Current Law Journal Content
Washington & Lee Law School
Current Law Journal Content
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Bio-Science Law Review
Volume 11, Issue 1, 2010
EUROPEAN COURT OF JUSTICE LIMITS PATENTS ON DNA SEQUENCES: MUCH ADO ABOUT NOTHING OR THE BEGINNING OF EROSION FOR BIOTECH PATENTS?
MICHAEL A. KOCK
On July 6, 2010, the European Court of Justice hands down a precedential judgment on the scope of protection for DNA sequences in Case C-428/08, Monsanto Technology v Cefetra. This ruling impacts biotech companies by narrowing the scope of protection for DNA sequences: Non-viable products in which the DNA is present as a mere residue are not be protected by a claim on the DNA sequence. A DNA sequence only enjoys patent protection when it is expressed, or at least able to be expressed, at the time of the infringement. Whether the ruling affects the protection for isolated, purified DNA sequences is unclear. Although there are arguments against, a risks remains which could affect especially the molecular diagnostic industry. The court refrained from adapting a clear position on purpose-bound protection for DNA sequences, although some statements in the ruling may suggest a preference for such view. It is clear that ECJ interprets the Directive now as having a restrictive effect on patentability, rather than serving, as originally intended, to strengthen and harmonize protection for biotech inventions provided by national patent laws. Some, but not all, of the effects of the ruling can be overcome by alternative claim drafting or employing different IP protection tools.
REFERENCE TO THE ECJ IN MEDEVA BV v THE COMPTROLLER GENERAL OF PATENTS CONCERNING THE CONDITIONS FOR THE EXTENSION OF PATENT TERMS FOR MEDICINAL PRODUCTS IN THE EU
In the EU, the term of a national patent or a European patent for drug products is extended through the grant of a supplementary protection certificate. This is governed by Council Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. The system recognises that significant periods of the 20 year patent term are lost due to the time it takes to obtain marketing authorisation for a new drug. The Court of Appeal has recently referred to the ECJ questions concerning the conditions that must be satisfied for the grant of a supplementary protection certificate, including whether it can be granted in relation to a patent which does not disclose all the active substances or components in the marketed drug. The current UK approach precludes an extension in such a case because the patent cannot be construed to "protect" the product as required by the regulation, even where the product and patent pass the "infringement test", that is the manufacture or supply of the product would infringe the patent. Other Member States, however, have adopted the infringement test, resulting in an important divergence in the approaches within the EU in respect of the same application for supplementary protection and resulting in dicta repeatedly calling for clarification by the higher court. This case note considers the issues that have led to the current reference to the ECJ and the diverging constructions that will be considered by it when determining the correct approach for patent term extension in the EU.
SO THAT'S SETTLED THEN? THE PATENTABILITY OF SECOND MEDICAL USES AND DOSAGE REGIMES
GEOFF LEES, TOM OLIVER AND PENNY GILBERT
Swiss Type claims have been examined in a series of decision from the EPO, Court Of Appeal and new guidance has been issued from the UK IPO. The authors examine the current state of play and in particular analysis the Kos Life Sciences decision.
EUROPEAN COMMISSION - Patents - First report on the monitoring of patent settlements ECJ - Generics -AstraZeneca v Commission - Patents on DNA sequences - Monsanto - Patents - Compatibility of proposed ECPC with the EU Treaties EPO - Biological Processes - oral proceedings G 2/07 and G1/08 - Synthia: A protected species?
DRAFTING AGREEMENTS IN THE BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRIES