EU Court Maintains Overlapping Orphan Product Exclusivity

An EU-level court has established a precedent that would allow drugmakers to protect orphan drugs from generic competition by developing and patenting a similar drug for the same orphan indications while the original therapy still enjoys market exclusivity.

The decision, upholding so-called overlapping exclusivity, held that the European Medicines Agency was right in denying Teva’s generic authorization for Novartis’ Glivec because Novartis had developed a second, similar leukemia therapy that protected the indications from competition for another 10-year orphan exclusivity period.

The case could provide brandmakers with a new tool to protect orphan drug exclusivity.

Novartis developed Glivec (imatinib) in 2001, giving it exclusivity through 2011. It developed Tasigna (nilotinib HCL monohydrate), a similar drug, in 2007 for the same indications, giving it exclusivity through 2017.

The Israeli firm argued that its generic application was on Glivec and should only be bound by Glivec’s orphan exclusivity, according to the ruling in Teva v. EMA.

Teva warned that allowing such overlapping exclusivity could enable brandmakers to indefinitely protect their products from generic competition by continuously developing new drugs based on existing orphan therapies. The company also charged that because the two therapies are similar, Tasigna should have been bound by Glivec’s exclusivity and wasn’t entitled to its own.

In deciding for the EMA, the General Court (Sixth Chamber) says European law clearly grants 10 years of exclusivity to any new drug granted orphan status, even if it is similar to another therapy. In theory, Teva could successfully pursue indications for its generic version not covered by the orphan exclusivity, the court adds.

Novartis markets imatinib mesylate in the U.S. under the brand name Gleevec.

Read the ruling at www.fdanews.com/03-20-15-EMAOrphanDrugRuling.pdf. — Bryan Koenig