Novartis Loses Claim On Extension Of Data Exclusivity

In a decision today, the European Court of Justice in Luxembourg put an end to a complaint by Novartis Europharm Ltd against the European Commission over the terms for data exclusivity (C-629/15 P). Novartis had appealed an earlier decision by the European Court (the first instance) which had rejected the claims by the pharmaceutical company that it should be granted additional data exclusivity for Aclasta, developed from Novartis’ older drug Zometa. No way, the Court of Justice said today, upholding the judgment by the lower court that had found that Novartis’ interpretation of the rules would effectively allow the extension of data exclusivity for a drug forever.

Both Zometa and Aclasta are based on zoledronic, a substance developed by Novartis for cancer treatments and authorised by the Commission pursuant to EU Regulation No 2309/93. After receiving the authorisation for Zometa in 2001, Novartis followed up with another application for market authorisation for Aclasta, which is prescribed for osteoporosis and other medical conditions. Due to the fact that Novartis decided for a new application in 2005, the pharma company held that authorisation of zoledronic-based generic drugs by the Commission violated its right to 10 years of exclusivity.

Data exclusivity grants pharma companies protection from the re-use of clinical test data they developed as a precondition to receive market authorisation for a new drug. Generic drug providers can refer to the results from the clinical tests for the original drug in their market authorization procedures. But they have to wait for 6 to 10 years according to EU legislation. Data exclusivity extends protection for original drug developers even after the original patent protection has ended.

So when the EU Commission in 2011 granted market authorisation for two medicinal products based on zoledronic for Teva Pharma and several zoledronic variants of Hospira, Novartis cried foul. Novartis argued that by going through the application process for Aclasta again instead of using a procedure to extend the Zometa market authorisation it was eligible for data exclusivity until 2015.

The highest European Court in its decision upheld the General Court verdict today. Regardless of what procedure an inventor chose to file for a new use of a drug, be it a brand new market authorisation allowing use of a new name or just the amendment of the existing, older authorisation – it all constitutes what the law subsumes under “global marketing authorisation”.

Global market authorisation (MA) “is accompanied only by a single regulatory data protection period which applies both to data relating to the original medicinal product and to data presented for its developments, such as additional strengths, pharmaceutical forms, administration routes, presentations, as well as variations and extensions,” the judges wrote. “That period begins with the grant of the MA for the original medicinal product.“

And Novartis had not criticised the General Court’s finding that “Aclasta differs from Zometa by new therapeutic indications and by a different strength appropriate for those new indications.”

To answer the claim of drug companies that innovation with regard to existing drugs has to be incentivized, the Court pointed to an additional year of data exclusivity protection that drug makers were eligible for beyond the original 10 years. That reflected the “desire ‘to promote research on new therapeutic indications with a significant clinical benefit and bringing an improvement to the quality of life and welfare of the patient’ while ensuring ‘an appropriate balance between such innovations and the need to favour the production of generic medicines’,” the European Court of Justice ruled.

Teva and Novartis are engaged in a bigger war over generic versions of their drugs. Today’s ruling in favour of Teva might come as a little relieve for the generic drug business, that was hit last year by a decision of the European Medicines Regulator recommended the suspension of more than 300 generic drug approvals, due to irregularities of testing conducted in India. Sandoz, Novartis’s generic drug arm, was hit massively by that recommendation.

 

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