Summary

With respect to the amendments to claims in patent invalidation procedures, the Guidelines for Examination provide that, "the specific manners of amendment are generally limited to deletion of a claim, combination of claims and deletion of a technical solution", and in the hearings of invalidation cases, the Patent Reexamination Board also implements the said rules. In an administrative dispute involving patent invalidation, the Beijing Municipal Higher People's Court held that, in addition to the said manners, an amendment in any other manner is also applicable provided that such amendment is in conformity with the relevant provisions concerning the amendments to claims in patent invalidation cases as set forth in the Patent Law and Implementing Rules of the Patent Law. The decision of the Beijing Higher Court was upheld by the Supreme People's Court. This article analyzes the grounds on which the Beijing Higher Court made the decision and the Supreme Court made the ruling, and also analyzes whether such decision and ruling will cause legal issues in the aspect of confirming a patent right.

Key Words: patent invalidation, claims, amendment manner, confirming a patent right

Supreme Court's Ruling on Amendments to Claims in Patent Invalidation Procedures

The Patent Reexamination Board (hereinafter referred to as the "PRB") filed a petition with the Supreme People's Court (hereinafter referred to as the "SPC") for a rehearing of the administrative dispute involving patent invalidation "Zhixingzi No.17/2011" arising between the PRB and Jiangsu Simcere Pharmaceutical R&D Co., Ltd. (Jiangsu Simcere Company), Nanjing Simcere Pharmaceutical R&D Co., Ltd. (Nanjing Simcere Company) and Li Ping (the third party to the litigation).

The SPC rejected the PRB's request for a rehearing. Under the decision delivered by the SPC it was found that, "in the patent invalidation procedures, while complying with amendment principles, the specific manners of amendment are generally limited to the three manners -- deletion of a claim, combination of claims and deletion of a technical solution; however it does not rule out other manners of amendment ."

Case profile

On 19 September 2003, Shanghai Jahwa Pharmaceutical Technology Co., Ltd. (Jahwa Company) filed an application with the State Intellectual Property Office (hereinafter the "SIPO") for a patent for invention named "amlodipine and irbesartan compound preparation" (hereinafter the "patent in issue"), which was declared to have been granted to the applicant on 23 August 2006.

Claim 1 of the patent reads as follows: "a compound preparation, characterized in that the preparation is a pharmaceutical composition composed of amlodipine or its physiologically acceptable salt and irbesartan as active components in the weight ratio of 1:10-30. The ratio 1:30 is described in the "9 dosage combination and corresponding dose ratio" as specified in Format 5 (page 9) of Part III "Test Result" of the description of the patent in issue. In this part, "the compound's effect on blood pressure" it is stated that, "when using 1 mg/kg of amlodipine to combine with different doses of irbesartan, only the use of 30 mg/kg of irbesartan in the combination can have a stable effect of decreasing blood pressure". It is disclosed in Part IV "Analysis and Conclusion" (page 10) of the description that "the combination of 1 mg/kg of amlodipine and 30 mg/kg of irbesartan is recommended as the most preferred dose combination due to its lasting and stable effect of decreasing blood pressure at a relatively small dosage". The working example 1 and example 2 of tablet preparation as specified on Pages 10 and 11 of the description of the patent in issue respectively disclose the combination of 2.500mg of amlodipine and 75.000mg of irbesartan and the combination of 5.000mg of amlodipine and 150.000mg of irbesartan.

With respect to the patent right in this case, Li Ping filed a request for an invalidation declaration. On 29 September 2009, the PRB held an oral hearing at which Jahwa Company presented the amendment of claims to the court namely that it had changed the ratio "1∶10－30" in claim 1 to "1∶30". On 14 December 2009, the PRB made decision No. 14275 concerning the request for an invalidation declaration (hereinafter "Decision No. 14275"), and held that Jahwa Company's amendment to claims went beyond the scope of the original description and claims, and its amendment to the technical feature that indicates the ratio relationship went beyond the scope of manners of amendment allowed in invalidation procedures, and such amendment was rejected. Hence the PRB declared the patent right invalid with respect to all claims on the ground that the claims of patent lacked support from the description according to the original authorization papers. Jahwa Company was not satisfied with the decision and commenced administrative proceedings. Decision No. 14275 was upheld by Beijing Municipal No. 1 Intermediate People's Court. Jahwa Company appealed. During the appeal, Jiangsu Simcere Company and Nanjing Simcere Company became the successors of Jahwa Company due to the patent's transfer. The Beijing Higher Court ruled that Jahwa Company's amendment to claims in the patent invalidation procedures was in compliance with the relevant rules and therefore set aside Decision No. 14257, and instructed the PRB to make a new decision. The PRB was not satisfied and filed a petition with the SPC for a rehearing. The SPC refused the PRB's request for a rehearing on 9 October 2011.

The SPC held that, in this case, the ratio of 1:30 was described as a preferred embodiment of the invention in the original description; the amendment neither went beyond the scope of the original description and claims, nor beyond the protection scope of the patent as granted. If we follow the PRB's opinions that such amendment is not allowed only because of the manner of amendment, and the restrictions imposed on the amendment would simply be a punishment imposed for the improperly written claims of the patentee, this is an unreasonable restriction. Furthermore, the Guidelines for Examination prescribe that the specific manners of amendment are generally limited to the three (listed) manners under the relevant principles, but this does not rule out other manners of amendment. The SPC believed it was right that the second instance judgment ruled the amendment incompliant with the Guidelines for Examination, the PRB's interpretations concerning the amendment to claims in invalidation procedures were too rigid, and its application for a rehearing was dismissed.

What is the conflict between the courts and the PRB?

The Beijing Higher Court and the SPC found the PRB's decision unreasonable on the basis of Article 33 of the Patent Law, which states that "An applicant may amend his or its application for a patent, but the amendment to the application of a patent for invention or utility model may not go beyond the scope of the disclosure contained in the initial description and claims", as well as Article 68 of the Implementing Rules of the Patent Law, which states that, "in the examination process of a request for an invalidation declaration, the patentee of a patent for invention or utility model may make amendments to the claims, but may not go beyond the protection scope of the patent as granted". The PRB's decision concerning the amendment in invalidation procedures is based on the provisions of the Guidelines for Examination (2006), which prescribe that, "the amendment to the documents of a patent for invention or utility model is limited to claims, and shall be in line with the principles which require that the amendment may not: (1) change the subject name of original claims; (2) go beyond the protection scope of the original patent compared with the patent right as granted; (3) go beyond the scope of the disclosure contained in the initial description and claims; and (4) add new technical features not included in claims as granted in general ". The above items (2) and (3) are the same as the provisions of the Patent Law and its Implementing Rules, but what is different is that the Guidelines for Examination add item (4), which make the examination standards on amendment contained in the Guidelines more rigid than that of those in the Patent Law and its Implementing Rules.

The first page of the Guidelines for Examination prescribes that, "The Guidelines for Examination are enacted under the Implementing Rules of the Patent Law of the People's Republic of China". This is based on Article 121 of the Implementing Rules of the Patent Law, which states, "The patent administrative authorities of the State Council shall establish the Guidelines for the Examination of Patents under the Patent Law and the Implementing Rules". This means that the Guidelines for Examination are enacted according to the Patent Law and the Implementing Rules; hence, in the event of any discrepancy between the Guidelines for Examination and the Patent Law and its Implementing Rules, the latter shall prevail.

Therefore, viewed from this point, the Beijing Higher Court's decision and the SPC's ruling are in compliance with the law.

Will Beijing Higher Court and the SPC's Ruling cause other problems?

Under the patent laws, confirmation of a patent right shall go through an administrative procedure, meaning that the patent right is granted by the patent administrative bodies of the State Council. As to this point, under the Patent Law, Article 38 reads: "After the applicant states his opinions on or makes amendment to the application for a patent for invention, if the patent administration department of the State Council still believes that the application does not conform to the provisions of this Law, it shall reject the application." Article 39 reads: "If no reason for rejection is discerned after the application for a patent for invention is substantively examined, the patent administration department of the State Council shall make a decision on the granting of the invention patent right and issue a certificate of patent for invention".

In the process of confirming a patent right, the possibly involved judicial procedure is set forth in Article 41 of the Patent Law, which reads, "Where an applicant for a patent is not satisfied with the review decision made by the Patent Reexamination Board, he may take legal action before the people's court within three months from the date of receiving the notification."

As we can see from the said provision, in the process of confirming or granting a patent right, a court is not entitled to the right of directly granting a patent right, and it only has the right to set aside the re-examination decision of the PRB.
In addition, it is also important to note that, pursuant to the provisions of the Patent Law, granting a patent for an invention should be subject to the substantive examination of the patent administrative authorities of the State Council.

In this case, the said disputes arose because the ratio "1:30" contained in the Claim 1 was not indicated in the text of the claims as granted. If the text of the claims as granted had contained the following claims, then the amendment would not have given rise to a dispute:

1. A compound preparation, characterized by the fact that the preparation is a pharmaceutical composition composed of amlodipine or its physiologically acceptable salt and irbesartan as active components in the weight ratio of 1:10-30.

2. Pursuant to the compound preparation as stated in Claim 1, it is characterized by the fact that the preparation is a pharmaceutical composition composed of amlodipine or its physiologically acceptable salt and irbesartan as active components in the weight ratio of 1:30.

The said Claim 2 was granted upon a substantive examination procedure, which is in compliance with the provisions of the Patent Law.

The SPC upheld the Beijing Higher Court's decision, so the PRB shall reissue a decision of invalidation on this case. If the PRB's new decision of invalidation declaration affirms the validity of the patent right, then the valid Claim 1 should read:

A compound preparation, characterized by the fact that the preparation is a pharmaceutical composition composed of amlodipine or its physiologically acceptable salt and irbesartan as active components in the weight ratio of 1:30.

It should be noted that this patent right was granted without going through a substantive examination procedure. This led to a problem: the patent right was not granted by the patent administrative authorities of the State Council, but by the court in an indirect manner. Based on previous analysis of the patent laws, we know that a court is not entitled to grant a patent right. Therefore, from this point, the Beijing Higher People's Court's decision and the SPC's ruling would likely result in a conflict between patent laws, and such conflict challenges the procedure of granting a patent right under existing patent law.

Conclusion

The primary responsibility of the PRB is to determine whether the decision of rejection is legal in the re-examination procedure and whether a patent right should be invalidated or affirmed in the invalidation procedure. With respect to a case concerning re-examination, if the petitioner amends the claims, the PRB may return the case to the patent administrative authorities of the State Council for a substantive examination again, while in the invalidation procedure, the PRB has no right to request the patent administrative authorities to grant re-examination. I guess the purpose of introducing the amendment principle that "generally may not add new technical features not contained in claims as granted" as set forth in the Guidelines for Examination is also to avoid a grant of technical solution without a substantive examination through the PRB. So I believe that the said principle in the Guidelines for Examination is reasonable and legitimate.

However, this may be unfair for a patentee, and this is one of the reasons why the court reversed the decision on request for invalidation. In consideration of this problem, I think we need to further improve the patent law, such as, introducing a re-examination procedure for cases concerning the grant of a patent right, or entitling the courts to invalidate or grant a patent right. This is only my own idea. Is it reasonable or legitimate? It should be further explored.