RA/IPR Committee KRPIA GM Meeting Seoul Club Mar 30, 2011

RA & IPR Committee Organization RA Committee Leader Inhwa Choi (Roche) BOD Sponsors Peter Jager (Novartis) Ki Hwan Park (UCB) Co-Leader Harriet Min (UCB) BS/CSA HR Bang(Abbott) SY Park(Bayer) NDA EJ Lim(Pfizer) OY Kim(Novartis) Quality YH Choi(Lilly) SJ Lee (GSK) PAM BI Kang(SA) KS Jang (Merck) EJ Shin(Pfizer) Biologics HN Park (MSD) HJ Kang(Roche) Regulatory Affairs Associates from Member companies IPR KRPIA Leader In-Sook Ju (KRPIA) Link with BODs. Support, report, coordination. Link with KRPIA executives. Communication i/e, actions’ follo w up, budget control. Chairing meetings and coordinating subcommittees according to action plan and coming issues Sponsor HK Cho (BMS) Sponsor YS Jeong(AZ) Sponsor HS Kim (Pfizer) Sponsor IH Choi (Roche) Sponsor Harriet Min(UCB) MH Doo(Janssen) KH Park(Servier) KRPIA Sponsor Weon Do(SA)

3KRPIA  Ensure timely registration of ND & IND through rules and practices consistent with global standards  Ensure full enforcement of DE & PL  Ensure effective influence on ongoing policy issues aligned with industry position  Strengthen collaborative partnership with KFDA 2011 RA & IPR Committee Priority Objectives

RA & IPR 2011 Plans Priority ObjectiveAction plans of sub-committeeKey Deliverables  Ensure timely registration of ND & IND through rules and practices consistent with global standards  Ensure full enforcement of DE & PL  Ensure effective influence on ongoing policy issues aligned with industry position  Strengthen collaborative partnership with KFDA Overall - Timely engagement in KFDA decision - Focus on priorities - Efficient communication with KFDA - Strengthen Regulatory intelligence - Strengthen Subcommittee activities - Regular meeting with K-FDA: F2F, Joint workshop, learning programs, etc - Annual workshop, consultation meeting, etc BS/CSA - IND requirement aligned with global - # Korean subjects for Bridging purpose - Clarify IND requirements for early phase trial - Publish of IND Booklet and Bridging Survey NDA - Streamline CPP - NDA requirement - Explore compelling evidence for CPP issue - Engage to review process on pre-approval package insert - Improve regulations on orphan drug and toll manufacturing Quality - Reduce QC retention samples - Reduce local QC testing of import goods - F/U on preservative and residual solvent - Grant Toll warehouse utilization - Improve requirements on GMS document - Develop position paper for optimization of retention samples and local QC test - F/U on preservatives and residual solvent aligned with industry position - Clarify regulations on Toll warehouse - Improve requirements on GMP document PAM - Safety information update - Annual report - Renewal system - PI labeling on Packaging materials -Clarify process for safety information update - Improve process on annual report - Develop renewal system aligned with industry and KFDA - Gap analysis on practice and regulations on packaging material Biologic - Improve Periodic GMP inspection plan - Reduce retention samples - Follow up biosimilar regulation implement - improve Labeling regulation - Define issues on IND requirements - Develop position on retention sample aligned with Quality - Identify biosimilar issues - Clarify requirement on medical device IPR - Set up Patent Registration linkage - Ensure Data exclusivity of R&D data - Collect foreign regulation data & evidence - Generate position paper for data exclusivity - Ensure full enforcement of PL

2011 KFDA TFT - Subcommittee No.KFDA TFTMembersSubcommittee 1Clinical Future Creation 2020 Planning Team W Choi(GSK), YS Kim(MSD)IND 2TFT to develop non-clinical trial guidelines YM Lee(Pfizer), JH Kim(MSD), HJ Koo(GSK), RE Park(Janssen) IND 3Orphan drugs TFTHarriet Min(UCB), YM Cho(Genzyme), HS Kwon(KRPIA) NDA 4Recall & Scrap TFTYH Choi(Lilly), JH Kim(GSK), HS Kwon(KRPIA)Quality 5GMP regulation rationalization TFTYH Choi(Lilly), KS Jang(Merck), HY Ahn(GSK), SG Yoon(BMS), HS Kwon(KRPIA) Quality 6TFT to review the quality of pharmaceuticals HS Kang(Astra), JY Lee(Allergan), YJ NG(Roche), HY An(G 나 ), JY Lee(MSD), YR Chun(Novartis) Quality 7OTC TFTEJ Shin(Wyeth), EH Ha(Novartis), YM Woo(Bayer), SY Kim(J&J) PAM 8Post approval management for overseas’ manufacturing site TFT MA Lee(Lundbeck), SH Cho(Lilly), Sanofi- Pasteur(MS Kim), HS Kwon(KRPIA) PAM 9TFT for handling on safety infoBI Kang(Sanofi-aventis)PAM 10Development for manufacturing facilities of Bio pharmaceuticals TFT HJ Kang(Roche), JH Kim(GSK), JM Baek(MSD)Biologics 11Tests & analysis specialist WGMS Jeong(Pfizer), HW Han(Bayer)KRPIA 12TFT to set up educational manual for BE test HJ Jung(Pfizer), HS Kwon(KRPIA)KRPIA 13KFDA-Industry team to develop English regulations Harriet Min(UCB), KB Sohn(Pfizer), JY Hong(GSK), JY Lee(Allergan), YR Kim(Bayer), BI Jung and HJ Kim(Novartis), DW Lee and JA Lee(Merck), HS Kwon(KRPIA) KRPIA 14Personalized treatment TFTSJ Park(GSK)KRPIA

MOHW Proposals for Patent Linkage System  Background: Progress of KORUS FTA, MOHW proposed law changes to adopt Patent Linkage System: PAA(Pharmaceutical Affairs Act)  Key contents: - KFDA shall develop patent list; - Manufactures who file a product approval application [ANDA] shall notify their filing to patent holders & product license holders except; i) Patent has expired ii) Marketing after patent expiration iii) Consent of patent holders iv) Patent is held invalid, or the product is held not to fall within the scope of patent rights by a decision of the Intellectual Property Tribunal or a judgment of the court prior v) Other cases equivalent to items 1 through 4 above as defined in the MOHW Decree

Patent Linkage  KRPIA Actions - Circulated draft amendment with member companies and overseas allies - Legal consultation - Submitted position paper to MOHW on Mar 17(Thur.)  Main Points of KRPIA’s Position - Based on the KORUS FTA, KRPIA proposed; i) To establish in the marketing approval process to prevent patent infringement ii) The notification should include both the factual information and legal ground for the patent concerned iii) PAA should explicitly prescribe that product approval shall not be granted until patent expiration iv) KFDA rather than application filer notify the patent holder of the application v) Establishment of appropriate penalty for failure to provide notice

Biologics Industry Association  Establishment of Biologics Industry Association (BIA)  Updates - Key members from Biologics Development Council(BDC) initiated to form BIA - BIA is likely to be established in April with more than 40 members including SamSung, Cell Trion, Green Cross, LG Life Science and other pharma companies

Thank you!