Patents Briefing (Pharma) - Hungary

Please give details of the major acts and directives governing patents in Hungary.

• Law No XXXIII of April 1995 on the Protection of Inventions by Patents. This is available in English at http://www.hpo.hu/English/jogforras/Patent_Act_XXXIII_1995_EN.pdf.
• Law No. II of April 1969 on the Protection of Inventions by Patents (entry into force in January 1970), as amended.

Is Hungary party to any international conventions on patent protection? When did it join these conventions?

Hungary is party to the following conventions:

• Paris Convention for the Protection of Industrial Property 1883 (Paris Convention), since 1909 http://www.wipo.int/treaties/en/ip/paris/index.html;
• Patent Cooperation Treaty 1970, since June 1980 http://www.wipo.int/treaties/en/registration/pct/index.html;
• Patent Law Treaty, since June 2000 http://www.wipo.int/treaties/en/ip/plt/index.html; and
• European Patent Convention 2000, as amended (EPC 2000). The full text of the EPC 2000 can be found at: http://www.epo.org/patents/law/legal-texts/epc.html.

Which are the major bodies responsible for assessing patent applications and granting patents?

Patent applications are assessed by, and patents are granted by, the Hungarian Patent Office (HPO).

Applications for European patents may be filed with the European Patent Office (at Munich, The Hague or Berlin). Alternatively, the HPO also acts as a receiving office for European patent applications.

The HPO also acts as a receiving office for international patent applications made by Hungarian nationals or applicants domiciled in Hungary. The application may also be filed with the International Bureau of WIPO (World Intellectual Property Organization) in Geneva.

What is the procedure for obtaining patent protection? What are the key stages of the process? What fee is payable?

The key stages for obtaining patent protection are as follows:

• Filing the application and examination: An application for a patent must be filed with the HPO. The application must consist of a request for the grant of a patent, a description of the invention with one or more claims, an abstract, drawings where necessary, and any other relevant documents. Following the filing of the patent application, the HPO will examine whether (a) the application satisfies the above-mentioned requirements for according a filing date, (b) the filing and the search fee have been paid and (c) in the case of foreign applications, whether the description, the abstract and the drawings have been filed in Hungarian language. The applicant will be given 30 days to rectify any errors or inconsistencies in the application.
• Examination of the formal requirements: When the conditions above have been satisfied, the HPO will examine the application to determine whether it satisfies certain prescribed formal requirements. If any irregularities are revealed during this examination, the HPO will invite the applicant to rectify the irregularities and will continue the procedure on the basis of the rectification. Where the applicant does not reply to the invitation to rectify the irregularities within the specified time limit, the application will be considered withdrawn.
• Novelty search and publication: The HPO will then conduct a novelty search and will compose a search report on the basis of the claims and with due regard to the patent description and any drawings. The search report will indicate those documents and data which may be taken into consideration in deciding whether the invention to which the patent application relates is new and involves an inventive step. The search report, together with copies of any cited documents, will be sent by the HPO to the applicant. After the expiry of 18 months from the earliest date of priority, the HPO will publish a notice of its performance of a novelty search, together with the patent application itself, in the Gazette of Patents and Trademarks. Publication gives rise to the obligation to pay a patent protection fee. The applicant will be notified of the date of publication and the amount of the annual fee before publication. Certain documents of the published patent application are available to the public for inspection upon payment of a fee to the HPO. Provisional patent protection, having retroactive effect from the date of application, begins with the publication of the application. It will become definitive if a patent is granted to the applicant. Rights conferred by the patent can be enforced only once definitive protection has been granted.
• Substantive examination: The HPO carries out a substantive examination of the published patent application at the special request of the applicant. Substantive examination may be requested simultaneously with the filing of the patent application or within six months at the latest after the date of publication of the novelty search notice. If any irregularities are revealed during the substantive examination, the HPO will invite the applicant to rectify the irregularities, to submit comments or to divide the application (if patent protection is claimed for a group of inventions in the same application), according to the nature of the objection. A patent application will be rejected in whole or in part if it does not meet the examined requirements following the rectification of irregularities or the submitting of comments. If the applicant fails to reply to the invitation or to divide the application, they shall be considered to have relinquished the provisional patent protection. The request for a substantive examination is subject to the payment of a fee.
• Pre-grant approval: Before the grant of a patent, the HPO supplies the applicant with a copy of the text of the description, together with the claims and drawings forming the basis of the grant. The applicant should raise any objections or signal his approval of this text within three months. If the applicant approves the text or fails to submit comments, a patent will be granted on the basis of the transmitted description, claims and drawings. If the applicant proposes amendments or files a new description, claims and drawings, the HPO must decide whether these will be taken into account.
• Grant of patent: If the patent application and the invention to which it relates meet all the requirements of the examination, the HPO will grant a patent for the subject of the application. After the grant of the patent, the HPO issues a patent certificate to the patent holder.

Various fees are payable both during the application process and during the life of the patent. An up-to-date list of fees is available on the HPO’s website at www.hpo.hu/English/szabadalom/nemzeti_ut/szab_dij_2004.html.

What are the criteria for patentability?

To be capable of patent protection, an invention must:

• be new – ie it must not form part of the state of the art;
• involve an inventive step – ie having regard to the state of the art, it must not be obvious to a person skilled in the art; and
• be capable of industrial application.

Is it possible to patent a gene or a drug target?

Under Article 5(2) of EC Directive 98/44/EC:

“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.”

It must be emphasised that the rights conferred by a patent do not extend to the human body and its elements in their natural environment. Patent protection does not cover the natural substance in situ. An excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that particular DNA molecule does not occur in that isolated, purified form in nature.

The EC Directive does not specifically oblige the EU Member States to grant patents on substances (DNA sequences). Article 5 (2) of the Directive is explicit only in allowing patents on sequences of a gene or other elements identical (in substance or in structure) to parts of the human body. It follows, however, from the purpose of establishing a common framework and the preamble of the Directive, that such elements may not be excluded a priori from patentability. This conclusion is corroborated by Recital 20:

“…it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability …”

Directive 98/44/EC has been implemented without amendment in Hungary.

How long is patent protection for healthcare products?

Patent protection lasts for 20 years from the date of filing of the application.

Is it possible to gain patent extensions, eg to cover delays in registration, or for additional or paediatric indications?

The patent protection period for medicinal products can be extended by a Supplementary Protection Certificate. A Supplementary Protection Certificate (SPC) allows the holder of a patent that protects the active ingredient present in an authorised medicinal product to obtain an extension of patent protection for the active ingredient or combination of active ingredients. The relevant law concerning this extension of rights is Council Regulation (EEC) No. 1768/92.

The SPC takes effect at the end of the lawful term of the basic patent and for a duration not exceeding five years. The SPC period is calculated first by establishing the time difference between the patent application date and the date of the first marketing approval in the first EU State and then deducting five years from this figure. If the result is greater than five years, the SPC period is restricted to the maximum five-year term. Where the result is under five year, the corresponding period is granted as an extension. Where the patent application came five years or less before the first marketing approval and the result is zero or a minus figure, then no SPC is allowed.

The European Commission will grant an additional six-month SPC to organisations that devote resources to developing paediatric medications. The SPC will be granted to marketing authorisation applicants who comply fully with the paediatric study requirements and whose product is subsequently authorised in all Member States (provided that the product is covered by a patent or SPC).

Under what circumstances can a patent be revoked or invalidated?

A party can apply for a patent to be revoked on the grounds that, at the time when the patent application was approved, the subject matter of the patent or the patent application did not fulfil the criteria for patentability. The reasons that serve as the basis for revocation have to be indicated in the request for revocation. A fee is also payable.

A patent will also be revoked where the patent holder fails to pay the annual maintenance fee after the expiry of the graqce period.

Patents can also be relinquished by way of a written declaration addressed to the HPO.

Please give details of the major acts and directives governing the entry of generic versions of a drug

EC Directive 2004/27/EC changed the position on the “data exclusivity period” afforded to pharmaceuticals, with respect to generic drugs. Under the Directive, pre-clinical and clinical trials of a pharmaceutical product need not be repeated if they are to test a generic version of a product authorised in the EU which has been on the market for at least eight years. In other words, generic manufacturers are able to use experimental data of an already-approved drug, in order to apply for marketing authorisation for the generic drug, as of the eighth year.

However, the generic may not be sold in the EU until ten years have elapsed from the initial marketing authorisation. A further extension of a year applies if, during those first eight years, the original marketing authorisation holder obtains an authorisation for one or more new therapeutic indications of the product which brings a significant clinical benefit over existing therapies. This is the so-called 8+2+1 rule.

Hungary has implemented Directive 2004/27/EC, but with an important exception. It has excluded the new 8+2+1 rule. The same 8+2+1 data and marketing exclusivity periods are contained in Regulation 726/2004, which introduced changes to the centralised approval procedure and came into force on 20 November 2005. This gives rise to the possibility that in Hungary the period of data exclusivity applicable for a pharmaceutical product would depend on the authorisation procedure used, with applications via the centralised procedure subject to the 8+2+1 data exclusivity period, but applications taking the decentralised route in Hungary subject to a data exclusivity period of only six years.

Does the legislation contain a “Bolar” provision allowing generic manufacturers to prepare production and regulatory procedures before patents expire?

Article 19(6)(b) of Act XXXIII states that a patent holder’s exclusive rights of exploitation do not extend to:

“acts done for experimental purposes relating to the subject matter of the invention, including experiments and tests necessary for the registration of medicines.”

What is the process for enforcing patent infringement?

The Metropolitan Court of Budapest is the sole court of first instance in patent infringement cases; the Budapest Appeal Court hears appeals from the first instance court.

In Hungary, a defendant in a patent infringement case cannot question the validity of a patent. However, it can launch a separate nullity (invalidation) proceeding against the patent. Proceedings concerning the validity of a patent and those initiated to establish non-infringement are dealt with by the Patent Office; the parties can appeal decisions of the Patent Office to the Metropolitan Court and then to the Budapest Appeal Court.

The decisions of the Budapest Appeal Court are final and enforceable. However, if the parties feel that a substantive or procedural law has been infringed during the court proceedings, they can file a request for supervision to the Supreme Court. If the Supreme Court finds that the request is justified, it will commence supervisory proceedings.

An applicant whose invention is subject to provisional protection may also institute proceedings for patent infringement. However, the proceeding will be suspended until the decision to grant the patent has become final.

Any person believing that proceedings for patent infringement may be instituted against them may, prior to the institution of such proceedings, request a decision ruling that the product or process exploited or to be exploited by them does not infringe the particular patent specified by them. A request for a ruling on the lack of infringement can only be filed in relation to one patent.

EC Regulation 44/2001 and the Brussels and Lugano conventions on the enforcement and recognition of judgments are applicable in the UK. Accordingly, proceedings must generally be brought in the defendant’s domicile under Article 2 of EC Regulation 44/2001. However, there are exceptions to this rule. For patent infringement proceedings Article 5(3) and Article 6(1) of EU Regulation 44/2001 are of particular importance. According to Aarticle 5(3), a person domiciled in a Member State may also be sued for matters relating to tort (e.g. infringement of a patent) in the courts where the harmful event occurred. Also, according to Article 6(1), a person domiciled in a member state may be sued, when he is one of a number of defendants, in the courts where any one of them is domiciled.

Once a final judgment has been obtained in Hungary, it is in principle readily enforceable in those countries that are signatories to the EU Regulation 44/2001.

What remedies are available to the patent owner?

Remedies available include:

• a declaration of infringement by the court;
• a declaration of infringement from the infringing party. The declaration may be made public at the infringer’s own expense;
• an injunction to prevent further infringement;
• damages;
• surrender of the profits obtained by infringement of the patent;
• a request for the seizure of the means used for infringement and of the infringing products; or
• destruction or auctioning of any infringing articles.

What are the rules on compulsory licences?

The provisions on compulsory licences are contained in Chapter IV of Act No. XXXIII. Article 31 of the Act states that a compulsory licence will be granted if, within four years from the filing date of the patent application or within three years from the grant of the patent (whichever period expires last), the patent holder has not exploited the invention in Hungary to satisfy the domestic demand or if he has not undertaken serious preparations or has not granted a licence for such purpose. This will not apply, however, if the patent holder is able to justify its lack of exploitation.

An applicant for a compulsory licence must first prove that the patent holder was unwilling to grant a voluntary licence, on appropriate terms and within a reasonable period of time, and that it is able to exploit the patented invention to the required extent.

The scope and duration of a compulsory licence is established by the court, taking into account the purpose of the exploitation authorised by the compulsory licence. A compulsory licence may be granted with or without limitation and, unless relinquished or cancelled, will have effect until expiration of the term of validity fixed by the court or until the lapse of patent protection. The patent holder is entitled to adequate compensation for granting a compulsory licence.

The holder of a compulsory licence may relinquish its licence at any time. If the holder does not begin exploitation within one year from the definitive grant of the compulsory licence, the patent holder may claim modification or cancellation of the compulsory licence.

The procedural rules regarding compulsory licences are outlined in Article 104 of Law XXXIII.

As a member of the World Trade Organization (WTO), Hungary is bound by the obligations of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and, as such, the compulsory licensing provisions of TRIPS are reflected in Hungarian Law XXXIII. The agreement has been signed and ratified by Hungary and was promulgated by Law No. IX of 1998. The TRIPS agreement allows compulsory licensing as part of the agreement’s overall attempt to strike a balance between promoting access to existing drugs and promoting research and development into new drugs.

On 28 April 2006, the European Council adopted at first reading a regulation on compulsory licensing that will allow companies to produce generic copies of patented medicines in order to export them to developing countries with public health problems. The regulation sets out a number of conditions for licensees as well as guarantees for licensors, in particular that the latter are entitled to adequate remuneration, that the number of products manufactured under a compulsory licence shall not exceed the amount necessary to meet the needs of the relevant importing country, and that the products cannot generally be reimported into the EU.

Please supply details of impending changes to the legislation governing patent protection.

Hungary has enacted Law XXIII of 2009 on the accession to the London Agreement dated 17 October 2000 on the application of Article 65 of the Convention on the Grant of European Patents. The Act was published in the Official Hungarian Gazette on 30 April 2009.

The instrument of accession to the Agreement is to be deposited between 1 and 30 September 2010, whereupon its entry into force in respect of the Republic of Hungary is expected on 1 January 2011.

The London agreement dispenses with the translation requirements of the major part of a patent application so that, apart from the Claims, it only need be published in one of the main languages of the EPO (ie English, French or German).

Useful contacts

Hungarian Patent Office

H - 1054 Budapest, Garibaldi utca 2.

Hungary

Mailing address: H-1374 Budapest, Pf. 552, Hungary

Tel: [phone]

E-mail: [email protected]

http://www.hpo.hu/English/