Context: A big pharma had a big problem: its lead blockbuster product, a anti-TNF monoclonal antibody for auto-immune diseases, including Rheumatoid Arthritis was facing a ‘patent cliff.’ Analysts conservatively predicted 65% company-wide revenue losses within an 18 month period upon patent expiration, with a multi-billion dollar loss in market capitalisation.
Solution: IPAV deployed a dual strategy: a strategic IP review in partnership with IP Asset LLP, and a ‘product plus’ strategy for the existing branded product, to differentiate versus incumbent biosimilars. The IP strategy identified unutilized IP within the company’s portfolio pertaining to the drug-drug interaction safety, this IP had a longer remaining patent life than the core biologic. Secondly, IPAV convened a group of global thought leaders in patient adherence and real time pharmacovigilance – from trusted academia and industry partners – to design an enhanced patient experience programme, improving data collection, patient-clinician communication and data sharing between patient groups and regulators.
Outcome: The unutilized IP was determined to be core to the mechanism of action of the blockbuster biologic, and thus three additional years of market exclusivity were conferred to the company’s leading product. And negotiations are currently underway with biosimilar manufacturers to cross-license this IP, generating additional revenue in emerging markets; Following the introduction of the patient experience programme, sales of the lead product have increased by a third in the US and clinicians and patient groups are committed to supporting the branded biosimilar, in preference to the competitive biosimilar, in due course. Analysts are now issuing a strong ‘buy’ recommendation for the company’s stock.