Legal & IP

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.

The latest twist in MSN’s legal fight with Novartis over Entresto has seen a US court rule that the FDA was correct to approve MSN’s skinny-label generic, which carves out certain protected Entresto indications. However, an appeal has already been filed and an imminent generic launch looks unlikely.

MSN Laboratories returned to court to attack more US patents shielding Exelixis’ blockbuster oncology drug Cabometyx. However, as with the first ruling, the Indian firm was met with further disappointment.

In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.

Fresenius Kabi is facing up to a patent-litigation suit over its proposed biosimilars to Amgen’s Prolia/Xgeva brands – although a prior lawsuit involving biosimilar sponsor Sandoz concluded with a settlement agreement.

The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.

Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.

The world’s best-selling diabetes medicine, with sales last year across the globe of around $14bn, is now in the crosshairs in the US for Viatris’ Mylan and its partner Natco, after the firms announced an agreement settling litigation that was pending before the US Patent and Trademark Office’s Patent Trial and Appeal Board.

Generics Bulletin reviews several critical US bills and the off-patent industry’s response, along with budget calculations and new proposals.

Biogen resorted to using unlawful, anticompetitive agreements to block the distribution of generic Tecfidera, while it scrambled to switch the market to its follow-on brand, according to another class action lawsuit brought against the originator.

Amgen has broken away from the pack of other US biosimilar challengers to Eylea in the US, by avoiding an injunction requested by originator Regeneron that would block the launch of its aflibercept rival. However, with litigation ongoing, any launch would be at risk.

While senator Coons ensured that the PREVAIL and PERA Acts would not “reverse” already achieved work on drug price reductions, industry players oppose the bipartisan bills, pushing the Senate to vote no.

The Unified Patent Court is beginning to see its first actions involving pharmaceutical patents. In a case brought before the court that sought to put a leash on Celltrion’s EU-approved biosimilar to Novartis/Genentech’s Xolair (omalizumab), the court sided with the Korean firm.

Hyloris’ dispute with AltaThera over the cardiovascular drug Sotalol IV has reached another milestone with a final verdict from an arbitration panel, which cleared Hyloris of financial liabilities while also denying its own claims.

A US district court “misapprehended its role in adjudicating the issue of patentability,” the US Federal Circuit found, as it vacated and remanded the lower court’s US patent invalidity decision, raising fresh questions in a market that has already seen generic launches from a pair of manufacturers.

Pharmacy benefit manager sues Federal Trade Commission, claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.

Sandoz and partner Liquidia have welcomed a US court decision which found that interference by United Therapeutics with the launch of their generic treprostinil injection rival to Remodulin caused the pair losses of more than $137m.