Legal Issues

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

In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.

Walmart has launched an attack on a host of industry-leading generics firms over historical price-fixing allegations, with the US retail giant seeking treble damages from a Pennsylvania district court.

The Health and Human Services Department's decision to eliminate the Richardson Waiver may be a blow for transparency, but will not completely eliminate scrutiny of regulations, experts said.

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

Fresenius Kabi has become the latest biosimilar sponsor to settle US litigation with Amgen over its Prolia/Xgeva rivals. The German firm revealed to Generics Bulletin details of launch dates for its denosumab in both the US and Europe.

Amgen’s biosimilar aflibercept formulation is keeping it head and shoulders above other would-be Eylea biosimilar competitors, while continuing to frustrate originator Regeneron’s push to block sales of the product while it battles Amgen over alleged infringement of a key US patent.

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.