Could you introduce Lee & Ko to our readers?

Established in 1977, Lee & Ko is the largest and the leading law firm in Korea, consisting of 310 professionals, including 246 Korean and foreign attorneys, 56 patent/trademark attorneys, and accounts, and about 500 staff members, with expertise and experience in all legal practice areas. As we are a premier full service law firm, Lee & Ko’s professionals are divided into four groups: Corporate Group, Banking/Finance & Securities Group, Litigation & International Arbitration Group, and Intellectual Property Group, and provide full legal service to domestic and foreign-based clients.According to many surveys conducted by law firm research and evaluation companies including Chambers Asia, Legal 500 and Asia Law, and the most widely read newspapers in Korea including Chosun Daily Newspaper and Seoul Economy Newspaper, Lee & Ko has continuously ranked in the top tiers in all of the practice areas, including corporate, banking/finance & security, litigation & arbitration, and intellectual property.Although Lee & Ko is a full service law firm, you were amongst the first in Korea to have a team dedicated to the pharmaceutical, healthcare and medical sectors.

Today, how would you assess the importance of the pharmaceutical sector for the firm and do you see it as a strategic area for growth in the coming years?

Overall, as a full service law firm, the pharmaceutical section represents a relatively small portion of our total activities, although it strongly contributes to our IP practice. Since its establishment, Lee & Ko has constantly strived to specialize in each of its practice area and focus on how to improve our specialty team capabilities. We will continue to do so in depth through education and training and indeed our pharmaceutical team has been growing since that time. Today, we count with a long track record in assisting pharmaceutical companies in Korea. Lee & Ko is assisting multinational pharmaceutical corporations, including Roche, Pfizer and Eli Lilly with patent prosecutions. In addition to these companies, Lee & Ko has been provided legal counseling to Sanofi-Avantis, Bayer, Novartis, Wyeth, Berna Biotech, Ferring, GE Healthcare, and Siemens Medical with compliance matters in connection with mergers & acquisitions, general corporate, employment and labor, tax, fair trade, pharmaceutical, cosmetics, and medical equipment related laws. Lee & Ko has also been providing these companies comprehensive counseling related to launch of new products, including clinical test approvals during research & development stage, new drug applications with Korea Food & Drug Administration, application for its insurance reimbursement price listing, drug pricing procedure, labeling and advertising, and inventor remuneration issues for multinational pharmaceutical corporations.Lee & Ko also represented pharmaceutical companies such as Eli Lilly, Novartis, Berna Biotech, LG Life Sciences, Hanmi Pharm in litigations in connection with patent infringement, approvals, and various administrative sanctions, and successfully represented clients with prosecutor and Korea Fair Trade Commission (KFTC) investigations in connection with pharmaceutical, fair trade, and criminal laws. Since these matters could have a significant impact on pharmaceutical companies, Lee & Ko treats them with high importance, and we believe they will become even more so in the firm’s future. The needs of the pharmaceutical sector in terms of legal services are very focused in some areas of expertise such as M&A, intellectual property or anti-trust.

In this context, what are the competitive advantages of a full service law firm such as Lee & Ko compared to more specialized ones?

Legal service in pharmaceutical and medical sectors cannot completely satisfy all of client’s needs if it focuses on one particular area of the law, such as M&A, intellectual property or anti-trust. Lee & Ko has traditionally been a leader in M&A area and has been accumulating various M&A experience in pharmaceutical sector, and its IP prosecution & litigation and anti-trust teams have been receiving evaluations as top tier in their respective fields.The reason Lee & Ko has come to acquire the current competitiveness in pharmaceutical industry is probably because the top attorneys and patent attorneys, equipped with expertise in pharmaceutical and medical sectors worked actively and passionately under the mottos of team and fair play.Our pharmaceutical /healthcare/medical team not only includes attorneys who majored in law with years of experience in providing advice and handling litigation for domestic and foreign companies, but also comprises attorneys with degrees in pharmaceutical and bio sectors, patent attorneys with chemical engineering degrees, etc., ensuring the highest expertise in South Korea. The latest news of the industry in Korea seem to be dominated by the Fair Trade Commission prosecution and sanctions over unethical business practices.

In an ever-changing regulatory environment, what are the main trends you have identified in the last few years in terms of legal support and services for this industry?

Indeed, over the past few years, large pharmaceutical companies have been sanctioned by the Korea Fair Trade Commission for illegal rebates, which increased the demand for legal counselling in connection with strengthening internal control over promotions through medical service providers and general compliance issues.Then, in addition to the general corporate matters, pharmaceutical companies have traditionally placed emphasis on strong protection of patents for new drugs that were invented after high research & development investments, and this trend has been continuing in the recent years. Indeed, our main areas of practice in this regard are patent registration, patent prosecution, and litigations on matters regarding patent infringement. Lastly, as the Korea Food & Drug Administration’s regulations on new drug application have been amended, legal services in connection with new drug application for various new and improved drugs are increasingly in demand. Furthermore, as the drug pricing-related regulation under the national health insurance law have also been amended, legal services in connection with its insurance reimbursement price listing and insurance payment standards are becoming important.If on the global scale the pharmaceutical industry is undergoing several major transactions, the big wave of M&A among local Korean players seems long overdue.

Do you see this happening in the coming years and how is Lee & Ko positioned in this segment?

M&A is one of our specialty areas. However, although Korea is a very segmented market with more than 200 small pharmaceutical companies, most of them are not manufacturing their own products, and therefore are not very financially stable. Aside from the top 10 or top 20 local companies, multinational companies might not have an interest in these smaller local companies as they have relative competitiveness in the market. However, M&A between foreign companies and medium-sized local companies are foreseeable. On the other hand, we do not expect that M&A between local companies will occur frequently.South Korea is in the process of signing several Free Trade Agreements, not only with the US but also with the European Union and other countries.

What are the main legal implications of these FTAs for pharmaceutical companies?

Even before the FTA, the Korean market didn’t have any entry barriers and was already open to foreign pharmaceutical companies. However, the FTAs are in the interest of foreign patent owners as they will have means of further protecting their IP. At the same time, most Korean companies which can compete with patent owners have also been preparing well for this new environment, so the impact of the FTA on the Korean market will be limited in this regard.

What are your ambitions for Lee & Ko in the coming years in the pharmaceutical, healthcare and medical sectors?

The pharmaceutical and biotech sectors have tremendous amount of potential and marketability, and we already see numerous new legal issues that are arising. Lee & Ko has long had strong interest in these sectors and has been training experts, who have already earned top recognition in their specialties. As the pharmaceutical and biotech sectors have been receiving the spotlight internationally, they are areas in which Lee & Ko can demonstrate its expertise with full energy and passion.

What would be your final message to the readers of Pharmaceutical Executive?

Lee & Ko is a law firm where the top experts in Korea have come together to provide legal services in all areas of the law to clients from all over the world. As the pharmaceutical and biotech sectors continue to grow, Lee & Ko is fully prepared and awaits to provide legal services in these sectors as well. As always, we will strive to provide the readers of Pharmaceutical Executive the highest quality of legal services. Thank you.