Date: 3 May 2022

In Part I, we covered the comparison between non-obviousness requirements concept, definition of “a person skilled in the art,” difference in regulation about grace period for chemical and biopharma patent applications in Europe, the United States, Taiwan, and China. In this part, we continue to compare the difference between the examination approaches to determining non-obviousness requirement for chemical and biopharma patents in Europe, the United States, Taiwan, and China.

D. Examination approach to determining non-obviousness requirement in Europe, the United States, Taiwan, and China:

European patents - EPO

According to part G-VII 5 of Guidelines for Examination in EPO, in practice, EPO adopts the“Problem-solution approach” for inventive step determination during patent examination, including the following detailed steps:

1. Searching for related documents and analyzing similarity between the prior art and the invention to determine the “closest prior art;”
2. Listing the distinguishing technical features between the application and the closest prior art, which means finding the technical features of the application which are not found in the closest prior art;
3. Judging the corresponding technical effects of the distinguishing technical features;
4. Establishing the “objective technical problem” to be solved, which is “how to achieve the technical effect via the distinguishing technical features;”
5. Considering whether or not the solution of the objective technical problem (i.e. the claimed invention), starting from the closest prior art, would have been obvious to the skilled person.

What needs to be noticed is that the inventive step argument becomes much harder if the examiner chooses inappropriate references as the closest prior art. Therefore, under such circumstances, it is recommended to argue the reason why the references are not appropriate evidence for the case. For example, the subject matter of chemical and biopharma patents is often chemical compounds. If a prior art with obvious drawback is chosen as the closest prior art, resulting in almost no motivation for those skilled in the art to invent starting from this prior art, the applicants may argue that such reference is not suitable as the prior art or it will lead to controversy over a hindsight bias. Also, when the examiner mentions that the application is a simple combination of several prior arts (usually no more than three in EPO examination), the reason why a person skilled in the art would not have motivation to combine the prior arts may be included in the response. For example, the technical features disclosed in the prior arts are not compatible or the prior arts belong to significantly different technical field. For chemical and biopharma patents, the technical effects are the effect shown by the experiment data disclosed in the specification.

The United States - USPTO

In the process of patent examination in the U.S., based on MPEP § 2142, USTPO bears the initial responsibility to establish a prima facie case to prove that the application would have been obvious for a hypothetical person skilled in the art before the valid filing date. Then, the patent applicants should provide evidence for rebuttal of the prima facie case. If necessary, it may be explained that the examiners adopted inappropriate documents as the prima facie case. When the examiners do not successfully establish a prima facie case, it is not necessary for the applicants to rebut. The rules to establish a prima facie case in USTPO include the following steps:

1. Determine the scope and content of the prior art, the differences between the claimed invention and the prior art, and the level of ordinary skill in the pertinent art;
2. Determine whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts;
3. If it would, rationale for combining the several references or rationale for reasonable expectation of success in achieving the claimed invention easily should be provided in Office Action;
4. Each claimed technical feature must be disclosed in the prior art.

That is, USTPO must prove that “a person of ordinary skill in the art has motivation to combine the teaching of the prior arts and reasonably expect the effects of the invention” if it wants to conclude that the invention is obvious.

The examples of common rationales under MPEP§ 2143 I include:

1. Combining technical features in prior art to obtain predictable results by using known technical methods;
2. Simple substitution to yield predictable results;
3. Use of general and routine technique to improve methods or products to achieve predictable results;
4. Selection from a known and limited range to obtain predictable results;
5. Teaching or suggestions in prior art leading a person of ordinary skill in the art to have motivation to conduct simple substitution or combine several prior arts to achieve the invention.

Different from Europe, the US does not limit the number of combined references. Thus, it is usual to combine many references.

In addition, in US practice, one can adopt the following strategies to demonstrate that the application is not obvious compared to the prior arts in the response: rebutting the prima facie case provided by the examiners, for example, providing that combination of the prior arts does not include all the claims elements, pointing out that there is no motivation to substitute or combine the prior arts and the claimed invention produces unpredictable effects after combing the prior arts etc. Common arguments include: the examiner failed to determine non-obviousness based on the whole invention; there is no motivation for a person of ordinary skill in the art to combine; effects of the invention are unpredictable; the invention is not achieved by merely doing limited numbers of tests to obtain predictable results; the prior art teaches away; and challenging the examiner's determination on the level of ordinary skill in the pertinent art etc.

Taiwan - TIPO

According to Page 2-3-16 of Taiwan Patent Examination Guidelines, TIPO may determine inventive step of a claimed invention with the following steps:

Step 1: determining the scope of a claimed invention;

Step 2: determining the contents disclosed in relevant prior art;

Step 3: determining the technical levels of a person ordinarily skilled in the art;

Step 4: determining the differences between the claimed invention and the relevant prior art;

Step 5: determining whether a person ordinarily skilled in the art can easily accomplish the claimed invention based on the contents disclosed in relevant prior art and common general knowledge at the time of filing.

In step 5, whether the invention can be easily accomplished is determined in the following order:

(1) Determining whether any of the factors in “factors negating inventive step” are applicable, including: “motivation to combine multiple references,” “simply changing,” and “simply scraping together.”

(2) Following item (1), if none of the factors in “factors negating inventive step” is applicable, the reasoning for lacking an inventive step cannot be established. The claimed invention could be considered as involving an inventive step.

(3) Following item (1), if any of the factors in “factors negating inventive step” is applicable, “factors affirming inventive step” should then be taken into consideration, including: “teaching away,” “advantageous effects,” and “auxiliary factors considered.”

(4) Following item (3), if there is no way to establish the reasoning for lacking an inventive step upon considering “factors negating inventive step” and “factors affirming inventive step,” the claimed invention could be considered as involving an inventive step. On the contrary, if the reasoning for lacking an inventive step can be established, the claimed invention could be considered as lacking an inventive step.

In practice, TIPO places great emphasis on “motivation to combine multiple references” in factors negating inventive step mentioned above and “invention producing an unexpected effect” in auxiliary factors considered. As long as reasonable explanation or proof can be provided to show that a person ordinarily skilled in the art would not have motivation to combine the references to accomplish the claimed invention and the claimed invention produces better and unexpected effects compared to the prior art, it can be a powerful argument to support that the invention involves inventive step. (See Wisdom News Volume 20 and Volume 43 for related cases.)

In addition, like in European practice, the Taiwan courts usually tend to judge that the claimed invention involves an inventive step if there are more than three references combined.

China - CNIPA

Section 3.2.1.1 of Chapter 4 of Chinese Guidelines for Patent Examination mentions the following three steps for determining whether the claimed invention is obvious compared to the prior art in CNIPA (also known as “three-step method”):

Step 1. Determining the closest prior art;

Step 2. Determining the distinguishing features of the invention and the technical problem actually solved by the invention;

Step 3. Determining whether or not the claimed invention is obvious to a person skilled in the art.

Take compound patents for example. In practice, in the process of invalidation examination or administrative litigation, when determining whether a patent application with compound as subject matter involves inventive step by using the three-step method, CNIPA usually adopts the prior art, which is usually the compound with closest structure, provided by the one requesting invalidation as the closest prior art in Step 1. However, in the actual development process, a person skilled in the art is supposed to choose the compound with greatest potential as the lead compound of the invention among the known compounds after comprehensively considering factors like the known properties, efficacy and so on. Thus, the lead compound is not necessarily the compound with closest structure. Furthermore, it may be doubted whether the compound with closest structure is chosen with the benefit of hindsight after the filing date.

Besides, motivation, teaching in the prior art and unexpected effects are also key points when determining inventive step. For example, if the prior art has disclosed the change in structure of related compound and the corresponding generated effects, the application will be examined based on it. Factors like the compound formula disclosed in the prior art, description of effects and so on will be considered comprehensively to determine whether a person skilled in the art would have enough motivation to make specific modification to the lead compound and whether the compound generates unpredictable effects after the specific modification. Again, such examination principle also emphasizes the importance of demonstrating technical effects by experimental data for chemical and biopharma patents when arguing for non-obviousness.

In the next part, the difference in auxiliary factors considered of non-obviousness requirement for chemical and biopharma patents between Europe, the United States, Taiwan, and China will be introduced in detail.