IP Newsletter | Spring 2016
	PATENT
	All Things Korean Biosimilars: Industry Developments and Biological Patent Listing
	Korea is emerging as a global leader in biosimilars. With recent regulatory approvals in multiple jurisdictions, Korean companies are making significant headway in the market. Boasting a market value of USD 10 billion, Celltrion, a pioneering and increasingly competitive Korean player in a global biopharmaceutical market long dominated by big-name drugmakers, has received approval to sell Remsima (its biosimilar version of the blockbuster drug Remicade) in over 50 countries worldwide, including Europe, Canada, Japan, and, earlier this month, the U.S (to be co-marketed with Pfizer as Inflectra). Not to be outdone, Samsung Bioepis, another Korean competitor, has received approval from the European Commission for SB4, a biosimilar referencing Amgen's Enbrel (etanercept) for the treatment of rheumatoid arthritis. Samsung Bioepis also is currently developing five other biosimilars which reference some of the world's top-selling biologics, including Remicade, Humira, Herceptin, and Avastin. In addition to keeping tabs on the development of the Korean biosimilars industry, this article discusses strategic considerations for brand biologics about juggling the "patent dance" procedure under the Biosimilar Approval Pathway of U.S.'s Biologics Price Competition and Innovation Act ("BPCIA") with the Korean patent listing rules for biologics. Korean Biosimilars Development As of 2015, twelve Korean biosimilars reportedly have been approved, while another 36 biosimilars are in the pipeline. In addition to Celltrion and Samsung, other Korean companies have joined the biosimilar frenzy:
	The Ministry of Food and Drug Safety gave approval in 2014 to Green Cross, a leading Korean pharmaceutical company, to market Neulapeg (pegfilgrastim), a biosimilar of Amgen's Neulasta. In 2014, LG Life Sciences, an affiliate of LG Electronics, and Mochida Pharmaceuticals of Japan entered a collaboration agreement to develop AbbVie's Humira. Dong-A Pharmaceuticals, another Korean pharmaceutical company, also has joined the foray into biosimilars by partnering with Japanese firm Meiji Seika Pharma to construct a biosimilars production plant to target global markets with antibody-based drugs, including a Herceptin biosimilar. In 2011, Merck acquired Hanwha Chemical's Davictrel, an etanercept biosimilar, for USD 720 million. The U.S. drug maker also is collaborating with Samsung to develop and commercialize MK-1293, an insulin glargine candidate for treating type 1 and type 2 diabetes and a biosimilar of Sanofi's blockbuster Lantus.
	With robust government support (35% of the national medical R&D budget was invested in biosimilars development in 2012), South Korea has set a goal to increase the value of pharmaceutical exports to USD 20.5 billion by 2020. Comparing Korean Patent Listing for Biologics and the "Patent Dance" under the U.S. BPCIA Effective March 2015, Korea began enforcing a patent linkage system for all pharmaceutical products, both traditional "small molecules" and biologics. Listing a patent covering its product on the Green List (the Korean equivalent of the U.S. FDA's Orange Book) enables a reference product sponsor ("RPS") to obtain the benefits of patent linkage, including enforcement of a stay against biosimilar launch, as in a typical "Paragraph IV" litigation under the Hatch-Waxman scheme. However, patent listing strategies under the Korean regulatory regime may not completely align with those of an RPS for engaging in the pre-suit information exchange with a biosimilar maker— the so-called "patent dance" — under the U.S. BPCIA. The information disclosed in the Green List effectively identifies the patent(s), on a claim-by-claim basis, covering — and those not covering — the biological product. While the effect of the Korean regulatory outcome on U.S. litigation is as yet unknown, at a minimum, the listed patents and claims of the Green List may serve to shed light on the scope of a patent claim to which there is a U.S. counterpart. Thus, RPSs are advised to weigh the pros and cons of listing a patent in the Green List and the associated consequences. The increasingly global nature of skirmishes between RPSs and biosimilars requires clients and practitioners to be aware of regulatory strategies in foreign jurisdictions and their effects on ongoing proceedings in their backyard. Companies should ably juggle the potential risks of disparate rules from various jurisdictions.
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