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Author
Ludmila Lisovskaya

Patent Specialist / Chemical Specialist

19 February 2019

The review of the changes made to the Rules of Composing, Filing and Considering the Documents, Which are the Basis for Committing Legally Significant Acts Related to the State Registration of Inventions

Order No. 527 of October 1, 2018 of the Ministry of Economic Development of Russia “On Making Changes to the Rules of Composing, Filing and Considering the Documents, Which are the Basis for Committing Legally Significant Acts Related to the State Registration of Inventions, and Their Forms and the Requirements to the Documents of an Application for Granting a Patent for an Invention” approved by Order of the Ministry of Economic Development of Russia No. 316 of May 25, 2016 N 316, came into force on December 15, 2018.

This review of the changes may be useful not only to the FIIP’s examiners, but also to the applicants who are currently planning to file applications for inventions, which subject matters are compositions (formulations, mixtures). The examples of the compositions are food products, drugs, household chemicals, building mixtures, paints, varnishes, the similar products consisting of several components.

In order to improve the regulatory and legal framework of the Ministry of Economic Development of Russia, it is proposed to make the following changes to the Requirements to the Documents of an Application for Granting a Patent for an Invention:

Paragraph 39, which is worded:

“When disclosing the essence of the invention relating to the composition, the following rules shall be applied:

1) to characterize the compositions, in particular, the following features shall be used:

– a qualitative formulation (ingredients);

– a quantitative formulation (the content of the ingredients);

– the structure of the composition;

– the structure of the ingredients;

2) to characterize the compositions of an unidentified formulation, their physical and chemical, physical and other characteristics, as well as the features of the preparation method shall be used.”

is supplemented with Subparagraph 3, which reads as follows:

“3) it is not allowed to characterize the composition using as its features the information, which does not relate directly to the composition (for example, the conditions and modes of using this composition in any process, method), a quantitative (measured or calculated) parameter characterizing at least one property of the composition, in the cases, when this parameter is a distinctive feature in the characteristic of the composition in the independent claim of the claims (for example, the parameters of the laminating strength, the resistance to crack under tension, a pharmacokinetic profile, and the like), the technical result, which is manifested at the manufacture or use of the composition. When characterizing a pharmaceutical composition, it is not allowed to the use the features relating to the method of treating or the prevention of a disease (for example, the indication of doses, the conditions or modes of using the composition or drugs derived from it).”

In addition, Subparagraph 14 of Paragraph 53 of the Requirements to the Documents of an Application for Granting a Patent for an Invention, which is worded:

“The claims relating to a composition shall contain its name with the indication of its purpose, the ingredients included in the composition and optionally the quantitative content of the ingredients.

If the claims relating to a composition contain a quantitative content of ingredients, they shall be expressed in any single-value units, as a rule, in two values characterizing the minimum and the maximum limits of the content.

It is allowed to indicate the content of one of the ingredients of the composition by one value, and the content of the remaining ingredients as the interval of values relative to this single value (for example, the content of ingredients is given per 100 parts by mass of the main ingredient of the composition or per 1 liter of solution).

It is allowed to indicate the quantitative content of antibiotics, enzymes, toxoids and the like in the composition formulation in the units other than the units of the remaining ingredients of the composition (for example, in thousands of units relative to the mass quantity of the remaining ingredients of the composition).

For the compositions, the purpose of which is determined only by an active principle, and other components are neutral carriers from the circle traditionally used in the compositions of this purpose, it is allowed to indicate in the claims only this active principle and its quantitative content in the composition formulation, including in the form of an “effective quantity.”

Another variant of characterizing such composition may be the indication in it, beside the active principle, of other components (neutral carriers) in the form of a “target additive” generalized concept. In this case, the quantitative content of the active ingredient and the target additive shall be indicated.”

is to be supplemented by an unnumbered paragraph, which reads as follows:

“It is not allowed to characterize the composition using the features indicated in Subparagraph 3 of Paragraph 39 of the Requirements to the Documents of an Application.”

In this case, in the Rules of Composing, Filing and Considering the Documents, Which are the Basis for Committing Legally Significant Acts Related to the State Registration of Inventions, and Their Forms Paragraph 70, which is worded:

“When checking the novelty, the invention shall be deemed to be new, if it is established that the aggregate of the features of the invention described in the independent claim of the claims is not known from the information, which has become open to public in the world before the priority date of the invention (hereinafter referred to as the prior art).

An invention relating to the product that differs from a known product only by a generic concept shall be deemed to comply with the novelty criterion, if the generic concept reflecting the purpose and (or) the field of use of the claimed product implies that the claimed product has the peculiarities (features) that are not included in the claims by the applicant, which help to distinguish the claimed product from the known product. If the difference of the generic concept is due only to the properties objectively inherent to the claimed product, including to the previously unknown properties, the claimed product shall not be deemed to be new. In this case, the applicant is entitled to characterize the claimed invention in the claims in the form of use of the product for the particular purpose indicated in the generic concept.

A chemical compound falling under the general structural formula of the group of known compounds, or a composition derived from it, shall be deemed to comply with the novelty criterion, if the chemical compound as such is unknown from the prior art and there is no information about the starting compounds, its preparation method and its properties that have become open to public in the world before the priority date of the invention.

An invention relating to a product expressed using the characteristics of its preparation method shall be deemed not to comply with the novelty criterion, if the product obtained is known from the prior art.

The claimed invention characterized in the form of use for a particular purpose shall be deemed not to comply with the novelty criterion, if the use of the same product or method for the same purpose is known from the prior art.” 

is supplemented by an unnumbered paragraph, which reads as follows:

“When checking the novelty of the invention relating to the composition, the features indicated in Subparagraph 3 of Paragraph 39 of the Requirements to the Documents of an Application shall not be taken into account.

            Paragraph 76, which is worded:

“The check of the inventive step of the invention can be performed according to the following scheme:

– the determination of the closest analogue of the invention in accordance with Paragraph 35 of the Requirements to the Documents of an Application;

– the identification of the features by which the claimed invention, characterized in the independent claim of the claims, differs from the closest analogue (the distinctive features);

– the identification from the prior art of the solutions that have the features coinciding with the distinctive features of the claimed invention;

– the analysis of the prior art in order to confirm the anticipation of the influence of the features that match the distinctive features of the claimed invention on the technical result indicated by the applicant.

The invention shall be deemed to be non obvious from the prior art to a specialist, if during the check no solutions that have the features matching its distinctive features are identified, or such solutions are identified, but the anticipation of the influence of these distinctive features on the technical result indicated by the applicant is not confirmed.”

             is to be supplemented by an unnumbered paragraph, which reads as follows:

“When checking the inventive step of the invention relating to the composition, the features indicated in Subparagraph 3 of Paragraph 39 of the Requirements to the Documents of an Application shall not be taken into account.

            Here are some examples for the better understanding of the above changes in the regulatory and legal framework.

Based on new Subparagraph 3 of Paragraph 39 of the Requirements to the Documents of an Application for Granting a Patent for an Invention, when patenting compositions, it is not allowed to use for their characteristics the information that does not relate directly to the composition, for example, in independent Paragraph 1 of the claims “Nasal composition for the treatment of allergic rhinitis” given below:

“1. The nasal pharmaceutical composition comprising an aqueous suspension of beclometasone solid particles and containing beclomethasone from 0.04 to 0.045% wt % of beclometasone on a dry basis, in which each injection of the composition delivers at least 1 µg of beclomethasone to obtain a metered dose.”

            The features “in which each injection of the composition delivers at least 1 µg of beclomethasone to obtain a metered dose” will not be taken into account, when checking the compliance with the patentability criteria “novelty” and “inventive step.”

            Therefore, identifying the drug for the treatment of allergic rhinitis known prior to the date of filing, which contains “an aqueous suspension of beclometasone solid particles in the amount from 0.04 to 0.045% wt % of beclometasone on a dry basis” is enough for an examiner to render a refusal due to the lack of “novelty.”

            Another example of the characteristic of the composition that is not allowed is independent claim 1 of the claims “A biocide varnish-and-paint composition”:

       “1. A biocide varnish-and-paint composition comprising a filmogenic substance in the form of a varnish-and-paint material and a biocidal additive, wherein as a biocidal additive it contains hydrophobic solventborne salt of polyhexamethylene guanidine or poly-(4,9-dioxadodecane guanidine), other than polyhexamethylen guanidine oleate, with the following components ratio, wt %: the filmogenic substance in the form of the varnish-and-paint material – 92.5-98.5, the biocidal additive – 1.5-7.5, while at first, the polyguanidine base is prepared by dehydrochlorinating polyguanidine hydrochloride in an aqueous solution in the presence of caustic soda, and then the resulting polyguanidine base is neutralized by the hydrophobic highest organic acid: oleic, undecylenic and pelargonic.”

The features “while at first, the polyguanidine base is prepared by dehydrochlorinating polyguanidine hydrochloride in an aqueous solution in the presence of caustic soda, and then the resulting polyguanidine base is neutralized by the hydrophobic highest organic acid: oleic, undecylenic and pelargonic,” when checking the compliance with the patentability criteria “novelty” and “inventive step” will not be taken into account as they relate to the method, but not to the composition.

Thus, in order to exclude the possible errors when registering an application for an invention for such complex subject matters as compositions and to take into account all necessary Requirements and Rules bearing in mind all changes made by the Order, which came into force on December 15, 2018, we would recommend the Applicants to seek help from the efficient specialists.

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