Annexes I: Provisions Of Law On Compulsory Licensing

CDIP/5/4

Annex I, page 256

(1) PROVISIONS OF LAW ON COMPULSORY LICENSING

ALBANIA : Article s 50 and 51 of the Law on Industrial P roperty No. 9977 of 07/07/ 2008

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.

ALGERIA : Article s 38 and 47-49 of the Ordinance No. 03-07 of 19/07/2003 - 1424

38. Toute personne peut, à tout moment après l’expiration d’un délai de quatre (4) années à compter de la date de dép?t de la demande d’un brevet ou de trois (3) années à compter de la date de délivrance du brevet d’invention, obtenir auprès du service compétent, une licence d’exploitation pour cause de défaut ou d’insuffisance d’exploitation.

Pour l’appréciation du délai cité à l’alinéa ci-dessus, le service compétent appliquera celui qui expire le plus tard.

La licence obligatoire ne peut être accordée par le service compétent, qu’après vérification de la réalité du défaut ou de l’insuffisance d’exploitation et s’il n’existe pas de circonstances qui justifient ce défaut ou cette insuffisance d’exploitation de l’invention brevetée.

47. Si une invention protégée par un brevet d’invention ne peut être exploitée sans qu’il soit porté atteinte aux droits découlant d’un brevet d’invention antérieur, il peut être accordé, sur demande, une licence obligatoire au titulaire du brevet d’invention ultérieur.

Une telle licence sera accordée dans la mesure nécessaire à l’exploitation de l’invention, pour autant que celle-ci présente un progrès technique notable et soit d’un intérêt économique important, par rapport à l’invention objet du brevet antérieur.

Le titulaire du brevet antérieur a droit à une licence réciproque, à des conditions raisonnables, pour utiliser l’invention objet du brevet ultérieur.

48. La licence obligatoire visée à l’article 38 ci-dessus sera non exclusive et aura principalement pour objet l’approvisionnement du marché national.

49. Une licence obligatoire peut être accordée à tout moment par le ministre chargé de la propriété industrielle à un service de l’état ou à un tiers désigné par le ministre, pour une demande de brevet ou pour un brevet d’invention, dans l’un des cas suivants :

1) Lorsque l’intérêt public, en particulier la sécurité nationale, la nutrition, la santé ou le développement d’autres secteurs de l’économie nationale l’exige, et notamment lorsque la fixation, pour les produits pharmaceutiques brevetés, de prix excessifs ou discriminatoires par rapport aux prix moyens du marché;

2) Lorsqu’un organe judiciaire ou administratif juge que la manière dont le titulaire du brevet ou son preneur de licence exploite l’invention est anticoncurrentielle et lorsque le ministre chargé de la propriété industrielle est convaincu que l’exploitation de l’invention en application du présent alinéa, permettra de remédier à cette pratique.

ANDORRA : Article 34 of the Patent Act of 10/06/1999

Article 34 - Compulsory licenses

(1) Any person who proves his ability to work the patented invention in Andorra, after the expiration of a period of four years from the filing date of the application or three years from the grant of the patent, whichever is later, may institute legal proceedings in front of the Civil Court to request a the grant of a compulsory license to exploit the patented invention if it is not worked or is insufficiently worked in Andorra .

(2) The scope and duration of any compulsory license shall be limited to the purpose for which it is granted, and such license shall be

(a) non-exclusive,

(b) non-assignable, except with that part of the enterprise or goodwill which enjoys such authorization,

(3) The grant of a compulsory license shall be subject to the payment of adequate remuneration to the proprietor of the patent. Such license may only be granted if, prior, the person requesting it has made efforts to obtain authorization from the proprietor on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time.

(4) A compulsory license shall not be granted if the Judicial Authority determines that circumstances exist which justify the non-working or insufficient working of the patented invention in Andorra , and in particular if the product covered by the patent is put on the market in Andorra in sufficient quantity to satisfy the needs in Andorra.

ANTIGUA AND BARBUDA : Sections 13-14 of the Patent Act No. 23 of 2003

13 . Exploitation by Government or person thereby authorized

(1) Where:

(a) the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy so requires, or

(b) the Registrar has determined that the manner of exploitation, by the owner of the patent or his licensee, is anti-competitive, and the Minister is satisfied that the exploitation of the invention in accordance with this subsection would remedy such practice,

agency or a third person designated by the Minister may exploit the invention.

(2) The exploitation of the patented invention shall be limited to the purposes for which it was authorized and shall be subject to the payment to the owner of an adequate remuneration therefor,

taking into account the economic value of the Minister’s authorization, as determined in the decision, and, where a decision has been taken under paragraph (b) of subsection (I), the need to correct anti-competitive practices.

(3) A request for the Minister’s authorization shall be accompanied by evidence that the owner of the patent has received, from the person seeking the authorization, a request for a contractual licence, but that that person has been unable to obtain such a licence on reasonable commercial terms and conditions and within a reasonable time.

(4) Subsection (3) shall not apply in cases of:

(a) national emergency or other circumstances of extreme urgency provided, however, that in such cases the owner of the patent shall be notified of the Minister’s decision as soon as reasonably practicable;

(b) public non-commercial use, and

(c) anti-competitive practices determined as such by a judicial or administrative body in accordance with subsection (1) b).

(3) The exploitation of a patented invention in the field of semi-conductor technology shall only be authorized either for public non-commercial use or where a judicial or administrative body has determined that the manner of exploitation of the patented invention, by the owner of the patent or his licensee, is anticompetitive and if the Minister is satisfied that the issuance of the non-voluntary licence would remedy such practice.

(4) The authorization shall not exclude:

(a) the conclusion of licence contracts by the owner of the patent; or

(b) the continued exercise, by the owner of the patent, of his rights under section 1 l(2); or

(5) Where a third person has been designated by the Minister, the authorization may only be transferred with the enterprise or business of that person or with the part of the enterprise or business within which the patented invention is being exploited.

(6) The exploitation of the invention by the Government agency or third person designated by the Minister shall be predominantly for the supply of the market in Antigua and Barbuda.

(7) Upon request of the owner of the patent, of the Government agency or of the third person authorized to exploit the patented invention, the Minister may, after hearing the parties, if either or both wish to be heard, vary the terms of the decision authorizing the exploitation of the patented invention to the extent that changed circumstances justify such variation.

(8) Upon the request of the owner of the patent, the Minister shall terminate the authorization if he is satisfied, after hearing the parties, if either or both wish to be heard, that the circumstances which led to his decision have ceased to exist and are unlikely to recur or that the Government agency or third person designated by him has failed to comply with the terms of the decision.

(9) Notwithstanding subsection (lo), the Minister shall not terminate the authorization if he is satisfied that the need for adequate protection of the legitimate interests of the Government agency or third person designated by him justifies the maintenance of the decision.

(10) The decisions of the Minister under subsections (1) to (1 1) may be the subject of an appeal before the High Court.

14. Non-Voluntary Licences.

(1) On request, made to the Registrar after the expiration of a period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last, the Registrar may issue a non-voluntary licence if he is satisfied that the patented invention is not exploited or is insufficiently exploited, by working the invention locally or by importation, in Antigua and Barbuda.

(2) Notwithstanding subsection (I), a non-voluntary licence shall not be issued if the owner of the patent satisfies the Registrar that circumstances exist which justify the non-exploitation or insufficient exploitation of the patented invention in Antigua and Barbuda.

(3) The decision issuing the non-voluntary licence shall fix

(a) the scope and function of the licence,

(b) the time limit within which the licensee must begin to exploit the patented invention, and

(4) The beneficiary of the non-voluntary licence shall have the right to exploit the patented invention in Antigua and Barbuda according to the terms set out in the decision issuing the licence, shall commence the exploitation of the patented invention within the time limit fixed in the said decision and, thereafter, shall exploit the patented invention sufficiently.