Celgene Wins Patent Row, Gets Generic Rival

18.02.2019 -

Within a week, US biotech Celgene, which is in the process of being acquired by Bristol-Myers-Squibb (BMS), dodged a challenge to its patent for the blockbuster multiple myeloma drug Revlimid (lenalidomide) and picked up generic competition from another drugmaker.

In the first case, the US Patent and Trademark Office rejected a bid by India’s Dr. Reddy’s to invalidate three patents, which put paid to the generic drugmaker becoming a competitor before 2023. Shareholders of both Celgene and BMS breathed easier. 

Days later, the idyll was shattered when Alvogen – a young US drugmaker founded in 2009 and now majority owned by private equity – launched a generic competitor in several European countries, including Romania, Croatia and Bulgaria. The Celgene drug had sales of $1.8 billion in the EU in 2017.

With the second challenge, shareholders of the mega-merger partners had reason to tremble anew as Celgene had said in reporting financial results for the 2018 third quarter it believed Revlimid was protected by patents in Europe until at least 2022.

The biotech has already settled challenges to its Revlimid patents from UK-based Accord Healthcare and India’s Natco Pharma.

As part of the deal with Accord, the British company agreed to end its challenges in exchange for permission to market a generic lenalidomide product for certain conditions prior to expiry of Celgene’s UK patent beginning Jan. 18, 2022 and in various other European countries beginning on Feb. 18, 2022.