Patent Term Extension in Korea Yoon Suk Shin October 22, 2012
Contents Patent Term Extension (PTE) System History of the PTE System Patents Eligible for PTE Requirements for Filing a PTE Application Scope of PTE PTE Cases Extendible Term Invalidation of PTE Statistics of PTE Applications and Grants Proposed Revisions to Patent Law and Implementing Decree Relating to PTE Case Law First Approval Questions 1
Patent Term Extension (PTE) System Prior to working an invention relating to a medicine or an agrochemical, the patentee who has acquired a patent for the invention must complete tests on efficacy and safety of the invention and obtain approval or registration from the relevant authorities. Since these procedures require a period of time to complete, the term for working a patent relating to a medicine or an agrochemical is inevitably shorter than that for other patents. In order to compensate for this disadvantage, a PTE system was introduced. According to this system, the term of a patent relating to a medicine or an agrochemical can be extended for up to five (5) years, so long as certain requirements are met. Patent Registration Approval Patent Term Expiration Original Patent Term Extended Term Term for Working the Patented Invention 1
History of the PTE System The system came into effect as of July 1, 1987 upon introduction of patents for chemical compounds. 1987: Approval-after-Petition 1990: Application for Patent Term Extension Korea is the second country in the world to have adopted the PTE system. (US: 1984; Japan: 1988; EU: 1993) 2
Patents Eligible for PTE Patents for which approval or registration under other laws or regulations was obtained prior to working Patents for which a lengthy safety testing period is required for obtaining approval or registration under other laws or regulations Patents relating to medicines that require marketing approval under Article 26(1) or Article 34(1) of the Pharmaceutical Affairs Act Patents relating to agrochemicals or raw materials that require registration under Article 8(1), Article 16(1) and Article 17(1) of the Agrochemicals Management Act Patents for Substance, Process, Use, and Composition 3
Requirements for Filing a PTE Application Only a valid patent is eligible for PTE. ApatenteecanapplyforPTE. Marketing Approval (MA) should be granted to the patentee or to an exclusive or non-exclusive licensee. PTE can only be applied within 3 months from the date approval or registration is obtained, but at least 6 months before the expiry of the patent term. [Example] For the same effective ingredient contained in one patented product, approvals for the final medicine and the raw material medicine were obtained at different times. In such case, a PTE application must be filed within 3 months from the date the first approval was obtained. 4
Requirements for Filing a PTE Application The claims of a patent subject to PTE must describe the effective ingredients. Where the claims are directed to a substance, the composition of the claimed substance must be identical to the composition of the substance for which approval has been obtained. Where the claims are directed to a process, the composition of a substance that can be produced by the claimed process must be identical to the composition of the approved substance. Where the claims include two or more inventions, the claimed inventions must contain the same substance as the approved substance, and the extended patent term will only be effective with respect to the approved substance. Where the claims defines a use that is different from the use of the approved substance, the claimed use must be identical to that of the approved substance. PTEisgrantedbasedonthefirstMAwithrespecttothepatent. 5
Scope of PTE Extended patent term will only be effective with respect to the approved substance and use. Only effective with claims directed to the approved substance and use Where the claims include two or more inventions, the extended patent term will only cover the invention relating to the approved substance. If the substance and use are the same, the scope of the PTE can be extended to a different formulation in terms of usage or dosage. 6
PTE Case 1 Where a plurality of approvals were obtained for a plurality of effective ingredients claimed in a patent, PTEcanonlybegrantedonceforonlyoneoftheapprovals. 7
PTE Case 2 Where a plurality of approvals were obtained for one ingredient claimed in a patent, PTE can only be granted for Approval A. 8
PTE Case 3 Where one approval was obtained for a plurality of patents, PTE can be granted for each of the Patents A, B and C relating to Approval D. 9
Extendible Term Where clinical tests (or bridging tests) were performed in Korea 10
Extendible Term Where clinical tests (or bridging tests) for a new drug developed outside of Korea were performed outside of Korea IfapprovalorregistrationwasobtainedonorafterJune17,2005, The extendible term will only include the period for administrative procedures required to obtain the approval or registration and not the period for supplementing the PTE application. IfapprovalorregistrationwasobtainedbeforeJune17,2005orifapproval or registration has been requested but not yet obtained, The extendible term will include the period for phase III clinical trials conducted in a foreign country after registration of a patent right and the period for administrative procedures for obtaining the approval or registration. It will be necessary to submit evidence proving that the approval/registration authorities of the country where the new drug was developed have acknowledged receipt or approval of clinical data relating to the foreign phase III clinical trials. Bridging test result should be submitted. 11
Invalidation of PTE PTE can be revoked through an invalidation trial before IPT. Interested party or examiner When revoked, the patent term is deemed never to have been extended. Grounds for Revocation When MA is not necessary to practice the patent When the MA holder is not the patentee or the patentee s exclusive licensee or registered non-exclusive licensee When the extended term is greater than the period that the patent could not have been practiced When the applicant of the patent term extension is not the patentee When an application is not filed by all the owners of the patent 12
Statistics of PTE Applications and Grants As of August 2012 99 00 01 02 03 04 05 06 07 08 09 10 11 12 Total Applns 8 2 12 6 11 22 9 15 26 35 37 33 24 28 268 Grant 7 2 9 6 11 20 9 15 24 29 25 29 10 2 198 13
Proposed Revisions to Patent Law and Implementing Decree Relating to PTE Patents eligible for PTE(Article 7 of the Implementing Decree) - Patents relating to a new substance having a novel chemical structure or a novel composition for which approval or registration was first obtained AnewdosageformofaknownactiveingredientisnoteligibleforPTE. A combination drug is eligible for PTE, but only if it contains a new active ingredient. The provision stating a lengthy period has been taken to complete the activity tests, safety tests, etc. was amended. Specifically, the term lengthy was deleted to comply with the practice of calculating the extendibletermonadailybasis.(article89ofthepatentact) Therevisionsareexpectedtobeenactedin2013. 14
Case Law First Approval PTE can only be granted based on the first approval. IPT Decisions (2009 Won 3927, 3928) A formulation comprising a hyaluronic acid and a human growth hormone Approvals 1 st : Diclasefortreatingdiseasesinadultsresultingfromadeficiencyin 2 nd : growth hormone Eutropin Plus for treating growth deficiency in a child due to lack of growth hormone from the pituitary glands The two medical uses in the first and second approvals, namely, for treating diseases resulting from a deficiency in growth hormone, are substantially identical. Further, the claims of the patent subject to PTE donotlimittheapplicationoftheformulationtoanadultorachild. New formulations for known ingredient PTEcannotbegrantedbasedonthesecondapproval. 15
Question 1 Combination Drugs Combination drugs comprising known active ingredients will not likely qualify for PTE according to the proposed revisions to the Implementing Decree of the Patent Act and the general position taken by the Korean Intellectual Property Office. MA for A+B combination: PTE can be granted for a claim for A, B or A+B, if it is the first MA. MA for A: PTE will not be granted for a claim for A + B. 16
Question 2 Pediatric Extension No discussion yet 17
Question 3 Biopharmaceutical Products PTE is based on the concept that a patented invention could not be worked after patent registration for a certain period of time due to time needed to complete tests on efficacy and safety and to obtain approval or registration from the relevant authorities. Where the investment in the development of biopharmaceutical products was made before the filing of a patent application, PTE may not be an appropriate means to recoup the investment. 18
Question 4 PTEbasedon3 rd partymarketingapproval NotallowedinKorea MA holder should be a patentee or a licensee of the patent in Korea. No compensation is necessary unless the patentee attempted to practice the patent and invested resources to obtain MA. 19
Any Questions? yshin@leeinternational.com