1. Choose an appropriate application opportunity to extend the protection period of patented drugs.
Patent application must cooperate with the overall patent strategy of the enterprise and serve the industrial manufacturing and sales of the enterprise. When you apply for a patent, you should choose a suitable application opportunity, neither too early nor too late. Applying in advance and making it public means providing your own technical information to your competitors in advance, wasting the limited patent protection period for no reason; However, if the application is too late, competitors may apply for patents first, which will not only protect the innovation achievements of enterprises, but will also be controlled by competitors' patents. Under normal circumstances, enterprises should consider the following factors when choosing the application opportunity: ① the degree of completion of the invention. Biomedical field usually needs experimental data (effectiveness, safety or stability, etc. ) to prove the feasibility of the invention and the effect achieved, so as to meet the minimum requirements of the patent application; (2) Pay close attention to the possible progress of competitors, and prevent innovations from being preempted by others; (3) Market planning: First, give consideration to the progress of patent application and drug registration, and try to synchronize as much as possible; The second is to give consideration to the marketing plan of the company's series products and the market demand of the products.
When there are many competitors with innovative achievements, or the R&D strength of the enterprise is equal to that of the competitors, or the market demand for innovative technologies is strong, or innovative technologies are easy to be imitated, it is suitable to apply first: when the enterprise has completed the R&D of the core technology, but the competitors have not developed the strength of the technology, the enterprise should pay close attention to the R&D of the peripheral technology, and can apply for patents together after the peripheral technology is developed; We can also apply for patents for technologies that are relatively advanced and difficult to be developed by others when competitors are about to catch up. In addition, according to the needs of the enterprise's overall patent strategy, we can sometimes apply for the patent of peripheral technology first, and then apply for the protection of core technology at an appropriate time. For example, when planning a patent application involving a drug on the market, an enterprise can apply for the compound of the general formula separately from the listed compound within an appropriate time interval, or appropriately delay the filing time of the patent application for the listed compound, thus relatively extending the patent protection period after the drug is listed.
2. Extend the protection period of patented drugs by selecting inventions.
Choosing an invention refers to purposefully selecting a single invention that is not mentioned in the prior art in a narrow range or has unexpected effects from a wide range disclosed in the prior art. Although the selected invention usually has a subordinate or dependent relationship with the existing patent, its implementation is limited by the prior patentee, if the right holder appropriately applies the selected invention, he can also cross-license the selected invention or negotiate with the prior patentee, thus effectively reducing the licensing and transfer cost or infringement risk of the enterprise. In addition, if the enterprise owns the core technology of the product itself, and there is no risk that the core technology will be leaked or cracked by others first, it can keep it when applying for a drug patent for the first time, only disclose the general technical scheme, and keep the preferred scheme or the best scheme at the same time, and then apply for an invention patent for the preferred scheme or the best scheme before or after the expiration of the basic patent protection period, so as to reasonably extend the protection period of patented drugs. For example, Lilly Company of the United States applied for an invention patent of benzodiazepine derivatives with the general formula in 1975, and chose olanzapine as the preferred compound from the range of compounds with the general formula in 1995 and applied for an invention patent, which reasonably extended the protection period of drugs on the market for nearly 20 years. AstraZeneca patented the compounds with general formula including omeprazole from 1974. With the deepening of research, its preferred compounds (omeprazole), intermediates and their modifications, metabolites, preparations and their compositions, preparation methods and their improvement methods, polycrystals (types), second medicinal use, combined use, basic salts and crystals were introduced one after another. Hydrate, S- enantiomer cNexiiJm) or its improvement, and gradually formed a strict patent protection network of omeprazole, which not only reasonably extended the patent protection period of omeprazole, but also continuously extended the protection scope of omeprazole, expanded its sales market and made it obtain high profits.
3 extending the protection period of patented drugs through peripheral inventions
Peripheral patents, that is, downstream improved inventions related to upstream basic inventions and limited by them. Enterprises can continue to develop better preparation methods, new uses or other downstream products (such as salts, esters, hydrates, polymorphs or group modifiers) after applying for patents of upstream pharmaceutical products, that is, they can use the subsequent peripheral patents to form an uninterrupted relay for basic patents, and then apply one after another at regular intervals, which can not only protect patented drugs in an all-round way, but also effectively extend the actual protection period and control period of their market share. The development of peripheral patents can generally consider the following aspects: ① Modification or improvement of existing compounds, development of new compounds, intermediates and their modifications, metabolites, new crystal forms f), new configurations, salts, esters, hydrates, compositions, different dosage forms or new preparation excipients, etc. (2) Specific selection of existing compounds or compositions: (3) Improving the existing preparation methods of pharmaceutical compounds or drugs, and developing new preparation methods or intermediate preparation methods; (4) Improve the indications or routes of administration of existing drugs, and develop new drug inventions. If these peripheral technologies or improved technologies have unexpected technical effects, you can apply for patent protection. For example, inventors of compounds such as dihydroartemisinin, artemisinin methyl ether, artesunate, etc., if they submit their applications in time when completing their research, It should be patentable: rosiglitazone maleate with good hypoglycemic effect screened by GlaxoSmithKline once monopolized the international market of this kind of hypoglycemic drugs; many companies benefited from the research and development of various crystal forms and amorphous patents of adefovir dipivoxil: Takeda, Japan, conducted me―too research on omeprazole and lansoprazole with better thermodynamics. In 1986, the oxidation stability, biological activity and lower toxicity than omeprazole were obtained, and they were protected by filing a patent application: after lansoprazole was successfully marketed, the preparation method of optically pure lansoprazole, its oral preparation and its preparation method, the method of oxidizing sulfide groups into sulfoxide groups, the crystallization method of (r)- or (s)- lansoprazole, [(substituted pyridyl) methyl.
4. Use priority to extend the protection period of patented drugs.
According to the provisions of China's patent law, the applicant can file a patent application for the same subject again within 12 months from the date of the first application for a patent for invention or utility model, and can enjoy priority. The legal effect of priority lies not only in excluding the same technology or patent application disclosed between the priority date and the actual application date, but also in extending the protection period of the latter application by no more than 12 months because the protection period of the patent is counted from the actual application date, that is, the priority can extend the protection period of the pharmaceutical patent from the application date of the earlier application to the application date of the later application.
5. Extend the protection period of patented drugs by administrative means.
Because there are many laws and regulations related to the protection of intellectual property rights of drugs in China, there are many protective measures such as national legal and judicial protection, departmental regulations and administrative protection. Therefore, drug patentees can make comprehensive use of these laws and regulations to reasonably extend the protection period of patented drugs. For example, the obligee who obtained a foreign drug patent during the period of 10/0/9861to 1992 12 3 1 can use the Regulations on Administrative Protection of Drugs to extend the drug preparation method or the actual use of the patent in China. Before the expiration of the patent protection period, the patentee of traditional Chinese medicine can apply for the protection of traditional Chinese medicine varieties by using the Regulations on the Protection of Traditional Chinese Medicine Varieties to further extend the market monopoly period of its drugs; If it takes a long time for an enterprise to develop a patented drug, and the patent application for the drug is filed earlier, which leads to the expiration of the patent protection period after the drug is listed, the market exclusive period of the drug can be extended with the help of the safety test period of the new drug of no more than 5 years and the data exclusive protection period of 6 years.
6 comprehensive use of technical secrets and patent means to extend the protection period of patented drugs.
Based on the limitations of patent protection (such as timeliness, openness, and regionality), enterprises need to protect their innovation achievements in various ways, for example, they can also protect their innovation achievements by means of technical secrets. Technical secrets can be used to protect technologies that have high commercial value, but may not meet the patent requirements and cannot be protected by patents. For example, the process, the best conditions, the best scheme, the technical links, the process parameters and the process conditions that affect the technical effect, as well as some formulas (the formulas of some drugs and the secret recipes of ethnic medicines) and production processes that are difficult to crack through reverse engineering. In addition, enterprises do not need to perform any legal procedures to protect innovation achievements by using technical secrets. As long as proper security measures are taken, it is difficult for competitors to crack innovative technologies, and the market monopoly period of products is not limited by time.
Of course, enterprises generally need to comprehensively consider the nature of innovation achievements, relevant market value, the advantages and disadvantages of various systems and other factors when choosing the protection method of innovation achievements. For high-tech content. High-tech that is difficult to be developed and completed by competitors in a short time or obtained through reverse engineering can generally be protected by means of technical secrets first. Once competitors are found to have the R&D strength involved in completing related products, they will file a patent application, which not only prolongs the protection period of innovation achievements, but also gives enterprises more time to evaluate the technical and commercial value of inventions for patent decision-making. If the innovative technology has a long life cycle and is just in its infancy, it should be regarded as a technical secret first, and then apply for patent protection after the technology is close to the application stage or considering the research and development situation of competitors. If the innovation not only meets the protection conditions of trade secrets and patents, but also contains many technologies, and the technology has broad market prospects and a long life cycle, one or more technologies that are easy to be cracked by reverse engineering can apply for patent protection, and one or more technologies that are not easy to be cracked by reverse engineering can be protected by trade secrets. However, when using technical secrets to protect R&D achievements, enterprises should strengthen the confidentiality management of technical secrets to prevent possible leakage risks.
7. Joint protection of patents and trademarks to extend the protection period of patented drugs.
Based on the timeliness of patent protection and the durability of trademark protection, pharmaceutical enterprises can use trademark rights to undertake after the expiration of drug patents, thus maintaining the market advantage of patented drugs. That is to say, pharmaceutical enterprises can use the exclusiveness of patent rights to form a monopoly position of products, and at the same time use trademark rights to continue to control the patented drug market before and after the expiration of the patent protection period, and use the brand effect of trademarks to maintain their image as market leaders, thus effectively maintaining their market dominance and maximizing the resource efficiency of enterprises.
What kind of strategy an enterprise chooses in actual management should be comprehensively considered and adjusted according to the characteristics of the enterprise, the market situation of drugs, the characteristics of the project and the progress of research and development, and all kinds of strategies should be comprehensively used to reasonably extend the protection period or market monopoly period of patented drugs, so as to obtain the maximum profit for the enterprise and recover the research and development cost to the maximum extent.