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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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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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Examination of European patent application

In proceedings before it, the European Patent Office shall examine the facts of its own motion; it shall not be restricted in this examination to the facts, evidence and arguments provided by the parties and the relief sought. The European Patent Office may disregard facts or evidence which are not submitted in due time by the parties concerned.

In proceedings before the European Patent Office the means of giving or obtaining evidence shall include the following: 

(a) hearing the parties; 

(b) requests for information; 

(c) production of documents; 

(d) hearing witnesses; 

(e) opinions by experts; 

(f) inspection; 

(g) sworn statements in writing.

The European Patent Office may, in accordance with the Implementing Regulations, invite the applicant to provide information on prior art taken into consideration in national or regional patent proceedings and concerning an invention to which the European patent application relates. If the applicant fails to reply in due time to an invitation, the European patent application shall be deemed to be withdrawn.

The European Patent Office shall examine, in accordance with the Implementing Regulations, whether the application satisfies the requirements for the accordance of a date of filing.

If a date of filing cannot be accorded, the application shall not be dealt with as a European patent application.

If the European patent application has been accorded a date of filing, the European Patent Office shall examine, in accordance with the Implementing Regulations as well as any other requirement laid down in the Implementing Regulations.

Where the European Patent Office in carrying out the examination notes that there are deficiencies which may be corrected, it shall give the applicant an opportunity to correct them.

If any deficiency noted in the examination is not corrected, the European patent application shall be refused unless a different legal consequence is provided for by this Convention. Where the deficiency concerns the right of priority, this right shall be lost for the application.

The European Patent Office shall, in accordance with the Implementing Regulations, draw up and publish a European search report in respect of the European patent application on the basis of the claims, with due regard to the description and any drawings.

The European Patent Office shall, in accordance with the Implementing Regulations, examine on request whether the European patent application and the invention to which it relates meet the requirements of this Convention. The request shall not be deemed to be filed until the examination fee has been paid.

If no request for examination has been made in due time, the application shall be deemed to be withdrawn.

If the examination reveals that the application or the invention to which it relates does not meet the requirements of the Convention, the Examining Division shall invite the applicant, as often as necessary, to file his observations and to amend the application.

If the applicant fails to reply in due time to any communication from the Examining Division, the application shall be deemed to be withdrawn.

An applicant claiming priority shall file a copy of the results of any search carried out by the authority with which the previous application was filed together with the European patent application, in the case of a Euro-PCT application on entry into the European phase, or without delay after such results have been made available to him. The copy shall be deemed to be duly filed if it is available to the European Patent Office and to be included in the file of the European patent application under the conditions determined by the President of the European Patent Office. The European Patent Office may invite the applicant to provide, within a period of two months, information on prior art.

Proceedings before the European Patent Office shall be interrupted: 

(a) in the event of the death or legal incapacity of the applicant for or proprietor of a European patent or of the person authorised by national law to act on his behalf. To the extent that the above events do not affect the authorisation of a representative as appointed, proceedings shall be interrupted only on application by such representative;

(b) in the event of the applicant for or proprietor of a patent, as a result of some action taken against his property, being prevented by legal reasons from continuing the proceedings; 

(c) in the event of the death or legal incapacity of the representative of an applicant for or proprietor of a patent, or of his being prevented for legal reasons resulting from action taken against his property from continuing the proceedings. 

When, in the cases, the European Patent Office has been informed of the identity of the person authorised to continue the proceedings, it shall notify such person and, where applicable, any third party, that the proceedings will be resumed as from a specified date.

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Filing of a European patent application

In proceedings before the European Patent Office, documents may be filed by delivery by hand, by postal services or by means of electronic communication. The President of the European Patent Office shall lay down the details and conditions and, where appropriate, any special formal or technical requirements for the filing of documents. In particular, he may specify that confirmation must be supplied. If such confirmation is not supplied in due time, the European patent application shall be refused; documents filed subsequently shall be deemed not to have been received.

Where the Convention provides that a document must be signed, the authenticity of the document may be confirmed by handwritten signature or other appropriate means the use of which has been permitted by the President of the European Patent Office. A document authenticated by such other means shall be deemed to meet the legal requirements of signature in the same way as a document bearing a handwritten signature which has been filed in paper form.

A European patent application may be filed: 

(a) with the European Patent Office, or 

(b) if the law of a Contracting State so permits with the central industrial property office or other competent authority of that State. Any application filed in this way shall have the same effect as if it had been filed on the same date with the European Patent Office.

The central industrial property office of a Contracting State shall forward to the European Patent Office any European patent application filed with it or any other competent authority in that State, in accordance with the Implementing Regulations. A European patent application the subject of which has been made secret shall not be forwarded to the European Patent Office. A European patent application not forwarded to the European Patent Office in due time shall be deemed to be withdrawn. 

A European divisional application shall be filed directly with the European Patent Office in accordance with the Implementing Regulations. It may be filed only in respect of subject-matter which does not extend beyond the content of the earlier application as filed; in so far as this requirement is complied with, the divisional application shall be deemed to have been filed on the date of filing of the earlier application and shall enjoy any right of priority. All the Contracting States designated in the earlier application at the time of filing of a European divisional application shall be deemed to be designated in the divisional application.

European patent applications may be filed in writing with the European Patent Office in Munich, The Hague or Berlin, or the National authorities. The authority with which the European patent application is filed shall mark the documents making up the application with the date of their receipt, and issue without delay a receipt to the applicant including at least the application number and the nature, number and date of receipt of the documents. 

If the European patent application is filed with an authority, such authority shall without delay inform the European Patent Office of the receipt of the application, and, in particular, of the nature and date of receipt of the documents, the application number and any priority date claimed.

Upon receipt of a European patent application forwarded by the central industrial property office of a Contracting State, the European Patent Office shall inform the applicant accordingly, indicating the date of its receipt. 

The applicant may file a divisional application relating to any pending earlier European patent application. 

A divisional application shall be filed in the language of the proceedings for the earlier application. If the latter was not in an official language of the European Patent Office, the divisional application may be filed in the language of the earlier application; a translation into the language of the proceedings for the earlier application shall then be filed within two months of the filing of the divisional application. The divisional application shall be filed with the European Patent Office in Munich, The Hague or Berlin. The filing fee and search fee shall be paid within one month of filing the divisional application. If the filing fee or search fee is not paid in due time, the application shall be deemed to be withdrawn. The designation fee shall be paid within six months of the date on which the European Patent Bulletin mentions the publication of the European search report drawn up in respect of the divisional application.

The filing fee and search fee shall be paid within one month of filing the European patent application. The Rules relating to Fees may provide for an additional fee as part of the filing fee if the application comprises more than 35 pages. The additional fee shall be paid within one month of filing the European patent application or one month of filing the first set of claims or one month of filing the certified copy, whichever period expires last.

The designation fee shall be paid within six months of the date on which the European Patent Bulletin mentions the publication of the European search report. Where the designation fee is not paid in due time or the designations of all the Contracting States are withdrawn, the European patent application shall be deemed to be withdrawn.

The date of filing of a European patent application shall be the date on which the documents filed by the applicant contain: 

(a) an indication that a European patent is sought; 

(b) information identifying the applicant or allowing the applicant to be contacted; and 

(c) a description or reference to a previously filed application. 

A reference to a previously filed application shall state the filing date and number of that application and the Office with which it was filed. Such reference shall indicate that it replaces the description and any drawings.

Where the application contains a reference, a certified copy of the previously filed application shall be filed within two months of filing the application. Where the previously filed application is not in an official language of the European Patent Office, a translation thereof in one of these languages shall be filed within the same period.

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Applying for European Patent

General requirements

Persons entitled to apply for and obtain a European patent

A European patent application may be filed by any natural or legal person, or anybody equivalent to a legal person by virtue of the law governing it. 

A European patent application may also be filed either by joint applicants or by two or more applicants designating different Contracting States.

The inventor shall have the right, vis-à-vis the applicant for or proprietor of a European patent, to be mentioned as such before the European Patent Office. 

The right to a European patent shall belong to the inventor or his successor in title. If the inventor is an employee, the right to a European patent shall be determined in accordance with the law of the State in which the employee is mainly employed; if the State in which the employee is mainly employed cannot be determined, the law to be applied shall be that of the State in which the employer has the place of business to which the employee is attached.

If two or more persons have made an invention independently of each other, the right to a European patent therefor shall belong to the person whose European patent application has the earliest date of filing, provided that this first application has been published.

In proceedings before the European Patent Office, the applicant shall be deemed to be entitled to exercise the right to a European patent.

If by a final decision it is adjudged that a person other than the applicant is entitled to the grant of the European patent, that person may, in accordance with the Implementing Regulations: 

(a) prosecute the European patent application as his own application in place of the applicant; 

(b) file a new European patent application in respect of the same invention; or 

(c) request that the European patent application be refused.

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