Life Sciences analysis: The saga of access to documents (ATD) cases in the European pharmaceutical legal landscape continues, this time with two promising opinions of Advocate-General Hogan. In summary AG Hogan found that the General Court had erred in law in its conclusions that (a) there was no general presumption of confidentiality and (b) access to the study reports submitted in a marketing authorisation application dossier at issue would not compromise the applicants’ commercial interests.

PTC Therapeutics International v European Medicines Agency, Case C–175/18 P—ECLI:EU:C:2019:709 and MSD Animal Health Innovation GmbH, Intervet international BV v European Medicines Agency, Case C–178/18 P—ECLI:EU:C:2019:710

What are the practical implications of this case?

As AG Hogan recognised in his opinions, the significance of these cases cannot be understated. When recent case law seemed to be inclined towards the erosion and extreme restriction of what may constitute commercial confidential information (CCI), these two opinions put into question the General Court’s interpretation of the exception afforded to private companies by law.

This is a very important development, as it recognises that the CCI exception may apply when there may be insufficient protection of fundamental commercial data, the disclosure of which may be abused in non-EEA countries. Crucially, the presumption of general confidentiality would give companies the right to an injunction, as the Court cannot automatically disregard claims for CCI protection but would instead need to look at the merit of the case on the facts of the case.

When the underlying information is of such high value to a company, every day of protecting this information counts. Whether the Court of Justice follows the AG’s opinion in its judgment and sets aside the General Court’s decisions or refers the cases back to the General Court (as in the AG’s view, the General Court must re-examine the complex issues of fact that arise), it is hoped that EU jurisprudence takes on board the AG’s concerns and the views long expressed by the innovative industry when applying the CCI exception.

It is noted that another case on the same matter is pending before the Court of Justice—Intercept Pharmaceuticals v EMA, Case, C-576/19 P. For the judgment of the General Court, see Case T-377/18.

What was the background?

The principle of transparency of information allowing for ATD is enshrined in Regulation 1049/2001 (the Transparency Regulation) which provides for the right to EU persons to have access to documents held by European institutions. The European Medicines Agency (EMA) has published two policies on the proactive publication of clinical data (Policy 70) and on the reactive publication to data pursuant to ATD requests relating to medicinal products (Policy 43). While certain guidance on Policy 43 is available, a number of uncertainties relating to it have resulted in a recent ‘stream’ of case law. Most notably, the legal challenges concern the exception to the right to ATD under the first indent of Article 4(2) of the Transparency Regulation, namely when information constitutes CCI.

Background to EU jurisprudence on ATD to date

By way of brief background, in the first such two cases, Abbvie (Cases T- 44/13 R and T- 29/13) and Intermune (Case T- 73/13 R), the applicants sought interim orders against the disclosure by the EMA of documents contained in the marketing authorisation application dossier—however these cases were withdrawn before the General Court could decide on the facts. The second wave of ATD cases were heard together, consisting of Pari Pharma (Case T-235/15 R), MSD Animal Health (Case T-729/15) and PTC Therapeutics (Case T-718/15). By its judgments dated 5 February 2018, the General Court sided with the EMA’s approach, taking a very restrictive position as to what information may be exempted from disclosure under the Transparency Regulation, and held that:

• the provisions of Article 39(2) and (3) of the Agreement on Trade-related aspects of Intellectual Property Rights (TRIPs) do not create a general presumption of confidentiality for information contained in an MA application, as they do not give absolute precedence to the protections of intellectual property rights over the principle of transparency. There is no general presumption of confidentiality protecting sensitive clinical and non-clinical documents contained in the dossier, but instead the claims of CCI should be examined on a case-by-case basis. In order to find that information should be withheld as CCI, the applicant should ‘specifically and actually’ evidence how release of the contested documents would undermine its commercial interests and enable a competitor to enter the market

• something additional is required to show that the information should reflect an inventive strategy and provide added value in order to merit CCI protection

• the balancing exercise between competing interests requiring showing an overriding public interest in the provision of the documents only arises once the EMA determines that an exception to ATD applies

The Court thus imposed a high standard of proof on companies seeking to prevent disclosure and required that the companies ‘describe in specific terms the professional and commercial importance of the information […] and the utility of that information for other undertakings which are liable to examine and use it subsequently’. Thus the Court excluded from the scope of CCI any information which is not new or which could be inferred by other publicly available information. The General Court took the same approach in its judgment in Case Amicus Therapeutics ( Case T-33/17).

The present case

PTC Therapeutics and Intervet appealed the decisions to the Court of Justice, forming the first instances where the questions of EU’s regime on ATD within the pharmaceutical and veterinary sectors came before the Court of Justice.

What did the AG opine?

AG Hogan found that the General Court applied the wrong test thus reaching the wrong conclusion on whether a general presumption of confidentiality should be recognised with respect to the documents at stake. In fact, between the General Court decisions and the appeal, the Court of Justice delivered judgment in ClientEarth v Commission (Case C‑57/16 P), setting the test for the recognition of a general presumption in respect of a new category of documents as showing ‘that it is reasonably foreseeable that disclosure of the type of document falling within that category would be liable actually to undermine the interest protected by the exception in question’, regardless of whether the information is new.

AG Hogan found that the specific documents satisfied the test, as the information covered was expensive and time-consuming and the publicly available information only contained a high-level summary of the underlying information. The information contained in the contested documents could enable a competitor to obtain key know-how without incurring financial or time expense. Therefore, these documents fulfil the criteria for the recognition of a general presumption of confidential.

In addition, AG Hogan also disagreed with the General Court’s conclusion in that he found that the provisions of TRIPs mean that the CCI exception should be interpreted consistently with ensuring that the data at stake can be protected against unfair commercial use and if effective steps are not otherwise taken to ensure that this disclosure will not compromise this protection, then releasing this information might undermine the applicant company’s data protection (regulatory data protection or RDP under Article 39 of Regulation 726/2004 and Article 13 of Directive 2001/82). This is even more so when effective protection cannot be ensure worldwide, in third countries outside the European Union/European Economic Area (EEA).

Case details

• Court: Court of Justice

• Advocate General: Hogan

• Date of opinion: 11 September 2019