On Friday, August 9, 2019, Amgen Inc. (AMGN:NASDAQ) announced that it had won its Enbrel patent case. The company advised 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. The firm advised that the court upheld the validity of patent claims directed to Enbrel and that the preliminary injunction is to remain in place.
In the release the company outlined the scope and findings in the case, "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."
The report further indicated 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.
After the ruling, Amgen's chairman and CEO Robert A. Bradway commented, "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."
Enbrel is one of Amgen's leading patented drug products; it is prescribed for rheumatoid arthritis and other arthritic diseases. In the firm's earnings report filed July 30 for the second quarter ending June 30, 2019, the company reported total revenue of $5.871 billion for Q2/19, of which $5.574 billion was from product sales. Sales of Enbrel in Q2/19 were $1.363 billion worldwide, representing 24.45% of the firms product revenues and its largest individual patented drug by revenue. In Q2/19, Enbrel sales were reported to have increased 5% over $1.302 billion for Q2/18 driven primarily by net selling price and favorable changes in inventory levels, offset partially by lower unit demand.
The firm announced on August 2, 2019, that its Board of Directors declared a $1.45 per share dividend for the third quarter of 2019 to be paid on Sept. 6, 2019, to all stockholders of record as of the close of business on Aug. 15, 2019.
Amgen states that it 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 states it 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. In addition to Enbrel, some of the firms largest patented medicines include Prolia, XGEVA, Neulasta and Aranesp.
Amgen shares opened up only slightly higher today at $197.90 (+$1.65, +0.84%). However, since the open, shares have traded higher, between $197.25 and $208.78, and are currently trading at $207.05 (+10.80, +5.50%).
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