INCREMENTAL INNOVATION

SUBMITTED BY
SHALINI RAO

NISHA RK
NIKITA GANGWANI SAISH KAMBLE HIREN JANI RONAK SHAH

Innovation
Innovation is the creation of better or more effective products, processes, services, technologies, or ideas that are accepted by markets, governments, and society.

Types of Innovation
Radical Innovation Incremental Innovation

Radical Innovation
Technological knowledge required to exploit it is very different from existing knowledge, existing knowledge will be obsolete

Radical Innovation(cont..)

Radical Innovation(cont..)
Anti-diabetic medication(OHA) : Biguanides Eg: Phenformin Sulfonylureas Eg: tolbutamide (First-generation agents )

Incremental Innovation
The knowledge required to offer a product builds on existing knowledge. Most innovation is incremental

Incremental Innovation(cont..)

Incremental Innovation(cont..)
Anti-diabetic medication(OHA) : Biguanides Metformin Buformin Sulfonylureas
Glipizide(Second-generation agents)

INCREMENTAL
An

RADICAL

incremental innovation will build upon existing knowledge and resources within a certain company competence-enhancing

A radical innovation, on the other hand, will require completely new knowledge and/or resources competence-destroying.

deals with different versions deals with NCEs altogether of the same drug having better efficacy, safety etc. Lovastatin was the first statin to be launched in the If oral insulin pills were to be market launched they would be an

Pros and cons of Incremental Innovation with respect to the Indian Pharmaceutical Scenario

Pros
Improves quality of drug products Eg: Heat stable insulin which will remain stable in the Indian climate Development of treatment for diseases prevalent in India such as TB, Malaria etc. Increasing the treatment option within a given therapeutic class. Enables Indian Pharmaceutical Companies to develop their innovation expertise. Important source of revenue for Indian Pharmaceutical Companies to become leaders in the discovery of new compounds. Reduces healthcare and other social costs in India by improving quality and selection of drug products. Increase drug price competition in India, and thus reduce price competition in India- which will in turn help the Indian Generic Industry.

Cons
There is an ambiguity in the definition of efficacy. India is a Product Patent Country- strong R&D required. Deters people from filing patents pertaining to incremental innovations in India. Similar to Evergreening by MNCs. Cure for diseases such as HIV AIDS cannot be done through incremental innovation.

NOVARTIS

C L A S H O F

SECTION 3(d)

OPPI

T H E
T I T A N S

IPA

INCREMENTAL INNOVATION
INTERNATIONAL

INCREMENTAL INNOVATION INDIA

CLASH OF THE TITANS NOVARTIS V/S SECTION 3(d)

28th MARCH 2012 WILL SHOW CLIMAX OF THE EPIC BATTLE AND WILL SEAL THE FATE OF SECTION 3(d) PREQUEL TO THE DISPUTE RATIONALE FOR REJECTION OF PATENT APPEAL BY NOVARTIS IN MADRAS HIGH COURT 1.A reversal of the Assistant Controllers rejection of Novartis application 2. An order declaring Section 3(d) unconstitutional 3. Violation of TRIPS STAND TAKEN BY MADRAS HIGH COURT WHY EFFICACY MURDERED NOVARTIS DREAM ?????

CLASH OF THE TITANS NOVARTIS V/S SECTION 3(d)

28th MARCH 2012 WILL SHOW CLIMAX OF THE EPIC BATTLE AND WILL SEAL THE FATE OF SECTION 3(d) PREQUEL TO THE DISPUTE RATIONALE FOR REJECTION OF PATENT APPEAL BY NOVARTIS IN MADRAS HIGH COURT 1.A reversal of the Assistant Controllers rejection of Novartis application 2. An order declaring Section 3(d) unconstitutional 3. Violation of TRIPS STAND TAKEN BY MADRAS HIGH COURT WHY EFFICACY MURDERED NOVARTIS DREAM ?????

CLASH OF THE TITANS NOVARTIS V/S SECTION 3(d)

28th MARCH 2012 WILL SHOW CLIMAX OF THE EPIC BATTLE AND WILL SEAL THE FATE OF SECTION 3(d) PREQUEL TO THE DISPUTE RATIONALE FOR REJECTION OF PATENT APPEAL BY NOVARTIS IN MADRAS HIGH COURT 1.A reversal of the Assistant Controllers rejection of Novartis application 2. An order declaring Section 3(d) unconstitutional 3. Violation of TRIPS STAND TAKEN BY MADRAS HIGH COURT WHY EFFICACY MURDERED NOVARTIS DREAM ?????

CLASH OF THE TITANS NOVARTIS V/S SECTION 3(d)

28th MARCH 2012 WILL SHOW CLIMAX OF THE EPIC BATTLE AND WILL SEAL THE FATE OF SECTION 3(d) PREQUEL TO THE DISPUTE RATIONALE FOR REJECTION OF PATENT APPEAL BY NOVARTIS IN MADRAS HIGH COURT 1.A reversal of the Assistant Controllers rejection of Novartis application 2. An order declaring Section 3(d) unconstitutional 3. Violation of TRIPS STAND TAKEN BY MADRAS HIGH COURT WHY EFFICACY MURDERED NOVARTIS DREAM ?????

CLASH OF THE TITANS NOVARTIS V/S SECTION 3(d)

28th MARCH 2012 WILL SHOW CLIMAX OF THE EPIC BATTLE AND WILL SEAL THE FATE OF SECTION 3(d) PREQUEL TO THE DISPUTE RATIONALE FOR REJECTION OF PATENT APPEAL BY NOVARTIS IN MADRAS HIGH COURT 1.A reversal of the Assistant Controllers rejection of Novartis application 2. An order declaring Section 3(d) unconstitutional 3. Violation of TRIPS STAND TAKEN BY MADRAS HIGH COURT WHY EFFICACY MURDERED NOVARTIS DREAM ?????

CLASH OF THE TITANS NOVARTIS V/S SECTION 3(d)

28th MARCH 2012 WILL SHOW CLIMAX OF THE EPIC BATTLE AND WILL SEAL THE FATE OF SECTION 3(d) PREQUEL TO THE DISPUTE RATIONALE FOR REJECTION OF PATENT APPEAL BY NOVARTIS IN MADRAS HIGH COURT 1.A reversal of the Assistant Controllers rejection of Novartis application 2. An order declaring Section 3(d) unconstitutional 3. Violation of TRIPS STAND TAKEN BY MADRAS HIGH COURT WHY EFFICACY MURDERED NOVARTIS DREAM ?????

SECTION 3(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 or the 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

The Explanation that accompanies Section 3(d) states: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

CLASH OF THE TITANS NOVARTIS V/S SECTION 3(d)

28th MARCH 2012 WILL SHOW CLIMAX OF THE EPIC BATTLE AND WILL SEAL THE FATE OF SECTION 3(d) PREQUEL TO THE DISPUTE RATIONALE FOR REJECTION OF PATENT APPEAL BY NOVARTIS IN MADRAS HIGH COURT 1.A reversal of the Assistant Controllers rejection of Novartis application 2. An order declaring Section 3(d) unconstitutional 3. Violation of TRIPS STAND TAKEN BY MADRAS HIGH COURT WHY EFFICACY MURDERED NOVARTIS DREAM ?????

Mashelkar report Raghunath Anant Mashelkar Former Director General of the (CSIR) Reason for Mashelkar report

History of the Mashelkar Committee Report

Main highlights
Article 27 of TRIPS Preventing Evergreening Encouraging Incremental Innovation Section 3(d) Examination

Patenting of Micro-organisms

Rejections under section 3(d)

1. Pfizer's Applications Claiming Caduet

2. Glaxo's Application for Rosiglitazone Salt 3. Gilead's application for the Tamiflu drug (Oseltamavir)

MASHELKAR REPORT
Drug makers criticise Mashelkar committee's report Analysis of the report Conclusion

Conclusion
Importance of radical innovation Leading hub of global innovation Provides right incentives

Development of drug Products

Encourage and protect in incremental pharmaceutical innovation

SUGGESTIONS
Define Efficacy Reform section 3(d) People with pharmacological background in indian patent office