In 2025, the total amount of authorized transactions for innovative drugs in China will exceed 130 billion US dollars, with over 150 authorized transactions, a significant increase compared to the full year of 2024 with 51.9 billion US dollars and 94 authorized transactions, setting a new historical high. At present, the number of new drug pipelines under development in China accounts for about 30% of the world’s total, ranking second in the world in terms of scale.

Patents are the core intangible assets of pharmaceutical companies and the legal foundation for products to enter overseas markets and achieve commercial realization. The export of pharmaceutical patents involves multiple countries’ laws, regulations, clinical and commercial rules, with both opportunities and risks. This article combines the latest industry trends, typical enterprise cases, and policy guidance to systematically sort out the core opportunities, practical challenges, and implementation strategies of domestic pharmaceutical companies’ patent going global.

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1、 Five major opportunities for the wave of patent going global

In recent years, the domestic pharmaceutical research and development capabilities have continued to improve, coupled with changes in the global industrial landscape, policy support, and improved professional service systems, leading to a golden period of development for pharmaceutical companies’ patent exports.

1.1 Overseas original drugs have expired, and there is a strong demand for domestic innovative technologies

Several long selling original drugs in Europe and America are gradually entering the “patent cliff”. According to data from the pharmaceutical era, over $300 billion worth of drugs with global sales will lose patent protection by 2030. After the invalidation of heavyweight drug patents, the revenue of original research enterprises has significantly decreased, coupled with insufficient supply of internal R&D pipelines. Overseas pharmaceutical companies urgently need to introduce high-quality new drugs and cutting-edge technologies globally.

After years of accumulation, Chinese pharmaceutical companies have the advantages of high research and development efficiency and low comprehensive costs. Last year, the number of BD projects authorized by Chinese pharmaceutical companies reached 165, an increase of 53 compared to 2024; The down payment exceeded 7.03 billion US dollars, a year-on-year increase of over 226.8%; The total amount reached 136.68 billion US dollars, a year-on-year increase of over 192.2%. Whether it is small molecule drugs, biopharmaceuticals, or cutting-edge technologies such as cell therapy and AI pharmaceuticals, they have become key resources that overseas partners are striving for.

1.2. Improved independent research and development capabilities, continuous expansion of high-value patent reserves

In the early years, domestic pharmaceutical companies mainly focused on generic drugs, with a relatively small number of independently developed core patents and weak international competitiveness. Nowadays, a large number of enterprises are deeply rooted in source innovation, gradually producing globally first and clinically effective drugs and technologies, and accumulating a large number of high-value invention patents.

In addition to mainstream innovative drugs, traditional Chinese medicine and characteristic plant-based medicines are unique competitive advantages in China. By relying on traditional formulas and exclusive extraction processes to create patents, we have formed differentiated competitiveness in the global plant medicine market, effectively avoiding direct competition with top pharmaceutical companies in Europe and America. At the same time, the layout thinking of domestic enterprises is also upgrading, shifting from a single drug patent layout to a systematic layout of technology platforms and complete patent combinations, gradually realizing the transformation from “single product output” to “complete technology output”, and further amplifying the commercial value of patents.

1.3 Dual support of domestic and foreign policies, continuous reduction of entry barriers for overseas travel

At the domestic level, the government continues to introduce policies to encourage pharmaceutical companies to “go global” and support them in conducting overseas patent applications and international multicenter clinical trials. The domestic drug evaluation standards continue to align with the international rules of the International Conference on Harmonisation of Pharmaceutical Technology for Human Use (ICH), and domestic clinical trial data is gradually gaining recognition from European and American regulatory agencies, opening up the entire process of “patent research and development clinical trials overseas listing”. At the same time, intellectual property financial services such as patent pledge and patent value assessment are becoming increasingly mature, effectively alleviating the financial pressure on enterprises’ overseas layout and research and development.

At the overseas level, Southeast Asia, Latin America and countries along the “the Belt and Road” have strong demand for medicine, but their local R&D capacity is weak, and they are willing to introduce foreign drugs and medical technologies. These regions have relaxed patent examination rules and low market access difficulties, making them very suitable for small and medium-sized pharmaceutical enterprises to explore and layout. In addition, with the implementation of international cooperation mechanisms such as PPH patent examination highways, the overseas patent examination cycle has been significantly shortened, and the authorization efficiency has been significantly improved.

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2、 The core challenge of patent going global

The global market is full of opportunities, but behind the trend, a series of problems such as differences in institutional rules, shortcomings in intellectual property management, and homogenization of research and development have also become practical obstacles to the long-term development of domestic pharmaceutical companies.

2.1 Shortcoming of the system: Lack of “export exemption” for patent compensation period, loss of market advantage

The current drug patent term compensation system, on the surface, encourages drug innovation and extends the sales protection period of patented products by five years. However, fundamentally, it has a strong side effect on the pharmaceutical industry: during the patent compensation period, due to manufacturing behavior being identified as infringement, domestic pharmaceutical companies are not allowed to produce patented products, including active pharmaceutical ingredients and formulations, which hinders Chinese pharmaceutical companies from exporting drugs to other countries without patent protection or whose patent protection has been terminated. At a deeper level, this has led to Chinese active pharmaceutical ingredients and formulations falling behind in the global market by five years, making it even worse for Chinese pharmaceuticals to face fierce competition from generic drugs worldwide.

At present, Article 42 (3) of the Patent Law of the People’s Republic of China stipulates: “In order to compensate for the time occupied by the review and approval of new drug launches, the patent administration department of the State Council shall, at the request of the patentee, provide compensation for the patent term of new drug related invention patents that have obtained marketing authorization in China. The compensation period shall not exceed five years, and the total effective patent term after the approval of new drug launches shall not exceed fourteen years

Chen Baohua, a National People’s Congress representative and President of Huahai Pharmaceutical, suggested adding a fourth paragraph “Export Exemption” to Article 42 of the Patent Law. According to the third paragraph of this article, if compensation is given for the duration of the patent right, during the compensation period, the manufacturing, use, sale, promise for sale, and import of products directly or ultimately intended for export shall not be considered as infringement of the patent right.

2.2 Coexistence of patent attack and defense, prominent pressure on cooperation risk control

Domestic pharmaceutical companies’ patent exports face triple tests of attack, defense, and contract risk control throughout the process, demanding extremely high technical, legal, and business capabilities.

On the offensive side, in order to enter overseas markets, it is necessary to challenge the patent barriers built by overseas original pharmaceutical companies, and carry out patent challenges, first imitation applications, and other work.

Case 1: Dongyang successfully challenged the patent of Novofengomode

Fingolimod is a heavyweight drug under Novartis that has been selling well for many years, with annual sales reaching billions of dollars. Novartis has laid out multiple patents around this drug, firmly holding onto the market.There are clear rules in the United States: generic drug companies that want to market similar drugs can voluntarily declare the original patent invalid and submit a generic drug marketing application to the US Food and Drug Administration. Once a challenge is initiated, the original pharmaceutical company will file a lawsuit within 45 days, and drug approval will be temporarily frozen for 30 months, leading to a patent tug of war between the two parties.Dongyang has been planning a generic version of this drug for a long time. During the challenge, Novartis presented a core patent that limits the daily oral intake of this drug to 0.5 milligrams and does not use the transitional medication plan of previous dosage increases. Dongyangguang has seized the loophole of this patent: the patent document only states’ cannot use transitional dosage ‘, but the original text has no textual basis to support this limitation, which is equivalent to an imprecise description of the rules.

After multiple rounds of trial, appeal, and review, the United States Federal Circuit Court ultimately ruled that the written patent specification had significant defects and declared the patent completely invalid. Dongyang has also become the only Chinese company to persist to the end and win the patent competition among multiple countries.

On the defensive side, overseas enterprises with independent patents are constantly facing infringement lawsuits and patent invalidation requests from competitors, as well as malicious lawsuits from overseas patent operating agencies (NPEs). They must fully protect their core intellectual property rights.

Case 2: BeiGene successfully invalidates AbbVie patent

BeiGene’s Zebutinib is a domestically produced original anti-cancer drug that ranks among the top in sales in the US market, directly benchmarking similar products from American pharmaceutical company AbbVie.In 2023, a subsidiary of AbbVie filed a new patent lawsuit against Zebutinib for infringement, demanding that the drug cease sales in the United States. Faced with the lawsuit, BeiGene did not passively respond, but adopted a mature response strategy: while dealing with the court’s infringement lawsuit, it also filed an application with the US Patent Office to declare the other party’s patent invalid.According to US regulations, the court will temporarily suspend the trial of infringement cases until the results of the patent office review are available. In 2025, the US Patent Office officially declared that the patent used by AbbVie in the lawsuit had obvious defects and all rights were invalidated. The other party lost the basis for prosecution and ultimately withdrew the lawsuit voluntarily.This victory is of great significance, as it proves that Chinese original pharmaceutical companies are not only able to produce good drugs, but also proficient in overseas patent rules and know how to take the initiative to counterattack. It also provides a set of directly referenceable response plans for domestic innovative pharmaceutical companies going abroad in the future.

2.3 Insufficient ability to maintain and manage overseas patents

Patent authorization is only the starting point for going global, and the long-term operation and maintenance of overseas patents in the future is a persistent challenge faced by enterprises. The rules and payment deadlines for patent annual fees vary from country to country around the world. The more overseas patents there are, the more difficult it is to manage the ledger and monitor the time limit. Once there is a loophole, it will directly lead to patent invalidation and the early layout will be in vain.

At the same time, most enterprises have weak patent warning systems, which cannot detect overseas competitors’ infringement behavior and competitors’ patent layout trends in a timely manner. From a cost perspective, maintaining a large-scale patent portfolio in multiple countries and regions often results in high operational costs. Many small and medium-sized enterprises, under financial pressure, can only voluntarily give up patent protection in some overseas markets. In addition, the chaotic management of patents within the same family and the inconsistent scope of patent rights in different regions have further amplified management risks.

2.4 Serious patent homogenization and insufficient differentiation competitiveness

Domestic pharmaceutical companies’ R&D resources are highly concentrated on popular targets such as PD-1, and the number of related patent applications ranks among the top in the world. However, the proportion of patents with unique technological advantages and the ability to form solid barriers is relatively low.

The core consideration for overseas partners in patent procurement and authorization negotiations is whether patents can establish real and effective technological barriers, rather than simply the number of patents. The crowded layout of popular tracks not only causes internal competition in the domestic industry, but also limits the bargaining power of domestic pharmaceutical companies in cross-border negotiations. How to create differentiated advantages and break out of the homogenization trap during patent writing and technology research and development is a question that all overseas enterprises need to deeply consider.

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3、 The way to break through: a new paradigm for Chinese pharmaceutical companies to export their patents overseas

Faced with opportunities and challenges, enterprises do not need to blindly follow the trend of expansion, but can steadily layout based on their own scale and business positioning.

3.1 Pre global planning, building a multi-level patent protection network

Simultaneously initiate overseas patent layout in the early stage of drug research and development, prioritize the layout in mainstream markets such as the United States, Europe, and Japan, and then expand into emerging markets such as Southeast Asia and Latin America. While laying out core compounds, apply for patents for peripheral technologies such as crystal forms, formulations, production processes, new indications, and combination therapies, and build a complete protective system.

3.2 Deep synergy between patents and clinical practice, connecting the value conversion chain

When planning overseas patent schemes, synchronously match international multicenter clinical trial designs to ensure that the scope of patent protection is consistent with clinical indications, medication plans, and applicable populations. Proactively benchmarking international regulatory standards, improving clinical trial design and data quality, and promoting the recognition of domestic data by overseas regulatory agencies.

Small and medium-sized enterprises can collaborate with overseas professional CRO institutions to share clinical costs. At the same time, we should shift our operational thinking and abandon the concept of “heavy application, light operation”. We should clarify the subsequent monetization path in the early stage of patent layout, choose authorized cooperation or independent listing mode, and truly generate profits from patent assets.

3.3 Strictly review cooperation terms to avoid cross-border transaction risks

In cross-border cooperation, it is important to pay attention to the following key contract terms:

Patent Usage Territory: Clarify whether the scope of authorization is global or specific to a particular region

Payment settlement methods: down payment, milestone payment, sales share ratio and payment conditions

Ownership of subsequent derivative technologies: Who owns the improved IP

Liability for infringement and rights protection: Who is responsible for protecting rights and how to share the costs when a third party infringes

Termination conditions for cooperation: technology return mechanism, rights restoration clause

In addition, special attention should be paid to regulatory requirements within China: confidentiality review must be conducted before applying for patents abroad; If the transaction involves related parties, a reasonable review of transfer pricing must be conducted; Simultaneously pay attention to export control, data export compliance, etc.

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4、 Summary and Prospect

Going global for pharmaceutical patents is not simply about submitting a few overseas patent applications, but a systematic project covering technology, law, clinical practice, and business. For enterprises, they should neither stop moving forward due to risks, nor blindly follow the trend and rush out to sea. It is necessary to first strengthen the patent layout and risk prevention and control capabilities, choose an appropriate overseas model based on one’s own strength, and steadily explore the international market.The window for patent export has opened.Can we seize these five years,It depends on the layout and preparation of the enterprise today.

With the continuous upgrading of domestic research and development capabilities and intellectual property service capabilities, more high-quality Chinese pharmaceutical patents will go global. Relying on hardcore technology and a sound patent protection system, China’s pharmaceutical industry will continue to enhance its international discourse power and steadily achieve a leap from a “pharmaceutical power” to a “pharmaceutical powerhouse”.

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