Application of Article 33 of China’s Patent Law

By Li Yue, Director of Chemical Appeals Division 1, the Patent Reexamination Board of SIPO,[Patent]

On the much debated issue over the proper application of Article 33 of the Patent Law, this article tries, with two typical cases of patent reexamination and invalidation, on the basis of legislative essence, to compare with examination practices in other countries, comment on views of judicial decisions, make an in-depth evaluation of the standard of examination and its impact in applying Article 33 in patent reexamination and invalidation cases, and consider appropriate handling of the standard, with a view of providing some reference for a better examination under Article 33.

I. Introduction
One hot issue in China’s patent examination and judicial practice over the recent years has been the amendment to patent application documents. Typical cases heard before the Supreme People’s Court in 2011, such as the ink cartridge, Simcere and Zen Guansheng cases, have had some impact on understanding and application of Article 33, leading to controversy over examination standard under Article 33. Although the problem arises in some individual cases of examination mechanically following the standard when handling amendments under Article 33, with certain irrational results in these cases, it has rippled among applicants or their agents and examiners, frequently among different examination departments and examiners, and even among different courts and different judges. The Article has been criticized for lacking of rationality and flexibility in individual examination case, to the extent of affecting protection of inventions. For this reason, the author tries to analyze the No. 8808 patent invalidation decision and No. 12303 patent reexamination decision, both rendered by the Patent Reexamination Board (PRB), on the basis of the legislative essence of Article 33, make a comparison of examination practices in other countries, comment on judicial decisions, and evaluate the standard set forth under Article 33 in patent reexamination and invalidation cases, in a bid to explore reasonable understanding of the standard.

II. Brief introduction of the examination model of article 33
Article 33 of the Patent Law provides, “An applicant may amend his patent application specification, but the amendment shall not exceed the scope of the written description or claims as first filed for invention or utility model applications, or the scope of the drawings or photographs as first filed for design patent applications.”

The Patent Examination Guidelines provides in key part: “As a principle, it shall not be permitted for any amendment to the written description (and the drawings) or the claims that is not in compliance with the provisions of Article 33 of the Patent Law.

Specifically, if what is applied for, by way of such addition, modification and/or deletion in part of the contents of the application, that it appears to a person skilled in the art as different from those described in the initial application and such information cannot be directly or unequivocally derived from those described in the initial application, such amendment shall not be allowed.

Here, what is applied for refers to the subject matter described in the original written description (along with the drawings) and claims, excluding the contents of any priority documents.”

Under the above provisions, SIPO does not take different examining approaches between amendments to claims and to written descriptions, and requires the amendments to be described or directly and unequivocally confirmed in the patent application documents as of the filing date. One result is that, because of the different opinions between applicants and the examining department, quite a number of patent applications are rejected annually due to incompliance with Article 33. Also, Article 33 related requests of invalidation are frequently made, mostly of two types: those regarding amendments to claims, and those to the written descriptions.

This Paper below will, through two typical cases, analyze consequences arising from the existing Chinese examination standard and explorations made by the PRB panel to solve the relevant problems in practice.

III. Typical case 1 (request for invalidation)

1. Introduction of case 1

(1) References and Parties

Patent number: 88108904.4
Invalidation Requester: Jiangsu Institute of Ecomones Co., Ltd. (Jiangsu Institute)
Patentees: Kumiai Chemical Industry Co., Ltd. (Kumiai); Ihara Chemical Industry Co., Ltd. (Ihara) (2) Summary of
Background and Facts

“Bispyribac” is a salicylic acid pyrimidine series herbicide jointly developed by Kumiai and Ihara. Its chemical abstract name is sodium 2, 6-bis [(4, 6-dimethoxy-2-pyrimidiny l) oxy] benzoate and its international generic name is bispyribac-sodium. Japan-based Kumiai and Ihara filed invention patent applications respectively in China with application No. 88108904.4 (the 88’ patent) and No. 92112424.4 (the 92’ patent). The 88’patent relates to the preparation process of herbicide “Bispyribac,” while the 92’ patent, a pesticide preparation with “Bispyriba” as an active ingredient. In response to invalidation request filed by Jiangsu Institute, PRB ruled to sustain validity of the 88’ patent by Decision No. 8808 and the 92’ patent by Decision No. 8823.

Kumiai and Ihara had sued Jiangsu Institute for patent infringement of the two patents in Nanjing Intermediate People’s Court. After the first and second instances, the Higher People’s Court of Jiangsu Province ruled, on June 8th 2005, that Jiangsu Institute had infringed upon the 88’ patent and indirectly infringed upon the 92’ patent in accordance with the principle of reversal of burden of proof, causing widespread impact in the agricultural chemical industry.

This Paper will introduce the decision rendered by PRB over the preparation methods of the “Bispyribac” protected in 88' Patent in response to a request for invalidation. The decision was upheld by the first and second instance courts later.

2. Trial

(1) Arguments of Parties and Related Facts

The invalidation requester argued that the amendment are unsupported because 1) the original written description disclosed a production method wherein Formula 1 is obtained when Formulas 2, 3 and 4 are reacted simultaneously; whereas the reaction as amended is subsequent, i.e., F1 first reacts with F2, and then with F4. The original written description does not disclose an instance when F3 with F4 are equivalents; nor was Plan (b) of the amended claim disclosed in the original written description; and 2) comparing the written description as issued with the published version, it can be seen that line 1 of page 14 through the line but last is missing.

The patentees responded by indicating that the missing part in the issued version in light of the published version was a correctible apparent error which occurred when a substitute page was submitted for the application document, and a request for correction has been filed with SIPO, which will not lead to exceedance of the original written description, and the patent thus complied with Article 33.

Both parties, when making invalidation argument and response statement over the Article 33 issues, referred to the page and locations of the published version of the patent specification, rather than the original version, and the parties consented that the relevant contents of the published version coincide with those of the original version. Although examination of the article should be based on the original version, the PRB Panel decided to use the page numbers and locations of the published version.

(2) Issues of the Dispute

The issues derived from the above arguments are: one, whether the amendment in claim 1, as issued, for the reaction process was supported by the original written description; and two, whether the missing part in the issued version in light of the published version shall lead to invalidation of the patent.

(3) Summary of the Decision

(a) On the First Issue

PRB opined in its No. 8808 invalidation decision that: as regards the first ground for the amendment exceeding the scope, the preparation method for F1 described on Page 7 of the original description is reaction between F2 and F3 (or F4). An ordinary person skilled in the art may, based on the structure of F1 and the three compositions, directly confirm that F1 is jointly prepared by F2, F3 and F4. As for the reaction sequence of the three raw materials, when D, E and A are all methoxy, F3 and F4 have the same compound. In this regard, whether the reaction takes place first between F2 and F3, then with F4, or F2 and F4 first, then with F3, the reaction sequences have no difference. Therefore, the person skilled in the art can directly and unambiguously determine that where F3 and F4 are the same, the preparation of F1 in the original description, as a COLUMN China Intellectual Property 62 China IP 3-4/2014 matter of fact, only has two reaction sequences, namely, F2 and F3 (or F4) react one by one in the same “amount,” or F2 reacts together with F3 (or F4) in twice the “amount.” The aforesaid plans are Plan (a) and Plan (b) described in the existing claims.

Secondly, the step-by -step reaction in Plan (a) of Claim 1 can be inferred from Method D on Page 13 of the original description and the description of Method D on Page 15 (please refer to the first paragraph of Page 14 for the definition of R2) together with definitions of A, D and E, and the reaction sequence as reflected in Example 10 is also the step-by-step reaction in Plan (a) of Claim 1. The step-by-step reaction in Plan (b) can be inferred from Method A on Page 13 and the last 4 and 5 lines of Page 14 which is Plan (b) of Claim 1 of reaction between Plan b and F3 twice the amount, together with definitions of A, D and E, and the reaction sequence as reflected in Example 9 is also the step-by-step reaction in Plan (b) of Claim 1. Based on the above, it can be concluded that the amendment to Claim 1 has not exceeded the scope of the original description.

(b) On the Second Issue

PRB opined in its No. 8808 invalidation decision that: the Panel found that the missing part in the patent specification, as issued, in column 6, in light of page 14 of the published version, relates to the written description, including definitions of some radical groups in the six reaction schemes (Method A to Method F), preparation methods of F2 composition and Method A as one of the reaction schemes on Page 13 of the published version. However, the requester failed to indicate and prove what impact such omission would have on the protection scope of the subject matter sought by the patent, or whether the impact, if any, could be directly and unequivocally derived from the original written description. Moreover, the Panel found no new matter, by the omission, where the Requester has to introduce from outside the patent specification or from information established after the filing date, leading to new scope sought to be protected.

In addition, the written description is meant to describe technical solutions seeking protection. The Panel has found the absence will not cause an ordinary person skilled in the art to misunderstand the description of the technical solutions in existing claims. For example, Methods A-F are further descriptions of the technical solutions seeking protection, but based on the above, descriptions of the technical solutions are not entirely dependent on Methods A-F. Furthermore, substituents in missing Methods A-F may be defined on the basis of definitions of substituents elsewhere in the description, in the product or examples. In the absence of definitions of substituents and the written description of Method A, the methods claimed for protection may still be described on the basis of schemes illustrated by Methods A-F and the entire context of the description.

It should also be noted that Article 33 targets at amendments in terms of contents and scope. In this case, since the patentee during substantive examination submitted to SIPO for approval the substitute page of amended text which included the part later missing, it can be concluded that in the absence patentee’s subjective intent to omit through amendment or objective fact of omission of the aforementioned contents, nothing, strictly speaking, has been omitted as a material act of “amendment” in this case; as to how the aforesaid contents were not included in the issued version, whether the patentee being responsible or not, it should not trigger Article 33 for forfeiture of the patent rights.

IV. Typical case 2 (reexamination aApplication)

1. Overview of the case

(1) References and parties

Patent application number: 02824170.3
Applicant: BASF SE

(2) Introduction of the case

PRB reexamination decision No.12303 relates to a patent at issue which seeks protection of a process for preparing ammonium salts of alkanoic acids by selecting a specific aprotic solvent to enable aromatic carboxylic acid to react with gaseous ammonia under certain conditions to produce ammonium salts. In the claim, the aromatic carboxylic acid applicable in the process was defined, but the previous examination department found the protection scope of the claim was too broad to be supported from the written description, which was not in conformity with Article 26 (4), of the Patent Law, and required applicant to further restrict the definition. Later, the examination department rejected the definition as amended for incompliance with Article 33.

The decision held that although in the description the benzene ring may be unsubstituted or substituted by 1-3 commonly used substituents, the description merely provides that one benzene ring or that having a benzene ring bonded directly to the carboxyl group of an aromatic carboxylic acid may be unsubstituted or substituted, and does not provide that the benzene ring on the benzoic acid may be substituted by commonly used substituents.

In the reexamination proceeding, the Panel found that the description conveys the information that aromatic carboxylic acid includes those compounds that have at least one benzene ring and a carboxyl that is bonded directly with the benzene ring or via C1-C4 alkylene chain, the benzene ring and the alkylene 3-4/2014 China IP 63 chain may be unsubstituted or substituted with 1-3 commonly used substituents; and that the method of the invention is particularly suitable to transform benzoic acid. Strictly speaking, the description has twolayer range of definitions, the first is aromatic carboxylic acid that may be substituted by commonly used substituents; the second is unsubstituted benzoic acid. Therefore, benzoic acid that can be substituted by commonly used substituents after amendment has been a new range generalized.

2. Trial

(1) Issue of Dispute

The issue of the dispute is whether information newly generalized by the definition of aromatic carboxylic acid, namely, “benzoic acid which has been substituted by selecting 1-3 substituents from C1-C4 alkyl, hydroxy, C1-C4 alkoxy, halogen and nitryl,” has exceeded the scope of the written description or the claim.

(2) Summary of the Decision

PRB held in its No. 12303 reexamination decision that: as the original written description has disclosed, on the one hand, the original description has clearly stated that benzoic acid is a species of aromatic carboxylic acid, which has even been the preferred and much-concerned part in drafting the written description; on the other hand, the written description has also clearly stated that aromatic carboxylic acid includes at least one benzene ring and a carboxyl that is bonded directly with the benzene ring, and the said benzene ring may be unsubstituted or substituted with a series of commonly used substituents as mentioned above. Since benzoic acid is made up of a benzene ring and a carboxyl that is bonded directly with the benzene ring, the ordinary person skilled in the art, after a comprehensive review of the aforesaid information, can unequivocally ascertain that the benzene ring in benzoic acid may also be unsubstituted or further substituted, and when it is substituted, the aforesaid substituent is bound to apply to the benzene ring used to substitute benzoic acid. In other words, benzoic acid which has been substituted by the benzene ring can be directly and unequivocally determined by the ordinary person skilled in the art; therefore, applicant’s amendment did not exceed the scope of the original written description and claims, which was in compliance with Article 33.

V. Case analysis and inspirations

1. Importance of standard under Article 33 as ordinary persons skilled in the art

The standard under Article 33 is the ordinary person skilled in the art. The examiner often adopts objective standard in the reexamination practice, namely, “direct and unequivocal determination.” But it cannot be ignored that the person making “direct and unequivocal determination” should be defined as a hypothetical person, namely, an ordinary person skilled in the art, who is determined by peculiarity of the object in patent reexamination. The requirement for the standard is also a guarantee against arbitrary and capricious examination. The standard, in making an Article 33 analysis, requires understanding of patent application as a whole and making a determination based on ordinary technical knowledge in the particular field. In patent examination, it is important to understand the essence of inventions from the technical perspective, rather than just to focus on the literal meaning of the words, which may result in mechanical application of law and a game of words. Therefore, in any proceedings, examinations under Article 33 cannot be simply transformed into “looking for differences” among words.

It can be seen from Case 1 that ostensibly the amended context has made relatively many amendments to the original description. However, as Article 33 has been cited as a ground for patent invalidation in an invalidation proceeding, the Panel, first of all, needs to determine the difference as a result of the amendment from the perspective of an ordinary person skilled in the art and ensuing impact on the rights obtained, which, as a matter of fact, is a step closer to the issue of the dispute. The importance of the determination lies in that the Panel, based on an overall review of the technical information stated in the lengthy patent description, and analysis and research of understanding and reasoning of the reaction sequence and definitions of substituents by technical personnel in the organic synthesis field, will narrow the examination to: whether the differences arising out of the amendment can be substantially proved in the overall application documents, and whether the impact that may have on the claim will be eliminated by technical information elsewhere in the application documents. From this case, it can be seen that the key to the direction of this case depends on whether the judge will be defined as an ordinary person skilled in the art, whether the judge can fully and accurately understand technical contents of the entire application documents and have the ability to use their analytical reasoning skills to identify the essence of the amendment through the verbal differences.

2. Application of Article 33 needs to follow the legislative intent and reflect the purpose of establishing the patent system as well

Examination criteria are abstract, so the application thereof should be guided by the legislative essence in face of a fresh case in practice. The drafting of criteria is to solve problems, therefore, the application thereof is not a simple “taking the right seat based on your number.” Moreover, accurate COLUMN China Intellectual Property 64 China IP 3-4/2014 understanding of Article 33 needs to consider the entire patent law system for, “an overall interpretation and coherent application.”

Firstly, understanding the legislative essence of Article 33 will help guide accurate and reasonable application of examination standard in specific cases. Application of law “needs not only to follow legal provisions, but also to achieve the ultimate goal, function and value of law. Adjudication by law does not mean rigid, mechanical and one-sided understanding of legal provisions.Decisions which are inconsistent with legal principles, impractical, produce absurd results or do not meet socially accepted notions of fairness and justice, are not in line with legal requirements. Applications of law which have led to such judgments are not correct applications.” The above requirements are also applicable in our examinations under Article 33.

Article 33 allows applicants to amend their application documents for the purposes of encouraging innovation and maintaining vitality of the patent system. Restrictions set on “amendments” are meant to protect “first-to-file principle,” prevent applicants from abusing rights to the detriment of the public interests, and achieve a balance of interests between applicants and the public. Specifically, Article 33 serves two purposes, firstly, the legislative essence of Article 33 is to prevent applicants/ patentees from adding, after the filing date, new matter which has not been described in the application documents disclosed at filing to improve their inventions with the view of gaining an unfair advantage, and to avoid compromising the interests of any third party that trusts the original patent application documents so filed. Applicants should file for protection of an invention completed on the filing date, either granting of an incomplete invention or request for an earlier filing date for protection of an invention completed afterwards is an encroachment on the public interest and not conducive to encouragement of real inventions. Secondly, it can also prevent applicants from paying less attention to writing application documents, maintain the authority of documents filed on the filing date and push applicants to fully disclose their inventions in application documents on the filing date, rather than through repeated amendments afterwards. The inventions filed for protection should be completed prior to the filing date, but the extent of completion of the inventions is primarily based on the written description in the patent application documents filed on the filing date. The written description not only serves as the factual basis for the follow-up examination, but also satisfies the notion of “quid pro quo” in the system to ensure clear and accurate public understanding of the inventions. In other words, the full openness provision is mainly used to ensure that applicants have fulfilled their obligations to disclose their inventions at the time of filing to the extent realizable to the ordinary persons skilled in the art. Restrictions on the patent amendment are meant to ensure full openness of the original application documents by means of forbidding applicants from fulfilling the obligations after the filing date. Both aim, from different perspectives, to maintain the balance of rights and obligations between applicants and the public. It can be seen that the aforesaid objective will not be achieved without strict restrictions on the amendment to the application documents.

Article 33 is set to serve the original purpose of the patent system more, while application of the article in a particular case shall not deviate from the legislative intent of China’s Patent Law. IP rights are private rights, and patent rights aim at restricting unspecified third parties from implementing relevant technologies and regulating the economic relationship between civil subjects with equal social status (the patentees and unspecified third parties). The essence of the patent examination is to offer effective protection for real inventions through proceedings of patent approval and determination of rights. In judging reasonableness of examination decisions rendered by examiners in practice over some amendment, we also need to further address the relationship between the amendment and effective protection of invention patents within the allowable boundary of law, consider the effects of the amendment on the rights protection. The effects not only relate to follow-up approval proceeding and prospects, but also to implementation of exclusive rights after the granting. In so doing, reasonableness of the application of law can be secured. Patent examinations aim to provide good inventions with certain level of protection consistent with their intellectual contributions to the specific field, while provisions over the amendment to patent documents under China's Patent Law regulate the interests between the applicant (patentee) and the public, and cannot be simply regarded as a unilateral constraint on the applicant. On the contrary, if the principle of Article 33 is mechanically applied to the amendment required in the claims, it means the applicant is unrealistically required to be absolutely sure of future scope of rights to be granted at the time of the filing, amounting to a waiver of the right to adjust the claims. The waiver is obviously not conducive to reliable protection of inventions as patents, nor conducive to improvement of the quality of patents.

It can be seen, after an analysis of Case 2, that the patent application at issue relates to a process invention. According to the rejection decision, the applicant 3-4/2014 China IP 65 has restricted aromatic carboxylic acid applicable in the invention to benzoic acid after two rounds of examinations in accordance with of Article 26(4) and Article 33, which means, according to judicial interpretations from the Supreme People’s Court, the applicant has admitted that part of the invention which relates to benzoic acid substituted by commonly used substituents has from beginning through end failed to satisfy the requirements of the Patent Law. As a result, in case of an infringement action, the applicant will not be able to incorporate the part into the protection scope of patent rights in line with the doctrine of equivalents. There is also a need to mention that judge Kong Xiangjun explained, in understanding and application of the aforesaid judicial interpretations, that “application of the rules will not be affected without regard to whether the amendment is voluntary or required by the examiner, whether there is any casual relationship with patent granting requirements, or whether the amendment will be accepted by the examiner”. The explanation seems to indicate that application of the doctrine of estoppel is “solute” in China, different from the opinion that the doctrine of estoppel should belong to the rebuttal bar in the U.S. and other countries. Although some judicial decisions held later that the restricted amendment by means of adding new technical features may be an exception to the doctrine of estoppel, the explanation has been questioned from the very outset. The Author personally doesn’t think the explanation will withstand scrutiny. In short, “absolute” application of the doctrine of estoppel is a “double-edged sword,” which makes all amendments in the patent application process more likely to have direct impact on future patent protection. When it comes to a considerable number of parties represented in this case, the impact is self-evident: for such a method invention, if the commonly used substituents which obviously will not affect completion of the method are not incorporated into the protection scope or applicable to the doctrine of equivalents, any competitor may easily bypass the restrictions set on the patent. Therefore, if the applicant’s amendment is not allowable, the applicant will be granted with figurehead patent rights. For the sake of protecting innovations, the impact arising out of application of the doctrine of estoppel should be reflected in understanding by SIPO of examination standard under Article 33.

In addition, judging from the way of thinking in the field and conventional habit of drafting patents, although the applicant failed to clearly document the protection scope of benzoic acid substituted by commonly used substituents, it is certain that this does not mean that the applicant did not want to protect this scope; on the contrary, the method invention is applicable to benzoic acid substituted by commonly used substituents, which is obvious to the applicant and the panel as well. The applicant erred to fail to anticipate the quandary due to strict understanding of Article 26(4) and Article 33, therefore, there was not a bargaining hint planned in advance, but is such “negligence” sufficient to put an end to this invention? The answer should be negative.

3. Due consideration to motives and reasons of the “amendment”

As a matter of fact, the dispute relating to the missing content of the description in Case 1 arises out of an adapted amendment by the applicant at the request of the examiner, such adapted amendment incorporates the content, which is permissible by the examiner and relates to the new claim, into appropriate locations of the description to get pro forma support. In this case, the adapted amendment has disrupted the order of the original pages, the late part of the original description on Page 8 has been moved into Page 8a (Note: The page here refers to the page without claims in the description). In filing the replacement pages for the amendment, the applicant had stated specifically the purpose and manner of the aforesaid amendment in the amended description, and submitted the replacement Page 8a. But in the end, the examiner did not include Page 8a in the granting documents made up of the replacement page submitted by the applicant, while the panel did not find the replacement Page 8a in the files deposited in SIPO. Later on, the patentee had requested for corrections repeatedly, but the requests were rejected on the ground that the corrections fell into circumstances not permissible after the grant, causing the issue to be included in the invalidation application.

The panel, after ascertaining the above-mentioned reasons for the “amendment,” held that the “amendment” was adapted at the request of the examiner, that as far as the missing content on Page 8a at issue is concerned, neither the patentee had the intent to delete the content on Page 8a by amendment, nor had factually deleted the content; therefore, strictly speaking, the case did not have a deletion-style “amendment” in existence; despite the fact that SIPO did not receive the replacement page due to either negligence or other reasons, the examiner was required to verify and examine the amending manner and content as stated by the applicant in the amended description; it is equally necessary to confirm the integrity of application documents in drafting the final version for the granting. Therefore, on the one hand, the panel ruled out of favor of the impact of the missing content on Page 8a of the description on the claims in accordance with judgment rules under Article 33; on the other hand, the panel, for the sake of fairness, pointed out that whether the patentee should assume certain liability for the COLUMN China Intellectual Property 66 China IP 3-4/2014 missing page will not lead to loss of the patent right due to incompliance with Article 33.

However, it remains controversial as to the role of the examination history of prior patent approval proceeding in understanding Article 33 in the invalidation proceeding. A view from the judicial decisions held that, given the principle of reliance interest protection, PRB should not question compliance of the context, which has been accepted in the approval proceeding, with Article 33. The Author holds that the invalidation proceeding is aimed at correcting improper granting of rights, therefore, in the approval proceeding, prior to granting of patent rights, the facts ascertained by the substantial examination department or PRB and ensuing examination decisions are not binding on the invalidation proceeding. Furthermore, the invalidation proceeding may usually further push the examination of the case based on the applicant’s proof, explanations and arguments from both sides, leading to the possibility of coming to different conclusions. Patent approval and rights determination proceedings are different from general administrative licenses, so the Author thinks that the principle in the administrative licensing law should not be applied directly.

The principle means justified reliance of the opposite party should be protected against administrative powers, and the administrative department shall not change the administrative acts already in force at its discretion. Where there is a need to change the administrative act, the opposite party shall be compensated for any loss that may be incurred. The basis is on the public trust in the country and its power, a prerequisite for public safety and clear predicability of their life and work. Patent grants or invalidations involve not only interests of the applicant or the patentee, but also the public interest. Particularly within the current legal framework, any amendment beyond the scope of the original description and claims will be regarded clearly as a ground for invalidation. Therefore, no unfavorable examination decision is permissible in the invalidation proceeding just because the amendment to the application documents in the granting proceeding is permissible.

However, the invalidation proceeding will in no way ignore the earlier examination history. After granting of patent rights, the patentees and the public will form a variety of relationship involving rights and obligations in the course of economic transactions. A balance should also be struck between protection of real inventions and adverse effects of improper granting on the public within the discretionary power in application of examination criteria in the invalidation proceeding to maintain stability of law and social relations and ensure operation effects of the entire patent system. Furthermore, the invalidation proceeding has set strict restrictions to the timing and manner of amending patent documents, if any amendment in the approval proceeding has been found problematic after granting, there will be a very slight possibility of overcoming the problem through further amendment; therefore, in the examination practice, particularly when it comes to facts relating to a specific dispute in the invalidation proceeding, it is necessary to properly go over the examination opinions, the motive and process of the amendment in the invalidation proceeding. After a full review of various opinions, determinations should be made as to whether the amendment may have exceeded the scope and have substantial effects on the protection scope of the claims, or whether it is sufficient to render invalidation decisions on the basis of the balance between interests of patentees and the public.

4. Examination notion of the manner of amendment by “secondary generalization”

Both Case 1 and Case 2 relate to the amendment manner known as “secondary generalization” or “intermediate generalization,” which belongs to combination of technical features, taking technical features out of their initial context and combining them with others for a new technical solution. Although panels of both cases ruled for such amendment, it is no denying the fact that the majority of examiners take a cautious approach in this regard. The Author holds that such combination is inevitable, for the sake of protection of inventions, and it is particularly prominent in terms of its technical features and peculiarities of writing application documents.

In chemical and pharmaceutical industry, patent applications often relate to technical solutions expressed in multiple variables. The common writing of such applications goes like this, on the one hand, the applicant adopts a progressive manner to present a multilayer preference range for each variable in the description, like, “variable X is ..., preferably ..., more preferably ..., and most preferably ...” On the other hand, different preference ranges for each variable will also be defined in different auxiliary requests.

Take the common “Markush” claim as an example, if a compound comprises several or dozens of substituents, each substituent also including several, or even hundreds of alternatives, the conventional writing in the industry goes like this, the applicant will describe and define in detail each substituent in the technical solution section of the description, rather than listing combinations of each layer of each substituent (oneby- one listing will be lengthy, making descriptions of inventions unclear). However, such an approach does not mean that these combinations are not 3-4/2014 China IP 67 within the scope of inventions.

During the examination process, the applicant, in order to overcome deficiencies pointed out by the examiner, usually combine the preference range of various layers of various variables, or combine a specific radical group in examples with the preference range of other variables in the compound, forming an intermediate range between the compound and the specific compound of examples. Because the applicant is not able to foresee the full content of examination opinions at the time of filing, if combination of the preference range of various layers of various variables is not allowable, it means that the applicant will have to narrow its protection scope to examples, which is obviously unfair to the applicant.

Some in the industry also hold that such a combination will prevent future selection inventions from obtaining patent rights. In this regard, the Author believes that, firstly, if applicants wish to overcome the lack of creativity by such an amendment, it will be clearly unnecessary to have such fear; there is a rather low possibility of having selection inventions in the relevant field, and the existing selection inventions are specific “points” with particular effects from some range, and there does not exist any precedent of a selection invention through “intermediate generalization.” Based on the above, the “one-size-fitsall” prohibition of such manner of amendment is in fact an approach of “stopping eating for fear of choking” and will inevitably hurt the innocent; Importantly, such amendment is allowed on the premise of getting support from the description, the examination should still be based on the initial description as filed to determine if the amended rights may be reasonably granted or generalized. Therefore, it will not affect later selection inventions and will not prevent various purposes of products discovered later from obtaining patent rights.

In addition, the attitudes towards such generalization both in patent approval and invalidation proceedings may from one perspective help correct our notion. The scope of the claim in the approval proceeding is still in a state of uncertainty, but if the approval proceeding comes to an end, the invalidation proceeding will face rights publicly disclosed and finalized by the approval proceeding. The invalidation proceeding is meant to correct improper grants by SIPO, allowing amendment to the patent documents in a bid to remedy some mistakes in the approval proceeding and, to some extent, taking into account stability of rights before the public. Therefore, the proceeding should have more strict restrictions on amendments by the patentee than the approval proceeding. That is to say, in the patent approval proceeding, it is reasonable for the applicant to be entitled to greater freedom in amending its claims in the approval proceeding than the invalidation proceeding. As a permissible manner of amendment in the invalidation proceeding, the amendment by combination refers to combination of claims which are not affiliated with each other but with an independent claim. The claim so combined comprises all technical features of auxiliary claims. If such manner of combination lacks corresponding information in the original patent documents, it will belong to combination of the aforesaid technical features or a circumstance of secondary generalization. In the invalidation proceeding, if such combination of technical features is disallowed under Article 33 for patent cases in the chemical and pharmaceutical field, it will indicate that the amendment by combination is null and void; however, it is relatively common to accept such kind of amendment. Otherwise, if the patent rights as a whole have been invalidated, far greater adverse impact will be caused on the public and the patentees. It can be seen that if the approval proceeding adopts more strict criteria than follow-up proceedings, it will be a violation of examination rules, making it difficult to bridge follow-up proceedings.

(Translated by Wang Hongjun)


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