The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now. Not so when it comes to similar procedures related to biosimilars. In fact, as a lawsuit over Sandoz's knockoff version of the Amgen therapy Neupogen shows, the two sides don't even agree on the rules.
After trying nearly everything in its power to protect lead product Copaxone from early generic competition, Teva just received some news it least wants to hear: Copycats are going after its new, long-acting version of the drug, too.
A federal court in Canada has now agreed with the industry that the country's price setting board has assumed too much authority and severely curtailed its ability to control prices over generic drugs in a case centered on Novartis' generic drug company Sandoz, and a unit of Teva Pharmaceutical Industries, which started as Ratiopharm.
Last week, generics makers asked the Supreme Court to let them launch their copies of Teva's Copaxone while it hears the Israeli company's appeal over the drug's patents. Now, they'll likely get that chance. Chief Justice John Roberts rejected Teva's bid to block competition until the court clash wraps, meaning generics could hit as soon as next month.
Attention deficit hyperactivity disorder drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis to recall nearly 22,000 bottles.
Teva wants generics makers to hold off on launching their copies of multiple sclerosis drug Copaxone until the Supreme Court hears its appeal in a patent fight over the drug. And unsurprisingly, those generics companies are not that into the idea.
Novartis, amid a company-wide strategic review, has said some of its underperforming units may be on the way out. But as it draws up its blueprints for the future, it's also working to bolster its star businesses, and Wednesday it announced some changes at the top of two of its key divisions.
On Monday, Teva asked Supreme Court Chief Justice John Roberts to consider a plea to block generic competition to Copaxone until SCOTUS has weighed its appeal. And now, he wants to know what generics makers think about it.
GlaxoSmithKline's asthma behemoth Advair may be losing ground in Europe, but a legal win may stop some of the bleeding--at least in Germany. The British pharma giant has obtained a preliminary injunction there to stop Novartis' Sandoz from hawking its generic, AirFluSal Forspiro, thanks to the inhaler's purple color.
Usually, it's the smaller drugmakers that take advantage of opportunities that present themselves when manufacturing problems arise at another company. But Novartis CEO Joe Jimenez is not above trying to drum up some business for his Sandoz generic drug unit by pointing out problems with some of the big drugmakers in India.