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 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. 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 remain far from achieving the level of proficiency required to flexibly leverage patent law 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 milestones 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, 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 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 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,” and it 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 strobilurin‑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 (i.e., flupyradifurone) by the company, a patent application was promptly filed covering methods for controlling insects using flupyradifurone, and the patent document included comprehensive biological data. This patent was ultimately granted, successfully securing the method‑related patent rights for flupyradifurone. The patent application, bearing the application number CN200880022218.X, was filed on June 20, 2008, under the 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: 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 substitu-ted isoxazole compounds and nearly all known fungicidal active ingredients in combination. Although the application was deemed withdrawn after the applicant failed to respond to the examination opinions during substantive examination, the prior publication of this 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 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 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 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 empirical values derived from actual experimental results and estimated values inferred from the 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 estimates 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 were falsified. 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 patents. Li Yue of the Patent Reexamination Board pointed out that, with respect to experimental evidence submitted on the basis of falsified data, such evidence should be presented in as complete a form 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 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, Pesticide The seven to eight years between filing a patent application for an active pharmaceutical ingredient and the product’s market launch represent an optimal window for implementing a robust patent‑defensive strategy. At the outset of such efforts, applicants can employ generic‑formula claims to obscure the compounds slated for commercialization, thereby preventing competitors from discerning these compounds from the patent application documents. Subsequently, R&D resources should be concentrated on completing the technology‑development roadmap as comprehensively as possible before market entry, promptly filing patent applications to leave competitors no room or time to secure preemptive patents. Importantly, avoid publicly promoting pending compounds in academic journals or other publications. Secondly, proactively address any attempts by competitors to file preemptive patent applications. Continuously monitor patent‑application activity related to the generic‑formula compounds; upon identifying such filings, submit third‑party comments to challenge the applications and prevent competitors from obtaining patent grants. Thirdly, when experimental data in a competitor’s granted patent application is called into question, compare it against your own experimental records using a traceability mechanism, and commission a qualified independent laboratory to verify the data. Leveraging the resulting evidence, file an invalidation request. Finally, leverage the patent system and legal remedies to safeguard R&D achievements. With respect to misappropriation of trade secrets, resolutely pursue all available legal avenues to defend your rights to the fullest extent. Pesticide Only by effectively safeguarding their R&D achievements and preventing competitors from exploiting any vulnerabilities can companies truly reap the value of innovation.