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.
MERGERS & ACQUISITIONS INTRODUCTION • In last 10 years, 1345 Deals worth M&ADRUG 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
DRUG DERIVATIVES INTRODUCTION • Enantiomers M&ADRUG DERIVATIVES • Salt FormBOLAR EXCEPTION • Chemical Derivatives PATENT LINKAGEDATA EXCLUSIVITY • Fixed Dose Combinations COMPULSORY LICENCING • Secondary Use Patent CONCLUSION
Patent Marketing PatentGranted 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
DRUG DERIVATIVES INTRODUCTION • Glivec (Novartis): M&A Imatinib salt form Imatinib mesylateDRUG DERIVATIVES 1993* 17 Jul 1998BOLAR 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)
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 aDRUG DERIVATIVES known substance which does not result inBOLAR 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 knownDATA EXCLUSIVITY process, machine or apparatus unless such process results in a new product or employs at COMPULSORY least one new reactant. LICENCING CONCLUSION
BOLAR EXCEPTION INTRODUCTION • It permits use of patented M&ADRUG DERIVATIVES products in experiments to proveBOLAR EXCEPTION Bioequivalence for the purpose of PATENT LINKAGE obtaining marketing approval ofDATA EXCLUSIVITY generics. COMPULSORY LICENCING CONCLUSION
ANDANDA ( New Patent Patent Expires (AbbreviatedDrug Appln) Granted NDA) Bioequivalence No Patent Protection, EMR EVERGREENING but still market monopoly
BOLAR EXCEPTION INTRODUCTION • Roche Product Inc v Bolar M&A Pharmaceuticals company:DRUG DERIVATIVES – Valium used in experiments beforeBOLAR 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
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 reasonablyDATA 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
PATENT LINKAGE INTRODUCTION • In Patent Linkage, Generic M&ADRUG DERIVATIVES Marketing Approval is “Linked” toBOLAR 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.
PATENT LINKAGE INTRODUCTION • Bristol-Myers Sqibb v Hetero Drugs Ltd: M&A Sprycel (Dasatinib) for Chronic MyeloidDRUG 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.
PATENT LINKAGE INTRODUCTION • TRIPS Article 33- Term of Protection: M&A – The term of protection available shallDRUG DERIVATIVES not end before the expiration of aBOLAR 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
DATA EXCLUSIVITY INTRODUCTION • Protection of clinical trial and other M&A test data which drug companies areDRUG DERIVATIVESBOLAR EXCEPTION required to generate and provide to PATENT LINKAGE national drug approval agencies inDATA EXCLUSIVITY order to achieve marketing approval COMPULSORY for a particular drug in a particular LICENCING country. CONCLUSION
Patent Marketing PatentGranted Approval in Expires 2007 Clinical Trials Data Exclusivity Generics’ Entry
Patent Marketing PatentGranted Approval in Expires 2007 Clinical Trials Data Bioequivalence Exclusivity Generics’ Studies Entry No Patent Protection, EMR EVERGREENING but still market monopoly
DATA EXCLUSIVITY Country Period (Yrs) INTRODUCTION Panama 10 M&ADRUG DERIVATIVES EU 10BOLAR EXCEPTION USA 7 PATENT LINKAGE China 6DATA EXCLUSIVITY Colombia 5 COMPULSORY LICENCING Brazil 5 CONCLUSION Egypt 5
DATA EXCLUSIVITY INTRODUCTION • TRIPS Article 39.3: M&A – Members when requiring, as theDRUG DERIVATIVES condition of approving the marketingBOLAR EXCEPTION of pharmaceuticals which utilise new chemical entities, the submission of PATENT LINKAGE undisclosed test or other data, theDATA EXCLUSIVITY origination of which involves a COMPULSORY considerable efforts, shall protect such LICENCING data against unfair commercial use. CONCLUSION
COMPULSORY LICENCING INTRODUCTION • Compulsory licensing is when the M&A government allows someone else toDRUG DERIVATIVES produce the patented product orBOLAR 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
COMPULSORY LICENCING INTRODUCTION • Approaching Innovator Company for M&A 1. Licence and offer them Royalty.DRUG DERIVATIVESBOLAR 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.
COMPULSORY LICENCING INTRODUCTION • Natco: M&ADRUG 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
COMPULSORY LICENCING INTRODUCTION • Section 84 (c) of Indian Patent Act: M&A – Reasonable requirements of the publicDRUG DERIVATIVES with respect to a patented inventionBOLAR EXCEPTION shall not be met if the patentee refuses to issue a licence on PATENT LINKAGE reasonable terms and which mayDATA EXCLUSIVITY prejudice the establishment or COMPULSORY development of commercial activity in LICENCING India. CONCLUSION
CONCLUSION INTRODUCTION • Public Interest Vs Incentives for M&ADRUG DERIVATIVES InnovationBOLAR EXCEPTION • Protecting IPR. PATENT LINKAGEDATA EXCLUSIVITY • Make your own choice. COMPULSORY LICENCING CONCLUSION