Emerging opportunities in East Asia
China, Japan and South Korea are three of the most developed markets in the world for pharmaceuticals but they still offer a wealth of opportunities for both innovators and generic drug companies. LSIPR looks at the protection available for those seeking to do business there.
The Bolar exemption: the need for agreement
There is no uniform interpretation of the scope of the Bolar exemption in Europe, but a CJEU opinion harmonising the issue may be on the way, says Rafal Witek.
Patent term: proceed with caution
The effect of obviousness-type double patenting on patent term extension and patent term adjustment in the biotech and pharma industry needs careful consideration, as Gaby L. Longsworth and Eric K. Steffe report.
The Copaxone battle: an update
Arguments over the term of the patents granted are at the heart of the Copaxone conflict, says Archana Shanker.
The Bolar exemption: the question of third parties
A new referral to the CJEU should shed light on the extent of the so-called Bolar exemption in Europe, says Bernd Allekotte.
Expiring soon: products up for grabs
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.
SPCs: a call for clarity
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 Glivec case: getting beyond efficacy
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.
Adapt or die: how to survive the patent cliff
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.
'Because he fears': should generics fear the high court's quia timet injunctions?
For generic drug makers, previous bad behaviour may affect new litigation, especially when it comes to injunctions, as Bethan Hopewell and Geraldine Quinn explain.