On 1 January 2019 new provisions amending the Patent Act entered into force. While one set of provisions addresses the professional use of pharmaceuticals, the other addresses incentives regarding research and development for paediatric pharmaceuticals.
The revised Patent Act includes two additional exemptions from patent protection that aim to safeguard the professional use of pharmaceuticals in favour of patients:
- Article 9(1)(g) exempts from patent protection the prescription, disposal or use of pharmaceuticals by medical doctors or similar persons in favour of patients. The exemption covers use in single cases only (ie, not serial uses or similar) and is intended to counterbalance the broader scope of patent protection, especially in the form of protection for second or further medical indications, which might prevent professionals from using generics for certain indications.
- Article 9(1)(h) exempts the preparation of pharmaceuticals by pharmacists and the use of such pharmaceuticals. Preparation must be ordered by medical doctors for use as a therapy to treat specific patients.
The revised Patent Act also aims to stimulate R&D for paediatric pharmaceuticals. To this end, patent owners may now request to extend their patent protection for six months if they conduct clinical studies concerning the paediatric use of a pharmaceutical. If such a requirement is met, owners may request either:
- a six-month extension of the pre-existing supplementary protection certificate; or
- a special paediatric supplementary protection certificate, which is valid for six months following the expiration of the patent term.
Applicants must prove that clinical studies have been conducted in accordance with paediatric examination concepts and that study results are published in the information covering the pharmaceutical. Further, requests cannot be filed more than six months after applying for marketing authorisation in the European Economic Area.
The deadline for filing a request to extend a pre-existing supplementary protection certificate is two years before the certificate expires, while the deadline to request a special paediatric supplementary protection certificate is two years before the patent term expires.
Transitional provisions will apply for five years from 1 January 2019.
For further information on this topic please contact Mathis Berger at Nater Dallafior Rechtsanwälte AG by telephone (+41 44 250 45 30) or email ([email protected]). The Nater Dallafior Rechtsanwälte AG website can be accessed at www.naterdallafior.ch.
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