European Court of Justice Makes Key Pharma Ruling

A European Court ruling is expected to have a significant influence over the pharmaceutical industry.

The decision of the of Court of Justice of the European Union in favour of Seattle Genetics will be welcomed by pharmaceutical companies all over the world.

Seattle Genetics went before the European court regarding the duration of supplementary patent protection afforded to the pharmaceutical industry.

EU legislation provides the possibility of a supplementary protection certificate to compensate a patent holder.

This is necessary due to the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation.

However, it is currently European law that no medicinal product may be commercially exploited before the relevant authority has issued marketing authorisation.

Prior to the Seattle Genetics case, there was confusion regarding the duration and calculation of a supplementary protection certificate.

EU legislation suggests that the certificate should be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”.

But confusion reigned regarding what constitutes the date of the first authorisation.

The ruling thus addresses this issue and creates a president in European law.

The Court of Justice ruled that “Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.”

Although this may seem an extremely technical and obscure issue, the ruling is nonetheless expected to have a significant influence over the pharmaceutical industry in the foreseeable future.

The court decision puts an end to any uncertainty faced by both innovative and generic pharmaceutical industry companies regarding the duration of effective patient protection, which will have potentially significant effect on the industry.

This is due to the fact that the marketing of medicinal products will often reach its peak towards the end of the patent term.

When one considers the vast number of pharmaceutical products that this ultimately relates to to, the potential delays involved are certainly not insignificant.

Additionally, following the Court of Justice’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation.

This will enable patent holders to be certain of a uniform duration throughout the EU.

Commenting on the court ruling, Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, was naturally pleased with the decision:

“The CJ’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJ on this matter.”

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European Court Ruling Offers Solace to Healthcare Workers

A ruling by the European Court of Human Rights could affect the daily working life of healthcare professionals across the UK.

The new ruling states that travelling from home to first client, patient or customer and home from the last one at the end of shift, should be considered as working time to be paid for by employers.

Unions that have been campaigning for the decision have welcomed the initiative by the European Court of Justice, which will have an impact on workers who travel on a regular basis in a wide variety of industries.

This legislation had been particularly strongly lobbied for by GMB, the union for British Gas, AA, meter readers and home care workers, and the union has naturally welcomed the European court judgement.

Speaking on the subject, Kathleen Walker Shaw, GMB Europe Officer, said “GMB welcomes today’s judgment by the Court of Justice of the European Union as important confirmation that the journeys made by workers without fixed or habitual place of work between their homes and the first and last customer of the day constitute working time.”

Aside from those carers who regularly provide care to people in their homes, the decision could also have a significant impact on GPs.

Central to the court’s decision was the fact that workers are generally facing more changes in their working practices and environment, and journeys made to and from work are often not the choice of the employee.

The Court of Justice acknowledged that in many cases workers were forced to take on new working patterns that were significantly detrimental to them, and that they should receive some form of remuneration for this time and inconvenience.

It was also noted in the court decision that the verdict of the European Court was in line with the Working Time Directive and its principles.

The Working Time Directive provides all workers with the right to a minimum 28 days of paid holidays each year, a 20-minute rest break after six hours work, and rest of at least 11 hours in any 24 hours. Restrictions are also legislated for regarding evening work.

Commenting on the importance of the Working Time Directive, Shaw added:

“The Working Time Directive is not ‘red tape’ as the CBI asserts. It was brought to combat the dangers of excessive hours to workers and the public. It is not only workers without fixed and habitual places of work who will benefit from this judgment today, but all workers in Britain and the EU.”

With David Cameron having announced his intention to introduce a seven-day working culture in the NHS, the decision made by the European court may impact significantly on healthcare workers all over the country.

It would seem that healthcare professionals will have to show increasing flexibility if these plans come to fruition, and there will be a relief among many that they can at least count upon claiming journeys at the beginning and end of the day as paid work.

The British Medical Association has frequently warned that it is not uncommon for junior doctors to work 100 hour weeks.

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