UPDATE 1-Novartis, Millennium lose bid to extend patents
Thu Apr 21, 2005 06:41 AM ET
(Updates with Novartis comment, background)
By David Lawsky
BRUSSELS, April 21 (Reuters) - Swiss drugmaker Novartis AG (NOVN.VX: Quote, Profile, Research) lost a bid before the European Union's highest court on Thursday to extend patents on two of its drugs in the 28-nation European Economic Area (EEA).
The ruling, in which the European Court of Justice advised two national courts on how to interpret the law, also turned down a bid by the U.S. drug firm Millennium Pharmaceuticals Inc (MLNM.O: Quote, Profile, Research) for patent extension.
The judgment could set a precedent shortening the period for which patents on many drugs originating in Switzerland are valid in the EU.
Each day a patent is extended means extra cash for drug companies, which can fend off generic competitors for longer.
In this particular case, however, the financial impact on Novartis will be limited, since sales of the two drugs involved are relatively small, according to a company spokesman.
Simulect, or basiliximab, is an immuno-suppressant used following organ transplant surgery, while Riamet is an anti-malarial combination of artemether and lumefantrin.
Patent extensions are pegged to the date on which a drug is originally authorised, so the later this date is, the better.
Novartis and Millennium wanted to count the time from the dates when their drugs were authorised in the EEA, rather than in non-EEA member Switzerland, which authorised them earlier.
CUSTOMS UNION
The case was complicated by the fact that EEA member Liechtenstein had automatically recognised the Swiss green light because of a custom union between the two countries, thus starting the clock on the validity of the patents.
The court ruled that the Swiss date was the right starting date, even though Switzerland is not a member of the EEA.
"A marketing authorisation issued by the Swiss authorities and automatically recognised in Liechtenstein in the context of its regional union with Switzerland must be regarded as a first marketing authorisation...," the court said in its decision.
The move will have most impact on Swiss drug companies, which often seek regulatory approval in their home market first.
But some non-Swiss companies could be affected too, since they sometimes opt to get approval from Swiss regulators for their medicines before winning an EU green light.
Merck KGaA (MRCG.DE: Quote, Profile, Research) and ImClone Systems Inc (IMCL.O: Quote, Profile, Research) , for example, won Swiss approval for the anti-cancer drug Erbitux in December 2003, more than six months before the product was cleared by the EU.
The ruling in the Novartis and Millennium cases had been sought by two national courts which wanted advice on how to apply the law, the UK patents court in the case of Novartis and the Luxembourg administrative court in the case of Millennium.
Basiliximab was authorised in Switzerland on April 7, 1998, and in the EEA on Oct. 9, 1998. Riamet, meanwhile, was authorised in Switzerland on Jan. 22, 1999, and in the EEA on Nov. 30, 1999.
The drug involved for Millennium was Integrelin, or eptifibatide, authorised in the EEA on July 1, 1999 and in Switzerland on Feb. 27, 1997.
Most EU legislation is valid throughout the EEA, a trade grouping that comprises the 25 EU member states plus Liechtenstein, Norway and Iceland. (Additional reporting by Tom Armitage in Zurich and Ben Hirschler in London) |
