Timing is the key to resolving drug patent disputes.

State Drug AdministrationEarly in2021YearApril is.ApprovedIt'sRoche (China) Investment Co., Ltd.(hereinafter referred to“Roche”）ofInnovative resistanceFlu drug Sufuda®(Mabalosawe Tablets)Listed in China.

The new drug is an influenza virus polymerase acidic endonuclease inhibitor, especially suitable for the treatment of acute simple influenza, not more than after the onset of symptoms 48hours and otherwise for healthy adults and 5Children aged and older, or at high risk of developing influenza-related complications, who are12 Adult and pediatric patients aged and above.

Suffering®inActive Ingredients Subject to SectionProtection of Chinese Invention Patent No. ZL 201180056716.8The patent is issuedJapanYaneyi Pharmaceutical Co., Ltd.All,Valid21 September 2031. The invention provides a substituted 3-hydroxy-4-pyridine with antiviral activity.ClassderivativesProdrug, especially with influenza virus growth inhibition activity, more preferably with cap-dependent.TypeCompounds with endonuclease inhibitory activity.

RocheObtainThe State Drug Administration approved it for three months.,Chinese pharmaceutical giantShiyao Group Ouyi Pharmaceutical Co., Ltd. (hereinafter referred to"Stone Medicine")Submitted a generic drugRegisterApplication. Drug Evaluation Center of State Food and Drug AdministrationInApplications will be accepted on 1 June 2022,ThereafterGenericInOctober 11, 2022 officiallyObtainListing Approval (Chinese medicine standard wordH20223746）。

Rock inThe statement issued on October 18, 2022 stated that it has been approved under the new drug patent link system.Stone MedicineTo file a lawsuit, will actively take legal measures to safeguard their legitimate rights and interests. Roche explained:

"In accordance with the relevant provisions of China's Patent Law, without the permission of the patentee, no individual or entity may manufacture, use, sell or promise to sell Mabalosavir compounds and/or pharmaceutical products containing a mabaloxavir compound.

SectionZL201180056716.8The patentee of the Chinese patent has never licensed any individual or entity other than our company and our affiliates to manufacture, use, sell or promise to sell Mabalosavir compounds and/or pharmaceutical products containing a mabaloxavir compound.

In particular, it should be pointed out that the approval of the State Drug Administration for the generic drug of Ouyi company does not mean that Ouyi company can manufacture, sell or promise to sell its generic drug mabalosavir tablets for the purpose of production and operation, otherwise it will constitute infringement of the above-mentioned patents.".

《the People's Republic of China Patent Law"Well.11Article 1, paragraph 1It's true.provisions,After the patent right for an invention or utility model is granted, unless otherwise provided in this Law, no unit or individual may, without the permission of the patentee, implement the patent, that is, may not manufacture, use, promise to sell, sell, or import the patented product for production and business purposes, or use the patented method and use, promise to sell, sell, or import the product directly obtained by the patented method.

From2021Year6Month1The so-called day.“China's Drug Patent Link System”Since its implementation,Right.in applicationListingApprovedofThe same is true of a generic drug applicant when the drug-related technical solution applied for registration falls within the scope of patent protection for another drug.:without the permission of the patentee,InExpiration of drug patentBeforeThe general rule is,Can'tGet listedApproved.

According《the People's Republic of China Patent Law"Well.76the provisions of article,Any patentee or interested person who believes thatToState Food and Drug AdministrationAfterIf the approved generic drug falls within the scope of patent protection that it owns or is legally implemented in other ways, it may file a lawsuit with the Beijing Intellectual Property Court., orRequest the Patent Administration Department of the State Council to make an administrative ruling on the dispute. This dual-track dispute resolution mechanism, which allows the patentee to choose between litigation or administrative adjudication, is further outlined in the following three measures:

1. By the State Food and Drug Administration, the State Intellectual Property Office in the organization to develop and self2021Year7Month4Date of implementationMeasures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial).
2. by the Judicial Committee of the Supreme People's Court No.1839Adoption of the meetingand self2021Year7Month5Date of implementationofProvisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Drugs Applied for Registration.
3. Adopted by the State Intellectual Property Office and since2021Year7Month5Date of implementationofAdministrative Adjudication Measures for Early Settlement Mechanism of Drug Patent Disputes.

Implementation Measures for the Early Settlement Mechanism of Pharmaceutical Patent Disputes (for Trial Implementation)Article 6 specifically stipulates that the generic drug applicant shall apply for listing.ApprovedEach drug patent related to a generic drug should be“Patent Statement”. endorses. The patent statement shall indicate that:

1. Class I statement: there is no patent information related to generic drugs in the patent information registration platform of listed drugs in China;
2. Class II statement: the patent rights related to generic drugs included in the Chinese listed drug patent information registration platform have been terminated or declared invalid, or the generic drug applicant has obtained the patent owner's relevant patent implementation license;
3. Three types of statements: China's listed drug patent information registration platform contains the generic drug-related patents, generic drug applicants promise that the generic drug applied for will not be listed before the expiration of the corresponding patent right;
4. Four types of statements: The patent rights related to generic drugs included in the patent information registration platform for listed drugs in China shall be declared invalid, or the generic drugs shall not fall within the scope of protection of the relevant patent rights.

however,AboveMaking patent declarationsofObligations,and constitutes a newdrug patent link systemAll other elements,Only in 2021 Year7 Effective in the first half of the month, it does not apply to generic drug applications submitted before that date.

Due to the generic application of stone medicine.In 2022Year7 Month1 was accepted by the State Food and Drug Administration, so it can be assumed thatApplicationfiled before that date. Accordingly, most legal experts believe that between Stone Medicine and RocheJustSectionZL No. 201180056716.8The drug patent.DisputesCan not pass the Chinese Patent Law No.76The provisionsNew Dispute Resolutionchannels for effective trial,andIt is believed that the patent link lawsuit filed by RocheIt's likelyIt will be rejected by the Beijing Intellectual Property Court.

Anyway, although the stone medicineMabalosawe TabletslistingApprovedbe revoked orDeclarationThe possibility of invalidity is very small, but Roche can still be issued under the Patent Law No.65Article LiftGeneralInfringement claim. In addition, RocheIn 2022Year10 Month18 Statement issued on the dayIt seemsis effective against generic drug competitionFirstCountermeasures:market participants have been warned, CSPCCooperation on its Mabalosawe tablets, if laterCSPCConvicted of infringing No.ZL201180056716.8Patents can be very costly.