In this case, the court found that “… each of the present patent specifications state a method of preparing an immunized mouse in accordance with an immunization program procedure and schedule, a method of preparing a hybridoma, a method of carrying out a screening and an epitope binning assay to identify and obtain binding neutralizing antibodies of PCSK9 and LDLR competing with a reference antibody. And it can be said that by the foregoing methods, any antibody, other than that disclosed in each of the present patent specifications, competing with the reference antibody can be obtained. If so, it cannot be said that the claimed invention can be carried out by a person skilled in the art based on the statements in the present patent specification limited to a specific antibody described in the patent specification or an antibody that has an amino acid sequence in which one or several amino acids at specific positions in an amino acid sequence of the specific antibody are substituted. Therefore, the following defendant’s argument cannot be accepted: the technical scope of the invention is limited to a specific antibody described in the patent specification or an antibody that has an amino acid sequence in which one or several amino acids at specific positions in an amino acid sequence of the specific antibody are substituted on the premise that a person skilled in the art can carry out the claimed invention based on the statements in the present patent specification limited to a specific antibody described in the patent specification or an antibody that has an amino acid sequence in which one or several amino acids at specific positions in amino acid sequence of the specific antibody are substituted.
⇒ This is a case which considers the technical scope of an invention stated by a functional expression in the claims. For example, in the Intellectual High Court Case No. 2012 (Ne) 10094; “Anti-theft Connector for a Computer and Other Equipment” case, the court indicated the general interpretation criteria for claims of functional definition stating that “in the case where the structure of the invention is stated by a functional or abstract expression in the scope of claims …, the technical scope of the invention should be ascertained in consideration of the statements in the detailed explanation of the invention in the description, … based on the technical ideas indicated in the specific structure disclosed therein. However, this does not limit the technical scope of the invention to the specific working examples stated in the description, … to include structures which are not stated as working examples but can be worked by a person who has ordinary knowledge in the technical field of the invention (a person ordinarily skilled in the art) based on the content of the statements concerning the invention disclosed in the description.”
In this case, the court closely examined the description of the patent specification and then found that “as stated in paragraph 2, a person skilled in the art could recognized from the description that various binding neutralizing antibodies of PCSK9 and LDLR competing with the reference antibody included in the scope of the claims of the invention other than neutralizing antibodies competing with the reference antibody in the description might be obtained by using a screening method described in the specification.”
⇒ Since in “paragraph 2” the court considered whether or not the defendant’s product falls under the technical scope of the plaintiff’s invention which is stated by a functional expression in claims, the above-mentioned finding of the court is considered to imply that the issue of whether or not the technical scope of the invention stated by a functional expression extends to any structure other than the structure specifically described in the “Examples” section, and the issue of whether or not any structure other than the structure specifically described in the “Examples” section is supported in the specification are two sides of the same coin and has the same items to be considered (and according to the judgment of this case, the issue of whether or not the statements in the description satisfy the enablement requirement is also inextricably linked thereto).
In the case where the technical scope of the invention stated by a functional expression in claims is found not to extend to any structure other than the structure specifically described in the “Examples” section (in other words, in the case where a person skilled in the art cannot carry out any invention other than those described in the “Example” section based on the statements in the description), the technical scope of the invention stated by a functional expression in claims is limited to those described in the “Example” section, and the invention is supported and can be carried out to that extent. In view of this, it can be said that they are two sides of the same coin.
The present invention is defined in the claims in functional terms with regard to the technical effect, that is, an antibody which (i) competes with the reference antibody, and (ii) is capable of neutralizing the binding of PCSK9 and LDLR; therefore it covers any antibody having such characteristic features even if it has not been discovered as of the filing date (so-called “reach-through” claims). With regard to whether or not the accused antibody falls under the technical scope of the invention stated by a functional expression in claims, if a person skilled in the art can prepare it based on a statement regarding the invention disclosed in the description, the accused antibody may be found to fall under the technical scope of the invention. On the other hand, (not just for claims of functional definition) the support requirement requires that a problem to be solved by the invention can be recognized by a person skilled in the art. Therefore, there is also an opinion that they are not simply two sides of the same coin.
Writer: Hideki TAKAISHI
Supervising editor: Kazuhiko YOSHIDA
Contact information for inquiries: h_takaishi@nakapat.gr.jp
Hideki TAKAISHI (The person in charge of this Article)
Attorney at Law & Patent Attorney
Nakamura & Partners
Room No. 616, Shin-Tokyo Building,
3-3-1 Marunouchi, Chiyoda-ku
Tokyo 100-8355, JAPAN