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A statement by the multinational pharmaceutical company Roche Pharmaceutical disclosed its patent dispute with O-Yi Company (hereinafter referred to as O-Yi Company), a subsidiary of CSPC Group, on mabaloxavir tablets, and also revealed the tip
of the iceberg of the "mutual fight" between original pharmaceutical companies and generic drug companies in China.
A search for the China Judgment Document Network using "drug patents" as the keyword shows 40 documents from 2011 to 2022
.
Although the amount is not large, almost every case has gone to the local higher people's court, and some have even dissatisfied with the judgment of the local higher people's court, and after the first instance, second instance, and retrial, the Supreme People's Court conducted a final review
.
Among the plaintiffs and defendants, there are well-known overseas pharmaceutical companies such as AstraZeneca and Sino-foreign Pharmaceutical Co.
, Ltd.
, well-known Chinese pharmaceutical companies such as Qilu Pharmaceutical, Jiangzhong Pharmaceutical and Chia Tai Tianqing, as well as non-market entities
such as the State Intellectual Property Office, the Provincial Food and Drug Administration, universities and hospitals.
The victory or loss of a lawsuit is often not linked to interests - in these lawsuits, sometimes the original drug company wins, but the generic drug has been included in the centralized procurement before the judgment, and even on the day of the judgment, the patent protection period of the original drug has expired; Sometimes generic drugs win, but due to pre-litigation injunctions, the launch of the product has to be delayed by 4 years
.
"For companies, the market and profit are the most important, and litigation is often the last resort
.
" Song Xiaoting, a professor at the Shanghai International Intellectual Property Institute at Tongji University, told Eight Point Jianwen
.
However, it is clear that even in China, where the pharmaceutical industry is still in a state of development, original pharmaceutical companies and generic drug companies are still in
conflict.
Pull the battle line
Pull the battle line This is a slightly gunpowder statement
.
On October 18, Roche Pharmaceuticals announced on its official WeChat public account that its innovative drug mabaloxavir tablets (trade name: Sofuda ®) was approved for marketing in China in April 2021, and the drugs and active ingredients are protected
by relevant Chinese invention patents.
However, "within three months of approval, Oui submitted a generic drug marketing application"
.
"Since July 2021, our company has repeatedly communicated with Euro-Italy on intellectual property issues, but on the one hand, Ouyi believes that its approved generic drugs fall within the scope of protection of China's invention patent No.
ZL201180056716.
8, and on the other hand, it has refused to promise not to carry out patent infringement during the above-mentioned patent protection period
.
" The official statement of Roche Pharmaceuticals reads
.
As the only approved single-dose oral drug for the treatment of influenza in China, mabaloxavir tablets can be used in patients aged 12 years and older with simple influenza A and B, and are administered as a single dose within 48 hours after the onset of symptoms
.
Xu Dang of Beijing University of Chinese Medicine analyzed the eight-point health news that mabaloxavir tablets have certain advantages, "for example, a single oral dose must have higher medication compliance than multiple consecutive days and multiple medications"
.
"Influenza viruses can easily develop drug-resistant strains
as the seasons change.
Antiviral drugs are prone to drug resistance in the later stage because the virus is easy to mutate
.
In terms of the mechanism of action, mabaloxavir tablets are an anti-influenza drug with a new mechanism of action, which should have good market application prospects
.
He said
.
If there is a market, it means that it is profitable
.
Roche's other anti-influenza drug oseltamivir once set a myth
of annual sales of more than 6 billion yuan.
The confrontation between the two sides is ostensibly a dispute over drug patent rights, but in fact it is a dispute
over market expectations for mabaloxavir tablets.
The expiration of patents means that the market exclusivity period collapses, and competing pharmaceutical companies have launched their own generic drugs, and the price of drugs is lower
than the other.
Therefore, for multinational original drug companies, it is necessary to wait for the competitors of generic drug manufacturers to catch up and firmly occupy the market in order to extend their sales opportunities
in the Chinese market as much as possible.
The crux of the question is, is the behavior of Euro-Italy legal? According to public information, the application for generic mabaloxavir tablets of O-Yi was accepted by the Drug Evaluation Center of the State Food and Drug Administration on July 1, 2021, and it can be inferred that O-e-Italy's application time was earlier than July 1
.
The specific linkage measures for resolving patent disputes involved in the approval and application stages of drug marketing authorization, namely the Implementation Measures for the Early Settlement Mechanism for Drug Patent Disputes (Trial Implementation) (hereinafter referred to as the "Implementation Measures"), which stipulates the drug patent linkage system (also known as the early dispute resolution mechanism for drug patents), were only promulgated and implemented by the State Food and Drug Administration and
the State Intellectual Property Office on July 4 of the same year.
Obviously, the application for registration of Euro-Italian companies occurred precisely at a time when
the specific measures were still blank.
When submitting an application for marketing authorization of a drug, an applicant for a chemical generic drug shall make a declaration for each relevant drug patent of the generic drug against the patent information that has been disclosed on the patent information registration platform of the drug listed in China, and the declaration is divided into four categories - these are all stipulated
in the Implementation Measures.
"Ouyi companies can submit their listing applications earlier than the time of the issuance of the Implementation Measures, and can submit applications and obtain approval
without making patent declarations.
" Yang Shanshi, deputy director of the Medical Science and Technology Information Research Department of the Shanghai Health and Wellness Development Research Center, said, "If Ouyi manufactures, sells or promises to sell generic versions of mabaloxavir tablets for the purpose of production and operation, Roche Pharmaceutical can seek relief
in accordance with China's Patent Law and other relevant laws and regulations.
" However, a marketing authorization decision that has been approved in accordance with the law will not be revoked and its validity
will not be affected.
”
Bai Wenhui, a practicing lawyer at Shanghai Hushi Law Firm, said that the public statement issued by Roche Pharmaceutical can still serve as a warning, "for example, potential upstream and downstream partners of this drug will be cautious and do not establish a cooperative relationship until the conclusion of whether the company is infringing on whether the company is infringing, so as to avoid more losses and gain more commercial benefits"
.
Tripartite wrestling
Tripartite wrestling The game between innovative drugs and generic drugs has been around for a long time
.
Even in the context of market competition of hundreds of millions of yuan, the word "fighting" is not exaggerated
.
Take Pfizer's blockbuster patented drug rispitor as an example
.
This is a statin used to lower blood cholesterol levels, once set a sales myth for Pfizer with annual sales of more than 10 billion US dollars, and is also one of the few drugs
in the world to enter the 100 billion dollar club.
After the US patent expired in November 2011 and the patent protection was lost in the UK on May 7, 2012, Lipitor global sales were cut in the second quarter of 2012, and sales in the United States plummeted by about
80%.
The original drug that has lost patent protection seems to be a piece of fat surrounded by wolves, but the original research pharmaceutical company is not without the ability to
fight back.
Many original pharmaceutical companies continue to expand their drug "patent network" through combination patents such as "basic patents, secondary patents", etc.
, in order to extend the validity period
of patents.
In many countries, generic drug companies also have the right to launch a "patent challenge" to drug patents, once the challenge is successful, not only the drug patent will be declared "invalid", but the first generic drug as the challenger can also have a fairly long period
of market exclusivity.
Focusing on drug patents and the absolute monopoly of the market they represent, original pharmaceutical companies and generic drug companies are constantly
fighting and gaming.
The government, as the third party representing the public interest, needs to strike a balance
between the two.
In order to encourage R&D and recoup its R&D costs, it is necessary to compensate innovation
with a patent protection system.
But the price of new drugs is too high to meet the drug needs of most people, and it is also necessary to incentivize high-quality generic drugs to stabilize drug prices
.
It's like adding and subtracting weights on a swinging balance to adjust the ratio
between patient needs and the current state of the industry.
The Drug Price Competition and Patent Term Compensation Act promulgated by the United States in 1984 made the original drug companies and generic drug companies reach a consensus: on the one hand, competitors should accelerate the passage, and on the other hand, the original drug companies should be given corresponding patent protection compensation
for the delay in the approval process of new drugs.
When then-President Ronald Reagan signed the bill, he even proudly said, "Overall, this bill will deregulate, increase competition, and save government spending
.
" Best of all, the American people save money and have access to the best drugs that pharmaceutical science has to offer, and everyone wins
.
”
China has undergone four amendments to the Patent Law, from the inclusion of "drugs and substances obtained by chemical methods" in patent protection in 1992, the introduction of the Bolar exception system in 2008, and the establishment of a pharmaceutical patent linkage system and a drug patent protection extension system in 2020.
"Why did the compound entity not be included in the scope of patent protection when the Patent Law was passed in 1984, because we must solve the problem that the people can afford medicine when they are sick, and if the drug patent is strongly protected, no pharmaceutical company can copy it, and the patented
drug is sold very expensive, and it is very easy to become poor due to illness and return to poverty due to illness.
" Song Xiaoting said
.
The Bolar exception system – in order to provide the information required for administrative approval, the manufacture, use, and import of patented drugs or patented medical devices, as well as those specifically manufactured or imported for them, are not considered patent infringement – is intended to help generic drug companies shorten the registration time and speed up the listing after the
end of the patent period.
The system provides a relatively relaxed policy environment for generic drug companies and promotes the vigorous development of China's generic drug industry, according to China Food and Drug Network, generic drugs accounted for 63% of China's drug market in 2020, with a market size of 808.
7 billion yuan
.
It's the art
of making decisions that balances innovation with price reduction.
In the first stage of the drug life cycle, new drugs enjoy a patent monopoly to pay for the huge expenditure of research and development of new drugs, and in the second stage, patents expire, competitors and drug prices plummet, and a new market game restarts
.
Restart the game
Restart the game A country's pharmaceutical patent protection system is constrained by many national conditions such as legal system, administrative system, industry development level, and residents' income level, so it shows different tendencies, and different tendencies also have their own advantages and disadvantages
.
Taking India as an example, as the world's largest supplier of generic drugs, India accounts for about 20% of the global generic drug market and about 40% of the generic drug market
in the United States.
This is countered by India's rather lax pharmaceutical patent policy – not a single drug was patented until the entry into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) signed in 1994 – and the gap
in innovative medicines that have almost lost room for development.
On the high scale, almost only generic drugs
remain.
China also has a
tendency in institutional design.
"For example, after the implementation of collective procurement, many generic drug companies lament that their lives are not good, which is precisely the purpose of policy orientation," an industry insider said, "China's generic drug market scale economy continues to increase, but it is still more concentrated in the cheap drug market with low capital entry threshold and low research and development level, and there has been a phenomenon
of overcapacity of low-end generic drugs.
" ”
Since 2016, heavy documents such as "Opinions on Carrying out Consistency Evaluation of the Quality and Efficacy of Generic Drugs" and "Opinions of the General Office of the State Council on Reforming and Improving the Policy on the Supply Security and Use of Generic Drugs" have been issued
successively.
But as if that weren't enough, this time, the government directly wrote the guidance into the rules and regulations - Article 1 of the "Implementation Measures" clearly stated that the purpose of the measures is: "to encourage new drug research and promote the development of
high-level generic drugs.
" ”
Promoting the development of high-level generic drugs is reflected in Article 11 of the Implementation Measures, which is to grant a market exclusivity period
to the first chemical generic drug that successfully challenges a patent and is the first to be approved for marketing.
The drug regulatory department under the State Council will no longer approve the marketing of generic drugs of the same variety within 12 months from the date of approval of the drug, except for
successful joint patent challenges.
In order to obtain the first generic drug market exclusivity period, the generic drug applicant needs to initiate a Type IV declaration
in accordance with Article 6 of the Implementation Measures.
For new drugs, if the innovation is enough to apply for drug patents, that is, to be the real first in class, the Chinese market with a large population base and a high proportion of unmet market shares will always be a place
for soldiers.
However, if it is based on others to imitate and innovate me too drugs, or without infringing patents, the molecular structure of the first in class drug is modified or modified, and the same or similar mechanism of action is found to be the fast follow mode, as the time gap between Chinese and foreign drugs is getting smaller and smaller, domestic medical insurance negotiations and collective procurement have become normal policies, etc.
, I am afraid that the future will not be too good
.
This is the rule of
the game that must be adapted to win the Chinese market.
It is worth mentioning that the research and development of patented drugs is still the core of the business of
large multinational pharmaceutical companies.
According to a study, between 2009 and 2018, the average investment in each of the 63 new drugs approved by the US Food and Drug Administration (FDA) was about $1,335.
9 million
.
Even though Lipitor has been declining in sales since the loss of patent protection, it seems that it is no longer a myth, but from its approval for listing in early 1997 to the end of 2018, its cumulative sales revenue reached 164.
43 billion US dollars
.
It is the world's first drug with sales of more than 10 billion US dollars, and it is also a well-deserved "drug king"
for chronic diseases.
