Pharmaceutical Composition for Use in Diabetes Treatment – Admission of Post-filing Experimental Data for Inventiveness

Takeda Pharmaceutical Co.,Ltd. v. PRB – Admission of Post-filing Experimental Data for Inventiveness (Administrative Ruling (2012) Zhi Xing Zi No.41 by the Supreme People’s Court on September 17, 2012)

In the procedure of granting and confirming a patent right, the patent applicant/patentee may intend to submit supplementary experimental data to prove the patent has inventiveness. Admission of the post-filing experimental data should be reasonable and objective in view of the proper balance between the interests of patentees and the public. This case highlights the premise to admit the post-filing experimental data for determination of inventiveness, i.e. such data should direct to the technical effect described in the original application documents.

The patentee, Takeda Pharmaceutical Co.,Ltd. (hereinafter “Takeda”), owns a invention patent No. ZL96111063.5 titled as “Pharmaceutical Composition for Use in Treatment of Diabetes” (hereinafter “the patent concerned”). Claim 1 was “pharmaceutical composition useful for prophylaxis or treatment of diabetes, diabetic complications, glucose or lipid metabolism disorders, which comprises an insulin sensitivity enhancer selected from pioglitazone or a pharmacologically acceptable salt thereof, and Sulfonylurea as insulin sensitivity enhancers.”

Sichuan Haisco Pharmaceutical Co.,Ltd.(hereinafter “Haisco”), Chongqing Institute of pharmaceutical industry Co., Ltd.(hereinafter “Chongqing Institute”) filed the invalidation request with the Patent Reexamination Board (PRB) on June 13, 2008 and July 18, 2008, respectively，based on the same grounds. One of the invalidation ground is that Claim 1 lacks inventiveness. In this regard, Takeda submitted counter-evidence 7 to prove that the patent concerned had unexpected technical effect.

The PRB rendered the Invalidation Decision No. 12712 not in favor of Takeda. According to the invalidation decision, it holds Takeda’s counter-evidence 7 inadmissible for authenticity and could not prove the inventiveness of claim 1.

Takeda appealed to the Beijing First Intermediate People’s Court (the first instance court). Meanwhile, Takeda submitted patent examination file of the patent concerned and its European family patent, arguing the experimental data submitted in the invalidation procedure was admitted in substantive examination both by the State Intellectual Property Office (SIPO) and European Patent Office (EPO).

The first instance court decided that the counter-evidence 7 was not the original lab reports and did not show institutions or individuals of the experiments; since Haisco and Chongqing Institute did not accept the counter-evidence 7, it is legitimate for the PRB not admitting it. The second instance court affirmed.

Takeda appealed to the Supreme People’s Court (SPC) for retrial. According to the SPC’s ruling, Takeda’s counter-evidence 7 described the specific experiment procedure and the clear result, as a unilateral proof of that the combination of pioglitazone and glimepiride has unexpected synergy. However, there is no evidence establishing that the examiner of either the SIPO or the EPO granted the patent because of the admission of the counter-evidence 7. The fact that the counter-evidence 7 existed in the related examination files can only prove that Takeda had submitted these materials in the substantive examination phase. Moreover, the counter-evidence 7 was not original and it did not show which institution or who made the experiments, nor it was notarized. At the same time, the counter-evidence 7 was not accepted by Haisco and Chongqing Institute. Thus, it was not improper for the PRB disallowing the counter-evidence 7.

Furthermore, the SPC holds that: experimental data filed after the date of filing is not contained in the original patent application document. If the technical effect of the patent was determined based on such experimental data, it would be contrary to the first-to-file principle, also violate the essence of the patent system. And it was not fair to the public to grant a patent application on this basis. When the patent applicant or patentee want to submit comparing experimental data to prove the claimed technical solution had inventiveness in respect to the prior art, the premise for admitting the data is that the experimental data should direct to the technical effect described in the original application documents.

To be specific, Takeda provided the counter-evidence 7 to prove the combination of pioglitazone and glimepiride had unexpected hypoglycemic effects compared with the effect when they are used alone or of other combination protocols. However, in the patent specification, there were only experimental results of combination of pioglitazone and voglibose, and combination of pioglitazone and glibenclamide, which claimed better hypoglycemic effect due to combination of insulin sensitivity enhancer and insulin secretion enhancer. It did not mention the effect among different combination protocols of drugs. The technical effect argued by Takeda based on the post-filing experimental data was not described in the original application documents, and awaited verification. Therefore, such experimental data cannot be used as the basis for evaluation of the inventiveness.

For the reasons above, the SPC rejected Takeda’s retrial petition.

Remarks

It has been a hot topic in the field of chemistry and medicine that whether supplementary experimental data submitted after the date of filing should be admitted. Chemistry and medicine are experimental science. For the inventions thereof, it is not possible to prove the inventiveness without experimental data. Sometimes, the applicant/patentee may intend to submit supplementary experimental data after filing to prove inventiveness with respect to the prior art. Admission of the post-filing experimental data should be reasonable and objective in view of the proper balance between the interests of patentees and the public.

First, the authenticity of the experimental data is a precondition. As for the post-filing supplementary experimental data, it should consider the reasons the evidence was formed by, whether it is original or a photocopy, the interests of the parties providing the evidence, etc. For an extraterritorial evidence, the notarization and authentication is important.

In this case, the source of the experimental data submitted by Takeda in invalidation procedure was not indicated, and the document was not notarized or authenticated. Therefore, since the other party did not accept the authenticity, under the Chinese laws, the PRB and the courts could not admit such evidence.

Second, if the counter-evidence 7 were notarized and proved to be true, is it possible the result would be different?

The counter-evidence 7 is post-filing experimental data. Generally, this type of data will not be admitted if it is related to the practical applicability under Article 22, Paragraph 4, enablement under Article 26, Paragraph 3, or support and clarity under Article 26, Paragraph 4 of the Chinese Patent Law, for the reason that such data cannot be derived by a skilled person from the prior art.

With respect to the determination of novelty and inventiveness, it may be different. That is to say, comparison experimental data between the patent concerned and the prior art should be allowed for submission to evaluate the inventiveness. However, the comparison experimental data should direct to the effect disclosed in the original patent application documents, or the effect derived from the existing technologies by a person skilled. In this case, the counter-evidence 7 does not satisfy this condition(s).

We can conclude that, according to the first-to-file principle and the essence of disclosure for protection of patent law, even if the authenticity of the counter-evidence 7 can be confirmed, it still cannot be used to prove the technical effect that was neither recorded in the application documents nor derived from the prior art.

In summary, when a patent applicant or patentee wishes to submit post-filing comparison experimental data to prove the inventiveness, the data should direct to the technical effect described in the original application documents clearly, because this determines whether the data can be accepted and admitted. Therefore, the applicant or patentee shall submit supplementary experimental data with caution. In addition, when drafting a patent, the effect or the desired effect should be fully explained. As for the technical effect or technical solution found after the date of filing, new or divisional application in the form of a method or a use patent can be considered.

Written by Jinchun PIAO and Jia DONG

Author Profile: Dr. Piao is a patent attorney in our Japanese & Korean division. She can work in Japanese, Korean, and English.

Email: jinchun.piao@beijingeastip.com

Ms. Dong is a patent attorney in our Japanese & Korean division. She can work in both English and Japanese.

Email: jia.dong@beijingeastip.com

Pharmaceutical Composition for Use in Diabetes Treatment Case – PowerPoint Presentation (Chinese Version)