①Prospect of the patent grant to embryonic stem cells (hereinafter referred to as ES cells) is shown in a table below.
1) Animal ES cells pertain to “animal varieties” and thus are not patentable. Examination on an invention relating to animal bodies is relatively loose as long as the invention does not claim animal ES cells per se. Inventions of manufacturing method thereof, use method thereof and cells other than totipotent stem cells which will not be
differentiated into an entire animal all may be granted a patent right.
2) Inventions relating to (i) a method of producing human ES cells, (ii) ES cells per se and (iii) transgenic ES cells are not patentable, and inventions relating to (v) stem cells other than ES cells are patentable.
(3) Regarding “induced pluripotent stem cells” (iPS cells), they can be
differentiated into all the in vivo cells and thereby form all the tissues and organs of the body. The latest research (relevant research was published on the journal Nature dated September 3, 2009, which proves totipotence of iPS cells, namely, iPS cells can be developed and
differentiated into any tissues of a body even developed into an entire individual) shows that iPS cells have totipotence the same with ES cells. Hence, iPS cells probably are not patentable, either.
Strategy:
(1) Animal ES cells are not patentable even if they are limited to “non-human ES cells”, because “non-human ES cells” are not patentable, either.
(2) For limitation to “stem cells other than ES cells”, if there is no literal expression about “stem cells other than ES cells” or sufficient examples in the description, it is generally unallowable to exclude portions related to ES cells from the technical solution of a claim, i.e., a “disclaimer” amendment, because in the patent examination practice in China, the examination as to whether an amendment goes beyond the scope of the original disclosure is quite rigorous.
(3) In the situation that the above amendment is not accepted by the examiner, we usually will explain to the examiner that the content of the amended claim can be obtained based on the disclosed technical solution. For example, ① though the description does not state contents like “stem cells other than ES cells”, the description discloses at least one example relating to “stem cells other than ES cells”, and the claim is amended based on the stem cells specifically disclosed in this example; or ② if the description literally discloses and/or discloses in the examples other contents that can be taken as amendment basis, e.g., “stem cells derived from somatic cells”, the claim can also be amended based on these contents.
3. Article 25 of the Chinese Patent Law:
For any of the following, no patent right shall be granted:
(1) scientific discoveries;
(2) rules and methods for mental activities;
(3) methods for the diagnosis or for the treatment of diseases;
(4) animal and plant varieties; …
1) Scientific discoveries
Case 3:
Natural nucleic acid, proteins and microorganisms etc. pertain to scientific discoveries and are not patentable because they exist in the nature without undergoing any technical treatment by the human.
Strategy:
① Only when a nucleic acid and/or a protein is a product of artificial modification or the like and has a particular industrial use, the nucleic acid and/or protein is patentable.
② Microorganism per se constitutes a patentable subject matter only when it is isolated into pure culture and has a particular industrial use.
2) Rules and methods for mental activities
Case 4:
1. A method of selecting a frame of a marker used in a diagnosis application, comprising:
defining diagnostic parameters;
establishing a relation between the diagnostic parameters so as to determine an optimized frame of a marker; and
selecting said frame.
Analysis:
This claim relates to a method of selecting a frame of a marker used in a diagnosis application, and it substantively is a statistical method guiding people to think and determine, so it pertains to the scope of rules and methods for mental activities and thus is not patentable.
3) Methods for the diagnosis or for the treatment of diseases (please refer to IPNEWS, No.82, edited in June 2015 by Linda LIU& Partners)
4) Animal and plant varieties
Transgenic plants or transgenic animals pertain to animal and plant varieties. Protection for animal and plant varieties can be claimed under laws other than the patent law. For example, a new plant variety can be protected in accordance with the
Regulations for Protection of New Plant Varieties.
As prescribed by paragraph 2 of Article 25 of the Chinese Patent Law, for processes used in producing animal and plant varieties, patent right may be granted. However, the production processes here refer to non-biological processes and do not include those for the production of animals or plants through essentially biological processes.
Whether or not a process is an "essentially biological process” depends on the degree of human technical involvement in the process. If the human technical involvement is the controlling or decisive factor for achieving the result or effect of that process, the process is not essentially biological.
Case 5:
A method of raising high yield dairy cattle through irradiation and a method of producing lean meat pigs by improving raising approach are patentable subject matters.
II. Restrictive Effect of a Dosage Regimen Feature on a Claim
In the patent examination practice in China, the dosage regimen feature is not deemed to have a restrictive effect on a drug per se or a use of the drug, so the function of the dosage regimen feature is not taken into account in the evaluation of novelty and/or inventiveness of a claim.
However, the EPO’s examination in this regard is relatively loose, and the EPO recognizes the restrictive effect of the dosage regimen feature.
To be specific, with regard to the following case, it is feasible to elaborate the restrictive effect of the dosage regimen feature with reference to the following analysis.
Case 6:
1. A singly administrated formulation comprising an enzyme A per intervertebral disc x unit.
(1) Considering that the formulation of the present invention is a singly administrated formulation that is only administrated once, when the formulation is singly administrated, the administration amount of the comprised enzyme A is equal to the content of the enzyme A in the formulation.
The content of an active ingredient in the formulation has a restrictive function to both the formulation per se and the use of the formulation.
(2) Even if it is deemed that the content of the active ingredient in the formulation is “a dosage regimen feature”, the preparation of a drug is not the preparation of the active ingredient or the raw materials, and it should comprise all the steps before the drug leaves the factory and of course comprise the so-called “dosage regimen features” such as dosage form and dosage, etc. Thus, the “dosage regimen feature” has a restrictive effect on the claim.
A medical use invention is substantively an invention relating to a method of using a medicine, so a technical feature about how to use the medicine, i.e., “dosage regimen features” such as dosage form and dosage, etc. should be technical features of a method of using a compound and therefore should be encompassed in the claim.
In the practice, there is a need to improve the so-called “dosage regimen features” such as dosage form and dosage, etc. so as to obtain an unexpected technical effect. Besides, the preparation of a drug is not the preparation of the active ingredient or the raw materials, and it should comprise all the steps before the drug leaves the factory and of course comprise the so-called “dosage regimen features” such as dosage form and dosage, etc. In the condition that a patentee has made improvement in aspects such as the used dosage form and dosage, disregard of those so-called “dosage regimen features” is unfavorable for the development of the medicine industry and the health requirements of the public and does not conform to the purpose of the patent law.
A medical use claim generally includes substance features of the medicine, features of the preparation of the medicine, and indication features, and the doctor’s treatment behavior only relates to a feature of how to use the medicine but does not relate to the features of preparation of the medicine, so it does not infringe a patent right. Therefore, the encompassing of technical features of dosage form, use dosage etc. in a medical use claim will not limit the doctor’s behavior.
Specifically, any medical use invention substantively is a new method of using a substance or composition for treatment on the basis of a finding of a use benefiting at least partial patients by applying the substance or composition. One of the biggest problems faced by the doctor is how to treat a patient safely and efficiently. After a medicine comes into the market, all the doctors hope to make a proper prescription for a patient in accordance with a proper dosage they deem and the administration method such as an effective dosage and administration form within the safe scope identified by the manufacturers. A proper prescription is capable of improving treatment effect, reducing side effect during the treatment, improving compliance of the patient and decreasing economic burden of the patient. Hence, for an invention of which the innovative characteristic lies in improvement to a dosage regimen in a known treatment method, it substantively is the same as a new treatment method and represents a technical progress. This kind of inventions providing improvement to the dosage regimen will not limit the doctor’s behavior.
In view of the foregoing, in the condition that a “dosage regimen feature” has a restrictive effect on a medical use invention, the “dosage regimen feature” also has a restrictive effect on products of the medicine-producing process – “medicine” or “formulation”. The function of the “dosage regimen feature” should be taken into consideration when determining novelty and/or inventiveness of a claim.
III. Inventions of Crystal Form of a Compound
In the chemical field, inventions of crystal form of a medical compound are presented for purpose of extending patent protection period of an active compound, saving research and development cost and the like. Inventions of crystal form of a medicine are a special kind of product inventions in chemical field. They relate to chemical substances characterized by both chemical structural features and microscopic physical structural features, so they not only have general characters of chemical products but also have specific characteristics of microstructure. In the SIPO’s
Guidelines for Patent Examination, there is no explicit stipulation about the examination of the compound crystal form.
Early patent applications relating to compound crystal forms could be easily granted a patent right in China, perhaps because it was deemed that the preparation of the crystal form was unpredictable to some extent and therefore an inventive step of the claimed crystal form was recognized in the condition that its novelty was recognized. However, for a patent right granted in accordance with the aforesaid evaluation standard, its stability is insufficient. For instance, among invalidation cases involving inventiveness grounds in the chemical field, the proportion of invalid patents is higher than that of patents which are maintained to be valid. Moreover, since conclusions about inventiveness given by the Patent Reexamination Board and the courts are quite consistent, the SIPO’s examination as to inventiveness of a patent application relating to compound crystal form has become rigorous during the substantive examination.
At present, it is also generally deemed by the SIPO during the substantive examination that although an invention relating to a medicine crystal form is an invention of a compound having a special microstructure, only the unpredictability in the microscopic characteristics of the crystal generally is not enough to constitute a sufficient reason for an inventive step of this kind of inventions. Inventiveness should be evaluated by considering this aspect in combination with technical effect, technical problem to be solved and technological level in the art.
According to the SIPO, there is a general motivation of making research around a valuable known compound to find a different crystal form. Moreover, in a case where the structure of a compound is known, one skilled in the art usually can obtain a crystal form of the compound by means of a conventional technical means such as recrystallization. Thus, where the contribution made by a claimed invention with respect to the prior art is only providing a crystal form and the crystal form does not have an unexpected technical effect, this crystal form generally cannot be deemed to be non-obvious.
In the light of present situation, for an invention relating to a compound crystal, to be granted a patent right and maintain stability of the right in China, the application document not only needs to describe identification data of the novel crystal form of the compound but also needs to describe various experimental data capable of reflecting effects possessed by the novel crystal form, such as stability, solubility in water, workability, bioavailability, dissolution rate, etc., so as to meet the requirement of “a novel crystal form needs to have an unexpected technical effect” by the evaluation of inventiveness. Such a determination standard is basically the same as that of the EPO or the USPTO. However, since experimental data filed by the applicant after the filing date usually can hardly be accepted by the SIPO during the examination procedures, in the practical examination, the SIPO’s standard for evaluating inventiveness of a crystal invention perhaps is stricter.
According to the EPO, the finding of a polymorph per se does not pertain to a technical problem unless this crystal form solves a practical technical problem. However, the EPO perhaps has a loose requirement for effects, and if the applicant provides favorable comparative experiments (e.g., stability), the EPO will generally accept them. While the USPTO deems polymorph to be general knowledge in the medical compound field, and the difference between different crystal forms only lies in the molecular stacking manner or molecular conformation, but this difference in physical property is obvious. A new crystal form of a known compound can hardly be granted a patent right unless it has advantage (advantageous effect or unexpected technical effect) with respect to the crystal in the prior art. The USPTO’s requirement for effects perhaps is relatively high. For example, if a crystal merely has an improved stability relative to an amorphous compound, the USPTO may not deem it as an unexpected technical effect.
The following are a reexamination case and an invalidation case about compound crystal forms in China, for reference.
Case 7:
Reexamination Decision No. FS34333
Claims 1 to 15 of the present application claim a benzenesulfonate salt of a compound and a Form I polymorph of the benzenesulfonate salt.
Example 39 of Reference 1 discloses a compound of formula (I), and other parts of Reference 1 further disclose that salts can be formed from the compound of formula (I) with a plurality of acids including benzenesulfonic acid and can exist in form of a polymorph or an amorphous matter.
According to the conclusion of the collegial panel, Reference 1 gives a technical suggestion that the PPARγ modulator of the general formula (I) can form salts which may be in form of a polymorph. Because the compound disclosed in Example 39 is a specific compound within the scope of the general structure I, according to the teaching from the other parts of Reference 1, one skilled in the art would be motivated to react the compound in Example 39 with an acid to form a salt and obtain a compound in form of polymorph by means of a conventional technical means.
The technical solution of claim 1 is merely a choice from some known possibilities. In the condition that no unexpected technical effect is obtained, claim 1 is obvious over Reference 1 and thus does not possess inventiveness prescribed by Article 22.3 of the Chinese Patent Law. Claims 2 to 15 claim a polymorph of the benzenesulfonate salt of a compound of formula (I). However, Reference 1 gives a technical suggestion for the preparation of a polymorph of a compound of formula (I), and one skilled in the art can specifically select one crystal form from the polymorph via simple experiments, e.g., evaporative crystallization or crystallization by cooling down a saturated solution. Therefore, the technical solutions of claims 2 to 15 do not possess inventiveness.
In view of this case, if an invention is a choice among from some known possible polymorphs, the invention will possess inventiveness in the precondition that the selected crystal form can obtain an unexpected technical effect.
Case 8:
Examination Decision on Request for Invalidation No. 12206
Title of invention: crystalline monohydrate, processes for the preparation thereof, and use thereof for the preparation of pharmaceutical compositions
The present patent relates to a crystalline tiotropium bromide monohydrate of a compound of formula (I), processes for the preparation thereof, a pharmaceutical formulation comprising the crystalline monohydrate and use thereof for the preparation of a medicament. The granted patent includes 8 claims. Later, the patentee amended the claims in response to the request for invalidation, and the amended claims include 6 claims. Because claims 1 to 6 do not possess inventiveness with respect to evidence 1 or the combination of evidence 5a and evidence 1, the Decision announces that all the patent rights are invalid.
According to the examination decision, in the collegial panel’s opinion, all of the crystalline tiotropium bromide monohydrate in claim 1 of the present patent, tiotropium bromide x-hydrate in evidence 5a and the tiotropium bromide crystal in evidence 1 have tiotropium bromide as a main structure, and the three substances are chemical products whose structures are very similar. Therefore, the chemical product in claim 1 can have an inventive step only when it has an unexpected use or effect.
As regards the use and technical effect of the chemical product claimed by claim 1, the description of the present patent discloses: (1) the tiotropium bromide monohydrate is used for preparing a pharmaceutical composition for treating asthma or COPD; and (2) the crystalline tiotropium bromide monohydrate according to claim 1 meets the stringent requirements imposed on pharmaceutically active substances, including the stability of effect of the starting material under various environmental conditions, stability during production of the pharmaceutical formulation and stability in the final medicament compositions.
With regard to the use and effect mentioned in (1) above, based on the Background Art, i.e., a family patent application EP418716A1 of evidence 1, the present patent determines that the crystalline monohydrate according to claim 1 has an activity for treating asthma and COPD. The patentee neither claim nor give evidence proving that the crystalline monohydrate according to claim 1 achieves an unexpected technical effect in treating asthma and COPD with respect to the existing chemical product in evidence 5a or evidence 1.
As regards the effect that the crystalline tiotropium bromide monohydrate according to claim 1 meets the stringent requirements imposed on pharmaceutically active substances, the description merely generally mentions the above-mentioned technical effects, but there is no evidence proving the existence of these technical effects. Thus, it cannot be deemed that the crystalline tiotropium bromide monohydrate according to claim 1 has an unexpected technical effect with respect to the existing chemical product in evidence 5a or evidence 1 in the aspect of meeting the stringent requirements imposed on pharmaceutically active substances.
The patentee also claims that the crystalline monohydrate of the present patent can form a single crystal, which has a high purity and is suitable for medical use, can be stored in a long term period and has a high chemical stability. With regard to these effects, the collegial panel holds the following opinions: what claimed by claim 1 is not a single crystal and there is no evidence showing whether the crystalline monohydrate can be produced into a single crystal, and no basis for its high purity and excellent quality; the anhydrous crystal in evidence 1 is more stable than the crystalline monohydrate according to claim 1 of the present patent.
From this examination decision, it can be seen that whether evidence for an unexpected use or effect will be taken into account and accepted depends on whether said technical effect is explicitly disclosed in the original application document.
IV. Chinese Patent Examination Practice of Product Claims Characterized by Parameter Features
(1) Whether a product claim characterized by parameter features is clear or not
In the patent examination practice in China, the examiner will first determine whether the parameter features meet the requirement for clarity.
The determination standards mainly include: (i) whether the name and/or technical meaning of the parameter per se are clear or not, and (ii) if different parameter values will be obtained by different measurement methods or in different measurement conditions but the measurement method or measurement condition for the parameter is not defined in the claim, then this parameter is not clear.
According to our practical experience and conditions learned from the examiner, the following parameter features usually are liable to be deemed to be unclear by the examiner:
melt flow rate, viscosity, specific surface area, hardness, flexural elastic modulus and bending strength.
The reasons mainly are as follows: although the meanings of these parameters per se are clear, there is a plurality of measurement methods or measurement conditions for them, and different parameter values will be obtained by different measurement methods or in different measurement conditions. If a claim does not define the specific measurement method or measurement condition, the claim is liable to be unclear.
(2) Whether a product claim characterizing by a parameter feature has novelty
As stipulated in Section 3.2.5 of Chapter 3 in Part II of the SIPO’s
Guidelines for Patent Examination, for product claims including feature of parameters, the examiner shall consider whether the feature of parameters in a claim implies that the claimed product has a structure and/or composition distinct from that of the product disclosed in the reference document, if YES, the claim has novelty. On the other hand, if one skilled in the art from the parameter feature cannot distinguish the claimed product from that disclosed in the reference document, it can be presumed that the claim does not possess novelty, unless the applicant can, based on the application or the prior art, prove that the claimed product is distinct from the product in the reference document in structure and/or composition.
In the patent examination practice in China, the examiner generally adopts such a standard to determine novelty. Objections presuming that a claim does not possess novelty are often seen.
(3) Whether a product claim characterizing by a parameter feature has an inventive step
Generally speaking, inventiveness of this type of claims is also determined by “three-step method”, i.e., compare the claimed invention with the closest prior art, determine the distinguishing technical feature and the technical problem to be actually solved, thereby determine whether it is obvious.
In practice, examination on inventiveness of parameters is much more complicated than that on inventiveness of an ordinary invention. The reason lies in complexity of the parameter per se. Even in the same form of parameter, different parameters reflect different contents, some reflecting structure and/or composition of a product, some reflecting properties and/or effects of the product, and some in between and it is difficult to determine or differentiate whether it reflects structure and/or composition or properties and/or effects.
Where a parameter feature of a claimed product constitutes a distinguishing technical feature from the closest prior art, the examiner may first determine the technical meaning of this parameter feature according to relevant description of this parameter in the description and/or ordinary technical knowledge in the art to determine whether this parameter feature is a “structural parameter” tending to reflect structure and/or composition of the claimed product or an “effect parameter” tending to reflect properties and/or effects of the claimed product, and then may adopt different subsequent examination manner for “structural parameter” and “effect parameter”.
If it is a “structural parameter”, the examiner may analyze its influence on the technical effect to be realized by the present invention or analyze whether there is a correspondence relation between them. Only in the condition that such an influence or correspondence relation exists, the technical problem to be actually solved by the invention can be determined based on this technical effect.
If it is a feature of “effect parameter” reflecting properties and/or effects, the examiner perhaps will unlikely determine the technical problem to be actually solved by the invention based on this property and/or effect feature but may first determine whether the claim characterized by this feature of “effect parameter” is supported by the description (see item (4) below). In the condition that the claim is supported by the description, then the examiner determines the technical problem to be actually solved by the invention based on this “effect parameter” and thereby determine whether it is non-obvious.
On the other hand, because the complexity of parameter per se makes it not easy for one skilled in the art to determine the technical problem to be actually solved by the invention, the examiner may deem a parameter feature constituting a distinguishing technical feature as a conventional technical means in the art and therefore question the inventiveness. In this case, the applicant can try to argue for inventiveness from a viewpoint of functions of this parameter feature and effects that can be realized by this parameter feature.
(4) Whether a product claim characterizing by a parameter feature is supported by the description
To determine whether this type of claims are supported by the description, the examiner usually refer to the stipulation for support of a claim containing “definition by features of function” in Section 3.2.1 of Chapter 2 of Part II of the SIPO’s
Guidelines for Patent Examination.
That is, as a general principle, parameter features reflecting properties and/or effects of the product contained in a claim shall be construed as embracing all the means that are capable of realizing said properties and/or effects. If said properties and/or effects are carried out in a particular way in the embodiments of the description, and one skilled in the art would not appreciate that said properties and/or effects could also be carried out by other alternative means not described in the description, or one skilled in the art can reasonably suspect that one or more means embraced in the definition by the parameter features reflecting properties and/or effects cannot solve the technical problem aimed to be solved by the invention and achieve the same technical effect, then the examiner possibly will question that this claim is not supported by the description.
The following case is analyzed as an example.
Case 9:
Claim: A polyethylene glycol-2,6-naphthalene film, characterized in that a surface of the film has a roughness Ra of 2 to 10 nm, and a plane orientation coefficient NS and an average refraction index na meet the following formula (1):
Formula (1): NS≥ 1.61na-2.43
The description discloses that when the surface roughness is 2 to 10 nm, an excellent walking ability and electromagnetic transduction property are achieved, and when the plane orientation coefficient NS and the average refraction index na meet the above-mentioned formula (1), higher longitudinal and transverse strength/Young 's modulus and excellent walking ability and electromagnetic transduction property are achieved.
Examples disclose surface roughness and electromagnetic transduction property of polyethylene glycol-2,6-naphthalene films meeting all the conditions defined in the claim, and surface roughness and electromagnetic transduction property of polyethylene glycol-2,6-naphthalene films not meeting the above-mentioned surface roughness and formula (1) are also described in Comparative Examples.
Analysis:
The technical problem to be solved by the present invention is how to enable the film to have a higher longitudinal and transverse strength/Young's modulus and meanwhile improve walking ability and electromagnetic transduction property of the film, and the technical means adopted is setting the surface roughness of the film to be within a special range and allowing the film to meet the mathematical formula (1).
As well known by persons skilled in the art,
there is a correlation between surface roughness and excellent waling ability and electromagnetic transduction property. However, formula (1) is not a parameter conventionally used in the relevant field, and it reflects very complicated technical information. The description merely gives Examples in which the technical problem of improving the electromagnetic transduction property and walking ability of the film can be solved when both the surface roughness and formula (1) are satisfied, and Comparative Examples in which said technical problem is not solves when both the surface roughness and formula (1) are not satisfied,
but not give Examples in which the technical problem of enabling the film to have a higher longitudinal and transverse strength/Young 's modulus is solved and said technical effects are realized when formula (1) is met.
According to the contents disclosed by the description,
one skilled in the art cannot determine whether there is a correlation between formula (1) and the technical problem aimed to be solved, i.e., how to enable the film to have a higher longitudinal and transverse strength/Young 's modulus, and the technical effects. That is, one skilled in the art has no idea about the influence of formula (1) on the technical problem to be solved and the technical effects to be achieved. Therefore, this claim is not supported by the description.
V. Study on Effectiveness of Supplementary Experimental Data for Verifying Inventiveness of a Patent
Use of supplementary experimental data to verify inventiveness of a patent mostly exists in patent examination practice of patent applications in chemical, biological and medical fields. Several years ago, the SIPO applied a relatively rigorous standard to supplementary experimental data in the patent examination practice. The examiners determined whether a patent application had an unexpected technical effect with respect to the prior art and thereby determined whether it had inventiveness only based on experimental data originally disclosed and substantially did not take the supplementary experimental data into account. But recently, in the patent examination practice in China, a looser standard has been adopted, but only supplementary experimental data of properties can be taken into account to prove inventiveness of a patent application.
Thus, people have paid wide attention to conditions in which supplementary experimental data will be accepted to prove inventiveness, or conditions in which such data will not be accepted. Here, the following case is described in the hope that a general principle can be concluded.
Case 10:
Administrative dispute about patent right between Takeda Pharmaceutical Company Limited and the Patent Reexamination Board of the SIPO, Sichuang Haisco Pharmaceutical Corporation, Chongqing Pharmaceutical Research Institute Co., Ltd.
[Written Administrative Ruling No. 41 (2012) by Supreme People’s Court]
Point in dispute and relevant judgment:
Whether it is wrong to not adopt counterevidence 7 (experimental data) in the No.12712 Examination Decision on Request for Invalidation
Course: During the invalidation examination procedure, Haisco Pharmaceutical Corporation and Chongqing Pharmaceutical Research Institute respectively filed requests for invalidation to the Patent Reexamination Board, asking the Board to announce that the concerned patent owned by the patentee Takeda Pharmaceutical Company Limited is invalid. The invalidation grounds mainly are that some claims do not possess inventiveness. To prove inventiveness of the concerned patent, the patentee Takeda Pharmaceutical Company Limited provided counterevidence 7 (supplementary experimental data). In the Examination Decision, the Patent Reexamination Board deems
that counterevidence 7 is not accepted as true. Because the truth of the counterevidence 7 cannot be confirmed, the counterevidence 7 cannot be used to prove that the present patent achieves an unexpected technical effect.
Being unsatisfied with the above Examination Decision, the patentee Takeda Pharmaceutical Company Limited brought an administrative action to the First Intermediate People’s Court of Beijing, and the court upheld the Examination Decision. Subsequently, the patentee appealed to the Beijing Higher People’s Court, and after the second instance, the higher court judged that
it was right for the Patent Reexamination Board
to not accept counterevidence 7. Then, the patentee requested retrial before the Supreme People’s Court.
The Supreme People’s Court mainly held the following opinions:
The description of a patent shall sufficiently disclose the invention or the utility model. Technical solutions,
technical effects etc. not disclosed in the description generally shall not be taken as basis for evaluating whether a patent application complies with legal standards for granting a right and determining a right. Experimental data supplemented after the filing date is not content described and disclosed in the original application document, and this information is unavailable to the public. If the experimental data is not content of prior art and cannot be known by one skilled in the art before the filing date of the patent application, the affirmation that a technical solution is capable of realizing said technical effect based on the experimental data violates the first-filing principle and the substance of the patent system – disclosure to seek for protection, and the grant of a patent right on this basis is unfair to the public.
When a patent applicant or patentee intends to prove that the claimed technical solution has inventiveness over the prior art by submitting comparative experimental data,
the data can be accepted in the precondition that the data must be directed at a technical effect explicitly disclosed in the original application document.
The technical effect to be verified by the experimental data supplemented by the patentee Takeda Pharmaceutical Company Limited
is not one described or verified in the original application document. Such experimental data cannot be taken as basis for evaluating inventiveness of the patent application.
Conclusion:
From the above-mentioned Decisions made by the Patent Reexamination Board and the Courts in China, it can be seen that the supplementary experimental data can be accepted in the precondition that the data
must be directed at a technical effect explicitly disclosed in the original application document, and supplementary experimental data shall not be taken as basis for evaluating inventiveness of a patent application if the supplementary experimental data is not disclosed or verified in the original application document.
From the above the following case can be derived:
A patent application relates to a composition comprising components (A), (B), (C), and the closest prior art also relates to a composition of the same subject matter, which comprises components (A) and (B).
During the examination, the examiner points out that the present patent application differs from the closest prior art only in component (C), but one skilled in the art would readily think of the combination of component (C) with components (A) and (B) according to a conventional technical means and thereby obtain the technical solution of the present patent application.
In this case, if the application document originally discloses a technical effect obtained by the combination of components (A), (B), (C), to prove inventiveness of the present application with respect to the prior art, the applicant can think about carrying out comparative experiments using the prior art composition comprising components (A) and (B) in the same conditions with the present application and supplementing the results of the comparative experiments as supplementary experimental data.
If the supplementary experimental data can reflect that the claimed composition exhibits a technical effect superior to that of the composition of the prior art, it can be used to prove inventiveness.
As can be seen, there is a precondition that the application document originally discloses a technical effect obtained by the combination of components (A), (B), (C). The supplementary experimental data is obtained by corresponding experiments using the prior art directed at the originally disclosed technical effect, to prove inventiveness of the present application.
In the patent examination practice in China, such supplementary experimental data is usually taken into account.
