Recently, our firm won the first instance of an administrative litigation case for invalidation of an invention patent, in which it is ruled that the invention patent should be comp...
Introduction In the chemical field, it is difficult to seek invalidation of a patent claiming to have achieved unexpected technical effect. This case provides a strategy for success...
Amendment Manners during Invalidation Procedure as Viewed from Adjudication of the Supreme People’s Court
SHEN Xianhua
Chinese Patent Attorney
Mechanical Engineering Department
Linda Liu & Partners
As stipulated in the SIPO’s Guidelines for Patent Examination, Part IV, Chapter 3, Section 4.6.1, in the invalidation procedure, “any amendment to the patent documents of a patent for invention shall be limited to the claims only, and shall follow the following principles: (1) the title of the subject matter of a claim can not be changed; (2) the extent of the protection can not be extended as compared with that in the granted patent; (3) the amendment shall not go beyond the scope of disclosure contained in the initial description and claims; and (4) addition of technical features not included in the claims as granted is generally not allowed. Subject to the above principles of amendments, the specific manners of amendment are generally limited to deletion of a claim, combination of claims, and deletion of a technical solution.” In previous invalidation examination practices, the Patent Reexamination Board (PRB) rigidly required that amendments to a claim be limited to the three manners – deletion of a claim, combination of claims, and deletion of a technical solution; and the applicant could not amend the claim in other ways. However, the aforesaid rigid examination practice was broken through by an intellectual property-related administrative adjudication No. 17 [2011] issued by the Supreme People’s Court1. A summary of the case related to this adjudication is introduced below.
Patent-grant Procedure
The SIPO announced a patent for invention No. 03150996.7 (hereinafter referred to as the present patent) on August 23, 2006, of which the title was “a compound preparation prepared from amlodipine and irbesartan.” The application date was September 19, 2003, and the patentee was Jahwa Pharmaceutical Technology Co., Ltd.
The claims of the announced patent were as follows:
1. A compound preparation, which is a pharmaceutical composition, composed of amlodipine or a physiologically acceptable salt thereof and irbesartan at a ratio by weight of 1:10-30 as active components.
2. The compound preparation according to claim 1 characterized in that said pharmaceutical composition is various medically acceptable peroral preparation.
3. Use of the compound preparation according to claim 1 in the manufacture of medicines for treating mild and modest hypertension.
4. The use according to claim 3 characterized in that said medicines are applicable to treatment of hypertensive with cardiovascular remodeling and to patients that have renal hypertension, hypertension combined with renal function damage or hypertension combined with diabetes and renal function damage.
Invalidation Procedure
An invalidation request against the present patent was filed by another party to the Patent Reexamination Board on June 19, 2009.
The patentee submitted amended claims during the oral hearing; wherein the ratio “1:10-30” defined in granted claim 1 was amended to “1:30.”
In the Invalidation Decision No. 14275 issued on December 14, 2009, the Patent Reexamination Board deemed that “the amended technical solution goes beyond the scope of the disclosure contained in the original description and claims, and it cannot be unambiguously determined from the initial claims and description.” The detailed reasons were as follows: “The ratio “1:10-30” in the granted claim 1 was amended to “1:30.” A specific ratio is selected among a continuous ratio range, but the initial claims and description neither expressly disclose this specific ratio nor suggest such a selection among the original ratio range. Although the description of the present invention discloses a combination of 1mg/kg of amlodipine and 30mg/kg of irbesartan, this is only a combination of medicines of a specific amount, and it does not reflect a whole ratio relationship. Moreover, the specific amount of the medicines is explicitly limited on page 10 of the description of the present patent as: ‘an amount ratio between amlodipine and irbesartan applicable to the present invention is: amlodipine: irbesartan = 2-10mg:50-300mg.’ Thus, it cannot be determined whether any combination satisfying the ratio 1:30 is capable of achieving the same effect as the combination disclosed in the description.”
Moreover, the Patent Reexamination Board indicated “the amendment to the technical feature reflecting a ratio relationship is not an allowable amendment manner during the invalidation procedure.”
Owing to the above two points, the Patent Reexamination Board decided that the amended application was not accepted and affirmed that this examination decision on a request for invalidation of a patent would be made based on the announced patent document of the present patent (in which claim 1 defines a ratio of “1:10-30”).
Wherein, this decision was made in accordance with the stipulation in the Guidelines for Patent Examination, Part IV, Chapter 3, Section 4.6.1, “in the invalidation procedure, the amendment to the claims shall not go beyond the scope of disclosure contained in the initial description and claims, and the specific manners of amendment are generally limited to deletion of a claim, combination of claims, and deletion of a technical solution.”
First Instance
The patentee, as the plaintiff, not satisfied with the invalidation decision made by the Patent Reexamination Board, brought administrative litigation against the defendant – the Patent Reexamination Board – with the Beijing First Intermediate People’s Court.
On June 18, 2010, the Beijing First Intermediate People’s Court issued a first-instance intellectual property-related administrative judgment No. 1364 (2010), which upheld the invalidation decision. Specifically, the court held the following viewpoint: “Even though the description of the present invention discloses a combination of 1mg/kg of amlodipine and 30mg/kg of irbesartan and this combination satisfies a ratio of 1:30, this is only a combination of medicines of specific amount but fails to reflect a whole ratio relationship, so it cannot be determined whether any combination satisfying the ratio 1:30 is capable of achieving an effect the same as the combination disclosed in the description.” The plaintiff amended the ratio “1:10-50” defined in the initially filed claim 1 to a point 1:30 that was not disclosed in the initial claims and description, so the amendment to the technical feature reflecting the ratio relationship is beyond the scope of the disclosure contained in the initial claims and description, and it cannot be unambiguously determined from the initial claims and description. Except for that, the court gave no evaluation on the viewpoint that “the amendment to the technical feature reflecting a ratio relationship is not an allowable amendment manner during the invalidation procedure” that was indicated in the invalidation decision.
Second Instance
The plaintiff, not satisfied with the first-instance intellectual property-related administrative judgment No. 1364 (2010) issued by the Beijing First Intermediate People’s Court, filed an appeal with the Beijing Higher People’s Court.
On December 20, 2010, the Beijing Higher People’s Court issued a final instance administrative judgment No. 1022 (2010) that denied the assertion that the amendment to claim 1 should not be accepted as given in the invalidation decision and the first-instance judgment. Instead, the higher court held the following view:
“Jahwa submitted amended claims during the oral hearing in the invalidation procedure and amended ‘1:10-30’ in claim 1 of the present patent to ‘1:30.’ This amendment does not extend the protection scope of the present patent and does not go beyond the scope of the disclosure contained in the initial claims, not to mention the addition of a technical feature that is not present in the claims of the granted patent. As for the assertion that the initial description does not disclose that any combination of amlodipine and irbesartan satisfying a ratio 1:30 is capable of achieving the same technical effect, which was held by the Patent Reexamination Board and the first-instance court, it relates to a problem as to whether the amended claim is supported by the description, namely, whether the amendment complies with Article 26.4 of the Chinese Patent Law, rather than a problem of whether the amended claim extends the protection scope as compared with the initial patent. Thus, the assertion that the amendment to claim 1 of the present patent is not accepted, as given in the No. 14275 invalidation decision and the first-instance judgment, lacks grounds and the assertion is rectified here. The Patent Reexamination Board shall conduct an examination based on the amended patent document submitted by Jahwa in the oral hearing in view of the corresponding grounds for invalidation presented by LI Ping.”
Adjudacation by the Supreme People’s Court
The Patent Reexamination Board was not satisfied with the second-instance judgment and requested a retrial before the Supreme People’s Court.
On October 8, 2011, the Supreme People’s Court issued an intellectual property-related administrative adjudication No. 17 (2011), rejecting the request for retrial filed by the Patent Reexamination Board. As asserted in the adjudication, “the description explicitly disclose a combination of 1mg amlodipine and 30 mg irbesartan, and such a combination is taken as a combination having an optimum content ratio. Moreover, there is also a preparation example satisfying the ratio 1:30. For one skilled in the art, 1mg/kg and 30mg/kg indicates a ratio relationship of two components rather than a combination of certain amount. Therefore, it should be deemed that the description already discloses the ratio 1:30. The ratio 1:30 is the optimum content ratio expressly recommended by the patentee in the description, so the amendment to 1:30 neither goes beyond the scope of the disclosure contained in the original description and claims nor extends the protection scope as compared with the initial patent. Therefore, this amendment does not pertain to the circumstances to be avoided in accordance with the provision regarding amendment in relevant laws. If in the view of the Patent Reexamination Board, this amendment is not accepted on the grounds that it does not satisfy the required amendment manners, then the limitation to amendments in the present case completely is a punishment to the patentee for inappropriate drafting of the claims. This obviously is unreasonable. Moreover, as stipulated in the Guidelines for Patent Examination, subject to the above principles of amendments, amendment is generally limited to the three manners mentioned above. That is, the other amendment manners are not absolutely eliminated. The second-instance judgment is right in affirming that the amendment complies with the stipulation of the Guidelines for Patent Examination. The Patent Reexamination Board is excessively rigid in explaining the requirements on amendment in the invalidation procedure, and the grounds for retrial are not supported.”
Throughout the above process, the dispute focused on two points: 1) whether the amendment to “1:30” went beyond the scope of the disclosure contained in the initial description and claims, and 2) whether this amendment was an allowable amendment manner in the invalidation procedure as stipulated by the Guidelines for Patent Examination.
Was the amendment to “1:30” beyond the scope of the disclosure contained in the initial description and claims?
The Patent Reexamination Board and the Beijing First Intermediate People’s Court determined whether the amendment to “1:30” was acceptable in accordance with the provision in Article 33 of the Chinese Patent Law stating that: “the amendment to the application for a patent for invention or utility model may not go beyond the scope of disclosure contained in the initial description and claims.” They deemed that the feature of “1:30” was not disclosed in the initial description and claims mainly because one skilled in the art could not reach “a ratio of 1:30” based on the combination of 1mg/kg amlodipine and 30 mg/kg irbesartan and could not determine whether any combination satisfying the ratio 1:30 was capable of achieving the same effect as the combination disclosed in the description.
The judgment of the Beijing Higher People’s Court did not mention whether “1:30” went beyond the scope of the disclosure contained in the initial specification. The judgment was made in accordance with Rule 69 of the Implementing Regulations of the Chinese Patent Law that stated: “In the course of the examination of the request for invalidation, the patentee for the patent for invention or utility model concerned may amend its or his claims, but may not broaden the scope of patent protection.” This provision did not relate to determination as to whether an amendment goes beyond the scope of the disclosure contained in the initial specification. However, in the Guidelines for Patent Examination, Part IV, Chapter 3, Section 4.6.1, the part relating to Rule 69 of the Implementing Regulations of the Chinese Patent Law explicitly stipulates “(3) the amendment shall not go beyond the scope of disclosure contained in the initial description and claims.” Therefore, it perhaps was improper for the Beijing Higher People’s Court to not consider whether “1:30” went beyond the scope of the disclosure contained in the initial specification.
The Supreme People’s Court definitely affirmed that the amendment to 1:30 did not go beyond the scope of the disclosure contained in the initial description and claims. This assertion overturned the Patent Reexamination Board and the Beijing First Intermediate People’s Court.
In the view of a person skilled in the art, “A1I30” in Table 5 of the description of the present patent indeed should be construed as a ratio of “1:30” rather than a specific combination of “1mg/kg” and “30mg/kg.” This understanding is consistent with the scope that the applicant originally intended to protect. The assertion made by the Patent Reexamination Board and the first instance court was too rigid, and the adjudication of the Supreme People’s Court was reasonable.
Was this amendment an allowable amendment manner in the invalidation procedure as stipulated by the Guidelines for Patent Examination?
In the invalidation procedure, the Patent Reexamination Board insisted that the amendment to “1:30” did not pertain to the three allowable amendment manners stipulated in the Guidelines for Patent Examination, i.e., deletion of a claim, combination of claims, and deletion of a technical solution. In the first instance, the Beijing First Intermediate People’s Court evaded the problem as to whether the amendment to “1:30” complied with the above three amendment manners. In the second instance, the Beijing Higher People’s Court affirmed that the amendment to “1:30” did not go beyond the scope of the patent protection and deemed that subject to the principles of amendments allowable in the invalidation procedure stipulated in the Guidelines for Patent Examination, the amendment to “1:30” was also allowed even though it was not one of the three amendment manners mentioned in the Guidelines. In the adjudication procedure by the Supreme People’s Court, the court supported the assertion of the second instance judgment and explicitly pointed out “as stipulated in the Guidelines for Patent Examination, subject to the above principles of amendments, amendments are generally limited to the three manners mentioned above. That is, the other amendment manners are not absolutely eliminated.”
The adjudication of the Supreme People’s Court broke through the limitation to the three amendment manners stipulated in the Guidelines. Thus, it can be predicted that in the future a patentee can respond to a request for invalidation filed by another person in a more initiative manner, which will strengthen the stability of the claims of a patent for invention or utility model to some extent. Nevertheless, according to this adjudication of the Supreme People’s Court, it is difficult to definitely determine what amendment manners are included by “the other amendment manners” besides “deletion of a claim, combination of claims, and deletion of a technical solution.” For the details, it is feasible to refer to the subsequent invalidation practices and relevant official interpretation.
Although the other amendment manners so far cannot be definitely determined based on the aforesaid adjudication of the Supreme People’s Court, it is advisable for the patentee, petitioner of invalidation and application to pay attention to other possible allowable amendment manners when drafting an application document.
As far as a patentee involved in an invalidation case, it is advisable to treat this adjudication discreetly and to make amendments in accordance with the three manners stipulated in the Guidelines as much as possible. If it is impossible to prevent the related patent from being invalidated by means of “deletion of a claim, combination of claims, and deletion of a technical solution” at present, the patentee then could try to make an amendment in another manner with reference to the adjudication of the Supreme People’s Court and try to make opportunity for a case that has been cornered with.
For example, amend a numerical range in a claim to an end point of this range, provided that the amended content does not go beyond the scope of the disclosure contained in the initial description and claims and does not extend the scope of the patent protection. It is likely that such an amendment will be accepted by the Patent Reexamination Board because it explicitly corresponds to the amendment in the aforesaid case. Considering the guiding significance of the adjudication made by the Supreme People’s Court, it is less likely that the Patent Reexamination Board will make an opposite decision.
However, introducing a technical feature that is only described in the description into the claims to narrow the protection scope of the claims, provided that the amended content does not go beyond the scope of the disclosure contained in the initial description and claims and does not extend the scope of the patent protection is another example. This amendment is close to the standards as to amendments to the claims in the substantive procedure, and it is much likely to be rejected by the Patent Reexamination Board. If this amendment is allowable, the three allowable amendment manners stipulated in the Guidelines seem meaningless. Obviously, this amendment manner is favorable to the patentee to maintain the stability of a patent via amendment, but it increases instability of the technical solution that is directed at in the invalidation procedure and thereby increases difficulty of the petitioner who files the request for invalidation and increases difficulty of the collegiate panel to make a determination.
As for the petitioner who filing the request for invalidation, it is advisable to adequately consider in advance that the patentee may try other amendments besides “deletion of a claim, combination of claims, and deletion of a technical solution” in accordance with this adjudication so as to evade the initial grounds for invalidation.
As for as an applicant who is drafting an application document, particularly an applicant who is drafting an application for a utility model, it is advisable to pay attention to improving the manner of drafting the detailed embodiments in the description so as to ensure that in special cases during the invalidation procedure it will be possible to make amendments besides “deletion of a claim, combination of claims, and deletion of a technical solution” based on the description to narrow the protection scope of the claims, and to ensure that it is possible to make an argument for inventiveness of the claims whose protection scopes are narrowed based on the contents of the description.
