Pages 296-331

NATIONAL JUDGES' PRESENTATIONS

RO Romania

Petre OHAN - OSIM - State Office for Inventions and Trademarks - Director of Appeal Department - Chairman of the Board of Appeal - Specific aspects with regard to administrative revocation in Romanian patent law (No. 64/1991, as amended in 2007)

1. Legal provisions regarding administrative revocation in Romanian Patent Law

1.1 Administrative revocation in the Romanian patent system

In my opinion, under the patent law (No. 64/1991, as amended in 2007), the Romanian patent system has no opposition or revocation procedure comparable to that of other patent systems.

However, under Articles 52, 53 and 56 of the patent law:

"Any interested person is entitled to apply with OSIM, in writing, on valid grounds, for the revocation of the patent, within six months of the publication of the mention of granting the patent (Article 52).

"…[T]he application for revocation, …, shall be settled within three months of registration thereof with OSIM, by a Board of Appeal within the Appeal Department of OSIM." (Article 53).

"A patent shall not be revoked …, without giving the owner the possibility to present observations concerning the revocation … and to make, in a reasonable period of time, amendments or corrections allowed by the Law" (Article 56).

So, does my assertion stand up?

The Romanian patent system actually has a combination of post-grant opposition and inter-partes appeal before the Patent Board of Appeal of the Romanian Industrial Property Office (OSIM). This procedure is called "revocation".

Typical post-grant opposition procedure in NPOs:

Revocation procedure at the OSIM:

This is because:

• any interested person (the interested party) before the OSIM has a time limit (six months) to file "the action"
• the patent owner must have the possibility to defend his patent, i.e. the type of action is an inter-partes one
• the competence to settle the action lies with the Patent Board of Appeal of the OSIM
• the Patent Board of Appeal is composed of:
• - a chairman + rapporteur + the legal member from the Appeal Department, and
• - two technically qualified members from the patent directorate
• if the action succeeds, the patent is revoked with ex tunc effect.

1.2 Cancellation

Patents granted by the OSIM, as well as European patents with effect in Romania, can be cancelled only by the Municipal Court of Bucharest (Tribunal).

The cancellation of a patent granted by the OSIM may be requested after the time limit provided for the application for revocation has elapsed (Article 55).

Taking account of this provision, the [administrative] revocation in our law is an "earlier cancellation" action within the competence of the OSIM.

As regards the relationship between European limitation proceedings and Romanian limitation and revocation proceedings, we have no experience of this so far but Romanian courts will probably decide to stay in the case of parallel proceedings.

The OSIM has no competence regarding limitation or revocation of European patents with effect in Romania.

2. The Patent Re-examining Commission (Patent Board of Appeal)

2.1. Hybrid nature of the Board of Appeal

The Patent Re-examining Commission of the State Office for Inventions and Trademarks (OSIM), as the Board of Appeal is called, is a body which performs administrative/judicial duties (administrative preliminary procedure).

This situation derives from the fact that, even though Romanian patent legislation has rules on the procedure before the Re-examining Commission (Rules 55 to 59), the provisions relating to the Board's judicial tasks are complemented "correspondingly" by the provisions of the Romanian Code of Civil Procedure.

The Board's judicial character becomes more evident in inter-partes cases and is highlighted by the possibility that a party can be represented not only by a professional representative (patent attorney) but also by an attorney at law.

2.2 Composition of the Board

In revocation and limitation cases, the Board consists of:

(a) the chairman – the Director-General of the OSIM or, by delegation of competence, the Director of the Appeal Department

(b) the rapporteur, a technically qualified member from the Appeal Department

(c) two technically qualified members, examiners from an examination division, who have at least five years' experience each

(d) a legally qualified member from the Appeal Department.

The composition of the Board reflects the nature of the action (a combination of opposition and appeal).

3. Procedural aspects in limitation and revocation

The Board acts as a second instance in applications for limitation cases and as first instance in revocation cases.

Appeal procedures consist in two stages: written and oral.

3.1 One-step written stage

The written proceedings consist in:

• written application, service of the application on the defendant,
• written observations of the defendant (defence), service of the observations to the appellant.

Only written documents are accepted as proof. Witness depositions are not admissible, but notary statements are accepted.

Any interested party may, in accordance with the Romanian Code of Civil Procedure, intervene in the revocation proceedings.

3.2 Oral proceedings for all cases

Under the law, the Board of Appeal must make provision for a hearing for each case before it takes a decision.

In each case, the examining commission (Patent Directorate) presents its point of view in respect of the appellant's/parties' arguments.

3.3 Dealing with exceptions first

Under Article 127 Civil Procedure Code, in order to expedite the proceedings, the Board of Appeal, before dealing with the merits of the case, ex officio or at the parties' request, will deal first with the exceptions.

The most frequent exceptions the Board have to consider are:

• late-filed request
• missing fee or wrong payment fee
• lack of interest.

3.4 Further appeal

The substantiated decision of the Board of Appeal is communicated to the parties within 15 days of pronouncement and may be appealed before the Court of Bucharest within 30 days of communication.

The decision on revocation is published in the Official Industrial Property Bulletin.

For technical reasons, the images embedded in this article are only available in the PDF version.

The decision on revocation procedure is taken by vote. In the majority of cases there are unanimous decisions, but a few decisions have been taken by a majority of votes. In these cases, according to the Code of Civil Procedure, dissenting opinions are also recorded and clearly taken into consideration in the written decision. So there is a transparent decision process, all members having the right to put forward their opinion. The outcome of a Board of Appeal's decision is published in the Official Industrial Property Bulletin.

If the Board of Appeal decides to keep the patent with some amendments, a new (amended) patent specification is issued by the OSIM.

4. Statistics

5. Introduction of the case study CRI 21/2010

5.1. Composition of the Board

Chairman:
Petre Ohan, engineer

Members:
1. Elena Bondar, PhD, rapporteur of the case (Appeal Department)
2. Cătălina Mihailescu, engineer (Patent Division)
3. Irina Babaligea, biochemist (Patent Division)
4. Carmen Solzaru, legal adviser (Appeal Department)

5.2. Decision of the Board of Appeal No. 212 / 3 December 2010 along with the dissenting opinion (extracts of the text are presented – see annex)

Keywords: administrative revocation of patent RO 122 951 of 7 February 2005: Film-coated tablet with modified release of active substance and process for preparing the same

• reasons for the request for revocation:
• scope of patent protection beyond the technical content of the application
• lack of novelty:
• use of the invention prior to the filing date of the patent application
• anticipation of novelty
• lack of inventive step

5.3 The most relevant prior art documents:

• EP A 1 195 160 (D1), invention published on 10 April 2002 disclosed a bi-component system for the release of the active substance from the pharmaceutical form, consisting of a hydrophilic component, HPMC included, and a hydrophobic component
• RO/EP 1 108 424 T2 (D2) published on 20 June 2001 relates to a matrix tablet for the prolonged release of trimetazidine as dihydrochloride, in a content of 35 mg
• The Romanian Market Authorisation No. 3976/2003/01-02 of 26 November 2003.

5.4 Situation with regard to EPO case T 1196/08 (appeal after opposition to EP 1 108 424), Decision date 10 November 2010

The owner of EP 1 108 424 initiated infringement proceedings in respect of patent RO/EP 1 108 424 T2 (D2), validated in RO through the extension system, against SC...GR Romania.

The motion to intervene made by SC...GR Romania based on Article 105(1)(a) EPC was not accepted on the ground that RO/EP 1 108 424 was not a European patent within the meaning of the Munich Convention.

6. Conclusion

There are some differences between revocation in the Romanian patent system and other national patent systems/the European patent system.

The OSIM's Patent Board of Appeal closely follows EPO case law on revocation or limitation in order to learn from it and to keep Romanian practice in line with EPO practice.

At the same time, the Board takes into account the specificity of the Romanian patent system, and tries to find solutions that are in keeping with the regulations and needs thereof.

ANNEX

RO ROMANIA
State Office for Inventions and Trademarks
Inventions Board of Appeal

Case CRI 21/2010

1. Composition of the board

Chairman:
Petre Ohan, engineer

Members:
1. Elena Bondar, PhD, rapporteur of the case (Appeal Department)
2. Cătălina Mihailescu, engineer (Patent Division)
3. Irina Babaligea, biochemist (Patent Division)
4. Carmen Solzaru, legal adviser (Appeal Department)
2. Decision of the Board of Appeal No. 212 / 3 December 2010 along with the dissenting opinion (extracts)

Keywords: administrative revocation of a patent in Romania

Reasons for the request for revocation:

• scope of patent protection beyond the technical content of the application
• lack of novelty:
• use of the invention prior to the filing date of the patent application
• anticipation of novelty
• lack of inventive step

Romania

State Office for Inventions and Trademarks

Inventions Board of Appeal

Case CRI 21/2010

Administrative revocation of a patent in Romania

I. Title of patent RO 122 951 of 7 February 2005: Film-coated tablet with modified release of active substance and process for preparing same

Independent claims:

Claim 1 - Film-coated tablet with modified release of active substance, containing 35 mg of trimetazidine dihydrochloride, characterised in that the active substance is released in the 12 h following tablet administration, by using the non-matrix components hydroxypropyl methylcellulose and hydrogenated cottonseed oil in a mass ratio of 1/0.02-0.08, where the hydroxypropyl methylcellulose is in a gravimetric ratio of 25%, at the most, of the tablet mass, preferably 18.7%, has a viscosity in the range of 4 000-100 000 cP, preferably 15 000 cP, and a grain size suitable for it to pass in a ratio of 95% through sieves of 20-50 mesh, preferably 99% of the material to pass through the sieve of 40 mesh, the hydrogenated cottonseed oil being in a ratio of 0.52-2% of the total mass of the tablet and the active substance representing 15%, at the most, of the tablet mass, preferably 13.06%.

Claim 7 - Process for preparing the film-coated tablet with modified release of trimetazidine dihydrochloride, according to claims 1-6, characterised in that it comprises the following stages: ... essentially, this claim mentions the stages of wet granulation (mixing of components, wet granulation, drying, dry granule homogenisation, powdered granule compression, suspension and homogenisation of the resulting suspension) along with the applicable parameters.

II. Reasons given by the requester

1. In view of the independent claims (claim 1 and claim 7) of patent RO 122 951, owner: SC ... Bucharest, Les ... France, represented by professional representative ..., the requester based his request for revocation on the following reasons, among others:

• the patent application had been significantly modified, the changes being inadmissible under Article 27(5) of Patent Law 64/1991, as republished in 2007 (hereinafter Law), having exceeded the limits of the initial filing; this argument was invoked pursuant to the provisions of Article 52(1)c) of the Law, and
• non-compliance with the requirement of novelty, because
• the subject-matter of patent application a 200 500 886 had been publicly used by the applicant before the filing date of the patent application: 7 February 2005;
• the subject-matter of the invention was known from the patent specification RO/EP 1 108 424 (D2), corresponding to European patent application No. 00 403 533.3 of 15 December 2000, with the priority FR 9 915 960 of 17 December 1999, in which RO was designated through the extension system (Law 32/1997), the anticipative document regarding novelty – European patent application No. 00 308 774.9 of 5 October 2000, published on 10 April 2002 (in respect of which patent EP 1 195 160 B1 was granted and published on 16 September 2009) – being subject to consideration as such or "as a document included ... in D1".
• non-compliance with the requirement of inventive step

under Article 12 of the Law and Article 46 of its Implementing Regulations, and in view of the following prior art: RO/EP 1 108 424 (D2), patent EP-A 1 195 160 (D1) and the relevant patent application; the authorisation to put the product Trimetazidina LPH 35 mg on the market; and general knowledge of pharmaceutical technique.

1.1. In support of the first reason, the requester showed that claim 7 contained technical characteristics that were not present in the description of the invention, as filed in the initial filing, such as:

• [wet granulation] with 13 parts by mass of purified water, for maximum 15 min; the granulation thus obtained is followed by drying the granules in a fluidised bed at a temperature of 40 °C, at most, for a maximum of two hours (stage I);
• homogenisation time of 35 min, as well as offsetting of drying losses with maize starch (stage ii);
• core breaking-resistance parameters ranging between 75 and 110N and core average mass of 260 mg +/- 5% (stage iii);
• in stage iv, all parameters and their values were added subsequently.

1.2. In support of the second reason, the requester showed that the subject-matter, i.e. tablet, of patent RO 122 951 was not new, as it had been disclosed by public use and by having been placed as a product on the market.

SC Labormed Pharma S.A. obtained market authorisation for the product which is the subject-matter of claims 1-6 in 2003, and has been selling the product since 2004. To that end, under the laws in force, SC Labormed Pharma S.A. took all the necessary steps to obtain the product price and to have the product included in the list of subsidised pharmaceuticals, conducted promotion campaigns for the product and introduced it in distribution networks supported by the Market Authorisation No. 3976/2003/01-02 of 26 November 2003. This authorisation sets out all the essential characteristics of the product Trimetazidina LPH 35 mg, as comprised in claims 1-6 of the patent:

"the product as such, sold on the pharmaceuticals market, contains the complete information of claims 1-6, made available to the public by use, hence, claims 1-6 do not comply with the requirement of novelty on the filing date of the application".

1.3. In support of the second reason, the technical problem solved by the invention claimed in patent RO 122 951, vis-à-vis the cited prior art documents, is obvious within the meaning of Article 12(1) of the Law, see Article 47(10)h) of the Implementing Regulations thereto.

The technical problem solved by RO 122 951 consists in preparing a tablet having as an active substance trimetazidine dihydrochloride in a concentration of 35 mg, with the controlled release of the active substance in the 12 hours following administration.

The technical problem is solved by the admixture of two agents intended to control the release of the active substance: hydroxypropyl methylcellulose (HPMC) and hydrogenated cottonseed oil in a ratio of 50 : 1.

Document D2 published on 20 June 2001 relates to a matrix tablet for the prolonged release of trimetazidine as dihydrochloride, in a content of 35 mg, where the prolonged release is controlled by the use of a cellulose-derived polymer selected from hydroxypropylcellulose, hydroxyethylcellulose, hydroxymethylcellulose, methylcellulose and hydroxypropyl methylcellulose.

The preferred formulation contains hydroxypropyl methylcellulose (HPMC) but it also contains a binder, a diluent, a lubricant and a flow agent. The tablet is intended to be administered twice per day, the prolonged release in the 12 hours following administration, and to be used in the prophylaxis of angina pectoris, in chorioretinal attacks and in the treatment of vertigo of vascular origin.

Document D1 published in EP Bulletin 2002/15 on 10 April 2002 relates to a controlled-release pharmaceutical composition based on trimetazidine dihydrochloride in association with hydrocolloid-forming materials, as well as with hydrogenated oils.

Market Authorisation
No. 3976/2003/01-02 presents a qualitative and quantitative composition of a film-coated tablet with modified release comprising trimetazidine dihydrochloride 35 mg, HPMC and hydrogenated cottonseed oil in a ratio of 50: 1.4.

According to the law and practice in the field of patent application examination, including EPO practice, the inventive step should be examined using the problem-solution approach.

• The main element determining the controlled release of the active substance and the solving of the technical problem in RO 122 951 is HPMC having a viscosity of 100 000 cP, preferably 4 000 cP and a hydrogenated cottonseed oil, in a ratio of 50 : 1.4, both of which are well-known from the prior art. The other materials used as carriers in the trimetazidine dihydrochloride tablet are materials known in the field and available to any person skilled in the art.
• the materials added in patent RO 122 951 to control the release of the active substance over a period of 12 hours do not differ from the materials known and used for the same purpose, as disclosed in documents D2 and D1 and in Market Authorisation No. 3976/2003/01-02.

The release of active substance in document D2 is almost identical to the one in the patent RO 122 951, which proves that the way of solving the technical problem in RO 122 951 does not represent any advance in the technical field in question, as provided under Article 16(1)d) of the Implementing Regulations. In other words, there is no inventive step vis-à-vis the technical solution known from document D2.

As regards the inventive step of claim 7, the process for preparing the tablet is also known from the prior art documents. The mere fact of specifying the values of viscosity and granulometry of HPMC, within the range known from document D2, does not represent any progress or contribution to the prior art.

In conclusion, patent RO 122 951 does not involve an inventive step as compared with the prior art, because it describes an obvious use of known means which are employed for the same purpose, without achieving new or surprising effects, thereby failing to comply with the requirement of inventive step as provided for under Article 47(9)a).

III. Reasons given by the patent owner

2. To the arguments presented above, the patent owner, represented by the professional representative ..., submitted the following defence:

2.1. The scope of claim 16 of the initial patent application is broader than the scope of claim 7 of the above-mentioned patent, so the content of the initial patent application has not been exceeded; on the contrary, it has been narrowed.

(a) More precisely, the initial version of the patent application refers in page 3, paragraph 2 and page 4, paragraphs 4, 5 and 6 and in claim 16, to the characteristics of the technological process employed, namely wet granulation. The mixing ratios of the components are implicit; they derive from the preferred embodiment F1 in the application. The order of adding/mixing said components is also specified. In the granted patent, other elements of said process were also specified, such as the amount of water (which is not to be found in the final product anyway), the time of granulation, the temperature and duration of the fluidised-bed drying, the duration of homogenisation, the hardness of tablets, the suspension and homogenisation of the film and certain parameters of the film-coating process.

(b) All of these details have been introduced in response to OSIM requests and, consequently, cannot be deemed to exceed the framework of the initial application, to the extent that they specify working modes or operation parameters which are obvious from a technical viewpoint (the initial application mentions the carrying out of the wet granulation process and covers both in vivo and in vitro profiles). Any person of average skill in the field of pharmaceutical techniques knows that wet granulation cannot last for more than 1 h, the fluidised-bed drying cannot exceed 75-100 °C, the press of the rotary machine needs to be set to a certain value intended to confer breaking resistance to the tablets below 150 N, the coating film needs to be suspended and homogenised, the film-coating temperature cannot exceed the vaporisation temperature of the suspension medium, etc.". "The narrowing... " was made in comparison with higher implicit limits known by anyone skilled in the field of pharmaceutical formulation. As regards Example 6, namely the in vivo release kinetics, it only specifies a characteristic of the product obtained in accordance with the patent (the preferred formula F1).

(c) As the doctrine shows, the limitation of possibilities to modify a patent application to certain cases explicitly provided for by the Law is necessary to confer legal certainty on the patent, especially in relation to third parties. To this effect, the provisions of Article 27(5) of the Law should mean that the modifications cannot exceed the content of the application on the filing date thereof, i.e. they cannot extend the initial subject-matter of the application. On the contrary, in case the modifications made as a result narrow the requested protection, they shall be admissible. Consequently, in the case concerned, the provisions of Article 27(5) of Patent Law 64/1991 have been completely complied with.

The data in Example 6 and Figure 2 are pharmacokinetic parameters obtained from in vivo experiments which are implicitly included in the initial filing, because said experimental findings were made in 2004, prior to the filing of the patent application with the OSIM, and they are referred to in the bioequivalence study submitted to the National Medicines Agency (NMA).

2.2. Defence of novelty

2.2.1. Claim 1 of RO 122 951 as compared with claim 1 of RO/EP 1 108 424 (D2)

• RO 122 951 claims protection of a new composition capable of leading to the delayed release of the active substance.
• Claim 7 (process claim) in patent RO 122 951, as compared with claim 16 (process claim) in D2, exhibits substantial differences: the control of the delayed release of the active substance is carried out based on two compounds, unlike the process in D2, in which the control of the delayed release of the active substance is carried out based on a single class of compounds.

- in RO 122 951 the profile of sustained release of the active substance depends on the mass ratio between the HPMC and the hydrogenated oil and on the HPMC granulometry and viscosity.

• in D2 the control of release of the trimetazidine dihydrochloride depends on a single control agent.

The amount of active substance in the formulation, as well as the amount of the release control agent are complementary, in the two opposing documents: the trimetazidine dihydrochloride is present in RO 122 951 in a ratio of 15%, at most, of the mass of the tablet, while, in D2 it is present in 15-30% of the mass of the tablet; HPMC is present in RO 122 951 in a ratio of 25%, at most, of the mass of the tablet, preferably 18.7%, while, in D2 it is present in 25-50% of the mass of the tablet.

• Although both processes use wet granulation, it is applied to different products: in RO 122951 it is used to obtain a product which differs from the product obtained in D2.

2.2.2. Although the owner marketed the product Trimetazidine 35 mg LPH prior to the filing date of the patent application No. a 2005 00086, said use is not novelty-destroying as it was carried out under trade secret conditions.

In this regard, reference is made to:

• Article 726(4) of Law 95/2006 with regard to reform in the public health area: the NMA makes the report results available to the public together with the reasons for its decision, except in the case of confidential commercial information.
• Article 5 of Law 11/1991 on the Repression of Unfair Competition: the disclosure of information concerning the results of experiments is prohibited.
• Article 39 of the TRIPS Agreement: with a view to ensuring effective protection against unfair competition, secret information with commercial value submitted to governments or governmental agencies as a condition for approval of the marketing of pharmaceutical products shall be protected.

2.3. Defence of inventive step

• The invention claimed in patent RO 122 951 involves an inventive step because it relates to a use of the technical means of the claimed invention in order to solve a technical problem in a way other than that resulting from the prior art documents analysed by the person skilled in the art (Article 47(9)f) of the Implementing Regulations).
• The technical solution described in RO 122 951 is a distinct way of associating certain excipients, in certain conditions, so as to determine the modulation of the release of the trimetazidine dihydrochloride in pharmaceutical form, with the effect of obtaining a new product having known usage properties, the product being characterised by robustness and flexibility.
• Thus, the control of the delayed release of the active substance is achieved based on two compounds, namely HPMC and the hydrogenated cottonseed oil (in a certain mass ratio, with a certain granulometry and viscosity), said association not being obvious to a person skilled in the art.

IV. Relevant legal provisions

3.1. As regards the grounds for revoking a patent and the disclosure of the invention upon regular filing, the Law stipulates that:

"(1) Any person is entitled to apply to the OSIM, in writing, on valid grounds, for the revocation of the patent, within six months of the publication of the mention of granting the patent, provided that:

a) the subject-matter of the patent is not patentable, under Article 7-10, 12 and 13;

b) the subject-matter of 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;

c) the subject-matter of the patent exceeds the content of the patent application, as filed.

(2) Where the grounds for revocation relate only to a part of the patent, the patent shall be revoked in part" (Article 52 of Patent Law 64/1991, as republished in 2007).

3.2. As regards the admissibility of modifications of the patent application after the regular filing, the Law stipulates that:

"At the request of the OSIM or on his own initiative, the applicant [...] may, until such time as a decision is made, modify the patent application, provided that the disclosure of the invention does not extend beyond the content of the patent application on the filing date" (Article 27(5) of Patent Law 64/1991, as republished in 2007)."

Said provisions are explained in Article 37(6)b) of Government Decision 547 of 2008:

"The changes brought by the applicant or the professional representative, as the case may be, during the preliminary or substantive examination shall be accepted by the OSIM, if they:

[...]b) refer to the content of the claims, but are based on features existing in the description and drawings in the regular national filing;"

3.3. As regards the disclosure of the invention by use, prior to the filing date of the patent application, the Law stipulates that:

"(1) An invention shall be considered to be new if it does not form part of the prior art.

(2) The prior art shall be held to comprise all knowledge that has been made available to the public by means of a written or oral description, by use, or in any other way before the date of filing of the patent application." (Article 10 of Patent Law 64/1991, as republished in 2007).

Said provisions are explained in Article 38(8) of Government Decision 547 of 2008:

"The information is deemed to have become available to the public by use, within the meaning of Article 10, paragraph (2) of the Law, if, on the relevant date, any person could gain said information by the display or use thereof. If a person sells an item to a third party, without any limitations, restrictions or obligations regarding the confidentiality, the item is deemed to have been rendered available to the public."

V. DECISION OF THE BOARD OF APPEAL No. 212 / 3 December 2010

V.1. Extension beyond the initial filing by adding new parameters in claim 7 (process claim).

• The Board decided to amend claim 7, eliminating from its text all the parameters which are not supported by the initial description (suspending time, amount of purification water, viscosity of the resulting suspension, rotation speed of the drum, suspension charging speed, pressure and temperature in the tablet bed, percentage of sodium carboxymethylcellulose).

Claim 7, as amended by the Board:

"7. Process for preparing the film-coated tablet with modified release of trimetazidine dihydrochloride, according to claims 1-6, characterised in that it comprises the following stages:

i. Mixing of 35 parts of trimetazidine dihydrochloride with 100 parts of manitol, 51.5 parts of starch and 9 parts of polyvinylpyrrolidone, wet granulation with purified water and drying in fluidised bed;

ii. Homogenisation of the dried and classified granule, for 35 min, with 50 parts of hydroxypropyl methylcellulose, having a viscosity of 15 000 cP and a grain size suitable for it to pass, in a ratio of 99% of the material, through the sieve of 40 mesh, with 1.4 parts of hydrogenated cottonseed oil, 4.2 parts of colloidal silicon dioxide, 6.3 parts of talcum, 2.6 parts of magnesium stearate and the difference of up to 260 parts representing drying loss being offset with maize starch;

iii. Compressing the powdered granule in a rotary compressing machine so that the resulting cores exhibit a breaking resistance on the diameter direction ranging between 75 and 110 N and an average mass of 260 mg +/- 5%.

iv. Suspending and homogenising the suspension by admixing 8 parts of a film-coating agent in purified water, the film-coating being achieved under conditions known per se, using sodium carboxymethylcellulose as a film-coating agent."

V.2. Example 6 shows the profile of in vivo release of the active substance which represents a highlighting of the pharmacokinetic parameters of the preferred formulation of the invention.

Figure 2, although not included in the initial filing, is a graphical representation of the average plasmatic concentration for the preferred formulation of the invention.

All these data may be maintained in the description of the invention because they are intended to permit a better understanding of the invention without influencing the scope of protection conferred by the patent.

V.3. In the assessment of novelty, the Board considered that:

The most relevant prior art document in comparison to which the novelty of the patent concerned is assessed is document EP A 1 195 160 (D1), because:

a. On the date of the regular national filing of patent application a 200 500 086 of 7 February 2005, D1 was already a public document (publication date 10 April 2002). Patent EP 1 195 160, published on 16 September 2009, did not exist at the time.

b. D1 contains a bi-component system for the release of the active substance from the pharmaceutical form, consisting of a hydrophilic component, HPMC included, and a hydrophobic component, consisting of fatty acids, fatty alcohols and hydrogenated oil, which ensures the prolonged release of trimetazidine over a period of up to 24 h, preferably 18 h (claim 15) and at least 12 h (claim 15) after oral administration.

The hydrogenated oil is an essential characteristic of the invention, as claimed, together with the HPMC. In D1, the system of controlled release of the active substance is a bi-component system and may comprise, besides HPMC, hydrogenated oils.

In RO/EP 1 108 424 T2 (D2), the release of the active substance is achieved by a single component, namely HPMC.

The Board ascertained that D2 does not comprise the hydrophobic component which represents one of the essential characteristics of the invention in RO 122 951.

Consequently, the Board considered that the assessment of novelty had been correctly conducted in relation to document D1, which brings together more essential characteristics of the invention than D2.

V.3.2. As regards the assessment of novelty in relation to the documents in the Authorisation File submitted by the owner with a view to obtaining the Market Authorisation No. 3976/2003/01-02 of 26 November 2003, the Board ascertained that:

V.3.2.1. The market authorisation issued by NMA represents a provisional authorisation to market the product Trimetazidine 35 mg. Said authorisation is earlier than the filing date of the patent application and presents the quantitative and qualitative composition of the product Trimetazidine, without mentioning all the essential characteristics of the film-coated tablet and the process for preparing same, as claimed.

The publication place and date of the Authorisation File are not clearly indicated in the annexes of the Market Authorisation (Patient Information Leaflet - Trimetazidine 35 mg, Abstract of product characteristics, Information on labelling).

In said excerpts of the NMA Bulletin, there is only the mention of the Market Authorisation application and the issuing of said authorisation. These excerpts do not present in extenso all the documents comprised in the Authorisation File, as required by the NMA for authorisation to place the product on the market.

The bioequivalence study, required to prove the capacity of the product Trimetazidine LPH 35 mg (generic product) to generate the same biopharmaceutical effect as the product Preductal 35 mg (reference product), indicates that the entire documentation is filed with the NMA under confidentiality conditions, based on a confidentiality agreement concluded between the NMA and the product owner.

Consequently, the Board considered that the documents in the Authorisation File were not public, except for the first three annexes of the Market Authorisation, according to Article 38(9) of the Government Decision 547/2008: "The knowledge that had become available to the public by oral means, by use or any other means shall be deemed to belong to the prior art only if it is confirmed by a dated document referring to its existence and demonstrating the date on which it became available to the public."

However, the Board analysed these documents submitted by the requester.

Thus, the Board ascertained that the Patient Information Leaflet (part of the Market Authorisation), Abstract of product characteristics, disclosed neither data concerning the bi-component system for the release of the active substance, nor data concerning the process for preparing the film-coated tablet.

Although the Market Authorisation comprises data on the qualitative and quantitative composition of the product, it does not specify the particular characteristics of HPMC (viscosity and granulometry), or the stages of the process for preparing the film-coated tablet, as claimed.

The final Market Authorisation for the product Trimetazidine 35 mg LPH was issued on 30 May 2005 (subsequent to the filing date of the patent application).

In the Protocol for the bioequivalence study concerning a unique or multiple dose of the product Trimetazidine LPH 35 mg as compared with the product Vastarel 35 mg and the product Preductal, the Board found data concerning the dosing of the tested medicament, as a unique or multiple dose, the applied methodology, and the volunteers subjected to trial.

The in vitro dissolving test points out the character of generic medicament of the claimed tablet without disclosing the elements of novelty, as claimed in RO 122 951.

Based on the analysis above, the Board found that the documents enclosed by the requester regarding the lack of novelty did not contain the essential technical characteristics of the film-coated tablet which is the subject-matter of patent RO 122 951.

V.3.2.2 As regards the lack of novelty of the film-coated tablet as a consequence of the use thereof before the filing date,

in accordance with Article 38(8) and Article 38(9) of Government Decision 547/2008, the Board found that:

• even if the product was made available to the public, by sale, before the filing date (7 February 2005), the Patient Information Leaflet of the product does not disclose completely the physical and chemical characteristics of the system for the controlled release of the active substance;
• although the product has been placed on the market so that any third person could determine the composition of the film-coated tablet by quantitative and qualitative analysis, said third person could not reproduce the physical characteristics of the tablet components which are responsible for the active-substance release. Moreover, the requester did not make available to the Board, besides the Patient Information Leaflet, any tests or laboratory analyses of the film-coated tablet bearing a date earlier than the filing date of the patent application a 2005 00886 and capable of proving the intrinsic characteristics of the tablet components.

Thus, the Board considered that the product had not been made available to the public in its entirety.

Consequently, the Board found by a majority that the provisions of Article 10 of Patent Law 64/1991, as republished, had been met.

V.4. As far as inventive step is concerned, the Board ascertained that:

• D2 relates to a pharmaceutical composition in which the system of controlled release of the active substance is a single-component one, comprising only HPMC (matrix component). Consequently, this document relates to a pharmaceutical composition which differs from the composition in the patent concerned. Moreover, in D2 HPMC is characterised only by its viscosity.

D2 also shows that "the kinetics of the release of the matrix tablet is not influenced by the quantity or quality of the used cellulose derivative". However, it acknowledges the existence of a specific synergy between Trimetazidine and the cellulose derivative (D2).

The Board found that the release of the active substance by means of the bi-component system is delayed as compared to D2, which employs a single-component controlled release system.

The Board noted that in D1 the trimetazidine, as an active substance, is contained in an amount of 60 mg (i.e. between 8 and 50% by weight), the hydrocolloid-forming agent is a cellulose derivative, HPMC included, and the hydrophobic component may be a hydrogenated oil, but without the cottonseed oil being mentioned. D1 does not specify the viscosity and granulometry characteristics of HPMC in the patent concerned, or the associating ratio between the hydrophilic and hydrophobic components.

Moreover, although D1 mentions the possibility of using the hydrogenated castor oil as a hydrophobic component, no embodiment of a formulation containing a hydrogenated oil is described.

Also, D1 does not describe any study of in vivo or in vitro active-substance release kinetics of a formulation containing a hydrogenated oil.

Corroborating the knowledge comprised in the Market Authorisation, D1, D2 and Pharmaceutical Technology, the Board considered that a person of average skill in the art could not carry out the technical solution of the patent, as claimed, without involving an inventive step to achieve the essential technical characteristics of the bi-component system for the release of Trimetazidine.

Consequently, the Board found that the claimed invention, as a whole, involved an inventive step in accordance with Article 12(1) of Patent Law 64/1991, as republished, and Article 47 of Government Decision 547/2008.

V.5. As regards the fact that "the subject-matter of the patent, as filed, does not disclose the invention in a manner sufficiently clear and complete for a person skilled in the art to carry it out", the Board found that:

Following an analysis of the description as filed initially, the Board ascertains that the five embodiments of the invention show: the qualitative and quantitative composition of the film-coated tablet along with the functional role of each component, the physical and chemical characteristics. The cumulated action of the bi-component system (hydrophilic-hydrophobic) upon the active-substance release kinetics is of a pharmacokinetic nature that is strictly required in specialised studies but less relevant for a person of average skill in the art intending to carry out the invention.

Thus, the Board considered that the components of the film-coated tablet and the process for preparing the same, as drawn up in both the initial filing and the granted patent, were sufficiently clearly and completely disclosed, pursuant to Article 18 of Patent Law 64/1991, as republished, for a person skilled in the art to carry out the invention.

As a consequence, the Board found by a majority that the invention having as subject-matter the product – film-coated tablet with modified release of the active substance containing 35 mg of trimetazidine dihydrochloride – and the process for preparing same was new, involved an inventive step and was susceptible of industrial application, under Article 7 of Patent Law 64/1991, as republished in 2007.

Based on the analysis presented above, pursuant to Article 53 of Patent Law 64/1991, as republished in 2007 and Article 59(3c) of Government Decision 547/2008, the Inventions Board of Appeal

DECIDED by a majority:

• to admit, in part, the request for revocation made by LES ..., FR, represented by the professional representative SC. CABINET M. OPROIU SRL, having its registered office in Bucharest, against the patent RO 122 951 entitled Film-coated tablet with modified release of active substance and process for preparing the same owned by SC ..., Bucharest;
• to change Decision No. 3/22/30 March 2010 to grant patent RO 122 951 with respect to claim 7 (process claim) only, as follows:

7. Process for preparing the film-coated tablet with modified release of trimetazidine dihydrochloride, according to claims 1-6, characterised in that it comprises the following stages:

i. Mixing 35 parts of trimetazidine dihydrochloride with 100 parts of manitol, 51.5 parts of starch and 9 parts of polyvinylpyrrolidone, wet granulation with purified water and drying in a fluidised bed;

ii. Homogenisation of the dried and classified granule with 50 parts of hydroxypropyl methylcellulose having a viscosity of 15 000 cP and a grain size suitable for it to pass in a ratio of 99% of the material through the sieve of 40 mesh, with 1.4 parts of hydrogenated cottonseed oil, 4.2 parts of colloidal silicon dioxide, 6.3 parts of talcum, 2.6 parts of magnesium stearate and the difference of up to 260 parts representing drying loss being offset by maize starch;

iii. Compressing the powdered granule in a rotary compressing machine so that the resulting cores exhibit a breaking resistance on the diameter direction ranging between 75 and 110 N and an average mass of 260 mg +/- 5%.

iv. Suspending and homogenising the suspension by admixing 8 parts of a film-coating agent in purified water, the film-coating being achieved under conditions known per se, using sodium carboxymethylcellulose as a film-coating agent.

The Decision, done on 3 December 2010, was subject to appeal before the Court of Bucharest within 30 days of communication.

VI. Dissenting opinion

4. Analysis of reasons vs counter-reasons

4.1. As regards the first reason, the Board ascertained that the requester's assertion was correct, i.e. that certain characteristics (which are explicitly mentioned above) of claim 7 were not contained in the initial filing of the description of the invention.

Under Article 37(6)b) of GD 547 of 2008, per a contrario, the owner's defence that "the scope of claim 16 of the patent application was broader than claim 7 of the patent" cannot be accepted because the narrowing of protection relating to the process was carried out based on certain characteristics which could not be found in the description of the invention in the initial filing, and such changes could not be accepted, and, in this context, "the subject-matter of the patent would go beyond the content of the patent application".

Claim 7 of the patent parametrised the wet granulation process, which is known in the pharmaceutical field (see WO 1998/036737 - Wet granulating method, published on 27.08.1998) for preparing tablets having the composition set out in claims 1-6. At first (claim 16 of the initial filing) the characteristics of the process were indicated as follows: "a preset mass ratio" between the active substance (trimetazidine dihydrochloride), the diluent (manitol), the binder (maize starch) and water during the dosing and mixing stage, and a "preset granulometry" of the "cellulose derivative" (HPMC) during the grain homogenisation stage.

The parameters and extra information in claim 7, as indicated by the requester, were not supported by the initial description.

Throughout the revocation procedure, the owner did not remedy this infringement of the provisions of GD 547/2008.

Consequently, pursuant to the provisions of Article 52(1)c) of Patent Law 64/1991, as republished in 2007, the Board admitted the request for revocation of claim 7, relating to the process for preparing the film-coated tablet with modified release of trimetazidine dihydrochloride.

4.2. As regards the second reason, the existing documents enclosed with the file and the arguments upheld before the Board by both parties led to the conclusion that the owner had been selling the film-coated tablet with modified release of trimetazidine dihydrochloride, as claimed in claims 1-6, on the Romanian market, since 2004, under the name TRIMETAZIDINA LPH 35 mg.

4.2.1. In this context, the owner was granted Market Authorisation 3976/2003/01-02 on 26 November 2003. In Annex 1 (Patient Information Leaflet) and in Annex 2 (Abstract of product characteristics) thereto, the composition of the product TRIMETAZIDINA LPH 35 mg was set out as follows:

TRIMETAZIDINE LPH® 35 mg

Film-coated tablets with modified release, 35 mg

Composition

One film-coated tablet with modified release contains trimetazidine dihydrochloride 35 mg and excipients: core – manitol, maize starch, hypromellose, polyvidone K30, talcum, colloidal silicon dioxide, hydrogenated cottonseed oil, magnesium stearate, film-coating – Opaglos 2 97W24263 Pink.

...

Posology and administration

The recommended dose is one tablet with modified release of TRIMETAZIDINE LPH 35 mg twice daily, mornings and evenings, with a sufficient amount of water, during meals. Both above-mentioned documents were made available to the public on the website of the NMA upon issuance of the Market Authorisation. Moreover, medicaments are sold in chemist's shops without any confidentiality clause. This is why the owner's defence, claiming that the product was sold under trade secret conditions, cannot be accepted.

With the additional explanations that hypromellose is the short word for hydroxypropyl methylcellulose (HPMC) and that the dose of two tablets daily indicates that the release system is capable of releasing trimetazidine dihydrochloride over 12 hours, we can ascertain that the description above is sufficient for a person skilled in the art and supposed to have knowledge of the prior art (represented, in this case, by D2 which presents the "innovative product" – as it was called by its very owner during the meeting – and by D1) to see that the product described in the Patent Information Leaflet has the same essential characteristics as the product claimed in claim 1 of the patent concerned, as follows:

"Film-coated tablet with modified release of the active substance containing 35 mg of trimetazidine dihydrochloride characterised in that the active substance is released in the 12 h following tablet administration, by using the non-matrix components hydroxypropyl methylcellulose and hydrogenated cottonseed oil in a mass ratio of 1/0.02-0.08, where the hydroxypropyl methylcellulose is in a gravimetric ratio of 25%, at most, of the tablet mass, preferably 18.7%, has a viscosity in the range of 4 000-100 000 cP and a grain size suitable for it to pass in a ratio of 95% through sieves of 20-50 mesh, preferably 99% of the material to pass through the sieve of 40 mesh, the hydrogenated cottonseed oil being in a ratio of 0.52-2% of the total mass of the tablet and the active substance representing 15%, at most, of the tablet mass, preferably 13.06%."

4.2.2. The other characteristics of the product, according to claim 1, concerning the ratio of components, in particular the mass ratio between the two components of the active-substance controlled-release mechanism – HPMC (hydrophilic) and hydrogenated cottonseed oil (hydrophobic) – can be determined through a chemical analysis of the tablets placed on the market by the owner in chemist's shops. The hydrophilic component/hydrophobic component ratio within a mechanism for releasing trimetazidine dihydrochloride from a pharmaceutical composition is also analysed in D1. In particular, upon laboratory weighing of a tablet, while knowing the amount of active substance (35 mg), the proportion of the active substance as per the tablet mass, as claimed in claim 1 – 13.06% – can be determined.

The viscosity and granulometry characteristics of HPMC do not essentially affect the tablet content, they being of secondary importance as regards the product (but being more process-specific characteristics) and, according to the requester's arguments, being part of the prior art.

4.2.3. During the revocation procedure, the owner was unable to indicate a single essential characteristic in claim 1 which could not have been disclosed by use, and he did not amend the claim accordingly. Claims 2-6 are dependent on claim 1 and therefore cannot subsist in a patent while claim 1 does not subsist.

Consequently, based on the provisions of Article 52(1)a) of Law 64/1991, as republished in 2007, the Board voted for the revocation request to be admitted in respect of claims 1-6 concerning the film-coated tablet with modified release of trimetazidine dihydrochloride, as the product was disclosed by voluntary use prior to filing the patent application.

5. As a consequence of these conclusions, the Board considered that an analysis of the other requester's reasons would have been useless and the Board voted for the revocation of patent RO 122 951 entitled Film-coated tablet with modified release of active substance and process for preparing the same, whose owner was SC ..., Bucharest.

VII. Regarding the administrative revocation action concerning patent RO 122 951B1, it is pending under appeal procedure before the Law Court of Bucharest.

Regarding the infringement action concerning patent RO/EP 1 108 424 (D2), validated in RO by means of the extension system, brought by the owner before the Law Court of Bucharest, against SC...Bucharest, in his summons, the plaintiff (requester-owner Les...France) requested that:

1. the Court establish the infringement of the rights conferred on him by the RO/EP patent.

2. the Court establish the prejudice of EUR 6 202 825 (lost income) caused to the plaintiff and order damage recovery in respect of the patent rights infringement.

3. the Court order comminatory damages recovery of EUR 500 per day of delay.

4. the Court's judgment be published in the mass media, i.e. in five newspapers selected by the plaintiff.

5. the defendant pay the plaintiff's legal expenses.

Through the Civil Sentence No. 1331 of 19 November 2009, the Law Court of Bucharest decided as follows:

"The Court admits the appeal in part, i.e. it orders the defendant to cease from manufacturing, offering for sale, selling or importing the product, to withdraw the product immediately from the Romanian market and to stop any type of commercial activity having as an object the pharmaceutical product TRIMETAZIDINA LPH 35 mg".

The Court orders that the defendant pay damages of LEI 3 573 584 (about EUR 1 million) in respect of patent rights infringement for the period 1 January 2006 - 31 December 2007.

The Court orders that the defendant pay the plaintiff's legal expenses."

Said civil sentence was appealed against by both parties before the Court of Appeal of Bucharest (case file 21477/3/2006 of 30 September 2010, http:\\portal.just.ro). The decision of the Court of Appeal was pronounced on 27 October 2011, the Court deciding as follows:

"The sentence appealed against has been changed in its entirety, i.e. the Court notes that the plaintiff has waived a hearing of the case, and orders the plaintiff to pay the defendant the latter's legal expenses of LEI 244 274.43."

The civil decision became final by lack of appeal.

Also, LES ..., FR, initiated infringement proceedings in respect of patent RO/EP 1 108 424 (D2), validated in RO through the extension system, against SC ... GR Romania.

C. A generic pharmaceuticals company from DE attacked patent EP 1 108 424 before the EPO (opposition and appeal, case T 1196/08), and the patent was maintained in amended form.

The motion to intervene made by SC ... GR Romania based on Article 105(1)a) EPC was not accepted on the ground that RO/EP 1 108 424 was not a European patent within the meaning of the Munich Convention.