EU High Court Upholds Orphan Exclusivity Ruling

Regulatory NewsRegulatory News | 23 March 2016 |  By 

Earlier this month, the EU's top court upheld a major ruling with implications for orphan drug exclusivity by rejecting an appeal by generic drugmaker Teva Pharmaceuticals Europe.

In its appeal, Teva contested the ruling of a lower court that found orphan product exclusivity covers all indications a product is approved for.


In 2001, Novartis won marketing authorization for its orphan product Glivec (imatinib), marketed as Gleevec in the US, as a first-line treatment for chronic myeloid leukemia.

In 2007, Novartis won approval for Tasigna (nitolimib) as a second-line therapy for chronic myeloid leukemia in patients who had previously been treated with Glivec. In 2011, the European Commission expanded Tasigna's indication to include its use as a first-line treatment for chronic myeloid leukemia based on data from a large study comparing Tasigna against Glivec, giving the two products an overlapping indication.

In January 2012, just months after Novartis' period of exclusivity for Glivec expired, Teva filed an application to market a generic version of the drug. The European Medicines Agency (EMA) rejected Teva's application, stating that it could not approve the generic for indications covered by Novartis' marketing exclusivity for Tasigna.

Teva contested EMA's decision, bringing the issue to the General Court of the Court of Justice of the European Union in March 2012.

Orphan Product Exclusivity

Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141/2000 to incentivize the development of rare disease treatments.

In the EU, authorized orphan products are granted ten years of market exclusivity under Article 8(1) of the regulation. Article 8(3) of the regulation establishes criteria for when a marketing authorization can be granted when another product has exclusivity on an indication:

"A marketing authorisation may be granted, for the same therapeutic indication, to a similar medicinal product if:

  1. the holder of the marketing authorisation for the original orphan medicinal product has given his consent to the second applicant, or
  2. the holder of the marketing authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product, or
  3. the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior.

General Court Ruling

Before the General Court, Teva argued that EMA misinterpreted Regulation (EC) No 141/2000 when it rejected its application for a Glivec generic.

Teva's argument at the time was based on three claims: That Tasigna should not have qualified for orphan product designation; that EMA should not have granted Tasigna its own 10-year period of exclusivity; and that if Tasigna was to get its own 10 year period of exclusivity, that exclusivity would only protect against similar products entering the market, rather than covering the indication.

Teva warned that by granting a second product its own 10-year period of market exclusivity, companies could effectively "evergreen" their orphan products' exclusivity by getting subsequent products approved for the same indication.

However, in its January 2015 decision, the General Court rejected Teva's claims, finding that market exclusivity applies to all indications an orphan product is approved for.

"Thus, the fact that the therapeutic indications for which both orphan medicinal products received marketing authorisation are similar cannot undermine the market exclusivity enjoyed by each of those medicinal products by virtue of Article 8(1) of that regulation for those therapeutic indications," the General Court wrote.

Teva's Appeal

Unsatisfied with the General Court's ruling, Teva appealed to a higher court, the Court of Justice of the European Union (CJEU).

After reviewing the case, the 6th chamber of the CJEU denied Teva's appeal. In its decision, the CJEU agreed with the lower court, finding that no provisions of Article 8(3) preclude a product granted marketing authorization from market exclusivity if the product would otherwise qualify for it.

The CJEU found that the lower court was also correct in rejecting Teva's claim that Tasigna not have been granted market exclusivity beyond the 10-year period granted to Glivec.

Finally, the CJEU rejected Teva's appeal that Tasigna's exclusivity should only apply to products similar to it, and not to products similar to Glivec. The court found that indeed, Tasigna's exclusivity would not preclude products similar to Glivec from entering the market after Glivec's exclusivity had ended, but that Tasigna's exclusivity does in fact cover all orphan indications it is authorized for.

CJEU Ruling (March 2016)

General Court Ruling (January 2015)                            


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