Whether it is a developed country or a developing country，The funds of medical protection are limited。So，Encouraging generic drug policy is the development direction of national conditions and policies of various countries。

 

  Many developed countries have begun to establish generic drug encouragement policies in recent years，For example, the share of Japan's proposal to propose the generic drug market will reach 80%。

 

  my country due to historical reasons，Number of generic manufacturers of generic drugs，Number of imitation drug batch texts nearly 100,000，Most batch of articles are repeated imitation status at low levels，Fierce market competition。Purchasing bidding in the hospital，Products with more than 5 manufacturers often fall into the lowest price of vicious competition.。Domestic manufacturers often use patents to obtain the improvement of the quality of generic drugs，The standard chemical composition before 2012、Preparation process and even packaging patents can be used as bonus points。

 

  In recent years，Bidding Purchasing Rules for Patent Incentives，The trend is only for the patent for the original research drugs, especially the domestic new drug 1.1 medicine，The patent of generic drugs will no longer be the focus of policy incentive。The incentives of bidding purchases for generic drugs are more concerned with whether the safety and biological equivalent of the original drug are consistent。

 

  The impact of patents Stake Sports Bettingon stake betting appgeneric drugs，It is also reflected in the problem that the original drug needs to be listed through other patents。It is expected that the number of suspected patent infringement disputes in generic drugs in my country will rise significantly，Patent infringement issues will become the & ldquo; blocking of Land Rover & RDQUO;。

 

  1. Chemical structure and their physical and chemical parameters

 

  The chemical structure and their physical and chemical parameters of the pharmaceutical substance are a necessary component of the right to apply for the patent application document。American drug patents mainly protect new compounds、Biotechnology products、Pharmaceutical crystal type、Optical heterogeneous、New dosage type、New complex preparation、Preparation methods and new indications。

 

  According to Article 56 of the Patent Law in China，The scope of protection of invention or utility model patent rights shall prevail as the content of its claims。So，Patent owners often use the chemical structure or physical and chemical parameters of drugs through the form of claims as the scope of protection of drug patents。The technical indicators of drug patent infringement are usually compared to the protection scope of the protection of infringement and patent claims，Determine whether the same or similar，In the end, it is inseparable from the verification of chemical experiments。

 

  The description of the chemical structure in the patent application document often adopts the Makushi method。The Makush structure is a chemical structure that contains a general class with one or more structures，The variable amount is determined by the number of exchanges for exchanges。That is to say，The chemical structure expressed in the Magash structure is not a certain compound，Can represent a few、dozens of or even thousands of compounds，Uncertainty of the compounds it represents，Interpretation of the scope of protection of claims brings difficulties。In the field of medicine，Families of compounds、The alternatives between homogeneous heterogeneous and simple alternatives between the same ethnic elements are the same or similar in biological activity between the pharmaceutical compounds，Write the pharmaceutical compounds into the Magash structure，It can broaden the interests of the inventor's interests。

 

  stake sports betting My stake betting appappIn addition，Uncertain factor of expressing pharmaceutical substances with physical and chemical parameters，It will also bring difficulties to the judgment of patent infringement。The physical and chemical parameters of drugs generally have a reasonable fluctuation value range，That is, the physical and chemical parameters may not be able to get a point through repeated tests，This will increase the difficulty of understanding the meaning representative of the judge's claims in the claims。

 

  2. Manufacturing method

 

  Method define product，means that the product manufacturing method is used as the technical characteristics to define a patent claim description method of the product，At present, the form of patent claims has been widely used。

 

  The authorization obtained by applying for a patent in the form of claims has strict restrictions。According to the second part of the "Examination Guide" issued by the State Intellectual Property Office of my country，Chemical product claims that cannot be clearly characterized by structure and / or) characteristics that are characterized by structures，Allows to further adopt physical chemical parameters and preparation methods。and stipulate that the application of the method of characterizing the product claim by method is limited to other characteristics outside the preparation method that cannot be fully characterized by the preparation method。but，The international market has some restrictions on the scope of the application of product claims by methods.，If the European Patent Office requires & ldquo; Only when the product itself meets the patent requirements (that is, the product itself is novel and creative)，Only allowed to define the right requirements of the product by product production method。

 

  3、& ldquo; Patent Network & rdquo; and & ldquo; submarine patent & rdquo;

 

  The patent person of the original drug research medicine to protect his original drug intellectual property，Usually not only applying for a basic patent of an isolated drug，but around its basic patent，Applying some peripheral patents such as crystal or adaptive symptoms in succession，Build a horizontal and vertical & ldquo; patent network & rdquo;，So as to protect the patent of drugs in all directions。Another，Patent owners will also set & ldquo; Submarine patent Stake Sports Betting& stake betting apprdquo;，Escape from being retrieved by the patent，Dimrenary use of rare words or different translations to apply for a patent in China，Patent retrieval of patent retrieval for domestic generic drug companies。

 

  4. Details related to drug registration

 

  In our country，The law stipulates that the clinical trial required for the application of drug registration、Clinical Test、Use of other people's patents，An exception to infringe patent rights。

 

  but，During the effective patent right of the original drug，Whether the behavior of drug registration applications proposed by the drug registration applicant belongs to infringe on the patent right of others，my country's "Patent Law" does not clearly specify。This makes CFDA approval difficulty，Also buried landmines & mdash; & mdash; after imitating pharmaceuticals obtained drug approval, they will face patent infringement disputes，Some imitation drugs approval is finally invalid。

 

  In the end，The provisions of Article 69 (5) of Patent Law of my country only borrowed the provisions of Article 271 (E) (1) of Article 271 (E) (1) of the US Patent Law，No reference to the formulation of infringement regulations on items (2) of this clause (that is, anyone will submit an application for new drug registration or generic drug registration applications to the drug administrative department in the patent protection period，All constitute an act of infringing patent rights)。

 

  American FDA in the process of approval，If the patent person proposes to invade the patent of generic drugs，then FDA provides a 30 -month patent litigation time to the patent person，and simplify the application materials of generic drugs for review。If the patent litigation time of 30 months，The patent protection period of the original research drug expires or the patent infringement litigation of the patent owner is defeated，and the application materials for generic drugs meet FDA's approval requirements，The final approval of generic drugs are listed，Effective date is the expiry date of the patent protection period of the original drug or the court's decision to take effect。If the patent period of a 30 -month patent litigation time has not expired，At the same time, the court did not make a final judgment on patent infringement disputes，FDA can directly approve the listing of generic drugs，Effective Stake Sports Bettingdate My stake betting appis 30 months of litigation time expires，But the approved imitation drug patent infringement risk is borne by the applicant of the generic drug。

 

  my country's current regulations are not conducive to domestic generic pharmaceutical companies proposed to confirm no infringement lawsuits before the expiration of the patent protection period，Can only resolve patent infringement disputes in the after -sales of generic drugs。If the pharmaceutical pharmaceutical will become the key medicine supported by my country，Patent Law should learn from the US drug patent system，Increasing patent dispute coordination mechanism for drugs during the registration process，and the result of patent infringement dispute judgment as a factor that affects the results of the approval，to reduce the possibility of a large number of patent infringement disputes after the successful registration of generic drugs，Maximum the social effects that the generic drugs should be exerted to the greatest extent。