In the discussion at the Trans-Pacific Health Sciences Dialogue meeting led by Grace Pan, a partner at Holland and Knight we heard from Dr. Judy Jarecki-Black is Global Head of the Intellectual Property Department at Merial, Inc., the Animal Health subsidiary of Sanofi-Aventis. And Fang Xie, Ph.D. is Of Counsel at international law firm Greenberg Traurig, LLP where she co‐leads the firm’s Biotechnology and Pharmaceutical Group.
Dr. Fang Xie and Dr. Judy Jarecki-Black enlightened the participants about what it takes to obtain a patent in China and the different types of patents. During that same talk they explained the challenges of bringing new vaccines to China.
Obtaining patent protection and bringing new drugs and vaccines to China is not, unfortunately, a simple process. China’s patent process, especially relating to vaccines, is sophisticated and data-driven, and companies new to the experience are likely to encountered several hurdles.
Language Barriers: The first hurdle encountered is simply that any patent in China must be filed in Mandarin. That makes obtaining a skilled translator an essential part of the process. Finding an IP attorney who is fluent in both English and Chinese and familiar with the Chinese patent process can overcome this obstacle; if nothing else, opt for a reputable, reliable translator.
The Patent Filing Process: Vaccines and other drugs must file for an invention patent, as opposed to a utility patent. The prosecution period for an invention can often last for years. However, at the same time, invention patents offer 20 years of protection.
Placing a Sample on File: In the patent filing process, you must place a sample of your vaccine on file. This can certainly be a cause for concern for companies who are used to working in other markets, but the policy is in place as a measure to track strains and mutations.
Obtaining Chinese Resources: Related to that matter is the fact that collaboration with Chinese scientists is often crucial to developing vaccines for the market. This is especially true in the veterinary industry, because many diseases have different strains from one region to the next and a vaccine that counters one may not work against another. Obtaining those samples is important for success; it is worth mentioning that the research happens at state-sponsored institutions.
Other Government Requirements: Any vaccines must be manufactured in China, which makes government assistance crucial to the process, and even makes it questionable whether you can truly establish a biotech company without the Chinese government’s assistance.
In addition, the process of clearing a vaccine for production in China is complicated by the government’s reluctance to accept the documentation provided for approval in Europe or the U.S. Obtaining a patent and regulatory approval will require reworking of your existing materials.
Multinational Development: Global companies that rely on development in several nations may find them wondering where to file first and what type of filing is required. For vaccines developed partially in China, the exact requirements will depend on a variety of circumstances; once again it is crucial to have an experienced IP attorney to guide you through the requirements.
All in all, filing for a vaccine patent in China could easily cost $20,000 just to obtain the patent, between translation fees and filing costs. And despite the challenges that companies will face, and complex legal environment, China remains a market poised for growth, making it an appealing nation to expand into.
The 15th Annual Trans-Pacific Health Sciences Dialogue was a meeting for biopharmaceutical industry executives and business development executives who wanted to accelerate, explore and develop collaborations and partnerships with their counterparts in the most important Trans-Pacific health care markets including Japan, China, South Korea and North America.
In a discussion led by Grace Pan, a partner at Holland and Knight we heard from Dr. Judy Jarecki-Black, who is Global Head of the Intellectual Property Department at Merial, Inc., the Animal Health subsidiary of Sanofi-Aventis. Also part of the discussion was Fang Xie, Ph.D., Of Counsel at international law firm Greenberg Traurig, LLP, where she co‐leads the firm’s Biotechnology and Pharmaceutical Group.
Dr. Fang Xie and Dr. Judy Jarecki-Black enlightened the participants about what it takes to obtain a patent in China, and the different types of patents that are available.
Understanding the Types of Chinese Patents
China’s patent law allows inventors and companies to file for one of three types of patents: utility, invention, and design. The time it takes to file, the cost to file, and the duration of protection depend on which type of patent you choose to pursue. They bear similar names to US patents, but don’t correlate exactly.
Chinese utility patents are granted to new solutions or improvements to items — such as a new shape or structural features added. They can only apply to physical products.. A Chinese utility patent has some similarity to Japanese or European utility model patents — but there is no direct US equivalent. Utility patents are not as innovative as invention patents; the degree of “inventiveness” is lower and there is far less scrutiny required.
Utility patents offer 10 years of protections as opposed to 20 years for invention patents. However, they can be obtained in less than one year because there is less scrutiny applied. This makes them attractive in industries where products become less valuable over time (electronics, for example).
The Chinese invention patent applies to both physical products as well as processes. It offers 20 years of protection to the patent holder, but compared to a utility patent, can take significantly longer to obtain — often several years. An invention patent is the appropriate choice for products with a long development time, or those that will remain valuable for a very long time.
It is possible to file for both utility and invention patents for a particular improvement, product or process— however, you cannot obtain both. During the prosecution (evaluation?) period, you will be asked to choose which one to pursue. If you opt for the invention patent, you must abandon the utility patent. Similarly, you may choose to keep the utility patent when it is granted and abandon the invention patent.
Chinese design patents relate specifically to the external features of a product, including any of the following:
- Pattern and shape
- Shape and color
- Pattern, shape and color
The only other requirement is that the patent be suitable for “industrial application” — that is, able to be mass produced. Like utility patents, design patents have a protection period of 10 years and can be obtained relatively quickly — within a year.
Additional Concerns for Chinese Patents
One common factor to all Chinese patents is that they must be filed in Mandarin, which means that translation is very important. In addition, patents are issued on a first-come, first-served basis, and cannot have been published or unveiled publicly before the patent application is approved. Demonstrating that a patented product was published or unveiled before the patent was issued could invalidate the patent.
Utility patents have a noteworthy feature in that patent holders have an option, in the case of infringement, to pursue action using the administrative branch of the patent office. This is far less costly and time consuming because there are no courts involved. The administrative branch will not assess any damages, either, but it will facilitate mediation so the affected parties can negotiate damages.