On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm AbbVie (NYSE:ABBV) against Thousand Oaks, CA-based drugmaker Amgen (NASDAQ:AMGN). According to reports, the settlement follows an agreement between the two companies to delay a generic version of the anti-inflammatory drug Humira from the U.S. market until 2023.
The patent infringement case between AbbVie and Amgen stems back to last August when AbbVie filed a patent infringement complaint against Amgen in response to a 351(k) biologics license application filed by Amgen with the U.S. Food and Drug Administration (FDA) seeking approval to market a drug which is biosimilar to AbbVie’s Humira. Such applications for FDA market approval of biosimilar drugs are permissible in light of Congressional passage of the Biologics Price Competition and Innovation Act of 2009, which created an abbreviated licensure pathway for biosimilar drugs. According to FDA guidelines, predecessors in interest who hold a patent covering a biosimilar are afforded similar rights to patent owners who may be impacted by an abbreviated new drug application (ANDA) filed for market approval of a generic version of a branded drug. When Amgen submitted its biosimilar application to the FDA, AbbVie proceeded with patent enforcement activities pursuant to 42 U.S.C. §262(l), providing Amgen with a list of patents covering Humira which could be reasonably asserted against Amgen’s biosimilar in April 2016. In June 2016, Amgen responded by contesting both AbbVie’s infringement allegations and the validity of the patents identified by AbbVie.
AbbVie’s complaint for patent infringement alleges that Amgen is seeking to benefit from Amgen’s significant investment in Humira including two decades of research and development. This R&D investment has led to significant industry recognition including the 2007 Galen Prize for Best Technology Product in patient care. “More importantly, AbbVie’s work has benefited patients immensely,” AbbVie’s complaint reads. “Children have gone from wheelchairs to playgrounds, and adults have gone from bed to work.” AbbVie holds more than 100 U.S. patents covering Humira, which the company says has helped more than one million patients to date. AbbVie identifies 61 patents as being infringed upon by Amgen’s biosimilar. These patents include:
- U.S. Patent No. 6090382, entitled Human Antibodies that Bind Human TNFa. Issued in July 2000, this patent covers an isolated human antibody, or an antigen-binding portion thereof, which specifically binds with human tumor necrosis factor alpha (a), a cytokine produced by various cell types which is implicated in the pathophysiology of various human diseases and disorders.
- U.S. Patent No. 8992926, titled Methods of Administering anti-TNFa Antibodies. Issued in March 2015, it discloses a method for treating rheumatoid spondylitis in a human subject by a subcutaneous administration of a human anti-TNFa antibody once every 13 to 15 days; biweekly dosing provides the benefits of a lower number of total injections, increased patient compliance and lower cost to healthcare providers.
- U.S. Patent No. 9067992, entitled Use of TNFa Inhibitor for Treatment of Psoriatic Arthritis. Issued in June 2015, it protects a method of treatment of moderate to severe psoriatic arthritis in adult patients who have more than three swollen and three tender joints and who have failed non-steroidal anti-inflammatory drug (NSAID) therapy to reduce the radiographic progression of joint disease in the patient.
AbbVie’s patent infringement complaint alleges that Amgen had not negotiated in good faith regarding that company’s application to market a Humira biosimilar:
“Despite knowing AbbVie’s position well in advance of the negotiations, Amgen refused to provide any counter-proposal 16 during the negotiation period. Amgen instead waited until the last day possible to provide AbbVie with the number of patents that it would agree to be sued on. That number was six.”
Thus, despite AbbVie’s argument that litigating all identified patents would be in the interest of judicial economy, it could only litigate a maximum of six patents instead of the 61 identified as being reasonably infringed.
Humira is by far the best-selling drug in AbbVie’s portfolio according to the company’s second quarter earnings report issued this July. Of AbbVie’s total $6.94 billion in net revenues from U.S. and international sales during the quarter, Humira contributed $4.71 billion in revenues. That represented a 13.7 percent increase in global sales of Humira compared to last year’s second quarter. Humira costs a reported $57,000 per patient each year.