Shire’s 70+ Year Commitment to the Hemophilia Community

Shire’s 70+ Year Commitment to the Hemophilia Community

January 15, 2018

Dear Hemophilia Community,

At Shire, we’ve been committed to the hemophilia community and the lives of every patient afflicted with this disease for more than 70 years. We are very proud of this legacy and take our role as the industry leader very seriously. We never, ever lose sight of who we serve: the patients, their caregivers and their health care providers. For me as a physician of nearly 30 years, this commitment is very personal.

Shire’s unwavering dedication to the hemophilia community can be measured in many ways: Our broad portfolio of 9 products in hemophilia, which are available in more than 40 countries. Our significant investment in research and development, which includes 20 on-going clinical trials in bleeding disorders, including one in gene therapy, as well as other novel potential pre-clinical advancements, such as orally administered therapies and a bispecific antibody. Our 100s of colleagues – the world’s leading scientists, researchers, and patient support specialists. And, most fundamentally, our collaboration with the hemophilia community, including patient associations that have enabled the diagnosis of more than 30,000 patients around the world. We are proud – and humbled – to champion for patients with rare diseases, including those with hemophilia.

Protecting Our Intellectual Property Preserves Our Ability to Innovate

For Shire, like any biopharma company, our intellectual property rights are vital. Our patents preserve our ability to continue to invest and develop innovative new therapies. Without them, we simply could not serve the hematology community in significant and meaningful ways as we have done for the last three quarters of a century. For these reasons, we must protect our innovations with patents, and, when companies unlawfully make use of our patented technologies, we must enforce them. Sometimes that requires intervention from the courts, but settlements are common in intellectual property lawsuits, and Shire has a consistent track record of pursuing reasonable settlements when these matters arise in hematology and across our other businesses.

In the interest of our continued transparency, we believe it is important to share our perspective on the current situation between our company and Roche subsidiaries Genentech Inc. and Chugai Pharmaceutical Co., Ltd.

As Roche has acknowledged, more than two years ago, Shire learned that Roche was developing a product that used Shire’s patented technology, and it became necessary for Shire to seek judicial intervention to protect our rights – first in Japan and more recently in the United States. In parallel, we initiated discussions with Roche and, over the last two years, actively sought a resolution that would afford Shire fair value for our patent rights while at the same time allow Roche to bring its product to market. Unfortunately, despite our repeated efforts, Roche has elected not to engage these discussions in a meaningful way.

Instead of confronting Shire’s bona fide claims that Roche infringed Shire’s rights and seeking an outcome that would ensure unfettered patient access, Roche ignored the pending court proceedings and made a commercial decision to proceed with the launch of Hemlibra in the United States. When it did so, Roche left Shire with little choice, and it became necessary for us to file a motion for preliminary injunction in the U.S. against Genentech and Chugai to protect our rights. Because we maintain patients at the center of everything we do, we refrained from requesting a wholesale injunction that would have prevented any and all sales of Roche’s product.

To be clear, no patient is currently being denied access to treatment with Hemlibra. There will be no patient impact until the court’s decision on the motion, expected in the summer of 2018, and if the court does decide to enter the injunction that will mean it has concluded that Shire is likely to prevail in our legal position. Further, as part of our legal motion, we have proposed that the court structure the injunction in such a way that ensures continued uninterrupted access to treatment for the majority of patients. While ultimately the scope of the injunction is at the court’s discretion, our goal is, and always has been, to protect our patients by ensuring that we are able to continue to invest in innovative treatments. Our sincere hope is that this matter will continue to have zero impact on patients by coming to a collaborative resolution with Roche without the courts deciding for us.

Shire Puts Patients First

Unfortunately, we are at this point now because Roche decided to launch its product knowing full well that there were ongoing legal proceedings regarding Roche’s infringements on Shire’s patent rights. In making that decision, Roche was fully aware that launching Hemlibra without resolving this on-going dispute could potentially impact patients but they proceeded anyway.

At Shire, we always put patients first. And we abide by the principles of operating as a legal and ethical company. We also have a demonstrated history of successfully resolving U.S. patent-related disputes when they arise, and, for more than two years, we have pursued precisely that outcome in the pending Roche actions. Despite Roche’s recalcitrance, our objectives have not changed, and we remain committed to resolving this matter as expeditiously as possible.

Howard Mayer, M.D.
Chief Medical Officer, Shire