PATENT PROTECTION
the 30-month stay never really comes into play; and even when a case goes beyond 30 months, it simply morphs
into typical litigation, in
which the generic could go ahead and market at risk, assuming it has obtained preliminary FDA approval by then.” At that point, the case becomes like any other patent litigation.
Tis type of litigation, whether a 30-month stay is involved or not, is by no means restricted to the US. Brands are increasingly fighting battles across the globe, particularly in Canada, Europe and Asia. In the context of cross-border litigation, the lack of uniform legislation is a major hurdle, and the patents themselves might differ in their wording or coverage, says Monroe. But maintaining a consistent approach is crucial. Te strategic position a brand adopts in its case in one country can affect its position in another country, meaning consistency and coordination are vital.
“Te biggest challenge is getting people to understand that the US litigation process is different from the processes in countries such as the UK, India and Canada,” says Singer. “What you do in these countries is very different from what you can do in the US and it can be hard to explain to foreign lawyers that the extent to
“MUCH WILL ALSO DEPEND ON HOW THIS PROCESS AFFECTS THE RULES THAT DIVIDE UP JURISDICTIONS BETWEEN THE SO- CALLED THEMATIC CLUSTERS AND THE REGIONAL DIVISIONS IN EUROPE.”
which they say something in, say, India can be used against the company in the US. It never goes the other way around. In fact, I had a case that recently turned in our favour on what the other side’s experts said in Canadian litigation.”
In Europe, infringing activity shows no respect for national boundaries, says Jonathan Radcliffe, partner at law firm Mayer Brown LLP in London.
“Patent owners must therefore enforce their patents through a carefully thought-out European litigation
strategy craſted to achieve their
commercial objectives. Articulating commercial goals is vital. Tis will determine where to litigate in Europe, timing, what remedies to seek, who to sue, and the like,” he says.
Where to sue
While the exact strategy a brand picks is usually case-specific, he says choosing where to sue is one of the most important decisions. According to Radcliffe, the English, German and Dutch courts have an “excellent” reputation for their expertise and quality,
and will be attractive choices.
For example, the English system offers highly developed and sophisticated rules enabling full documents to be fully discovered and disclosed, experts and witnesses to be rigorously cross- examined, and experiments to be conducted.
And Germany’s bifurcation system—the splitting of validity and infringement cases— oſten favours patentees, he says. “Tese split proceedings allow patentees to run slightly different claim interpretations, and limit the ability of
defendants to run ‘squeeze’ arguments. Te time lapse between an interim
www.worldipreview.com
World Intellectual Property Review July/August 2012
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