On April 26, 2020 (the World Intellectual Property Day), the China National Intellectual Property Administration (CNIPA) announced the top 10 patent reexamination & invalidation cases of 2019.

Among them, three are related to chemical/pharmaceutical technologies. According to the CNIPA, these cases were selected for their guiding value in certain topics typical for patent examination, as well as the considerable social attention focused on them. The opinions reflected in the Decisions of these cases would undoubtedly impose great influence on the practices of both substantial examination and invalidation, and can also be cited as supporting reference or evidence to benefit similar cases. Therefore, we summarize below the case brief and introduce the focuses of the three invalidation cases of chemical/pharmaceutical invention.

Request for Invalidating Invention Patent “Light-emitting device and display device” (Decision No. 33344)

Patentee: Company A

Petitioner: Company B

Patent number: ZL97196762.8

Foreign family members: US7531960B, JP4530094B, etc.

Decision: patent right maintained

The patent in question belongs to a patent family which protects the white LED technology of Company A. This patent family covers dozens of the patents and applications in countries such as Japan, the US, Europe, China and Korea. Some patents have also gone through multiple litigations worldwide, e.g., the validity of Japanese patent member JP4530094B2 has been challenged several times in trials.

The claim set of this Chinese patent ZL97196762.8 has been amended in a restrictive manner in a previous invalidation proceeding and finally maintained valid according to Invalidation Decision No. 19300. As for the case in discussion, the focus mainly relies on the standard of inventiveness. In the invalidation proceeding, both the patentee and the petitioner submitted a large amount of evidence, including Decisions and Judgements on other members of the same patent family. For example, the petitioner submitted the Judgement of the US patent member (US7531960B) and the Invalidation Decision of the Taiwan patent member, while the patentee submitted and Judgement of the European patent member (EP0936682B). This is also an illustration of the divergence of opinion about whether this patent should be maintained valid in different countries. After all, in China, the validity of the core technology protected by the patent has been maintained in the outcomes of two invalidation trials.

Claim 1 targeted by this invalidation is set forth as below.

[Claim 1]

A light emitting device, comprising a light emitting component using a semiconductor as a light emitting layer and a phosphor which absorbs a part of light emitted by the light emitting component and emits light of wavelength different from that of the absorbed light, wherein

said light emitting layer of the light emitting component is composed of a nitride compound semiconductor,

said phosphor contains a garnet fluorescent material comprising 1) at least one element selected from the group consisting of Y and Gd, and 2) at least one element selected from the group consisting of Al and Ga, and being activated with cerium,

the emission peak of the light emitting component is within the range from 400 nm to 530 nm, and the main emission wavelength of the phosphor is longer than the main emission peak of the light emitting component.

The inventive point lies in the combination of the “blue-light emitting component” with the specific “phosphor”, so as to obtain the white-light emitting device. Both the blue-light emitting component and the phosphor defined in Claim 1 are already disclosed in the prior art.

As indicated in the description, technologies for making the light emitting diodes capable of emitting a white light source by color mixing have been reported. However, conventional light emitting diodes have such problems as color tone deviation due to deterioration of the fluorescent material, lowered efficiency of extracting light that derived from darkening of the fluorescent material, low weatherability and the like. The specific combination disclosed by the patent can provide a white-light emitting device having excellent weatherability and stable working performance.

The prior art references submitted by the petitioner can be divided into two groups. References of Group 1 disclose a light emitting device capable of emitting blue light, and a white-light emitting device formed by combing the aforementioned light emitting device with a phosphor which emits light of longer wavelength. References of Group 2 discloses the specific phosphor defined in Claim 1 and the property thereof in absorbing light of blue wavelength and emitting light of longer wavelength.

The petitioner also claims that: references of Group 1 already describe that, by combining with a blue-light LED, a phosphor may experience the problem of deterioration over time; references of Group 2 further disclose that the yttrium-aluminum-garnet phosphor involved in the present invention has good weatherability and is capable of working under various display conditions and light sources. Therefore, the skilled in the art would have motivation to combine the specific phosphor disclosed by references of Group 2 with the blue-light emitting device disclosed by references of Group 1, so as to solve the technical problem of “providing a white-light emitting device capable of working stable”.

The Panel does not support the claims of the petitioner and issues opinions as below.

When a blue-light LED is used as the light source to stimulate the emission of white-light from the phosphor, the chip will be exposed to an extremely tough environment (i.e., exposed to a light that even stronger than the sunlight). Although references of Group 2 mention that “the yttrium-aluminum-garnet phosphor is capable of working under various display conditions and light sources”, the skilled in the art should find out that the toughness of real working environment of light-emitting involved therein is much less than the environment surrounding a blue-light LED, based on a thorough understanding of these references. Therefore, the references of Group 2 merely provide some general ideas concerning weatherability of the phosphor, rather than specifically teaching the solution to the technical problem of the present patent. In the present invention, in consideration of the environment to be applied (i.e., surrounding a blue-light LED), even though the combined phosphor per se has already been well-known, inventive effort is still necessary to select it out from the numerous amount of inorganic- or organic-phosphors that are known in the prior art.

In our opinions, the Decision reflects a thorough understanding of the “technical problem”, and also keeps in line with the principle emphasized in 2019 version of Patent Examination Guidelines, i.e., “the technical problem actually solved by the invention should be decided based on the technical effect achieved by the distinguishing feature in the invention”. We expect that the opinions in this Decision can be instructive to the substantive examination, and is particularly suitable for correcting the situation in which some examiners tend to generalize the “specific technical problem solved by the invention” into a more abstract one, and thus devaluate the inventiveness of the entire invention.

Request for Invalidating Series of Invention Patents “Dipeptidyl peptidase inhibitor for the treatment of diabetes” (Decision Nos. 38950, 38951, 38952)

Patentee: Company C

Petitioner: Company D

Patent numbers: ZL200680042417.8, ZL201210332271.8, ZL201210399309.3 (hereinafter referred to as Patent 417, Patent 271, and Patent 309, respectively)

PCT publication number: WO2007/033266

Decisions: patent right of Patent 417 maintained, patent right of Patent 271 maintained on the basis of amendment, all patent rights of Patent 309 declared invalid

The series of patents relate to the inhibitors of DPP-4, such as alogliptin. Except for the case of Decision No. 38950, which is based on Patent 417 and is listed as one of the Top 10 Cases, the petitioner also challenged the validities of two other divisional patents (Patent 271 and Patent 309) at the same time. However, the three cases receive totally different Decisions from the same Panel, even though the invalidation reasons regarding the novelty issue thereof are actually based on a same set of logics. Therefore, the cases provide useful guidance towards the drafting of pharmaceutical invention, especially those the inventive point lies in the administrative dosage.

Herein we set forth the first claim in three Decisions.

The application dates of the three pieces of patent are all September 13, 2006, and the priority dates thereof are all September 14, 2005.

The application date of D1, which is submitted by the petitioner, is December 15, 2004, and the publication date thereof is October 13, 2005. That is to say, D1 was disclosed on the day between the priority date and the application date of the patent in question. The invalidation reasons raised by the petitioner against novelty can be summarized as follows.

D1 discloses Compound I, the pharmaceutically acceptable salt thereof, and the pharmaceutical composition comprising Compound I. D1 also discloses that Compound I can be used for treating type II diabetes through oral administration, “an oral dosage form comprising 10-100mg Compound I” has been described as a preparation example in the description. That means the aforementioned solutions have already been disclosed in D1 (application date: December 15, 2004), which was filed at least one year earlier than the patent in question (application date: September 13, 2006). Therefore, the technical solutions of the patent in question which are also presented in D1 cannot have the priority right. Consequently, D1 become the prior art and destroy the novelty of these technical solutions, since the publication date (October 13, 2005) of D1 is earlier than the application date (September 13, 2006) of the patent.

Therefore, the focus of the cases lies in whether the priority right can be established based on the different drafting forms of Claim in three cases. In other words, it is necessary to decide whether the technical solution covered by each of the three forms of Claim 1 has been disclosed in D1.

In view of the above table, Claim 1 of Patent 417 or Patent 271 is a product claim, the difference therebetween lies in that Patent 417 defines that “single dose form comprises between 5 mg and 250 mg of Compound I”, while Patent 271 defines that “Compound I is administered in a daily dose of between 5 and 250 mg”. In other aspect, Claim 1 of Patent 309 is a claim in the form of pharmaceutical use (the so-called Swiss-type claim).

For the three forms of claim, the Panel held that: although it looks like an administration feature, the feature of “single dose form” used in Patent 417 actually reflects the amount of active ingredient contained in a smallest unit of a medicine (e.g., a piece of tablet), and should be construed as a substantive limitation on the composition of the product. Therefore, such feature has limitation on the scope of Claim 1 of Patent 417. Since none of the product disclosed in D1 has a single dose form between 5 mg and 250 mg of Compound I, Claim 1 of Patent 417 can have the priority right. D1 thus cannot become the prior art for evaluating the novelty thereof.

Regarding Patent 271, the Panel indicates that “a daily dose” is a pure administrative feature, which does not reflect the amount of active ingredient contained in the medication, and thus cannot impose any limitation on Claim 1 of Patent 271. According to the Panel’s opinion, Claim 1 of Patent 271 actually equals to “a pharmaceutical composition comprising Compound I having the structure represented by the following formula and a pharmaceutically acceptable carrier, wherein Compound I is in the form of pharmaceutically acceptable salt or free alkali.” Given the solution has been described in D1, Patent 271 cannot have the claimed priority right. Therefore, the preparation example disclosed in D1 can destroy the novelty of Claim 1 of Patent 271.

Regarding Patent 309, the Panel held that regarding a medication which can be used for treating new disease and has a specific structure and/or composition, the protection scope of a Swiss-type claim can be extended to both the manufacture and the downstream sales conducted by the medication manufacturers or sellers, but cannot cover the administration procedures. Feature of “a daily dose of Compound I between 5 and 250 mg” in Claim 1 of Patent 309 does not impose any limitation on the manufactural process of the medication, therefore, Claim 1 of Patent 309 actually equals to “the use of Compound I in preparing a pharmaceutical composition used for treating type II diabetes, wherein the pharmaceutical composition is orally administered, and Compound I is in the form of pharmaceutically acceptable salt or free alkali.” Based on the similar reasons as Patent 271, Patent 309 cannot have the claimed priority right, and is not novel compared with D1, either.

Claims of the three patents are actually based on the same inventive point, but receive totally different results in invalidation proceedings mainly because of the different drafting forms thereof.

In our opinions, the series of invalidation cases have provided a very explicit guidance towards the drafting of inventions involved with administrative dosage. In China, a method of treating disease is not a patentable subject matter. Meanwhile, as to the alternative form of the treating method, the use in a “product claim defined by use feature” is generally deemed as having no limitation on the product per se, since the influence of the use on the composition of the product can hardly be admitted. Therefore, most of the use inventions of a known medication have been drafted into a Swiss-type claim as Patent 309 does, in order to seek protection for the use in conditions that is previously unknown. However, for those the administrative dosage is the essential inventive point, if both the inventive compound and the involved condition have already been disclosed, the chance for a Swiss-type claim to obtain a grant will become extremely low, even the administrative dosage has been defined in the claim. The reason is because the administrative dosage is generally considered as a feature about administration, which has no limitation on the manufacture process of the medication. Given the positive opinions made in this Decision, it is more possible for the aforementioned invention to seek a stable patent right in form of a product claim which is drafted as “a pharmaceutical composition in a single dose form”

Request for Invalidating Invention Patent “Pyrrole substituted 2-indoline ketone protein kinase inhibitor” (Decision No. 42407)

Patentees: Company E and Company F

Petitioner: Company G

Patent number: ZL01807269.0

PCT publication number: WO2001/060814

Decision: patent right maintained

The patent in question relates to the DPP-4 inhibitor represented by the following formula (I). Multiple focuses have been discussed in this case, including the allowable amendment during invalidation proceedings, the acceptability of supplementary experiment data, the determination of novelty and inventiveness of a Markush compound in comparison with prior art Markush compounds, etc.

Below we set forth our opinion with reference to Claim 1.

[Claim 1]

A compound of Formula (I):

wherein:

……

R6 is -C(O)R10,

……

R10 is -NR11(CH2)nR12,

……

R12 is -NR13R14, hydroxyl, -C(O)R15, phenyl or heterophenyl,

……

or a pharmaceutically acceptable salt thereof.

(1) Allowable amendment of Markush compound during invalidation proceedings

The patentee attempted to define R12 into “-NR13R14” in the invalidation proceeding, but the amendment was refused by the Panel. According to the Decision, R12, as a variable in the whole Markush formula, is comprised in R10 together with another variable R11, R10 per se is further comprised in R6 which is one of the seven variables comprised in Formula (I). Therefore, the selection of R12 would actually cause changes of the Markush compound at multiple levels, the cancellation of one option from R12 is not equivalent to the cancellation of one parallel technical solution.

The aforementioned conclusion is somewhat surprising. The amendment of Markush claim is always disputable when it comes to whether the simultaneous cancellation of multiple variables should fall within the allowance. However, in the judgement over a milestone case represented by our firm, Beijing Wansheng Pharmaceutical Co., Ltd. v. Daiichi Sankyo Co., Ltd., the Supreme People’s Court held that, although not all combined cancellations are allowed, the amendments that do not introduce a new and inventive solution over the original document may be allowed. That is to say, the amended claims should cover the technical solutions described in the Examples (Case No.: Supreme People’s Court 41 [2016], Administrative Retrial, SPC).

According to our practice, if the cancellation of option only happens to one variable of a general formula, it is generally acceptable in the invalidation proceeding. In this case, the validity of patent right has been maintained over the broader scope defined by the granted claim set, therefore the patentee suffers no negative impact by now even if the voluntary amendment was not accepted in the invalidation proceeding. However, the Decision set up such a strict standard for the manner of amendment that actually denies any chance of amending a Markush claim in the invalidation stage, which imposes uncountable risk to the stability of all Markush claims. In consideration of the risk, it would be advisable for the applicants to design and organize a set of dependent claims which can full-protect the core compounds in the substantive examination stage.

(2) Whether the experiment data supplemented in the invalidation proceeding can be accepted

In the invalidation proceeding, the patentee submitted the supplementary experiment data as a counter-evidence, in order to prove that the IC50 value of the bio-assay is meaningless, thus should not be used as the foundation for comparing the technical effect. The supplementary data had also been submitted in the prosecution of the European patent member.

The date authenticity of the supplementary experiment was refused by the petitioner, since the experiment was conducted unilaterally by the patentee. However, the petitioner still cites those data as an evidence to support the claim that the bio-activity of the patented compound is worse than the specific compound in the prior art.

The Panel held that, the data obtained from the supplementary experiment can neither be taken into consideration in determining the inventiveness, nor be used by any party to verify their claims, because the involved supplementary experiment was conducted unilaterally by the patentee, and was not further supported since the patentee submitted no additional evidence for reference or offered no witness for questioning.

The Decision does not refuse the acceptability of supplementary experiment data, although the attitude of the Panel is very cautious based on the reasons and conclusion thereof. In our opinions, the chance for supplementary data, which is obtained from a unilateral experiment, to be accepted by the Panel will be considerably low in invalidation proceedings. However, such chance may be increased if the experiment can be conducted by a third party with public credibility, the original experiment records can be submitted, or the relevant laboratory staff can attend and be testified in the court, etc.

(3) Novelty and inventiveness in comparison with the Markush compound in the prior art

In view of the novelty and inventiveness issues, the focus of this case lies in that, the prior art references already discloses that Formula (I) can be synthesized by the reaction between Structure (2) and Structure (3), and it further discloses four preparation examples of Structure (2) and Structure (3). If one of Structure (2) is reacted with one of Structure (3), a compound falling within the scope of Formula (I) can be obtained. However, the prior art reference does not disclose explicitly the specific structure of the aforementioned compound that obtained from the hypothetic reaction.

Generally, for a Markush compound disclosed in the prior art, the disclosure of the whole Markush formula would not be deemed as equivalent to the disclosure of any combination of the options in each substitute. However, in some perspective, if the number of potential combination has been limited to a reasonable level, all the specific combination can be deemed as being disclosed. The Beijing Higher People’s Court is on the side of latter opinion, according to the previous judgements issued thereby.

In this Decision, based on the Structure (2) and Structure (3) disclosed in four preparation examples, there are merely 12 types of potential combination. However, the Panel avoids discussing whether the 12 combinations can be deemed as limited or not, but focuses on such a fact in the prior art reference that discloses “the pyrrole moiety is substituted with one or more hydrocarbon chains which themselves are substituted with at least one polar group (i.e., the pyrrole moiety is directly connected with the hydrocarbon chain, then connected with the polar group)”. Based on this fact, the Panel held that the prior art reference is not interested in synthesizing the compound of the present invention, which has “a pyrrole moiety directly connected with a polar group such as amide group and then indirectly connected with a hydrocarbon chain”. Therefore, the prior art does not disclose or suggest a compound falling within the scope of Formula (I) of the patent.

In our opinion, the Decision does not turn over the previous judgement, i.e., “if the number of potential combination has been limited to a reasonable level, all the specific combination can be deemed as being disclosed”. Therefore, the applicant should still fully consider the risk of self-disclosure in drafting a compound application, so as to prevent a situation where the subsequent alternative invention has been disclosed by the previous application.