While there are numerous particular IPR and regulatory issues to be resolved across the intersection between Big Data and the life sciences there is a growing awareness of the importance of data and specifically Big Data by market authorities. Antitrust enforcement agencies, those in the United States, and competition enforcement agencies in Europe, are taking note of Big Data, and there is an increasing trend of the need for enforcers to examine closely the collection, use and access of Big Data for anticompetitive effects.
Although much of the current antitrust focus on Big Data is directed towards internet use and the collection and use of consumer data, there are strong indications that the scope of the law, especially in Europe can and will be extended to Big Data in the life science sector . Despite these indications it is fair to say that the intersection of Big Data and antitrust law is an area that is very much in flux. There remains no consensus on the application of antitrust law to Big Data much less as to how it applies. Disagreement aside there is a growing number of decisions, which highlight the use of antitrust rules to Big Data cases. Historically the European and the U.S. agencies have been marked with different approaches to the assessments of anticompetitive behaviours. Although in the merger of Reuters and Thomsen that led to the formulation of Thomsen Reuters both the U.S. and the European regulators had concerns stemming from Big Data. Both the Department of Justice and European Commission took the position that the need for a company to collect vast amounts of financial data to effectively compete with the merged firm in the market for data terminals created a significant barrier to entry. To address this concern, both the U.S. and the European authorities approved the merger on the condition that the merged firm would make copies of its database available for purchase by existing and new potential competitors. The previous decision of the European Court of Justice in the IMS Health case has already set out that there are limitations to the extent IPRs can be used to protect access to data. National European authorities have also begun to take a proactive approach to the access of data.
The 2013 Court of Milan in the Ryanair database case found that control of significant data could bring the controlling company in the scope of the competition rules. Likewise, in the Servier case, European competition rules are applicable where companies acquire IPRs with the direct intent to reduce technological dissemination into the market, thus restricting the availability of data from product introduction. The control of data to protect a market position or to block out competitors is something, especially in Europe, that is likely to attract the attention of the competition authorities.
In the Cegedim investigation the French Competition Authority examined whether or not market leader Cegedim was entitled to refuse to sell access to its widely-used CRM medical database to pharmaceutical laboratories using Euris software while selling to laboratories using Cegedim’s own and other competing CRM management software. Following the decision from the French Authority finding that the refusal was unjustified it is clear that refusal to sell may in certain circumstances give rise to liability if they are discriminatory. Considering the recent case of Huwaei, it is now the position in Europe that where information can be considered as part of standardised collection of material or technology that is necessary to comply with industry standards whether that standard is industry led, regulatory or de facto is not a concern and the technology or data owner is in general obliged to license on fair, reasonable and non-discriminatory terms.
These are issues that remain unanswered in the antitrust narrative but all indications are that the future holds more application of the antitrust rules in the future. Against this background, this contribution will analyze current case law with particular relevance for the Health and Life Sciences and discuss selected areas, such as Systems Biology, personalized medicine and biobanking, where tensions between Big Data applications in the Life Sciences and Competition Law are emerging.