Marketing Authorisation: Medicinal Products The case of R (on the application of Merck Sharp and Dohme Ltd) v Licensing Authority [2005], concerned the application for marketing authorisation for a generic product which was based on Product C (see below).
The claimant had marketing authorisations for three medicinal products used in the treatment of osteoporosis and three generic companies sought marketing authorisation for Product C.
Product A - was authorised by the European Community in 1993;
Product B - was authorised in 2000
Product C - was a generic product based on Product B (a copy of Product B).
When a company applies for marketing authorisation for a product, it is a requirement under the European Parliament and Council Directive (EC) 2001/83 (the "Directive"), to supply a full set of data in order to show the safety and efficacy of the product.
There are instances under the Directive when an applicant can simply rely on data submitted in respect of a previously authorised product. For instance, the applicant could refer to data already submitted in respect of a product with marketing authorisation, where the applicant is seeking authorisation for a product 'essentially similar' to a product holding a marketing authorisation for ten years (as per the United Kingdom and pursuant to art 10(i)(a)(iii) of the Directive).
In seeking marketing authorisation for Product C, the generic companies relied on data submitted in relation to Product A and Product B. However, although Product A and Product B contained the same active ingredient, they were not 'essentially similar' within the meaning of the Directive. This meant that they differed in respect of their posology (the schedule of dosage). The defendant accepted that the generic companies did not have to provide any further data but the claimant argued that such an approach was unlawful and in breach of the Directive. The claimant made a reference to the European Court of Justice ("Court of Justice").
The claimant contended that the issue was as yet unresolved by the rules laid down in previous decisions of the ECJ. In particular, it was argued, that there had been no cases where a difference in posology had been the subject of a decision.
The application was dismissed. The ECJ held that:
The principles laid down by the ECJ in earlier decisions were clearly applicable in this case and there was no uncertainty;
Although it was true that a change in posology had not previously been the subject of a decision, it was for the ECJ to interpret the EC Treaty and the relevant principles by which it was to be interpreted, and for the domestic court to apply those principles to the particular case. No new principles arose in the instant case.
If you require further information contact us.
Email: enquiries@rtcoopers.com
© RT COOPERS, 2005. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.
Rosanna Cooper is a partner in RT Coopers Solicitors a full service law firm in London. The firm specialises in patents, trade marks, copyright, designs, technology transfer, biotechnology and pharmaceutical law. The firm has a flexible approach to fees and provides the highest quality legal advice.
Contact us at enquiries@rtcoopers.com. visit our website at http://www.rtcoopers.com
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
I remember a friend in college who would blush, sweat, and tremble when required by a teacher to speak in class... Read More
If you joints are constantly killing you, here are three suggestions:1... Read More
Madeline Mann once weighed less can a can of soda making her the tiniest surviving newborn known to medicine... Read More
"If you're one the nine out of ten adults in the United States who suffers from low back pain, I have good news for you!" states Dr... Read More
According to Dr... Read More
Whether you're a weekend athlete, or a gardener that overdid it, or a person with arthritis, there's hope for you... Read More
Pill Proof LLC introduces the first, easy to use medication compliance kit for consumers and medical professionals... Read More