Legal Issues

Lupin has moved quickly to begin rolling out the first generic version of the blockbuster blood thinner Xarelto in the US, despite continued legal action over a patent expiring in 2039.

Medicines for Europe’s director general described the directive as detrimental to the industry, patients, and the Commission’s ambitions to bolster the supply of critical medicines in the bloc as part of the Critical Medicines Act.

Teva will have to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March, as the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

Sandoz CEO Richard Saynor has spoken of his frustration at a lawsuit from J&J seeking to prevent the launch of a private-label ustekinumab biosimilar in the US, which he described as “the desperate actions of an originator trying to protect its market.”

In its latest legal case, Vanda lost its case against the FDA and Teva over the alleged unlawful approval of the Israeli firm’s generic Hetlioz.

The US Association for Accessible Medicines says it is looking to “protect the public’s interests in ensuring that patents do not let inventors control more than they invented,” as it moved to file in support of MSN Laboratories’ legal tussle with Novartis over a key patent shielding the originator’s $7.8bn Entresto blockbuster.

The same day as Samsung Bioepis and Sandoz launched their partnered Pyzchiva biosimilar rival to Stelara in the US, originator J&J hit the Korean developer with a lawsuit claiming that a private-label commercialization deal with a US pharmacy benefit manager violates the ustekinumab settlement that allowed the firms to launch.

Philips, the last of the global top-three imaging companies to report 2024 financial results, said the soft China market put the brakes on its growth. The regional outlook for early 2025 is no different, and US-China tariffs will present another challenge.

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.