In June of this year, a US federal court decision shook the entire in vitro testing (IVD) industry, and the court decided that the patent for detecting free fetal DNA in maternal blood was invalid!
Sequenom, Inc. holds US 6,258,540 (US '540) patent and used it in March 2012 in the Northern District of California, USA to Ariosa Diagnostics, Inc., Natera, Inc. and Verinata Health, Inc. When the company filed a patent infringement lawsuit, Ariosa also filed a patent invalidation lawsuit against Sequenom in the Northern District of California in March 2012. After a series of lawsuits, the US federal court ruled that the Sequenom patent was invalid.
The reason for the court's invalidity is that the US '540 patent protects a natural phenomenon in the human body and is not covered by patents. This judgment has caused widespread controversy in the United States, and its influence has begun to spread to the global biotechnology and pharmaceutical market, especially for the IVD industry with the detection of "biomarkers" as the main body of technology. It is estimated that this judgment may result in a large number of US patents for detecting diseases with biomarkers, which greatly affects the research and development and commercial market development of the global IVD industry.
1. Sequenom rises to the beginning and end of patent litigation
In 2012, Sequenom said that Ariosa and other companies infringed on their company's US' 540 patent, requiring Ariosa to stop the non-invasive fetal genetic testing business, but the US District Court held that the US' 540 patent claims related to patent eligibility and did not agree with Sequenom's requirements. . Sequenom appealed to the federal court, and the federal court sent it back to the district court for a second trial. Finally, the district court held that the scope of the US '540 protection only contained the natural phenomenon, so the patent was invalidated. Sequenom refused to accept the result and appealed to the federal court again. In June of this year, the Federal Court upheld the District Court's decision to determine that the US' 540 patent was invalid.
The US '540 patent primarily protects a non-invasive method for detecting fetal genetic disease by extracting free fetal paternal genetic DNA from maternal serum or plasma samples and further amplifying it. Traditional prenatal testing, such as amniocentesis, poses a certain degree of risk to the mother and the fetus, and maternal blood samples obtained by other methods are discarded directly. Therefore, the biggest contribution of the US' 540 patent is the discovery of free fetal DNA in the maternal blood, and the use of gene amplification and detection techniques such as PCR to detect fetal genetic diseases, and not only improve the detection accuracy, but also greatly reduce the risk. However, as any practitioner in the field of biotechnology can imagine, the presence of free fetal DNA in maternal serum is a natural phenomenon, as is true for all pregnant women. The question is whether patents can protect pure natural phenomena, and does the US' 540 patent protect innovations other than natural phenomena?
The well-known Myriad case of the US Supreme Court and the jurisprudence of the Mayo case greatly influenced the reasons for the Sequenom case. The Federal Court of Justice considers that the US '540 patent, while incorporating the step of amplification of DNA (ie, the amplification of DNA by PCR) and the detection of specific genetic diseases, does not alter the nature of its protection of natural phenomena, and DNA The step of zooming in and the method of detecting disease have long been known in the field of biotechnology. The US' 540 patent does not have any breakthrough in these methods, so the patent was invalidated. The Federal Court added that even though the US ' 540 patent has contributed greatly to prenatal testing, it has not changed the purely exclusive nature of the US ' 540 patent, and the patent is a major discovery rather than an innovative invention. . Endings As you know, Sequenom's non-invasive prenatal testing products have lost key patent protection.
We, Jiangsu YanFang Medical Technology Co., Ltd, commenced our medical gloves manufacturing in 2020. Currently, we possess a total of 12 high-capacity NBR Glove Dipping Production Lines.
Likewise, we are not only certified with ISO9001, ISO13485 but also fully complied with the essential USFDA, CE Compliances, as well as obtaining relevant accreditation of FDA510K, EN455, and EN374.
Nonetheless, our NBR Examination, Chemotherapy, and Food Grade products are being well established in both US and Europe markets.
We look forward to cooperating and working closely with our valuable customers and stakeholders, who are seeking long-term business relationships in high-quality NBR glove supplies.
Medical Examination Nitrile Gloves,Disposable Nitrile Gloves,Medical Safety Nitrile Gloves,Exam Gloves
Jiangsu Yanfang Medical Technology Co.,Ltd. , https://www.yanfangchina.com