The standard for determining the scope of the effect of a patent of a drug, the term of which has been extended, and whether the patent holder has the effect of a patent on the pharmaceutical product, and whether the effect of a patent, the term of which has been extended, is limited to the extent that a person with ordinary skills can easily choose the pharmaceutical product that has been produced by the other party in a patent infringement lawsuit, although there is difference between the pharmaceutical product permitted under the Pharmaceutical Affairs Act and the pharmaceutical product that has been produced by the other party in a pharmaceutical license, etc., but

Article 89 of the former Patent Act (amended by Act No. 11117, Dec. 2, 201; hereinafter the same) provides that “In cases of an invention prescribed by Presidential Decree, which requires a long period of time due to an activity, safety test, etc. necessary for executing a patented invention, for authorization, registration, etc. (hereinafter referred to as “authorization, etc.”), the term of the relevant patent may be extended by up to five years for the period during which the invention cannot be worked, notwithstanding Article 88 (1) of the former Enforcement Decree of the Patent Act (amended by Presidential Decree No. 20127, Jun. 28, 2007).” Article 7 subparag. 1 of the former Enforcement Decree of the Patent Act (amended by Presidential Decree No. 20127, Apr. 16, 2007) provides that “an invention requiring authorization, etc. under the Pharmaceutical Affairs Act, one of the “an invention prescribed by Presidential Decree, for which the term of the patent invention cannot be worked” (Article 88(1) of the former Pharmaceutical Affairs Act).

On the other hand, Article 95 of the former Patent Act provides that "the effects of a patent, the term of which has been extended, shall not extend to any act other than the working of the patented invention with respect to the goods subject to permission, etc. on which the extension is registered (if the use of the goods is specified in the permission, etc., any goods used for such purpose)." The Patent Act provides for the scope of effects of a patent, the term of which has been extended, not based on the claims, but on the scope of "working of the patented invention with respect to the goods subject to permission, etc. on which the extension is registered," and does

In light of the provisions of such Acts and subordinate statutes and the purport of the system, the scope of effect of a patent, the term of which has been extended, should be determined based on whether the effective substance expected to have the effect of treating a specific disease, treatment effect, and usage are identical with that of the drug approved under the Pharmaceutical Affairs Act for the purpose of embodying the patented invention. Even if there is a difference between the drug approved under the Pharmaceutical Affairs Act and the drug produced by the other party in a patent infringement lawsuit, etc. (hereinafter “infringed product”), if a person with ordinary knowledge in the technical field to which the invention pertains (hereinafter “infringed product”) differs in pharmaceutically permissible salt, etc., the effect of the patent, the term of which has been extended, should be deemed to affect the infringed product.

Articles 89 (see current Article 89(1) and 95 of the former Patent Act (Amended by Act No. 11117, Dec. 2, 2011); Article 7 subparag. 1 of the former Enforcement Decree of the Patent Act (Amended by Presidential Decree No. 20127, Jun. 28, 2007)

Supreme Court Decision 2017Hu882, 899 Decided November 29, 2017

1. As to the violation of the provisions of Article 13(1) of the Civil Act, the provisions of Article 13(1) of the Civil Act shall apply mutatis mutandis.

Copia Co., Ltd. (Attorney Kim Sung-sung, Counsel for the plaintiff-appellant)

Hanmi Pharmaceutical Co., Ltd. (Law Firm LLC, Attorneys Jeon Dong-ju et al., Counsel for the plaintiff-appellant)

Patent Court Decision 2016Na1929 Decided June 30, 2017

The lower judgment is reversed, and the case is remanded to the Patent Court. The application for intervention by the Defendant’s assistant intervenor is dismissed. The litigation cost incurred by the application for intervention is borne by the Defendant’s assistant intervenor.

The grounds of appeal are examined (to the extent of supplement in case of supplemental appellate briefs not timely filed).

1. Article 89 of the former Patent Act (amended by Act No. 11117, Dec. 2, 2011; hereinafter the same) provides that “In cases of an invention prescribed by Presidential Decree, which requires a long period of time due to activity, safety tests, etc. necessary for executing permission, registration, etc. (hereinafter referred to as “permission, etc.”) of patented invention, the term of the relevant patent may be extended by up to five years for the period during which the invention could not be worked, notwithstanding Article 88 (1) of the former Enforcement Decree of the Patent Act” (see, e.g., Supreme Court Decision 2017Hu82, 899, Nov. 29, 2017). In order to implement the patented invention, Article 78 (1) of the former Enforcement Decree of the Patent Act or Article 78 (1) of the former Enforcement Decree of the Patent Act, the term of the patent right may be extended by up to five years for which the patented invention cannot be worked in order to obtain permission, etc. under the Pharmaceutical Affairs Act. (see, etc.).).

On the other hand, Article 95 of the former Patent Act provides that "the effects of a patent, the term of which has been extended, shall not extend to any act other than the working of the patented invention with respect to the goods subject to permission, etc. on which the extension is registered (if the use of the goods is specified in the permission, etc., any goods used for such purpose)." The Patent Act provides for the scope of effects of a patent, the term of which has been extended, not based on the claims, but on the scope of "working of the patented invention with respect to the goods subject to permission, etc. on which the extension is registered," and does

In light of the provisions of such Acts and subordinate statutes and the purport of the system, the scope of effect of a patent, the term of which has been extended, ought to be determined based on whether the effective substance expected to have the effect of treating a specific disease, treatment effect, and usage are identical with that of the drug permitted under the Pharmaceutical Affairs Act for the purpose of embodying the patented invention. Even if there is a difference between the drug permitted under the Pharmaceutical Affairs Act and the drug produced by the other party in a patent infringement lawsuit, etc. (hereinafter “infringed product”), if a person with ordinary knowledge in the technical field to which the invention pertains (hereinafter “ordinary technician”), such difference is difficult if the treatment effect or usage manifest by the pharmacological action of the active substance absorption into the human body is substantially identical, the effect of the patent, the term of which has been extended, shall be deemed to affect the infringed product.

2. The reasoning of the lower judgment and the evidence duly admitted reveal the following.

A. The name of the patented invention (patent number omitted) of this case (patent number omitted) for which Plaintiff 2 filed an application for the instant patent invention (patent number omitted) with the Republic of Korea (hereinafter “Plaintiff 2”) for the Republic of Korea (hereinafter “Plaintiff 2”) filed for the instant patent invention (patent number omitted) was “new quiloidine leading and its pharmaceutical products.” The Plaintiff 2/3 of the instant patent invention (patent number omitted) was granted a non-exclusive license for the instant patented invention from the Plaintiff 2/100 of the instant patent invention.

The instant patent invention is a material patent characterized by “a compound with a specific basic framework which has the effect of treating emulsion, etc.” and a specific compound in the form of free base can form a variety of acids and salt compounds, including sudic acids or fladic acids.

B. On March 30, 2007, Plaintiff 2: (a) from the Minister of Food and Drug Safety on March 30, 2007, Plaintiff 2 obtained the import approval of drugs with regard to “beatise 5 milligrams (suic acid finna),” which is subject to the instant permit relating to the instant patent invention, the drugs and quantities of the raw materials for “one unit of one unit (154mg) of the total 1 unit (154mg), the main ingredient of which are susibide 5.0 milligrams (5.0 milligrams, finite, etc.).”

C. On June 26, 2007, Plaintiff 2 filed an application to register the extension of the term of the instant patent invention with the Commissioner of the Korean Intellectual Property Office, requesting the extension of the term of the instant patent invention for the said period on the ground that Plaintiff 1 and June 16 had been infected with the marketing approval of the instant patent invention for the purpose of embodying the instant patent invention. The said application contains the following: “general name (product name) souran, product name (trademark name), efficacy and effect (use) and private or commercial symptoms.” On August 21, 2007, the Korean Intellectual Property Office examiner decided to register the extension of the term of the instant patent invention on June 16, 2007. Accordingly, the expiration date of the patent claim 1 through 8 of the instant patent invention was extended from December 27, 2015 to July 13, 2017.

D. On July 25, 2016, the Defendant obtained permission from the Minister of Food and Drug Safety for the manufacture and marketing of the prescription drugs “Abcare 4.98mg and 9.96mg ( Solofin infection)” from the Minister of Food and Drug Safety. The foregoing medicine is a pharmaceutical product created for the purpose of preventing or treating urine diseases in urine and urine diseases in chronic urine infection (hereinafter “Defendant products”).

3. We examine these circumstances in light of the relevant laws and records as seen earlier, including the legal principles as seen earlier.

A. (1) The Defendant’s product constitutes “malincinic drug” with the instant patented invention and active ingredients identical to “surinic acid” and with “surinic acid” from “surinic acid. The Defendant’s product submitted materials on safety and effectiveness tests as provided by Article 2 subparag. 8 of the Regulations on Product Approval, Report, and Examination of Drugs, which were applied at the time of application for permission for the product. The Defendant’s product was exempted from submitting materials on clinical trials on the level of safety and efficacy tests, which are subject to the requirements provided by Article 28(5) of the said Regulations, on the ground that “the Plaintiff’s basic framework is the same as that of the medicine permitted in the Republic of Korea (referred to as “beecinic acid” with the imported product permission. The same is presumed to be almost the same as that of the medicine permitted, and it is obvious that the Defendant’s product is absorbed with the same ingredients as that of the medicine permitted within the firefighting system, and thus, is frequently used as the drug.” The Defendant’s product’s toxicity and toxicity materials on clinical tests, etc.

(2) Generally, the salt of a drug generally serves as a combination with a chemical in the form of free salt in order to increase the degree of melting and absorption rate of the drug. So-called so-called so-called so-called so-called so-called so-called so-called saccinate and so-called so-called saccinate and so-called saccinate are in a state in which so-called saccinate and so-called saccinate are considerably combined by ion combinations, and when saccinate and so-called saccinated into the body, the so-called so-called so-called so-called so-called so-called so-called so-called saccinate and so-called saccininate. This separated so-called so-called so-called so-called saccinininate and so-called saccinininin

(3) Therefore, the treatment effect shown by the pharmacological action of active ingredients absorption into the human body cannot be deemed to vary solely on the following grounds: the nature of cryptitis and succinate infection (melting point, water solution, etc.) and the detailed difference between the medicine subject to permission and the administration capacity of the Defendant’s products.

B. The specification of the instant patent invention states the succinic acid and maccinic acid, etc., other than cancer, as an active ingredient, as organic acid that can be selected to form succinate and salt. The succinic acid of the Defendant’s product is classified as “Clas 1 (Class 1)” and is widely known that the internal administration and absorption process of succinate and succinic acid are identical to that of succinate or succinic acid. Thus, changing the succinic acid into succinic acid is merely a matter easily selected by anyone if an ordinary technician is a person.

C. Therefore, although the Defendant’s product differs from the pharmaceutical product subject to permission in this case, a person with ordinary skills can easily choose the modified salt, and the treatment effect absorption into the human body is substantially identical, it shall be deemed that it falls under the scope of the right to the instant patent invention, the duration of which has been extended.

Nevertheless, the lower court determined otherwise by deeming that the effect of a patent, the term of which has been extended extends extends only to the scope of the drugs specified by the permission for manufacture or import items and the drugs that need not be separately manufactured or imported because they are treated as identical items, and thus do not fall under the scope of the right to the patented invention of this case, the term of which has been extended. In so determining, the lower court erred by misapprehending the legal doctrine on Article 95 of the former Patent Act with regard to the scope of the right to the patent, the term of

4. As to the legitimacy of the motion to intervene by the Defendant Intervenor

In order to intervene in a lawsuit, there must be legal interests as to the outcome of the lawsuit concerned. The interests asserted by the Defendant’s Intervenor are nothing more than the factual interests, and cannot be said to be the legal interests. Therefore, the instant application for intervention is unlawful on the grounds that it does not meet the requirements for participation.

5. Therefore, the lower judgment is reversed, and the case is remanded to the lower court for further proceedings consistent with this Opinion. The application for intervention by the Defendant’s Intervenor is dismissed, and the litigation cost incurred by the intervention is assessed against the Defendant’s Intervenor. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Kwon Soon-il (Presiding Justice)