*AI-generated translation, for reference only.

[Keywords]

Administrative; Invention Patent invalidation; Inventiveness, Reasonable expectation of success; The closest prior art; Technical motivation

[Judgment Digest]

1. When determining whether a patent in the fields of chemistry and biology is inventive by applying the "three-step approach", whether a person skilled in the art has a reasonable expectation of success regarding the relevant invention or creation is a factor to be considered when assessing whether there is an improvement motivation or technical inspiration, rather than a factor for determining the closest prior art. If a party denies the determination of the closest prior art on the grounds that there is no reasonable expectation of success, the people's court will not support it.

2. In determining whether there is a reasonable expectation of success in patent cases in the fields of chemistry and biology, the standard should be whether a person skilled in the art considers it necessary to "make an attempt", rather than requiring "certainty of success" or "a high probability of success". If a person skilled in the art has the motivation to attempt to start from the closest prior art and can reasonably expect to obtain the patent technical solution, it can be determined that the patent technical solution is not inventive.

 [Case Facts]

 [REDACTED] Nuo Co., Ltd. (hereinafter referred to as "Nuo Company") is the patentee of the invention patent named "Pharmaceutical Compositions Containing Valsartan and NEP Inhibitors" (hereinafter referred to as "the involved patent"). The filling date of the patent is January 16, 2003, the priority date is January 17, 2002, and the date of patent is April 8, 2015. the involved patent's claim 1 defines a pharmaceutical composition containing valsartan and NEP Inhibitors, and claim 2 defines a medicament kit. The involved patent's specification states that the composition can be used for treating or preventing hypertension, heart failure, myocardial infarction and other diseases.

On April 5, 2017, [REDACTED] Dai filed a request for invalidation of the involved patent with the Patent Reexamination Board of the former China National Intellectual Property Administration, and submitted 19 pieces of evidence materials during the invalidation procedure. Among them, attachment 13 is a copy of the European patent application publication text and partial Chinese translation with a publication date of February 4, 1992, which discloses a composition of NEP inhibitors and angiotensin II receptor antagonists for treating hypertension and congestive heart failure; attachment 12 is a copy of the US patent application publication text and partial Chinese translation with a publication date of June 8, 1993, which discloses that sacubitril and its pharmaceutically acceptable salts belong to NEP inhibitors and can be used for treating hypertension; attachment 14 is an article titled "Research on New Antihypertensive Drug - Angiotensin II Receptor Antagonist Valsartan" published in "Chinese Journal of New Drugs (Volume 8, Issue 9, 1999)", which discloses that valsartan belongs to angiotensin II antagonists, and its antihypertensive effect is not inferior to that of existing antihypertensive drugs, with few adverse reactions; attachment 15 is an article titled "New Angiotensin II Receptor Antagonist: Valsartan" published in "Medical Guide (Volume 20, Issue 3, March 2001)", which discloses that valsartan belongs to angiotensin II antagonists, plays a key role in regulating systemic blood pressure and maintaining electrolyte and fluid balance, and has the advantages of safety, long-lasting effect, convenient administration, mild adverse reactions and low cost.

On December 27, 2017, the China National Intellectual Property Administration made a decision (hereinafter referred to as "the decision under review") that claims 1 and 2 of the involved patent lacked inventiveness in view of the combination of attachment 13 and attachments 12, 14, and 15, and thus declared the involved patent wholly invalid. After the decision was announced, Nuo Company was dissatisfied and filed a lawsuit with the Beijing Intellectual Property Court, requesting to revoke the decision under review and order China National Intellectual Property Administration to make a new decision.

[Judgement]

On June 26, 2019, the Beijing Intellectual Property Court issued the administrative judgment (2018) Jing 73 XC 6483, dismissing the lawsuit filed by Nuo Company. Nuo Company appealed to the Supreme People's Court. On June 30, 2021, the Supreme People's Court issued (2019) SPC IP Admin. Final 235, dismissing the appeal and upholding the original judgment. Nuo Company remained dissatisfied and applied for a retrial to the Supreme People's Court. On September 29, 2022, the Supreme People's Court issued the administrative ruling (2022) SPC Admin. Retrial Application 72, dismissing Nuo Company's application for retrial.

[Judge's Opinion]

In this case, the challenged decision held that claim 1 and 2 of the involved patent lacked inventiveness in view of the combination of Attachment 13 with Attachments 12, 14 and 15, essentially taking Attachment 13 as the closest prior art. The respondent, however, argued that since Attachment 13 did not have a reasonable expectation of success in obtaining the technical solution of the involved patent, it should not be regarded as the closest prior art. This argument actually confuses two different issues: one is whether Attachment 13 can be regarded as the closest prior art for evaluating the inventiveness of the involved patent; the other is whether a person skilled in the art, based on Attachment 13, had a reasonable expectation of success in obtaining the technical solution of the involved patent and the impact of this on the determination of the inventiveness of the involved patent.

I. Whether Attachment 13 can be regarded as the closest prior art for evaluating the inventiveness of the involved patent.

The "three-step aproach" is a widely used method for determining inventiveness in patent examination practice. Its basic steps are: first, determine the closest prior art to the patent's technical solution; second, identify the distinguishing technical features and, based on the functions and roles of these features in the patent's technical solution, determine the technical problem that the patent's technical solution objectively needs to solve; finally, determine whether there is a technical motivation, that is, whether the prior art as a whole provides a technical motivation to combine the closest prior art with the distinguishing technical features to obtain the patent's technical solution, and whether this technical motivation would motivate a person skilled in the art to improve the closest prior art and obtain the patent's technical solution when facing the corresponding technical problem. If such a technical motivation exists, the invention is considered to lack inventiveness. Among them, determining the closest prior art is the first step of the "three-step aproach". In principle, the core consideration for determining the closest prior art is whether the prior art and the invention address the same or similar technical problems and have the same or similar technical objectives. On this basis, it is also necessary to further consider whether the technical solution of the prior art is sufficiently close to that of the invention. Whether a person skilled in the art has a reasonable expectation of success in obtaining the invention based on the closest prior art usually depends on whether there were cognitive limitations or research and development conditions that prevented them from obtaining the invention before the application date or the priority date. This is a consideration factor when determining whether there is a technical inspiration after identifying the closest prior art, rather than a requirement or preferred factor for determining the closest prior art. For the invention claimed for protection, even if the closest prior art is determined to be one that addresses the same or similar technical problems, has the same or similar technical objectives, and has a sufficiently close technical solution, a person skilled in the art may still not have a reasonable expectation of success in obtaining the invention due to limitations in technical cognition or research and development conditions before the application date or the priority date, and thus may not have the motivation to combine this closest prior art with other prior art or common knowledge to obtain the technical solution of the invention. However, this cannot be used to overturn the determination of the closest prior art. Of course, if the closest prior art is obviously infeasible, a person skilled in the art would not be able to complete the invention based on this infeasible prior art, and such infeasible prior art is generally not suitable to be regarded as the closest prior art.

In this case, Attachment 13 addresses the same or similar technical problems as the technical solution of the involved patent, has the same or similar technical objectives, and the technical solutions are sufficiently close. Therefore, Attachment 13 can be regarded as the closest prior art for evaluating the inventiveness of the involved patent. Nuo Company claimed that a person skilled in the art did not have a reasonable expectation of success in obtaining the technical solution of the patent in question based on Attachment 13, and further asserted that Attachment 13 did not constitute a qualified closest prior art. Essentially, it was attempting to overturn the determination of the closest prior art by arguing the lack of a reasonable expectation of success. As previously stated, whether a person skilled in the art have a reasonable expectation of success based on the closest prior art is not, in principle, a factor or a preferred factor for determining whether a certain prior art is qualified as the closest prior art. It is more appropriate to consider it in the third step of the "three-step aproach". Nuo Company's claim that Attachment 13 is not the closest prior art based on the above reasons lacks basis and should not be supported.

II. Regarding whether a person skilled in the art have a reasonable expectation of success in obtaining the technical solution of the patent in question based on Attachment 13 and its impact on the determination of the patent's inventiveness. Under the premise that the closest prior art has disclosed the medicinal functions of two types of known compound combinations, the patent in question is actually the development of a specific combination with medicinal effects. At this point, the "reasonable expectation of success" for the medicinal effects of a specific compound combination is an important consideration factor in judging "technical inspiration". If a person skilled in the art do not have a reasonable expectation of success for the medicinal effects of a specific compound combination, but the patent applicant still made attempts and obtained the corresponding specific combination with medicinal effects, then this specific medicinal combination technical solution is usually recognized as having inventiveness. If a person skilled in the art have a reasonable expectation of success for the medicinal effects of this specific compound combination, then only when verifying the medicinal effects of the specific combination requires creative labor or achieves unexpected technical effects, can this specific medicinal combination technical solution be considered as having inventiveness.

A reasonable expectation of success is an objective assessment and rational prediction made by a person skilled in the art on the possibility of success in obtaining the patent technical solution based on their technical knowledge and the general experimental conditions in the field before the filling date or priority date of the patent in question. It does not depend on the subjective will of the patent applicant. A reasonable expectation of success only requires reaching the degree that a person skilled in the art consider it "necessity to try", without the need for "certainty of success" or "high probability of success". Having a reasonable expectation of success usually does not require that the implementation of the expected attempt necessarily or highly likely achieve the technical goal or solve the technical problem. It only requires that after a person skilled in the art comprehensively consider factors such as the existing technical situation in the specific field, the characteristics of technological evolution, the mode and conditions of innovation, the average innovation cost, and the overall innovation success rate, they still do not give up this kind of attempt.

Nuo Company claimed that a person skilled in the art did not have a reasonable expectation of success in obtaining the technical solution of the patent in question (i.e., using the combination of valsartan and sacubitril to treat hypertension), mainly based on the following reasons: Angiotensin II antagonists and NEP inhibitors show opposite and complex physiological effects; Attachment 13 acknowledges the unpredictability of the mechanism of action of angiotensin II antagonists and NEP inhibitors and does not provide any conclusion; there are "ineffective combinations" in the combination of angiotensin II antagonists and NEP inhibitors where the antihypertensive effect cannot be achieved. In this regard, the specific analysis is as follows: As the closest prior art, Attachment 13 discloses that the combination of angiotensin II antagonists and NEP inhibitors can be used to treat hypertension, and it also provides technical information such as experimental methods, experimental conclusions, administration methods, and treatment doses. It offers clear technical guidance to ordinary skilled persons in the art on choosing specific angiotensin II antagonists and specific NEP inhibitors for treating hypertension. Even if the development of specific drug combinations with the relevant medicinal functions does not have "certainty of success", it is not sufficient to prove that ordinary skilled persons in the art would abandon the development of specific angiotensin II antagonists and specific NEP inhibitors with blood pressure-lowering functions based on Attachment 13. On this basis, considering that Attachment 12 discloses sacubitril as an NEP inhibitor and its use in treating hypertension, and Attachments 14 and 15 disclose valsartan as an angiotensin II antagonist with blood pressure-lowering effects, it can be concluded that ordinary skilled persons in the art would have the motivation to attempt to develop a drug composition containing valsartan and sacubitril for treating hypertension based on Attachment 13 and could reasonably expect to achieve success. Therefore, ordinary skilled persons in the art have a reasonable expectation of success in obtaining the technical solution of the patent in question based on Attachment 13, and the technical solution of the patent in question lacks inventiveness.

[Legal Provision]

Paragraph 3, Article 22 of the Patent Law of the People's Republic of China (Amended in 2020) (The provision applicable to this case is Paragraph 3, Article 22 of the Patent Law of the People's Republic of China which was amended in 2000)