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    How should pesticide companies respond to competitors’ attempts to secure patent filings?


    Release Date:

    2018-06-26

    Pesticide manufacturing is a patent‑intensive industry, with its development heavily reliant on the acquisition and effective utilization of patents. As China’s national intellectual property strategy has evolved, pesticide companies—key innovation players—have gradually deepened their understanding of the patent system; however, they still fall far short of the level required to master and flexibly apply patent law in order to effectively safeguard their R&D achievements. From research and development through to market launch and commercialization, pesticide innovation demands not only substantial R&D investment but also a well‑crafted patent‑filing and portfolio‑management strategy. This encompasses everything from active ingredients and their preparation processes, intermediates and their synthesis methods, formulated compositions and application techniques, to finished formulations and their manufacturing procedures.

       Pesticide Manufacturing is a patent-intensive industry, and its development heavily relies on the acquisition and utilization of patents. With the advancement of China’s national intellectual property strategy, Pesticide Enterprises—as the primary innovators—are steadily deepening their understanding of the patent system; however, they still fall far short of the level required to master and flexibly leverage the system in order to effectively safeguard their R&D outcomes. Pesticide Innovation, from research and development to market launch and promotion, not only requires substantial R&D funding but also a well‑crafted patent‑filing strategy to ensure protection. From… Pesticide The active ingredient and its preparation process, the intermediates and their preparation processes, the formulated compositions, the methods of use, as well as the finished formulations and their preparation processes all fall within the scope of patent protection. Generally speaking, from… Pesticide With the filing of active‑ingredient patent applications, applicants typically seek patent protection for their R&D outcomes at each stage of a predefined technological development roadmap. The subject matter of these patents corresponds to the research and development achievements attained at various milestones along that roadmap. Since… Pesticide The technological R&D roadmap is relatively mature, making it easy for competitors to build directly on existing research outcomes, advance subsequent developments, and secure patent filings. At this point, the differences in mastery and application of the patent system become evident. Pesticide Does the enterprise leave its competitors with opportunities to leverage layout‑design strategies to secure patent applications?
      1. Typical Cases of Competitors Employing Layout Strategies to Secure Patent Applications
      Case 1: On July 14, 1999, the Shenyang Research Institute of Chemical Industry filed an application with application number CN99113093.6, titled “Heterocyclic Substituted Isoxazolines as Fungicides,” which was granted on September 25, 2002. Subsequently, in 2004, the institute published in… Pesticide The journal published the preferred compound SYP‑Z048 from that patent—known in Chinese as diniconazole—and provided a detailed description of it. Subsequently, on December 23, 2004, BASF filed a patent application for a fungicidal composition containing diniconazole, which encompassed diniconazole combined with virtually all known fungicidal active ingredients. On December 21, 2005, BASF re‑filed a formal application, claiming priority from the earlier filing; the application number was CN200580044738.7, with the invention titled “Fungicidal Mixture.” The patent was granted on June 16, 2010, and independent claim 1 reads: “A fungicidal mixture for controlling plant pathogenic fungi, comprising two active ingredients in a weight ratio of diniconazole to a phalloidin‑type compound ranging from 20:1 to 1:20.” Because the Shenyang Research Institute of Chemical Industry failed to promptly initiate research and development on diniconazole‑based formulations or file corresponding patent applications, and also did not implement confidentiality measures for diniconazole, BASF successfully secured the patent for diniconazole‑based mixtures ahead of the Shenyang Research Institute.
      Case 2: Flupyradifurone is a product from Japan. Pesticide The product developed by the corporation had its active‑ingredient patent filed on November 2, 2000, under application number CN00136858.3. The invention is titled “Substituted Aminoquinazolinone (Thione) Derivatives or Their Salts, Intermediates Thereof, and Pest Control Agents and Methods of Use.” Due to Japan… Pesticide In Patent CN00136858.3, the company only lists the structural formula of flupyradifurone in the table and does not provide any biological data on the compound’s insecticidal activity; therefore, Syngenta, upon learning of Japan… Pesticide Following the submission of the chemical structural formula for pyrifluquinazone (also known as flupyradifurone) by the company, a patent application was promptly filed covering methods for controlling insects using flupyradifurone. The patent included comprehensive biological data and was ultimately granted, successfully securing a method‑related patent for flupyradifurone. The patent application, filed on June 20, 2008, bears the application number CN200880022218.X, with the invention title “Methods for Controlling Insects.” The granted claims recite: a method for controlling insects comprising applying the active ingredient 1-acetyl-1,2,3,4-tetrahydro-3-[(3-pyridinylmethyl)amino]-6-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]quinoxaline-2-one, in its free form or as an agriculturally acceptable salt, to Coleopteran insects.
      Case 3: On September 9, 2005, Syngenta filed an application with the international patent number WO2005US32080, titled “Substituted Isoxazoles as Fungicides,” which was published on March 23, 2006. BASF, by contrast, filed a priority document on June 6, 2007, and subsequently submitted a formal national application on June 5, 2008, bearing the Chinese application number CN200880019173.0, entitled “Fungicidal Compositions.” The formal application included the substituted isoxazole compound along with nearly all known fungicidal active ingredients in combination. Although this application was deemed withdrawn after the applicant failed to respond to the examination opinions during the substantive examination phase, the prior publication of the patent rendered all such formulated compositions public domain, thereby directly impacting Syngenta’s subsequent patent‑filing strategy.
      In the three cases mentioned above, the patent applications were all filed by multinational corporations; however, in China… Pesticide Companies are well aware of this strategy when it comes to securing patent applications for compounded compositions.
      Case 4: The active‑ingredient patent for chlorantraniliprole, developed by China National Chemical Corporation and the Shenyang Research Institute of Chemical Industry, bears application number CN200810116198.4, was filed on July 7, 2008, and is titled “1‑Substituted Pyridyl‑Pyrazole Amide Compounds and Their Applications.” It was granted on April 13, 2011. Meanwhile, Shaanxi Thompson Biotechnology Co., Ltd. filed a substantial number of patents in January 2013 covering chlorantraniliprole‑based formulated compositions, thereby securing early priority in this area and directly impacting the patent‑filing strategy of the original active‑ingredient patent holder.
      2 The Importance of Experimental Data in Securing Patent Applications
      With respect to preemptive patent filing, the length of time elapsed from learning about another party’s research and development成果, through conducting one’s own innovative research and achieving R&D results, to finally filing a patent application, is critical in determining whether such preemptive filing can succeed. Moreover, Pesticide It belongs to the experimental applied disciplines, Pesticide The efficacy of a pharmaceutical product is highly dependent on the experiments and their associated data; accordingly, the experimental data disclosed in patent applications constitute the primary evidence for demonstrating the technical effects of the claimed invention. However, with respect to the objectivity of such experimental data, it can be categorized—based on its origin—into true values derived from actual experiments and empirical values inferred from prior art. In some cases, to expedite the development process, inventors may substitute partial or complete empirical values for true values in the specification. When the difference between true values and empirical values is negligible, the experimental data does not undermine the patent’s stability; by contrast, when a significant discrepancy exists between the two, the patent’s stability may be affected by the experimental data.
      Case 5: A certain… Pesticide A company and a university have jointly developed a new… Pesticide compound and filed a patent application; subsequently, while the company was investigating this compound in comparison with known… Pesticide When studying their combined use, it was found that competing companies considered this compound along with all known agents that could potentially be used in combination. Pesticide A large number of patents have been filed for combination‑use claims; however, the underlying experimental data are clearly unreliable and internally inconsistent. Consequently, the company has filed a request for invalidation on the grounds that the experimental data are false. Yet the competing firm has warned that, given the considerable difficulty of individually demonstrating in the invalidation proceedings that the experimental evidence supporting these “combination‑therapy” patents is flawed, it demands that the company license it to use the earlier‑filed… Pesticide Compound patents. Li Yue of the Patent Reexamination Board pointed out that, for experimental evidence submitted with falsified data, efforts should be made to ensure its formal completeness at the time of submission. At a minimum, the information contained in such evidence—ranging from the experimental procedures to the results—must be clear and detailed, so as to enable the public to verify the objective authenticity of the experimental findings based on the provided information. Furthermore, the names of the natural persons and institutions that conducted the experiments should be disclosed, allowing for subsequent verification of the experimental circumstances.
      3. Measures and Recommendations for Countering Competitors’ Patent‑Filing Aggressions
       Pesticide How can companies counter competitors who use patent‑filing strategies to secure a competitive edge? First and foremost, implementing robust defensive confidentiality measures is essential. Drawing on extensive experience in the research and development of numerous novel compounds, in… Pesticide The seven to eight years between filing a patent for an active pharmaceutical ingredient and the product’s market launch represent an optimal window for implementing a robust patent‑defensive strategy. When initiating such a strategy, applicants can conceal the compound slated for commercialization by claiming it in the form of a generic structural formula, thereby preventing competitors from discerning its identity from the patent application documents. Subsequently, R&D resources should be concentrated on completing the development roadmap as thoroughly as possible before market entry, promptly filing patent applications to leave competitors no room or time to secure patents. Importantly, avoid publicly promoting the compound in academic journals or other public forums. Second, proactively address any attempts by competitors to file preemptive patent applications. Continuously monitor patent filings related to the generic structural formula; upon identifying such applications, submit third‑party observations to challenge them and prevent competitors from obtaining patent grants. Third, if experimental data in a competitor’s granted patent application appear questionable, compare them against your own experimental records using a traceability mechanism, commission qualified third‑party laboratories to verify the data, and leverage the resulting evidence to file a request for invalidation. Fourth, leverage the patent system and legal remedies to safeguard R&D achievements. With respect to misappropriation of trade secrets, resolutely pursue legal action and fight to the end. Pesticide Only by effectively protecting their R&D achievements and preventing competitors from exploiting any vulnerabilities can companies truly reap the value of innovation.

     

    Author: Wang Tingting, Sun Xiaozhen Source: Pesticide Science and Management

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