Patent Linkage System now available in China
On 4 July 2021, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly announced the enactment of Implementing Measures for the Early Resolution Mechanism for Drug Patent Disputes. With the issuance of these Measures, the patent linkage system is officially in effect, which represents a significant step by the government in the reform of the pharmaceutical industry in China. In addition, on the same day, the NMPA published a Notice on the implementation of the Measures, which invited brand-name companies to upload patent information to the patent registration platform and requested generic companies to submit declarations and send the declarations and the supporting documents to the drug marketing authorisation holder.
On 5 July 2021, the CNIPA issued the Administrative Adjudication Measures for Early Settlement Mechanism of Drug Patent Disputes, and the Supreme People's Court issued the Provisions on Several Issues Concerning the Application of Law to the Trial of Civil Dispute Cases Related to Patent Rights Pertaining to Drugs under Application for Registration. The Adjudication Measures and Provisions took effect on the same day.
Please click here for a Law-Now Article on the three updates related to patent linkage system in China. Please click here for the full text (Chinese only) of the Measures, here for the full text (Chinese only) of the Adjudication Measures and here for the full text (Chinese only) of the Provisions.
China proposes amendments to Patent Examination Guidelines
On 3 August 2021, the China National Intellectual Property Administration (CNIPA) published Draft Amendments to the Guidelines for Patent Examination for public comment before 22 September 2021.
The Draft provides detailed rules on patent term adjustment (PTA), patent term extension (PTE), and invalidation involving drug patent disputes arising under the newly established patent linkage system. In addition, it provides:
amendments to the examination of formality especially the examination of incorporation by reference, correction, addition or restoration of priority claims;
amendments to the examination of design patents, particularly the examination of national priority, design patents for product parts, graphical user interfaces and the application of international design patents and international design patents entering the national stage in China, corresponding to amendments to the Patent Law;
amendments to the determination of grace period for early publication without destroying novelty;
examples for drafting computer programme product or process claims, and the examination of novelty and inventive steps in these areas;
detailed rules concerning the newly established open licensing system.
Please click here for a Law-Now Article in relation to PTA, PTE and invalidation involving drug disputes. Please click here for the full text (Chinese only) of the Draft.
CNIPA seeks comments on Judgment Standards for General Trade Mark Violations
On 17 August 2021, the China National Intellectual Property Administration (CNIPA) published Judgment Standards for General Trade Mark Violations (Draft for Comments). Public comments on these Judgment Standards can be submitted until 1 October 2021.
According to the Draft Standards, general trade mark violations include:
not using a registered trade mark when required;
using a mark that cannot be used as a trade mark;
improperly using the wording "well-known trade mark" in commercial activities;
a trade mark licensee failing to indicate its name and the place of origin on the goods;
during the use of the registered trade mark, the changing of the mark, registrant, address and other matters of the trade mark;
using an unregistered trade mark as a registered one;
failing to perform the management obligation of a collective trade mark or a certification trade mark;
failing to fulfill the management obligation when printing the trade mark; and
applying for trade mark registration in bad faith.
The Draft Standards also clarify the terms and judgment standards in the relevant laws and regulations, such as Trade Mark Law and Implementing Rules of the Trade Mark Law.
Please click here for the full text (Chinese only) of the Standards.
SPC issues Judicial Interpretation Civil Infringement Disputes over new plant varieties
On 5 July 2021, the Supreme People's Court (SPC) published Several Provisions (II) of the Supreme People's Court on Issues Concerning the Application of Law in the Hearing of Cases Involving Disputes over Infringement upon the Rights of New Plant Varieties, which came into effect on 7 July 2021.
These Provisions reflect the trend in judicial practice in civil disputes concerning plants. The Provisions made several exceptions to the current non-infringement circumstances, including producing, reproducing and selling the propagating material obtained after the production and reproduction of the propagating material, and exporting the propagating materials to countries or regions that offer no protection for the plant genus or species of the variety for production and reproduction purposes. Producing and reproducing the new plant varieties for non-profitable purposes, such as scientific research and production for self-consumption, are recognised as non-infringement.
The SPC also clarifies matters such as:
disputes between co-owners regarding the distribution of profits;
the eligibility of an assignee to initiate infringement lawsuit;
recognition of advertisements and exhibitions as selling activities;
the burden of proof for proving non-infringement or damages;
the punishment for obstructing preservation; and
situations that can be recognised as serious infringement activities.
Please click here for the full text (Chinese only) of the Provisions.
Beijing publishes regulations on intellectual property protection
On 13 August 2021, the Beijing Municipal Intellectual Property Office published the Beijing Regulations on Intellectual Property Protection (Draft for Comments). The public had until 11 September to submit comments on this Draft.
The Draft includes a comprehensive joint-protection mechanism for intellectual property holders and applicants, and underscores the determination of the Beijing Municipal Intellectual Property Office to protect intellectual property and enhance its development. Measures adopted in the Draft include:
the strengthening of intellectual property protection through administrative forces;
working jointly with public organisations and implementing protection mechanisms;
promoting and encouraging the creation of intellectual property;
establishing multiple efficient dispute resolution mechanisms; and
clarifying liabilities for violations.
Please click here for the full text (Chinese only) of the Draft.
Hong Kong Customs combats counterfeiting activities of US-bound goods
On 3 August 2021, the Customs and Excise Department published a press release (the “Press Release”) regarding a targeted operation to combat cross-border counterfeiting activities involving goods bound for the US underscoring how the Customs and Excise Department is increasing inspections particularly in relation to suspicious air consignments.
Approximately 60,000 items of suspected counterfeit goods with an estimated market value of HKD 3.2 million were seized. The suspected counterfeit goods included mobile phones and accessories, watches, handbags, shoes and clothing.
The Hong Kong Customs and Excise Department continues to work closely with overseas law enforcement agencies to combat cross-border counterfeiting activities through intelligence exchanges and joint-enforcement actions.
Please click here
for the full text (English only) of the department's Press Release.
Public consultation on proposed intellectual property (amendment) bill
The Intellectual Property Office of Singapore (IPOS) conducted a public consultation on the draft of a proposed Intellectual Property (Amendment) Bill.
Following from the public consultation in August 2020 on proposed changes to Intellectual Property legislation to streamline IP processes and improve user experience with digital initiatives, the IPOS intends to implement these legislative changes to give effect to the intended policies and seek feedback on the Proposed Bill and the corresponding amendments to the respective IP subsidiary legislation. The proposals are intended to both simplify and clarify procedures in the various IP regimes and align procedures for IP prosecutions.
Please click here for the full text of the Consultation.
New initiatives introduced for registration of therapeutic products
To streamline the registration process of therapeutic products, the Health Sciences Authority (HSA) has introduced an online self-guided tool for post-approval of minor variation applications (MIV), and provided updates on the Drug Master Files (DMFs) submission process.
The Therapeutic Products Branch (TPB) of HSA has recently launched a new online self-guided tool for MIVs, which provides industry stakeholders with quick answers on typical application queries, such as application type, variation category and documentary requirements for each variation.
In addition, the HSA has updated their guidelines on DMFs. A DMF is typically a reference that provides information about specific processes or components used in the manufacturing, processing and packaging of a drug. The DMF contains information of a proprietary nature that is not available to the drug product manufacturer or the applicant of a product registration submission. Since 1 September 2021, applicants have been required to submit the HSA’s acknowledgement email for all registration applications that are supported by a DMF. Along with the acknowledgment email, applicants will need to submit a copy of the Letter of Access along with the open part of the DMF (in PDF format).
Please click herefor the full text of the new initiatives.
ASPEC AIM Pilot Programme extended to 2023
The ASPEC Acceleration for Industry 4.0 Infrastructure and Manufacturing Pilot (ASPEC AIM) Programme was introduced under the ASEAN Patent Examination Cooperation (ASPEC) in 2019 to expedite Industry 4.0 patent applications by giving priority to key emerging technologies, such as cybersecurity and fintech applications.
ASPEC has extended the ASPEC AIM from an initial pilot period of two years to four years (ending on 26 August 2023). This regional patent cooperation project is a programme for IP Offices of participating ASEAN member states (AMS) to utilise the search and examination (S&E) results from another participating AMS IP Office. Currently, the participating AMS IP Offices are Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, the Philippines, Singapore, Thailand and Vietnam. The application capacity remains 50 applications per year.
Please click here for the full text of the update. The ASPEC Document Submission Guideline can be viewed here.
COVID-19 measures at IP offices
IP Australia has published several updates regarding business continuity measures and arrangements in view of the COVID-19 situation. In these updates, IP Australia has provided clarification on the following issues:
Extensions of the time for patents, trade marks and designs;
Processing arrangements for the rights applications of plant breeders, including potential deferrals; and
The mode of future hearings.
For patents, trade marks and designs, a request for an extension of time will be considered on a case-by-case basis by the Commissioner or Registrar. An applicant must submit the request for an extension through the IP Australia online portal along with a declaration to explain why a deadline cannot be met.
For plant breeder’s rights (PBR), as COVID-19 restrictions ease PBR examiners may be able to travel to certain trial sites (subject to state restrictions). It is advisable for qualified persons currently managing or establishing field trials that may be ready for examination in 2021 to contact the PBR office to discuss examination options.
Hearings at IP Australia are being conducted via video conference, telephone, or written submission. If an in-person hearing is required, the party is advised to contact the IP Australia office directly.
For more information on IP Australia’s business continuity measures, please click here.
According to a memorandum circular issued by the Intellectual Property Office of the Philippines (IPOPHL), the deadlines for filing and making payments falling due during the Modified Enhanced Community Quarantine (MECQ) will not be extended. This is in response to the recent downgrade in the Philippines' National Capital Region risk calculation. However, the IPOPHL is likely to continue its current work-from-home and skeleton workforce arrangement, and any filings, submissions and payments can be made through IPOPHL’s online facility.
In view of the on-going COVID-19 pandemic situation in Vietnam, the Intellectual Property Office of Vietnam (IPOV) has issued a notice extending certain deadlines (e.g. deadlines relating to priority claims, supplementing documents, responding to IP Office decisions/notifications, renewal and extension of the validity of protection titles, payment of fees and charges, and filing of appeal petitions). According to the notice, deadlines that fall between 30 June 2021 and 31 August 2021 will be automatically extended to 30 September 2021.
On 9 September 2021, the IPOV issued a further notice granting additional deadline extensions for IP applicants. Under this notice, all deadlines falling between 30 June 2021 and 31 October 2021 will now be automatically extended to 30 November 2021.
Co-contributed by Eugene Wong