Part III – How to approach the examination of non-obviousness requirements for chemical and biopharmaceutical patents in Europe, the United States, Taiwan and China
In Part II, we covered the comparison between the examination approach for determining the non-obviousness requirement for chemical and biopharmaceutical patent applications in Europe, the United States, Taiwan and China. In this part, we continue to compare the difference between considered ancillary factors related to the non-obviousness requirement for chemical and biopharmaceutical patents in these jurisdictions.
E. Auxiliary factors taken into account:
European patents – EPO
Part G-VII 10.3 of the Guidelines for Examination in the EPO states that “where the invention solves a technical problem which the person skilled in the art has endeavored to solve for a long time, or otherwise solves a long-felt need, this may be considered an indication of inventive step. As for commercial success alone, it should not be considered an indication of inventive step. However, if the invention meets a felt need of long standing in addition to immediate commercial success, and the examiner is confident that commercial success stems from the technical features of the invention and not from other influences of business skill (e.g., sales techniques or advertising) , it can also be considered as an indication of inventive step.However, it should also be noted that if the technical characteristics of the claimed invention are related to commercial success. European vet T 1212/01 (2005), the patent which more specifically described the pharmaceutical effects of Viagra for sexual dysfunction was declared invalid. The conclusion of the decision stated that although Viagra had received various awards and accolades in various journals, the evidence provided did not establish that the commercial success and prizes awarded resulted from the claimed inventive technical features.
The United States – USPTO
In the United States, applicants may also provide evidence of ancillary factors considered to support that the invention of the application involves an inventive step under MPEP§ 716.01-07. Auxiliary factors considered include ‘unexpected effects’, ‘commercial success’, ‘long-felt but unresolved needs’, ‘failure of others’, ‘expert skepticism’, ‘copy by d ‘others/the design simulation’, ‘industry praise’, ‘license’ and so on.
As described above, applicants bear the responsibility of establishing objective evidence of the ancillary factors considered to support that their invention involves an inventive step and of explaining or proving that there is a connection ― that is, a causal relationship or correlation ― between the evidence and the claimed invention, in which the evidence is proportionate to the full scope of the claims of the original application. If plaintiffs submit rebuttal evidence, the initial prima facie case becomes invalid. The Examiner must re-examine all of the evidence. If the effects or properties confirming the inventive step indicated by the evidence offered are actually generated by the technical features other than the distinguishing technical features in the claims, there is no connection between the evidence and the effects generated by the claimed invention. Thus, applicants must prove that the effects or properties asserting the inventive step are not derived from the technical features included in the state of the art.
The common supporting factors considered as previously described are shown below:
1. Unexpected effects
In chemistry and biology, minor changes in experimental conditions can give completely different results. Therefore, the fact that the invention has unexpected effects is the argument most commonly applied for chemical and biological patents when asserting non-obviousness. The examiner also often asks applicants to submit experimental data to compare the claimed invention and the state of the art. It should be noted that if the evidence covers every claim of the original application and the numerical range thereof to avoid a possible narrowing application.
2. Commercial success
Commercial success must result from the effects disclosed or implied in the specification. It is legally presumed that if an idea is obvious to a person skilled in the art, the idea should have been successfully realized in the market sooner in response to market strength. Thus, evidence of this type typically includes advertising and market demand data related to the alleged effects as well as sales figures, market share, sales period, etc.
3. Long felt but unresolved needs
To substantiate the non-obviousness, applicants may describe the problem the claimed invention seeks to solve and demonstrate how long the problem has not been solved in the art and how the invention solves the problem or meets the need.
4. Failure of others
Providing a workable solution to long-standing but unresolved problems can further reinforce the non-obviousness. Necessary evidence usually includes a statement of a failure by others to solve the problem that the claimed technical features are supposed to solve and that the experts did not foresee that the solution provided by the application was feasible.
5. Expert skepticism
Expressions of disbelief regarding the technical features of the claimed invention by experts (e.g. the FDA) prior to the filing of the invention patent application constitute strong evidence of non-obviousness. According to MPEP§716.05, for example, the process of the claimed invention converts all sulfur compounds in a certain effluent gas stream to hydrogen sulfide and then treats the resulting effluent to remove the hydrogen sulfide. Before the invention was disclosed, chemical experts believed that the reduction of sulfur compounds to hydrogen sulfide in previously applied methods would not adequately solve the problem.
6. Copy by others/design simulation
Evidence of deliberate copying by others/simulation of design, particularly when the narrow claim of the application is selected from among the many prior arts, can help establish non-obviousness. However, proof 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. Praise from the industry
Similarly, applicants must prove that the reason why the invention wins industry acclaim is related to the claimed technical features of the invention in order to establish a connection between the industry acclaim and the invention.
The presence of a license implying that the market accepts the validity of the patent may constitute proof of the non-obviousness of the claimed invention. However, the mere presence of a license is generally insufficient to overcome the determination of the obviousness of the invention by the initial prima facie case. It must be proven that the license is approved because of the effects of the claimed invention.
Taiwan – TIPO
In Taiwan, according to page 2-3-24 of the Taiwan Patent Examination Guidelines, the auxiliary factors taken into account that can be used to support non-obviousness of an invention in substantive examination include:
- Invention producing an unexpected effect: compared to a relevant state of the art, the effect produced comprises a significant improvement in efficiency (i.e. a quantitative change) or a new performance (i.e. i.e. a qualitative change), said effect not being expected by a person ordinarily skilled in the art at the time of filing.
- Invention solving a long-felt but unsolved problem: A claimed invention may solve a long-felt but unsolved problem in the prior art or satisfy a long-felt need of the public.
- Invention overcoming technical harm: A claimed invention uses a technical means abandoned due to a technical harm to address a certain technical problem in a certain technical field and said technical means solves the problem.
- Invention achieving commercial success: A claimed invention achieves commercial success and the technical features of the invention directly lead to that success, rather than other factors such as sales technique or advertising.
Among them, “technical prejudice” refers to the understanding of the art deviating from objective facts before the filing date, which prevents a person skilled in the art from considering another possibility.
In Taiwanese practice, “commercial success” is subject to a stricter determination. It must be proven that the “commercial success” results directly from the technical characteristics of the patent, which also means proving that there is a causal link. Therefore, there are still no definite chemical and biopharmaceutical patents involving an inventive step based on “commercial success”.
China – CNIPA
Section 5 of Chapter 4 of China’s Guidelines for Patent Examination, titled “Other Factors Considered in Determining Non-Obviousness of an Invention”, lists ancillary factors considered similar to Taiwanese regulations. It is also specified in section 5.3 that if the invention produces unexpected technical effects compared to the available technique, there is no reason to doubt that the technical means has important and substantial distinctive characteristics and it can be concluded that the invention involves an inventive step, which demonstrates that China attaches great importance to whether the invention produces unexpected effects upon examination.
In the following section, the regulatory differences regarding the submission of post-filing experimental data for chemical and biopharmaceutical patents in Europe, the United States, Taiwan and China will be presented in detail.