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10 November 2017Big Pharma

LSIPR 50 2017: Thomas Kirkbak—Communication is key

IP infringement covering pharmaceuticals typically takes place where generic companies can make the most profits, according to Thomas Kirkbak, chief IP litigation specialist and attorney-at-law at Lundbeck.

“If a lot of money can be made by entering a generic product on a certain market, my experience is that the generic companies are willing to take substantial risks of infringing the originator’s IP rights,” he says.

Kirkbak explains that a generic will usually first infringe in the US, because that is where the biggest profits can be made. This is followed by challenges to the IP rights in the UK and Germany.

“The challenge to IP rights in the US will normally be in the form of a paragraph 4 certification, leading to Abbreviated New Drug Application litigation. In the UK the generics will often try take the ‘clear the way’ approach, combined with a threat to launch at risk, unless the court orders the generics to refrain from launching while the validity case is ongoing.

“Such an order normally entails an undertaking from the originator to the court to pay damages if the challenged IP rights turn out not to be valid/infringed,” he adds.

Lundbeck, a Danish pharmaceutical company, uses a small team of specialists for each IP litigation. Kirkbak’s main duty is to take a broad view of the case and its legal framework. This includes making sure the company has the best external lawyers, that there is coordination between the case and any other suits regarding the same patent family, and that the external lawyer gets the input and decisions he or she needs from Lundbeck.

Kirkbak has been with Lundbeck since 2012, when he started as an attorney-at-law. He became Lundbeck’s chief IP litigation specialist in 2013. Before joining Lundbeck, he was an attorney at Philip & Partners for nearly six years.

Explaining the concepts

The biggest litigation challenge that Kirkbak faces is ensuring that the complicated technical/chemical issues in the cases are conveyed to the courts in a way that can be understood by judges, who do not necessarily have a technical background in the area.

“If the courts do not sufficiently understand what the IP rights cover and how infringement can be determined, then the outcome of the cases becomes unpredictable,” says Kirkbak.

"only by being close to the case can we ensure sufficient support on the technical/chemical explanations and details."

“For this reason, it is essential that the lawyers presenting the case are able to master this communication task, supported of course by internal and external experts.”

Kirkbak explains that Lundbeck manages its cross-border litigation in-house.

“We believe it is important that we stay very close to the case. The experience we have is that only by being close to the case can we ensure sufficient support on the technical/chemical explanations and details,” he says.

According to Kirkbak, working on the cross-border litigation in-house enables the company to coordinate litigation in various jurisdictions so that, to the extent possible, information from one case is taken into consideration in the other cases. It also ensures optimal timing of new arguments between the cases.

Looking ahead, Kirkbak says that the future of the Unified Patent Court (UPC) and the effect of Brexit will play a big role in Lundbeck’s IP strategy.

“The current uncertainty makes it challenging to set a clear IP strategy,” he adds.

But the uncertainty surrounding the UPC is not the only concern, as he concludes: “On an even more general level, uncertainty as to whether IP rights will be respected and whether it is acceptable to litigate to defend them is perhaps the biggest challenge.”