A new referral to the CJEU should shed light on the extent of the so-called Bolar exemption in Europe, says Bernd Allekotte.
Several of the world’s 10 top-selling drugs lose exclusivity this year. LSIPR takes a look at the products, their major competitors, and their manufacturers’ strategies for keeping a grasp of market share.
The CJEU has delivered its judgment in three SPC cases, in an attempt to address fundamental issues in the SPC Regulation, as well as uncertainties arising from earlier rulings. Although questions have been answered, others have been raised, say David Carling and Michael Pears.
The Indian Supreme Court has failed to provide the clarity which is craved by practitioners in its latest pronouncement on the controversial Section 3(d), says Jitesh Kumar.
Many of the world’s biggest selling drugs have lost exclusivity in recent years, presenting huge opportunities for generic drugs companies but, as LSIPR finds out, it doesn’t have to be a dead end for the innovators.
For generic drug makers, previous bad behaviour may affect new litigation, especially when it comes to injunctions, as Bethan Hopewell and Geraldine Quinn explain.
The law of patents and SPCs has yet to be tested in the context of medicines which can be used to treat specific groups of patients, as Paul England explains.
While the global trend is towards a “more hostile IP environment” for pharmaceutical companies, Danish healthcare giant Novo Nordisk A/S continues to perform. LSIPR talks to Lars Kellberg, corporate vice president, about how it meets the challenges.
To read much of the reaction to recent pharmaceutical rulings in India, you might think that the country is waging a war against Western innovation. But while there is certainly cause for concern, that’s not the whole story, as LSIPR finds out.
Challenging the validity of a patent through the court systems of Europe and the US can be a time-consuming and expensive process. Jane Wainwright and Daniel Young look at the alternatives.