October, 2018｜News Letter

1. May Post-Filing Experimental Data be Considered for Examining Inventive Step?

Celltrion Inc. v. Genentech Inc., Case No. 2017 (Gyo-Ke) 10106 (Decision rendered on October 22, 2018)

The Patentee, Genentech, obtained a patent relating to a medicament comprising an anti-ErbB2 antibody for treating a human patient diagnosed with a breast tumor in 2014. Against the Genentech’s patent, Celltrion filed an invalidation trial with the JPO in 2016. During the trial procedure, Genentech demanded a correction of the description of the specification. The JPO admitted the correction, and dismissed the Celltrion’s demand. Celltrion filed an appeal against the JPO's decision to the IPHC in 2017.

The Claim 1 of the Genentech’s patent at issue claims as follows:
A medicine comprising a therapeutically effective amount of a humanized 4D5 anti-ErbB2 antibody, for treating a human patient diagnosed with a breast tumor in which ErbB2 protein is expressed, wherein the treatment comprises the following steps, performed sequentially: (a) treating the patient with the medicine; (b) surgically removing the tumor; and then (c) treating the patient with the medicine or a chemotherapeutic agent.

One of the main issues in this case related to whether post-filing experimental data may be considered for examining inventive step. The IPHC answered to the issue as follows:

In the JPO’s decision, the JPO determined that the reasons for invalidation on account of lack of novelty and lack of inventive step were not acceptable on two grounds:
(1) Claim 1differed from the invention disclosed in prior art reference (p.a.r.) 1 in that a medicament containing anti-HER2 antibody is applied to "a therapy comprising the steps performed sequentially of (a) treating a patient with the medicament, (b) surgically removing the tumor, and (c) treating the patient with the medicament, or a chemotherapeutic agent".
(2) The effects of Claim 1 have been confirmed by the publications after the priority date of the patent at issue and the effects mentioned in the publications could not be anticipated from the disclosures of the p.a.r. 1.

However, the IPHC overturned the above JPO’s decision as follows:

First, having reviewed various p.a.r.s, the IPHC found that the following matters were common technical knowledge:
(1) The anti-HER2 antibody binds to the extracellular region of the HER2 protein to suppress proliferation of breast cancer cells overexpressing the HER2 protein and concurrently to show antibody-dependent cell-mediated cytotoxicity (ADCC).
(2) Overexpression of HER2 protein is observed not only in metastatic breast cancer but also in 25% to 30% of early stage breast cancers.
(3) In clinical trials of patients with metastatic breast cancer with tumors overexpressing HER2 protein, compared with the single administration group of a specific chemotherapeutic agent including paclitaxel, enhanced antitumor effects were observed in the group of combined administration of two antibodies of the chemotherapeutic agent and the anti-HER2 antibody, for example, the time-period of disease progression (progression-free period) lengthened, overall response rate (ORR) improved, the median of response period lengthened, and the survival rate for one year increased.
(4) In clinical trials of anti-HER2 antibody, in both cases of single administration and combined administration with a chemotherapeutic agent, the cases where HER2 protein was more strongly expressed tended to show more excellent antitumor effects and progression-free period.
(5) In developing a therapeutic drug for breast cancer, the anticancer effects on patients with operable breast cancer are confirmed on the basis of the anti-cancer effects on patients with metastatic breast cancer.
Further, the IPHC found that p.a.r. 2 suggested preoperative prescription of a combination of anti-HER2 antibody with chemotherapy for patients with early-stage breast cancer.
On the basis of the above findings, the IPHC decided that those skilled in the art having regard to p.a.r. 1 could have easily conceived of applying a therapeutically effective amount of the medicament disclosed in p.a.r. 1 which is a medicament containing anti-HER2 antibody to treat operable breast cancer overexpressing HER2 protein.

Then, the IPHC further found that the following matters were also common technical knowledge:
(6) In breast cancer, the success or failure of breast conservation generally has a great impact on the QOL (quality of life) of females, and it was indicated that neoadjuvant therapy makes operation simpler and allows breast conservation at a high rate.
(7) In operable breast cancer, it is commonly practiced as a general therapy to perform preoperative chemotherapy, then to surgically remove the tumor, and further to perform adjuvant chemotherapy.

By taking the above findings together with the suggestion of p.a.r. 2 mentioned above, the IPHC decided that those skilled in the art having regard to p.a.r. 1 could have easily conceived of administering the medicament of the invention disclosed in p.a.r. 1 in combination with a chemotherapeutic agent before the operation, performing the operation and further administering the medicament of the invention disclosed in p.a.r. 1 in combination with a chemotherapeutic agent after the operation to treat operable breast cancer overexpressing HER2 protein.

Additionally, the IPHC considered and decided on the effects of Claim 1 as follows:

The present specification as amended does not show results of clinical trials, and simply mentions that "patients who have been treated according to the method of treatment mentioned above will show wholly improved survivors and/or lengthened time of tumor progression (TTP)."
In breast cancer, survival rate and time of tumor progression (TTP) are general indices for weighing the effects of anticancer drugs. Therefore, the effects of Claim 1 are limited to having qualitative effects of improving survival rates and lengthening time of tumor progression (TTP) as compared to those in the case where the medicament of Claim 1 is not administered.
According to the disclosures of p.a.r. 1, it is possible to understand that the medicament of the invention disclosed in p.a.r. 1 produces qualitative effects of improving survival rates and lengthening time of tumor progression (TTP) in patients with metastatic breast cancer overexpressing HER2 protein. When the medicament of the invention disclosed in p.a.r. 1 is applied to operable breast cancer overexpressing HER2 protein by a process of Claim 1, those skilled in the art could have anticipated that qualitative effects of improving survival rates and lengthening time of tumor progression (TTP) would be produced compared to those of the case where the medicament is not administered.
Even if the experimental data of the publications published after the priority date of the present application cited by the trial decision are considered within the limit of showing the qualitative effects mentioned above within the scope of disclosures of the present specification as amended, the qualitative effects mentioned above could have been anticipated by those skilled in the art and it cannot be said that prominent effects are produced. On the other hand, considering the experimental data mentioned above beyond the qualitative effects mentioned above exceeds the scope of the disclosures of the present specification as amended, and therefore the data cannot be considered as effects of Claim 1.

Conclusively, the IPHC upheld the Celltrion’s appeal, and cancelled the JPO’s decision.

An appeal to the Supreme Court was filed against this decision, but then was withdrawn, and thus the decision is final and binding.

K&P’s Comments As seen from the above IPHC’s decision, the IPHC rules that experimental data showing specific quantitative effects cannot be considered as effects of the claimed invention for examining inventive step when the specification at issue discloses only qualitative effects, since such quantitative effects exceed the scope of the disclosures of the specification at issue.

(by Katsumasa OSAKI, Patent Attorney)

In October 2018, the IPHC handed down 17 decisions including the above case on patent and utility model, and overturned the previous decisions in 5 cases.

In October 2018, the IPHC handed down 4 decisions on trademark, and maintained all the previous decisions.

In October 2018, the IPHC handed down no decisions on industrial design.