1. China Rolls Out Measures for Resolving Drug Patent Disputes
China's two government agencies—National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA)—recently issued the Measures for Implementing the Early Resolution Mechanism for Drug Patent Disputes (Trial) (hereinafter referred to as the Measures) with immediate effect.1
Before the Measures' promulgation, China has implemented some policies and regulation on drug patents (see in previous report China Rolls Out Measures to Establish Drug Patent Linkage System). But there was still a vacuum of detailed regulations for settling patent disputes.
Luckily, the new Measures outlines the process for resolving patent disputes early before the generics get approval. As the Measures and other patent-related policies and regulations are put into action, China has built up a skeleton of the drug patent linkage system. Though not yet fully-fledged, the system can operate with the newly enacted Measures and improve itself in the future.
The Measures, according to NMPA and CNIPA, draws upon the experience of the international practices. That's probably why the Measures highly resembles the US Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act2.
From setting a stay period to hold off the approval of the disputable generic application to rewarding the first successful generic challenger with 12-month market exclusivity, the Measures in China is largely modeled after some regulations in the US Hatch-Waxman Act. But the Measures still feature some details that are tailored to China's conditions.
2. Similar Goals of China and the US
China's new-born Measures on drug patents was conceived in response to the domestic pharmaceutical industrial trends. There is a surge of new drug applications (NDAs), and the number of drug patent registration applications has grown to the highest in the world. In 2020, China saw 68,720 patent registration applications, 6.6 percent of which are for health technologies.3
Besides, China needs to tackle the existing and potential drug patent disputes as it is incentivizing the development of high-quality and inexpensive generics (see in the Catalog of Encouraged Generic Drugs in China) and encouraging the import of Overseas New Drugs Urgently Needed in China's Clinical Settings.
As the US has a comparatively developed drug patent linkage system, China is building up a system by learning from the US, especially from the Hatch-Waxman Act. The Measures and the Hatch-Waxman Act share some similar aims:
To balance the patent protection of brand-name drugs and the development and registration of generics;
To encourage the innovation in the pharmaceutical industry;
To prevent market monopoly resulting from undue exploitation of patent barriers;
To help people access to safe, effective, and reasonably priced drugs.
3. Measures Differ with Chinese Characteristics
Below is a generalized comparison between the drug patent linkage regulations in China and the US. If you need detailed contents of China's Measures, please refer to BaiPharm's previous report How Does China's Drug Patent Linkage System Work.
Comparing Drug Patent Linkage Regulations in China and the US
Patents for Registration
Chemical drugs (except drug substances): active substance compound, drug recombinant with active substance and medical use.
Traditional Chinese medicines (TCMs): recombinant, extract and medical use.
Biological products: sequential structure of active ingredient, and medical use.
NOT including intermediate products, products of metabolism, crystal shapes, methods of preparing and manufacturing the drugs, testing methods, etc.
Chemical drugs: patents for drug substance (active ingredient), drug product (formulation or composition), and/or approved method (usage or indication) of using the approved drug product.
NOT including patents for manufacturing method of drug substances, intermediates, or products of metabolism.
Biological products: Patent dance under Biologics Price Competition and Innovation Act (BPCIA)
Time to Register/List the Patent
Within 30 days upon receiving the drug registration certificate, an NDA holder shall register the following information on the Patent Information Registration Platform for Drugs Marketed in China
Before NDA approval: submit patent information with NDA;
After NDA approval: list patent in the Orange Book within 30 days after NDA approval/supplement or within 30 days of after the patent gets granted.
Certifications by Generic Drug Applicant
Type I: There is no relevant patent registered on the platform;
Type II: The registered patent has expired or been invalidated, or the generic drug applicant has acquired permission from the patentee to exercise relevant rights;
Type III: The generic drug applicant promises not to sell the drug product until the relevant registered patent expires.
Type IV: The relevant registered patent shall be invalidated, or the generic drug is outside the protection scope of the patent.
Paragraph I: The patent information has not been listed in the Orange Book;
Paragraph II: The listed patent in the Orange Book has expired;
Paragraph III: The generic drug will not go on sale until the listed patent in the Orange Book expires;
Paragraph IV: The listed patent in the Orange Book is invalid or will not be infringed by the generic drug in the abbreviated new drug application (ANDA).
Beijing Intellectual Property Court/ China National Intellectual Property Administration (CNIPA): ruling on whether the ANDA falls within the patent protection scope.4
CNIPA (Reexamination and Invalidation Office) for patent validity.
Sequential order: if the patentee/NDA holder first sues at the Beijing Intellectual Property Court (the court for first trial5), CNIPA won't accept a petition for administrative ruling. If first going to CNIPA and disagreeing with the ruling, the patentee/NDA holder can continue to sue at the court.
No stipulated sequential order in applying for a ruling from the federal court or United States Patent and Trademark Office (USPTO).
Federal court for patent validity ruling and infringement suit.
USPTO for patent validity ruling.
Certification Notice to Patentee
Time to bring suits or apply for an administrative ruling
Within 45 workdays from Center for Drug Evaluation (CDE) releasing the ANDA information
Within 45 days from receiving the notice letter
Stay: How Long the Regulator Holds off the Approval of the ANDA
9-month stay from NMPA receiving the copy (sent by the generic applicant) of the notice that says the court has accepted the case or CNIPA has accepted the administrative appeal
30-month stay begins on the receipt date of notice of paragraph IV certification by any owner of the listed patent or by the NDA holder (or its representative(s)), whichever is late
Market Exclusivity for the first Successful Generic Challenger
4. Elaborating on Three Differences Between China and the US
4.1. Difference in Dispute-Resolving Process
In China, a patentee or an NDA holder can bring a civil suit to Beijing Intellectual Property Court or request an administrative ruling by CNIPA. If the patentee or NDA holder disagrees with CNIPA's ruling, it can sue at the court and the CNIPA's ruling may be overturned.
There is a sequential order for filing a suit and an administrative ruling. If the patentee or NDA holder first sue at the court, the CNIPA won't accept the request for an administrative ruling. If the patentee or NDA holder first goes to CNIPA and gets an unsatisfactory ruling, it can still sue at the court.
The court or CNIPA only rules on whether the ANDA falls inside the patent protection scope. To challenge the patent's validity, the ANDA applicant needs to request for initiating the patent invalidation procedures to the Reexamination and Invalidation Office under CNIPA.
In the US, a patentee or NDA holder can bring an infringement suit against the ANDA applicant who made a Paragraph IV Certification. In the court, the ANDA applicant can challenge the validity of the patent, object to the allegations of infringement or both.
The ANDA applicant can challenge a patent by requesting a reexamination procedure at the USPTO before or during the civil litigation at the Federal Court.
4.2. Difference in Stay of ANDA Approval
In China, the stay of disputable ANDA is 9 months. It could leave the disputing parties dangling as the court may not be able to a final ruling during such a period of time.
In the US, the stay is as long as 30 months. Plus, the court can shorten or extend the stay in case of any delays caused by the plaintiff or the defendant failing to cooperate in the litigation.
4.3. Difference in Market Exclusivity
The market exclusivity in China is 12 months, almost twice of the 180 days in the US. Instead of copying the US regulations, China designates a longer period according to its own conditions.
Market entry for generics in the US are comparatively easier through pharmacy benefits manager (PBM) procurement. In contrast, the procedure for generics to step into the Chinese market is much more complex and time-consuming.
To access to more patients, approved-ANDA holders often scramble in the price negotiation with China National Healthcare Security Administration (NHSA) for their products to enter the National Reimbursement Drug List (NRDL) and the volume-based procurement (VBP) (also known as the National Centralized Drug Procurement) program.
During the negotiation with NHSA, their generic drug products cannot eschew price cuts. Only after that can the generic grab a chance to get admitted into public hospital's procurement plan and finally be procured by the hospital's pharmacies.
But there is still good news—China has initiated a "double channel" management system to allow the distribution of NRDL-listed drugs at both hospitals and designated drugstores. Thus, drug makers can turn to the designated drugstores for a marketing channel besides the hospitals.
5. Advice for Pharma Companies
As China has started implementing the Measures, pharmaceutical companies need to pay attention to relevant requirements.
5.1. Be aware of the time limits:
NDA holder should register the patent information within 30 days from receiving the drug registration certificate or from the date when the change to an approved NDA takes effect.
Generic applicant shall send the patent statement and its supporting evidence to the MAH of the patent drug within 10 workdays from the date when CDE accepts the ANDA.
For objections to an ANDA applicant's patent statement, the NDA holder/patentee should file a lawsuit or administrative ruling within 45 days from CDE releasing the ANDA and the patent statement.
The NDA holder or patentee should send the duplicate of the notice showing the court has put the case on file or CNIPA has accepted the request within 15 workdays from the court or CNIPA issuing the notice.
The NDA holder, patentee and the ANDA applicant should send the court/CNIPA ruling documents to CDE within 10 workdays from receiving the ruling.
5.2. NDA holder/patentee should register the patent information according to the Measures (See in How Does China Implement the Drug Patent Linkage System). For patentees that don't register on the platform, they shall not resort to the Measures for resolving disputes.
5.3. ANDA applicant shall be responsible for the patent statement.
Before making a statement, ANDA applicant should search meticulously on CDE's patent registration platform to see whether there are relevant patents, whether the relevant patents are valid, etc.