IP Newsletter | Summer/Fall 2014
	PATENT
	Korean Court Holds for the First Time that "Skinny Labeled" Generic Still Infringes a Patent for a Non-labeled Indication
	Summary Where a drug is approved for multiple indications, one or more of which (but not all) is covered by a patent, a question may be raised whether a generic company infringes that patent by making or selling a generic version of the drug for any use. In general, if a generic company makes or sells a generic drug for an indication which is not covered by a patent, then it is not infringing the patent. However, in Warner-Lambert Company LLC, et al. v. Samjin Pharmaceutical (Seoul Central District Court Decision No. 2013 Kahap 1717 rendered on February 5, 2014), the generic company was held to infringe the asserted patent even though its product information leaflet carved out the patented indication ("skinny labeling"). This is the first time a Korean court has decided the issue of whether a generic product with skinny labeling infringes a patent for a non-labeled indication. Facts Korean Patent No. 491,282 ("Present Patent") is directed to a second use of pregabalin1 for treating pain, which is the main indication for Lyrica®, one of Pfizer's best selling drugs.2 Pregabalin was first developed as a medicine for treating epilepsy. Lyrica® has been approved for both epilepsy and pain indications. Due to the Present Patent, some generic companies obtained market approvals for their generic drugs only for the epilepsy indication. However, other generic companies, including Samjin Pharmaceutical and CJ, obtained market approvals for both epilepsy and pain indications. Subsequently, after filing invalidation actions against the Present Patent with the Intellectual Property Tribunal ("IPT"), these other companies launched their generic products. As a result, the patentee and its exclusive licensee, Pfizer Korea, filed a first patent infringement action against CJ, in which Pfizer successfully obtained a preliminary injunction from the Seoul Central District Court on May 20, 2013.3 After the Seoul Central District Court decision against CJ, Samjin deleted the pain indication from its product information leaflet while maintaining its product approval for the pain indication. Thus, the patentee and Pfizer Korea filed another patent infringement action seeking a preliminary injunction against Samjin. Issue As its main defense, Samjin argued that since it manufactured and sold its product only for the epilepsy indication, it did not practice the invention embodied in the Present Patent. Further, Samjin claimed that because it stopped selling its product for the pain indication, it should not be held liable for medical doctors prescribing its product for the pain indication since such prescriptions were made independently by such doctors. Since, unlike the U.S., an act of inducing patent infringement is not recognized as patent infringement under Korean patent law, the main issue in the case was whether Samjin itself was practicing the invention of the Present Patent. Samjin also argued that the Present Patent was invalid. However, because the IPT had already held the Present Patent valid and been affirmed by the Patent Court, patent validity was not a major issue in the infringement action.4 Court Decision The Seoul Central District Court issued a preliminary injunction order against Samjin, holding that Samjin committed acts of practicing the invention of the Present Patent. In reaching its decision, the Court noted the following facts.
	(i) Samjin obtained market approval and listed the maximum reimbursement price for its product for both pain and epilepsy indications. (ii) Immediately after the market approval and price listing, Samjin began to market its product for the pain indication, as demonstrated in local industry newspapers reporting Samjin's marketing activities. (iii) Although Samjin argued that it deleted the pain indication from its product information leaflet, it still mentioned the efficacy of the drug for the pain indication in the general warning section. (iv) Between May 22, 2013 and October 18, 2013, Samjin's product was prescribed 1,541 times for the pain indication but only 38 times for the epilepsy indication.
	In view of the above facts, the Court found that Samjin had fully completed its administrative preparations for manufacturing and selling the accused product for the pain indication. The Court further found that Samjin actually had begun to manufacture and sell the accused product for the pain indication and, even after the IPT decision holding the Present Patent valid, that Samjin planned to sell the accused product for the pain indication. Moreover, the accused product was largely being prescribed for the pain indication as of the decision in the present infringement action. The accused product was also listed as a pain treatment drug in many hospitals and Samjin's sales of the accused product were still increasing. As such, the Court concluded that Samjin committed acts of practicing the invention of the Present Patent by manufacturing, selling or offering to sell the accused product for the pain indication. Regarding Samjin's deletion of the pain indication from its product information leaflet, the Court specifically noted that the accused product is a prescription drug, and that medical doctors would pay more attention to facts on the market approval and pricing of the accused product rather than the product information leaflet. Thus, the fact that the pain indication was deleted from the product information leaflet alone would not have any meaningful influence on the decisions by medical doctors to prescribe the accused product. As a result, the Court found that Samjin clearly manufactured and sold the accused product for the pain indication regardless of its deletion of the pain indication from the product information leaflet. Comments This case is not a typical skinny labeling case since the generic company maintained its product approval for the patented indication, although it carved out the patented indication from its product information leaflet. It is unclear whether Samjin would still be held liable for patent infringement if its product approval was only based on the non-infringing indication (particularly where doctors continued to prescribe the accused products for the patented indication). However, it seems that Korean courts will decide whether a generic company has substantially practiced a patented invention after considering the totality of the circumstances, as in the above case.
	1 Pregabalin is (S)-3aminomethyl-5-methylhexanoic acid, which is known to be a derivative of a depressive neurotransmitter, GABA (gamma-aminobutyirc acid). 2 The present invention was conceived by a research team at Northwestern University and then assigned to Warner-Lambert LLC., a subsidiary of Pfizer. 3 See Kim & Chang Newsletter – Summer/Fall 2013, article titled "Pfizer Successfully Obtains Preliminary Injunction in Korea with Correction Pending Patent Claims." 4 The generics' appeal of the Patent Court decision in the invalidation action is currently pending before the Supreme Court.
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