EU Court Rules on Orphan Product Exclusivity

Regulatory NewsRegulatory News | 19 March 2015 |  By 

A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity.

In its ruling, which has the potential to influence how companies develop orphan products, the court found that authorized orphan products are entitled to market exclusivity, even when they are similar to an already approved product.


Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141/2000 to spur the development of products to treat rare conditions. The regulation established the procedure for orphan product designation and provides incentives for products granted orphan designation.

In the EU, orphan products are given a period of 10 years market exclusivity for a given indication. If a company wants to market their product during that time for the same indication, permission is required from the company that first received market exclusivity.

Market exclusivity is covered in Article 8(1) of Regulation (EC) No 141/2000, which states:

“Where a marketing authorization in respect of an orphan medicinal product is granted … the Community and the Member States shall not, for a period of 10 years, accept another application for a marketing authorization, or grant a marketing authorization or accept an application to extend an existing marketing authorization, for the same therapeutic indication, in respect of a similar medicinal product.”

Several cases are defined in Article 8(3) in which a marketing authorization can be granted for the same indication as a product with market exclusivity:

    1. “The holder of the marketing authorization for the original orphan medicinal product has given his consent to the second applicant, or
    2. The holder of the marketing authorization 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 authorized, is safer, more effective or otherwise clinically superior.”

Market exclusivity should not be confused with regulatory data protection (also referred to as data exclusivity), which prevents companies from marketing generic versions of products while the original product is covered by this protection.

Case History

In 2001, Novartis received approval for its cancer treatment Glivec, giving the product market exclusivity until 2011. In 2007, Novartis was granted a marketing authorization for a second orphan product, Tasigna, which had the same indication as Glivec. Typically, a second product would not be able to receive authorization for the same indication during the 10-year period of exclusivity, but because Novartis developed both products, it was able to consent to Tasigna’s approval. Had Tasigna been developed by a competitor, Novartis would likely refuse to consent to its authorization during Glivec’s period of exclusivity.

In 2012, Teva Pharmaceuticals applied for a marketing authorization for its generic version of Glivec. Teva’s application was rejected by the European Medicines Agency (EMA), despite the fact that Glivec’s market exclusivity expired in 2011. In EMA’s response to Teva, the agency said that the Teva’s product could not be approved as its application covered “the same therapeutic indications for which … Tasigna enjoyed marketing authorization … on the ground that those indications were still subject to market exclusivity protection under Article 8(1) of Regulation No 141/2000.” The agency also said it would consider approving the generic for indications that are not covered under Tasigna’s market exclusivity.

The Case and Court Ruling

Teva took EMA to court, arguing that EMA misinterpreted portions of Articles 3(1) and 8(1) of Regulation (EC) No 141/2000 when it rejected the company’s application. The case, Teva v the European Medicines Agency (Case T-140/12), was heard by the General Court of the Court of Justice of the European Union (CJEU) in September 2014.

Teva alleged that Tasigna should not have qualified for orphan product designation, saying that Tasigna did not demonstrate “significant benefit” over Glivec. The court found this claim to be inadmissible, as Teva did not raise this objection during its application or initial reply to EMA, saying “EMA was not entitled to rely on [the claim] in refusing [Teva’s] request.”

Teva’s second claim was that EMA should not have given market exclusivity to Tasigna as EMA considered it to be a similar product to Glivec. Teva testified that Tasigna should have shared the 10-year period of exclusivity with Glivec, citing a communication from the European Commission in 2003. Alternatively, Teva suggested that if a second orphan product gets its own 10-year period of exclusivity, “that second period of exclusivity would preclude only authorization for … products that are similar to the second orphan product.”  Part of Teva’s argument was that allowing a second, independent, period of market exclusivity could allow companies to “evergreen” their orphan products by attempting to get subsequent products approved with orphan designation during the first product’s exclusivity period.

The court rejected this claim, deciding that:

“Market exclusivity attaches to that medicinal product for all those therapeutic indications, irrespective of the fact that the medicinal product in question, which is itself similar to another orphan product which has been granted marketing authorization, relied on one of the derogations laid down in Article 8(3) of the regulation at the time of that authorization. Thus, the fact that the therapeutic indications for which both orphan medicinal products received marketing authorization 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.”

This means that even though Novartis’ products were considered similar, each period of exclusivity is independent of any others. The court also specified that market exclusivity “cannot be regarded as equivalent to the data protection periods enjoyed by any medicinal product which has been granted marketing authorization, as the effects and scope of each of those mechanisms are different.”


General Court Judgement


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy