Jie Zhao
Wanhuida Intellectual Property | China
Original link: https://www.lexology.com/commentary/intellectual-property/china/wanhuida-intellectual-property/china-issues-implementation-measures-on-pharmaceutical-patent-linkage-system#Introduction
Introduction
On 4 July 2021 the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly released the Measures for the Implementation of Early Resolution Mechanism for Pharmaceutical Patent Disputes (for Trial Implementation) (the measures), ironing out the operational details of the pharmaceutical patent linkage system.
The measures, which predate the Supreme Court's Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases involving Patent Disputes Related to the Application for the Registration of Pharmaceuticals, are the first legal document exclusively dedicated to the pharmaceutical patent linkage system in China. This article provides a brief introduction of the measures' key takeaways.
Establishment of patent information registration platform for marketed drugs
The NMPA is tasked with coordinating the creation of a Patent Information Registration Platform for Marketed Drugs, whose creation and operation falls within the remit of the agency's affiliate Centre for Drug Evaluation (CDE) (rules 2 and 3 of the measures).(1)
Rule 4 of the measures enumerates the information to be registered with the platform and the time limit to register the information and record any changes. The registered particulars must be consistent with the patent information recorded in the Patent Register. The marketing authorisation holder (MAH) will answer for the truthfulness, accuracy and integrity of the registered information and verify and handle any dissent received thereabout.
Registration scope for pharmaceutical patent information
When seeking regulatory approval for chemical drugs, applicants may register with the platform patent information on active ingredients, pharmaceutical composition and pharmaceutical uses.
Applicants for biological products may register patent information on sequence structures and pharmaceutical uses, while applicants for traditional Chinese medicines (TCM) may register patent information regarding composition, extraction and pharmaceutical uses (rule 12 of the measures).
Filing patent status statements
When filing for regulatory approval, chemical generic drug applicants must make a statement with reference to each drug patent whose information has been registered with the Patent Information Registration Platform for Marketed Drugs in China (rule 6 of the measures). Such statements are categorised as follows:
type I – there is no existing patent relating to the generic drug application;
type II – the patent to be exploited by the generic drug has expired or been declared invalid, or the generic drug applicant has obtained a licence from the patentee to exploit the patent;
type III – there is an existing patent relating to the generic drug application and the generic drug applicant agrees to seek regulatory approval upon the expiration of such patent; and
type IV – the patent to be exploited by the generic drug should be declared invalid or the generic drug does not fall into the patent's protection scope.
The CDE will publish the application particulars and the statement of a chemical generic application within 10 working days from the receipt of such application (rule 6 of the measures).
Informing MAH of patent status statements
Generic drug applicants must inform the MAH of the patent status statement and the grounds on which such statement is made. As well as hard copies, generic drug applicants must also provide the MAH with the aforementioned information via email (the MAH's email address is available in the Patent Information Registration Platform for Marketed Drugs) (rule 6 of the measures).
If the MAH is not the patentee, the MAH is responsible for informing the patentee of the generic drug applicant's statement and grounds (rule 6 of the measures).
Raising objections
The patentee or an interested party contesting a type IV statement may file a lawsuit before the court or request an administrative adjudication before the CNIPA within 45 days of the publication date of the generic drug application (rule 7 of the measures).
The administrative adjudication made by the CNIPA may be appealed before the court (rule 7 of the measures).
If the patentee or an interested party neither files a lawsuit before the court nor requests an administrative adjudication before the CNIPA within 45 days, the generic drug applicant may file a lawsuit or request an administrative adjudication requesting affirmation that the technical solution of the generic drug does not fall within the protection scope of the pertinent patent (rule 8 of the measures).
Delays in generic drug approvals
Rule 8 of the measures provides a nine-month one-off stay for chemical generic drug applications should a patent dispute arise in the approval process; however, technical evaluation will not be suspended during the nine-month stay.
Granting of regulatory approval
The granting of regulatory approval for chemical generic drugs depends on the technical assessment outcome if a type I or type II statement is filed. Regulatory approval upon the expiration of the pertinent patent and the market exclusivity could be granted to a chemical generic drug that has passed its technical assessment in the case of a type III statement (rule 10 of the measures).
In the context of a type IV statement, if the patentee or interested party does not raise any objections against it, the granting of regulatory approval depends on the technical assessment outcome and the statement of the generic drug applicant. If an objection is filed and a stay period is triggered, the granting of regulatory approval depends on an array of factors – including the outcome of both the technical assessment and the court or administrative decision – and is thus premised on:
the affirmation of patent invalidity;
the determination of non-infringement;
the reconciliation between the two parties; or
the expiration of the stay period in the absence of a decision.
Otherwise, the granting of regulatory approval is postponed until the expiration of the pertinent patent (rules 8 and 9 of the measures).
Similarly, the granting of regulatory approval for biosimilars and TCM with identical names and formula depends on the technical assessment outcome. Apart from the technical assessment decision, the marketing of biosimilars and TCM with identical names and formula will be postponed until the expiration of the pertinent patent if the technical solution of such drug is found to fall within the protection scope of the pertinent patent by a court or administrative adjudication decision (rule 13 of the measures).
Encouraging generic drug applicants to challenge patent validity
Rule 11 of the measures grants a 12-month exclusivity to the first generic drug applicant that succeeds in challenging the validity of a chemical pharmaceutical patent and acquiring the first regulatory approval. This applies only when a generic drug applicant files a type IV statement and has had the pertinent patent invalidated through an invalidity proceeding. Such market exclusivity will not exceed the original duration of the patent right being challenged.
Post-approval pharmaceutical patent dispute resolution
After the regulatory approval and actual marketing of chemical generic drugs, biosimilars or TCM with identical names and formula, the patentee or interested party which deems that such a drug infringes the pertinent patent right must cite the Patent Law or other laws to resolve the disputes. The arising of a dispute will have no bearing on the efficacy of regulatory approval, which will not be withdrawn (rule 14 of the measures).
For further information on this topic please contact Jie Zhao at Wanhuida Intellectual Property by telephone (+86 10 6892 1000) or email (zhaojie@wanhuida.com). The Wanhuida Intellectual Property website can be accessed at www.wanhuida.com.
Endnotes
(1) The platform can be found here: https://zldj.cde.org.cn/home
