Alzheimer’s is one of the most feared diseases in the world. Despite many attempts to find an effective therapy to prevent or delay its effects, the disease remains largely untreatable. Many of us know someone with Alzheimer’s. For me, it was my father who was faced with early onset of the disease. By his mid-sixties he started showing signs of Alzheimer’s that were often dismissed as forgetfulness and aging. Living in a rural area, even after seeking medical counsel he was not given a diagnosis. Finally, a dedicated neurologist made his Alzheimer’s diagnosis and we were able to start arranging the necessary support for both my parents. It was a real struggle that required my parents to move in with one of my brothers to address caregiving needs in a supportive environment. My father’s own fight ended when he passed away from another disease but watching him lose his independence and the strain on my family – particularly my mother – has forever changed my appreciation for the difficulties of this mysterious disease and its impact on patients and their families.
In the absence of effective treatments, the Alzheimer’s health crisis is well on its way to becoming a global economic crisis. Right now, U.S. government spends more than $20 million an hour caring for Alzheimer’s patients. Globally, the costs of caring for Alzheimer’s patients are expected to double in the next decade, as the number of people suffering soars from 50 million to more than 80 million.
Unfortunately, developing Alzheimer’s treatments has proven to be incredibly daunting. Because of the complexity of the illness, high failure rates and the need to measure the rate of a patients’ cognitive decline over time, the timeline for studying an Alzheimer’s medicine is much longer than most medicines. A longer timeline means patients wait longer for a treatment – and higher research costs. It also means that a drug will likely lose its patent protection by the time it’s finally able to enter the marketplace.
Why is this? Patents provide 20 years of protection for a new medicine, but that 20-year clock starts ticking the moment a molecule is deemed to be a drug candidate and a patent is filed - many years before clinical trials even begin.
As a result, biopharmaceutical companies tend to focus their investments in disease areas with faster clinical trials and lower failure rates than Alzheimer’s – not necessarily the medicines patients need most.
How do we change this? At Lilly, we believe a more sustainable solution would be to set a global standard for data exclusivity.
Data exclusivity is essentially the intellectual property protection granted to an inventor on the data generated during clinical trial testing. Data exclusivity prevents a second company from introducing a copycat version of a medicine without first generating its own clinical studies and data.
Data exclusivity starts on the date a medicine is approved by regulators, which offsets the years of patent life lost due to extended clinical trials. More on data exclusivity can be found here.
Since joining Lilly in May, I have been fortunate to work with many dedicated and talented individuals, all focused on improving the lives of patients. I am especially proud of the work Lilly does to engage and partner with the patient advocacy community. Lilly’s sponsorship of the 2019 BIO Patient and Health Advocacy Summit is just one of the many ways we hope to provide advocacy organizations with meaningful opportunities to learn and grow. Lilly’s reputation among the patient community is one of the many reasons I am proud to be part of the team.
Earlier in my career I worked advancing public policy solutions for those living with multiple sclerosis. Helping those with MS, and those who care for them, was some of the most rewarding work I’ve ever done. I want to do the same for those living with Alzheimer’s disease. I will always consider myself a patient advocate no matter my professional role. We all have our own stories and experiences and it’s important we continue to work together to advance discovery and treatments.
Patients are counting on a breakthrough treatment for Alzheimer’s. It’s our hope too. And a strong IP system can help get us there.
By Shawn O'Neail, VP of Government Affairs, Eli Lilly and Company
Author Shawn O'Neail, VP of Government Affairs, Eli Lilly and Company
Shawn is a veteran of several political campaigns, and has worked in the Executive Branch of government, patient advocacy, and the biopharmaceutical industry. He lives in the Washington D.C. area with his wife and twin daughters. Together they enjoy traveling, cooking and cheering on the St. Louis Cardinals.