ADVERTISEMENT
Patents
Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.
The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.
With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.
A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.
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.
In the pharma and cosmetic sectors, innovation often arises from new uses for known compounds. While the compounds may not be patentable, their new applications can be. European law allows patents on substances used in medical methods, but not on the methods themselves.
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.
While Celltrion has scooped approval for the first biosimilar to Genentech/Novartis’ Xolair in the US – where the reference product achieved sales close to $3bn last year – Genentech’s parent Roche has stated consistently that it is not expecting to face biosimilar competition in 2025.
Lupin and Sun Pharma’s Taro, which have just won the first US Food and Drug Administration approvals for generics to J&J/Bayer’s blockbuster Xa inhibitor Xarelto, remain locked in litigation over a patent expiring in 2039.