Illumina Files Patent Infringement Lawsuits Against MGI Amid U.S. Tech Restrictions on Chinese Firms

U.S. imperialism, with its unrelenting intent to undermine China, has continuously suppressed Chinese high-tech sectors deemed threatening to the United States, in an effort to curb China’s technological advancement. In the U.S.-China trade war, America has employed every conceivable tactic, including pressuring tech giants such as Google to impose technical blacklists on Huawei, while the laboratory of Chinese-American biologist Xiaojiang Li was abruptly shut down.

MGI Tech’s domestically produced gene sequencers represent another area posing a threat to U.S. technological monopoly, and have received high praise from the People’s Daily:

People's Daily: How MGI Tech Breaks Monopolies and Promotes the Popularization of High-Throughput Sequencing Technology Through Key Core Technology Breakthroughs

Leveraging its proprietary technological roadmap, it has developed a series of core sequencing technologies and products, expanding its user base to 16 countries and regions.

To date, MGI Tech has cumulatively invested over RMB 5 billion in research and development, achieving breakthroughs in a number of key core technologies. It has established a foundational patent portfolio for sequencing technologies, filing more than 580 technical patents, including over 80 PCT patents. Furthermore, the company has successfully developed a suite of core technologies and products, including compatible sequencing reagents, materials, and biochemical reaction systems.

“For instance, in the realm of key sequencing technologies, traditional PCR (polymerase chain reaction) sequencing methods separate the double-stranded DNA like a pair of chopsticks and then replicate each strand, leading to exponential amplification—1 becomes 2, 2 becomes 4, and so on. However, this approach has its drawbacks; an error at any stage will propagate through subsequent steps,” introduced Wang Jingjing, Product Manager for Sequencers at MGI Tech. “The DNA fragment rolling circle amplification method we developed consistently ‘copies’ the original DNA template, akin to sharpening a pencil with a rotary sharpener. This effectively eliminates the accumulation of amplification errors, thereby enhancing sequencing accuracy.”

On the other hand, MGI Tech has developed a new-generation single-tube long-fragment library preparation technology, capable of generating long-fragment genomic information up to 300 kb in length, which holds significant importance for advancing the application of high-precision genome sequencing in both research and industrial sectors.

Leveraging its proprietary technological roadmap, MGI has installed over 1,100 gene sequencers worldwide since 2015, covering 16 countries and regions, serving more than 300 users, and contributing to over 300 high-impact scientific publications. George Church, Director of the Center for Genomics at Harvard Medical School, stated, “With core technologies in hand, MGI can make sequencing affordable while achieving near-zero error rates.”

Regarding the company’s innovative DNA, Mou Feng stated, “Established three years ago, we now have nearly 1,000 employees, with R&D personnel accounting for over 50% of our workforce. Our team comprises experts in life sciences as well as specialists in optics, mechanics, and other disciplines, demonstrating strong capabilities in integrated innovation.”

Currently, MGI Tech possesses research and development as well as manufacturing capabilities in the three upstream sectors of instruments, reagents, and software—a rarity on the international stage. In 2017, MGI Tech jointly invested with the Changchun Institute of Optics, Fine Mechanics and Physics of the Chinese Academy of Sciences to establish Changguang Huada Gene Sequencing Equipment (Changchun) Co., Ltd., dedicated to the R&D and production of gene sequencers and other instrumental equipment. “We believe that cross-disciplinary technological applications will transform this industry, and we place great emphasis on the integration of technology in the innovation process,” said Liu Jian.

“Practice in the development of modern technology has shown that whoever achieves breakthroughs in tools first can gain a technological first-mover advantage,” said Mu Feng. “In the past, we were followers in many fields, but in the era of life sciences, we have been basically in step with the world from the outset. Therefore, we must address the shortcomings in key core technologies as soon as possible and produce pioneering achievements.”

Recently, global gene sequencing giant Illumina has also acted as Trump’s enforcer, suing MGI Tech for patent infringement to curb the development of China’s gene technology:

Illumina, the global leader in gene sequencing, announced last month that it had filed a patent infringement lawsuit against MGI Tech’s Latvian subsidiary at the Regional Court of Düsseldorf, Germany. The complaint alleges that MGI Tech’s sequencing products, including the BGISeq-500, MGISeq-2000, and related chemical reagents, infringe upon Patent No. EP 1 530 578 B1. This patent covers Illumina’s proprietary sequencing-by-synthesis technology.

This month, Illumina announced another patent infringement lawsuit filed against BGI Europe A/S, a subsidiary of the BGI Group, at the Danish Maritime and Commercial High Court. The complaint alleges that BGI’s sequencing products, including the BGISEQ-500, MGISEQ-2000, and related chemical reagents, infringe Patent No. EP 3 002 289 B1, which covers Illumina’s proprietary sequencing-by-synthesis chemistry. It further claims that BGI’s use of the MGISEQ trademark infringes upon Illumina’s registered EU Trademark No. 8972127 for the MISEQ name.

A review of Illumina’s official website reveals that, according to its May 29 announcement, a Senior Vice President of Illumina stated that the company cannot tolerate the unauthorized use of its proprietary patented technologies. Illumina filed the lawsuit to safeguard its substantial investments in its industry-leading sequencing technologies. The company will also continue to monitor patent infringement activities.

Notably, a 2010 announcement on Illumina’s official website revealed that BGI Group had purchased its HiSeq 2000 sequencing system from Illumina. At the time, Zhang Xiuqing, Deputy Director of the BGI Shenzhen Institute, stated that this acquisition represented a significant step for BGI Group in providing foundational sequencing infrastructure to support scientists worldwide.

MGI Tech is the sequencing instrument R&D and manufacturing subsidiary under the BGI Group. In the current global mainstream second-generation sequencing instrument market, MGI Tech ranks among the top three worldwide, resulting in intense competition between the two companies in the production and sales of sequencers. On the other hand, the sequencing services division of the BGI Group was once a major customer of Illumina. However, with MGI Tech’s breakthroughs in second-generation sequencing technology, BGI has ceased procurement from Illumina and shifted to purchasing MGI Tech products instead.

BGI Group responded that it is highly confident in its proprietary technologies. MGI, a subsidiary of BGI Group, has cumulatively invested over RMB 5 billion in research and development, achieved source-level patent deployment in sequencing technology, and broken the market monopoly in the upstream sector of the gene sequencing industry. Regarding the patent dispute, the company is actively responding and will take appropriate legal actions, including but not limited to filing counterclaims, to safeguard its legitimate rights and interests.

In addition, it is reported that the sales of MGI’s related products domestically and internationally have not been affected so far.

MGI Tech’s Latvian subsidiary was established to prepare for sales in Europe, while the products involved in the current dispute originated from Complete Genomics, a company previously acquired by MGI Tech. Prior to its acquisition by MGI Tech, Illumina had engaged in several patent litigation disputes with Complete Genomics, which were settled in 2013.

A search of the European Patent Office’s official website revealed that both patents were filed in 2003. Industry insiders noted that, given the standard 20-year patent term, competitors typically begin preparing for commercial launch one to two years before expiration. According to these sources, Illumina’s allegations appear to concern certain minor technical aspects of sequencing reagents—technologies that, while not particularly complex, are essential for sequencers and cannot be circumvented. Due to the technical complexity involved, industry experts believe it is difficult to predict precisely which specific points Illumina is alleging infringement on, or how it intends to substantiate its claims.

Public information indicates that a German company, QIAGEN GmbH, was previously involved in litigation with Illumina over the patent EP 1 530 578 B1 at issue.

Another industry insider stated that, in principle, the underlying technologies of both parties’ products are identical, but their implementation paths differ.

According to Jiang Hui, COO of MGI Tech, the core technology used in MGI Tech’s sequencers is called DNBSEQ, which is based on single-strand rolling circle amplification. Another technology employed by other companies is bridge PCR on chips, where PCR amplification takes place on the chip. These two technologies represent distinct technical approaches in short-read high-throughput sequencing.

Furthermore, mutual patent litigation has become commonplace in the field of gene sequencing. Illumina has filed patent lawsuits against multiple companies worldwide, but has also faced counterclaims from Qiagen and Columbia University in the United States.