Regulatory Focus™ > News Articles > Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

Posted 08 October 2015 | By Zachary Brennan 

Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies.

The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compensate innovators for the long periods of time needed to obtain regulatory approval.

The Case

In this case, US-based biotech company Seattle Genetics applied to the Austrian Patent Office (APO) for, and was granted, an SPC based on the basic patent for Adcentris (brentuximab vedotin). The APO calculated the term of the SPC starting from the date that Seattle was granted marketing authorization (MA), but the company challenged this, stating that the term should be determined using the date that it was notified of the approval, which some lawyers claim is now common practice in various EU member states, but not in Austria.

Ruling

Tuesday’s decision confirms that the term of an SPC will be determined from the date of notification of the relevant MA to the innovator, rather than from the date of the decision to grant the MA. Effectively that means that SPCs will see a slightly longer duration, which means more money for pharma and biotech companies.

More specifically, the ruling means the addition of about two to five days of patent protection, which is the typical time between the granting of an MA and notification to the applicant.

Commentary

But that short period can be a lucrative time for pharma and biotech companies, "particularly so as the market for a medicinal product will often reach its peak towards the end of the patent term. Taking this into consideration, the additional days per product, in every member state in which the product is marketed, potentially multiplied by several products is not insignificant," according to a blog run by EU lawyers.

Others lawyers have said those few days can amount to many millions of Euros of sales. In the Seattle case, the decision effectively adds five days on to the period of SPC protection.

 “This is a decision of significant importance for the innovative pharmaceutical industry which invests millions in developing a medicinal product," Marie Manley, partner and head of the British law firm representing Seattle Genetics in the case. "As such, the duration of SPC protection is essential for their medicinal products. Importantly the decision provides certainty to both innovative and generic pharmaceutical companies by clarifying when SPCs expire."

Prior to this case, the CJEU had never weighed in on the correct calculation of when the SPC starting date should take effect under European law.

CJEU Judgment

SPC Blog

Analysis from Marks & Clerk

 


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe