EVERGREENING

Presented by: Pokale Rahul

INTRODUCTIONEvergreening: Variety of legal and

business strategies concerning:• Patents about to expire.• Retaining the patent by various tactics.• Retaining market monopoly.• Buying out or frustrating competitors.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

MERGERS & ACQUISITIONS

• In last 10 years, 1345 Deals worth $694 B were inked.

• Suppression of Competitive Business.

• In India 100% FDI allowed in Pharma Sector.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

MERGERS & ACQUISITIONSAcquisition of Acquisition By Worth (Billion $)

Wheth Pfizer 68

Ranbaxy Daiichi Sankyo 4.8

Piramal Healthcare. Ltd Abbott 3.7

Ratiopharm, Ivax, Barr Pharmaceuticals

Teva Pharmaceuticals 19.8

Genentech Roche 46.8

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

DRUG DERIVATIVES• Enantiomers• Salt Form• Chemical Derivatives• Fixed Dose Combinations• Secondary Use Patent

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

Marketing Approval

Patent Granted

Marketing Approval in

2007

Patent Expires

Crystalline Form in

1998

Patent Expires in

2018

8 YEARS12 YEARS 8 YEARS11 YEARS20 YEARS23 YEARS 3YEARS

EVERGREENING

DRUG DERIVATIVES• Glivec (Novartis):

Imatinib salt form Imatinib mesylate 1993* 17 Jul 1998

• Lipitor (Pfizer):AtorvastatinJune 2011# Lawsuits Nov 2011

crystalline form 2016, 2017 fixed dose comb. 2018

(*Approval Dates) (# Patent Expiry)

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

DRUG DERIVATIVES• Section 3d of Indian Patent Act:

(In accordance with Article 27 of TRIPS)It states: The mere discovery of a new form of a known substance which does not result in increased 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 process results in a new product or employs at least one new reactant.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

BOLAR EXCEPTION• It permits use of patented

products in experiments to prove Bioequivalence for the purpose of obtaining marketing approval of generics.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

Patent Granted Patent Expires

NDA ( New Drug Appln)

ANDA (Abbreviated

NDA)

BioequivalenceBioequivalenceBioequivalence

EVERGREENINGNo Patent Protection, EMR but still market monopoly

BOLAR EXCEPTION• Roche Product Inc v Bolar

Pharmaceuticals company:– Valium used in experiments before

patent expiry to prove bioequivalance for ANDA.

• Bayer Corporation v Cipla:– Delhi High Court on 18th Aug 2009.– Drug - Soranib

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

BOLAR EXCEPTION• Section 107a of Indian Patent Act (Amended in

May 2003):(Similar to 271-e-1 of Hatch Waxman Act)It states: Certain acts will not be deemed to amount to patent infringement if they are performed "solely for uses reasonably related to development and submission of information required to obtain regulatory approval for the manufacture, construction, use, sale or import of any product ”

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

PATENT LINKAGE• In Patent Linkage, Generic

Marketing Approval is “Linked” to the Expiration of the Pioneer Drug Patent.

• Drug Approving Authority (e.g. DCGI, FDA) have to monitor for drug infringement.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

PATENT LINKAGE• Bristol-Myers Sqibb v Hetero Drugs Ltd:

Sprycel (Dasatinib) for Chronic Myeloid Leukemia.– Delhi High Court’s Ruling on 19th Dec 2008

supported Patent Linkage.• Bayer Corporation v Cipla, UoI: Soranib

(Sorefenib tosylate) for Renal Cancer.– Delhi High Court Ruled against Bayer

disapproving Patent Linkage and sponsoring Bolar Exception.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

PATENT LINKAGE• TRIPS Article 33- Term of Protection: – The term of protection available shall

not end before the expiration of a period of twenty years counted from the filing date.

• US- Orange Book• India- www.cdsco.nic.in

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

DATA EXCLUSIVITY• Protection of clinical trial and other

test data which drug companies are required to generate and provide to national drug approval agencies in order to achieve marketing approval for a particular drug in a particular country.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

Patent Granted

Marketing Approval in

2007

Patent Expires

Clinical TrialsGenerics’

Entry

Data Exclusivity

Patent Granted

Marketing Approval in

2007

Patent Expires

Clinical TrialsGenerics’

Entry

Data Exclusivity

Bioequivalence Studies

No Patent Protection, EMR but still market monopolyEVERGREENING

DATA EXCLUSIVITYCountry Period (Yrs)

Panama 10

EU 10

USA 7

China 6

Colombia 5

Brazil 5

Egypt 5

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

DATA EXCLUSIVITY• TRIPS Article 39.3:– Members when requiring, as the condition

of approving the marketing of pharmaceuticals which utilise new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable efforts, shall protect such data against unfair commercial use.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

COMPULSORY LICENCING• Compulsory licensing is when the

government allows someone else to produce the patented product or process without the consent of the patent owner.

• Took effect in Jan 1995 as per TRIPS.• Paragraph 6 of Doha Declaration

endorsed it.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

COMPULSORY LICENCING

1.

•Approaching Innovator Company for Licence and offer them Royalty.

2.

•Approach Government for Compulsory Licence.

3.

•Production for Domestic Use or Export to Least Developed countries.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

COMPULSORY LICENCING• Natco:– Nexavar ( Bayer)

Sorafenib tosylate: Jan 07– Celcentri (Viiv)

Maraviroc: Nov 09Viiv: Collaboration of GSK and Pfizer.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

COMPULSORY LICENCING• Section 84 (c) of Indian Patent Act:– Reasonable requirements of the public

with respect to a patented invention shall not be met if the patentee refuses to issue a licence on reasonable terms and which may prejudice the establishment or development of commercial activity in India.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION

CONCLUSION• Public Interest Vs Incentives for

Innovation• Protecting IPR.• Make your own choice.

INTRODUCTION

M & A

DRUG DERIVATIVES

BOLAR EXCEPTION

PATENT LINKAGE

DATA EXCLUSIVITY

COMPULSORY LICENCING

CONCLUSION