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IP Newsletter | Fall 2017
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PATENT
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Original Drug Maker Obtains First Court Decision in Korea Finding Infringement of Patent for Second Medicinal Use
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Pfizer successfully enforced its patent covering a secondary use of its Lyrica® product (active ingredient: pregabalin) against 13 generic drug manufacturers in Korea, and was awarded a total of about KRW 2.2 billion (approx. USD 2 million) in damages (Seoul Central District Court Decision Nos. 2016Gahap517156, 2016Gahap517163, 2016Gahap521919 and 2016Gahap521926 rendered on June 30, 2017).
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Facts
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Pregabalin was originally developed to treat epilepsy, but was later discovered also to relieve pain (such as neuropathic pain and fibromyalgia). Pfizer's subsidiary, Warner-Lambert, obtained a second medicinal use patent to cover the use for pain treatment. In Korea, Pfizer Korea obtained an exclusive license to said patent from Warner-Lambert. Pfizer Korea also obtained an approval for the Lyrica product in 2005 for the treatment of (1) epilepsy, (2) neuropathic pain, and (3) fibromyalgia. After launch, Lyrica became a blockbuster drug, achieving annual sales of over several million dollars in Korea. Over 90% of prescriptions for Lyrica are for the treatment of pain, while the proportion of prescriptions for epilepsy treatment is relatively insignificant.
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Many generic drug manufacturers seeking to sell Lyrica generics in Korea filed invalidation actions against the subject patent beginning in 2011. Subsequently, the generic drug manufacturers began to sell and market generic versions of Lyrica in 2012, prior to the patent expiration. After five years of litigation, the Supreme Court confirmed the validity of the subject patent in 2016. Then, Warner-Lambert and Pfizer Korea (collectively, "Pfizer") pursued patent infringement and damages actions against selected generic drug manufacturers ("Defendants"). In the meantime, the Defendants obtained their generic Lyrica approvals with indications for both pain and epilepsy treatments, although they later carved out the pain indication from their product approvals.
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In the infringement and damages actions, the Defendants argued that (i) the patent could not be enforced because of patent invalidity, (ii) there was no infringement after the patented pain indications were deleted from their product approvals, and (iii) the damages amounts alleged by Pfizer were unreasonable. One of the Defendants filed another invalidation action for failure to meet all patent description requirements one day before the Supreme Court's decision concerning the first invalidation action was issued.
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Court Decision
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Regarding the invalidity issue, the district court rejected the generic's arguments for lack of data, and acknowledged the validity of the subject patent based on the following grounds: the specification sufficiently disclosed the pharmaceutical effect of treating neuropathic pain and fibromyalgia, meaning it sufficiently met description requirements for pharmacological data as a medicinal use invention.
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As to the infringement issue, the district court found infringement with respect to the manufacture and sales of generic drugs that occurred prior to deleting the pain indication from the Defendants' product approvals.
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Further, regarding the calculation of damages, the district court granted approximately 72% of the total amount of damages claimed by Pfizer. Proving actual damages was difficult because the Defendants did not produce any sales or profit data. The court therefore awarded damages amounts in accordance with Article 128, Paragraph 7 of the Patent Act (covering calculation of damages where patent infringement is confirmed but the damages amount is difficult to prove), after considering the totality of the arguments and evidence. In this regard, the court asked the Health Insurance Review & Assessment Service ("HIRA") to produce data concerning doctors' prescriptions of generic drugs for the treatment of pain, and calculated the total damages amount based on this information. In doing so, the court also included in its damages calculation any prescriptions that were issued after the pain indications were deleted from the generic product approvals, noting that those prescribed generic products had been manufactured while the pain indications were included in the product approvals.
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Significance
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This is the first court decision in Korea in which a court awarded damages for infringement by generic drug manufacturers of a second medicinal use patent.
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Back to Main Page
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If you have any questions regarding this article, please contact:
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For more information, please visit our website: www.ip.kimchang.com
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