Recently,PlaintiffNanjing Huaxun Intellectual Property Consultants Co., Ltd.(hereinafter referred to as Nanjing Huaxun)In the case of administrative litigation dispute over patent invalidity with the defendant State Intellectual Property Office and the third party Pfizer, the Beijing Intellectual Property Court approved Nanjing Huaxun's claim,JudgmentRevocation of the decision made by the State Intellectual Property Office to review the request for invalidation.

The caseAfter

this case lasted more than three years,PlaintiffIn2019Year11The monthly pair patent number isZL201180009237.0, the name is“8-Fluorine-2-{4-[(Methyl amino)Methyl]Phenyl}-1,3,4,5-Tetrahydro-6H-Azaand[5,4,3-cd]indole-6-salts and polymorphs of ketones”The invention patent filed invalid request,2021Year4The State Intellectual Property Office believes that the patent hasNew Creationsex and declared to maintainTheThe patent right for the invention is valid.

Nanjing Huaxun litigation team after analysis that the invalid decisionNo.The testimony of witnesses should be taken.,andRight.NoveltyIdentification error,At the same time, becauseWrong identification of technical effectsleadRight.CreativityIdentificationError.Therefore,Patent involvedAll claims shall bebe invalidated.

2021Year7In January, Nanjing Huaxun filed an administrative lawsuit with the Beijing Intellectual Property Court, requesting the cancellation of the invalidation decision. after the court hearing,2023Year6MonthMidThe court madePart of the plaintiffClaimsbe givenThe decision was upheld and the invalidation decision was set aside.

Judgment rescinding invalid decisionthe background,Rationale and its conclusions

Patent claims involved 

Claim1Protection of a8-Fluorine-2-{4-[(Methyl amino)Methyl]Phenyl}-1,3,4,5-Tetrahydro-6H-Azaand[5,4,3-cd]indole-6-Camphorsulfonate of ketones (hereinafter referred to as lucaparib).

Claim2-5respectivelyIt is further defined that the salt is a crystal, a crystalline anhydrous salt,S-camphorsulfonate andR-Camphor sulfonate.

Claim6-8respectivelyCorresponding pharmaceutical compositions, pharmaceutical compositions and pharmaceutical uses of salts are protected.

Background

based on this caseMakeagainst the plaintiffNovelty-related claims are not supported.,to createSex-related claimsbe givenJudgment in Support,Here the author only brief introductionRevocation of the invalidation decisionofThe key part, the creative part.

in an invalid decision,ForInvolvedpatent claims1(In afterRight1)of creativity,PlaintiffusedClosest to existing technologyfor evidence1,3. Right1and evidence1,3The distinguishing feature is only that the salt type is different, where the right.1claimed is the camphorsulfonate of Lucaparib, the evidence1,3Publicly, it's phosphate.Based on this distinguishing feature, the respondent decided that because ofPatent involvedInstruction and counter-evidence3(I. e.Supplementary experimental data) can be seen in the records of the right1Evidence of Lucaparib camphorsulfonate relative1,3The phosphate has better crystal stability and non-hygroscopicity, and the prior art does not give technical inspiration for the choice of camphor sulfonate for Lucapali to solve the technical problem of providing a salt type with crystal stability and non-hygroscopicity, therefore,Patent involvedRight1Be creative.At the same time,Claim2-8 based on right1the creativitybeIdentificationAlsoBe creative.

The accused decision concludesAboveThe conclusion is based on non-hygroscopicity and crystalline form stability,The plaintiff's reasons for prosecution are also aimedThistwo technical effects, so the courtFirst of allForPatent involvedRight1Whether it has the above technical effectsJudgment,andpointed out that:The premise that the above technical effects can be used to judge creativity is that,Patent involvedRight1within the scope of protection“All”The technical solutions all have the above technical effects.

Rationale and its conclusions

1. should not be“crystal form stability”recognized as right1within the scope of protection“All”Technical effects that can be achieved by technical solutions 

InvolvedPatentRight1The protection is Lucaparib camphorsulfonate,AndThe instructions not onlyThePolymorphs of saltsAType,BType,CThe amorphous form is also characterized. It can be seen that the salt form includes both crystal form and amorphous form. Because the amorphous Lucapali camphorsulfonate is unlikely to have the technical effect of crystal stability, even if the various crystal forms ofTheThe salt has crystal stability, and it alsoNonRight1within the scope of protection“All”The technical solutions all have technical effects.

Based on this,The court foundThe accused decision is in the right.1Consideration of creative judgments“crystal form stability”This technical effect is wrong..

2. should not be“Non-hygroscopic”recognized as right1within the scope of protection“All”Technical effects that can be achieved by technical solutions

1. The instructions on non-hygroscopic records correspondS-camphorsulfonate polymorphAtype, does not involve other crystal forms and amorphous. ForAOther crystal forms other than the type, the instructions are mainly general records.itstechnical effects, such as physical stability and1(Lucapali)Compared with other salt forms, it is not easy to hydrate, especially suitable for the preparation of solid dosage forms, etc., and is not specific to non-hygroscopic..Those skilled in the art are based onThe above instructionsrecorded, it is only possible to speculate that it is related to non-hygroscopicity,But...It is impossible to know that other crystal forms and amorphous forms also have basically equivalent non-hygroscopic properties..

(2)counter-evidence3is the patent involvedR & D staff of drug-licensed Clovis OncologyJeffrey.B.EtterWritten testimony by Dr.,Used to prove the technical effect of the patent involved..The court found thatWitness testimony does not reflectPatent involvedThe objective state of research and development prior to the filing date is thus not sufficient to prove that the patentee has verified the technical effect of non-hygroscopicity prior to the filing date.,The reasons are as follows:1)The testimony does not indicate that the relevant content is a recollection of the experimental situation during the development process.;2)This evidenceandNo other evidence shows that the witness was involved.Patent involvedThe R & D process;3) even ifThe testimony is a memory of the experimental situation at the time, but for the experimental situation several years ago, human memory cannot be completely accurate;4)According to common sense, there should usually be a written record of the relevant experimental situation in the drug development process.,AndThe third person did not submit it in this case.RelatedWritten records;5)counter-evidence3in relation to non-hygroscopicityTestThe content is aimedS-camphor sulfonatepolymorphAtype, not mentionedTheOther crystal forms of the salt as well as non-hygroscopic data for the amorphous form.

Based on the above analysis, whether it is based onPatent involvedThe description of the instructions, or consider the counter-evidence3The content cannot be determined.Patent involvedRight1within the scope of protection“All”The technical solutions all have a non-hygroscopic technical effect. Based on this,The court foundThe alleged decision was made inPatent involvedRight1Consideration of creative judgments“Non-hygroscopic”The technical effect of the approach is wrong.

To sum up,In view of the above technical effects are notPatent involvedRight1within the scope of protection“All”The technical solutions all have technical effects, so the decision of the accused is based on the consideration of the above technical effects.Patent involvedRight1The creative conclusion is wrong. On this basis, because the available evidence can not be seenPatent involvedRight1relative to the evidence 1,3What kind of technical effect, thereforePatent involvedRight1relative to the evidence 1,3The technical problem to be practically solved is only to provide another salt form of lucaparib, namely lucaparib camphorsulfonate. in evidence1In the case of the formation of camphor sulfonate, which has been clearly documented in Lucapali, the skilled person in the art has the motivation to make relevant attempts to obtain Lucapali camphor sulfonate, according to which,Patent involvedRight1The acquisition does not require creative work. The relevant claims of the plaintiff are established,Courtbe supported.The accused decisionThe determination was wrong,CourtNot maintained.In additionThe accused decisionclaim in2-8based on right1the creativitybeIdentificationAlsoBe creative,The accused needsto itsYesNo creative.Re-Commentary.