Global product launch

All of our pharmaceutical clients have impressive internal IP teams — so where do we fit in?

Here’s an example of a global clearance for a pharmaceutical client.

Product ‘X’ came up on the radar as a development candidate. So, the standard patent searches were ordered and we were asked to be part of the review process to assess the strength of competitor’s IP Estates. The standard monitoring program was put in place to identify new patents coming to light before launch.

Things got busy at the client end for a while, so we were asked to take the review into the next phase. This involved the usual exhaustive analysis of the claims of the relevant patents in priority countries and documenting, working and reworking the non-infringement and invalidity cases. Not surprisingly, the invalidity work entailed further detailed rounds of prior art searching and analysis. We roped in some technical experts to test our thinking along the way.

We worked through the case and brainstormed further ideas for the country-by-country strategy and roll-out. We talked about things such as the timing of regulatory approval, litigation and launch in each country, which Counsel to use and why.

Our client used the brief we had prepared on the non-infringement and invalidity cases to instruct outside Counsel in various countries and we set deadlines for initial draft opinions. We were asked to review and comment on opinions as they came in and to focus on the overall strategy, our understanding of the prior art and the local law in each country we were dealing with. We don’t know the law better than the local attorneys, but we’ve seen it applied in quite a few ways. Local Counsel were asked to identify and brief suitable local experts.

Through a series of conference calls, we reworked the opinions from each attorney until we were happy that they would provide a solid blueprint for the litigation. Local Counsel then commenced preparing evidence and court documents ready to commence legal proceedings. We kept involved as needed and reviewed pleadings and expert reports to help coordinate arguments across the jurisdictions.

A while later, we commenced proceedings in the first jurisdiction, and seemed to have caught the main competitor by surprise. It took them a while to find Counsel and experts and this gave us the opportunity to commence proceedings in two further jurisdictions to keep them off-guard. Local counsel in the first jurisdiction managed to obtain a fast timetable for the litigation which kept the pressure on the innovator’s legal team.

Our client kept us involved in the case as needed and asked us to attend conference calls with Counsel from around the world from time to time.

(Photo credit: dkinney)

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