Intellectual Property Attorney / IP Attorney
Definition : Intellectual Property Attorney / IP Attorney
Marketing authorizations can give rise to various legal problems, including:
If a product approved under a marketing authorisation causes harm to a patient, the manufacturers may be held liable for that harm. Victims may bring proceedings to obtain compensation, which can entail substantial financial cost for manufacturers.
Products that obtain a marketing authorisation may be protected by patents, trade marks or other forms of intellectual property. Patent issues can be particularly complex for pharmaceutical products, since several patents may cover different aspects of the same product.
marketing authorisations may affect competition in the market, since they allow manufacturers to market exclusive products for a given period. Regulators must ensure that marketing authorisations do not impede competition in the market.
Manufacturers must supply confidential data in order to obtain a marketing authorisation, and regulators must maintain the confidentiality of that data. Legal difficulties may arise if it is disclosed or used improperly.
Manufacturers must comply with the applicable regulations in order to obtain a marketing authorisation. Regulators may bring proceedings against manufacturers that fail to comply.