|Subject｜||[Patent] Patent Court Decision, 2016Heo8636, decided June 30, 2017|
Patent Court Decision, 2016Heo8636, decided June 30, 2017 (Solifenacin Case)
The validity of patent with its patent term extended affects not only the medicine designated by the clause for manufacturing and import permit but also the medicine regulated to receive permit for manufacturing and import as they are practically treated as equivalents as well as the medicine which does not require separate permit for manufacturing and import that are practically equivalent to medicine that receive permits for manufacturing and import.
The challenged inventions of the plaintiffs in this case had “solifenacin” in common as active ingredient with the subject invention in this case and their respective salts were altered from “succinic acid” to “fumaric acid” or “tartaric aid” and according to ‘Regulation Regarding Safety and Validity Examination for Medicine, etc.’, any medicine of new composition with new category of effect or active ingredient with altered salts were designated as medicine subject to manufacturing and import permit thus making these challenged inventions neither eligible to be treated as practically equivalent items thus making it able to receive manufacturing and import permit nor to be treated as medicine that are already practically equivalent to a medicine that was permitted for manufacturing and import which makes separate permit unnecessary and therefore, these challenged inventions fall under the category of medicine that must receive manufacturing and import permit separate from the subject invention in this case. Therefore, the validity of patent for the subject invention in this case with extended patent term does not affect these challenged inventions.
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