“Novel crystalline form of Pitavastatin calcium” Case: A case in which, by understanding the problem to be solved by the invention abstractly and conceptually, the support requirement for specifications was found to be satisfied.
In order for a grandchild application to be deemed as having been filed at the time of filling of a parent application, not only the grandchild application but also a child application must respectively fulfill the requirements for division in relation to the parent application.
⋯ in the patent specification, there is a description to the effect that Pitavastatin calcium is used for the treatment of patients with hypercholesterolemia, different polymorphs thereof influence pharmaceutical properties, and Invention 1 is the discovery of new crystalline polymorph forms of Pitavastatin calcium designated as constituent components A to E. Therefore, it can be said that the problem to be solved by Invention 1 is to provide crystalline forms of Pitavastatin calcium identified as constituent components A to E. ⋯
In the patent specification, there is a description to the effect that a crystalline polymorph of Pitavastatin calcium was prepared by the process described in [0047]; the prepared product exhibited 26 relative intensity patterns with no deviation, and a water content thereof measured by thermogravimetry coupled with FT-IR spectroscopy was approx.10%. Further, in the patent specification, there is a description about deviation. So it is recognized that those skilled in the art can prepare a crystalline polymorph (element corresponding to the constituent component D) of Pitavastatin calcium (element corresponding to the constituent component C), which exhibits 26 relative intensity patterns within the deviation (element corresponding to the constituent component A), and a water content thereof measured by thermogravimetry coupled with FT-IR spectroscopy is about 10% (element approximating to the constituent component B). Furthermore, those skilled in the art can recognize, taking into consideration the technical common knowledge, that a crystalline polymorph containing water less than 10.5% (w/w) or more than 10.7%, but not 10% (w/w), can be prepared by changing the dry condition of preparation process described in [0047].
In addition, the fluctuation range of relative intensity of the peak in a power X-ray diffraction pattern is relatively large, and, for this reason, a relatively small peak value may not be accurately measured. The foregoing is the technical common knowledge of those skilled in the art at the time of filing the present application. ⋯ Therefore, regarding X-ray powder diffraction pattern, those skilled in the art can recognize, taking into consideration the technical common knowledge, that the constituent component E prepared by the process described in [0047] does not always exhibit 26 relative intensity patterns within the deviation.
Therefore, those skilled in the art can recognize, taking into consideration the description of the present patent specification and the technical common knowledge, that crystalline polymorph forms of Pitavastatin calcium identified as constituent components A to E can be prepared. ⋯
In view of this, it can be said that those skilled in the art can recognize, taking into consideration the description of the present patent specification and the technical common knowledge, that the problem to be solved by Invention 1 which is to provide crystalline polymorph forms of Pitavastatin calcium identified as constituent components A to E can be solved.
The substantive requirements for a lawful divided application are as follows: (i) more than two inventions were included in the description, statement of the scope of claims, or drawings of the original application; (ii) the invention pertaining to the new application is a part of the inventions stated in the description, statement of the scope of claims, or drawings, of the original application; and (iii) the invention pertaining to the new application falls within the scope of the matters initially stated in the description, etc. of the original patent application. In order for the application in question to be deemed as having been filed at the time of the filing of the first application, the application in question, the third application, and the second application must respectively fulfill the abovementioned requirements for division (i) to (iii) in relation to the original application. ⋯
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