- 1. Secret Weapon?: Unveiling the new definition of "confidential invention" and security regulations for keeping your innovations under wraps.
- 2. Who Owns the Spark?: Clarifying who deserves credit for brilliant creations with updated rules on invention ownership.
- 3. Novelty Checkup: Revamping the test for originality, ensuring fresh ideas get protected, not mere copies.
- 4. Challenging Champions: Introducing a new opposition system, giving anyone a voice to contest questionable patents.
- 5. Patent Police on Patrol: Strengthening measures to invalidate undeserved patents and keep the system fair.
- 6. Application Essentials: Streamlining the application process with revised general requirements for clear and thorough submissions.
- 7. Patent Path Twists: Adding new grounds for rejecting applications, ensuring only truly deserving inventions made the cut.
- 8. Deeper Dives: Introducing more rigorous patent examination procedures for a thorough vetting of each claim.
- 9. Pharmaceutical Payback: Addressing delays in approving new drugs with fair compensation for patent holders.
- 10. Forced Sharing: Exploring compulsory licensing options to ensure vital inventions benefit the public when necessary.
- 11. Supplement of provision on Compensation for Patent holder due to delay in granting approval of pharmaceutical products in Vietnam
- 12. Amendment of provision on Compulsory Licensing in Vietnam: Balancing Public Access with Fair Compensation
1. Secret Weapon?: Unveiling the new definition of "confidential invention" and security regulations for keeping your innovations under wraps.
For the first time, Vietnam's Intellectual Property Law shines a light on the shadowy realm of "Confidential Inventions." Before the 2022 amendments, this enigmatic category remained undefined, shrouding innovations deemed vital to national security in secrecy. However, Article 4.12.a now lifts the veil, declaring that only inventions officially classified as state secrets by a competent authority qualify as "Confidential Inventions." This crucial distinction ensures that inventions with genuine national security implications receive the necessary protection while preventing the blanket designation for personal gain.
While the definition provides clarity, the finer details remain concealed. The onus now falls on the Vietnamese government to unveil the cloak of secrecy surrounding confidential inventions. A separate decree will be the key, outlining the precise procedures for applications, examination, and granting of protection for these sensitive innovations. This decree will act as a roadmap, navigating the delicate balance between safeguarding national security and fostering innovation.
The introduction of "Confidential Inventions" marks a significant shift in Vietnam's IP landscape. It acknowledges the unique needs of inventions intertwined with national defense and security while establishing a framework for their protection. However, the success of this framework hinges on the forthcoming decree, which will determine how effectively Vietnam can balance secrecy with transparency, promoting both national security and a thriving innovation ecosystem.
2. Who Owns the Spark?: Clarifying who deserves credit for brilliant creations with updated rules on invention ownership.
Genetic Guardians Empowered:
- Recognizing the importance of protecting and utilizing genetic resources responsibly, the amended IP Law now grants specific ownership rights to those entrusted with managing these valuable assets. Organizations and individuals managing or providing access to genetic resources and traditional knowledge under relevant contracts now have the power to register inventions derived from them (Article 86.1.b). This empowers communities and stakeholders to reap the benefits of their knowledge and incentivizes sustainable resource management.
State Innovation, Shared Rewards:
For breakthroughs born from the public purse, the amended IP Law clarifies ownership in Article 86a. Here's the gist:
- Full State Funding: Inventions achieved entirely through state-funded research automatically belong to the lead organization, without any financial payback to the state. This incentivizes public research institutions to maximize the return on public investment.
- Mixed Funding Model: If multiple sources, including some state funding, contribute to an invention, ownership rights are proportionally allocated, reflecting the state's contribution. This ensures fairness and encourages collaboration while safeguarding the public interest.
- National Security Matters: Innovations in the critical realm of national defense and security, fueled by state funding, remain under state ownership. This safeguards sensitive technologies and prioritizes national interests.
These changes reflect a nuanced approach to ownership rights, balancing the needs of innovators with the interests of the public and communities that contribute valuable resources. By clarifying who owns what, Vietnam fosters a more equitable and transparent IP environment, encouraging responsible research, innovation, and benefit-sharing.
3. Novelty Checkup: Revamping the test for originality, ensuring fresh ideas get protected, not mere copies.
The age-old battleground in patent law - balancing the inventor's reward with public access to knowledge - takes a new turn in Vietnam. Until recently, Article 60.1 of the IP Law 2005 vaguely defined "novelty" for inventions, leaving the scales tipped precariously. This ambiguity could favor patent holders, potentially restricting public access to valuable advancements. Recognizing this imbalance, the 2022 amendments sharpen the definition, injecting much-needed clarity.
Gone are the days of interpretive limbo. The amended Article 60.1 now throws down two clear lines in the sand, declaring an invention not novel if:
- The cat's out of the bag, anywhere in the world, before the patent application was filed. Whether whispered in a workshop or showcased at a global expo, prior public disclosure of the invention torpedoes its novelty.
- Another patent, filed earlier, already spilled the beans (even if kept under wraps). Even if unpublished, a prior patent application for the same invention can steal the thunder of a later claim.
These amendments represent a decisive step towards a more balanced system. By tightening the definition of novelty, Vietnam ensures that patents reward genuine groundbreaking inventions, not mere repackaged knowledge already floating around the world. This fosters a more vibrant innovation ecosystem, where public access to existing knowledge fuels further advancements while incentivizing true pioneers with the exclusive rights granted by patents.
However, the battle for balance is never truly over. The amended definition leaves room for future debate and interpretation. Determining what constitutes "public disclosure" or dissecting the nuances of prior patent applications will likely keep courts and legal minds busy. Time will tell how effectively Vietnam navigates these complexities, ensuring a system that rewards both the ingenuity of inventors and the broader progress of society.
4. Challenging Champions: Introducing a new opposition system, giving anyone a voice to contest questionable patents.
The IP Law of 2005 offered a limited mechanism for third parties to express concerns about pending patent applications. However, these opinions were merely whispers in the wind, serving as informal references for IP officials without any binding impact on decisions.
But the amended IP Law of 2022 amplifies these whispers into a resounding voice of dissent, introducing a formal patent opposition system. This game-changer empowers anyone—competitors, researchers, or concerned citizens—to actively contest patent applications they deem unjustified.
Here's how the new system raises the stakes for patent applicants:
- Time is of the essence: Opponents have a 9-month window from the publication of a patent application to file their opposition, ensuring timely scrutiny and preventing unwarranted monopolies.
- Evidence is key: Objections must be backed by solid evidence, including documents or cited sources, to substantiate claims and prevent frivolous challenges.
- Fees for fairness: A fee structure safeguards the system from abuse, ensuring that oppositions are based on genuine concerns rather than mere tactical maneuvers.
- Ministerial guidance: The Minister of Science and Technology will provide comprehensive guidelines, ensuring a transparent and efficient opposition process.
This groundbreaking shift promises to strengthen Vietnam's IP landscape by:
- Enhancing patent quality: The threat of opposition incentivizes applicants to meticulously refine their inventions and claims, promoting a robust patent system with only the most deserving innovations receiving protection.
- Promoting public interest: The opposition system empowers diverse stakeholders to safeguard the public good, ensuring that patents foster a competitive and innovative environment rather than stifling progress.
While the specific procedures for opposition remain under development, the introduction of this mechanism signals a bold move towards a more transparent and balanced patent system in Vietnam. By empowering public scrutiny, Vietnam aims to create a vibrant and equitable IP landscape, where groundbreaking inventions thrive alongside a fair and competitive marketplace.
5. Patent Police on Patrol: Strengthening measures to invalidate undeserved patents and keep the system fair.
In two specific circumstances, a patent faces complete invalidation, leaving no trace of its former protection:
- National Security Trumps All: If a patent application clashes with security control regulations, its validity crumbles entirely. This safeguards sensitive technologies and strategic interests, ensuring that innovation doesn't come at the cost of national security.
- Genetic Resources Demand Transparency: Patents rooted in genetic resources or traditional knowledge must meticulously acknowledge their origins. Failure to do so results in a complete invalidation, protecting the rights of communities and preventing the exploitation of their invaluable knowledge.
Partial Invalidation: Trimming the Excess
Not all patent flaws warrant a complete takedown. In six distinct scenarios, authorities can surgically invalidate specific aspects of a patent, preserving its core while addressing problematic elements:
- Rightful Ownership is Paramount: Only those with legitimate ownership or assignment rights can claim a patent. Unauthorized attempts to secure a monopoly will be swiftly invalidated.
- Protection Conditions Must Be Met: Patents must demonstrate novelty, inventiveness, and industrial applicability to remain valid. Inventions deemed unethical, harmful to society, or lacking these qualities will face partial or full invalidation.
- Scope Matters: Amendments or supplements that significantly broaden the scope of a patent application beyond its original disclosure invite invalidation. This prevents sneaky attempts to expand monopolies beyond their rightful boundaries.
- Clarity is Key: Patents must provide sufficient detail for an average person in the relevant field to understand and replicate the invention. Insufficient clarity can lead to partial invalidation.
- Stick to the Script: Patent claims that venture beyond the initial disclosure in the specification risk invalidation. This ensures consistency and prevents unwarranted extensions of protection.
- First to File Wins: If a patent violates Vietnam's "first to file" principle, granting rights to the earliest filer, it faces potential invalidation. This upholds fairness and encourages timely disclosure of inventions.
These expanded grounds for invalidation signal Vietnam's commitment to a robust and equitable patent system. By establishing clearer boundaries and empowering authorities to revoke unjustified patents, the amended IP Law aims to create a more transparent and competitive landscape, fostering genuine innovation while safeguarding the public interest.
6. Application Essentials: Streamlining the application process with revised general requirements for clear and thorough submissions.
The amended Vietnam IP Law 2022 has supplemented point d.1 of Article 100, specifically: “Documents explaining the origin of genetic resources or traditional knowledge about genetic resources in a patent application, for inventions directly created on the ground of genetic resources or traditional knowledge of genetic resources”.
7. Patent Path Twists: Adding new grounds for rejecting applications, ensuring only truly deserving inventions made the cut.
The IP Law 2005 has stipulated three cases of refusal to grant a Patent, which are:
- The patent application does not fully meet the protection criteria;
- The patent application does not meet the “first to file” principle;
- There is no consent from all of the applicants according to Paragraph 2 Article 90 of this Law.
The amended Vietnam IP Law 2022 has supplemented six more cases of refusal to grant a Patent, which are:
- The applicant neither has the right to register the invention nor is assigned such right;
- Amendments and supplements to a patent application widen the scope of the object disclosed or stated in the application or change the nature of the object requested for registration stated in the application;
- Patented inventions go beyond the scope of disclosure as specified in its original specification;
- The invention has not been disclosed sufficiently and clearly to the extent that a person with average skill in the art can carry it out;
- The patent application fails to disclose or incorrectly disclose the origin of the genetic resources or traditional knowledge of genetic resources;
- The patent application is filed in contravention of the security control regulations.
8. Deeper Dives: Introducing more rigorous patent examination procedures for a thorough vetting of each claim.
The IP Law of 2022 has been amended to include a new provision that allows the National Office of Intellectual Property (NOIP) to use the results of substantive examination from a foreign IP Office when examining patentability in Vietnam. The Minister of Science and Technology will provide detailed guidance on this provision.
9. Pharmaceutical Payback: Addressing delays in approving new drugs with fair compensation for patent holders.
Imagine investing years in developing a life-saving medication, only to face frustrating bureaucratic delays before bringing it to those who need it most. For pharmaceutical companies in Vietnam, this was a harsh reality with significant financial consequences. Until recently, patent holders faced paying maintenance fees even while their drug approval lingered in limbo, impacting their bottom line and potentially hindering innovation.
But a new dawn has arrived with Article 131.a, a game-changer in Vietnam's Intellectual Property (IP) law. This unprecedented provision, born from Vietnam's commitment under the European Union–Vietnam Free Trade Agreement (EVFTA), offers a beacon of hope for the pharmaceutical industry.
Here's what this revolutionary Article means:
- Financial reprieve for delayed approvals: No more paying fees during approval delays! Patent holders can breathe a sigh of relief, as Article 131. exempts them from maintenance fees for the exact period their drug's approval gets stuck in bureaucratic gears. This financial safety net protects their investments and keeps innovation thriving.
- Aligning with global standards: EVFTA paved the way for this shift towards a more balanced and investor-friendly IP environment. Vietnam recognizes the importance of harmonizing its practices with international norms, fostering trust, and attracting foreign investment in its pharmaceutical sector.
- Clearer details to come: While Article 131.a lays the groundwork, the Vietnamese government is crafting a dedicated decree to flesh out the nitty-gritty. This decree will spell out the precise procedures and eligibility criteria for claiming compensation, ensuring transparency and smooth implementation.
Potential ripple effects:
- A boost for pharmaceutical innovation: With financial worries mitigated, companies can channel their resources and energy towards developing life-saving drugs, potentially accelerating Vietnam's journey towards pharmaceutical self-sufficiency.
- Sharper regulatory focus: The prospect of compensation might serve as a gentle nudge for regulatory agencies to streamline approval processes. This could expedite access to new medicines for patients and enhance the overall efficiency of the system.
- Global investment magnet: A more supportive IP environment aligned with international standards can attract increased foreign investment, fueling Vietnam's pharmaceutical industry with expertise and capital, ultimately benefiting both the economy and public health.
Article 131.a represents a bold step forward, paving the way for a more dynamic and equitable pharmaceutical landscape in Vietnam. By acknowledging the financial burden of delayed approvals and taking steps to alleviate it, Vietnam demonstrates its commitment to fostering a thriving environment where life-saving innovations can flourish and reach those who need them most.
10. Forced Sharing: Exploring compulsory licensing options to ensure vital inventions benefit the public when necessary.
The IP Law 2005 provides four compulsory grounds for the licensing of patents.
The amended IP Law 2022 has supplemented the fifth ground for compulsory licensing of an invention, specifically in the case of the use of an invention to meet the demand for pharmaceutical products for the prevention and treatment of diseases of another country that is eligible for import under international treaties to which Vietnam is a contracting party.
11. Supplement of provision on Compensation for Patent holder due to delay in granting approval of pharmaceutical products in Vietnam
In a landmark shift for Vietnam's intellectual property landscape, patent holders in the pharmaceutical sector now have a safety net against unwarranted delays in the approval process. Inspired by the European Union–Vietnam Free Trade Agreement (EVFTA), the amended IP Law of 2022 introduces a novel provision that safeguards patent rights amidst bureaucratic hurdles.
Here's how this unprecedented change levels the playing field:
Breaking Barriers with Article 131.a:
- Protecting Patent Holders from Financial Strain: When bureaucratic delays impede the timely approval of pharmaceutical products, patent holders often face the added burden of maintenance fees, even though their inventions haven't yet reached the market. Article 131.a breaks this cycle of financial strain by exempting patent holders from paying these fees during periods of approval delay. This ensures that innovators aren't penalized for factors beyond their control.
- EVFTA Paving the Way: This provision directly aligns with Vietnam's commitments under the EVFTA, fostering a more balanced and investor-friendly IP environment in line with international standards.
- Decree in the Works: While Article 131.a sets the foundation, the finer details of implementation remain under development. The Vietnamese government is expected to release a decree that outlines the specific procedures and requirements for claiming this compensation, providing clarity and guidance for patent holders.
Potential Impact:
- Boosting Innovation in Pharmaceuticals: By alleviating the financial impact of delayed approvals, this provision could encourage further research and development in the pharmaceutical sector, fostering a more vibrant and innovative landscape.
- Enhancing Regulatory Efficiency: The prospect of compensation might incentivize regulatory agencies to streamline approval processes, ensuring timely access to new medications and fostering a more efficient system overall.
- Attracting Foreign Investment: A more supportive IP environment, aligned with international standards, could attract increased foreign investment in Vietnam's pharmaceutical industry, contributing to economic growth and technological advancement.
While the full implications of Article 131.a will depend on the upcoming decree, this provision marks a significant step forward for Vietnam's IP regime. By acknowledging the financial impact of delayed approvals and providing compensation, Vietnam demonstrates its commitment to fostering a more equitable and innovation-friendly environment in the pharmaceutical sector.
12. Amendment of provision on Compulsory Licensing in Vietnam: Balancing Public Access with Fair Compensation
Vietnam's IP landscape takes a nuanced approach to balancing public access to knowledge with the rights of patent holders. A key tool in this balance is compulsory licensing, where authorities can mandate the transfer of patent rights under certain circumstances. Understanding how compensation works in such scenarios is crucial.
Previously, under the 2005 IP Law, compulsory license holders, those granted the right to use a patented invention, faced a rigid structure for compensation. They had to pay a "satisfactory" sum based on the invention's economic value, guided by government-set brackets. This often led to disputes and uncertainties, hindering the potential benefits of compulsory licensing.
The 2022 amendments to the IP Law bring much-needed flexibility:
- Emphasis on Agreement: The new law prioritizes reaching an agreed-upon compensation amount between the patent holder and the compulsory license holder. This fosters a more collaborative and potentially faster resolution, benefiting both parties.
- Government as a Backstop: If an agreement isn't reached, government regulations come into play, providing a fallback mechanism to ensure fair compensation.
- International Treaty Exception: A crucial nuance applies when compulsory licensing involves pharmaceuticals and international treaties Vietnam is part of. If compensation has already been paid in the exporting country for the same invention, no further payment is required in Vietnam. This avoids double compensation and facilitates access to critical medicines.
These changes signal a more nuanced approach to compulsory licensing in Vietnam. By prioritizing agreements, providing a regulatory safety net, and recognizing international agreements, the amendments aim to balance public access with fair compensation for patent holders. This fosters a more dynamic and equitable IP landscape, encouraging innovation while ensuring vital advancements reach those who need them most.
If you need further explanation on this subject, please don't hesitate to contact us through email at dung@luatminhkhue.vn or phone number: +84986 386 648. Lawyer To Thi Phuong Dzung.