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

Release Date:

2018-08-24

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 advanced, pesticide companies—key innovation actors—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. The scope encompasses active ingredients and their preparation processes, intermediates and their synthesis methods, formulated compositions, application techniques, as well as finished formulations and their manufacturing processes—all of which are subject to patent protection.

　　 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 remain far from achieving the level of proficiency required to flexibly leverage the system and 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 protected by these patents corresponds to the research and development achievements attained at specific nodes along that roadmap. Since… Pesticide The technological R&D roadmap is relatively mature, making it easy for competitors to build directly upon existing research outcomes, pursue follow-up developments, and secure patent filings. At this point, the differences in mastery and strategic utilization of the patent system become evident. Pesticide Does the enterprise leave competitors with opportunities to leverage its layout strategy 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 Isoxazoline Compounds 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 an overview 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 is CN200580044738.7, with the invention title “Fungicidal Mixture,” and was granted on June 16, 2010. The granted 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, with the invention title “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 flupyradifen) by the company, a patent application was promptly filed covering methods for controlling insects using flupyradifen. The patent included detailed biological data and was ultimately granted, successfully securing a method‑related patent for flupyradifen. 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 specify: 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: Syngenta filed on September 9, 2005, an application with the number WO2005US32080, titled “Substituted Isoxazoles as Fungicides,” which was published on March 23, 2006. BASF, by contrast, first filed a priority document on June 6, 2007, and subsequently submitted a formal application on June 5, 2008, bearing the 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 substantive examination, the prior publication of the patent rendered all such combined formulations 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 for 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 will succeed. Moreover, Pesticide It belongs to the category of 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 serve as 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 the combined use of [substance], it was found that competing companies considered this compound along with all known substances 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 filed a request for invalidation on the grounds that the experimental data are false. Yet the competing firm has threatened that, given the considerable difficulty of individually demonstrating in the invalidation proceedings that the experimental evidence supporting these “combination‑therapy” patents is flawed, it will demand that the company license its earlier‑filed… Pesticide Compound patent. Li Yue of the Patent Reexamination Board pointed out that, for experimental evidence submitted with falsified data, the submission should be as formally complete as possible. At a minimum, the information contained in the experimental evidence—ranging from the experimental procedures to the results—must be clear and detailed, so that the public can 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, enabling subsequent verification of the experimental circumstances.
　　3 Measures and Recommendations for Countering Competitors’ Patent‑Filing Aggressions
　　 Pesticide How can companies respond when competitors employ patent‑layout strategies to secure a competitive edge in patent filings?
　　First and foremost, implementing robust defense and confidentiality measures is essential. Drawing on the extensive experience gained from the research and development of numerous new compounds, Pesticide The 7–8-year period between filing a patent application for an active pharmaceutical ingredient and the product’s market launch is an ideal window for implementing a robust patent‑defensive strategy. When initiating such a strategy, applicants can employ generic structural formulas to obscure the compounds slated for commercialization, thereby preventing competitors from discerning this information from the patent application documents. Subsequently, R&D resources should be concentrated on completing the technology development roadmap as comprehensively as possible prior to market entry, promptly filing patent applications to leave competitors no room or time to preemptively secure patents. Moreover, under no circumstances should compounds intended for commercialization be disclosed in academic journals or other public forums.
　　Secondly, proactively address patent‑squatting practices. Continuously monitor patent applications related to the generic compound; upon identifying such filings, promptly submit third‑party observations to prevent competitors from obtaining patent grants.
　　Third, when doubts arise regarding the experimental data in patent application documents that have been appropriated and licensed by competitors, conduct a comparative analysis based on your own data‑tracing mechanisms, commission a qualified third‑party testing laboratory to verify the data, and, relying on the empirical evidence issued by the third party, proactively file a request for invalidation.
　　Fourth, leverage the patent system and legal measures to safeguard R&D achievements. With regard to the theft of trade secrets, we will resolutely employ the law to fight such violations to the very end. Pesticide Only by effectively safeguarding their R&D achievements and preventing competitors from exploiting any vulnerabilities can companies truly reap the value of innovation.