Mumbai

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India-Chem 2006
Strategic Alliances in Generic Marketing

by Dilip G Shah Secretary General Indian
Pharmaceutical Alliance
Mumbai November 9, 2006
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Strategic Alliances in Generic Marketing
Outline of Presentation

• Critical Issues Affecting Generic Markets
• Regulatory IPR Hurdles
• Marketing in Diverse Environment

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Critical Issues Affecting Generic Markets
Challenges

• Price Erosion Less in Value Added Segments
• Fewer New Products
• Resistance to Pathways for Biosimilars

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Critical Issues Affecting Generic Markets
Opportunities

• Strong Primary Care to Drive Long Term Generic
  Potential
• Low Cost Manufacturing to Maintain Sustainable
  Margins
• Specialists and Speciality Products to Drive
  Growth
• Emergence of Chindia

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Critical Issues Affecting Generic Markets
Response

• Penetration of Harvested Markets
• Rapid Harvesting of New Markets
• Sharing Cost of Development
• Facing IPR Litigations

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Regulatory IPR Hurdles

• Regulatory Barriers Growing Complexities
• Patent Proliferation Risking Litigations
• Data Exclusivity Denying Entry

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Regulatory IPR Hurdles
Regulatory Barriers Growing Complexities (Illustr
ative, Not Exhaustive)

• Use of INNs for Biosimilar Products
• Pedigree of Intermediates
• Disparity Between Domestic and Foreign Plants

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Regulatory IPR Hurdles
Patent Proliferation Risking Litigations (Illustr
ative, Not Exhaustive)
Polymorphs

• Polymorphs are substances with the same chemical
  formula and biological activity. However, the
  arrangement of the molecules in the crystal
  lattice differs, which may result in some
  physical characteristics like solubility, melting
  point and stability differing.

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Regulatory IPR Hurdles
Patent Proliferation Risking Litigations (Illustr
ative, Not Exhaustive)
Polymorphs
Product Ribavarin (REBETOL) Innovator
Schering 1st Patent US 3,798,209
filed on 1 June 1971 Marketing Approval 3 June
1998 Polymorph Patent US 6,051,252 to
Schering on 18 April 2000 Claim 1 A Compacted
Ribavarin Composition Substantially free of
other Ribavarin Polymorphic Forms
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Regulatory IPR Hurdles
Patent Proliferation Risking Litigations (Illustr
ative, Not Exhaustive)
Polymorphs
Product Donepezil Hydrochloride
(ARICEPT) Innovator Eisai 1st Patent
US 4,895,841 Filed on 20 June 1988 Marketing
Approval 25 November 1996 Polymorph Patent
US 6,140,321 to Eisai on 31 October 2000 Claim
1 Form III of Donepezil Hydrochloride, which is
the Marketed Form
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Regulatory IPR Hurdles
Patent Proliferation Risking Litigations (Illustr
ative, Not Exhaustive)
Substantially Pure
Patents are often obtained for the compound
without any reference to purity. Thereafter, a
patent is sought for a Substantially Pure
compound. The later obtained patent becomes a
block for generic companies, as it is well known
that pharmaceutical products have to be
Substantially Pure.
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Regulatory IPR Hurdles
Patent Proliferation Risking Litigations (Illustr
ative, Not Exhaustive)
Substantially Pure
Product Fexofenadine Hydrochloride
(ALLEGRA) Innovator Aventis 1st
Patent US 4,254,129 Filed on 10 April
1979 Marketing Approval 25 July 1996 Pure
Product Patent US 5,578,610 on 26 November
1996 Claim 1 Substantially Pure compound,
which is the product on the market
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Regulatory IPR Hurdles
Patent Proliferation Risking Litigations (Illustr
ative, Not Exhaustive)
Substantially Pure
Product Ondansetron Hydrochloride
(ZOFRAN) Innovator Glaxosmithkline
Compound Patent US 4,695,578 Filed on 17
November 1986 Marketing Approval 4 January
1991 Pure Product Appln WO 02/055492 A2 Filed
by Teva 11 January 2002 Claim 1
Ondansetron Hydrochloride having a purity of at
least 99.0 (Generic Companies are also
attempting to block other generic companies to
limit competition)
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Regulatory IPR Hurdles
Data Exclusivity Denying Entry (Illustrative,
Not Exhaustive)

• UK High Court Invalidated Patent for Seretide
• but Data Exclusivity Denied Entry of Generic
• European Commission Confirmed that CL
• Will Not Override Data Exclusivity for
  Tamiflu

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Marketing in Diverse Environment
Key to Success

• Thinking Global, Acting Local
• Access to Specialists Speciality Products
• Insight into Business Practises

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Marketing in Diverse Environment
World Audited Market - 2005
7.1
Source IMS Health MIDAS, MAT March 2005
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Marketing in Diverse Environment
World Generics Market - 2008
Source IMS Health, The European Generic
Medicines Association, The Canadian Generic
Pharmaceutical Association William Blair
Company, LLC Estimates Compiled by William Blair
Company 2004
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Strategic Alliances in Generic Marketing
Summing Up

• Global Giants Have Enormous Strength
• Generics Have Meagre Resources
• Pulling Together Makes Sense

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THANK YOU
dgshah_at_vision-india.com
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