Global Insight Perspective | |
Significance | Bayer HealthCare is suing Abbott Laboratories, claiming that Humira (adalimumab) infringes a Bayer patent on anti-TNF-alpha antibodies. |
Implications | The German firm is seeking undisclosed damages and legal costs from Abbott, but does not appear to want an injunction placed on further sales of Humira. The patent in question is set to expire in 2014, and Abbott will throw its full weight behind efforts to prove it is no longer valid. |
Outlook | Since Humira is not the only anti-TNF-alpha drug marketed in the United States, producers of Enbrel (etanercept) and Remicade (infliximab) could potentially be targeted by Bayer HealthCare as well, although the filing states that the lawsuit is an exceptional case. |
Bayer Mounts Surprise Legal Challenge
A U.S. division of German pharmaceutical giant Bayer HealthCare has taken legal action against U.S. drug maker Abbott Laboratories. The patent-infringement lawsuit was filed on 24 December at the District Court for the Eastern District of Texas, and accuses Abbott of marketing its auto-immune drug Humira (adalimumab) in violation of a patent held by Bayer HealthCare LLC on antibodies that bind to the tumour necrosis factor (TNF)-alpha. Bayer HealthCare's court filing reveals that the U.S. patent 5,654,407 on "Human Anti-TNF Antibodies" was granted in 1997 and is only set to expire in 2014.
Bayer HealthCare claims that Abbott has been aware of the '407 patent since it began marketing Humira—an antibody that also binds to TNF-alpha—in 2002. Abbott, meanwhile, has flatly denied any infringement of the patent and has vowed a strong defence against such accusations. Meanwhile, according to The Wall Street Journal, an Abbott spokesman has also called the patent's validity into question.
No Injunction Sought
While Bayer HealthCare is seeking undisclosed damages from Abbott related to the alleged patent infringement and subsequent sales of Humira, it appears that the German firm is not looking to actively block further U.S. marketing of the drug. No injunction has been made to request a suspension of Humira's sales, and a blanket ban on its turnover is not in Bayer HealthCare's legal strategy. Humira is a blockbuster anti-TNF, and is approved in the United States as a treatment for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, moderate to severe chronic plaque psoriasis, ankylosing spondylitis and Crohn's disease. It is also Abbott's top-selling drug, with US$3.2 billion in turnover during the first nine months of 2008, US$1.5 billion of which came from sales in the Unites States.
Outlook and Implications
The sudden legal move against Abbott raises several important questions on Bayer HealthCare's future plans. Since Humira is not the only anti-TNF-alpha drug currently marketed in the United States, there is technically nothing to prevent the German pharma heavyweight from filing patent-infringement lawsuits against other producers as well. Two other widely-sold treatments within the same drug class are Enbrel (etanercept), co-marketed by U.S. firms Amgen and Wyeth, and Remicade (infliximab), sold by U.S. pharma majors Schering-Plough and Johnson & Johnson. A potential reprieve for these companies, however, lies in the fact that Bayer HealthCare has noted in its legal complaint that its lawsuit against Abbott is "an exceptional case".
In financial terms, 2008 has been a reasonably strong year for Bayer HealthCare, propped up by strong sales from its biggest unit, Bayer Schering Pharma. Yet while the performance of cancer drug Nexavar (sorafenib) continues to shine, the company faces tough times ahead as its top-selling contraceptive drug Yasmin (drospirenone and ethinyl estradiol) is genericised in the United States, and multiple sclerosis blockbuster Betaferon (interferon beta-1a) nears patent expiry. As such, and given that the lawsuit was issued some six years after Humira first came to market, it is possible that this is simply a cash-raising move on the part of Bayer HealthCare. Its success will, of course, depend on how well the validity of the '407 patent stands up in court. In a worst-case scenario, Abbott might need to strike a royalty-based deal with Bayer HealthCare, although this is highly unlikely.