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Requirements for Approval of Literature of Prior Art

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KH

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2010-05-14

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Requirements for Approval of Literature of Prior Art


I. Trial for Invalidation of Patent Registration No. 287083

Patent Court’s Decision No. 2005HEO49 published on Jun. 8, 2006
Supreme Court’s Decision No. 2006HU1957 published on Nov. 27, 2008
- dismissed

1. Gist of the present patented invention and cited invention

(1) Present patented invention (claim 1)

The present patented invention relates to a vaccine composition comprising a hepatitis B surface antigen (HBsAg) and a number (n) of other antigens in combination with an adjuvant comprising one or more adjuvant of aluminium phosphate (AP) or aluminium hydroxide (AH), wherein n is 3-6, the adjuvant used to absorb HBsAG is aluminium phosphate (AP), and the other antigens includes the three kinds of antigens providing immunity against diphtheria (D), tetanus (T) and pertussis (P).

(2) Cited invention

The cited invention is a thesis entitled ‘Study of the relation of a hepatitis B vaccine and the other vaccines’.

① To produce a vaccine capable of preventing hepatitis B and another contagious disease(s), a hepatitis B vaccine is combined with a DPT, Japanese encephalitis and MMR vaccines, and the combination vaccine is administered to guinea pigs and mice. The purpose of the study is to find out the correlation between the hepatitis B vaccine and the other vaccines, by observing differences in the immune response and protection ability and side effects in a body when administering only the hepatitis B vaccine and when administering the combination vaccine.

② The combination vaccine of 1ml includes a hepatitis B surface antigen of 3.0㎍ , diphtheria toxoid of 50Lf, bordetella pertussis of 20 billions, tetanus toxoid of 20Lf, and AIPO4 of 1.2mg. The combination vaccine is adsorbed by agitation (a Gyrotary shaker, G-2, NBS Co., U.S.A.), at 100rmp and for 12 hours.

③ The relative potency of anti HBs of the hepatitis B-DPT vaccine is 0.86 on 30 days after the guinea pigs are immunized, 0.96 at 60 days, 0.96 at 90 days, and 0.95 at 150 days. The results indicate that the vaccines are not mutually influenced greatly in generating antibodies. The relative potency of diphtheria of the hepatitis B-DPT vaccine is 1.14 in the guinea pigs. The relative potency of pertussis is 1.09 in mice. The relative potency of tetanus is 1.41 in the guinea pigs. Even if the combination of the hepatitis B vaccine and the DTP vaccine is used for immunization, the effect of preventing infection does not decrease, compared with the case where each vaccine is separately applied.

2. Patent Court’s decision (2005HEO49)

(1) Requirements as prior art

If a cited invention used to determine the novelty or inventive step(s) of an invention is clearly described with respect to the technical constitution in its entirety, or even if it is insufficiently described due to a lack of materials or it has a defect in a part of the contents, it can be subjected to comparison as far as any person skilled in the art can easily understand its technical contents, based on the technical common sense or the rule of experience. However, if the contents of a cited invention are clearly against the basic common sense or the rule of experience in the corresponding art, and if such errors are of great importance in the cited invention so as to make the entire contents of the cited invention unreliable, it is difficult for the person skilled in the art to understand the technical contents properly. Even if the skilled person understands the technical contents, since there is no objective possibility to consider the cited invention as prior art, such an invention cannot be regarded as a legal cited invention.

However, if a cited invention is clearly described in terms of the constitution and effects, and if a patented invention factually has the same effects through the same constitution as the cited invention, the cited invention shall not be hastily excluded from the category of prior art on the reason that the cited invention has a certain error or a point making the reliability of the contents doubtful. Exceptionally, if the contents of the cited invention are against the technical common sense or the rule of experience such that any person skilled in the art cannot help but exclude the technical meaning of the cited invention, such a cited invention shall be excluded from the prior art. However, the aforementioned reason shall be individually judged by considering all circumstances, such as the features of a corresponding technical field, the technical level and the rule of experience of the skilled person, how easy it is for the skilled person to avoid or correct the problems included in the cited invention by considering the time interval between the time when a cited invention is publicly known and the time when an application of a patented invention is filed and the extent of technological development in the meantime, the urgency to solve the problems in the corresponding technical field at the time of filing the application of the patent invention, and so on.

(2) It cannot be denied that the cited invention is insufficiently described due to the lack of materials or it has an error in a part of the contents. However, considering the technical common sense at that time where the priority of the present patented invention was filed, a person having ordinary knowledge in the technical field to which the invention pertains can easily understand, from the disclosure in the cited invention, the technical contents, “the combination vaccine, which is prepared by adsorbing all of the hepatitis B surface antigen (HbsAg) and antigens against diphtheria (D), tetanus (T) and pertussis (P) to aluminium phosphate (AP), has no big difference with respect to the potency, compared with a single vaccine including the hepatitis B surface antigen (HBsAg)”. Therefore, the cited invention is considered as prior art, which is provided to determine the novelty and inventive step(s) of the present patented invention relating to the “combination vaccine including the hepatitis B surface antigen and the other antigens.”

3. Supreme Court’s decision (2006HU1957)

Regarding a comparative invention which is provided to determine the novelty and inventive step(s) of an invention, not only the comparative invention which is clearly described with respect to the technical constitution in its entirety but also the comparative invention which is an incomplete invention, which is insufficiently described due to the lack of materials or which has an error in a part of the contents can be regarded as prior art if a person having ordinary knowledge in the corresponding technical field can easily understand the technical contents by considering the technical common sense at the time of filing an application of the invention.


II. Trial for Invalidation of Utility Model Registration No. 277081

Patent Court’s Decision No. 2006HEO6283 published on Jun. 15, 2006
Supreme Court’s Decision No. 2006HU1872 published on May 29, 2008
- dismissed

1. Patent Court’s decision (2006HEO6283)

(1) Requirements as literature of prior art

Regarding a cited device which is provided to determine the novelty and inventive step(s) of a device, not only the cited device which is clearly described with respect to the technical constitution in its entirety but also the cited device which is an incomplete device or which is insufficiently described due to the lack of materials can be considered as prior art if a person having ordinary knowledge in the corresponding technical field can very easily understand the technical contents based on the rule of experience. However, to approve that a device is disclosed in a publication, at least it is required to present which constitution the device has. Therefore, when a device is characterized by its inside but its outside picture is disclosed, the device is  

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