The legal argument in the case centred on European law ondata exclusivity, which prevents generic manufacturers fromrelying on clinical data produced by originator drug companieswhen they apply for approval to sell copies of a medicine. This gives additional market protection for originatorcompanies, beyond patents, by stopping regulators from acceptingapplications for generics during the period of exclusivity. AUSTRIAN DRUG FROM 1963 The challenger in the case, Generics UK, had based itsapplication for a generic version of Reminyl on the old drugNivalin, which contains the same active ingredient as Reminyland was approved in Austria in 1963 — way before the countryjoined the European bloc. The MRHA ruled Nivalin could not be used as a referenceproduct and, since Reminyl’s 10-year period of regulatory dataexclusivity had not yet expired, it did not approve theapplication That decision has now been endorsed by the ECJ “A medicinal product, such as Nivalin …
the placing ofwhich on the market in a member state was not authorised inaccordance with the applicable Community law, cannot beconsidered to be a reference medicinal product,” the ECJ rulingsaid. Shire, Britain’s third-largest drugmaker, co-markets Reminylin Europe with Janssen-Cilag AB, a unit of Johnson & Johnson. Nivalin’s original authorised use was for treating polio,although that was modified in 1995 to include experimental usein 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 authorised, wasnever updated in line with EU law now prevailing in Austria, itsaid. Grant Castle, a partner at law firm Covington & Burling, wholed the case for Shire and Janssen-Cilag, said the judgment wasimportant for both originator and generic industries, sincegeneric companies had been looking at newer EU member states asa source of reference products on which to base applications “The ECJ firmly rejected this … this decision is the firstpro-innovator ECJ judgment in well over a decade,” he said.Alzheimer’s is a degenerative condition for which there isno cure. Drugs such as Reminyl can ease symptoms but do not stopthe disease.
(Reporting by Jeremy Smith and Ben Hirschler; Editing by DanLalor and Simon Jessop) Stocks Regulatory News. TOKYO, June 18 (Reuters) – Japanese computer chip makerElpida Memory Inc (6665.T) plans to apply for public funds asearly as Friday to shore up its depleted capital, Kyodo NewsAgency said on Thursday. Japan Elpida, which plans to tie up with a new memory chip firm setup by Taiwan, has been battered by low dynamic random accessmemory prices even as it chases bigger rivals Samsung ElectronicsCo Ltd (005930.KS) and Hynix Semiconductor Inc (000660.KS). Elpida spokeswoman Kumiko Higuchi declined to comment on thereport (Reporting by Mayumi Negishi) Japan. DUBLIN–(Business Wire)–Research and Markets( http://) hasannounced the addition of John Wiley and Sons Ltd’s new report “Introduction toInternational Economics, Study Guide, 2nd Edition” to their offering.
