AI is magical but NOT magic! Be specific in your AI patents!

What is the standard of sufficient disclosure for AI-related patents: A case study in China

The rapid growth of AI patent applications present significant challenges to existing patent application and examination practices. One of them is satisfying the requirement for sufficient disclosure. The following case was featured in the 2023 CNIPA Compilation of Key Decisions on Patent Reexamination and Invalidation Cases (“2023 Compilation”) as an example to elucidate the current standards for sufficient disclosure in examining AI patent applications in China.

Rejection of Alipay’s AI + Brainwave Patent

The applicant Alipay1 had a Chinese Patent2 on an invention relating to a method and system that trains and utilizes AI models with people’s brainwaves and purchase history data to facilitate online payment operations.

All claims were initially rejected by the CNIPA for lacking inventive step and then again by the Re-examination Panel (“the Panel”) for non-sufficient disclosure, which was also the focus of the oral hearing.3

Alipay argued that the patent had sufficient disclosure by stating that “the historical brainwave data in the sample must match acquisition corresponding to actual payment. This requirement effectively explains the (allegedly missing) characteristics of the sample data in the specification.”4 Furthermore, Alipay stated that the machine learning models were existing, generic ones that could be reproduced by those skilled in the art.

However, the Panel did not accept Alipay’s arguments and maintained that technical means provided in the claims are vague to a skilled person in the art, making it impossible to implement them based on the specification.

Firstly, the application doesn’t clearly explain how to train the models. It lacks details on data characteristics, such as whether to categorize by gender or age, or which brainwave parameters—amplitude, frequency, or time range—should be collected. The training method appears to be more of a collection of ideas than a specific approach.

Secondly, it is essential to examine the relationship between the input training data and the model's outputs. However, the current specification lacks experimental data, making it difficult for a skilled individual to determine their correlation.5

Therefore, the Panel upheld the rejection decision.

CNIPA’s Standpoint on Sufficient Disclosure of AI Patents

In the 2023 Compilation, CNIPA commented on the rejection in this case, providing a more explicit statement about the current standards of sufficient disclosure of AI patent application examination in China: the specification must clearly define the meaning of the data; specify the employed model; describe the training/optimizing methods (if necessary).6

EIP Thoughts

From this case, we can see several characteristics of AI inventions that could make their patent applications uniquely challenging to traditional practices regarding sufficient disclosure.

  1. Complexity and Black-Box Nature of AI Models. Many AI models operate as "black boxes," where even the developers may not fully understand how specific results are derived. This makes it difficult to describe how the invention works clearly. However, traditional standards assume that the mechanisms underlying an invention can be explicitly defined, which may not be feasible with some AI systems.
  2. Data Dependency. AI systems rely on training data, and the quality and characteristics of this data greatly influence the resulting models. We agree with the Panel that without a clear description of these characteristics, a skilled person cannot effectively implement the solution needed to train the models of the patented AI system.
  3. Evolving Nature of AI Models. AI models can evolve over time as they are retrained with new data, making the invention less static than traditional technologies. This raises questions about whether the disclosed AI system is a fixed invention or an evolving process, complicating the sufficiency of disclosure.
  4. Interdisciplinary Complexity. AI inventions often combine concepts from multiple fields, such as computer science, mathematics, neuroscience, and finance in the case discussed. Examiners may struggle to determine whether the invention is sufficiently disclosed for skilled persons across these fields.
  5. Lack of Experimental Data. Many novel AI models lack supporting experimental results or benchmarks for their claimed effects. In the case discussed, the connection between brainwaves and payment decisions is still theoretical, making it challenging to prove the invention's operability and reproducibility.
  6. Generalized vs. Specific AI Applications: AI models are often described in broad terms. However, sufficient disclosure requires detailed descriptions of training solutions that train generic models with application-specific data. Simply stating that any generic model will work is insufficient.

To better reach sufficient disclosure standards for AI patents in China, we can learn several key lessons from this provided case:

  1. Clarity in Data Characteristics. Simply stating general data acquisition or relationships is insufficient; explicit and detailed descriptions are essential. The specification must clearly define the data involved, including:
    • Types, i.e., the nature of the input and output data (e.g., numerical, categorical, or signal-based);
    • Attributes, i.e., the fundamental properties such as frequency or amplitude.
    • Contents: specific data representations, e.g. gender, age, etc.
    • Data collection or acquisition procedures.
  2. Specification of AI models. Naming an AI model without providing details about its implementation can lead to rejection. The specific AI model used must be identified, including:
    • If the model is known in the field, its usage must still be sufficiently described in the application context.
    • If a new model is proposed, its architecture, functionality, and distinguishing features must be elaborated.
  3. Training and optimization processes. Model training and optimization descriptions should not appear as mere concepts or proposals but as actionable steps that can be replicated. For AI inventions, the specification should explain:
    • How the model is trained;
    • How the data is used in training (e.g., preprocessing, feature extraction);
    • How the optimization of the model is conducted to achieve the intended results.
  4. Relationship between input, model, and output. The more difficult it is to understand the black-box nature of AI inventions, the more test details should be provided. The specification should include experimental results or examples to validate the claimed relevancy between input data characteristics, data processing, and the generated output.
  5. Technical Implementability. A person skilled in the art must be able to implement the claimed solution based solely on the information disclosed in the specification. Ambiguity in AI methods, parameters, or data characteristics undermines this standard.
  6. Supporting Experimental Data. A lack of experimental data or concrete evidence of the AI model's effectiveness may weaken the application’s credibility. The specification should ideally include experimental results, simulations, or practical examples to support the feasibility and functionality of the invention.

AI seems "magical" compared to traditional computer technologies, although it is not unpatentable magic. As AI systems evolve unpredictably, their consistency diminishes, resembling complex natural systems classified as an "unpredictable art" by patent laws. For these arts, experimental data is vital for fulfilling enablement and support requirements. Consequently, as AI becomes more unpredictable, the criteria for patenting AI inventions may mimic more and more the stricter data standards seen in life sciences.

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

How a Secondhand Ground Brush Wiped Away a Chinese Patent

A Chinese robot vacuum company digs up “hidden evidence” to successfully invalidate a patent owned by its biggest competitor. 

Highlights

  1. Proof of original sales date of a secondhand product 
  2. Proof of product launch date 

Background 

With the growth of online shopping, it is easier than ever to provide evidence of a sale when the product is still being sold on the market. But what if the product is no longer being sold? It’s much more challenging to prove the original disclosure date for a secondhand item, especially in a jurisdiction like China, which has very stringent notarization and legalization1 requirements for introducing evidence into a proceeding.

The case below demonstrates an example of how one major Chinese robot company successfully dug up and introduced sufficient evidence to invalidate a patent owned by its biggest competitor. This case was highlighted in the CNIPA’s published “Compilation of Key Decisions from Typical Cases of Patent Re-examination Invalidity in the Year 2023”.

About the Patent 

The Chinese Utility Model “Ground Brush Mechanism and Cleaning Device” with patent no. ZL 202122747982.9 was filed on 10 November 2021 and granted on 13 May 2022. An invalidation request to this patent was submitted on 16 February 2023 and the Decision to revoke the whole patent was issued on 26 December 2023.

In this case, two of the largest manufacturers of robot vacuums in China were involved. The patent was owned by Dreame and the invalidation request was filed by TINECO. TINECO attempted to invalidate Dreame’s patent using Tineco’s own products, which fell within the scope of Dreame’s patent claims and were allegedly sold prior to the filing date thereof.

Chain of Evidence 

It is difficult to prove the original sale date or launch date for a discontinued product. However, TINECO provided sufficient notarized chains of evidence as shown below.

Proving the original sale date from a secondhand product 

TINECO provided as evidence two secondhand units of TINECO’s floor cleaning machines from two different sellers on Xianyu. Xianyu (Chinese name: 闲鱼) is a member of Alibaba Group, China's largest consumer-to-consumer (C2C) community and marketplace for second-hand goods.

The chain of evidence related to the original sale date is as follows: 

Evidence

What to be proved

Order records and online chatting records with the sellers, in which the sellers provided screen caps of their original purchase records from online vendors Tmall and JingDong, respectively.

  • the original sale date

  • the buying action

Email from the sellers providing the tax invoices of the original purchase. The tax invoices showed the model numbers, the serial numbers, and dates of purchase of the units

  • the original sale date

  • the units received were the same units as the ones originally sold

The acts of receiving the parcels containing the units, unpacking, disassembling, taking photos, and resealing the parcels were all recorded and notarized by notaries

  • the units received were the same units having the same serial numbers as the ones originally sold when comparing with the tax invoice

  • the units remained intact from repairing, forging, replacement of internal components at time of receiving

The notary resealed units were provided to the patent invalidation board for investigation

  • the units provided to the invalidation broad were the ones that were purchased from the seller

Authenticity of the Evidence 

The types of evidence that TINECO provided were considered authentic for the following reasons.

Tmall and JingDong are B2C platforms in China like Amazon in the United States. The date of purchase is automatically generated by the system and is unlikely to be forged.

A tax invoice is an official invoice issued by the Chinese Tax Bureau (but provided by the seller) for any goods or services purchased within the country. The Chinese government uses these invoices to track tax payments and deter tax evasion. Tax invoices are strong proof of the date of purchase, as they are trackable, and it is unlikely that one could provide a tax invoice without an actual purchase action on the platform.

Proof of Product Launch Date 

Other evidence related to the product launch date include: 

  1. Launch and sales information from AVC Revo, showing that the launch date was in April 2021 and the sales data was from April to July 2021
  2. Unboxing reviews from some famous China websites, such as China Fortune Network, Sohu Focus, What's Worth Buying, Sina Public Test and ZOL in May and June 2021
  3. Reviews and post follow-up comments posted by customers in Tmall on 9 November 2021

From all these, we can see that the sequence of these events aligns with the typical order of pre-sale promotion, official sales, review by evaluation websites, user purchase, and user reviews. This is in line with industry practices.

Based on all these factors and the fact that the different pieces of evidence can corroborate each other, the CNIPA concluded that a public sale had occurred before the patent application date.

Admission from Patentee 

The patentee admitted the two units provided to the invalidation board for investigation were identical. Although the patentee raised objections to some of the evidence, they did not provide any contrary evidence.

EIP Thoughts 

There has been an upward trend in patent disputes and invalidations in China. As a result, the CNIPA is setting more standards and providing more examples on evidence. 

General Standards

From this case and some other cases published by the CNIPA, we note the following general standards: 

  1. Notarization: Evidence needs to be notarized by a notary public officially recognized in China
  2. Complete Chain of Evidence: Each part of a sequential set of actions should be seamlessly recorded and notarized by a China-recognized notary public
  3. Formal and/ or Recognized Sources of Evidence: Evidence can come from different types of sources, such as famous services providers, famous websites, documents recognized by the Chinese government, documents officially issued by a registered service provider
  4. Corroborating Evidence: Evidence that are consistent with each other and support a certain position from different aspects
Quality of Evidence

This case provides a good example of how external evidence further strengthened TINECO’s position. We believe that TINECO in fact possessed internal evidence to support the first sales date and launch date of their product. However, they still chose to present third party evidence instead, since CNIPA or the opposing side could argue that any internal evidence they provide could be altered or falsified.

Evidence in a Digital World

As the world advances towards more digital transactions, we are seeing more cases and regulations2 clarifying how to “fix” evidence using modern technology. We see positive examples such as sales dates captured digitally on well-established online sales platforms, and the use of corroborating third-party evidence in various digital formats.

In this coming age of AI where falsified evidence is a growing concern, corroborating third party evidence is even more important. Having such evidence lowers the chances that a single piece of faulty evidence could derail an entire case. As such, we highly recommend keeping good records (notarized, if at all possible) of external third-party sales records at a product’s first launch. This information could be very useful in the future for potential invalidations and/or legal proceedings.

Reference

Top Ten Cases Analysis: Request for Invalidation of “Axial-flow windwheel” Invention Patent Right, published on 22 June 2022 in Chinese (Chinese Title:【 十大案件】评析“轴流风轮”发明专利权无效宣告请求案) 

https://www.cnipa.gov.cn/art/2022/6/22/art_2648_176140.html

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

Eagle IP is a top-tier boutique patent firm with a unique mix of experienced US and Chinese patent professionals with significant cross-border knowledge and experience. Our technically expertise covers wide range of technologies including, but not limited, to life sciences, biotechnology, diagnostics, medicine, pharmaceuticals, material and environmental science, chemistry, bioengineering, AI, software, mechanical engineering, and consumer electronics. We have years of experiences in drafting and prosecuting patent applications involving biological deposits, sequence listings, small and large molecules, drug discovery and development, material science, software and engineering, and many others.

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

 About the Authors

Polly Wong is a qualified Chinese Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Yolanda Wang is a Principal, Chinese Patent Attorney, and Chinese Patent Litigator at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Jennifer Che, J.D. is President & Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Beijing IP Court Reverses CNIPA Decision and Upholds Ozempic® semaglutide patent in China as VALID based on Novo Nordisk’s Post Filing Data

Recently, all eyes have been on China as the fundamental patent covering semaglutide, the active ingredient in Ozempic® and Wegovy®, will expire on March 20, 2026. It goes without saying that generics are ramping up bigtime in China (and also around the world), preparing to manufacture and sell this blockbuster drug to one of the biggest markets in the world. Any shortening of the patent term for this key semaglutide patent in China could cause an immediately shift in the Chinese Ozempic market (not to mention directly impacting Novo Nordisk).

Novo Nordisk’s Semaglutide Patent in China

On September 5, 2022, the China National Intellectual Property Association (China’s patent administrative office, hereinafter “CNIPA”) declared Novo Nordisk's key semaglutide patent in China1 to be invalid.2

The petitioner was Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“Huadong”), a Chinese drug manufacturer that currently already sells a generic version of liraglutide, another GLP-1 receptor agonist originally developed by Novo Nordisk. The CNIPA indicated that Novo Nordisk’s patent disclosure did not contain any actual experimental data, making it difficult to confirm that all the compounds possessed the surprising technical effects asserted in the specification.

The amended claims at issue3 claimed a single compound (semaglutide), compositions comprising the compound, and preparations of a medicament comprising the compound for treating a variety of different medical conditions (e.g., hyperglycemia, diabetes, IBD, etc.).

Translation of amended claim 1 (which refers to semaglutide)

  1. A compound, wherein said compound is
A chemical structure with letters and numbers from semaglutide patent in China

N-ε26-[2-(2-[2-(2-[2-(2-(2-[4-(17-carboxyheptadecanoylamino)-4(S)-carboxybutanoylamino]ethoxy)ethoxy]acetylamino)ethoxy]ethoxy]ethoxy)acetyl][Aib8, Arg34]GLP-1-(7-37) peptide.

Novo Nordisk submitted significant evidence in the form of post-filing experimental data showing that semaglutide had increased half-life and a longer duration of action when compared with liraglutide, the closest prior art.

Nevertheless, despite the amended claim scope and post-filing data, the panel of 3 judges concluded that the patent was entirely invalid. The data itself was compelling and showed improvement over the closest prior art (liraglutide). However, the CNIPA argued that the technical effect about the longer duration of action “could not be obtained from the specification as originally filed.”

Novo Nordisk appealed to the Beijing IP Court, which reversed the CNIPA’s invalidation and upheld the patent.

In order to fully understand the nuance of the Beijing IP Court’s decision and rationale, we provide first a brief “primer” about post-filing data in the patent world.

Post-Filing Supplemental Data: why this is such a hot topic

One of the biggest concerns amongst life science patent attorneys with regards to China has been post-filing data; more specifically, about China’s lack of flexibility in accepting it. In general, China is notoriously strict about experimental data requirements in patents, especially in fields that are “unpredictable”, such as biology, chemistry, and the like. Patent applicants typically can only obtain a scope of protection tightly around aspects of their invention that they have “proven” through working examples.

Contrast this to other jurisdictions, like the US and Europe, which usually allow broader scopes of protection based on less number of working examples. Furthermore, jurisdictions like the US and Europe are more lenient when it comes to allowing patent applicants to rely on data generated after the patent filing to help support a broader claim scope after-the-fact. As a result of this difference, most patentees get much narrower patents in China compared to the US and Europe, at least in “unpredictable” fields such as the life sciences.

In 2021 the United States and China signed Phase One of the US China Economic and Trade Agreement. Under this agreement4, China agreed to update its patent laws to “permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step.”

While China had been accepting post-filing data under certain circumstances prior to 2021, in the 2021 Examination Guidelines, China further solidified the instructions for Examiners to consider post-filing supplemental data. Specifically, Part 2 Chapter 10 Section 3.5.1 of the current Examination Guidelines stipulates that Examiners shall consider post-filing supplemental data

The Examination guidelines provided several helpful examples to demonstrate how Examiners should treat post-filing data (we’ve written a more extensive article about these examples in this blog post).

Novo Nordisk’s Post-Filing Data

As we saw from above, Novo Nordisk had mountains of data on semaglutide, most of it probably generated after the original patent application was filed. The Beijing IP Court had to decide whether to accept this data. The key question centered upon: what is the standard for “could undoubtedly be obtained by a skilled person in the art from the disclosure as originally filed”?

What was in the Disclosure as Originally Filed?

The patent disclosure described a genus of compounds that were effective as GLP-1 receptor agonists. Notably, there were 22 actual example compounds that were described specifically with their preparation methods and characterization data, including semaglutide. The patent disclosure described screening studies using db/db mice and minipigs. However, it did not specify which GLP-1 compound(s) were used in these screening studies.

Semaglutide Patent in China Rejected for Lack of Inventive Step

During the invalidation, all claims were rejected for lack of inventive step (Article 22.3), in view of the closest prior art, liraglutide. Although the two compounds were not identical, they shared a lot of common molecular structures. The CNIPA argued that one of skill in the art would expect that semaglutide would behave similarly to liraglutide, given their similar structure and their similar mechanisms of action.

Nova Nordisk argued that semaglutide had surprising technical effects that were markedly improved over liraglutide, pointing to post-filing comparison data showing semaglutide’s significantly improved half-life (60-70 hours in minipigs) and long duration of action (48 hours in db/db mice) compared to liraglutide (24 hours).

As the original specification did not specify which compoundspossessed the above-mentioned surprising effects, (and thus no mention of semaglutide specifically having such technical effects), the CNIPA opined that the effects demonstrated by the supplemental data “could not be undoubtedly obtained by a skilled person in the art from the disclosure as originally filed”.

The Beijing IP Court’s Reasoning

Long Duration of Action

However, the Beijing IP Court sided with Novo Nordisk, agreeing that the patent disclosure as originally filed did possess sufficient support for the idea that semaglutide had a long duration of action. Specifically, the Beijing IP Court pointed to paragraph [0534] in the specification, which stated:

[0534] 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.”

According to the Beijing IP Court, the statement “the GLP-1 agonist” was referring to the entire genus of compounds, and thus was asserting that all the compounds (or at least the 22 examples in the specification) had a duration of action at least 24 hours after administration. The Beijing IP Court judge wrote in a follow up statement about this case, “[a]lthough this technical effect is not specifically described as a technical effect of semaglutide, it can be reasonably inferred that semaglutide has this technical effect since it is a specific compound within the scope of protection of the general formula compound.”

In essence, the general statement in paragraph [0534] was strong enough that the technical effect demonstrated by the supplemental data (duration of action after 24 hours) could undoubtedly be obtained by a skilled person in the art. The court emphasized that if a patentee has already demonstrated that a general formula has a particular effect, then it can be presumed that all the compounds within the general formula have this effect. In this case, the patentee should have the right to submit post-filing data to confirm the effects of a specific compound within the general formula. Otherwise, if this was not allowed, the patentee would need to recite the results of each specific compound in the original specification, which would not be reasonable nor practical.

Prolonged Half Life

The Beijing IP Court contrasted the above case to the other study using minipigs on prolonged plasma half-life. Below is an English translation of two other paragraphs from the specification (emphasis added):

[0543] One aspect of the present invention is the preparation of GLP-1 analogues/derivatives with prolonged plasma half-life suitable for weekly administration. Pharmacokinetic properties can be assessed in minipigs, or domestic pigs as described below.

[0550] A second part of the pharmacokinetic screening was conducted on those compounds with an initial terminal half-life of 60-70 hours or more. This screening consisted of a single dose intravenous and subcutaneous administration of 2 nmol/kg to six minipigs for each route of administration. […]

The Beijing IP Court argued that in the study using minipigs, the specification did not clearly indicate which GLP-1 analogs have the technical effect of having a longer half-life. Instead, the property of having “an initial terminal half-life of 60-70 hours or more” was recited as the conditions required for a second screening rather than recited as technical effects in paragraph [0550]. The judges argued that, based on the conditions stated in paragraph [0550], one of skill the art would not be able to infer that semaglutide could be suitable for the second part of the screening, and there was no way for one of skill in the art to know undoubtedly that semaglutide would possess the technical effects of having a half-life of 60-70 hours or more. As a result, the post-filing supplemental data regarding increased half-life was not accepted by the court.

Since Novo Nordisk only needed to demonstrate that semaglutide had improved properties over liraglutide with respect to one aspect (duration of action > 24 hours), the patent was upheld based on the admissibility of the post-filing data.

Eagle IP Thoughts: semaglutide patent in China

This is a HUGE case for so many reasons. The sheer importance of the product, the economic and legal impact of the decision, and the fine line the Court ultimately drew to clarify China’s position on post-filing supplemental data make this a fascinating case to study.

At a minimum, this case broadens the standard for what types of statements in a specification could be sufficient to demonstrate that an idea can be “undoubtedly obtained” from the disclosure as filed. Importantly, in this case semaglutide was never specifically called out as having significantly good PK properties. Instead, the specification held a general position that the compounds (implicitly all the compounds) had a >24 hour duration of action.

Drafting Strategies

For patent practitioners, the ability to have this additional “hook” based on generic language could be a lifesaver in a lot of situations. Astute patent drafters should consider carefully what types of general statements asserting technical effect they wish to add. A general statement that’s not entirely true (and unsupported by data) could be fatal, while a general statement that is true could literally save the life of a patent (as it did in this case). Be careful making statements that imply only a subset of compounds have a certain technical effect (unless it’s true and supported by data).

To hedge against future inventive step challenges, consider adding “hooks” describing as many different and unique properties of a lead molecule as possible. For example, one could add physical properties, PK properties, efficacy data in various models, and more. For any of these unique features that may help distinguish the to-be-patented product from the prior art, try to provide at least one method of testing that feature. It’s hard to know what type of data is needed to overcome unexpected prior art. Having the “hooks” makes it much easier to submit post-filing data to demonstrate inventiveness over the cited reference.

What If . . .

It begs the question, though. What would happen if Huadong were able to show that some of the compounds in the group of 22 examples did not have such property? Would that negate the statement entirely? In the case above, would the other compounds showing negative results negate the general statement, and thus remove the support for the surprising effects of semaglutide? Would the court still accept semaglutide’s good post-filing data in this case?

This case isn’t completely over yet. Huadong has appealed to the Supreme People’s IP Court. March 20, 2026 is still two years away, but we expected to hear a final decision before the patent expiration date. As always, we are watching this case closely and will report updates as soon as we hear more.

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

About Eagle IP

Eagle IP is a top-tier boutique patent firm with a unique mix of experienced US and Chinese patent professionals with significant cross-border knowledge and experience. Our technically expertise covers wide range of technologies including, but not limited, to life sciences, biotechnology, medicine, pharmaceuticals, material and environmental science, chemistry and consumer electronics. We have years of experiences in drafting and prosecuting patent applications involving biological deposits, sequence listings, small and large molecules, drug discovery and development, material science, software and engineering, and many others.

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

About the Authors

Jennifer Che, J.D. is President & Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Audrey Cheung is a qualified Chinese Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Yolanda Wang is a Principal, Chinese Patent Attorney, and Chinese Patent Litigator at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Stay Ahead: Getting a Chinese Patent in Three Months?

The China National Intellectual Property Administration (CNIPA) has announced a significant development in the realm of patent prosecution: the initiation of the "PPH Improvement Initiative" in collaboration with key patent offices from the United States, Europe, Japan, and South Korea. This initiative aims to elevate the user experience of the Patent Prosecution Highway (PPH) by setting ambitious targets for the average cycle time of the first office action and the average cycle time for replying to applicants' responses, both now set at three months starting from 2024.

Here's a concise summary of the specific changes:

Timeline

Before

After

Average Cycle Time for First Notice1

Within Four Months

Within Three Months

Average Cycle Time for Replying to Applicants’ response

NA

Within Three Months

The PPH serves as an expedited patent examination pathway between different countries or regions, facilitating quicker patent examination processes through shared work among patent examination authorities. Since its inception in November 2011, CNIPA has established PPH cooperation with patent offices in 32 countries or regions.

In order to enhance the predictability of PPH application examination timelines, ongoing discussions among the IP52 have led to this initiative. Initially proposed by Japan and the United States, China's active participation underscores its commitment to this policy. Ideally, receiving a notice of grant within three months (or even shorter) is now within reach.

For enterprises aiming to penetrate global markets, this improvement policy promises to make examination timelines across different countries more predictable. It is anticipated that this will enable companies to manage their intellectual property systematically and strategically expand into the global market.

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

Eagle IP is a top-tier boutique patent firm with a unique mix of experienced US and Chinese patent professionals with significant cross-border knowledge and experience. Our technically expertise covers wide range of technologies including, but not limited, to life sciences, biotechnology, medicine, pharmaceuticals, material and environmental science, chemistry and consumer electronics. We have years of experiences in drafting and prosecuting patent applications involving biological deposits, sequence listings, small and large molecules, drug discovery and development, material science, software and engineering, and many others.

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

About the Authors

Yolanda Wang is a Principal, Chinese Patent Attorney, and Chinese Patent Litigator at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

New Remedy in China for Fixing "Errors" in a Patent Application: Incorporation by Reference

Background

As mentioned in our earlier article, the Implementation Regulations of the Chinese Patent Law (“Regulations”, similar to the CFR in the US) were approved in November, and the CNIPA finally made public the full text of the Regulations just before the arrival of the New Year. At the same time, the CNIPA also released the new Patent Examination Guidelines (“Guidelines”, like the MPEP in the US), along with specific implementation dates and transitional methods. These changes became effective as of 20 January 2024. Today’s article will focus on incorporation by reference.

The Regulations provide more details on the newly “incorporation by reference” provision in the Chinese Patent Law, which align this aspect of Chinese Patent Law with international practices.

New Rule 45 states: “If an invention or utility model application lacks or incorrectly submits claims, descriptions, or parts of the claims or descriptions, but where the applicant has made priority claim(s) on the filing date, the applicant can supplement or rectify the corresponding parts or documents by citing the "previous application" (i.e., certified priority application) within 2 months from the filing date or within the period specified by the Patent Office. If the supplementary documents comply with the relevant regulations, the filing date of the application shall be maintained."

In other words, applicants can “rectify” missing or incorrect information in a patent application if the correct information was present in a priority document, provided such request for rectification is made within 2 months from the filing date. This is consistent with the incorporation of reference standards for PCT international applications.

Requirements for Incorporation by Reference

This rule also applies to international applications entering the National Phase in China. If the incorporation by reference happens during the PCT international phase, a Chinese translation of the certified copy of the priority document is also required, in addition to the Chinese translation of the specification which is normally required for the National Phase Entry application, so that the Patent Office can review whether the incorporation complies with the regulations.

Under this rule, the items or parts incorporated by reference from the priority document are considered "original specification and claims" as defined in Article 33 of the Patent Law.

Exclusion

Official fees

The request of an incorporation by reference per se does not incur any official fee. However, additional fees for extra claims or pages are required if the number of claims exceeds 10 and/or the number of specification pages exceeds 30 pages after amending an application using incorporation by reference based on Rule 45. If the required fees are not paid by the prescribed period (two-month from the filing date or one-month from receiving a ‘Notice of Missing Fees’), the whole application will be deemed withdrawn.

Impact on Examination Time

Delays caused by incorporation by reference fall under one of the instances of unreasonable delays caused by the applicant as stipulated in Rule 79 of the new Implementation Regulations.2 The extension of examination time caused by incorporation by reference shall not be counted towards patent term compensation.

EIP Thoughts

The provision of incorporation by reference provides applicants with an additional option to fix an application where portions of the claims, specification, or drawings, or even the entire claims, specification, or drawings are missing, as long as the application is claiming priority, while the original filing date of the application can be retained.

Before the effectiveness of the new Implementation Regulations, an application missing the entire claims, specification, or drawings would not be accepted by the Patent Office, and there was no remedy for such defects other than filing a new application, which could incur substantial amount of fees and push back the filing date. Sometimes, such mistakes would be fatal if a novelty-destroying event (e.g., a publication) occurred after the original (“unfixable”) filing date.

Before these new Regulations, if an application was missing portions of claims, specification, or drawings, applicants could rectify the missing parts by incorporating content from the priority document. However, the filing date would be revised from the priority date (if any) to the date when all missing parts were submitted. The only way to “restore” the original filing date would be to delete the missing portions from the specification. In these unfortunate situations, applicants would lose their priority rights completely due to the re-determined filing date.

Therefore, the real effect of "retaining the original filing date" in new Rule 45 is to safeguard against losing priority. With the new Implementation Regulations now in force, applicants have much more flexibility within two months to modify and “correct” applications without losing priority, and in some cases, can also save costs.

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

Eagle IP is a top-tier boutique patent firm with a unique mix of experienced US and Chinese patent professionals with significant cross-border knowledge and experience. Our technically expertise covers wide range of technologies including, but not limited, to life sciences, biotechnology, medicine, pharmaceuticals, material and environmental science, chemistry and consumer electronics. We have years of experiences in drafting and prosecuting patent applications involving biological deposits, sequence listings, small and large molecules, drug discovery and development, material science, software and engineering, and many others.

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

About the Authors

Hebe Chau is a Chinese Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, and Shenzhen.

Audrey Cheung is a qualified Chinese Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Jennifer Che, J.D. is President & Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong and Shenzhen.

Updates on Hong Kong Patents Examination Guidelines in 2024

The Intellectual Property Department of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China (HKIPD) has recently made several updates to the Hong Kong Patents Examination Guidelines, effective from 26 January, 2024. These changes mainly clarify and reflect the Registry’s current practices regarding patent examination for Standard Patent (R) Applications, Standard Patent (O) Applications (i.e., Original Grant Patents (OGP)), and Short-Term Patent Applications. We briefly summarize the key revisions below:

Section 1: Novelty - This section only made a minor textual revision to correct a typographical error to refer to the correct section (from section 1.61 to 1.62) in 1.61. The change made is not substantial.

Section 4: Exclusions from Patentability: Excluded Subject Matter - The revisions in Section 4.7 clarify that art falling within the field of section 9B(3)1 of the Ordinance will not be excluded for consideration when assessing the contribution that an inventor has added to human knowledge in the second step of the Aerotel/Macrossan test2. In other words, all art falling within the definition of “state of the art” under 9B(3) shall be included within the scope of “human knowledge”.

Section 7: Kinds of Claims - The amendments made to Section 7.6 aim to clarify the examples of claims that are not necessarily dependent claims in substance. In brief, the amendments clarify that (1) a claim referring to another claim of a different category (e.g., an apparatus for carrying out the process of claim 1); and (2) a claim to one part referring to another co-operating part of another claim (e.g., a plug for co-operation with the socket of claim 1) are not necessarily dependent claims in substance. In other words, they are considered independent claims.

Section 13: Patent Applications - The revised guidelines in section 13.24(b) clarify the examination standards of the statement of entitlement to apply. In brief, an updated official register of the designated patent office or an official communication from the designated patent office confirming a transfer, assignment or mortgage will no longer be recognized as a supporting document that can establish an applicant’s entitlement to apply for a request for registration and grant of a Standard Patent (R) if the applicant for the request for registration and grant is not the same as the entity named in the register (i.e., the applicant for request to record). The applicant will need to submit a copy of the duly executed transfer, assignment or mortgage agreement.

Section 15: Substantive Examination of Standard Patent (O) Applications and Short-term Patents - This section has undergone significant changes to provide further clarity and guidance on the role of hearings as part of the patent prosecution process. In brief, for a Standard Patent (O) and Short-Term application, if the Registrar issues a review opinion and/or a further review opinion(s) to the applicant, the Registrar will generally offer the applicant an opportunity to file a request for a hearing if the Registrar thinks it fit to do so. In addition, before a Standard Patent (O) application is refused (section 15.29A) or a Short-Term patent is revoked (section 15.50A), the applicant or the proprietor must be given an opportunity to be heard. In other words, OGP and Hong Kong Short-Term applicants generally will have an opportunity to conduct a hearing in response to a review opinion and/or further review opinion(s), especially before an application is finally rejected/revoked.

EIP Thoughts

Since its launch in December 2019, the Standard Patent (O) (i.e., OGP system) has enriched the patent landscape in Hong Kong. This system allows applicants to directly file patent applications in Hong Kong without the need for a prior granted patent from China, Europe, or the UK. As we enter the fifth year of its implementation, a significant number of initial applications have now reached the substantive examination stage. We believe that the HKIPD has recognized the need for clarification of certain aspects of the Patents Examination Guidelines to ensure consistency with the latest practices and examination procedures. For further details and the complete revised guidelines, please refer to the Hong Kong Intellectual Property Department's official website.

We hope this information proves useful and assists you in navigating the Hong Kong patent examination processes effectively. As always, we remain dedicated to providing Hong Kong patent law updates.

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

About the Authors

Bill Yip is a qualified Chinese Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Jennifer Che, J.D. is Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

IP Strategies for the Newly Released Implementation Regulations of the 4th Amendment of the Chinese Patent Law: Part 3: The 15-Day Mailing Period is Mostly Going Away

A Closer Look at the New Presumed Receipt Date Calculation

Background

China has finally released the long-awaited Patent Law Implementation Regulations (“Regulations”) and associated "Patent Examination Guidelines" (“Guidelines”, similar to the United States' MPEP) which provide further clarity and details of the new Chinese patent law. Today’s article will focus on changes that impact how patent applications and related deadlines are managed.

Understanding the Shift in Presumed Receipt Dates

Traditionally, the China National Intellectual Property Administration (CNIPA) presumed the receipt of official documents to be 15 days post-issuance, similar to the European Patent Office's 10-day mailing period. Recent modifications (2023) in European procedures raised questions about potential parallels in China's approach, which has now materialized.

Distinguishing Based on Submission Method

The new regulations determine the presumed receipt date of a patent office submission based on the method of submission — paper or electronic. For paper submissions, either through mail or direct delivery, the status quo remains, preserving the 15-day mailing period. However, for electronic submissions, the receipt date for electronically submitted documents is now the date of entry into the e-filing system, abolishing the traditional 15-day buffer. This adaptation aligns CNIPA’s practices with the broader movement towards digitalization led by prominent organizations like the EPO and WIPO.

Impact of Electronic Filing Dominance

With electronic filings constituting over 90% of applications, this change in deadline calculation is expected to have widespread effect. It notably shortens the response window for applicants, a development that has garnered mixed reactions. While the ease and efficiency of electronic filing are undeniable, the reduction in the time to file a response has sparked concern among patent agents and applicants.

Special Circumstances and Proof of Receipt

Just like the European Patent Office, CNIPA has made accommodations for special cases wherein the actual receipt date diverges from the presumed date. In such scenarios under the new Guidelines, the onus is on the parties involved to substantiate the actual date of receipt, not the CNIPA. This approach is distinct from the EPO’s method, where the burden of proof in disputes about receipt dates lies with the EPO itself, as stipulated by Rules 126(2) and 127(2) EPC.

Transitional Provisions and Future Implications

These changes are not retroactive and will apply to future deadlines set within documents issued by the CNIPA from January 20, 2024, onwards. An intriguing implication of this timeline is the difference in deadlines for documents received just a day apart in January 2024. For instance, a First Office Action received on January 19 would have a response deadline of June 3, 2024, while one received on January 20 would have an earlier deadline of May 20, 2024.

EIP Thoughts

Virtually 100% of our cases at the CNIPA are handled electronically, so this change certainly impacts all of our clients and shortens the time for responding to an office action in China.However, in China it’s relatively straightforward to revive cases that were abandoned due to failure to reply to an office action. Even before that, there are extensions available. As such, even though we will miss the 15-day mailing period, we think having a robust digital patent system at the CNIPA is much more useful overall.

Navigating the New Landscape

As the landscape of China's patent law undergoes these significant changes, it is crucial for stakeholders to stay informed and adapt their strategies accordingly. Our team remains committed to providing expert guidance through these evolving regulations, ensuring that your intellectual property interests in China are managed effectively and in compliance with the latest legal framework.

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

About the Authors

Yolanda Wang is a Principal, Chinese Patent Attorney, and Chinese Patent Litigator at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Jennifer Che, J.D. is Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

IP Strategies for the Newly Released Implementation Regulations of the 4th Amendment of the Chinese Patent Law: Part 1: Delayed Examination

December 2023 appears to have been an exceptionally busy and fruitful month in the China patent space. Following the State Council’s approval of the long-awaited Patent Law Implementation Regulations (“Regulations”, similar to the CFR in the US) in November, the CNIPA finally made public the full text of the Regulations just before the arrival of the New Year. At the same time, the CNIPA also released the new Patent Examination Guidelines (“Guidelines”, equivalent to the MPEP in the US), along with specific implementation dates and transitional methods. We will, over the coming period, undertake a detailed analysis and commentary on these amendments and their consequential impacts. Today’s article will focus on the delayed examination.

Delayed Patent Examination

Under normal Chinese prosecution procedures, applicants must request substantive examination by a three-year deadline in order to begin the substantive examination process.

In 2019, CNIPA amended the Patent Examination Guidelines to formally introduce the Delayed Examination procedure. The procedure allows applicants to file requests for delayed examination for invention and design patent applications. The Guidelines also provide that, if necessary, the Patent Office may initiate examination on its own and notify the applicant that the period of “delayed examination” is terminated.

Summary of the Changes

The latest amended Regulations and Guidelines in 2023 have made some updates to the delayed patent examination procedure, which are summarized below. The main changes include the possibility of withdrawing the delay request, the addition of a 1-year delayed examination option for Utility Model patents, and counting the delayed examination period for Design patents by months instead of by years.

  Before the 2023 change After the 2023 change
Invention patent Can request a delay of 1, 2, or 3 years

(at the time of filing the request for substantive examination)

 No change
Utility Model patent No Can request a delay of 1 year (at the time of filing)
Design patent Can request a delay of 1, 2, or 3 years

(at the time of filing)

 Can request a delay of up to 36 months, counting by months (at the time of filing)
Can it be withdrawn? No Yes, and then will be examined in normal order
Is patent compensation (PTA) available? Not Applicable No

Using Delayed Examination in Patent Strategy

Having more flexibility over when to start examination has many potential strategic advantages.

For example, applicants can take a “wait and see” approach, delaying examination in China to see (and possibly use) examination results from corresponding applications in other jurisdictions. Using delayed examination in conjunction with other tools (e.g., PPH), could reduce overall patent prosecution costs in a large portfolio.

Applicants can also make use of delayed examination to postpone the timing of certain public disclosures to better align with business objectives. This could be especially useful in the cases of Utility models and design patents, which typically grant (and therefore publish) quite quickly.

There are other benefits to delayed examination. For instance, an inventor may need extra time to generate more experimental data to submit to the patent office to demonstrate surprising technical effect. Similarly, a business may need more time to determine which claims in the patent application are most important to the company.

Finally, keeping a parent application pending by delaying examination offers various strategic advantages, such as preserving the ability to file voluntary divisional applications, deterring competitors, and more precisely aligning overall patent strategy with product development timelines.

In the latest commentary on China’s Ministry of Justice website, Professor Cui Guobin summarizes it well. “This revision strengthens the advantages of delayed examination, allowing applicants to draft appropriate claims based on the latest technological progress, market competition conditions, or changes in the international standards, thereby making patent protection more targeted. They can also take advantage of the latest patent examination policies, such as supplementary experimental data, storage media in the computer field, protection of software products, etc.”[1]

Limitations of Delayed Examination

However, there are limitations of the delayed examination system. It’s important to note that delayed examination merely postpones the examination process and does not provide additional time for applicants to amend their applications (i.e., the voluntary amendment window stays the same). Additionally, it offers no assurance of a specific timeline for receiving examination results after the delay. Importantly, the actual duration of the delay becomes an "applicant-induced unreasonable delay." As a consequence, this period is counted against the applicant when calculating patent term compensation (“PTA”), a topic we will delve into in a separate article.

Conclusion

Overall, delayed examination is a helpful tool that patent practitioners can use to map out creative patent strategies. Combined with other tools such as the Patent Prosecution Highway (PPH), priority examination, divisional applications, voluntary amendments, and more, applicants have access to many interesting options and pathways to meet their overall IP and business goals. The recent changes broaden the availability of these tools and also adds flexibility to the system overall.

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

  1. Cui, Guobin, Intellectual Property Law Research Center, Tsinghua University Law School, “Commentary on the latest revisions to the Implementing Rules of the Patent Law”, Official Website of the Ministry of Justice, People’s Republic of China. December 21, 2023 https://www.moj.gov.cn/pub/sfbgw/zcjd/202312/t20231221_492072.html ↑

About the Authors

Yolanda Wang is a Principal, Chinese Patent Attorney, and Chinese Patent Litigator at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Jennifer Che, J.D. is Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Twice the Trouble: Unraveling a Single Case of Dual Patent and Trademark Infringement

Can a rights holder sue the same infringer separately based on one single infringing act that infringes both trademark and patent rights? An interesting case this year from China’s Supreme People’s Court that addresses this specific issue ((2023)最高法知民终235号).

Beijing Run De Hong Tu Technology Development Co., Ltd. (“Run De Hong Tu”) sued an individual named Li XX[1] for patent infringement based on his activities as a small retailer selling a certain sewage pipe branded as “Submarine”. In fact, Run De Hong Tu had initiated multiple similar lawsuits, primarily targeting small and micro retailers, and had been able to secure substantial compensation in these cases.

Run De Hong Tu, along with its affiliated company, Bo Rui Run Xing Co., Ltd., employed a strategic approach in their litigation activities. First, Bo Rui Run Xing reached a one-time settlement agreement with small and micro retailer Li XX over a trademark right dispute. This settlement, however, did not address any patent right issues. Li XX did not conduct any further infringement thereafter. However, Run De Hong Tu subsequently initiated a separate lawsuit against Li XX for the same sales activities, but this time alleging patent infringement.

The Supreme People’s Court (second-instance court), in its judgment emphasized that Run De Hong Tu's conduct violated the principle of honesty and credibility and constituted an abuse of rights. The court highlighted that both Run De Hong Tu and Bo Rui Run Xing were aware that the sales activities in question infringed both trademark and patent rights, in view of their experience in IP litigations. Bo Rui Run Xing's omission of the patent right issue in the settlement and Run De Hong Tu's subsequent lawsuit appeared to be a calculated move to obtain additional compensation.

Furthermore, the court criticized the companies for targeting small and micro retailers instead of focusing on the source of the infringement. This approach not only increased the legal and financial burdens on the defendants but also led to an unreasonable use of judicial resources. As a result, the court dismissed Run De Hong Tu's appeal, upheld the original judgment, and ordered Run De Hong Tu to compensate Li XX for reasonable expenses incurred in the lawsuit amounting to 1,000 yuan.

EIP Thoughts

  1. There’s nothing in the Chinese patent law that says one should sue the manufacturer versus the retailer, although China’s litigation system has always leaned in that direction (e.g., methods of medical treatment are not patent eligible, but claims directed to the manufacture of a medicament are patentable). This case is interesting in that the SPC clearly indicated that suing small and micro retailers is not the optimal way to uphold patent rights. Small and micro retailers may not have an obvious intent to infringe, and do not have the resources to defend themselves. Interestingly, the court decided against the patentee not because there was no patent infringement, but because of the litigation strategy. Foreign companies should definitely pay attention to this nuance of Chinese litigation.
  2. In the new Chinese Patent Law, New Article 20 codified guiding principles into the patent law that included statements about patent applications “following principles of good faith” and “not harming public interest or the legitimate rights or interests of others”. In this case, the court concluded that the IP rights holder was involved in “misleading settlements” and ”suing twice for the same matter.” In other similar lawsuits, the court brought up "induced infringement" and “trap evidence gathering,” as other forms of abusive behaviours which violated principle of honesty and credibility. It’s clear that such types of more aggressive litigation strategies should be avoided, or at least used cautiously in China.
  3. Beyond just strengthening the judicial protection of intellectual property rights, China appears to also be attempting to regulate how IP rights holders exercise their rights, with the ultimate goal of reducing unnecessary litigation cases and avoiding the misuse of judicial resources.

If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

  1. full name redacted by the Court ↑

About the Authors

Yolanda Wang is a Principal, Chinese Patent Attorney, and Chinese Patent Litigator at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Jennifer Che, J.D. is Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Do Promotional Marketing Materials Constitute an “Offer for Sale” under Chinese Patent Law? Bayer IP GmbH v. Nanjing Hang Seng Pharmaceutical

Bayer's blockbuster drug Rivaroxaban has seen its share of patent litigations in China, several of which are big enough to be listed as Top 10 IP cases or 50 Representative IP cases. We summarized an invalidation case back in 2020 where all of Bayer’s claims directed towards the compound were upheld. Recently, another Rivaroxaban case made it onto China’s 50 Representative IP cases in 2022, this time in a final judgement from the Supreme Court of an infringement case against a generic company who was marketing the patented drug before the patent expiration date.

At the heart of the case is a dispute over (1) what acts by a generic company are considered “offers to sell” under Chinese patent law and (2) what is the scope of protection provided by the “Bolar exemption” — two pivotal issues that carry significant implications for the pharmaceutical industry.

Decision no.

〔最高人民法院（2021）最高法知行终451号行政判决书

Decision day

August 21, 2020

Invention Title

取代的噁唑烷酮和其在血液凝固领域中的应用

Substituted oxazolidinones and their use in the field of blood coagulation

Appellant

南京恒生制药有限公司

Nanjing Hang Seng Pharmaceutical Co., Ltd.

(Wholly owned subsidiary: 南京生命能科技发展有限公司 Nanjing Life Energy Technology Develop. Ltd)

Appellee

南京市知识产权局

Nanjing Intellectual Property Office

Patentee

拜耳知识产权有限责任公司

Bayer Intellectual Property GmbH

Patent No.

ZL00818966.8

Application date

December 11, 2000

Earliest Priority Date

December 24, 1999

Grant Date

July 05, 2006

Rivaroxaban is a widely used anticoagulant drug that treats and prevents various conditions that involve blood clots. It was the first orally available direct factor Xa inhibitor. Since its approval in the US and Europe in 2011, and later in China in 2014, it has achieved a staggering market size of approximately $7 billion USD.

Quick Summary of the Case

Bayer holds a Chinese patent ZL00818966.8 on substituted oxazolidinones and their use in the field of blood coagulation, which includes the drug product Rivaroxaban. The claims were amended during the invalidation to specifically recite Rivaroxaban, as shown below.

  1. A compound or pharmaceutically acceptable salt or hydrate thereof, the compound having the structure of the following formula:

In 2018 the generic company (Appellant) Nanjing Hang Seng Pharmaceutical Co., Ltd. (“Hang Seng”) showed a photo of the drug product together with its CAS number on the company’s official website. Nanjing Life Energy Technology Development Co. (“Life Energy”), a wholly-owned subsidiary of Hang Seng printed the product information on promotional materials and both Life Energy and Hangseng’s company names on the business cards. Life Energy also showed promotion information about the drug product on a display board which included Hang Seng and Life Energy’s Trademarks in a Shanghai exhibition of generic manufacturers.

Bayer sued for patent infringement.

Key Issue: were Hang Seng and Life Energy’s actions sufficient to be considered an “offer for sale” of the drug product, and thus patent infringement?

Article 11 of the Chinese Patent Law prohibits the making, using, offering for sale, selling, or importation of a patented invention. However, the interpretation of what constitutes an 'offer to sell' can be complex, as highlighted below.

Petitioner Argues there’s No Offer for Sale

Hang Seng argued that there was no actual product available for sale—no pricing or supply volume was provided at an exhibition, and there was no approved financial amount, implying that there was no actual 'offer to sell'. The argument hinged on the absence of a sellable product, as the promotional materials were not labeled with prices and supply volumes. Hence, such actions only constituted targeted promotion, and thus was evidence against the claim of patent infringement.

The Supreme People’s Court (SPC) disagreed, stating that an 'offer to sell' may or may not require a specific target customer. The absence of certain transaction terms—like price or volume—does not preclude the determination of an offer to sell. The SPC pointed to the product information shown in the promotional materials in the exhibition and the company's website under the “Product Center” section, as clear indications of an offer to sell.

Article 24 of the SPC’s "Several Provisions on Applicable Legal Issues in the Trial of Patent Dispute Cases" clarifies that the "offer for sale" referred to in Articles 11 and 69 of the Patent Law includes advertising, displaying in store windows, and displaying at trade fairs, all of which are considered actions having an express intention to sell goods.

Petitioner Argues Their Actions are Exempt under the Bolar Exemption

China’s version of the Bolar exemption[1] states that those who manufacture, use or import patented drugs or medical devices for the purpose of providing information needed for administrative examination and approval, and those who specially manufacture or import patented drugs or medical devices shall not considered patent infringement.

The petitioner argued that the Bolar Exemption should also be interpreted to include selling and offering to sell. They argued that since their promotions targeted generic drug companies, the Bolar exemption should also apply.

The SPC Decision

The SPC disagreed, stating that the Bolar exemption is strictly limited to two types of entities:(1) those who enforce the patents in order to obtain the information required for administrative approval of generic drugs and medical devices; and (2) those who specifically enforce patents for the aforementioned individuals. Such exceptions do not extend to commercial promotions such as offering to sell, especially for companies like Hang Seng, who could not provide any evidence demonstrating that they could claim to be such type of entity. Therefore, the original judgement was upheld.

EIP Thoughts

This case emphasizes that even preliminary commercial activities, such as advertising or displaying at exhibitions by a generic manufacturer, can constitute an 'offer to sell' under the Chinese patent law. There’s no need for the “offers” to be directed towards a specific consumer, nor does there need to be specific information like price, supply volume etc. This is different than in the US, where courts have traditionally interpreted both the “on sale bar” of 35 U.S.C. 102(a)(1) and the “offer to sell” standard for infringement under 35 U.S.C. 154(a)(1) using the standard for a commercial offer for sale under contract law. A valid commercial offer for sale typically requires a description of the product and a price. The definition of an “offer” under Chinese patent law seems to be much, much broader than an offer under normal contract law.

Additionally, this case also clarifies that the Bolar exemption has a narrow application and does not extend to preemptive or promotional marketing activities, which is a very reasonable conclusion.

This case gives drug/medical device innovator companies a very strong tool for monitoring and identifying infringing activity. Of course it can apply to preliminary marketing activities done by generic companies before a patent has expired, but in fact this case really changes the landscape for all innovator companies.

Unlike in the US, where potential infringers may be able to advertise yet keep actual offers and sales private (thus making infringement harder to detect and prove), in China a simple brochure or display, even without a price, is sufficient to be considered infringing activity. This makes identification of infringing activity and subsequent enforcement much, much easier in China.

About Eagle IP

Eagle IP is a top-tier boutique patent firm with a unique mix of experienced US and Chinese patent professionals with significant cross-border knowledge and experience. Our technically expertise covers wide range of technologies including, but not limited, to life sciences, biotechnology, medicine, pharmaceuticals, material and environmental science, chemistry and consumer electronics. We have years of experiences in drafting and prosecuting patent applications involving biological deposits, sequence listings, small and large molecules, drug discovery and development, material science, software and engineering, and many others.

This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.

  1. Article 69.5 of the Chinese Patent Law: the manufacture, use or import of patented drugs or patented medical devices for the purpose of providing information required for administrative approval, as well as the manufacture or import of patented drugs or patented medical devices exclusively for the purpose of such manufacture or import, shall not be regarded as infringement of patent rights. ↑

About the Authors

Pauli Wong is a Principal and Chinese Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

Jennifer Che, J.D. is Managing Director and a US Patent Attorney at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.

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