In the past ten years, many companies and academic institutions related to sequencing have emerged. In the veritable emerging industry of high-throughput gene sequencing , technological improvements and changes are accompanied by intellectual property games between established pharmaceutical giants and emerging start-ups. Part 1 - The world of war-torn patents The gene sequencing industry has both industry giants and burgeoning startups, one of which is inevitably mentioned as Illumina. Illumina is a leader in gene sequencing and is at the heart of patent litigation. Key companies in the sequencing area of ​​patent disputes with Illumina, including litigation between Solexa, Complete Genomics, and Huada Gene, mergers and acquisitions, and key issues in the NIPT field, including Illumina, Sequenom, Verinata, Ariosa, Litigation, mergers and acquisitions and cooperation between Natera, Roche and ISIS. There are several patents behind these litigations, mergers and acquisitions and cooperation that play an important role. There has also been a dispute between the Chinese company Huada Gene and Illumina for the acquisition of Complete Genomics (CG). After the offer of the acquisition of CG by Huada, Illumina also expressed its willingness to acquire CG, which is 5% higher than the bid of Huada Gene and does not require the approval of relevant US authorities. Illumina also filed several patent infringement suits against CG. It was not until March 2013 that Huada Gene successfully completed the acquisition of CG. Part 2 - Non-invasive pre-production patent dispute In the non-invasive prenatal diagnosis, Sequenom filed a patent infringement lawsuit against Ariosa's patent infringement of US6258540 patent ('540 patent). In response, in February 2012, Ariosa, Natera, and Verinata and Stanford University jointly sued Sequenom, proposing that the technology of these three companies is different from Sequenom's technology, and there is no patent infringement. During the lawsuit, Verineta further used three patents '017, '018, '415 to counter the Sequenom infringement and sought a temporary injunction from the court. In addition, during the lawsuit, Ariosa patented Sequenom's US '540 patent. Three years later, in June 2015, the US Court of Appeals for the Federal Circuit finally ruled that the '540 patents were all invalid and were not subject to patent law protection and were not patentable. Sequenom has since lost the most basic patent of Professor Lu Yuming in the non-invasive prenatal field. Sequenom was dissatisfied with the verdict, but in December 2015, the Federal Circuit Court of Appeal rejected the request of the entire judge for reconsideration by Sequenom. The case will go all the way into the Supreme Court. Part 3 - Gene patentability (Wanji case) In the aspect of tumor gene detection, Myriad Genetics (Wanji) has attracted public attention. It was originally because the famous movie star Angelina Jolie tested the BRCA gene at Wanji and was diagnosed with 87%. The risk involved breast and ovarian cancer, followed by Julie's bilateral mastectomy. Wanji Company monopolized the detection market of BRCA gene, so it earned a lot of money, but it also caused great dissatisfaction with the university genetic testing laboratory and breast cancer patients. Finally, both parties entered the court. After repeated trials and great public attention, on June 13, 2013, the US Supreme Court unanimously ruled that the separate DNA patent owned by Wanji Company was invalid. The court believes that genes that exist in nature are not only patentable because they are separated. cDNA is not naturally produced and therefore satisfies patentability. After the Supreme Court's decision, several companies including Ambry Genetics announced that they would provide genetic testing services that compete with Wanji's products. Wanji Company applied to the court for a temporary injunction based on other patents. However, on December 17, 2014, the Federal Circuit Court of Appeal again ruled that Wanji’s six claims, whether it is a primer for genetic testing or a method for testing, are not US patents. Article 101 of the Act may grant the subject of a patent. Part 4 - The global impact of patent litigation Although the Supreme Court’s decision was contrary to the practice of the US Patent and Trademark Commission’s long-standing review practice, the United States Patent and Trademark Office, one of the most direct affected persons of the Wanji case, issued a memorandum on the day of the verdict, requiring its reviewers to Article 101 of the Patent Law stipulates the product claims of naturally occurring nucleic acids or fragments thereof, whether or not they are separated. Since the Wanji case, a series of judicial decisions have led the USPTO to modify the review guidelines several times. In Australia, Wanji is also facing an appeal. Yvonne Darcy, a 69-year-old cancer survivor, brought Myriad Genetics to court and asked the court to invalidate Wanji's BRCA1 and BRCA2 patents. After a lengthy judicial process and repeated appeals, on October 7, 2015, the High Court of Australia overturned the Full Federal Court's decision on the BRCA1 gene patent, ruling that "the isolated nucleic acid encodes the BRCA1 protein. , with specific mutations used to indicate susceptibility to breast and ovarian cancer" is not a "patentable invention" in the sense of Australian patent law. At the same time, in other parts of the world, such as Europe, Japan and China, it seems that the licensing standards for gene patents have not been tightened.
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