Date: 9 June 2022

In Part II we covered the comparison between examination approach to determining non-obviousness requirement 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 auxiliary factors considered related to non-obviousness requirement for chemical and biopharma patents in these jurisdictions.

E. Auxiliary factors considered:

European patents - EPO

Part G-VII 10.3 of Guidelines for Examination in EPO states that “where the invention solves a technical problem which workers in the art have been attempting to solve for a long time, or otherwise fulfils a long-felt need, this may be regarded as an indication of inventive step.” As for commercial success alone, it should not be regarded as an indication of inventive step. However, if the invention fulfils a long-felt need besides achieving immediate commercial success, and the examiner is convinced that the commercial success is derived from the technical features of the invention and not from other influences of business skills (e.g., selling techniques or advertising), it may also be regarded as an indication of inventive step. However, it should also be noticed that whether the technical features of the claimed invention are related to the commercial success. In European patent case T 1212/01 (2005), the patent which more specifically described the pharmaceutical effects of Viagra for sexual dysfunction was determined to be invalid. The conclusion of the decision indicated that even if Viagra had received various awards and praise in various journals, the provided evidence did not establish that the commercial success and awarded prizes resulted from the claimed inventive technical features.

The United States - USPTO

In the U.S., applicants may also submit evidence of auxiliary factors considered to support that the invention of application involves an inventive step according to MPEP§ 716.01-07. The auxiliary factors considered include “unexpected effects,” “commercial success,” “long-felt but unsolved needs,” “failure of others,” “skepticism of experts,” “copying by others/design simulation,” “industry praise,” “licensing” and so on.

As previously described, the applicants bear the responsibility to establish the objective evidence of auxiliary factors considered to support that their invention involves an inventive step and explain or prove that there is nexus―that is to say, causal relationship or correlation―between the evidence and the claimed invention, wherein the evidence is commensurate with the whole scope of claims of the original application. If the applicants submit rebuttal evidence, the initial prima facie case becomes invalid. The examiner must consider anew all of the evidence. If the effects or properties affirming inventive step indicated by the offered evidence are actually generated by the technical features other than the distinguishing technical features in the claims, there is no nexus between the evidence and the effects generated by the claimed invention. Thus, the applicants must prove that the effects or properties affirming inventive step are not derived from the technical features included in the prior art.

Common auxiliary factors considered as previously described are further introduced below:

1. Unexpected effects

In chemistry and biology, minor changes in experimental condition may yield completely different results. Therefore, that the invention includes unexpected effects is the most commonly applied argument for chemical and biological patents when arguing non-obviousness. The examiner also often demands the applicants to submit experimental data to compare the claimed invention and the prior art. It is worth noting that whether the evidence covers each claim of the original application and the numerical range thereof to avoid possible narrowing demand.

2. Commercial success

Commercial success must result from effects disclosed or implied in the specification. It is legally presumed that if an idea is obvious for a person skilled in the art, the idea should have been successfully realized in the market earlier in response to market force. Thus, evidence of this type usually comprises advertising and market demand data linked to the claimed effects as well as sales figures, market share, sales period and so on.

3. Long-felt but unsolved needs

To support non-obviousness, applicants may describe the problem that the claimed invention is intended to solve and demonstrate the length of time of lacking solutions for the problem in the art and how the invention solves the problem or satisfies the need.

4. Failure of others

Providing feasible solution for long-standing but unsolved problems may further support non-obviousness. Necessary evidence usually includes statement of a failure of others to solve the problem that the claimed technical features are intended to solve and that experts did not foresee that the solution provided by the application was feasible.

5. Skepticism of experts

Expressions of disbelief about the technical features of the claimed invention by experts (e.g. FDA) before the invention patent application is filed constitute strong evidence of non-obviousness. According to MPEP§716.05, for example, the process in the claimed invention converted all the sulfur compounds in a certain effluent gas stream to hydrogen sulfide, and then treated the resulting effluent for removal of hydrogen sulfide. Before the invention was disclosed, chemistry experts thought that reducing sulfur compounds to hydrogen sulfide in the earlier applied methods would not adequately solve the problem.

6. Copying by others/design simulation

Evidence of deliberate copying by others/design simulation, especially when the narrow claim of the application is selected among the many prior arts, may help to establish non-obviousness. However, evidence that others may also choose to copy other patented products (that others have access to other patented products) may be required at the same time.

7. Industry praise

Similarly, the applicants must prove that the reason why the invention wins industry praises is related to the claimed technical features of the invention to establish nexus between the industry praises and the invention.

8. Licensing

Presence of license implying that the market admits the validity of the patent may be the evidence supporting non-obviousness of the claimed invention. However, mere presence of license is usually insufficient to overcome the obviousness determination of the invention by the initial prima facie case. It must be proved that the license is approved due to the effects of the claimed invention.

Taiwan - TIPO

In Taiwan, according to Page 2-3-24 of Taiwan Patent Examination Guidelines, auxiliary factors considered which may be used to support non-obviousness of an invention during substantial examination include:

1.  Invention producing an unexpected effect: as compared with a relevant prior art, the produced effect includes a significant enhancement of an efficacy (i.e., a quantitative change) or a new performance (i.e., a qualitative change), wherein said effect cannot be expected by a person ordinarily skilled in the art at the time of filing.
2.  Invention solving a long-felt but unsolved problem: a claimed invention can solve a long-felt but unsolved problem of prior art or satisfy a long-felt need among the public.
3.  Invention overcoming a technical prejudice: a claimed invention uses a technical means abandoned due to a technical prejudice to deal with a certain technical problem in a certain technical field and said technical means solves the problem.
4.  Invention achieving commercial success: a claimed invention achieves commercial success and the technical features of the invention directly bring about such success, rather than other factors such as selling technique or advertisement.

Among them, “technical prejudice” refers to the understanding in the art that departs from the objective facts before the filing date, which prevents a person skilled in the art from considering other possibility.

In Taiwan practice, “commercial success” is subject to stricter determination. It must to be proved that “commercial success” directly results from the technical features of the patent, which also means to prove that there is causal relationship. Therefore, there is no chemical and biopharma patents determined involving an inventive step based on “commercial success” so far.

China - CNIPA

Section 5 of Chapter 4 of Chinese Guidelines for Patent Examination, titled “Other Factors Considered When Determining Non-Obviousness of An Invention”, lists the auxiliary factors considered similar to Taiwanese regulations. It is also clarified in Section 5.3 that if the invention produces unexpected technical effects compared to the available technique, there is no need to doubt whether the technical means has prominent and substantive distinguishing features and it can be concluded that the invention involves an inventive step, which demonstrates that China puts a lot of emphasis on whether the invention produces unexpected effects during examination.

In the next part, the difference of regulations about post-filing experimental data submission for chemical and biopharma patents in Europe, the United States, Taiwan, and China will be introduced in detail.

Previously covered:

You can read the other parts of How to Approach Non-Obviousness Requirement Examination for Chemical and Biopharma Patents in Europe, the United States, Taiwan, and China:

• Part I: Concept of Non-obviousness requirement, Definition of “person skilled in the art”, Regulations about prior art exception (Grace Period)
• Part II: Examination approach to determining non-obviousness requirement in Europe, the United States, Taiwan, and China
• Part III: Auxiliary factors considered