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The need for unexpected technical effects supports the creativity of the new crystals of the compound

2013-5-2 16:59| Announcer: admin

In this case, the Supreme Court has confirmed that the compound crystals are "compounds that are structurally close to the structure of known compounds" and that there is an unexpected technical effect to support creativity; and evidence that the technical effects not documented in the original application document should be supplemented Accept the letter. 
Case background: 
Due to the particularity of the invention of the crystal compound of the drug compound, in the case of the prior patent right procedure, whether or not the physical conditions such as how to judge the creativity of the claim, the support of the instructions, and the full disclosure of the instructions are met, in particular, how to judge its creativity, Long time 
In August 2008, the Patent Reexamination Board made a request for review of the invalidation of No. 12206 (hereinafter referred to as Decision No. 12206), declaring that the invention of the new tiotropium monosulfonamide patent No. 01817143.5 was null and void because of its lack of creativity. The patentee refused to accept, then instituted administrative proceedings, the case after the first instance, second instance, final judgment to maintain decision 12206. The patentee and the Supreme People's Court to the retrial, was finally rejected the retrial application. 
In April 2013, the Supreme People's Court published the main points of the Administrative Order No. 86 (2011) on the reconsideration case. For the first time in the Supreme Court's case, given the known compounds, the new crystals are creatively related to the legal application and Determine the ultimate identification of the standard, which in the future to deal with similar cases have important guiding significance. 
Case introduction: 
The patentee claims to protect the crystalline monohydrate of tiotropium bromide. 
Approval of the Patent Reexamination Board 
Invalid declaration of the request submitted by the applicant for the evaluation of the creative evidence of tiotropium bromide X hydrate and tiotropium bromide crystals, which are related to the patented tiotropium bromide crystalline monohydrate are the basic core of tiotropic Ammonium compounds. According to the provisions of the Creative Review section of Chapter 10, Section 6.1 of the Review Guide, the compounds that are close to the known compound structure must have unpredictable technical effects to support their creativity. In the case where the patent in question does not provide evidence to prove that such effect exists, the invention is not creative. 
In addition, the patentee submits a counter-evidence in an invalid procedure. The present invention proves that the present invention has a technical effect of "particle size stabilization", but the effect is not described in the original filed patent application document and can not be used Involved in the patentability of the patent. 
The focus of the patentee's argument 
Pharmaceutical compounds Crystals are found to be different from those of new compounds that have been modified in the structure of existing compounds. Therefore, it should not be applied to the "review guidelines" on the "structure with the known compound structure close to the compound, must have unexpected technical effects "The creative judgment criteria. 
Determination of the Supreme People 's Court in the Determination 
The Patent Reexamination Board does not use the relevant provisions of the Review Guide on the creative review of compounds to evaluate the creativity of its crystals. In the practice of review, the above criteria have been applied to evaluate the creativity of the drug compound crystals. This patent should also be applied to the crystalline monohydrate of the compound brominated tropine. 
It is also emphasized that those skilled in the art will endeavor to prepare crystals by conventional crystallization methods after discovering that certain compounds have some pharmacological activity, generally based on the prevailing motivations such as stability and high purity. If crystals can be prepared, the crystal performance is detected; whether the crystal has an unexpected technical effect is to determine whether it is a key factor in creativity. 
With regard to supplementary evidence, the ruling supports the reaffirmation's determination that the technical effect of "particle size stabilization" described in Proof 1 is not documented in the original specification. Therefore, the technical effect of the supplementary certificate should not be taken into account in the creative evaluation. 
Case Study: 
The Supreme Court ruling in this case confirms at least the following aspects of creativity related to the creation of such crystal inventions.: 
1. On the application of law 
Even if the molecular arrangement of the different crystals of the compound may lead to some differences in the physicochemical parameters, the crystalline compound is inherently of the compound category and may be applicable to the relevant provisions of Chapter 10 of Part II of the Review Guide on the inventiveness of the compound. 
2. Judgment criteria for creative height 
The term "structurally close compounds" as referred to in the Review Guide only refers only to the fact that the compound must have the same core or basic ring, rather than a comparison of the differences between the microscopic crystal structures. Therefore, the comparison of the new crystals of the compound with the compound itself or with other known crystals should be based on the determination that the term "structurally close to the known compound has to be expected to have an unexpected use or effect" standard.  
3. Criteria for adoption of evidence of supplementary proof of creativity 
The application of the principle of the first application, the application submitted to prove that the original application documents are not recorded, and according to the existing technology and the contents of the original application documents can not directly determine the technical effect of the evidence can not be used to support the inventiveness of the invention The 
Case Revelation: 
This case is worthy of attention in the case of applicants who specialize in crystal research and development of pharmaceutical compounds and patent attorneys of such cases: 
First of all, the case corrects the emergence of previous authorization procedures, as long as the new crystal on the natural recognition of its creative knowledge and practice. It is now found that the motive for the preparation of crystals is ubiquitous and that the new crystals do not constitute prominent substantive characteristics and that "creativity or effect is expected" is used to prove creativity. 
Second, according to the original standard to obtain the authorization of such patents, are similar to the possibility of being declared invalid. 
Third, in the development or preparation of patent application documents, to fully explore and explain the invention of crystal products, the beneficial effects, and to achieve the "unexpected" level, to prove that the invention of the crystal inventive; the original application documents are not recorded, and Through the follow-up procedures to supplement, usually can not be accepted.
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