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The administration characteristics and certain therapeutic effects do not impose a limiting effect on the requirements for pharmaceutical use

2014-2-11 16:24| Announcer: admin

Our patent law protects the pharmaceutical use of known compounds, but how should such claims be written and how to determine their scope of protection has been a highly controversial issue in the industry 
There are often technical features such as administration of the subject, dosage, time interval, medication effect, and the like in such claims. Whether or not to consider the limitations of these technical features on the technical use of pharmaceuticals has an important and even decisive impact on whether it has novelty and creativity. 
In April 2009, the Patent Reexamination Board made a decision on the invalidation of request No. 13188 (decision 13188), and the invention patent No. 99812498.2 (the pharmaceutical use of methicillin) was null and void because of its lack of novelty and creativity. The patentee filed an administrative suit, the first instance, the second instance decided to maintain decision 13188. The patentee to the Supreme People's Court to the retrial, and in the Supreme Law recently made (2012) Know the word No. 75 administrative ruling was final dismissed. 
Beijing Boss & Young is pleased that the client's appeal has been supported by the Patent Reexamination Board and the Administrative Litigation Courts at all levels and is willing to share this case with you. 

Case introduction: 
The use of a monosporine in the preparation of a medicament for the treatment of a bacterial infection in a patient without the need for skeletal muscle toxicity, wherein the dose for the treatment is 3 to 75 mg / kg Wherein the dose interval is once every 24 hours to once every 48 hours. 
Decision 13188 
Since there is no evidence that further understanding of the side effects of doxorubicin do not produce skeletal muscle toxicity makes it possible to distinguish the pharmaceutical use claimed in claim 1 from the known use of evidence 6, and the dosage, repeated administration and administration interval feature is a physician In the course of treatment for patients to select and determine the information belonging to the medication process information, and the pharmaceutical process has nothing to do, so these technical characteristics of the drug itself does not limit the role. On this basis, the pharmaceutical use of claim 1 can not be distinguished from the known use of evidence 6, so that it does not have novelty; it is determined that the dependent claims are not creative. 
The argument of the patentee 
& Quot; does not produce skeletal muscle toxicity & quot; makes claim 1 directed against a new indica of dicamycin, which causes it to be substantially different from the pharmaceutical use of the prior art; the dosage, time interval is not a medication The results of the selection of treatment programs, but in the development process, the pharmaceutical process for the determination of the process of treatment, and the pharmaceutical process is closely related. It is the pharmaceutical process to determine the drug instructions, the contents of the label, the subsequent occurrence of the prescription medication prescription restrictions. Thus, these characteristics have a limiting effect on the pharmaceutical process and should be taken into account. 
The highest law 
First, "do not produce skeletal muscle toxicity" is the result of changes in certain indicators of the body after the administration of methicillin, not the symptoms presented before the medication; it does not alter the subject and the indication of the treatment, nor the drug New performance. 
Second, the patent law of the pharmaceutical process usually refers to the specific steps, processes, conditions, raw materials to prepare specific drugs themselves behavior, does not include the drug manual, label and packaging and other drugs manufactured before packaging process. 
Furthermore, the unit dose usually refers to the amount of drug contained in each drug unit, depending on the amount of drug added when the drug is formulated. Dosage refers to the amount of each or daily dose, refers to the use of drugs, drugs by the user's own decision, is the use of drugs. The dosage and administration time interval characteristics defined in claim 1 are to be understood as administration characteristics which do not necessarily affect the pharmaceutical process and do not exhibit medical practice in the pharmaceutical phase. 
Thus, the administration and administration effects of claim 1 are not necessarily linked to the pharmaceutical preparation itself, and the pharmaceutical use of claim 1 is not different from the known pharmaceutical use of the prior art. 

Case Study: 
1. On the meaning of pharmaceutical use in the sense of patent law 
The highest law finds that the listing of drugs, labels and packaging of drugs and other drugs involved in the factory before the attachment and packaging processes do not belong to the patent law of the technical characteristics of the drug should not be determined to determine the patent law on the use of pharmaceutical purposes The factors that should be considered when dealing with patentability.  
2. How to consider the characteristics of drug effects 
It can be seen from this case whether the efficacy of the drug has a limiting effect on the use of the pharmaceutical application, depending on whether the effect reflects a change in the treatment of the indication and whether it has a substantial effect on the drug preparation process. 
3. The difference between unit dose and dose is treated 
In this case, the Supreme Law has introduced the concept of unit dose only when comparing the differences, but this quotation indicates that the unit dose in the pharmaceutical formulation or dosage form should still be used as a technical feature in relation to the pharmaceutical process Sexual evaluation to be considered. Although both are dose, but in the patent sense, both of the role of the limits of the use of pharmaceuticals are significantly different. 
It can be seen from the trial process that the characteristics of drug use in the pharmaceutical compounds of the known compounds do not have a limited role in the current patent administration and the judiciary in China has a more unified understanding. The case clearly indicates the place where the applicant and the agent should pay attention to the future preparation of such an application document.
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