Life Sciences: Q&A

Liad Whatstein, Liad Whatstein & Co Law Office

In an interview with Who’s Who Legal, Liad Whatstein discusses the internationalisation of sector-related disputes, the increasing importance of data protection and security matters and upcoming challenges facing lawyers in the area.

Liad

WWL: To what extent has the litigation landscape become more international over recent years? How has this changed the outlook of lawyers working in the sector?

Patent litigation in Israel traditionally involved action by patentees against local generic companies launching at risk, or defending patents that have been challenged by generics at the Patent Office level. The landscape of patent litigation has significantly evolved in recent years due to biosimilar litigation between the major pharmaceutical companies. While patent litigation is inherently international, biosimilar litigation involving some of the major players on an international level requires an even greater degree of coordination and alignment of arguments with other jurisdictions. In addition, because of quicker examination and also because of the aggressive nature of some local generic companies, numerous patent challenges are instituted in Israel before corresponding patents are challenged in other jurisdictions. Litigation in Israel thus becomes the first “testing ground” of validity and infringement arguments. There have been several major proceedings in Israel in which the parties submitted highly complex experiments and developed very technical scientific arguments to evaluate how the opposing party will react to such arguments and whether they can be “exported” to other jurisdictions at a later stage. Patent litigation in Israel is also becoming more international because Israeli courts are very attentive to foreign case law. Therefore, cases are also argued on the basis of EP, UK and US case law and sometimes also on the basis of case law from additional jurisdictions.  

WWL: Is the US still the most patent holder-friendly jurisdiction for life sciences products?

It appears that the statistics of the IPR proceedings instituted in the US a few years ago can certainly cast some doubts as to whether the presumption that the US is the most patent holder-friendly jurisdiction is still accurate. Broadly speaking, it appears that patents are sometimes reviewed from an overly formalistic perspective and judged too harshly by courts or patent offices. This can result in situations where patents are disqualified for instance due to an extremely strict approach to support issues or unrealistic claim construction principles although the invention itself merits protection. While the Israel PTO seems to have taken a stricter approach to certain categories of inventions (polymorph patents in particular), evaluation of patentability in Israel both at the Patent Office level and the court level focuses much more on the “inventive narrative” rather than on formal issues. As stated in an old Supreme Court judgment, if the invention merits protection, the court should seek ways to uphold the patent not to revoke it.

WWL: How has an increasing emphasis on data protection and security matters influenced client concerns in the sector?

Data protection is a buzzword in the legal sector and many organisations are in the process of evaluating their compliance and data security for the purpose of implementing better means to safeguard data integrity. Some recent massive ransomware and hacking attacks have also given rise to concern. It is not only the case that data security issues, of course, plague the legal sector, but it seems that the legal sector may be more conservative and therefore slower to adapt more sophisticated IT solutions. In addition to the data security challenges, the new IT scene provides numerous opportunities to improve client service and reduce costs. This can, among other things, involve data management and the forming of organisational knowledge databases, which can ensure transparency and sharing of the knowledge generated within the organisation, to the benefit of the professional staff and clients alike.    

WWL: To what extent is the Asia market now competing with the US and Europe on developing a modern and robust legal infrastructure for the life sciences industry?

From an Israeli perspective, China’s efforts to become a global leader in the life sciences sector are very vividly felt. There is a significant number of Chinese investment funds that invest in novel life science technologies developed in Israel, and there is an ongoing presence of Chinese investors in the Israeli life sciences sector. In addition to the major investments in innovative technology and the sourcing of technology developed in other countries such as Israel, the recent China’s FDA reform will also encourage life science innovation in China. Such efforts are naturally followed by the development of a more robust legal system specialised in the protection of innovation. Indeed, in recent years there have been several IP-related reforms in the Chinese legal system. However, due to the inherent differences in the political and legal systems, as well as the language barriers, it is not realistic to assume that the Chinese legal system will be competing with well-established legal systems in the US and Europe.     

WWL: What is the biggest challenge lawyers in this market look to face in the coming years?

The biggest challenge lying ahead of patent practitioners, which also makes patent litigation even more exciting, is that cases become more technical and more demanding scientifically. Developing the arguments and, when relevant, orchestrating the experiments in support of the client’s arguments require in-depth understanding of the relevant scientific discipline. Israeli courts and the Israeli Patent Office allow extensive cross-examination of the opposing parties’ experts and the battle between counsel and expert require total immersion in the technical details of the matter. Another challenge which has evolved in recent years in Israel is the attempt to create a deterrence against legitimate enforcement of patents or even against the mere filing of patent applications by means of competition law. There is a pending appeal at the Supreme Court that will delineate the boundaries between patent and competition laws and will hopefully clarify that absent fraud instituted for anticompetitive objectives, competition laws should not be used to interfere with innovation.

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