Amendments to the Patent Law of the Estonian Republic

The Law comprises important amendments concerning the expansion of protectable subject matters; in particular, there has been introduced supplementary protection for medicinal and plant protection agents comprising active substances protected by patents (chapter VIII).

§ 6 Subject of invention

The term "strain of microorganism" has been replaced by the term "biological material". §6(3) reads as follows: "For the purpose of this Act, a biological material is any material, including microorganisms, which contains genetic information and is capable of reproducing itself or being reproduced in a biological system".

§ 7 Inventions not patentable

The non-patentable subject matters have been specified and supplemented. The following biotechnological inventions shall not be protected with patents: 
- processes for cloning or modifying the genetic identity of human beings and animals, 
- processes which are essentially biological and are used for deriving biological material, producing plant or animal varieties, except microbiological processes for deriving microorganisms; biotechnological inventions that can be used solely for one particular plant or animal variety.
- A process which is essentially biological and used for deriving biological material or for producing plant or animal varieties is defined as a process which is entirely based on natural phenomenon, including crossing and selecting.

A microbiological process is defined as any process using a microorganism or aimed at the deriving of a microorganism.

§ 11 Priority

The documents certifying the claim for priority shall be presented in the patent application or within 16 months from the priority date (i.e. within 4 months from the Estonian filing date, if the application is filed on the last day before expiry of the 12-months priority deadline).

The Law has been supplemented by § 15' (1), (2) and (3) Extension of exclusive right of patentee: (1) If the biological material has been patented, the exclusive right of the patentee shall extend to any other biological material with the same qualities which has been derived from that biological material through propagation or multiplication in an identical or divergent form.
(2) If the process for obtaining the biological material has been patented, the exclusive right of the patentee shall extend to any other biological material with the same qualities which has been derived from the biological material produced by the patented process through propagation or multiplication in an identical or divergent form.
(3) If an invention contains genetic information, the exclusive right of the patentee shall extend to the entire biological material containing this invention and functioning according to this genetic information, except the human body and parts of it.

The Law has been supplemented by § 17/ Exhaustion of rights.

The patentee shall not be entitled to prohibit further commercial use of a product protected by a patent which has been put on the market by him or with his consent in the territory of the Republic of Estonia or of any member state of the Agreement on the European Economic Area.

§21 Examination on filing

The patent office no more refuses to approve of a patent application if drawings or illustrative materials are missing.

§ 21 was supplemented by subsection (5): The filing date of a patent application approved for processing shall be the date of receipt of the patent application at the Patent Office except in cases where the documents received by the Patent Office do not contain a drawing or other illustrative material necessary for disclosing the subject matter of the invention referred to in the description. If the drawing or other illustrative material is missing, the Patent Office shall invite the applicant to furnish it within one month. If the missing drawing or other illustrative material is furnished by the due date, the filing date of the patent application shall be the date of receipt of the drawing or other illustrative materials at the Patent Office. If the missing drawing or illustrative material is not furnished by the due date or the applicant refuses to furnish them, all references in the patent application to said document shall be deemed to be repealed and the filing date of the patent applicaiton shall be the date of receipt of the patent application at the Patent Office.

§ 23 Substantive examination

In the new wording (amended subsections 5 and 6) § 23 reads as follows: (1) In the course of the examination the Patent Office shall examine the compliance of the invention with the conditions for patentability pursuant to § 8 of the Act.
(2) The applicant may, pursuant to Article 15 (5) of the Patent Cooperation Treaty concluded at Washington on 19 June, 1970, file a request for international-type search. Upon filing the request the applicant shall pay the state fee and the payment for international-type search.
(3) The Patent Office may demand that the applicant provide oral or written explanations and correct or supplement the claims, the description, the drawings or other illustrative material and the abstract of the subject matter of the invention. The Patent Office shall prescribe a term of two to six months for providing explanations or presenting corrections and supplementations.
(4) The Patent Office shall be entitled to demand that the applicant furnish copies of decisions made by foreign patent offices regarding his analogous applications, it shall also be entitled to exchange information on the patent application with patent offices of other states.
(5) If the Patent Office considers that the subject of the invention is protectable as a patent pursuant to §§ 6 and 7 of the Act and the subject matter of the invention in the wording of the patent claim, if compared with the state of art, meets the conditions for patentability provided for in § 8 of the Act and the form and substance of the application documents are in compliance with the formal and substantive requirements established pursuant to subsection 19(2) of the Act, the Patent Office shall terminate the substantive examination, make the decision on granting a patent and notify the applicant of this in writing.
(6) If the Patent Office considers that the subject of the invention is not protectable as a patent pursuant to §§ 6 and 7 of the Act and the subject matter of the invention in the wording of the patent claim, if compared with the state of art, does not meet the conditions for patentability provided for in § 8 of the Act, or the form or substance of the application documents is not in compliance with the formal and substantive requirements established pursuant to subsection 19(2) of the Act or the applicant fails to provide explanations or present corrections and supplementations required pursuant to subsection 3 of this Section or to furnish copies required pursuant to subsection 4 of this Section, the Patent Office shall terminate the substantive examination, make the decision on rejecting the patent application and notify the applicant of this in writing.

Subsections 2 and 3 of § 26 Withdrawal of a patent application have been specified as to the deadlines. An application is considered withdrawn if the applicant failed to respond to the invitation of the Patent Office regarding the providing of explanations or corrections or supplementing application documents wihin three months from the due date prescribed pursuant to subsection 22(3) of this Act established by the Patent Office for submitting a response.

The Law has been supplemented by Chapter VIII' (§§ 391 - 399) Supplementary protection of medicinal agents and plant protection agents containing active substances protected by patents. In § 391 a medicinal agent is defined as "a agent containing at least one active substance protected by a patent and used for the following purposes:
1) prevention and treatment of diseases in humans or animals;
2) making a medical diagnosis for humans or animals;
3) restoring, correcting or modifying physiological functions in humans or animals."

In § 392(1) a plant protection agent is defined, in § 392(2) there is also defined an active substance of a plant protection agent as "natural or synthetic chemical substance or composition of substances with additives inevitably resulting from the manufacturing process".

In § 393 the term basic patent is defined as "a patent which protects the active substance or their combination, a process of manufacture or use of the active substance of a medicinal or plant protection agent".

§ 394 Grant of supplementary protection refers to the requirements for obtaining additional protection.

In accordance with § 394(1) "supplementary protection shall be granted for a medicinal or plant protection agent by extending the term of rights conferred by the registration of invention protected by a basic patent upon the expiration of the term of the basic patent."
In accordance with § 394(2) "supplementary protection shall be granted in the following cases: 1) the basic patent is valid on the filing date of supplementary protection application;
2) the medicinal agent has been registered pursuant to § 11 of the Medicinal Agent Act;
3) the plant protection agent has been registered pursuant to subsection 12(1) of the Plant Protection Act;
4) the registrations of the medicinal or plant protection agent referred to in clauses 2 and 3 of this subsection is primary and it has not been deleted;
5) the same medicinal or plant protection agent has previously not been granted supplementary protection."

In accordance with § 394(3) "supplementary protection shall be granted to the same medicinal or plant protection agent solely on the basis of one patent."
In accordance with § 394(4) "on the basis of one and the same patent, supplementary protection can be granted to several different medicinal agents or plant protection agents."
In accordance with § 394(5) "supplementary protection grants the same rights as the basic patent and is subject to the same restrictions and obligations."

§ 395 Applying for supplementary protection

(1) The right to apply for and to be granted supplementary protection shall belong to the owner of the basic patent or to his legal successor.
(2) The supplementary protection application shall be filed within six months from the date of entry into force of the registration of the medicinal agent or plant protection agent. If this date is earlier than the date of granting the basic patent, the supplementary protection application shall be filed within six months from the date of granting the basic patent.
(3) The supplementary protection application shall contain the following documents:
1) the request for the grant of supplementary protection;
2) the document certifying the registration of the medicinal or the plant protection agent;
3) the document cetrifying the payment of the state fee;
4) the authorisation if the supplementary protection application is filed through a patent attorney.
(4) The request for the grant of supplementary protection shall set out:
1) a statement requesting the grant of supplementary protection to a medicinal or plant protection agent;
2) the name and address of the applicant for supplementary protection;
3) the number of the basic patent and the title of the invention;
4) the number and date of issue of the document certifying the registration of the medicinal or plant protection agent;
5) the date of registration of the medicinal or plant protection agent;
6) the identification data of the agent specified in the document certifying the registration of the medicinal or plant protection agent;
7) the given name and surname of the patent attorney if the supplementary protection application is filed through a patent attorney.

§ 396 Examination of supplementary protection application

The Patent Office examines if the application complies with the requirements pursuant to § 395 (1) and (2) and § 395 (3) as to the presence of the necessary documents and their compliance with formal and substantive requirements and the validity of the basic patent or registration. The Patent Office in writing informs about deficiencies and establishes a term of 3 months for removing them.
Further, if the application is in compliance with the formal requirements pursuant to § 395 (1-3) and § 394 (2, clauses 1-3), the Patent Office shall make a decision on granting supplementary protection and notify the applicant of this in writing, and if not, it shall make a decision on refusing supplementary protection; it follows publication and issuance of the certificate.

§ 398 Term of supplementary protection

(1) The term of supplementary protection shall be up to five years from the date of expiration of the basic patent. The date of expiration of supplementary protection cannot be later than the date of expiration of 15 years from the issue of the basic patent or from the first day of term of the document referred to in clause 2 of subsection § 395 (3) of the Act, whereby the later date is taken into consideration.
The maintainance of the supplementary patent upon payment of annuities (9800 krones - 1225 DM), its invalidation, contestation and protection are analogous to the provisions for regular patents.

In accordance with § 61 Entry into force of the Act, supplementary protection can be applied for registered medicinal or plant protection agents until July 30, 2000, if they contain an active substance that has been granted a basic patent before January 1, 2000. 

Additionally, § 43 - 46 of the Act concerning the transfer of rights to apply for patents, transfer of patent applications, transfer of patents and licences have been amended and redrafted.

The translation of old § 1 of Section 46 was misleading. (old Law:"Patentee may transfer, in whole or in part, the right to use or command a patented invention to another person (licensee) by a licence." - new Law: "...to one or several persons...").

We contacted our Estonian colleague and she confirmed that in the old as well as in the new Law, a licence can be transferred to one or more persons.