Patent and Related Issues

Dr. Niteen S. Ahire.Dept. of Pharmacology

SVNGMC, Yavatmal

• INTRODUCTION TO IPR• PATENT OVERVIEW• INDIAN PHARMACEUTICAL INDUSTRY

AND PATENT SYSTEM.• PATENT LAWS IN INDIA• IMPORTANT PROVISION FOR PUBLIC

HEALTH SAFEGAURDE• PHARMACEUTICAL CLAIMS FOR PATENT• INDIAN PATENT SYSTEM FRAME WORK. 2

• OBTAINING A PATENT.• INDIAN PHARMACEUTICAL IN PATENT

ERA.• CONCLUSION.• REFERENCES.

3

INRODUCTION

Property • In lay term, property means some material object

belonging to a particular person.

Ownership• It means the right to possess, use and dispose of the property.

4

Intellectual property

Intellectual property is an intangible creation of human mind, usually expressed or translated into a tangible form that is assigned certain

rights of property.

IPR:• “Intellectual Property Rights” are legal rights,

which result from intellectual activity in industrial, scientific, literary & artistic fields.

• These rights Safeguard creators and other

producers of intellectual goods & services by granting them certain time-limited rights to control their use.

6

7

8

Major Types of IP

Functional & Technical Inventions

Patents Act, 1970 Amended

in 1999 & 2005

Purely Artistic works

Copyright Act,1957

Amended in1982,1984, 1992,

1994 & 1999

A symbol, logo, word, sound, color, design, etc.

TrademarkAct, 1999Amended in 1994,1996 & 2000

Patent• A patent is an exclusive right granted for an invention, which is

a product or a process that provides a new way of doing something, or offers a new technical solution to a problem.

10

Trademarks• A trademark is a distinctive sign that identifies certain goods

or services as those produced or provided by a specific person or enterprise.

• They may consist of drawings, symbols, three- dimensional signs such as the shape and packaging of goods, audible signs such as music or vocal sounds, fragrances, or colours used as distinguishing features.

11

Copyrights• Copyright is a legal term describing rights given to creators for

their literary and artistic works. • The kinds of works covered by copyright include: literary

works such as novels, poems, plays, reference works, newspapers and computer programs; databases; films, musical compositions, and choreography; artistic works such as paintings, drawings, photographs and sculpture; architecture; and advertisements, maps and technical drawings.

The rights under copyright includes :- Right of reproduction Communication to the public Adaptation of work Translation of work

12

What is covered by copyright?

Literary Films Dramatic

Musical Sound RecordingArtistic

Duration of Copyright

Copyright lasts for- Author’s lifetime + 50 years from the end of calendar year in

which the author dies 50 years for films & sound recordings 25 years for typographical arrangements of a published

edition Copyright protection always expires on December 31 of the

last calendar year of protection

Geographical Indications (GI):• GI are signs used on goods that have a specific geographical

origin and possess qualities or a reputation that are due to that place of origin.

• Recently the GIs of goods like Chanderi Sarees, Kullu Shawls, Darjeeling tea,etc. have been registered.

15

Industrial Designs:• Industrial designs refer to creative activity, which result in the

ornamental or formal appearance of a product, and design right refers to a novel or original design that is accorded to the proprietor of a validly registered design.

• Under the TRIPS Agreement, minimum standards of protection of industrial designs have been provided for.

• As a developing country, India has already amended its national legislation to provide for these minimal standards.

16

Trade Secrets• It may be confidential business

information that provides an enterprise a competitive edge may be considered a trade secret.

• Usually these are manufacturing or industrial secrets and commercial secrets.

• These include sales methods, distribution methods, consumer profiles, advertising strategies, lists of suppliers and clients, and manufacturing processes.

17

Layout Design for Integrated Circuits• Semiconductor Integrated Circuit means a product having

transistors and other circuitry elements, which are inseparably formed on a semiconductor material or an insulating material or inside the semiconductor material and designed to perform an electronic circuitry function.

18

Protection of New Plant VarietyThe objective of this act is- • to recognize the role of farmers as cultivators and conservers

and the contribution of traditional, rural and tribal communities to the country’s agro biodiversity by rewarding them for their contribution

• to stimulate investment for R & D for the development new plant varieties to facilitate the growth of the seed industry.

19

Patent- Overview

Patent • The criteria for patentability require that a product or manufacturing

process fulfills the conditions of

• Novelty• Inventiveness (Un-obviousness)• Industrial applicability (or utility)

• Whether a claimed invention meets the tests of novelty and non-obviousness is determined by comparing it to the body of previously disclosed information in the same field.

• This information is usually called “prior art.”

• The most commonly used prior art consists of published patents that have already been issued or published by the world’s patent offices.

21

“New” means….

Sec. 2(j) Invention • Any new product or process• Involves an Inventive Step• Capable Of Industrial Application

Sec. 2(j a) Inventive Step – Feature involving• Technical advancement; or• Economic significance; or • Combination of above• and makes it non obvious to a person skilled in the

art

22

Life & Duration

Term of the patent is 20 years from the date of filling for all types of inventions

The date of patent is the date of filing the application for patent

The term of the patent is counted from this date

Fees For Filing Patent

Why I go for getting a patent ??

25

TO ENJOY THE EXCLUSIVE RIGHTS OVER INVENTIONS

TO ENSURE COMMERCIAL RETURNS

TO PROTECT MY INVENTIONS & PROCEEDINGS

26

What Does a Patent look Like?

BENIFITSBiggest source of scientific & technical knowledge

More than 40 million Patent Documents and 1 million

being added every year

Identifies emerging technologies, research areas and business opportunities

To prevent others from illegally exploiting the invention

Avoids duplication of research and Acts as a stepping Stone for Scientific Research.

Linking creativity to wealth28

Problems

• Patented products may put excessive economical burden on its users.

• Majority group of users who can not afford it, will be refrained from using a newer, sometimes more beneficial inventions. Specially in case of medicinal products.

29

What are not patentable in India

(under sec 3 of Patent Act 1970) Invention area

- Which is frivolous or contrary to established natural laws

- Which is contrary to public order or morality

- Mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature

- Mere discovery of a new form, property or use of a known substance without any enhancement

- Mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way

30

What are not patentable in India

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

- Method of agriculture or horticulture

- Process for the medicinal or other treatment of human beings or animals to render them free of disease

- Mere scheme or rule or method of performing mental act or method of playing game

- Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals

31

What are not patentable in India -A mathematical or business method or a computer program per se or algorithms

-A presentation of information

-Topography of integrated circuits

-An invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components

-Relating to atomic energy32

The Pharmaceutical Industry and the Patent System

Patents and Pharma sector• The pharmaceutical sector is a major user of the patent system.

• Pharmaceuticals is a research based industry and needs innovative and creative approach which is the key to generation of intellectual properties

• Compared to other industries, the balance of rights and obligations are very delicate in Pharma, since the inventions need to serve the needs of health care and nutrition of the community making essential medicines affordable and accessible to the needy, world over.

34

SPECIAL PROBLEMSI. Since capital investment in the pharmaceutical industry

disproportionately is directed to laboratory research and clinical trials rather than the manufacture of the final product, patent exclusivity is the only effective way to protect and receive a return on that investment.

II. The culture of medical research, however, emphasizes very early disclosure of inventions

III. a “Buyer Beware” philosophy

IV. Extensions of patent term to compensate for the inability to market inventions due to safety and efficacy regulation.

V. “Regulatory Exception” / Bolar provision

35

From history to present….

International Bureau for the Protection of Intellectual Property (19th Century)

The World Intellectual Property Organization (1967)• Headquartered in Geneva• WIPO is the specialized United Nations Agency that serves as

the secretariat for administration of most of the global intellectual property treaties.

• It is the principal forum for negotiation of new patent treaties and the leading provider of technical assistance to developing countries in the field of intellectual property rights.

• WIPO Currently has 179 member states. 36

From history to present….

The World Trade Organization (1994)• WTO was established in Marrakech following the successful

conclusion of the Uruguay Round of Trade Negotiations. • The predecessor to the WTO was the General Agreement on

Tariffs and Trade (GATT). • A key reform of the Uruguay Round was the Agreement on

Trade Related Aspects of Intellectual Property Rights (TRIPS) codified as an annex to the treaty establishing the WTO.

• After TRIPS Agreement in 1994 many developing countries that have joined the WTO have obligated themselves to provide such protection, least developed countries are not required to meet this obligation until 2016. 37

Major requirements of the TRIPS agreement • WTO Member States must provide a level of rights equal to those

provided in the major global intellectual property treaties administered by WIPO

• WTO member states may not discriminate among technologies in providing patent protection

• WTO member states must provide patent protection for at least 20 years from the date of filing a patent application

• WTO Member States must provide effective judicial enforcement of intellectual property rights.

• A TRIPS Council was created to coordinate WTO policy in the area of intellectual property rights and to manage the resolution of disputes among states on implementation of TRIPS obligations.

38

Doha Ministerial Declaration

• Doha Declaration on the TRIPS Agreement and Public Health was adopted by the WTO Ministerial Conference of 2001 in Doha on November 14, 2001.

• DOHA Declaration has reiterated-

Access to medicine is a critical factor in poor countries.

TRIPS Agreement has flexibilities. Developing countries should make use of these flexibilities. 39

Patent Laws In India

1856 THE ACT VI OF 1856 ON PROTECTION OF INVENTIONS BASED ON THE BRITISH PATENT LAW OF 1852. CERTAIN EXCLUSIVE PRIVILEGES GRANTED TO INVENTORS OF NEW MANUFACTURERS FOR A PERIOD OF 14 YEARS.

1859 THE ACT MODIFIED AS ACT XV; PATENT MONOPOLIES CALLED EXCLUSIVE PRIVILEGES (MAKING. SELLING AND USING INVENTIONS IN INDIA AND AUTHORIZING OTHERS TO DO SO FOR 14 YEARS FROM DATE OF FILING SPECIFICATION).

1872 The Patterns and Designs Protection Act’ (Act XIII of 1872)

1883 THE PROTECTION OF INVENTIONS ACT.

1888 CONSOLIDATED AS THE INVENTIONS & DESIGNS ACT.

1911 THE INDIAN PATENTS & DESIGNS ACT.

1972 THE PATENTS ACT (ACT 39 OF 1970) CAME INTO FORCE ON 20TH APRIL 1972.

1999 ON MARCH 26, 1999 PATENTS (AMENDMENT) ACT, (1999) CAME INTO FORCE FROM 01-01-1995.

2002 THE PATENTS (AMENDMENT) ACT 2002 CAME INTO FORCE FROM 2OTH MAY 2003

2005 THE PATENTS (AMENDMENT) ACT 2005 EFFECTIVE FROM Ist JANUARY 200541

Patents Act 1970 – Salient Features• Only process patents for food, pharmaceuticals

and chemical products.

• Product and process patents in all other areas

• Term of patent – variable (7 / 14 years)

• Elaborate public interest provisions (License of right, Government use)

42

Patents Act 1970 – How it helped Indian Pharma Sector

• Allowed Indian companies to legally produce generic versions of medicines that were under patent elsewhere

• Developed thriving generic drug industry

• Indian drug manufacturers were capable to produce low-cost drugs.

43

TRIPS

This Agreement links intellectual property and trade issues for the first time and provides a multilateral mechanism for settling disputes between states.

TRIPS Agreement mandates

• Product Patent• Term of Patent• Mailbox Provision• EMR 44

Amendment of the Patent Act

India has made three amendments in its original Patent Act 1970.

• Ist amendment-1999

• IInd amendment-2002

• IIIrd and Final Amendment-200545

Ist Amendment-1999

Mailbox provision - “Transitional arrangements”-which allowed product patent applications to be filed through a ‘mailbox’.

Exclusive Marketing Rights (EMRs) -Kind of exchange for permission to delay the granting of product patents until January 1, 2005.

• Novartis for anti-cancer medicine, Gleevec

46

IInd amendment-2002• 20 years term

• Definition of invention

• Reversal of burden of proof

• Modification of compulsory licence provision

• Right of patentee (include importation also)47

IIIrd amendment-2005

• Introduction of product patents in the area of chemicals, pharmaceuticals, agricultural chemicals and food.

• The Act repealed the Section 5(1) of the Patents Act, 1970, which provided for process patents in this field.

48

Indian Patent Act

• Invention, inventive step, pharmaceutical product redefined.• Clarification on definition of “new entity”• Inventions Excluded from Patents (Section 3)• Re-introduction of Product Patents for Drugs, Medicines and

Foods including products of Chemical Reactions• Reversal of burden of proof• Patent Term 20 years• Substantially reduced time-lines• Enlarged framework for Compulsory Licence

49

Important Provisions For Public Health Safeguard

Important provisions for public health safeguard

I. Compulsory licensing

II. Parallel Import

III. Pre-grant opposition

IV. “Bolar” Provision/ Research Exception

51

Compulsory licensing

• Article 31 of the TRIPS Agreement

• Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner.

• The patent owner still has rights over the patent, including a right to be paid for the authorized copies of the products.

52

Compulsory licensing

• Normally the person or company applying for a licence has to have tried to negotiate a voluntary licence with the patent holder on reasonable commercial terms. Only if that fails can a compulsory licence be issued.

• For “national emergencies”, “other circumstances of extreme urgency” or “public non-commercial use” (or “government use”) or anti-competitive practices, there is no need to try first for a voluntary licence.

53

Parallel Import

• Products marketed by the patent owner or with the patent owner’s permission in one country and imported into another country without the approval of the patent owner.

• E.g. In Mozambique 100 units of Bayer's ciprofloxacin (500mg) costs US$740, but in India Bayer sells the same drug for US$15 (owing to local generic competition). Mozambique can import the product from India without Bayer's consent.

• “Theory of Exhaustion” of intellectual property rights54

Pre-grant opposition

• Opposition prior to grant of Patent can be made on any ground on which opposition can be made after grant of Patent.

• Personal hearing will also have to be given at pre-grant stage to opponent, if requested.

• 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 55

Bolar Provision• This allow researchers to use a patented invention for

research, in order to understand the invention more fully.

• Some countries allow manufacturers of generic drugs to use the patented invention to obtain marketing approval — for example from public health authorities — without the patent owner’s permission and before the patent protection expires.

• The generic producers can then market their versions as soon as the patent expires. This provision is sometimes called the “regulatory exception”

56

Pharmaceutical Claims For Patent

Types of claimsI. Product claims: i. Pharmaceutical substances: a. New Chemical Entities; b. Formulations/Compositions; c. Combinations/ dosage/dose; d. New forms of known substance such as: Salts, Ethers and Esters; Polymorphs;Solvates, including hydrates;Clahrates;Stereoisomers;Enantiomers;Metabolites and pro-drugs;Conjugates;Pure forms;Particle size;Isomers and mixtures thereof;Complexes;Derivatives of known substances; and

ii. Kitsiii. Product-by-process.

58

Types of claims

II. Claims for process/method of manufacturing;

III. Claims related to new property, new use of known substance or use claims, including second indications;

IV. Claims for method of treatment and/or diagnosis of human beings and animals;

V. Claims related to selection inventions (relating to product and process)

59

Formulations and compositions• The same active ingredient may be

presented in formulations, e.g. as tablets, capsules, ointment or aqueous solutions for parenteral administration.

• New use of known substance or its new use in a pharmaceutical composition is not normally patentable.

60

Combinations

• Combinations claims are rejected unless the combination generates a new and non-obvious synergy or distinct effect.

• If, however, a new and non obvious synergistic effect is considered a basis for patentability, it should be properly demonstrated by biological tests and appropriately disclosed in the patent specifications.

61

Dosage/dose• Some patent applications claim inventions consisting of

the dosage for administration to patients of an existing product, including pediatric dosages.

• Some countries admit patents on dosages under certain circumstances. E.g.UK Guidelines allows for the patenting of a dosage where there is a new medical indication and the dosage is substantially different

62

New forms of known substance

• Salts are normally formed to increase stability or solubility of the drug & it iscommon knowledge in the pharmaceutical field that salts result in different solubility and, therefore, in different bioavailability.

• There may be exceptional cases in which new salts present unexpected advantages in properties as compared to what is in the prior art.

63

Isomers

• Isomers having the same empirical formula but having structural differences may be considered novel and may not normally offend “obviousness” as they are structurally different.

• Stereo Isomers are prima facie obvious. Hence product patent may not be granted for the enantiomers.

64

Metabolites

• A metabolite is unpatentable since giving the drug to a patient naturally and inevitably results in formation of that metabolite.

65

Prodrugs

• The inventive aspects of prodrug may be decided based on the merits of the case.

• However, if there is a marked improvement over the primary drug, prodrugs may be patentable.

inactive active

66

Analogy processes

• Manufacturing processes (often called ‘analogy processes’)

• Non-novel or obvious pharmaceutical processes, regardless of whether the starting materials, intermediaries or the end product are novel or inventive are not patentable as such.

67

Medical use of a product, including first and second indications

• According to TRIPS Agreement, members should be under no obligation to grant use claims, including second indications.

• Claims relating to the use, including the second indication, of a known pharmaceutical product can be refused, inter alia, on grounds of lack of novelty and industrial applicability.

68

Method of treatment

• Some patents claim methods of treatment, including prophylaxis, cure, relief of pain, diagnosis or surgical methods.

• These claims do not cover a product per se, but the way in which it is used in order to obtain certain effects.

• National patent policies considerably differ on this subject and, in some cases, adopt a very expansive approach

• Methods of treatment are deemed non patentable where industrial applicability is required as a condition for patentability.

69

Selection patents• A “selection patent” is a patent under which a single element

or a small segment within a large known group is “selected” and independently claimed based on a particular feature not mentioned in the large group.

• A “selection invention” may be applied for, for instance, when a range of products characterized as having n-carbon atoms has been patented, and later on a patent on a specific range (e.g. C1-C4) is claimed.

• Patent owner may use the selection patent to extend the term of protection for the selected subset

• Selection patents can be denied when the supposed advantage is a property shared by all or nearly all the large group. 70

Markush claims

• Often broad (“generic”) patent claims are drafted covering a family of a large number (sometimes thousands or millions) of possible compounds.

• They may be used to obtain a wide patent coverage including a large number of compounds whose properties have not been tested, but only theoretically inferred from the equivalence with other compounds within the claim.

• E.g. R1 is selected from phenyl, pyridyl, thiazolyl, thioalkyl, alkoxyl and methyl; R2-R3 are methyl, tolyl or phenyl… the compounds are used as a pharmaceutical for increasing the oxygen intake capability of blood.

71

Examination of Markush claims(i) it discloses all the possible embodiments covered under the claimed Markush formula;

(ii) such embodiments share a common use or property;

(iii) such possible embodiments share common structure;

(iv) physical and chemical properties of claimed compound are disclosed;

(v) test conducted for each embodiment is provided;

(vi) at least one process for preparing the compounds is disclosed when more than one processes are claimed.

72

Indian Patent System - Framework

Protection Of Intellectual Property In India (Patents, Designs, Trade Marks & Copyrights)

CONTROLLER GENERAL OF

PATENTS, DESIGNS & TRADE MARKSREGISTAR OF COPYRIGHT

MINISTRY OF COMMERCE & INDUSTRY

MINISTRY OF HUMAN RESOURCE DEVELOPMENT

DEPT. OF EDUCATIONDEPT. OF INDUSTRIAL POLICY & PROMOTION

74

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

AHM’BAD

P.I.S. Nagpur

KOLKATA

PATENT OFFICE

CHENNAI

75

76

office Territorial Jurisdiction

Patent Office Branch, Mumbai Maharashtra ,Gujrat ,Madhya Pradesh , Goa and Chhattisgarh and the Union Territories of Daman and Diu & Dadra and Nagar Haveli.

Patent Office Branch, Chennai AP, Karnataka, kerla , Tamil Nadu , Union Territories of Pondicherry and Lakshadweep,

Patent Office Branch , New Delhi Haryana ,Himachal Prades , J&K ,Punjab ,Rajasthan ,UP ,Uttaranchal , Delhi and Union Territory of Chandigarh

Patent Office , kolkata Rest of India.

STAGES - GRANT OF PATENT

. PUBLICATION OF APPLICATION

PROMPTLY AFTER 18 MONTHS

REQUEST FOR EXAMINATION WITHIN 48 MONTHS FROM F.D

GRANT OF PATENT

REVOCATION / AMENDMENT

POST GRANT OPPOSITION• WITHIN 12 MONTHS

FILING OF APPLICATIONPROVNL. / COMPLETE

DECISION OF CONTROLLER

EXAMINATION: GRANT OR REFUSAL ALL OBJECTIONS TO BE COMPLETED WITHIN 12 MONTHS

APPEAL

APPELLATE BOARD

PRE GRANT OPPOSITIONWITHIN 6 MONTHS

77

References• Guidelines D, Examination F, Patent O, In A, Field T,

Pharmaceuticals O. No Title. • Inventions not Patentable in India. 1962; • Heath C. Parallel Imports and International Trade 1.

1996;661(October 1995):1–13. • Lehman B. The Pharmaceutical Industry and the Patent

System. 2003;1–14. • Intellectual S, Protection P. Pharmaceutical Patents. • Services I. PATENT OPPOSITION SYSTEMS IN. 2008;

78

Indian Pharmaceuticals In Patent Era

The Indian pharmaceutical market (IPM) is valued at 72069 crore INR in 2013 as against 65654 crore INR in 2012.

It has experienced a slowdown with its growth going down to 9.8% from 16.6% in 2012.

R&D expenditure over Rs.1000 crores

Projected exports of domestic pharma products - $4 billion by 2010 $6 billion by 2015

Indian pharmaceutical industry

80

Advantage To Pharma India• Abundant scientific and technical manpower, hence strong

intellectual capital

• Large and diverse patient base to conduct international clinical trials

• US FDA/WHO compliant manufacturing facilities

• Strong base in bulk drugs manufacture

• Entrepreneurial skills

• Cost Competitiveness

81

Indian pharmaceutical companies set to become innovation driven

Boost to Research and Development

Strategies for development: Strategic alliances and partnerships Joint Ventures and In-licensing deals Marketing, Research and Manufacturing tie –ups Collaborative partnerships particularly in the area

of research

Future Of Pharma India

82

Patent laws helps in protecting the IP and thus preventing the duplication as well as indiscriminate/ illegal use of it.

It also helps to reimburse the huge investment & thus promoting more R & D for the advancement of medical field also betterment of patient care.

But at same time non affording and needy patient population may not get the benefit for the early advanced treatment.

With combined approach of pharmaceutical owners and regulators' from government as well as from public sector, we may hope to overcome ever-growing concerns of the effect of patent laws on treatment accessibility to the patients

83

84

References• Information on intellectual property in the WTO, news and

official records of the activities of the TRIPS Council, and details of the WTO’s work with other international organizations in the field, 2014; obtained fromhttp://www.wto.org/english/tratop_e/trips_e/trips_e.htm

• AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS, 2011 :319–51.

• Ghai D. Patent protection and indian pharmaceutical industry. 2010;3(2):43–8.

• Technology I. CHAPTER I AN OVERIVEW OF INTELLECTUAL PROPERTY SYSTEM. :5–45.

85

86

87

88

89

Filing of Application

• 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 90

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

91

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

92

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

93

Examination

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

• Examiner undertakes examination:whether the claimed invention is not prohibited for

grant of patent

whether the invention meets the criteria of patentability

94

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 check 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

95

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

96

Pre-grant Opposition

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

• Opportunity of hearing the opponent is also available

• Opposition (documents) is sent to the applicant

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

97

Grant of a Patent

• A certificate of patent is issued within 7 days

• Grant of patent is published in the official journal

Post grant opposition:• Within 12 months

98

References• Guidelines D, Examination F, Patent O, In A, Field T,

Pharmaceuticals O. No Title. • Inventions not Patentable in India. 1962; • Heath C. Parallel Imports and International Trade 1.

1996;661(October 1995):1–13. • Lehman B. The Pharmaceutical Industry and the Patent

System. 2003;1–14. • Intellectual S, Protection P. Pharmaceutical Patents. • Services I. PATENT OPPOSITION SYSTEMS IN. 2008;

99

Obtaining A Patent