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Regulatory Focus™ > News Articles > 8 > Effective Protection Period for Medicines has Declined in Last Decade, EC Report Finds

Effective Protection Period for Medicines has Declined in Last Decade, EC Report Finds

Posted 09 August 2018 | By Zachary Brennan 

The European Commission (EC) on Thursday released a report detailing how patents and various exclusivity periods are used to protect pharmaceuticals from generic and biosimilar competition in the EU.

The report establishes a new term, known as the “effective protection period,” which is the “period where the medicinal product enjoys protection from primarily generic competition in any of the EU countries.”

For the 558 unique medicinal products used in its data set, the EC found that this effective protection period has declined from an average of 15 years to 13 years during the period 1996 to 2016.

“We speculate that part of the reason for this decrease may be attributed to the increase in regulatory requirements both at the EU and national level,” the report says. “The decrease in the average effective protection period could also reflect that companies have been taking on more complex and risky research and development projects with longer expected development times.”


Of the 558, 62% enjoy an effective protection period of between 10 and 15 years, while 24% enjoy an effective protection period of between 15 and 20 years.

As far as patents, for 51% of the 558 drugs, a patent is the last measure of protection to expire, while for the other 49%, either the supplementary protection certificate (SPC) or another incentive or reward (i.e. Orphan or pediatric reward) are the last measure of protection to expire.


And when generic drugs enter the market in the EU, the EC found that their price is on average 50% lower than the initial price of the corresponding innovator product in the first five quarters after the launch of the generic.

The report also offers a thorough rundown of what all these terms – from SPC to market exclusivity to mutually exclusive and non-cumulative incentives – mean from a practical perspective.

Country Comparisons

In terms of differences between the US and EU, the report notes that though the patent protection period is the same, the patent “restoration” period is capped at a total maximum of 14 years of protection in the US and 15 years in the EU.

The US also has a provision for 12 years data protection for biologics, which the EU does not have, and in the US, a generic company can issue a paragraph 4 challenge, whereas the EU does not have a similar scheme.

“The key differences between Canada and EU is that market and data protection are both 2 years shorter in Canada than in the EU,” the report notes. In addition, Canada provides no protection for orphan drugs, though a patent restoration is available for a maximum of 2 years in Canada, compared to up to 5 years in the EU through the SPC. Other comparisons with China, Japan, India and China are also made.



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