Patents

The main source of patent law in Romania is the Romanian Patent Law (64 11 October 1991) and the implementing regulations enacted by the Romanian government in 2008. Other important sources of patent law are the international treaties to which Romania is a party (including the European Patent Convention) and EU law (eg, the Supplementary Protection Certificate Regulation ((EC) 469/2009) and the IP Enforcement Directive (2004/83/EC)).

As Romania is a civil law country, case law is not a source of law and thus is not binding for the courts; but it can be used as persuasive authority.

A patent can be registered by the inventor or his or her successor in title.

A patent grants the owner the exclusive right to exploit the invention and to exclude others from:

• where the invention is a product, making, using, offering for sale or selling the product, or importing it with a view to using, offering for sale or selling it; and
• where the invention is a process, using the process or using, offering for sale, selling or importing products obtained directly by that process.

The patent owner can enforce its rights through civil and criminal proceedings. In terms of civil proceedings, it can submit not only a patent infringement claim, but also a preliminary injunction claim, if it wants to obtain urgent and temporary measures until resolution of the infringement claim. In addition, under the EU Customs Regulation (608/2013), the patent owner can request the customs authorities to detain or suspend the release of potentially infringing goods.

Provided that the maintenance fees are paid, patents are generally enforceable for 20 years from the filing date. See also question 3.6 for cases in which the patent term can be extended.

The patent application can be submitted to the State Office for Inventions and Trademarks (SOIT) for national patents or to the European Patent Office (EPO) for European patents designating Romania as one of the member states for which protection is sought.

The SOIT fees from filing to registration are around €700, which comprise:

• the filing fee (€30 for a hard-copy filing and €20 for an electronic filing);
• the application publication fee (€100 if publication is sought within 18 months of the filing date and €50 if publication will occur thereafter);
• the examination fee (€500 if the examination is to be conducted within 18 months of the filing date and €300 if it will be conducted within 18 months of the payment date); and
• the patent publication fee (€100).

Additional fees are owed if the patent has more than five claims and/or if the patent specifications, claims and drawings exceed 20 pages. The fees may be reduced if the applicant meets certain criteria provided by law. Also, once granted, annual renewal fees are payable to SOIT starting from the third year of protection, which must be paid retroactively if the patent is granted at least three years after the filing date.

A patent application may be dismissed by SOIT on grounds such as the following:

• The patent lacks novelty;
• The patent lacks inventive step;
• The patent lacks industrial applicability;
• The subject matter is not considered an invention or is excluded from patentability;
• The patent application 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;
• The patent application was submitted by someone who is not entitled to it;
• Where the patent specification, claims and drawings were submitted in a foreign language, a Romanian translation was not submitted;
• The applicant did not comply with the notices sent by SOIT; or
• A foreign applicant failed to designate a Romanian representative.

The applicant may accelerate the patent application by requesting SOIT to accelerate its publication. The request need not be reasoned, but an additional fee is payable. The patent application will be published within four months of the filing date (as opposed to the normal term of 18 months).

In addition, the applicant may request the acceleration of the examination term upon payment of an additional fee. In such case, the examination will be performed within 18 months of the filing date.

Romania is not participating in the global Patent Prosecution Highway (PPH) programme and thus it is not possible to have a fast-track examination from this perspective.

There are no limitations on the formats of claims that may be included in a patent application. However, as discussed in question 3.7, claims directed to certain types of subject matter, such as methods of medical treatment, are not patentable in Romania. The patent examiners within SOIT follow the European Patent Office Guidelines for examination in this respect.

In the case of patents for medicinal or plant protection products, the term can be extended by means of a supplementary protection certificate (SPC) under EU Regulations 1610/1996, 1901/2006 and 469/2009. The extension corresponds to the period necessary to obtain the marketing authorisation, but cannot exceed five years (an additional six-month extension is available if the SPC relates to a paediatric medicine).

A patent can be granted for any invention whose subject matter is a product or a process, in any field of technology, provided that it is new, involves an inventive step and is capable of industrial application.

Non-patentable subject matter includes:

• discoveries, scientific theories and mathematical methods;
• aesthetic creations;
• schemes, rules and methods for performing mental acts, playing games or doing business, and computer programs;
• presentation of information;
• inventions whose exploitation would be contrary to public policy or morality, or which are harmful to human, animal or plant life and health, or substantially harmful to the environment;
• plant or animal varieties or essentially biological processes for the production of plants or animals, except for microbiological processes or the products thereof;
• the human body in its different formation and development stages, as well as the mere discovery of one of its elements, including the total or partial sequence of a gene; and
• methods for treatment of the human or animal body by surgery or therapy and diagnostic methods (except for substances or compositions for use in any of these methods).

In terms of biotechnological inventions, the following subject matter is patentable:

• biological material which is isolated from its natural environment or produced by means of a technical process, even if it previously occurred in nature;
• plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;
• a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety; and
• 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.

Decisions of the Examination Board can be challenged before the Patent Office Board of Appeals within three months of communication. Decisions of the Board of Appeals can be challenged at the Bucharest Tribunal within 30 days of communication. Decisions of the Bucharest Tribunal can be appealed to the Bucharest Court of Appeals within 30 days of communication.

A patent’s validity can be challenged in post-grant proceedings before the State Office for Inventions and Trademarks (SOIT) or in court.

A patent’s validity can be challenged before SOIT by means of a request for revocation or before the Bucharest Tribunal by means of a request for annulment. In addition, the patent’s validity can be challenged in court by means of a counterclaim submitted by the defendant in infringement proceedings.

A patent can be invalidated on the following grounds:

• The patent lacks novelty;
• The patent lacks inventive step;
• The subject matter is not considered an invention or is excluded from patentability;
• The patent lacks industrial applicability;
• The 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;
• Matter has been added to the patent since grant; or
• The patent was granted to someone who is not entitled to it.

There are no formal rules on evidentiary standards and the courts may assess the evidence produced by the parties as they deem fit. In invalidity proceedings, the burden of proof lies with the party claiming the lack of validity, which must provide conclusive evidence in this regard.

A third party may challenge the validity of the patent by any of the means discussed in question 4.2 (revocation proceedings before SOIT/annulment proceedings in court).

Any party with a legitimate, actual and personal interest can submit a revocation request.

A third party may request SOIT to revoke a decision to grant a patent within six months of publication in the Official Bulletin.

The grounds for revocation of the patent before SOIT are as follows:

• The patent lacks novelty;
• The patent lacks inventive step;
• The subject matter is not considered an invention or is excluded from patentability;
• The patent lacks industrial applicability;
• The 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; or
• Matter has been added to the patent since grant.

SOIT may revoke the patent (in whole or in part) or maintain it either as granted or in amended form if the owner files a request for limitation of the patent during the revocation proceedings.

In the revocation proceedings, the burden of proof lies with the party seeking revocation of the patent. There are no formal rules on evidentiary standards and SOIT’s Board of Appeal may assess the evidence produced by the parties as they deem fit.

Decisions issued by SOIT in revocation proceedings can be challenged at the Bucharest Tribunal within 30 days of communication. Decisions of the Bucharest Tribunal can be appealed at the Bucharest Court of Appeals within 30 days of communication. In both cases the decisions can be challenged/appealed on all of their aspects (factual and legal).

A patent may become unenforceable if:

• the term of the patent has expired;
• the patent is revoked; or
• the patent ceases to have effect due to non-payment of the renewal fee.

There are no provisions on inequitable conduct in Romanian patent law.

Romanian patent law does not provide for a duty of candour.

Any of the following acts performed without the owner’s consent constitute patent infringement:

• where the invention is a product, making, using, offering for sale or selling the product, or importing it into Romania with a view to using, offering for sale or selling it; and
• where the invention is a process, using the process, or using, offering for sale, selling or importing into Romania products obtained directly by that process.

The law provides that, for the purpose of determining the extent of protection conferred by a patent, due account will be taken of any element which is equivalent to an element expressed in the claims. An element is deemed equivalent to an element expressed in the claim if it is obvious to a person skilled in the art that by using such element, essentially the same result would be achieved as that achieved by means of the element expressed in the claim.

In order for a party to be liable for infringement of a Romanian patent, an infringing act must have taken place in Romania. However, in view of the Brussels I Regulation, the Romanian courts will have jurisdiction to hear a claim regarding a party’s illicit acts performed abroad; but to this end, the patent must be protected in that other jurisdiction and the acts in question must amount to patent infringement in that jurisdiction.

Romanian patent law contains no specific provisions on wilful infringement. Also, there are no additional remedies against wilful infringement.

An infringement claim can be brought by the patent owner or by a licensee, with the owner’s consent. An exclusive licensee can submit an infringement claim without the owner’s consent if it informed the owner of the infringing acts and the latter did not take legal action within the specified timeframe.

Patent infringement actions (aimed at cessation of the infringement) can be brought for as long as the infringement lasts. Claims for damages, however, are subject to a three-year limitation period from the date on which the claimant knew or should have known of the damage and the person liable for it (the infringer).

The statement of claim by which a suit is initiated should contain:

• the names, addresses and other identification details of the parties and their representatives;
• the relief sought;
• the estimated value of the claim;
• the factual and legal grounds on which the claim is based (including the claimant’s patent rights and the defendant’s actions that are alleged to constitute patent infringement); and
• the evidence on which the claimant intends to rely.

The claimant must submit, together with its statement of claim:

• the written evidence on which it intends to rely and Romanian translations thereof; and
• the names and addresses of the witnesses.

A prior cease and desist letter is common practice, but is not mandatory.

Romania does not have specialised IP/patent courts. Thus, patent infringement cases are heard within the civil court system, under the general jurisdiction rules. Claims can be brought before tribunals where the financial value of the claim exceeds RON 200,000 and before the municipal courts otherwise.

The claimant has a choice between courts from a territorial perspective only. Thus, the patent infringement claim can be submitted either at the court of the defendant’s domicile or at the court of the place where the infringement was committed or where the damage resulted.

The courts must have:

• general jurisdiction – the Romanian courts have general jurisdiction if the patent infringement occurred in Romania or if the defendant is domiciled in Romania;
• subject-matter jurisdiction – as discussed in question 6.8, tribunals have subject-matter jurisdiction if the financial value of the claim exceeds RON 200,000; in the other cases, subject-matter jurisdiction belongs to the municipal courts; and
• territorial jurisdiction – as discussed in question 6.8, the courts have territorial jurisdiction if the defendant’s domicile or the place where the infringement was committed or where the damage was produced is located within the court’s geographical area.

The judge determines the facts of the case. He or she may appoint an expert to provide clarification on the technical issues of the case.

No, the fact finder will always be the judge.

Prior to trial, three submissions will be filed (statement of claim, statement of defence and answer to statement of defence). Additional briefs can and usually are filed, but are not mandatory. The parties must file all evidence on which they intend to rely, together with the statement of claim and statement of defence. Additional evidence will be accepted only under certain conditions. All documents must be translated into Romanian.

The trial takes place as a series of hearings over the course of two to four years, involving the following steps:

• The parties will briefly present their oral arguments on the objections and the court will rule on them.
• Witnesses will be examined and cross-examined under oath.
• The parties will propose questions/objectives for the expert report; the court can accept the questions as they have been proposed by the parties or in amended form, or can ask its own questions.
• Following submission of the expert report, the parties will present their objections to the report; if they are accepted by the court, additional questions will be sent to the expert.
• The parties will briefly present their oral arguments on the merits, by report to the evidence submitted in the case.

The patent owner can obtain the following remedies:

• preliminary or permanent injunctions to cease the infringement;
• damages;
• disclosure of sales, names and addresses of producers, distributors, suppliers and so on;
• destruction of infringing goods and the materials and means used to produce them;
• recall and removal of the infringing goods from the channels of distribution;
• publication of the judgment; and
• award of costs.

Patent infringements are criminal offences, which may lead to fines or imprisonment for up to two years.

A first instance judgment in infringement proceedings can be appealed on all of its aspects (factual and legal). The appeal decision may be subject to a second appeal, which is limited to errors in the application of the law.

There are no discovery proceedings under Romanian law. However, after the commencement of the proceedings, under certain conditions, a party, a third party or a public authority may be ordered to present to the court specific documents which are relevant to the matter in dispute.

For instance, under the law implementing the Directive on the Enforcement of Intellectual Property Rights 2004/48/EC, the defendant may be compelled to provide information on the origin and distribution networks of the allegedly infringing products.

In addition, under the general rules of procedure, a party can request the court to order the opposing party to present certain documents regarding the matter in dispute. The party must identify the document(s) requested and show that these are in the possession of the opposing party.

The request will be accepted if:

• the document is mutual to both parties;
• the opposing party referred itself to that document; or
• the opposing party is obliged under the law to present the document.

The request will be dismissed if:

• the content of the document refers to strictly private issues regarding the dignity and private life of a person;
• submission of the document in court would infringe the legal duty to keep a secret (eg, professional secret); or
• submission of the document would lead to the criminal prosecution of the party, of his or her spouse or of a relative up to the third degree.

Under similar conditions, a party may request the court to order a third party or a public authority to present documents regarding the matter in dispute.

As discussed in question 7.1, a party may request the court to order an opposing party or a third party to disclose specific documents which are at that other party’s disposal. The request for disclosure must be specific and must concern documents of relevance to the matter.

See question 7.1.

The claim terms are defined/interpreted by the court in the decision rendered on the patent infringement action.

Similar to the approach of the European Patent Office, Romanian law establishes the following rules for interpretation of the patent claims:

• The extent of the protection conferred by a patent is that defined by the strict, literal meaning of the wording used in the claims. The description and drawings can be employed only for the purpose of resolving ambiguity found in the claims.
• The claims should not be interpreted in the sense that they serve only as a guideline, and the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent owner has contemplated.

The claims are to be interpreted as defining a position between these extremes, which combines fair protection for the patent owner with a reasonable degree of legal certainty for third parties.

The characteristics used in the claims shall be interpreted as having their usual meaning in the relevant technical prior art, unless the specifications provide for a different meaning.

For the interpretation of the patent claims, the court may take into consideration the patent specifications and the drawings. In principle, the issue of claim interpretation is a question of law for the court. However, if, to interpret the claims, the court needs clarifications on certain technical issues, it can appoint an expert in order to provide such technical clarifications. In addition, depending on the circumstances of the case, written evidence may be taken into consideration – for example, in order to determine the commonly recognised meaning of that term in the technical field of the patent.

Yes. Both preliminary and permanent injunctions are available.

Preliminary injunctions are available both before and after the commencement of the main proceedings. They have effect until the resolution of the main proceedings and aim to prevent infringement of the patent during the litigation.

As regards permanent injunctions, if in the main proceedings the court determines that the patent has been infringed, it can then grant an injunction prohibiting any further infringement.

A preliminary injunction is granted if:

• there is a prima facie patent infringement;
• there is urgency (ie, the need for an urgent decision to avoid a harm that would be difficult to repair);
• the measures requested by the claimant are temporary; and
• the issuance of the preliminary injunction does not prejudice the merits of the infringement claim.

The court may order the claimant to submit a bond if the measures requested by it are likely to cause damage to the defendant; but there is no mandatory requirement in this respect. Usually, the courts order the submission of a bond if the defendant makes a request in this respect and proves the likelihood of its damage.

A permanent injunction is granted following a finding that the defendant has committed patent infringement (eg, where the object of the patent is a product, it must be proved that the defendant’s product realises all the features of the patent claim and that the defendant has committed one of the acts that constitute patent infringement under the law – see question 2.1). The court will not assess the validity of the patent in an infringement claim, unless the defendant submits a counterclaim seeking annulment of the patent.

Yes, damages are available.

In line with the Directive on the Enforcement of IP Rights (2004/48/EC), Romanian law provides that damage assessment should take into account all appropriate aspects, such as the claimant’s lost profits, any unfair profits made by the infringer and so on. As an alternative, damages may be set as a lump sum on the basis of elements such as at least the amount of royalties which would have been due had the infringer obtained a patent licence.

Punitive damages are not available.

See question 9.2.

No, damages in Romania are intended to compensate the patent owner for the loss that it suffered as a result of the infringement. Punitive damages are not available.

Sanctions are available in criminal proceedings. In civil proceedings, sanctions are available if the parties do not observe their obligations throughout the proceedings.

From a criminal law perspective, patent infringements are criminal offences, which may be sanctioned with fines or imprisonment for up to two years.

In civil proceedings, if a party does not observe its procedural obligations throughout the proceedings, the court can order it to pay a fine. In addition, if the claimant does not comply with the obligations set by the court, the latter can stay the proceedings until the claimant fulfils its obligations; if the claimant does not fulfil its obligations within six months of the date on which the court ordered the stay of the proceedings, the case will be closed due to lack of activity.

If an injunction has been granted and the defendant does not comply with it, and the injunction cannot be enforced and the obligations fulfilled by another person at the defendant’s expense, the court may order the defendant to pay penalties. In addition, non-compliance with a court judgment can constitute a criminal offence, which may lead to fines or imprisonment for up to two years.

Yes, the successful party can be awarded litigation costs, including attorneys’ fees. However, as further discussed in question 9.10, the court may reduce the costs granted for attorneys’ fees.

If the successful party has not succeeded in all aspects of the case, the costs will be granted in proportion to its degree of success. In addition, the court may reduce the costs granted for attorneys’ fees if they are disproportionate to the litigation’s value or complexity, the attorney’s work throughout the proceedings and other circumstances of the case.

The patent owner can license any or all its rights under the patent (ie, making, selling, using, offering for sale or importing the patented invention). In addition, the licensed rights can relate to the entire Romanian territory or only part thereof.

The rights obtained by a licensee will also depend on the type of licence that is granted:

• Under an exclusive licence, the licensee has exclusive rights to use the invention, which means that the licensor may not grant any other licences and, if the licence agreement expressly so provides, use the invention itself. An exclusive can bring patent infringement proceedings without the owner’s consent if it informed the owner about the infringing acts and the latter did not take legal action within the requested deadline.
• In the case of a non-exclusive licence, the licensee has the right to use the invention, but the licensor may grant as many other licences as it wishes to other parties and may use the invention itself.

There are no specific provisions with respect to the limits that a patent owner can impose on a licence. Thus, in principle, the patent owner is free to establish the licence terms as it sees fit. It can impose several limitations on a licence – for example, by:

• limiting the scope of the licence to part of Romania’s territory and to a period less than the lifetime of the patent;
• offering an exclusive or non-exclusive licence;
• restricting the licensee’s right to sub-license the patent; and
• establishing how the licensed rights may be exercised.

However, competition rules apply and, as a consequence, any terms in a licence agreement which result in a restriction of competition might be prohibited (eg, price fixing, limitations on output, allocation of customers), subject to the exemptions in Article 101(3) of the Treaty on the Functioning of the European Union and the corresponding national provisions, and block exemption regulations.

It is possible that the exercise of patent rights may, in certain circumstances, amount to anti-competitive conduct contrary to Articles 101 and 102 of the Treaty on the Functioning of the European Union.

In addition, in case of a patent essential to a standard established by a standardisation body, a defence based on antitrust law could be invoked to prevent relief for patent infringement being granted in the conditions set forth by the Court of Justice of the European Union in its Huawei decision (Case C-170/13) regarding fair, reasonable and non-discriminatory licensing. Although the Romanian courts have considered this decision in some preliminary injunction cases, to our knowledge they have not dismissed patent infringement allegations based on antitrust grounds so far.