Counter-generics strategies needed 10 years before patent expiration


New study says drug companies are failing to plan far enough in advance

Drug research companies are strengthening their task forces to protect the patents for their products, but planning far enough in advance of patent expiry remains a challenge for many teams, according to a new study by Cutting Edge Information.

‘Countering Generic and Biosimilar Threats: Near-Term and Long-Term Strategies’ examines counter-generics task forces and ad hoc teams who come together to guide generics defence strategies. The study includes data that show which functions make up counter-generics teams, the size of these teams, and when they begin operating.

On average, 40% of companies deploy counter-generics task forces. These groups are present at 67% of the pharma industry\'s top 10 firms that participated in the study. The presence of task forces at the largest of companies makes sense because these firms manage entire therapeutic lines. At the same time, task forces are also beneficial to smaller companies, whose fortunes may rest on a few key brands.

‘Besides the actual strategy setting and problem-solving involved, these groups strengthen cross-functional communication because of the array of functions involved,’ said Jason Richardson, president of Cutting Edge Information. ‘Even if the teams form only when there is a generic threat to be addressed, they build invaluable expertise.’

But task forces are not immune to the challenges of proper planning. The study finds that 31% of responding companies form task forces zero to two years out from patent expiry. Another 31% form these groups two to four years from patents expiring. Unfortunately, this leaves less time to develop strategy. When reviewing data by company size, 86% of the surveyed top 10 companies form task forces within four years of patent expiry.

‘Ideally, companies should form task forces from four to 10 years before a patent expires,’ said Richardson. ‘The additional time will expand their range of options, and teams can think more carefully about their next moves.’

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The study examines 12 tactics to combat generics, complete with investment, ROI/results data, case studies, and brand profiles to guide these teams in planning for maximum lifecycle profitability. It also provides metrics and strategic recommendations for proactively preparing for biosimilar competition.