Part I – How to Approach Non-Obviousness Requirement Examination for Chemical and Biopharma Patents in Europe, the United States, Taiwan, and China

Date: 27 April 2022

Non-obviousness requirement is usually the biggest hurdle applicants would face during patent prosecution. Also, since regulations on non-obviousness requirement differ greatly across different countries, it is difficult for applicants to obtain the largest scope of rights in different countries with the same drafting and response strategy. Furthermore, different determination methods are adopted for patent applications in different technical fields, such as chemical inventions and mechanical inventions. This article aims to focus on chemical and biopharma patent applications, compare different regulations on non-obviousness requirement in USPTO, CNIPA, EPO and TIPO, and provide our strategies for applicants. We will discuss concept of non-obviousness requirement, definition of “person skilled in the art”, regulations about prior art exception (grace period), examination approach to determining non-obviousness requirement, auxiliary factors considered and post-filing experimental data submission respectively in this series of articles.

A. Concept of Non-obviousness requirement

European patents - EPO

For non-obviousness requirement, Article 56 of European Patent Convention states that “an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. If the state of the art also includes documents within the meaning of Article 54, paragraph 31 , these documents shall not be considered in deciding whether there has been an inventive step.”

The United States - USPTO

Article 103 of the U.S. Patent Act states that “a patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 1022 , if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” The most notable difference between USPTO and EPO lies in that USPTO tends to focus on whether the invention is obvious as a whole. (For more details, please refer to the comparison between each country on examination approach below.)

Taiwan - TIPO

Referring to Page 2-3-16 of Taiwan Patent Examination Guidelines, TIPO also emphasizes that non-obviousness should be determined based on the whole invention, and whether an invention can be easily accomplished cannot be determined solely by an individual or part of technical features or the difference between the invention and the prior art. Paragraph 2 of Article 22 of Taiwan Patent Act states that “an invention that is without the circumstances prescribed in the subparagraphs of the preceding paragraph3 but can be easily made by a person ordinarily skilled in the art based on prior art shall not be patented.” According to Page 2-3-15 of Taiwan Patent Examination Guidelines, inventions which can be easily made are those expected to be accomplished simply by utilizing common general knowledge at the time of filing.

China - CNIPA

Article 22 of China Patent Law states that “any invention or utility model for which a patent right may be granted must possess the characteristics of novelty, inventiveness and usefulness…inventiveness means that, compared with the technology existing before the filing date of the application, the invention has prominent and substantive distinguishing features and represents a marked improvement….” Furthermore, it is described in Section 2.2 and 2.3 of Chapter 4 of Chinese Guidelines for Patent Examination that “prominent and substantive distinguishing features” means that the invention is not obvious with respect to the prior art for a person skilled in the relevant field of technology and that “marked improvement” means that the invention can produce beneficial technical effects compared to the prior art. While determining non-obviousness, the technical problem solved and the effects produced by the invention should be taken into consideration and it is also emphasized that the object should be the whole invention.

 

B. Definition of “person skilled in the art”

European patents - EPO

The definition of “a person skilled in the art” in EPO is a conceptual skilled practitioner in the relevant field of technology who is possessed of average knowledge and ability. A person skilled in the art is presumed to be aware of common general knowledge in the art and is able to combine two teachings to solve a particular technical problem. (Part G-VII 3 of Guidelines for Examination in EPO)

The United States - USPTO

According to MPEP Chapter 2100,2141.3, USTPO defines “a person of ordinary skill in the art” as a hypothetical person who is presumed to have known the relevant art at the time of the invention but not an expert in the relevant art. Also, the one is creative at ordinary level rather than an automaton and is able to combine the teachings of multiple patents together like pieces of puzzle.

Taiwan - TIPO

The definition in Taiwan is closer to that in Europe. It is stated in Section 3.2.1 of Chapter 3 of Taiwan Patent Examination Guidelines that “a person ordinarily skilled in the art refers to a hypothetical person who is possessed of general knowledge and ordinary skill of the technical field to which the invention pertains at the time of filing, and is able to understand and utilize technologies known at the time of filing.”

China - CNIPA

For CNIPA, “a person skilled in the art” is a fictional person who is presumed to be aware of all the common technical knowledge and have access to all the technologies existing before the filing date in the technical field to which the invention pertains, and have capacity to apply all the routine experimental means before that date but not presumed to have creativity.

C. Regulations about prior art exception (Grace Period)

European patents - EPO

There is no regulation of “grace period” in Europe. Part G-V of Guidelines for Examination in EPO states that there are only two specific instances in which a prior disclosure of the invention is not taken into consideration as the prior art during novelty and non-obviousness requirement examination if happening within 6 months before the filing date. One is evident abuse, and the other is display of the invention at an officially recognized international exhibition.

China - CNIPA

The regulations about grace period are also relatively strict in Article 24 of China Patent Law. An invention does not lose its novelty because of disclosure if it is first made public for the purpose of public interest during national emergency, exhibited at an officially recognized international exhibition or academic meeting or disclosed by any person without the consent within six months before the date of application.

The United States - USPTO

The grace period in the U.S. is one year. A disclosure of the invention by the inventor or related person within one year before the filing date of US application does not affect patentability examination of the invention, referring to Article 102(b) of the U.S. Patent Act.

Taiwan - TIPO

Paragraph 3 of Article 22 of Taiwan Patent Act stipulates that a disclosure made by or against the applicant’s will shall not be deemed as the prior art which determines the novelty or non-obviousness requirement of the invention of application, only if, similarly, the patent application is filed within 12 months after the date of the disclosure.

In addition, one should notice that the patent application with earlier filing date but published later is deemed as part of the prior art to determine non-obviousness requirement of the application in the U.S.4 , but not in Taiwan5 , China6 and Europe7 .

In the next part, the examination approach of non-obviousness requirement for chemical and biopharma patents in Europe, the United States, Taiwan, and China will be introduced in detail.

  

 

[1]It refers to the patent application with earlier filing date but which is published later. (see also Article 53 of European Patent Convention)

[2]It refers to novelty requirement. (also seeing 35 U.S. Code § 102)

[3]It refers to novelty requirement. (see also Paragraph 1 of Article 22 of Taiwan Patent Act)

[4]35 U.S. Code § 102(a)(2)

[5]Article 23 of Taiwan Patent Act

[6]Article 24 of China Patent Law

[7]Paragraph 3 of Article 54 of European Patent Convention

 

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