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The rules of the pharma game

It is fast-paced, frantic and the stakes are high. The rules are complicated, and sometimes unseemly fights break out between the participants. It’s also become a national sport in Canada

All this may be true of hockey. But it also applies to the complex world of pharmaceutical litigation. It was appropriate then that four workshops yesterday were devoted to pharmaceutical issues, spanning: utilty/disclosure requirements; biosimilars; patent term extension/SPCs; and early resolution mechanisms for patent disputes regarding approved drug products.

Not surprisingly, given its long history of disputes between innovator and generic companies, Canada featured prominently in all of yesterday’s panels. In the first workshop, William P Mayo of Aitken Klee discussed the Plavix case pending before the country’s Supreme Court, in which AIPPI yesterday filed an amicus brief (see below), which concerns the doctrine of “promised utility”.

“It will be nice to have clarity from the Supreme Court on the notion of ‘promise’,” said Mayo. But he also stressed that, whatever the outcome, applicants should not lose sight of the fact that Canadian courts will apply the legal principles case-by-case: “Not all patents are being defeated on the basis of crazy promises in Canada.”

As moderator Mary Ann Dillahunty of Oncolytics Biothech said, utility requirements can be key in deciding when and where to file pharmaceutical patents. Jürgen Meier of Vossius & Partner in Germany discussed EPO practice on “the plausibility test”. He summarized this as: “You need to give a plausible explanation why your invention is working … It’s not enough to put laundry lists of compounds and diseases. You need a clear and unambiguous teaching which is plausible in your application.” Meanwhile, in China, as Bonan Lin of Zhongzi Law Office explained, SIPO requires evidence of utility in the patent specification, but has relaxed its policy on accepting test data during prosecution in the past year.

Biosimilar basics

In the second workshop yesterday, Masahisa Yamaguchi of Chugai Pharmaceutical in Japan provided an introduction to biologics development and regulation, looking at the EU, Japan and the US as well as other countries. He explained that the question of naming is “a hot topic”, in particular whether biosimilars should have a different nonproprietary name. “Which is better for practitioners and patients? There are different opinions,” said Yamaguchi.

Dominic Adair of Bristows in the UK asked why there has not been more litigation over biosimilars. He noted that though 17 biosimilars have been approved by the EMA, there has only been one case in the UK (Hospira v Genentech). Adair discussed a number of IP and regulatory factors that affect litigation strategies.

Canada was in the dock again in the day’s final session, on early resolution mechanisms. Warren Sprigings of Sprigings IP Law outlined Canada’s version of the US Hatch-Waxman system, noting that it does not work as well: “The whole system in Canada is far from preferable in terms of its connection to the US … I suggest that countries that are considering this issue look at the Canadian system and run as far away as possible.”

By contrast, Young Kim of Kim & Chang had a more upbeat report from Korea, which is in the process of adopting a patent linkage system that is similar to that in the US. Phase 1 (Patent Listing and Generic Notice) was introduced in March 2012 and Phase 2 (stay of generic sales) will begin in March 2015.

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