How to calculate Patent expiry & Exclusivity in EU

How to calculate Patent expiry & Exclusivity in EU

A generic medicine can only be marketed once the patents and the supplementary protection certificates (SPCs) covering the originator product have expired. Data exclusivity also limits the time when a generic manufacturer can make an application for a marketing authorisation based on demonstrating bioequivalence with the originator product. 

Patents: Patents are used to protect a product, process, apparatus or use that has a practical purpose. Registration provides a patentee the right to prevent anyone making, using, selling, or importing the invention for 20 years. Any given pharmaceutical product is typically protected by  

20-40 different patents on various aspects and properties of the product. The pharmaceutical properties eligible for patenting is different from country to country.

Pharmaceutical properties eligible for patenting in EU:

• Primary uses
• Processes and intermediates
• Bulk forms
• Simple formulations
• Composition of matter
• Expansive numbers of uses
• Methods of treatment
• Mechanism of action
• Packaging
• Delivery profiles
• Dosing regimen
• Dosing range
• Dosing route
• Combinations
• Screening methods
• Chemistry methods
• Biological target
• Field of use

To get patent expiry date, add 20 years to application date shown on front page of patent.

SPC (Supplementary Protection Certificate): It is a unique intellectual property (IP) right that provides an additional monopoly that comes into force after expiry of a patent upon which its based.The purpose of the supplementary protection certificate for medicinal products is to remedy the disparities and shortcomings in national patenting systems for pharmaceutical research. It aims in particular to guarantee sufficient protection for the development of medicinal products in the European Union (EU).

Criteria to get SPC:

• The product is protected by a basic patent in force;
• The product, as a medicinal product, has been granted a marketing authorisation;
• The product has not already been the subject of a certificate;
• The marketing authorisation is the first authorisation to place the product on the market as a medicinal product.

The certificate cannot be granted for a period exceeding five years. Furthermore, the duration of protection afforded by a patent and by the certificate cannot exceed 15 years overall for the holder's first marketing authorisation.

Exclusivity:  An application for approval of a New Chemical Entity must contain data to allow assessment of the safety and efficacy profile. These data include pharmacological and toxicological tests and the results of clinical trials.

To avoid repeating such tests and trials, applications for generic pharmaceutical substances are not required to include these data; instead they may rely on the data provided in relation to the NCE application. However,EC directive 2001/83/EC prevents regulatory authorities from accepting applications for approval of generics that rely on this data until a data exclusivity period has expired.

This period starts on the day of the first marketing authorisation in the European Community, and expires either six or ten years thereafter, depending on the country in which the application is to be filed and the procedure used to file it.

Data exclusivity relates to the active ingredient per se, new periods of data exclusivity are not applied to later approval of new dosage forms, routes of administration or indications.

Two types of provisions are there in EU for Regulatory Data Protection:

• 6/10 years Old provision
• 8+2+1 years New provision

6/10 years Old provision: This provision is applicable to medicinal products (Reference products) application was submitted before 31 October 2005.

10 Years for national authorisations granted by: Belgium, Germany, France, Italy, the Netherlands, Sweden, United Kingdom, Luxemburg.

6 years for national authorisations granted by: Austria, Denmark, Finland, Ireland, Portugal, Spain, Greece, Poland, Czech Republic, Hungary, Lithuania, Latvia, Slovenia, Slovakia, Malta, Estonia, Cyprus and also Norway, Liechtenstein and Iceland.

10 years for all medicinal products authorised through the centralised procedure.

• To calculate the expiry of the data exclusivity period for centralised applications add 10 years to the corresponding European First Marketing Authorisation Date.
• To calculate the expiry of the data exclusivity period for national or mutual recognition procedure applications, add (6 years or 10 years depends on country) to the corresponding European First Marketing Authorisation Date.

8+2+1 years New provision: The 2001/83/EC Directive introduces a harmonized "8+2+1" formula for new drugs approved either through the centralized procedure or the mutual recognition procedure.

This provision is applicable to medicinal products (Reference products) application was submitted after 31 October 2005.

• 10 (8+2) years market exclusivity

• 8 years data protection

• 2 years for generic companies to prepare, apply 
   

  for and receive a MA. The generic MAH is not 

   

  
  
  
  

  allowed to place his product on the market until 10 

   

  
  
  years have expired

• +1 year: During the first eight years of those ten years, the MAH obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.

To get data exclusivity expiry date: Add 10 years to the corresponding European First Marketing Authorisation Date, plus another 1 year if a new indication has been approved. To calculate the earliest date for filing a generic application, add 8 years to the corresponding European First Marketing Authorisation Date.