Analysis by GenericsWeb Reveals More Than a Third of Granted or Pending SPCs are Potentially Invalid.

Share Article

Following the recent Medeva rulings, GenericsWeb, the leader in established pharmaceutical patent analysis and searching, decided to verify every SPC to determine their potential invalidity. The result of this analysis is that more than a third of granted or pending SPCs have questionable validity on the basis of these recent rulings.

After the recent decisions handed down by the Court of Justice of the European Union (CJEU) in Medeva (C 322/10) and the related Georgetown (C-422/10), Queensland (C-630/10), Yeda (C 518/10) and Daiichi (C-6/11) referrals, the requirements for validity of supplementary protection certificates (SPCs) for combination products was clarified. The CJEU ruled that SPCs could only be granted to products containing active ingredients that were specified or identified in claims of the basic patent.

Following these rulings, GenericsWeb, the leader in established pharmaceutical patent analysis and searching, analysed and verified every SPC applied for which references a combination product as the subject of the extension and which has a potential expiry date after 1st January 2012 to determine whether the claims of the basic patent 'specifies' or 'identifies' all active components of the combination.

GenericsWeb then flagged those SPCs where one or more of the active components are either not claimed in the basic patent or are claimed in general terms. GenericsWeb has incorporated this analysis into the Pipeline Scope database allowing to easily search and identify these SPCs with questionable validity in addition to those already flagged for use of an inconsistent first EU marketing authorisation date across SPCs filed for a given INN.

A key finding of this analysis is that more than a third of granted or pending SPCs have questionable validity on the basis of these recent rulings.

For more information, please read this special article, published in the latest edition of Generic Bulletin:
http://www.genericsweb.com/Medeva_ruling_may_render_third_of_combi_SPCs_invalid_article.pdf

About GenericsWeb – The Search Is Over
GenericsWeb, the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Yoann Bretonnet
GENERICSWEB
(029) 262-7696
Email >
Visit website