THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. District Court for the District of New Jersey has ruled in Amgen's favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it.
Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the patent infringement action in Federal Court against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (together, Sandoz). Before trial, Sandoz acknowledged that its biosimilar etanercept infringes seven patent claims in U.S. Patent Nos. 8,063,182 and 8,163,522. Trial proceeded only on Sandoz's challenges to validity of those claims. After careful consideration, the Court found that Sandoz had not met its burden to prove all seven asserted claims invalid.
Immunex/Amgen and Sandoz have entered into an agreement with respect to a preliminary injunction regarding Sandoz's etanercept as set out in the Court's order of June 7, 2018.
"We are pleased with today's decision recognizing the validity of these patents. Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients," said Robert A. Bradway, chairman and chief executive officer at Amgen.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
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