Patents

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.

Catalyst saw its share price jump by around 14% after striking what the market termed a favorable patent-litigation settlement agreement with ANDA sponsor Teva over its rare disease drug Firdapse.

Boehringer Ingelheim’s sale of three diabetes brands in India, with the same composition as Jardiance, Jardiance Met and Glyxambi, to Torrent comes ahead of the expiry of the Indian patent for empagliflozin. A launch for other indications is also expected.

Fresenius Kabi was unable to persuade a US court that its proposed generic version of Heron Therapeutics’ Cinvanti (aprepitant) injectable emulsion for chemotherapy-induced nausea and vomiting would not infringe a pair of patents stretching into the next decade.

Will Novartis’ monopoly on Entresto, one of the biggest-selling small molecule drugs in the US, last until its proffered mid-2025 date? An unfavorable decision by the US Court of Appeals for the Federal Circuit that has handed victory to ANDA sponsor MSN Labs could upend the originator’s projection.

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

The wait for US competition to AbbVie’s Lumigan 0.01% glaucoma brand, launched more than a decade ago, goes on, after Mankind bowed to infringement of a key US patent.

A watershed moment is on the horizon for US biosimilars, with Amgen looking poised to debut competition to Eylea (aflibercept).

With sales projected to peak at nearly $700m a year, Galafold – the first oral monotherapy for people living with the ultra-rare genetic disorder Fabry disease – is a lucrative target for ANDA sponsors. However, Teva, which has just put pen to paper on a patent-litigation settlement agreement, will have to wait more than a decade to roll out its generic product.