priority of the invention in case the disclosed invention is only at a conceptual stage and a delay is expected in submitting full and specific description of the invention. No patent is granted on the basis of a provisional specification.

Complete specification -the complete specification is the document in which all the details of the invention for which patent protection is desired are disclosed


Contents of Specification • Title of the invention• Field of the invention • Background of the invention (PRIOR ART)• Object of the invention• Summary of the invention• Brief description of drawings, if any• Detailed description of the invention• Examples • Claims- not required in provisional

• Abstract- not required in provisional


Provisional Specification…..

• It should describe the nature of invention & contain the description of essential features of the invention.

• Claims and abstract are not a part of provisional specification

• Fees is same as for complete specification• Complete specification must be filed within 12 months from

date of filing of provisional application.


Complete Specification

• Compared with the provisional, the complete specification shall:

a) contain the full description of the invention and its operation, b) the best method of making the invention. c) end with a claim or claims, which are the most important component in the complete patent specification. It is the legal operative part which define and determine the legal protection sought for. d) be accompanied by an abstract to provide technical infromation on the invention.


Complete Specification…..• If applicant mentions a biological material in the specification,

which cannot be described in such a way to satisfy clauses a) and b), and

• If material is not available to the public, the application shall be completed by depositing the material to the international depository authority,

• Deposit of the material shall be made not later than date of filing of patent application.

• In India biological material can be submitted at Institute of Microbial Technology (IMTECH), Chandigarh.


Statutory Fees:

Particular Natural person (Rs)

Other than natural person (Rs)

For filing patent application 1000 4000

For each sheet of specification in addition to 30

100 400

For each claim in addition to 10 200 800


Cognate filing• In addition to this, u/s 9(2)- there is a provision that where

two or more applications in the name of same applicant are accompanied by provisional specifications in respect of inventions which are cognate or of which one is a modification of another and controller is of the opinion that the whole of such inventions are such as to constitute a single invention and may properly be included in one patent, he may allow one complete specification may be filed in respect of all such provisional applications.


• u/s 9(3)-complete application can be converted to provisional application on request by the applicant to the controller of the patents at any time within twelve months from the date of filing of the application.

Complete to provisional


• u/s 9(4)-where a complete specification has been filed in pursuance of an application accompanied by provisional specification, the controller, may, if the applicant so requests, at any time before grant of patent, cancel the provisional specification and post-date the application to the date of filing of the complete specification.

Post-dating


• [Rule 24] A patent application will be published automatically in the official journal after expiry of 18 months from date of filing or date of priority of the application containing title, abstract, application no. and name of applicant[s] and inventor[s].

• This way, the world is informed about the fact that a patent can be expected on that particular invention.

• Someone else using the invention could then switch to a different technology, or make reservations to pay for a license once the patent is granted.

Publication


Publication………..

• Request for early publication: [Rule 22A] To expedite the process of grant of patent a request for publication under Section 11(A)(2) can be made in Form 9 any time after filing of the application. Upon such request, the application will be published in one month from the date of such request.

• Fees for Request for Early Publication for Natural person is Rs. 2,500

• Fees for Request for Early Publication for Other than natural person is Rs. 10,000


Importance of Publication• On and from the date of publication of the application for

patent and until the date of grant of a patent in respect of such application, the applicant shall have the like privileges and rights as if a patent for the invention has been granted on the date of publication of the application.

• The applicant shall not be entitled to institute any proceedings for infringement until the patent has been granted

• Right of the patentee in the case of applications filed u/s 5(2) shall accrue from the date of grant of the patent



[Section 25(1)] Upon publication, but before the grant of patent any person, based on different grounds may file a pre grant opposition, in writing, represent by way of opposition to the Controller against the grant of patent.

However the opposition will be taken by the patent office only after the filing of Request for Examination.


Time limit: May be filed within 3 months from the date of publication of the application [sec 25(1); rule 55(1)] OR Before the grant of patent, whichever is later.

Fee:NO FEE



Request for Examination

• No Request, No Grant

• In Form 18 [sec. 11B; rules 20(4)(ii) and 24B(1)(i)] in duplicate within period of 48 months from date of filing or priority.

• Statutory Fees for Request for Examination for Natural person is Rs. 2,500• Statutory Fees for Request for Examination for other than

natural person is Rs.10,000


First Examination Report

[Section 12; 24B(3)] After proper examination of patent application, on the

criteria of novelty, inventiveness and industrial application, which involves checking all the literature available to it to find documents that describe the invention in part or in whole. In this search, only documents that were published before the date of filing of the application are to be considered. The Patent Examiner will issue a First Examination Report (FER) and will send along with the application and specification to the applicant or authorized agent.


Amendment of objections by the applicant

• The issued FER give an opportunity to the applicant to file a response and overcome the objections raised by the Examiner.

• Time limit: [Rule 24B(4)(iii)] Within 12 months from the date on which the First Examination Report has been issued to the applicant, the application should be placed in order of acceptance.

• In case of the unjustified response, the Controller has power to refuse the grant of patent or ask for amended claim[s] or make order for the Division of Application [Section 15, 16].


Grant of Patent• The Controller will grant the application upon overcome the

all objections raised in the FER.

• On the grant of a patent the application will be accorded a number, called serial number in the series of numbers accorded to patents under the Indian Patents and Designs Act, 1911(2 of 1911).


Post grant Opposition

• [Section 25(2)] Upon grant of patent, any interested person, based on different grounds may file a post grant opposition in Form 7 to the Controller against the grant of patent.

• Time limit: Within one year after the grant of a patent.

• Statutory Fees for Notice of Opposition for Particular Natural person is Rs.1,500

• Statutory Fees for Notice of Opposition for other than natural person is Rs.6,000


Renewal fees

1.To keep a patent in force, the renewal fees shall be payable at the expiration of the second year from the date of the patent or of any succeeding year and the same shall be remitted to the patent office before the expiration of the second or the succeeding year.

2. While paying the renewal fee, the number and date of the patent concerned and the year in respect of which the fee is paid shall be quoted.

3. The annual renewal fees payable in respect of two or more years may be paid in advance.


Fees…

Up to 6 years Rs. 2,000/ year

7-10 years Rs. 6,000/ year

11-15 years Rs. 12,000/ year

16-20 years Rs. 20,000/ year


Fees…• The period for payment of renewal fees may be extended to

a period but not more than six months if the request for extension in Form 4 with fees.

• Statutory Fees for extension in Form 4 for Particular Natural person is Rs.300 per month• Statutory Fees for extension in Form 4 for Other than natural

person is Rs.1,200 per month


Filing of International application

• It is possible to file an international application in India in all patent offices. All these offices act as Receiving Office (RO) for international application.

• International application can be filed directly to International Bureau (IB), Geneva, on-line.


Documents required for filing

• Covering letter indicating list of documents: Request Complete specification in triplicate Abstract- in triplicate Fees- transmittal fees


Fees Payable under PCT

• Transmittal Fee: Rs. 8000/-• Fee for priority document: Rs. 4000/- each• International Fee: $ 1,184 for 30 pages• Fee for each page in addition to 30 pages: $ 13• Search fee: According to search authority


Search Authorities along with fee

SearchAuthority

Fee (in USD)

AT 257

AU 1,091CN 280EP 2,184

SE 2,164

US 2,080


National phase entry

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First Application Family Application

8 patent jntu pharmacy

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