About

One year before joining Amarin, a biopharmaceutical company focused on the commercialisation and development of therapeutics to improve cardiovascular health, Joseph T. Kennedy was honoured as an Irish-American by the President of Ireland for contributions to the life science industry as one of the inaugural, “Irish Life Science 50”. He enjoyed 11 years serving in the in-house legal functions of various healthcare companies in the US before moving to Amarin to, in his own words, ‘[lead] a series of innovative approaches to solve the company’s business issues’. Specifically, this meant heading litigation initiatives and victories that helped brand Amarin as a legal “trailblazer” that could punch above its weight. Kennedy played a vital role in the company’s landmark and much publicised free speech, US constitution-based federal court ruling and 2016 related settlement, allowing the promotion of truthful and non-misleading off-label data on FDA-approved drugs. This case supported more informed and thus better care for people with cardiovascular disease. Regarding this, he has the following to share: ‘When advising on FDA drug promotion restrictions, I could not reconcile to myself how the US government could – or why they should – criminalise truthful speech about drugs – especially when useful data on drug efficacy and risk, presented in the appropriate, context could lead to better patient care. This led me to look deeper for ways to solve the company’s business issue by looking further afield for legal answers than traditionally comfortable among seasoned professionals in this practice area. The case validated the value at Amarin of legal initiatives to help meet business objectives and led me to seek out other creative solutions to solve different problems’. Another seminal company victory against the FDA that Kennedy was the 2015 court win effectively reversing FDA’s denial of five-year, new chemical entity (NCE) exclusivity for Amarin’s drug. The case preceded the First Amendment case and was brought in support of greater incentives for drug development from naturally derived complex mixtures. ‘The win helped re-shape how drug exclusivity is determined at FDA’, explains Kennedy. He has added to these important decisions in 2017 when Amarin field a complaint with the US International Trade Commission (ITC) against a group of synthetic omega-3 oil manufacturers to prevent import into the US, and the further sale of synthetic omega-3 products that contain predominantly EPA, the active ingredient of Amarin’s drug Vascepa. ‘This litigation, like the two prior I led at Amarin, provides regulatory synergies by advancing Amarin’s interest while also providing benefits to public policy. Also like the prior litigations, it shows the benefits of a multi-disciplined approach to creatively solve complex business and legal problems’, says Kennedy, adding, ‘it took a lot of creativity and work bringing together the science and lawyers from the relevant disciplines together. This effort further solidified my firm belief that lawyers with diversified skillsets can add unrecognised value to the businesses they serve’. With such landmark cases and achievments under his belt, Kennedy is rightly considered amongst the top general counsel in his industry.