CLINICAL TRIAL DATA
undermine the legitimate economic interest of the applicant/MAH”.
However, CCI appears to be in the eye of the beholder. A paper titled Open Clinical Trial Data for All? A View from Regulators was the first to outline the EMA’s proposed transparency policy back in 2012. Te article, written by a group of regulators including the EMA’s director Guido Rasi, discusses the failed attempt by medical journal BMJ and independent organisation, the Cochrane Collaboration, to access clinical study reports about flu treatment Tamiflu (oseltamivir phosphate) from its manufacturer Genentech.
Te authors agreed with the BMJ and Cochrane, believing that trial data should not be considered CCI as “most patients enrolling in clinical trials do so with an assumption of contributing to clinical knowledge”. Quoting the BMJ’s paper, they added: “Non-disclosure of complete trial results undermines the philanthropy.”
Furthermore, clinical trial data may include
privileged information, such as know-how, trade secrets or information that is protected by IP, which if disclosed could compromise a company’s commercial position.
So, aſter the EMA’s new transparency policy on clinical trial data comes into force next year, how can companies ensure their sensitive information is protected?
Balancing act
On October 2 the EMA announced that from January 1, 2015 all pharma companies with approved medicines in the EU aſter that date will be required to make the data that supported those medicines’ approval available to the public.
Te EMA said it embarked on the process to introduce the policy because “it believes that the release of data, making it accessible to all who wish to see it, is about establishing trust and confidence in the system”.
Te finalised policy has been in the making for longer than two years, and takes on board views and concerns of hundreds of stakeholders and organisations. However, before the current policy was a glimmer in the EMA’s eye, it was clear it might run into problems.
In early 2013, US-based pharma companies AbbVie and InterMune filed lawsuits against the EMA to stop it granting other companies access to information that supports MA applications for their drugs.
AbbVie, seeking to protect its $3 billion-a-year Crohn’s disease drug Humira (adalimumab),
12 Life Sciences Intellectual Property Review
filed two complaints at the EU General Court in January 2013. It argued that the agency’s decision to grant this access violated AbbVie’s “fundamental right to the protection of confidential commercial information”.
Similarly, in its February 2013 complaint that focused on lung medicine Esbriet (pirfenidone), InterMune accused the EMA of failing to engage in the “balancing exercise” which, it said, is required when assessing whether there is any public interest in disclosing disputed information that overrides the need to protect its commercial interests.
AbbVie’s suits have since closed, but InterMune’s still stands and is awaiting guidance from the Advocate General of the Court of Justice of the EU (CJEU).
Tese lawsuits demonstrate just how long a tightrope promoting transparency
may be.
AbbVie and InterMune both told the Bloomberg news organisation that they were in favour of transparency but opposed the release of certain privileged information, oſten described as “commercially confidential information” (CCI).
Commercially confidential
One of the key concerns that emerged from the EMA’s invitations to comment on preliminary draſts of the transparency policy was the concept of CCI, and how to protect it from unfair commercial use by other companies.
Te EMA defines CCI as “any information contained in the clinical reports submitted to the agency by the applicant/marketing authorisation holder (MAH) that is not in the public domain or publicly available and where disclosure may
Volume 2, Issue 1
Te EMA admits that in stakeholders’ competing interests, a compromise had to be made. It says that the “overwhelming majority” of data in clinical reports is not CCI.
It includes a provision whereby sponsors may propose which parts of their applications should be redacted, along with justifications on why those parts should be redacted, although it will make the final decision on what information should be removed.
But what if the agency and company do not agree on what information should be redacted? Information considered confidential may enter the public domain and damage the MA applicant’s market position.
To avoid problems later, companies may have to rethink their patenting strategies now.
A matter of time
“Te agency’s proactive publication policy could prejudice later patent
filings on subsequent
inventions made on known products,” says Diana Heimhalt, a senior associate in Taylor Wessing’s Munich office.
Once information within the MA application has been disclosed, it becomes prior art and cannot then serve as the basis for an invention and patent application, she explains.
“MA applicants would no longer be able to use the currently confidential information to obtain patents for the inventions relating to the information in an MA application if it is disclosed to the public.”
She adds that companies will have to make a judgement on when it is more profitable to file their
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