|Title:||Articles 50 and 51 of the Law on Industrial Property No. 9947 of 07/07/2008|
|Field of IP:||Patents|
|Type of flexibility:||Compulsory licenses and government use|
Article 50 - Compulsory Licenses
1. On request, the court is entitled to grant a compulsory license to any Person who can demonstrate the capability to exploit the invention which is the subject-matter of the granted patent in the Republic of Albania when he meets all the requirements defined in the implementing regulation of this Law, provided that:
a) four years have expired from the filing of the application and three years have expired from the grant of the patent;
b) the patent owner has not exploited the patent on reasonable terms or has not made effective and serious preparations to do so, unless he provides legitimate reasons to justify his inaction.
c) the Person requesting the compulsory license has made efforts to obtain authorization from the patent owner on reasonable commercial terms and conditions, and if such efforts have not been successful within a reasonable period of time.
2. On request, the court is entitled to grant a compulsory license in respect of a first patent to the owner of a subsequent patent who cannot use his patent without infringing the first patent, provided that the invention in the second patent involves an important technical advance of considerable economic significance in relation to the invention claimed in the first patent. In the case of a compulsory license in respect of a dependent patent, the owner of the first patent shall be entitled to use the subsequent patented invention on reasonable terms.
3. On request, the court is entitled to grant a compulsory license in respect of patents and supplementary protection certificates relating to the manufacture and sell of pharmaceutical products, when such products are intended for export to importing countries in need of such products in order to address public health problems, subject to the implementing regulation.
4. The type of use covered and the conditions to be met shall be specified by the court. The following conditions shall apply:
a) The scope and duration of the exploitation shall be limited to the purpose for which it was authorized;
b) The exploitation shall be non-exclusive;
c) The exploitation shall be non-assignable. In the case of a compulsory license in respect of a dependent patent, the exploitation authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.
d) The amount of products manufactured under the license shall not exceed what is necessary to meet the needs of the importing country or countries cited in the application, taking into account the amount of products manufactured under other compulsory licenses granted elsewhere.
5. The exploitation shall be authorized, above all, to supply the market of the Republic of Albania, except in the case provided in paragraph 3 of this article.
6. A compulsory license shall be valid until the end of the time period designated by the court or until the end of the term of the patent. However, the court may, on reasoned request, decide to cancel the authorization, subject to adequate protection of the legitimate interests of the Persons so authorized, if and when the circumstances which led to it cease to exist and are unlikely to recur.
7. Compulsory licenses shall be registered in the patent register.
8. The owner of the patent shall be entitled to adequate compensation for a compulsory license, taking into account the economic value of the authorization. When the parties do not agree, the amount of this compensation shall be set by the court.
9. The holder of a compulsory license may renounce at it at any time. If the holder does not begin exploitation within one year from the final grant of the compulsory license, the owner of the patent may claim for the compulsory license to be modified or annulled.
10. The requirements of paragraphs 1(c) and 5 of this article shall not be applicable when such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account of in determining the amount of remuneration in such cases. The court shall have the authority to refuse termination of an authorization if the conditions that led to such authorization are likely to recur.
Article 51-Exploitation by the Government or Third Parties Authorized by the Government
1. When the interests of essential defense or national security require it, the Minister of Defense or the Minister of Health may, even without the approval of the owner of the patent or the applicant, by a notification in the GDPT Gazette, authorize a governmental agency or a specific Person to make, use or sell the invention for which the patent application was submitted, or the patent was granted, subject to payment of equitable remuneration to the owner of the patent or to the patent applicant. The owner of the patent or the patent applicant shall be notified as soon as possible.
2. An appeal to the court can be taken against the decision of the Minister of Defense or the Minister of Health.