Legal

The biotech industry faces a surge in litigation due to stricter regulations and patent disputes. This legal storm challenges companies and investors, but there are proactive strategies for mitigating risk in this dynamic landscape.

A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.

While the UK Court of Appeal’s decision in Merck Serono v Comptroller-General will be unwelcome by innovators, it provides much-needed certainty for companies seeking – or seeking to invalidate – supplementary protection certificates based on marketing authorizations for new uses of known active ingredients.

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.

In September last year, J&J lost a court case surrounding its 2019 purchase of Auris health, and was ordered to pay over $1bn in damages. Reactions to the potentially precedent-setting news were harsh and quick. In Vivo spoke to legal, M&A and BD experts from across the medtech industry to learn more about the true impacts.

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader outline key compliance aspects that pharma and their global capability centers may need to factor as India moves to strengthen the framework for the protection of digital personal data.

A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.

Novartis has been spooked by the potential for MSN Laboratories to launch its generic version of the originator’s $3bn Entresto (sacubitril/valsartan) heart failure brand, filing an emergency motion in an appeals court in Washington DC just days ahead of the proposed expiry of one of Entresto’s US patents.

The new court ruling could enhance the appeal of the Unified Patent Court for enforcing European patents.

The exact causes leading to Chinese authorities’ investigation of the UK major remain unclear at this point, but its key oncology drugs are facing fierce local competition from homegrown rivals.