General Directorate of Patents and Trademarks
Albania

• Section 1 General
• Section 2  Private and/or non-commercial use
• Section 3  Experimental use and/or scientific research
• Section 4  Preparation of medicines
• Section 5  Prior use
• Section 6  Use of articles on foreign vessels, aircrafts and land vehicles
• Section 7  Acts for obtaining regulatory approval from authorities
• Section 8  Exhaustion of patent rights
• Section 9  Compulsory licensing and/or government use
• Section 10  Exceptions and limitations related to farmers' and/or breeders' use of patented inventions
• Section 11  Other exceptions and limitations

Section 1: General

1. As background for the exceptions and limitations to patents investigated in this questionnaire,what is the legal standard used to determine whether an invention is patentable?  If the standard for patentability includes provisions that vary according to the technology involved, please include examples of how the standard has been interpreted, if available. Please indicate the source of law (statutory and-or case law) by providing the relevant provisions and/or a brief summary of the relevant decisions.

According to Article 5 of our Law No 9947 date 07/07/2008 Patentable Inventions are:

- Patents shall be granted for inventions, in all fields of technology, provided that they are:

(a) new;
(b) involve an inventive step; and
(c) are susceptible of industrial application.

- The subject-matter of an invention protected by a patent may be a product or a process.

- Biotechnological inventions shall also be patentable if they concern:

(a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;
(b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;
(c) microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety;
(ç) an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

Correspondingly, please list exclusions from patentability that exist in your law.  Furthermore, please provide the source of those exclusions from patentability if different from the source of the standard of patentability, and provide any available case law or interpretive decisions specific to the exclusions.

According to Article 6 of our Law No 9947 date 07/07/2008 Patents shall not be granted in respect of:

-. Inventions the commercial exploitation of which would be contrary to public order, morality or public health and human life; such exploitation may be deemed to be so contrary even if it is not prohibited by law or regulation. On this basis, the following, in particular, shall be considered unpatentable:

(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c)uses of human embryos for industrial or commercial purposes;
(ç)processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

-. Plant or animal varieties or essentially biological processes for the production of plants or animals, without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process;

- The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.

- Methods for treatment of the human body or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Substances obtained through internal nuclear transformations for military purposes.

The following in particular shall not be regarded as inventions within the meaning of paragraph 1 Article 6 of Law No 9947 date 07/07/2008:

(a) discoveries, scientific theories and mathematical methods;
(b) aesthetic creations;
(c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
(ç) presentations of information.

- The above paragraph shall exclude patentability of the subject-matter or activities referred to therein only to the extent to which a patent application or a patent relates to such subject-matter or activities as such.

2. As background for the exceptions and limitations to patents investigated in this questionnaire, what exclusive rights are granted with a patent? Please provide the relevant provision in the statutory or case law. In addition, if publication of a patent application accords exclusive rights to the patent applicant, what are those rights?

According to Article 36 of our Law No 9947 date 07/07/2008 the rights conferred by a patent are:

1. When a patent is related to a product, the owner of the patent shall have the exclusive right to prohibit any third party from performing the following actions without his authorization: making, using, offering for sale, selling, stocking or importing for these purposes that product.

2. When the patent is related to a process, the owner of the patent shall have the exclusive right to prohibit third parties from performing the following actions without his authorization:

(a) to use the process that constitutes the subject of the patent;
(b) to use, offer for sale, sell, stock or import for these purposes at least the product obtained directly by that process.

3. The owner of a patent has the right to assign and to transfer the patent to his successors in title, as well as to make license agreements on the patent.

Article 37. Prohibition of indirect use of the invention

1. The owner of a patent shall have the right to impede third parties, other than those who have gained the right to use the invention for which the patent was granted, from supplying or offering to supply to a Person, other than one entitled to exploit the patented invention, means relating to an essential element of the invention, for putting it into effect therein, when the third party has knowledge, or when from the circumstances it becomes clear that those means are suitable and intended for putting that invention into effect.

2. This provision shall not apply if these means are staple commercial products, except when the third party induces the Person supplied to commit acts prohibited by article 36.

3. Which exceptions and limitations does the applicable law provide in respect to patent rights (please indicate the applicable exceptions/limitations):

Private and/or non-commercial use;
Experimental use and/or scientific research;
Preparation of medicines;
Prior use;
Use of articles on foreign vessels, aircrafts and land vehicles;
Acts for obtaining regulatory approval from authorities;
Exhaustion of patent rights;
Compulsory licensing and/or government use;
Exceptions and limitations related to farmers’ and/or breeders’ use of patented inventions.

Section 2: Private and/or non-commercial use

4. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 38 (a) Limitation of the Effects of the Patent

The rights conferred by the patent shall not extend to:

(a) Acts performed privately, not for commercial purposes;

5. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat: response was not provided.]

6.(a) What are the public policy objectives for providing the exception

Law 9947 date 07.08.2008 “On Industrial Property” is approximated with EPC 2000 and EU directives concerning inventions

(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:

[Note from the Secretariat: response was not provided.]

7.-10.

[Note from the Secretariat: response was not provided.]

Section 3: Experimental use and/or scientific research

11. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 38(b) Limitation of the Effects of the Patent

The rights conferred by the patent shall not extend to:

(b) acts performed merely for experimental purposes relating to the subject matter of the invention;

12. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat:  response was not provided.]

13.(a) What are the public policy objectives for providing the exception?

Law 9947 date 07.08.2008 “On Industrial Property” is approximated with EPC 2000 and EU directives concerning inventions

(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:

[Note from the Secretariat: response was not provided.]

14.-16.

[Note from the Secretariat: response was not provided.]

17. If any of the following criteria is relevant to the determination of the scope of the exception, please indicate:

Research and/or experimentation must be conducted on or relating to the patented invention (“research on”)

Please explain by citing legal provision(s) and/or decision(s):

Acts performed merely for experimental purposes relating to the subject matter of the invention (Article 38(b)).

18.-22.

[Note from the Secretariat: response was not provided.]

Section 4: Preparation of medicines

23. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 38 (c) Limitation of the Effects of the Patent

(c) The extemporaneous individual preparation of a medicine in a pharmacy according to a medical prescription or with other processes that lead to its preparation.

24. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat: response was not provided.]

25.(a) What are the public policy objectives for providing the exception? Please explain:

Law 9947 date 07.08.2008 “On Industrial Property” is approximated with EPC 2000 and EU directives concerning inventions

(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:

[Note from the Secretariat: response was not provided.]

26. Who is entitled to use the exception (for example, pharmacists, doctors, physicians, others)?  Please describe:

27. Does the applicable law provide for any limitations on the amount of medicines that can be prepared under the exception?

No.

28.-30.

[Note from the Secretariat: response was not provided.]

Section 5: Prior use

31. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 43.

1. The rights conferred by a patent shall have no effect on Persons who within the territory of the Republic of Albania, have used the invention or are in the process of serious and effective preparations for its use, before the filing date of the application, or, in cases when priority is claimed, before the priority date. These Persons shall have the right to continue use or preparations for use.

2. The right of prior use may be transferred, with the enterprise or company, or with that part of the enterprise or company where the use or the preparations for use have been made.

32. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat: response was not provided.]

33.(a) What are the public policy objectives for providing the exception? Please explain:

Law 9947 date 07.08.2008 “On Industrial Property” is approximated with EPC 2000 and EU directives concerning inventions

(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:

[Note from the Secretariat: response was not provided.]

34.-35.

[Note from the Secretariat: response was not provided.]

36. According to the applicable law, can a prior user license or assign his prior user’s right to a third party?

No.

37. In case of affirmative answer to question 36, does the applicable law establish conditions on such licensing or assignment for the continued application of the prior use exception?

[Note from the Secretariat: response was not provided.]

38. Does this exception apply in situations where a third party has been using the patented invention or has made serious preparations for such use after the invalidation or refusal of the patent, but before the restoration or grant of the patent?

No.

39.-41.

[Note from the Secretariat: response was not provided.]

Section 6: Use of articles on foreign vessels, aircrafts and land vehicles

42. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 38 Limitation of the Effects of the Patent

The rights conferred by the patent shall not extend to:

(ç) the use on board of other countries of the Paris Union of devices forming the subject of the patent in the body of the vessel, in the machinery, tackle, gear and other accessories, when such vessels temporarily or accidentally enter Albanian waters, provided that such devices are used there exclusively for the needs of the vessel;
(d) the use of devices forming the subject of the patent in the construction or operation of aircraft or spacecraft or land vehicles of other countries of the Paris Union, or of accessories of such aircraft or land vehicles, when those aircraft or spacecraft or land vehicles temporarily enter Albania;

43. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat: response was not provided.]

44.(a) What are the public policy objectives for providing the exception? Please explain:

Law 9947 date 07.08.2008 “On Industrial Property” is approximated with EPC 2000 and EU directives concerning inventions

(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:

[Note from the Secretariat: response was not provided.]

45. The exception applies in relation to:

Vessels;
Aircrafts;
Land Vehicles
Spacecraft.

46. In determining the scope of the exception, does the applicable law apply such terms as “temporarily” and/or “accidentally” or any other equivalent term in relation to the entry of foreign transportation means into the national territory?

Please provide the definitions of those terms by citing legal provision(s) and/or decision(s):

The rights conferred by the patent shall not extend to the use on board vessels of other countries of the Paris Union of devices forming the subject of the patent in the body of the vessel, in the machinery, tackle, gear and other accessories, when such vessels temporarily or accidentally enter Albanian waters, provided that such devices are used there exclusively for the needs of the vessel

47. Does the applicable law provide for any restrictions on the use of the patented product on the body of the foreign vessels, aircrafts, land vehicles and spacecraft for the exception to apply (for example, the devices to be used exclusively for the needs of the vessel, aircraft, land vehicle and/or spacecraft)? Please explain your answer by citing legal provision(s) and/or decision(s):

Patent Act explicitly stipulates that the subject matter of the patented invention is used exclusively for the needs of the vessel. Article 38(ç).

48.-50.

[Note from the Secretariat: response was not provided.]

Section 7: Acts for obtaining regulatory approval from authorities

51. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 38 Limitation of the Effects of the Patent

The rights conferred by the patent shall not extend to:

(a) acts performed privately, not for commercial purposes;
(b) acts performed merely for experimental purposes relating to the subject matter of the invention;
(c) the extemporaneous individual preparation of a medicine in a pharmacy according to a medical prescription or with other processes that lead to its preparation;
(ç) the use on board vessels of other countries of the Paris Union of devices forming the subject of the patent in the body of the vessel, in the machinery, tackle, gear and other accessories, when such vessels temporarily or accidentally enter Albanian waters, provided that such devices are used there exclusively for the needs of the vessel;
(d) the use of devices forming the subject of the patent in the construction or operation of aircraft or spacecraft or land vehicles of other countries of the Paris Union, or of accessories of such aircraft or land vehicles, when those aircraft or spacecraft or land vehicles temporarily enter Albania;
(dh) biological material obtained from the propagation or multiplication of biological material placed in the market by the holder of the patent or with its consent, where multiplication or propagation necessarily results from the application for which the biological material was marketed, provided that the material obtained is not subsequently used for other propagation or multiplication;
(e) the use by a farmer of the product of his crop for propagation or multiplication on his own holding, provided that the reproductive vegetable material was sold or otherwise commercialized by the holder of the patent or with his consent to the farmer, for agricultural purposes;
(ë) the use by a farmer of protected livestock for farming purposes, on condition that the breeding animals or other animals reproductive material was sold or otherwise commercialized to the farmer by the holder of the patent or with his consent. Such use includes the provision of the animal or other animal reproductive material for the purposes of his agricultural activity, but not the sale as part of or for the purpose of commercial reproductive activity.

52.-54.

[Note from the Secretariat: response was not provided.]

55. The exception covers the regulatory approval of:

Any products

56. Please indicate which acts are allowed in relation to the patented invention under the exception?

Making;
Using.

57.-59.

[Note from the Secretariat: response was not provided.]

Section 8: Exhaustion of patent rights

60. Please indicate what type of exhaustion doctrine is applicable in your country in relation to patents:

National

If the exception is contained in statutory law, please provide the relevant provision(s):

Article 39 Exhaustion of rights

The rights conferred by a patent shall not extend to acts committed in the Republic of Albania with regard to a product protected by the patent after the said product has been put on the market in the Republic of Albania by the patent's owner or with his consent.

If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat: response was not provided.]

61.-64.

[Note from the Secretariat: response was not provided.]

Section 9: Compulsory licensing and/or government use

Compulsory Licenses

65. If the exception is contained in statutory law, please provide the relevant provision(s):

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.
(ç) 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.

66.-72.

[Note from the Secretariat: response was not provided.]

73. If the applicable law provides for the grant of compulsory licenses on the ground of refusal by the patentee to grant licenses on “reasonable terms and conditions” and within a “reasonable period of time”, please provide the definitions given to those terms by citing legal provision(s) and/or decision(s):

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.

74.-80.

[Note from the Secretariat: response was not provided.]

Government use < /p>

81. If the exception is contained in statutory law, please provide the relevant provision(s):

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.

82. If the exception is provided through case law, please cite the relevant decision(s) and provide its(their) brief summary:

[Note from the Secretariat: response was not provided.]

83. What grounds for the grant of government use does the applicable law provide in respect to patents (please indicate the applicable grounds):

Refusal to grant licenses on reasonable terms;
Public health;
National security.

84.(a) What are the public policy objectives for providing government use in your country?

(b) Where possible, please explain with references to the legislative history, parliamentary debates and judicial decisions:

[Note from the Secretariat: response was not provided.]

Section 10: Exceptions and limitations related to farmers' and/or breeders' use of patented inventions

Farmers' use of patented inventions

89. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 38 Limitation of the Effects of the Patent

The rights conferred by the patent shall not extend to:
e) the use by a farmer of the product of his crop for propagation or multiplication on his own holding, provided that the reproductive vegetable material was sold or otherwise commercialized by the holder of the patent or with his consent to the farmer, for agricultural purposes.
ë) the use by a farmer of protected livestock for farming purposes, on condition that the breeding animals or other animals reproductive material was sold or otherwise commercialized to the farmer by the holder of the patent or with his consent. Such use includes the provision of the animal or other animal reproductive material for the purposes of his agricultural activity, but not the sale as part of or for the purpose of commercial reproductive activity. 

90.-94.

[Note from the Secretariat: response was not provided.]

Breeders' use of patented inventions

95. If the exception is contained in statutory law, please provide the relevant provision(s):

Article 38 Limitation of the Effects of the Patent

The rights conferred by the patent shall not extend to:

(ë) the use by a farmer of protected livestock for farming purposes, on condition that the breeding animals or other animals reproductive material was sold or otherwise commercialized to the farmer by the holder of the patent or with his consent. Such use includes the provision of the animal or other animal reproductive material for the purposes of his agricultural activity, but not the sale as part of or for the purpose of commercial reproductive activity.

96.-100.

[Note from the Secretariat: response was not provided.]>

Section 11: Other exceptions and limitations

101.-103.

[Note from the Secretariat: the applicable law of Albania does not provide other exceptions and limitations.]

[End of questionnaire]

October 2011