On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by Samsung Bioepis. Eticovo is a biosimilar to Enbrel® (etanercept), which is marketed by Amgen, Inc. (“Amgen”). Like Enbrel, Eticovo was approved across five eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic
Benjamin R. Holt
Jury Finds Amgen Antibody Patents Not Invalid
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of high cholesterol. The case reached an important milestone recently as a jury entered a verdict largely upholding the validity of Amgen’s asserted patents, to the disappointment of Sanofi and Regeneron. A similar…
RFEM’s Biosimilars Inter Partes Review (IPR) Dashboard
RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar products.
PTAB Exercises its § 325(d) Discretion to Deny IPR of Piglet Vaccine Patent
The August 2018 Update to the PTAB Trial Practice Guide added guidance regarding the Patent Trial and Appeal Board’s (“the Board”) discretion under 35 U.S.C. § 325(d) to deny institution of an AIA trial when the same or substantially the same prior art or arguments were previously presented to the United States Patent and Trademark…
Litigation vs. Licensing: Manufacturers of the Two Most Recently Approved Biosimilars Take Different Approaches to Reference Drug Patents
The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb), which is manufactured by Amgen and was approved as a biosimilar to Genentech’s Avastin (bevacizumab) on September 14, 2017.
On October 6, 2017—about three weeks after the FDA approved Mvasi—Amgen provided Genentech with a notice…