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Shire Pharmaceuticals: A culture of excellence
LSIPR provides a look behind the scenes of Shire Pharmaceuticals, the Irish company valued at £46 billion by its acquirer Takeda.
Marketing authorisation: Splitting the bill
An increasing number of pharmaceutical companies are turning to joint representation—where they pool their funds and hire one firm to represent them all—for ANDA litigation. Mark Remus, shareholder at Brinks Gilson & Lione, outlines the pros and cons of this new direction.
Antibody patents: Danger ahead for biologics
The evolution of antibody written description standards at the USPTO has put some drug portfolios at risk, say John Heithaus and Gerald Murphy of Birch, Stewart, Kolasch & Birch.
Warner-Lambert: the plausibility test for sufficiency of disclosure
In November, the UK Supreme Court ruled that Warner-Lambert’s patent for a second medical use of pregabalin for the treatment of pain is invalid for insufficiency of disclosure. Sheena Linehan of Potter Clarkson explores the lessons for patent drafting.
Mexico: new links between patents and pharmaceuticals
A new facet of Mexico’s linkage system between patents and pharmaceutical drugs raises several questions that necessitate a careful approach from patent assignees and agents, as Mariana Gonzalez-Vargas of Becerril, Coca & Becerril reports.
Generic competition: when one door closes, another opens
With several major drugs set to face generic or biosimilar competition as patent protection expires, LSIPR analyses how well prepared their manufacturers are and how badly their sales may be affected.
I-MAK: saving lives by curing the patent system
Non-profit organisation I-MAK is waging a global challenge against what it sees as invalid pharmaceutical patents, with access to life-saving drugs its main priority. LSIPR speaks to co-founder Tahir Amin to find out more.
SPC waiver: good intentions, but not the right deal?
The European Commission’s proposed export waiver for supplementary protection certificates has exposed a number of likely flaws which have not gone down well with patent owners. LSIPR reports.
USITC: a powerful forum for biologics patent owners
Biologics patent owners should consider the US International Trade Commission as a supplement (or alternative) to district court litigation, say Filko Prugo, Charlotte Jacobsen, Matt Rizzolo and Henry Huang of Ropes & Gray.
A patent attack on three fronts
A recent case in India reveals the various ways in which pharmaceutical patents can be challenged, as Neeti Wilson, Arpita Kulshreshtha and Gitika Suri of Anand and Anand report.
