Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post.

On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation (“MA”) application process (the “MA Documents”).  The MA Documents at issue included EMA Assessment Reports on similarity and superiority between Pari’s product (Vantobra) and Novartis’ product (TOBI Podhaler), which has an EU MA as an orphan medicine.  Novartis made the request to the EMA for access to the MA Documents under the Transparency Regulation 1049/2001.  The main case is currently pending before the General Court (Case T-235/15).

The thrust of Pari’s argument before the General Court was that the MA Documents contain Pari’s regulatory strategy for obtaining MA approval, disclosure of which might cause Pari serious and irreparable financial damage.  The President of the General Court acknowledged that the case raised complex issues in the area of confidentiality and stated that the main proceedings (rather than an interim hearing) is the appropriate forum to address such issues..  As such the President considered that the MA Documents fell under a presumption of confidentiality  and ordered the EMA not to disclose the MA Documents.

Background

On 20 July 2011 the Commission granted Novartis an MA for its orphan medicinal product, TOBI Podhaler (tobramycin dry powder for inhalation).

On 26 July 2012 Pari applied to the Commission for an MA for its product, Vantobra (tobramycin nebuliser solution). During the application process Pari submitted reports to argue that Vantobra was both dissimilar and clinically superior to TOBI. These reports and subsequent correspondence led to the Commission granting Pari an MA for Vantobra on 18 March 2015.

On 13 April 2015 the EMA informed Pari that it had received a request to access the MA Documents, which specifically included the reports. On 24 April 2015 the EMA decided to release the MA Documents without all of Pari’s proposed redactions of commercially confidential information being applied to the MA Documents. In support of its decision, the EMA relied on the general principle that such documents are disclosable unless, amongst other things, the information contained within them is commercially confidential.

Proceedings

On 15 May 2015 Pari applied to the General Court to annul the EMA’s decision to release the MA Documents. On the same day Pari made an interim application to suspend the EMA’s decision to disclose the MA Documents pending the outcome of the main proceedings.

In support of its interim application Pari argued that disclosure of the MA Documents would undermine its efforts to keep proprietary information confidential. Pari further argued that the disclosure requested would reveal its strategy in obtaining an MA for Vantobra when a potentially similar product TOBI benefitted from market exclusivity. Pari argued that the disclosure of such a strategy would allow competitors to copy its regulatory strategy and more easily obtain an MA for their competitor products.

The EMA argued that large parts of the MA Documents were already publicly available and were therefore not confidential, and that there was an overriding public interest in disclosing them.

General Court Interim Order

The President of the General Court upheld Pari’s arguments that it was sufficiently foreseeable that disclosure of the MA Documents might result in serious and irreparable financial damage because competitors could exploit the disclosed information to bring a competing product to market earlier anywhere in the world.

The General Court held that as there is no decided case-law relating to confidentiality relevant to this case, the MA Documents should benefit from a presumption of confidentiality until a decision on the merits. The EMA’s arguments concerning the public availability of information and the overriding public interest, while relevant to the main proceedings, did not outweigh the risk of damage to Pari in the interim.  The General Court could not rule out that that Pari’s specific use of confidential and non-confidential information would be treated as a confidential inventive strategy in the main proceedings.

The General Court therefore suspended the EMA’s decision to disclose the MA Documents.

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Photo of Grant Castle Grant Castle

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products. He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the London Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Mr. Kelly’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law, and product liability…

Brian Kelly is a partner in the London Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Mr. Kelly’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Mr. Kelly as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Mr. Kelly’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Mr. Kelly has also been advising on UK and European “Brexit” related issues including tariffs.

Mr. Kelly has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Mr. Kelly is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Mr. Kelly is an honorary lecturer at University College London.