Newsletter
Amendment to the Patent Examination Guidelines for Biology-Related Inventions: Clarification of the Support and Non-Obviousness Requirements for "Antibody-Related Inventions"
Due to the evolution of technology in antibody-related inventions antibody-related field, it has been observed that the claims of the patent applications for such inventions change from defining the claimed antibody by the hybridoma producing the monoclonal antibody with the hybridoma deposited with a domestic depository institute designated by the Specific Patent Agency to defining the claimed antibody by the variable region sequences of the heavy/light chains of the antibody. In recent years, an increasing number of patent applications covering antibody-related inventions have the claimed antibodies defined by epitopes recognized by the antibodies (see the figure below).
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Source: MABS, Volume 10, 2018 - Issue 2, pp. 204-209. https://doi.org/10.1080/19420862.2017.1402998
In response to the above technological development of antibody-related inventions, the Patent Examination Guidelines for Biology-Related Inventions should be amended accordingly. Part II, Chapter 14 of the Patent Examination Guidelines, entitled “Biology-Related Inventions,” was announced on May 21, 1997, and was revised three times on December 12, 2002, August 6, 2007 and January 1, 2013. The Intellectual Property Office (IPO) held a public hearing for a draft amendment to the Patent Examination Guidelines for Biology-Related Inventions on October 11, 2018, and announced an Amendment to the Patent Examination Guidelines for Biology-Related Inventions on December 7, 2018. The amendment came into effect on January 1, 2019. The purpose of this amendment is to conform the criteria for determining the inventive step of biology-related inventions to the amendment to Part II, Chapter 3 “Patentability,” Section 3 “Inventive Step” of the Patent Examination Guidelines. The "examination examples for claims being supported by the specification" and "unity of invention," parts of the Patent Examination Guidelines for Biology-Related Inventions were also amended according to current patent practice of the IPO. However, as can be seen in the public hearing summary sheet that contains public opinions and the IPO's responses, the IPO has further explained the novelty requirements and how claims should be drafted with respect to biology-related inventions. Since antibody-related inventions and emerging developments are associated with biological preparations used in immunotherapies and cell therapies, their patentability has received much attention.
The most common issues that arise during substantive examination of antibody-related invention patent applications are those related to the definiteness of claims, support by the specification and inventive step. The determination of definiteness, support and inventive step requirements for antibody-related inventions in the amendment to the Patent Examination Guidelines for Biology-Related Inventions are further explained as follows:
1. Definiteness and Support Requirements
Regarding claims directed to antibodies, Section 5.1 (7) of the Patent Examination Guidelines states that "(an antibody) can be defined with an antigen identified thereby, a hybridoma that produces the antibody, cross-reactivity and the amino acid sequences in the complementarity determining regions (CDRs) of its heavy and light chains." The part "defined with the amino acid sequences in the complementarity determining regions (CDRs) of its heavy and light chains" is newly added based on current patent practice. However, in practice, if the claimed antibody is defined solely with the antigen identified thereby or with the cross-reactivity, the applicant often receives an office action in which the claimed invention is alleged "indefinite" or "not supported by the specification." In this regard, the IPO’s response to the public hearing opinions is that "defining the claimed antibody with an antigen identified thereby will not be deemed indefinite. As to whether the claimed antibody meets other requirements set forth in Article 26 of the Patent Act, such as the enablement and support requirements, determinations should be made on a case-by-case basis." It can be determined from the foregoing that if the antibody is defined by an antibody-binding epitope, the IPO should not directly reject the application for lacking definiteness. Although the Patent Examination Guidelines do not provide an examination example for the enablement requirements for antibody-related inventions, it can be known from the IPO's responses at the public hearing that if the specification has provided sufficient embodiments to support various aspects and effects of the claimed invention, there should be more flexibility in the determination of enablement and support requirements.
2. Inventive Step Requirement
Examples relating to the inventive step of antibody inventions are mainly specified in Section 6.3(3)(b), i.e., "when the claimed invention is a monoclonal antibody of an antigen, if the antigen is already known and it is clear that the antigen has immunogenicity (e.g., if polyclonal antibodies of the antigen are already known, or if the antigen is a polypeptide having an extremely large molecular weight, the antigen definitely has antigenicity), the monoclonal antibody invention is deemed as lacking an inventive step in principle. However, if the monoclonal antibody is further limited by other technical features capable of bringing about a technical effect, such as the amino acid sequences in the complementarity determining regions (CDRs) of its heavy and light chains, thereby enabling the monoclonal antibody to bring about an unexpected effect, the monoclonal antibody invention is deemed as having an inventive step." Differences from the original Patent Examination Guidelines lie in the underlined part. According to the IPO’s responses to the public hearing opinions, when the monoclonal antibody is defined with the amino acid sequences in the complementarity determining regions (CDRs) of its heavy and light chains, as long as such amino acid sequences are distinguished from those disclosed in prior art, the claimed monoclonal antibody is deemed as having an inventive step in principle. In this case, there is no need for the applicant to prove that the claimed monoclonal antibody has an unexpected effect. Under current practice, some examiners tend to question the inventive step of the claimed antibody over antibodies bonded to the same antigen disclosed in prior art, without providing any comparison of sequences. This Amendment facilitates overcoming an obviousness rejection of antibody inventions on the aforementioned ground.
Nevertheless, regarding the inventive step of antibodies defined with specific epitopes on an antigen commonly known in the art, the IPO responded to the public hearing opinions by stating that "if the claims employ closed-ended phrases (e.g., 'consisting of') to define the epitopes recognized by the claimed antibody, since a person having ordinary skill in the art can predict possible epitopes with stronger antigenicity on an antigen by using computer programs and so forth, and prepare an antibody which can recognize such epitopes according to the amino acid sequences of the commonly known antigen, the claimed antibody is deemed as lacking an inventive step in principle, unless it has an unexpected effect." According to the foregoing response, even though the lack of novelty issue can be addressed by employing closed-ended phrases in the claims to define the epitopes recognized by the claimed antibody, the applicant still has to present arguments or data to demonstrate that the claimed antibody has an unexpected effect, so as to prove its inventive step.
Given the foregoing, the amendment to the Patent Examination Guidelines for Biology-Related Inventions will facilitate the grant of antibody-related invention patent applications, make local patent examination criteria of relevant inventions more consistent with international standards and help to improve the patent examination quality in Taiwan.