Settlement of Pharma Disputes and Competition Law in Korea October 22, 2012 Monica Hyon-Kyong Leeu AIPPI PHARMA WORKSHOP I
Topics Patent Disputes in Korean Pharma Industry Korean Competition Law and KFTC s IPR Guidelines KFTC s Investigation Future Changes 1
Drug Lifecycle and Patent Disputes Generic Drug Approval before Patent Expiration Post-Marketing Surveillance Expiration Generic Approval/Pricing Generic Marketing Original Drug Patent Expiration Stage 3 Original Approval Original Pricing/Marketing Stage 2 Stage 1 Patent Disputes 2
Original Drug Price Linked to Generic Entry Pricing System (Dec 2006) Recent Reform (Feb 2012) 120 120 100 80 60 40 20 100 When 1 st generic is listed 80 68 (80*0.8) 61.2 (68*0.9) 55.08 (61.2*0.9) 100 80 60 40 20 100 When 1 st generic is listed 70 59.5 (70*0.85) 53.55 (59.5*0.9) After 12 months / 3 generics 0 original original when 1 st generic is listed 1 st -5 th generics 6 th generic 7 th generic 0 Previous price of original original when 1 st generic is listed 1 th generic all drugs 3
Increase in Pharma Patent Disputes Number of Patent Trials and Lawsuits Number of cases Scope Confirmation Trial Damage Action Correction Trial Invalidation Trial Preliminary Injunction Others Permanent injunction Opposition Total [KFTC Report in Case No. 2011 2111] 4
Korean Competition Law Monopoly Regulation and Fair Trade Law ( FTL ) enacted in 1980 Abuse of Dominance and Restrictive Practices (Unilateral Conduct /Unfair Trade Practice) Mergers and Acquisitions Regulated Activities Cartels Others (Sub-contracting, Unfair Advertising, etc.) Abuse of Intellectual Property Rights 5
Korea Fair Trade Commission Approximately 500 personnel; 5 regional offices Broad investigative and enforcement power comparable to that of EC Dawn raids, summoning respondents/witnesses, seizure of evidence One of the most active competition authorities in the world Sensitive to global trends of antitrust law enforcement Various methods of enforcement 1 2 3 4 Cease and desist orders Surcharges, Administrative fines Public announcement of violation Filing of criminal complaint 6
KFTC Guidelines on IPR Abuse Legitimate exercise of IP rights NOT affected by the FTL (Article 59) Not only domestic companies but also foreign companies if the acts of those companies had impact on Korean market Generally, rule of reason: efficiency vs. anti-competitive effects Types of IPR abuse Refusal to grant license or restrictions in license Patent pools and cross-licenses Exercise of patent rights in relation to technology standards Abuse of patent litigation Unfair settlement of patent litigation Assignment of patent rights constituting a major business 7
KFTC Guidelines Unfair Patent Settlements Factors to Consider Are the parties competitors? Is the purpose of settlement to restrict competition in the relevant market? Is market entry by the party delayed beyond the patent term? Is entry into a market not directly related to the patentbeing delayed? OR Are the parties aware or is it objectively obvious that the disputed patent is invalid? 8
KFTC s IPR Investigation June 2010 August 2010 ~ Early 2011 October 2011 Status survey sent to 48 companies in pharma industry Status survey sent to 59 companies in IT industry On-site investigations and additional questionnaires sent to companies in pharma and IT industries Status survey sent to 31 companies in chemical and machinery industries Ongoing examinations Ongoing investigations 9
KFTC s Investigation of Pharma Industry Status Survey in 2010 Covering activities during 2000 2009 Questions about ever-greening strategy in patent filings, patent disputes to block generic entry, restrictive terms in agreements for 220 APIs On-Site Investigation in 2011 Focus on whether abuse of IP rights resulted in unfair exclusion of competitors Finding of a reverse payment issue 10
Competition Policy vs. IPR Protection Settlements allow for the safeguard of profits guaranteed by IP law, reinforce legal certainty and protect incentives to continue to develop new drugs In the short run, a competition policy may result in more competition in the market, but in the long run, it can undermine the incentives to engage in R&D Need a balance between competition policy and IPR protection 11
Patent-Approval Linkage Antitrust Implications Under Korea-US FTA: new patent-approval linkage system March 15, 2012: Patent listing & generic notice (1 st phase) March 15, 2015: Stay of generic approval (2 nd phase) Will first generic exclusivity be included? How long? More antitrust scrutiny? 12
KFTC s Future Plans We will strengthen enforcement against reverse payment settlements in the pharmaceutical industry Chairman, Mr. Dongsoo Kim Plan to enact a requirement that pharmaceutical patent settlement agreements be submitted to KFTC for review 13
Practical Considerations for Patent Settlements Any settlement agreement of a patent dispute may be submitted to KFTC Review potential FTL issues before entering into a settlement agreement Need to closely monitor antitrust cases and issues in other jurisdictions 14
Thank you I n t e l l e c t u a l P r o p e r t y Monica Hyon-Kyong Leeu Direct: 82-2-3703-1211 E-mail: hkleeu@ip.kimchang.com