This article comes from WeChat public number: Lin Hua (ID: gh_4d992808ffdf) , author: Lin Hua
I. Patents are familiar strangers
New England Journal of Medicine （NEJM） On January 31, 2020, the first global patented drug in the United States was published online Redesivir (Remdesivir, GS-5734) Treatment The successful dissertation of the new coronavirus immediately brought Redecive to the global spotlight.
Rumors of Trump exempting China’s use of Radixivir have just been falsified, Wuhan Pharmaceutical Research Institute (hereinafter referred to as Wuhan Pharmaceutical Research All) The announcement of the application for the invention of the method of use of Redecivet has caused widespread controversy.
According to the official website of Wuhan Pharmaceutical Research Institute on February 4, “Chinese scholars have made important progress in screening anti-coronavirus drugs for 2019” disclosed that Wuhan Institute of Pharmacy has “… From the perspective of protecting national interests, on January 21, a Chinese invention patent was declared (Use of anti-2019 new coronavirus) and will be approved by the PCT (Patent Cooperation Agreement) enter major countries around the world. If relevant foreign companies intend to contribute to China’s epidemic prevention and control, we both agree to When the state needs it, it does not require the implementation of the rights claimed in the patent for the time being, and hopes to work with foreign pharmaceutical companies to contribute to the epidemic prevention and control.
In the 21st Century Finance and Economics, Gilead responded to the Wuhan University of Virology’s “squatting” of the Redsilver Patent, citing a response from a person familiar with the matter at the Chinese Academy of Sciences to explain more clearly the intention of the new patent application:
“ This is the basic requirement for scientific research. We do drug research and make New results will go to apply for a patent. The scope of this patent’s rights is the use of Radixivir against new coronaviruses. Clinical trials are currently underway, regardless of whether the test results prove that Radixivir is effective, we must apply for this patent … This approach is also to protect national interests. If we do not pre-register the use of drugs, the supply and price of this drug will not be guaranteed in the future. Foreign companies will give you medicine if you do n’t want to give you medicine, you wo n’t give you medicine if you do n’t want to give you medicine, and you will have to pay as much as you want. In this way, China will be controlled by others … Use patents, other patents we can cross-license with foreign companies, this is also a negotiation method. “
The following key information can be understood from the opinions of Wuhan Institute of Pharmacy and the Chinese Academy of Sciences.
First, the institute applied for a patent for a method of treating new crown virus on the basis of a patent of a pharmaceutical compound owned by Gilead Corporation; second, The newly applied method patent will become the negotiation card with the US patentee, which will effectively limit the patent right of the compound.
The public is no stranger to patents frequently reported in the media. Wuhan Pharmaceutical Research Institute’s first application for a patent also shows that it is familiar with the patent system.
However, from the public opinions of Wuhan Institute of Pharmacy to relevant persons of the Chinese Academy of Sciences to the media comments, many misunderstandings can still be read.
Professional and non-professional media focus on whether the patent application of Wuhan Pharmaceutical Research Institute is a squatting, but the patent application is not except in a few specific situations, such as the agreement between inventors There is a concept of cybersquatting. It is wrong to criticize the cybersquatting of patents, and it is also wrong to assume that the Wuhan Pharmaceutical Research Institute has applied for no defects just because there are no cybersquatting patents, because patents themselves are the object of deliberation.
Patents may be familiar strangers to everyone.
Second, right or wrong may not be a simple dispute
Chinese patent law provides two invention patents for products and methods. A patent may not be applied repeatedly. Applying for a method of use on the basis of another person’s product (compound) does not violate patent law, nor is it a patent. Duplicate application.
Patent rights are monopoly rights to protect technical solutions. Different technical solutions under the same or related technical subject can generate different patent rights. For example, the technical solution of a manufacturing method patent gives the temperature interval in the manufacturing process. If an optimized temperature interval is proposed in this temperature interval, the optimized solution can still apply for a new patent.
Proposing a new method of use for an existing patent protected product may also be authorized. In fact, the well-known Viagra patent is an existing treatment for heart disease drugs for the treatment of male dysfunction. Application method patent.
Compared with the long-standing emphasis on research and protection in China’s scientific community, Wuhan Pharmaceutical Research Institute’s consciousness of applying for patents for the first time is worthy of recognition. As pointed out by a person in the Chinese Academy of Sciences, “… when you do drug research, you will apply for a patent if you make new results.” However, the analysis still needs to be extended. The possibility of applying for a patent does not mean that the application meets the authorization requirements, and the ethics of science and technology between patent application and medical treatment is also worth thinking about.
According to China News Agency, the US Centers for Disease Control and Prevention confirmed the cumulative diagnosis of new crowns on February 3 this year11 cases of parvovirus. According to the National Health Commission, 20,438 cases were confirmed on February 3 of the same year. Comparison of this set of data shows that the coronavirus is a serious threat to China’s social health. The demand for the development and treatment of coronavirus in China is far more urgent than in the United States. When Wuhan Pharmaceutical Research Institute applied for a patent on January 21, 2020, it had already “made new achievements” as the relevant person of the Chinese Academy of Sciences said. . Unless existing reports are inaccurate.
This is a good place to quote Gilead’s CEO Daniel O’Daywe to answer a reporter ’s question on the method patent incident to evaluate the relationship between fighting for technical results and treating patients:
“… will protect our intellectual property as a separate step of the process. But patients first.” (Protection of intellectual property rights is one aspect, but for us the patient comes first)
If you look at it from another perspective, according to the February 3 Pharmacy Research Institute’s paper, the research result of Wuhan Pharmacy Research Institute is “Ruide Civir can effectively inhibit 2019-nCoV infection at the cellular level …. The role in the human body has yet to be clinically proven. “ If there is no further evidence in the Wuhan Pharmaceutical Research Institute patent application that Radixivir can be used for In the actual treatment of patients, it is difficult to meet the practical requirements of patents. This is discussed further below.
So far, this patent application of Wuhan Pharmaceutical Research Institute has been in a dilemma, or the foundation of practicality is not strong, or the research and development and patentClosely linked, but disconnected from treatment needs.
Three, the mystery of novelty
Article 22 of the Patent Law stipulates that invention patents must meet three basic conditions, that is, the three characteristics of a patent commonly known as newness, creativity, and practicality .
According to the provisions of the Patent Law, novelty means that the invention or utility model does not belong to the prior art. Specifically, but generally speaking, is the technical solution for patent application before application. Not publicly known by anyone.
Although all media reports point to the United States being the first country to use Redesivir to treat New Coronavirus, comparing the two timelines, the United States was on January 26, 2020 The trial of Radixivir was only started. The treatment results were published publicly on January 31 of the same year. The Wuhan Pharmaceutical Research Institute had already submitted a patent application on January 21 of the same year.
The novelty of a patent is considered to be disrupted by being published. The publication date of the American paper on January 31 was significantly later than the patent application date of January 21 of Wuhan Pharmaceutical Research Institute.
However, novelty judgment not only considers time, but also considers the relevance of the prior art. This is a practical and creative judgment.
Gilead not only applied for product invention to Radixivir as an inventor, but also applied for a patent for a method of invention that specifies the use of a coronavirus. Chinese Patent Application Publication No. . For an easy-to-understand patent summary, see Youbin’s “Will the Wuhan Virus Application for Redecive Use Patent be Authorized?” Is it valuable?”.
Part II, Chapter 10, Section 5.4 of the Patent Examination Guidelines states:
“For a pharmaceutical use invention involving a chemical product, its novelty review shall consider the following aspects: (1) the new use and Whether the previously known uses are substantially different. Inventions that differ only in the form of expression but belong to the same use are not novel. “
The new coronavirus that broke out from Wuhan this time is the first new virus that appeared in nature, but the new coronavirus is a subset or subordinate concept of coronavirus, virus The characteristics did not exceed the coronavirus standard. This may also be the reason why the United States was the first to use redecide to treat patients with a new type of coronavirus. Whether the Wuhan Pharmaceutical Research Institute has applied for a patent for a method for treating coronavirus can pass the novelty examination at first has been controversial.
Creativeness that is difficult to cross
Creativity under the patent law means that the invention has outstanding substantive features and significant improvements compared to the prior art. If the novelty examination mainly wipes out patent applications that are obviously unreliable, the creative examination is the obstacle that most patent inventors have to face.
The accepted killer in creative examination is the Revelation Rules of the Prior Art . For details, please refer to Chapter 4, Section 2.2 of the Patent Examination Guidelines: < / p>
“If the invention is available to those skilled in the art on the basis of the prior art through only logical analysis, reasoning, or limited experimentation, the invention is Obviously, it does not have outstanding substantive characteristics. “The” three-step method “of the review guide’s summary of creative evaluation includes:
The first step is to determine the closest prior art;
The second step is to determine the technical characteristics of the invention that are actually solved by comparing the technical characteristics of the invention and the closest to the prior art.
The third step is to determine whether the claimed invention is obvious to those skilled in the art.
According to the three-step rule of the review guidelines, you can first determine that Gilead previously designated an anti-coronal virus method The method patent application is closest to the prior art.
Second, it can be found that the difference between the Gilead method patent application and the Wuhan Pharmaceutical Research Institute method patent application is like a black swan and a swan, Obviously only the upper (Gilead) and the lower (Wuhan Pharmaceutical Research Institute) < / span>.
Part II, Chapter 10, Section 5.4 of the Examination Guidelines stipulates in the novelty examination:” … (3) Whether the new use belongs to the higher-level concept of the originally known use. It is known that lower-level applications can destroy the novelty of higher-level applications. It is known that the lower-level application can destroy the novelty of the higher-level application “, which means that the higher-level use disclosed by the prior patent scheme cannot destroy the novelty of the lower-level application of the later patent scheme, but does not hinder the creativity of the later application scheme.
The fact that Redesivir is almost simultaneously identified in the United States and China as a new crown virus symptomatic program can prove that the program is obvious to those skilled in the art.
According to the above analysis, the probability that the Wuhan Pharmaceutical Research Institute’s application will be rejected by creative examination is very high. The only opportunity is to invoke the special provision for creative judgment in Chapter 4, Chapter 4, Section 4.5 of the Patent Examination Guidelines, “If the new use is to take advantage of the newly discovered properties of a known product and produce Unexpected technical effects, this use invention has outstanding substantive characteristics and remarkable progress, and is creative. “
It is certain that if Radesivir is eventually proven to be an effective drug against new coronaviruses, the technical effect of the antiviral method is very obvious. But how to judge “unexpected” here has become controversial.
From the content of the patent scheme of the front-to-back method and the simultaneous use of Redesivir in the treatment of new coronavirus infections, those skilled in the art can use general professional reasoning or limited This scheme can be obtained through experiments, which is difficult to classify as “unexpected”. So creativity will be the biggest obstacle to blocking the authorization of Wuhan Pharmaceutical Research Institute.
Fifth,Practicality in dispute
According to the provisions of the Patent Law, Practicality means that the invention or utility model can be manufactured or used and can produce positive effects.
According to the paper of Wuhan Institute of Pharmaceutical Research, at least it is clear that as of the patent application, there are only in vitro cell tests, and no clinical trials have been conducted. There is no human trial data as an example of implementation. effect. The embodiment in patent writing is part of the patent specification, and the patent claims must be interpreted based on the patent specification.
Mr. Yang Songcheng, a specialized and patent attorney, confirmed that once the embodiment described in the patent specification is submitted, all modifications will not exceed the scope of the original application document. That is to say, clinical trials as an example after applying for a patent prove that it is effective not only for in vitro cells but also for the human body, which is not allowed.
But here comes the controversial part in the implementation of the patent law, that is, all drug patents and drug use method patents should be in strict accordance with the patent law. Clinical trials should be used as examples to prove Produces positive results.
After consulting Mr. Liu Hui, head of intellectual property rights of WuXi AppTec, the opinion given is also “specific to whether the indication patent needs clinical data, depending on the data provided by the patent combined with known Whether the data support this indication. ” However, the actual situation of drug patent applications makes it possible for the practice of authorizing the scheme that has no cell test only in clinical practice. Considering the special situational background of Wuhan Pharmaceuticals Research Institute’s application for the patent of Radixivir application method, the flaws without clinical trials may be ignored.
Sixth, is it a big move to apply for a new anti-crown patent?
As mentioned above, Wuhan Institute of Pharmacy and the Chinese Academy of Sciences both believe that the application of the patent for the anti-neovirus method is to counteract the patent rights owned by Gilead, otherwise Redecive “supplied, Prices are not guaranteed … China will be subject to others … If China has a drug patent for Radixivir, we can cross-license other patents with foreign companies, which is also a negotiation method. “
But from the perspective of patent law, even if the method patent applied by Wuhan Pharmaceutical Research Institute is authorized, the hope of competing against Gilead’s product patent rights is untenable.
First of all, Gilead ’s patent for Radixivir compounds is the basis of all related patents. All applications without the basic technology of this patent are impossible.
Second, there is an obvious loophole in the optimistic judgments of Wuhan Institute of Pharmaceutical Sciences and the Chinese Academy of Sciences. It does not take into account that Gilead is only responsible for production, is not responsible for treatment, and is not subject to use method patents. Impact.
Even if Wuhan Pharmaceutical Research Institute holds the patent of Radixivir’s anti-neocrown virus method, it will not affect Gilead’s rights at all. Furthermore, the vast majority of patients and treatment behaviors are in China. If the ultimate burden of fees will be passed on to Chinese patients, this is by no means what we would like to see.
Finally, as many patent colleagues have pointed out, even if Wuhan Pharmaceutical Research Institute applied for a patent for a method of use, its scope of patent protection is quite narrow to be similar to comfort Agent, The global demand for the treatment of new crown virus still cannot bypass cooperation with Gilead.
Medicine’s mission is to save people. Wuhan Pharmaceutical Research Institute’s consciousness of intellectual property protection in applying for patents for the first time is certainly certain, but in the critical moment of anti-epidemic situation, it did not follow up in time for treatment, which is unfortunately behind the United States. Patent at the same time