Here are some examples of evergreening by Pharma companies illustrated with timeline. It's Indian perspective.

1. EVERGREENING
Presented by: Pokale Rahul

2. INTRODUCTION
INTRODUCTION Evergreening: Variety of legal and
M&A business strategies concerning:
DRUG DERIVATIVES • Patents about to expire.
BOLAR EXCEPTION
• Retaining the patent by various
PATENT LINKAGE tactics.
DATA EXCLUSIVITY
• Retaining market monopoly.
COMPULSORY
LICENCING • Buying out or frustrating
CONCLUSION competitors.

3. MERGERS & ACQUISITIONS
INTRODUCTION
• In last 10 years, 1345 Deals worth
M&A
DRUG DERIVATIVES
$694 B were inked.
BOLAR EXCEPTION • Suppression of Competitive
PATENT LINKAGE
Business.
DATA EXCLUSIVITY
COMPULSORY • In India 100% FDI allowed in
LICENCING
Pharma Sector.
CONCLUSION

4. MERGERS & ACQUISITIONS
INTRODUCTION Acquisition of Acquisition By Worth (Billion $)
M&A
Wheth Pfizer 68
DRUG DERIVATIVES
BOLAR EXCEPTION Ranbaxy Daiichi Sankyo 4.8
PATENT LINKAGE
Piramal Healthcare. Ltd Abbott 3.7
DATA EXCLUSIVITY
COMPULSORY Ratiopharm, Ivax, Barr Teva Pharmaceuticals 19.8
LICENCING Pharmaceuticals
CONCLUSION Genentech Roche 46.8

5. DRUG DERIVATIVES
INTRODUCTION
• Enantiomers
M&A
DRUG DERIVATIVES • Salt Form
BOLAR EXCEPTION
• Chemical Derivatives
PATENT LINKAGE
DATA EXCLUSIVITY • Fixed Dose Combinations
COMPULSORY
LICENCING
• Secondary Use Patent
CONCLUSION

6. Patent Marketing
Patent
Granted Approval in
Expires
2007
12 YEARS 20 YEARS YEARS
23 8 YEARS 11 YEARS3YEARS
8 YEARS
Crystalline EVERGREENING
Marketing
Patent
Expires in
Form in
Approval 2018
1998

7. DRUG DERIVATIVES
INTRODUCTION • Glivec (Novartis):
M&A Imatinib salt form Imatinib mesylate
DRUG DERIVATIVES
1993* 17 Jul 1998
BOLAR EXCEPTION
PATENT LINKAGE
• Lipitor (Pfizer):
DATA EXCLUSIVITY
Atorvastatin
COMPULSORY June 2011# Lawsuits Nov 2011
LICENCING crystalline form 2016, 2017
CONCLUSION fixed dose comb. 2018
(*Approval Dates) (# Patent Expiry)

8. DRUG DERIVATIVES
INTRODUCTION • Section 3d of Indian Patent Act:
M&A (In accordance with Article 27 of TRIPS)
It states: The mere discovery of a new form of a
DRUG DERIVATIVES known substance which does not result in
BOLAR EXCEPTION increased efficacy of that substance or the mere
discovery of any new property or new use for a
PATENT LINKAGE
known substance or of the mere use of a known
DATA EXCLUSIVITY process, machine or apparatus unless such
process results in a new product or employs at
COMPULSORY
least one new reactant.
LICENCING
CONCLUSION

9. BOLAR EXCEPTION
INTRODUCTION
• It permits use of patented
M&A
DRUG DERIVATIVES
products in experiments to prove
BOLAR EXCEPTION Bioequivalence for the purpose of
PATENT LINKAGE obtaining marketing approval of
DATA EXCLUSIVITY generics.
COMPULSORY
LICENCING
CONCLUSION

10. ANDA
NDA ( New
Patent
Patent Expires
(Abbreviated
Drug Appln)
Granted
NDA)
Bioequivalence
No Patent Protection, EMR
EVERGREENING
but still market monopoly

11. BOLAR EXCEPTION
INTRODUCTION • Roche Product Inc v Bolar
M&A Pharmaceuticals company:
DRUG DERIVATIVES – Valium used in experiments before
BOLAR EXCEPTION patent expiry to prove bioequivalance
PATENT LINKAGE
for ANDA.
DATA EXCLUSIVITY • Bayer Corporation v Cipla:
COMPULSORY – Delhi High Court on 18th Aug 2009.
LICENCING – Drug - Soranib
CONCLUSION

12. BOLAR EXCEPTION
INTRODUCTION • Section 107a of Indian Patent Act
M&A (Amended in May 2003):
DRUG DERIVATIVES (Similar to 271-e-1 of Hatch Waxman Act)
BOLAR EXCEPTION
It states: Certain acts will not be deemed
to amount to patent infringement if they
PATENT LINKAGE are performed "solely for uses reasonably
DATA EXCLUSIVITY related to development and submission of
COMPULSORY information required to obtain regulatory
LICENCING approval for the manufacture, construction,
use, sale or import of any product ”
CONCLUSION

13. PATENT LINKAGE
INTRODUCTION
• In Patent Linkage, Generic
M&A
DRUG DERIVATIVES
Marketing Approval is “Linked” to
BOLAR EXCEPTION the Expiration of the Pioneer Drug
PATENT LINKAGE Patent.
DATA EXCLUSIVITY
COMPULSORY
• Drug Approving Authority (e.g.
LICENCING DCGI, FDA) have to monitor for
CONCLUSION drug infringement.

14. PATENT LINKAGE
INTRODUCTION • Bristol-Myers Sqibb v Hetero Drugs Ltd:
M&A Sprycel (Dasatinib) for Chronic Myeloid
DRUG DERIVATIVES Leukemia.
BOLAR EXCEPTION – Delhi High Court’s Ruling on 19th Dec 2008
PATENT LINKAGE supported Patent Linkage.
DATA EXCLUSIVITY • Bayer Corporation v Cipla, UoI: Soranib
COMPULSORY (Sorefenib tosylate) for Renal Cancer.
LICENCING – Delhi High Court Ruled against Bayer
CONCLUSION disapproving Patent Linkage and
sponsoring Bolar Exception.

15. PATENT LINKAGE
INTRODUCTION
• TRIPS Article 33- Term of Protection:
M&A
– The term of protection available shall
DRUG DERIVATIVES
not end before the expiration of a
BOLAR EXCEPTION
period of twenty years counted from
PATENT LINKAGE
the filing date.
DATA EXCLUSIVITY
COMPULSORY • US- Orange Book
LICENCING
CONCLUSION
• India- www.cdsco.nic.in

16. DATA EXCLUSIVITY
INTRODUCTION
• Protection of clinical trial and other
M&A
test data which drug companies are
DRUG DERIVATIVES
BOLAR EXCEPTION
required to generate and provide to
PATENT LINKAGE national drug approval agencies in
DATA EXCLUSIVITY order to achieve marketing approval
COMPULSORY for a particular drug in a particular
LICENCING
country.
CONCLUSION

17. Patent Marketing
Patent
Granted Approval in
Expires
2007
Clinical Trials Data
Exclusivity Generics’
Entry

18. Patent Marketing
Patent
Granted Approval in
Expires
2007
Clinical Trials Data Bioequivalence
Exclusivity Generics’
Studies
Entry
No Patent Protection, EMR
EVERGREENING
but still market monopoly

19. DATA EXCLUSIVITY
Country Period (Yrs)
INTRODUCTION
Panama 10
M&A
DRUG DERIVATIVES EU 10
BOLAR EXCEPTION USA 7
PATENT LINKAGE
China 6
DATA EXCLUSIVITY
Colombia 5
COMPULSORY
LICENCING Brazil 5
CONCLUSION
Egypt 5

20. DATA EXCLUSIVITY
INTRODUCTION • TRIPS Article 39.3:
M&A – Members when requiring, as the
DRUG DERIVATIVES condition of approving the marketing
BOLAR EXCEPTION of pharmaceuticals which utilise new
chemical entities, the submission of
PATENT LINKAGE
undisclosed test or other data, the
DATA EXCLUSIVITY origination of which involves a
COMPULSORY considerable efforts, shall protect such
LICENCING data against unfair commercial use.
CONCLUSION

21. COMPULSORY LICENCING
INTRODUCTION • Compulsory licensing is when the
M&A government allows someone else to
DRUG DERIVATIVES produce the patented product or
BOLAR EXCEPTION process without the consent of the
PATENT LINKAGE patent owner.
DATA EXCLUSIVITY • Took effect in Jan 1995 as per TRIPS.
COMPULSORY • Paragraph 6 of Doha Declaration
LICENCING
endorsed it.
CONCLUSION

22. COMPULSORY LICENCING
INTRODUCTION
• Approaching Innovator Company for
M&A
1. Licence and offer them Royalty.
DRUG DERIVATIVES
BOLAR EXCEPTION
PATENT LINKAGE
• Approach Government for
2. Compulsory Licence.
DATA EXCLUSIVITY
COMPULSORY
LICENCING • Production for Domestic Use or
CONCLUSION
3. Export to Least Developed countries.

23. COMPULSORY LICENCING
INTRODUCTION
• Natco:
M&A
DRUG DERIVATIVES
– Nexavar ( Bayer)
BOLAR EXCEPTION Sorafenib tosylate: Jan 07
PATENT LINKAGE – Celcentri (Viiv)
DATA EXCLUSIVITY
Maraviroc: Nov 09
COMPULSORY
LICENCING Viiv: Collaboration of GSK and Pfizer.
CONCLUSION

24. COMPULSORY LICENCING
INTRODUCTION • Section 84 (c) of Indian Patent Act:
M&A – Reasonable requirements of the public
DRUG DERIVATIVES with respect to a patented invention
BOLAR EXCEPTION shall not be met if the patentee
refuses to issue a licence on
PATENT LINKAGE
reasonable terms and which may
DATA EXCLUSIVITY prejudice the establishment or
COMPULSORY development of commercial activity in
LICENCING India.
CONCLUSION

25. CONCLUSION
INTRODUCTION
• Public Interest Vs Incentives for
M&A
DRUG DERIVATIVES
Innovation
BOLAR EXCEPTION • Protecting IPR.
PATENT LINKAGE
DATA EXCLUSIVITY
• Make your own choice.
COMPULSORY
LICENCING
CONCLUSION