Shire and Johnson & Johnson won the backing of Europe's highest court on Thursday in their battle for data exclusivity against a generic rival for Alzheimer's drug Reminyl, the court said.
The decision represents a wider victory for originator drug companies, since a ruling against Shire and J&J could have opened the door to generic versions of other medicines developed in relatively new European Union member states.
It also marks a welcome piece of good news for makers of brand-name drugs at a time when they are being probed by the European Commission for supposedly blocking access to cheap generics.
The European Court of Justice (ECJ) backed the view taken by Britain's Medicines and Healthcare products Regulatory Agency (MHRA) that a product approved in a country before it joined the EU -- and not upgraded since then -- could not be used as a reference for a generic drug application.
The legal argument in the case centered on European law on data exclusivity, which prevents generic manufacturers from relying on clinical data produced by originator drug companies when they apply for approval to sell copies of a medicine.
This gives additional market protection for originator companies, beyond patents, by stopping regulators from accepting applications for generics during the period of exclusivity.
AUSTRIAN DRUG FROM 1963
The challenger in the case, Generics UK, had based its application for a generic version of Reminyl on the old drug Nivalin, which contains the same active ingredient as Reminyl and was approved in Austria in 1963 -- way before the country joined the European bloc.
The MRHA ruled Nivalin could not be used as a reference product and, since Reminyl's 10-year period of regulatory data exclusivity had not yet expired, it did not approve the application.
That decision has now been endorsed by the ECJ.
A medicinal product, such as Nivalin ... the placing of which on the market in a member state was not authorized in accordance with the applicable Community law, cannot be considered to be a reference medicinal product, the ECJ ruling said.
Shire, Britain's third-largest drugmaker, co-markets Reminyl in Europe with Janssen-Cilag AB, a unit of Johnson & Johnson.
Nivalin's original authorized use was for treating polio, although that was modified in 1995 to include experimental use in treating Alzheimer's disease, the court said.
However, it was not in dispute that the original dossier, on the basis of which Nivalin's marketing was authorized, was never updated in line with EU law now prevailing in Austria, it said.
Grant Castle, a partner at law firm Covington & Burling, who led the case for Shire and Janssen-Cilag, said the judgment was important for both originator and generic industries, since generic companies had been looking at newer EU member states as a source of reference products on which to base applications.
The ECJ firmly rejected this ... this decision is the first pro-innovator ECJ judgment in well over a decade, he said. Alzheimer's is a degenerative condition for which there is no cure. Drugs such as Reminyl can ease symptoms but do not stop the disease.
(Reporting by Jeremy Smith and Ben Hirschler; Editing by Dan Lalor and Simon Jessop)