IPR Aspects of Herbal Drugs

IPR ASPECTS OF HERBAL DRUGS

Supriya Ramacha

13

April 2

02

3

AGENDA

1. Analyzing patentability of an invention

Patentability Criteria

Patent searching

2. Obtaining patent rights.

Overview: patent process- patent filing.

© 2

01

2 B

ananaIP

13

April 2

02

3

BACKGROUND- PATENT RIGHTS

Rights of patentee Make Use Sell Offer for sale Import

Negative rights

Term

Jurisdiction

© 2

01

2 B

ananaIP

13

April 2

02

3

ANALYZING PATENTABILITY OF AN INVENTION

© 2

01

2 B

ananaIP

13

April 2

02

3

PATENTABILITY REQUIREMENTS

Patentable subject matter

Utility

Novelty

Non-obviousness / Inventive step

Specification

© 2

01

2 B

ananaIP

13

April 2

02

3

SUBJECT MATTER

Inclusion list – herbal drugs

Product

Process

Apparatus

© 2

01

2 B

ananaIP

13

April 2

02

3

Exclusion list Section 3 and 4

Not patentable examples Medical methods (sec. 3(i)) New form/ new property/ new use of known

substance (sec. 3(d)) Mere admixture (sec. 3(e)) Plants, animals, seeds, varieties, species or any

parts (excl. microbes) (sec. 3(j)) Traditional knowledge (sec. 3(p))

TKDL

© 2

01

2 B

ananaIP

13

April 2

02

3

UTILITY / INDUSTRIAL APPLICABILITY

Industrial application Capable of being made or used in an industry Present use

Relatively one of the easiest requirement to fulfill.

© 2

01

2 B

ananaIP

13

April 2

02

3

NOVELTY

New in light of prior art Prior art: known prior to filing anywhere

Rule - compare one prior art at a time

© 2

01

2 B

ananaIP

13

April 2

02

3

INVENTIVE STEP / NON OBVIOUSNESS

Inventive step Technically advanced / economic significance;

and Not obvious to a person skilled in the art

Person skilled in the art

© 2

01

2 B

ananaIP

13

April 2

02

3

CONT...

Problem-solution approach Identify the problem Proposed solution obvious in light of existing ones

Secondary indications Teaching away Commercial success Copying Praise by experts Unexpected results Long felt need

Rule - combine all relevant prior art references

© 2

01

2 B

ananaIP

13

April 2

02

3

SPECIFICATION

Meet all the guidelines specified in the act

Written description Describe in a detail manner

Best mode Best method of performing the invention

Enablement Capable of being worked independently by a

person having skill in the art

© 2

01

2 B

ananaIP

13

April 2

02

3

EXAMPLE

Invention

Chair with wheels

Prior art

1. Chair

2. Wheels for toys

© 2

01

2 B

ananaIP

13

April 2

02

3

EXAMPLE

Invention

Door knob-porcelain

Prior art

1. Door knob-metal

2. Kitchen utensils- porcelain

© 2

01

2 B

ananaIP

13

April 2

02

3

EXAMPLE

© 2

01

2 B

ananaIP

Invention

thiazolidinedione compound-maleic acid salt

hydrate form

Prior art

thiazolidinedione compound

pharmaceutically acceptable acids (such as

Hydrobromic acid, Hydrochloric acids, methanesulphonic, maleic acids,)

• Patent application No. IN/PCT/2000/00080/MUM M/s. Smithkline Beecham Plc

13

April 2

02

3

Patentable ?

Efficacy ?

© 2

01

2 B

ananaIP

13

April 2

02

3

EXAMPLE

© 2

01

2 B

ananaIP

Mr. Golu files an application in India for a herbal composition used to treat obesity and ulcers :

Caralluma fimbriata extract

Liquorice extract

Priort art 1 A extract for reducing

body weight comprising Caralluma fimbriata extract.

Prior art 2 A method for treating

peptic ulcers by administering liquorice extract

13

April 2

02

3

Patentable? © 2

01

2 B

ananaIP

13

April 2

02

3

TURMERIC CASE

US5401504 Claim: A method of promoting healing of a wound in

a patient, which consists essentially of administering a wound-healing agent consisting of an effective amount of turmeric powder to said patient.

© 2

01

2 B

ananaIP

13

April 2

02

3

PATENTABILITY CRITERIA MET

© 2

01

2 B

ananaIP

Fig: Kalyan’s Patent filter model

13

April 2

02

3

PRACTICAL PERSPECTIVE – OBTAINING A PATENT All requirements can broadly be classified under 3 stages

Stage 1 – Pre-search stage Subject matter Utility

Stage 2 - Patentability assessment-Patent search and analysis Novelty Non-obviousness

Stage 3 - Application drafting and filing Specification

Written description Enablement

© 2

01

2 B

ananaIP

PATENT SEARCH

13

April 2

02

3

PRACTICAL SCENARIO

Patentability Analysis invention in hand

Landscape Analysis conceptualization

© 2

01

2 B

ananaIP

13

April 2

02

3

Resources: Patent databases

Methodology Keyword search Classification search

© 2

01

2 B

ananaIP

13

April 2

02

3

OBTAINING A PATENT PATENT PROCESS - OVERVIEW

© 2

01

2 B

ananaIP

13

April 2

02

3

PATENT FILING

Patent Application Provisional application Complete application

Priority date-filing date of the first application in the chain of applications

© 2

01

2 B

ananaIP

Filing in India

Was the filing a complete or a provisional?

File the complete specification (12 months)

Provisional

Complete

Publishing (18 months*)

Request for examination (48 months)

Examination

Examiner decision (grant/refusal)

Indian Patent Process

*Can be reduced to 2 months by filing a RFP

13

April 2

02

3

Thank You

For More Details Visit

www.bananaip.com

Blog: www.bananaip.com/sinapse-blog

Email: [email protected]

© 2

01

2 B

ananaIP