The Right Of Defense In Pharmaceutical Patent Infringement Litigation In The Law Applies In Patent Law

The right of defense as a passive and defensive right, is established to balance the legitimate rights and interests between the parties, so is the right of defense in patent law. But for the specific applicable condition of the statutory rights of defenses, and the application in the drug field, there are always differences between the relevant judicial interpretations and trial practice, this confusion in application of law is not conducive to timely protect the legitimate rights and interests of the parties, also is not conducive to realize the legislative purpose of the right of defense in patent law.Looking through the relevant cases and found that the pharmaceutical patent infringement case mostly involving the defense of prior art, right of prior use of defense, bolar exceptional defense, so the article only study in the application of the above rights of defense in pharmaceutical patent infringement litigation.Firstly, the article discussed the domestic and foreign legislative status, status of existing research and status of the research of application in pharmaceutical patent infringement litigation about the prior art defense, right of prior use of defense, bolar exceptional defense by the method of researching; comparative analysis of the differences of the provisions about the application conditions of the above right of defense in"a number of patent infringement advices (Trial)" issued by the People's High Court of Beijing, "the trial of patent infringement cases on the statute of disputes applicable to the provisions of the system a number of issues (conference discussion paper 2003.10.27-29)" announced by the Supreme People's Court, "the Interpretation on Issues Related to Law Application in the Trial of patent infringement disputes" released by the Supreme People's Court; then statistics of the pharmaceutical patent infringement litigation cases involved in the above right of defense, made classification and summarized, to find out the focus of controversy; Deep exploration about the applicable conditions of the right of defense in patent law in pharmaceutical patent infringement litigation with typical cases, especially for the contentious issues by interviewing experts, to give some personal suggestions, in order to provide reference for the application of law in pharmaceutical patent infringement litigation.The conclusion is in applying the prior art defense, firstly should compare the infringing technology with the patent technology, if the result is falling into the scope of patent protection (whether by way of falling into the same or equivalent), and then compare all the technical characteristics of the scope in infringing technology with the corresponding technical characteristics in the prior art, if they are the same or not materially different, then the prior art defense succeed. Which the prior art is limited to an independent and integrated technical solutions or simple combination of general knowledge or known technologies by a person skilled in the relevant field of technology. In addition, as a special case, if founding the fact that both the accused technology and the prior art are the same technology, then the prior art defense succeed. In the pharmaceutical field mainly refers to the drug standard as a mandatory standard, all the pharmaceutical companies and relevant departments must be strictly observed, if the standard itself is the prior art, so the producers'behavior complying with the standards does not constitute patent infringement, t is noteworthy that, in patent infringement disputes, when the accused technology and the prior art are equivalent, if the evidence provided by the defendant is insufficient to destroy creative of the patent in invalidation proceeding, The decision is still remain patent effective, the court reviews the principles of the prior art defense, should not directly make the sentence based on the decision, but should compare all the technical characteristics of the scope in infringing technology with the corresponding technical characteristics in the prior art, then further reviews the prior art defense.In applying right of prior use of defense, for the pharmaceutical field, in order to meet the element "make the necessary preparations to manufacture, using", The defendant can provide the preparations of production facility, to proof has prepared the main equipment for the production of the drugs, if the drug requires special equipment, you should provide evidence that has purchased special equipment; if you have the generic drug equipment, you can provide the evidence of raw materials, technical drawings or technical documents and other aspects of preparing to prove. On the element of "the original scope", first of all the dependant should bear the burden of providing evidence to proof that only to continue to manufacture, use within the original scope. On the definition of original scope, refer to the definition of "the Interpretation on Issues Related to Law Application in the Trial of patent infringement disputes" released by the Supreme People's Court. In addition, I believe that the source of the first use technology is not a necessary condition for the success of right of prior use of defense, but if the plaintiff claims an illegal source of the technology used by defendant, the Court should insist the principle of "illegal does not support" based on the relevant evidence, and the defendant bear the adverse consequences of the defense.The right of prior use of defense requires the higher completeness of the evidence, in applying right of prior use of defense, the evaluation of "whether make the necessary preparations or not", regards to the issues that the defendant has already submitted an drug application for registration, the application of pharmaceutical production license or has granted drug approval number, pharmaceutical production license and has made the samples and passed the test, should be judged in the specific circumstances of the case.In applying bolar exceptional defense, firstly should strictly control the uniqueness of purpose-to provide the information needed by administrative approval; Secondly, the type of the implementation behavior is limited to the manufacture, use, import, rule out behavior of sale and offering for sale, need to notice that, the behavior of enlargement production for the purpose of sales, are also violations; In addition, tort immunity includes not only the defendant who direct implementation, but also third person who provide patented products; Finally, the provision is limited to patented drug or patented medical devices. The above implementation behaviors can choose to play in any time from the patent publication date to the expiry of patent protection, the relevant pharmaceutical companies can strictly grasp the deadlines according to the actual situation, for the product can be immediately marketed after. The patents expire.