The Role of Detailed Disclosures and Supplemental Data in Patent Law – A Case Study from China
Justice Manmohan Singh of the Delhi High Court has remarked in a judgment, “The world is a global village.” This sentiment captures the essence of our interconnected era, where globalization and interconnected markets continually redefine our world. Today, the judgments handed down in courtrooms across the globe can have far-reaching consequences and the ripples of these legal decisions extend far beyond their local jurisdictions, influencing economies and industries worldwide.
Welcome to “A View from Afar,” a series dedicated to examining international judgments and their far-reaching impacts. Through this series, we aim to bridge the gap between diverse legal systems and their global repercussions, offering you a panoramic view of the intricate interplay between law and commerce.
We will delve into landmark rulings from various corners of the world, unpacking the legal reasoning behind such decisions and scrutinizing their practical implications. Each article will provide a thorough analysis, shedding light on how these judgments affect not only the parties directly involved but also affect the regulatory frameworks, corporate strategies, and market dynamics on a global scale.
Whether it is a judgment delivered in the United States or the European Union, we will share our views on its profound impact in other jurisdictions navigating through the labyrinth of international jurisprudence.
Recently, the Beijing Intellectual Property (IP) Court reversed the China National Intellectual Property Administration (CNIPA) decision and upheld the validity of Novo Nordisk’s semaglutide patent. This patent covers the active ingredient in Ozempic® and Wegovy®, both of which are crucial in treating diabetes and obesity.
Join us in the third instalment of “A View from Afar” as we delve into the nuances of this case, unpacking the legal arguments, exploring the court’s reasoning, and analysing the significance of this ruling due to the imminent expiration of the patent on March 20, 2026, which has prompted generic manufacturers to prepare for entry into the lucrative Chinese market.
On September 5, 2022, CNIPA invalidated Novo Nordisk’s key semaglutide patent at the behest of Hangzhou ZhongmeiHuadong Pharmaceutical Co., Ltd. (Huadong). Huadong, a Chinese pharmaceutical company already marketing a generic version of liraglutide (another GLP-1 receptor agonist developed by Novo Nordisk), challenged the patent applied for. CNIPA’s invalidation was based on the lack of actual experimental data within the patent disclosure, which hindered the confirmation of the surprising technical effects asserted in the specification.
The contested claims in the patent application included the single compound (semaglutide), compositions containing the compound, and preparations of a medicament comprising the compound for treating various medical conditions such as hyperglycemia, diabetes, and inflammatory bowel disease (IBD).
One of the central issues in this case was the admissibility of post-filing supplemental data. Historically, China has been stringent about experimental data requirements in patents, particularly in unpredictable fields such as biology and chemistry. Unlike jurisdictions such as the United States and Europe, where broader scopes of protection can be granted based on fewer working examples, China’s requirements have been restrictive.
However, the 2021 Phase One US-China Economic and Trade Agreement mandated changes to Chinese patent law, allowing pharmaceutical patent applicants to rely on supplemental data to satisfy patentability requirements, including sufficiency of disclosure and inventive step. The 2021 Examination Guidelines provided further clarity, stipulating that examiners should consider post-filing data if the technical effect demonstrated by the supplemental data could undoubtedly be obtained by a skilled person in the art from the disclosure as originally filed.
Novo Nordisk appealed against CNIPA’s decision to the Beijing IP Court, presenting substantial post-filing experimental data to support the validity of the semaglutide patent. The Beijing IP Court had to determine whether this data could be considered based on the original patent disclosure.
The Court found that the original disclosure sufficiently supported the idea that semaglutide had a long duration of action. Paragraph [0534] of the specification stated:
“[In one aspect of the invention, the GLP-1 agonist has a duration of action of at least 24 hours after administration to db/db mice at a dose of 30 nmol/kg.]”
The Court interpreted this to mean that all compounds described in the disclosure, including semaglutide, had a duration of action of at least 24 hours. This general statement was deemed strong enough to allow the post-filing data demonstrating semaglutide’s duration of action to be considered.
In contrast, the Court did not accept the post-filing data regarding prolonged plasma half-life. The patent specification did not clearly indicate which GLP-1 analogs had the technical effect of a longer half-life. Instead, the property of having “an initial terminal half-life of 60-70 hours or more” was mentioned as a condition for further screening rather than a stated technical effect. Consequently, the Court ruled that a person skilled in the art could not have undoubtedly inferred from the original disclosure that semaglutide would have the claimed half-life.
This case and the facts surrounding it, prompted me to consider its implications in the Indian patent landscape and offer my insights and lessons to be learnt by patent drafters and the legal community, particularly within the pharmaceutical and life sciences sector.
- Significance of Detailed Patent Specifications: The case underscores the paramount importance of including detailed and comprehensive experimental data within the initial patent disclosure. The initial invalidation of the patent application by CNIPA was primarily based on the absence of actual experimental data in Novo Nordisk’s patent, which hindered the confirmation of the surprising technical effects claimed. Similar to the Chinese context, Indian patent law requires a detailed and enabling disclosure at the time of filing. Patent drafters must ensure that all technical effects are thoroughly documented and supported by experimental evidence in the original filing or subsequent prosecution. A detailed disclosure can serve as a strong foundation to support future claims and supplemental data, potentially safeguarding against challenges to the patent’s validity.
- Strategic Use of General Statements: The Beijing IP Court’s decision highlighted the potential value of well-supported general statements in patent specifications. The Court accepted post-filing data for semaglutide’s duration of action because the original specification included a strong general statement that semaglutide had a long duration of action. Hence, Patent practitioners should be meticulous in crafting general statements that assert technical effects, ensuring broad but substantiated statements regarding the technical effects of their inventions. This approach can be particularly useful in defending against invalidation proceedings where post-filing data may be brought into consideration.
- Navigating Jurisdictional Differences: This case illustrates the differences in patent law and practice across jurisdictions. China’s historically stringent requirements for experimental data in patents, especially in unpredictable fields like biology and chemistry, contrast with broader protections granted in jurisdictions such as the United States and Europe.
Similarly, while the Indian patent law has its unique provisions and practices, it shares similarities with other major jurisdictions. The Indian patent system, influenced by both European and U.S. practices, requires careful navigation of its specific requirements. Patent Practitioners must be acutely aware of these jurisdictional nuances and prepare filings that can withstand scrutiny in various legal contexts. It is also important for patent practitioners to stay informed about international developments and harmonize their strategies accordingly to ensure robust patent protection.
- Leveraging Supplemental Data: The introduction of the 2021 Phase One US-China Economic and Trade Agreement, which allows pharmaceutical patent applicants to rely on supplemental data, marks a significant shift in Chinese patent law. The Beijing IP Court’s decision reinforces the importance of this provision, demonstrating that post-filing data can be critical in upholding a patent’s validity if it aligns with the original disclosure.
- The Role of Post-Filing Data: The evolving acceptance of post-filing data in China, as influenced by international agreements, can also find parallels in Indian patent law. While India has traditionally been stringent about post-filing data, recent trends indicate a more flexible approach, especially in the pharmaceutical sector. Patent drafters in India should prepare their initial filings with the potential inclusion of post-filing data in mind, ensuring that the original disclosure is comprehensive enough to support such data if needed.
- Lessons from Global Precedents: Indian Courts often refer to global precedents in complex patent cases. The Novo Nordisk decision can serve as a persuasive reference point in Indian legal proceedings, especially regarding the admissibility of post-filing data and the interpretation of general statements in patent specifications. Indian patent attorneys should leverage such international rulings to bolster their arguments and strategies in domestic cases.
The Beijing IP Court’s reversal of CNIPA’s decision is a landmark ruling with profound implications for pharmaceutical patents. The case highlights the critical importance of detailed and precise patent drafting, the strategic use of general statements, and the potential of supplemental data in defending patent validity. As the legal battle continues, with the patent for semaglutide set to expire in 2026 and the case under appeal to the Supreme People’s IP Court, the outcomes will be closely monitored by stakeholders across multiple jurisdictions.