Category: European Patent

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Protection of Biotechnological Inventions

Definitions:


Biological material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

Microbiological process means any process involving or performed upon or resulting in microbiological material,

Essentially biological process for the production of plants or animals means such a process, which consists entirely of natural phenomena such as crossing or selection.


Patentable biotechnological inventions

Biotechnological inventions are 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, or

c) microbiological or other technical process and a product, other than a plant or animal variety, obtained by this way.


Exclusions of patentability

Patents shall be not granted to

a) inventions, whose commercial exploitation would be contrary to public policy or to principles of morality, namely to processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, processes of using human embryos for industrial or commercial purposes or 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 to animals resulting from such processes; however, the contradiction to public policy or to principles of morality shall not be deduced merely from the fact that the exploitation of the invention is prohibited by legal regulation,

b) human body at 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; it does not apply to 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, even if the structure of that element is identical to that of a natural element, and

c) plant and animal varieties or essential biological processes for the production of plants or animals.

 

Special provisions on the application of biotechnological invention

Where an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in a patent application in such a manner as to enable the invention to be reproduced by a person skilled in the art, the description shall be considered inadequate unless:

a) the biological material has been deposited no later than the date, from which the right of priority belongs to the applicant, with the recognised depositary institution, which has acquired this status by virtue of Article 7 of the Budapest Treaty of 28 April 1977 on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure,

b) the application of invention as filed contains such relevant information as is available to the applicant on the characteristics of the biological material deposited, and

c) the patent application states the name of the depository institution and the accession number of the sample.

Access to the deposited biological material shall be provided through the supply of a sample:

a) between the first publication of the application and the granting of the patent, to anyone requesting it (hereinafter referred to as the “petitioner”) or, if the applicant so request, only to an independent expert, or
b) after the patent has been granted, and notwithstanding cancellation of the patent, to anyone requesting it.
The sample shall be supplied only if the petitioner or an independent expert in terms of paragraph 2 undertakes, for the term during which the patent is in force:

a) not to make the sample or any material derived from it available to third parties, and

b) not to use the sample or any material derived from it except for experimental purposes, unless the applicant for or proprietor of the patent, as applicable, expressly waives such an undertaking.
The applicant is entitled to limit access to the deposit material for 20 years from the date on which the patent application was filed to anybody, except an independent expert, even in case, where the application is refused or withdrawn.

The applicant shall notify the limitation of access to the deposit biological material to the Office of the Contracting State at the latest on the date, on which the preparations for publishing the patent application have been completed. The Office will publish such a limitation of access to the deposit biological material together with the invention application in the National Bulletin of the Office.

If the biological material deposited ceases to be available from the recognised depository institution, a new deposit of the material shall be permitted on the same terms as those laid down in the Budapest Treaty.

Any new deposit shall be accompanied by a statement signed by the depositor and certifying that the newly deposit biological material is the same as that originally deposited.

If the application concerns an invention of the sequence or partial sequence of a gene, their industrial applicability must be made obvious in the patent application.

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Grant of Supplementary Protection Certificates (SPC) for Medicaments and Plant Protection Products

Where applicable, the National Office shall grant supplementary protection certificates for substances protected on the territory of the Contracting State by the valid patent, if they are the active substances of the products which prior being placed on the market, are subject to the registration according to the special regulations.

The active substance shall mean:

  • a chemically manufactured substance or
  • a combination of substances,
  • a micro-organism or
  • a combination of micro-organisms,

which have general or specific therapeutic or preventive effects with regard to human or animal diseases

or

which may be administered to the human beings or animals in order to disease diagnosis, improvement or arrangement of their health condition

or

which are destined to the protection of plants or plant products.

The product referred to in first paragraph shall mean any active substance or a combination containing one or more active substances put up in the form for being placed on the market as a medicament or a plant protection product.


Application for a certificate

The application for a certificate shall be filed by the proprietor of the patent, whose subject-matter is a substance, except for the patent granted under special provisions, or a method for obtaining a substance or a use of a substance as a medicament or as a plant protection product, or his successor in title.

The application for a certificate shall be filed within 6 months from the date on which the decision on the registration of the product is issued according to special regulations. If the registration is made prior to the grant of the basic patent, the application for a certificate shall be filed within the period of 6 months from the date on which the patent is granted.

The application for a certificate shall contain:

a) a request for the grant of the certificate stating in particular:

1. the name and address of the applicant;

2. the name and address of the representative, if any;

3. the number of the basic patent and the title of the invention;

4. the number and date of the first registration of the product according to special regulations; 4d

b) a copy of the decision on the registration of the product issued according to special regulations, where the product is identified, including the product data summary, if it is a medicament;

c) chemical, generic or other terminology enabling to identify the substance protected by the basic patent with the registered product.

When filing the application for a certificate, the applicant shall pay the administrative fee according to the special regulations.

The National Office shall record the filing of the application for a certificate to the Patent Register and publish it in the Bulletin. The publication shall contain the name and address of the applicant, the number of the basic patent and the title of the invention protected by the patent, the number and the date of the registration, including of the mention of the product, putting on the market of which is authorised by means of this registration.


Conditions for obtaining a certificate

The National Office shall grant a certificate, if the following conditions are met on the date of filing the application:

a) the basic patent is valid on the territory of the Contracting State;

b) the product contains the active substance protected by the basic patent and is validly registered as a medicament or a plant protection product according to special regulations;

c) the certificate has not yet been granted to the substance;

d) the registration referred to in the letter b) is the first authorisation to place a medicament manufactured en masse in the Conrtacting State or the first authorisation to place a plant protection product on the market in the Contracting State.


Grant of the certificate

If the application for a certificate meets said conditions and the substance, for which the certificate is applied for, meets the conditions as well, the National Office shall grant the certificate and record it in the National Patent Register. The certificate shall contain:

a) the name and address of the proprietor of the certificate;

b) the number of the basic patent and the title of the invention;

c) the number and date of the first registration, the authority having issued the decision on the registration, and the mention of the product, placing on the market of which is authorised by means of this registration;

d) the duration of the certificate.

The Office shall publish the grant of the certificate in the National Bulletin.

If the application for a certificate does not meet conditions, the National Office shall invite the applicant to remedy the deficiencies within a set time limit. If the applicant fails to complete the application within the set time limit, the National Office shall terminate the procedure; the applicant shall be notified about this consequence.

If conditions for the grant of the certificate are not met the application a certificate shall be rejected.


Subject-matter and effects of the certificate

Within the limits of the protection conferred by the basic patent, the protection by the certificate shall extend to the chemical substance or a combination of substances, micro-organism or a combination of micro-organisms, which represent the active substance of the registered product, as well as to every use of the subject-matter of the patent as a medicament or plant protection product, which was authorised before the expiry of the certificate.

The certificate shall confer the same rights as conferred by the basic patent; the certificate shall be subject to the same limitations and the same obligations.


Duration of the certificate

The certificate shall take effect for a period equal to the period, which elapsed between the filing date of the basic patent application and the date of the first registration enabling to place the product on the market in the Contracting State as a medicament or plant protection product, reduced by 5 years, but at most 5 years from the date, on which the certificate takes effect.

The certificate shall take effect after the expiry of the lawful term of the basic patent.

For maintaining the certificate, the proprietor shall pay yearly administrative fees according to the special regulations.

Rights of third persons who started, after the lapse of time for payment of the fee for maintenance of a certificate in force, to use the invention in good faith or performed serious and effective preparations for such use, shall not be affected by payment of this fee within additional period of time.


Lapse of the certificate

The certificate shall lapse

a) by expiry of its duration period;

b) if its proprietor surrenders it;

c) if its proprietor does not pay administrative fees for maintaining the certificate in force;

d) if the product may no longer be placed on the market following the revocation or expiry of the registration;

e) by revocation of the certificate.

The Office shall record the lapse of the certificate to the National Patent Register and announce it in the National Bulletin.


Revocation of the certificate

The National Office shall revoke the certificate, if

a) the conditions for its grant have not been met;

b) the basic patent has lapsed before its duration term;

c) the basic patent has been revoked or limited to the extent that the substance, for which the certificate was granted, is no longer protected by the basic patent; it shall apply also in case of the basic patent revocation, which occurred after its lapse.

The request for revocation of the certificate may also be submitted after the lapse of the basic patent under, if the applicant proves his legal interest.

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Adversarial and non-adversarial proceedings

Opposition, limitation or revocation procedure

At the request of the proprietor, the European patent may be revoked or be limited by an amendment of the claims. The request shall be filed with the European Patent Office in accordance with the Implementing Regulations. It shall not be deemed to have been filed until the limitation or revocation fee has been paid.

The request may not be filed while opposition proceedings in respect of the European patent are pending.

The European Patent Office shall examine whether the requirements laid down in the Implementing Regulations for limiting or revoking the European patent have been met. If the European Patent Office considers that the request for limitation or revocation of the European patent meets these requirements, it shall decide to limit or revoke the European patent in accordance with the Implementing Regulations. Otherwise, it shall reject the request. The decision to limit or revoke the European patent shall apply to the European patent in all the Contracting States in respect of which it has been granted. It shall take effect on the date on which the mention of the decision is published in the European Patent Bulletin. 

If the European patent is limited, the European Patent Office shall publish the amended specification of the European patent as soon as possible after the mention of the limitation has been published in the European Patent Bulletin.

Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. The opposition shall apply to the European patent in all the Contracting States in which that patent has effect. Opponents shall be parties to the opposition proceedings as well as the proprietor of the patent. Where a person provides evidence that in a Contracting State, following a final decision, he has been entered in the patent register of such State instead of the previous proprietor, such person shall, at his request, replace the previous proprietor in respect of such State.

Opposition may only be filed on the grounds that: 

(a) the subject-matter of the European patent is not patentable;

(b) the European patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

If the opposition is admissible, the Opposition Division shall examine, in accordance with the Implementing Regulations, whether at least one ground for opposition prejudices the maintenance of the European patent. During this examination, the Opposition Division shall invite the parties, as often as necessary, to file observations on communications from another party or issued by itself.

If the Opposition Division is of the opinion that at least one ground for opposition prejudices the maintenance of the European patent, it shall revoke the patent. Otherwise, it shall reject the opposition. 

If the Opposition Division is of the opinion that, taking into consideration the amendments made by the proprietor of the European patent during the opposition proceedings, the patent and the invention to which it relates 

(a) meet the requirements of this Convention, it shall decide to maintain the patent as amended, provided that the conditions laid down in the Implementing Regulations are fulfilled; 

(b) do not meet the requirements of this Convention, it shall revoke the patent. 

If the European patent is maintained as amended, the European Patent Office shall publish a new specification of the European patent as soon as possible after the mention of the opposition decision has been published in the European Patent Bulletin.

Each party to the opposition proceedings shall bear the costs it has incurred, unless the Opposition Division, for reasons of equity, orders, in accordance with the Implementing Regulations, a different apportionment of costs. 

The procedure for fixing costs shall be laid down in the Implementing Regulations. Any final decision of the European Patent Office fixing the amount of costs shall be dealt with, for the purpose of enforcement in the Contracting States, in the same way as a final decision given by a civil court of the State in which enforcement is to take place. Verification of such decision shall be limited to its authenticity. 

Any third party may, in accordance with the Implementing Regulations, intervene in opposition proceedings after the opposition period has expired, if the third party proves that  

(a) proceedings for infringement of the same patent have been instituted against him, or 

(b) following a request of the proprietor of the patent to cease alleged infringement, the third party has instituted proceedings for a ruling that he is not infringing the patent. 

An admissible intervention shall be treated as an opposition. 

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European Patent Validation

Effects of the European patent in Contracting State

The patent granted by the European Patent Office shall have the same effects, as the national patents granted in Contracting states.

The European patent shall have the effects in the Contracting State as from the date, when the grant of the European patent was announced in the European Patent Bulletin.

The proprietor of the patent shall be obliged to

  • submit to the Office the translation of the patent specification to the national language within 3 months since this date, and

  • to pay the administrative fee for the publication

In the same time, the proprietor of the patent shall be obliged to

  • submit to the Office the address in the Contracting State, where the official notifications concerning his patent are to be sent.


The Office shall announce the grant of the European patent in the Bulletin and publish the translation of the European patent specification.

If the translation of the European patent specification to the national language is not submitted within the period specified above, the proprietor of the European patent may submit it in the additional time limit of 3 months, provided that he will pay the administrative fee according to the special regulation.

If the translation of the European patent specification to the national language is not submitted even within the additional time limit according to the above paragraph, the European patent shall be considered in the Contracting State as null and void from the outset.

After the announcement of the grant of the European patent in the European Patent Bulletin, the Office shall enter the European patent to the National Register of European patents with the data.


Extent of protection from the European patent

The text of the European patent in the language of the proceedings before the European Patent Office shall be decisive for the determination of the extent of protection conferred by the European patent; nevertheless, if the extent of protection conferred by the translation of the patent specification, submitted to the National Office of the Contracting State is narrower than in the language of proceedings, third parties can refer to this translation.

The proprietor of a European patent is entitled to submit to the Office the corrected translation of the European patent specification to the national language. The corrected translation shall have effects instead of the original translation as from the publication of the corrected translation by the National Office; the proprietor of the European patent shall pay the fee for the publication according to special regulations.

The rights of third persons, which on the territory of the Contracting State in good faith have used or have realised serious and effective preparations to use the subject-matter, which pursuant to the translation valid in the period before the publication of the corrected translation by the National Office was not covered by the extent of this European patent, are not affected by the delivery of the new translation.


Prohibition of the simultaneous protection

If the national patent is granted to the invention, to which the European patent has been granted with the same right of priority to the same proprietor of the patent or his successor in title, the national patent shall cease to have effect to the extent that it is identical with the European patent, from the date, on which the period for filing the notice of opposition to the European patent expires without such notice being filed, or the date of entry into force of the decision, by which the European patent has been maintained in the opposition proceedings.

The national patent shall not have effects to the extent that it is identical with the European patent, if it was granted after the expiry of the period for filing the notice of opposition to the European patent without such notice being filed, or after the date of entry into force of the decision, by which the European patent has been maintained in the opposition proceedings.

The provisions mentioned in the above two paragraphs shall not be affected by the revocation of the European patent.

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European Patent

Term of the European patent

The term of the European patent shall be 20 years from the date of filing of the application.

Nothing in the preceding paragraph shall limit the right of a Contracting State to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents: 

(a) in order to take account of a state of war or similar emergency conditions affecting that State; 

(b) if the subject-matter of the European patent is a product or a process for manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State. 

It shall apply mutatis mutandis to European patents granted jointly for a group of Contracting States.


Rights conferred by a European patent

A European patent shall confer on its proprietor from the date on which the mention of its grant is published in the European Patent Bulletin, in each Contracting State in respect of which it is granted, the same rights as would be conferred by a national patent granted in that State.

If the subject-matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process.

Any infringement of a European patent shall be dealt with by national law. 

The European patent application and the resulting European patent shall be deemed not to have had, from the outset to the extent that the patent has been revoked or limited in opposition, limitation or revocation proceedings.


Extent of protection

The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.

For the period up to grant of the European patent, the extent of the protection conferred by the European patent application shall be determined by the claims contained in the application as published. However, the European patent as granted or as amended in opposition, limitation or revocation proceedings shall determine retroactively the protection conferred by the application, in so far as such protection is not thereby extended.

In any designated Contracting State a European patent application and a European patent shall have with regard to a national patent application and a national patent the same prior right effect as a national patent application and a national patent. A national patent application and a national patent in a Contracting State shall have with regard to a European patent designating that Contracting State the same prior right effect as if the European patent were a national patent. Any Contracting State may prescribe whether and on what terms an invention disclosed in both a European patent application or patent and a national application or patent having the same date of filing or, where priority is claimed, the same date of priority, may be protected simultaneously by both applications or patents. 

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