Talk about the surrounding legal affairs of the drug patent link system

Author: Zhang Yaohong

On July 4, 2021, the State Food and Drug Administration and the State Intellectual Property Office jointly issued the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" (the "Implementation Measures")
.

On July 5, the Supreme People's Court issued the "Regulations of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Drugs Applied for Registration" ("Judicial Interpretation")

Since the official public document [1] officially discussed this issue in 2017, the medical circle and the intellectual property legal circle have discussed it year after year, and finally waited until the day when the policy was implemented
.

The above-mentioned "Implementation Measures" and "Judicial Interpretation" have been sorted out, sorted out, and comparatively studied by diligent colleagues for several rounds, so I don't need to add too much
.

Since this was the subject of the author's thesis of the Master of Laws when he was studying in the United States, I hope to discuss the surrounding legal issues of the drug patent linkage system from the legislative background and practical direction

1.
What is the drug patent linkage system?

1.
What is the drug patent linkage system?

When talking about drug patent links, we must talk about the Hatch-Waxman Act of the United States
.

Created in 1984, this bill, which claims to encourage innovation and ensure the availability of medicines, hopes to achieve a balance of interests between the original research drug companies and the generic drug companies.

Obviously, China has gradually introduced the corresponding content of the Hatch-Waxman Act in accordance with the development level of domestic pharmaceutical research and innovation and changes in the economic environment, and most of the content has been appropriately adjusted, rather than mechanically
.

However, since the Hatch-Waxman Act is a complete system from the beginning of the system design, it balances the interests of both the original research drug company and the generic drug company.

Take the European Community as an example.
Since it is the base camp of the original research drug company, it has not established a drug patent link.
Instead, it provides strong protection for the original research drug company with the help of test data protection and supplementary protection certificates (that is, patent protection period compensation)
.

Even with the exception of Bolar, the European Community Patent Convention does not clearly stipulate it, but only exempts patent infringement liability based on the "implementation of patents for experimental purposes", but the definition of "for experimental purposes" is not uniform in practice in various countries [3]

Although we have launched many innovative drugs in recent years, as of now, China is still a big country of generic drugs
.

So are generic drug companies calling for the establishment of a patent linkage system?

2.
Who is calling for or needing a drug patent linkage system?

2.
Who is calling for or needing a drug patent linkage system?

Let us first look at two cases: Sinopharm Group Enbipu Pharmaceutical Co.
, Ltd.
and Livzon Group Limin Pharmaceutical Factory infringement of invention patent rights disputes [(2018) Jingmin Zhong No.
474, (2019) Supreme Law Civil Application No.
2178] He Astellas Pharmaceutical Co.
, Ltd.
, Madison Medical Company, and Sichuan Kelun Pharmaceutical Research Institute Co.
, Ltd.
Infringement of invention patent dispute case [(2019) Chuanzhiminzhong No.
53]
.

The plaintiffs in these two cases are the patentees or exclusive licensees of the drug patents, that is, the original research drug companies, and the defendants are generic drug companies, and the alleged infringements are all more than 2 years before the expiration of the drug patents.
Time (12 years before the patent expires in the Sichuan Kelun case) generic drug companies filed related administrative license applications to the Food and Drug Administration.
The former is for production registration and the latter is for clinical applications
.

Based on the Bolar exception, all courts determined that it did not constitute patent infringement

It is not uncommon for generic drug companies to be approved for listing within the patent validity period of the original research drug-related compound; in the first 10 months of 2019, 10 generic drugs have been approved [4]
.

According to the 2007 "Administrative Measures for Drug Registration", "For drugs that have obtained Chinese patents, other applicants can apply for registration 2 years before the expiration of the drug patent.

In China, the Bolar exception is placed in the "not considered as infringement of patent rights" in the "Patent Law" along with exhaustion of rights, prior right of use, and exclusively for scientific research and experimental purposes
.

That is to say, Bolar’s ​​behavior of exception regulation is fully in line with the constituent elements of patent infringement, that is, manufacturing, using, and importing patented drugs or medical devices for production and business purposes; only the law grants them special treatment, when these manufacturing, using, and importing patents When a drug or medical device is used for administrative examination and approval to obtain information, it is not regarded as an infringement of patent rights.
To be precise and reasonable)
.
However, the act of "application for administrative approval" itself, the Hatch-Waxman Act assumes it is an infringement, which is the so-called fictitious infringement; China's law does not stipulate whether it constitutes a patent infringement.
There is still no stipulation (many colleagues in the industry have always held a negative attitude towards the treatment of "fictitious infringement" in the United States), but from the perspective of "whether the relevant technical solutions of the drug applied for listing fall within the protection scope of the relevant patent rights" The legal basis for generic drug companies to submit for marketing approval before the expiration of the original research drug patent
.

With the above "Implementation Measures", CSPC and Astellas have a legal basis to sue or request administrative rulings, and the court or patent administrative department must determine whether the relevant technical solutions for the listed drugs fall within the protection scope of the relevant patent rights.
Make a verdict
.
The original research pharmaceutical company can finally get out of the helplessness that has been tortured by Bolar's exception in the past ten years
.

Therefore, in the Chinese market, the most urgent need for the drug patent linkage system is precisely the original research drug company
.
Moreover, even if the generic drug company's application for listing is ultimately determined to not fall into the scope of protection of the original research drug patent, the original research drug company can still win a 9-month waiting period
.

3.
What can the drug patent linkage system bring to generic drug companies?

3.
What can the drug patent linkage system bring to generic drug companies?

According to the "Implementation Measures", when a chemical generic drug applicant submits a listing application, it shall make a statement for each related drug patent of the generic drug in accordance with the patent information that has been published on the Chinese drug patent information registration platform
.
The declarations are divided into four categories: one: the patented drug is not included; two: the rights of the included drug have been terminated or declared invalid, or the applicant for the generic drug has obtained a license; three: the patented drug is included, and the applicant for the generic drug promises to be in the patent right The generic drugs will not be listed until the expiration of the validity period; four: the drug patents included should be declared invalid, or the generic drugs do not fall into the protection scope of relevant patent rights
.
Regardless of the waiting period or the market exclusivity period, the prerequisite for activation is that the generic drug company has made the fourth type of declaration; moreover, only the original research drug company (including its licensee) will determine whether the related technical solutions of the generic drug fall into the relevant patent rights.
The nine-month waiting period will start when the scope of protection is sued or the administrative ruling is requested; only the first generic drug company approved for listing successfully invalidates the patents related to the original research drug, and the 12-month market exclusivity period starts
.

The period of market exclusivity is of course the greatest benefit that the drug patent linkage system brings to generic drug companies
.
Before infringement lawsuits occurred, it was difficult for generic drug companies to decide to initiate invalidation procedures, because on the one hand, the beneficiaries of successful invalidation also included competitors—other generic drug companies
.
The establishment of the market exclusivity period can obviously dispel the hesitation of generic drug companies as the first invalid requester
.
At the same time, this also reminds generic drug companies that they must request invalidation by real-name, and can no longer use the scarecrow like before
.

According to the "Implementation Measures", the fourth category of declarations includes that the drug patents included should be declared invalid, or the generic drugs do not fall into the scope of protection of relevant patent rights
.
In fact, in addition to seeking for market exclusivity, generic drug companies will choose to request invalidation of the original research drug patents, and it is more likely that they cannot carry out circumvention designs to prevent generic drugs from falling into the protection scope of the original research drug patent rights
.
Taking chemical drugs as an example, the patents of original research drugs that comply with the drug patent linkage system only include patents for active ingredient compounds, patents for pharmaceutical compositions containing active ingredients, and patents for medical uses
.
But at the same time, in accordance with the 2016 "Announcement on Issuing the Work Plan for the Reform of Chemical Drug Registration Classification" ("Chemical Drug Registration Classification Announcement"), generic drugs are required to have the same active ingredients, dosage forms, specifications, indications, and medications as the original drugs.
Ways and usage and dosage
.
Therefore, as long as it is a generic drug application, it is destined to have the same active ingredients and medical uses as the original drug, and it is difficult not to fall into the protection scope of the original drug patent
.
This is not like the Orange Book of the United States, which can also include the crystal form patent of the original research drug; the generic drug company can wait for the compound patent to expire, apply for the generic drug through the new crystal form that has circumvented the design, and make a non-infringement statement; And if such a challenge is successful, generic drug companies can also win a 180-day period of market exclusivity
.
In addition, the United States has also set up a special paragraph VIII statement, that is, the ANDA can request the FDA to delete the applicable diseases that are still in the patent validity period from the drug instructions, but this approach will not activate the waiting period or the market exclusivity period.
The advantage is generic drugs.
Can be listed in advance
.
For ANDA, the United States also requires the same active ingredients, route of administration, dosage form and strength (strength) as the original drug.
However, if any of the above items in the ANDA is different from the original drug, the US FDA also allows further investigation procedures to confirm Whether the ANDA drug has the safety and effectiveness of the original research drug, so that the ANDA can still be approved [6]
.

At present, in the Chinese market, the situation that the author can think of a generic drug that does not fall into the scope of patent protection of the original research drug may have applicable symptoms: the original research drug’s instructions include indications that are not included in the claims in the corresponding patent.
It is precisely this indication that is required when applying for generic drugs; but the reduction of such indications is not in line with the definition of generic drugs in China's chemical drug registration classification announcement
.
For pharmaceutical compositions, it is relatively easy for generic drug companies to circumvent the design direction of changing the adjuvant, drug structure, etc.
to adjust the drug release rate, solubility or stability, etc.
, but in this case, it must meet the same usage and dosage as the original drug.
And specifications, it will be relatively difficult
.
Therefore, it seems that there are not many opportunities for generic drug companies to declare that they do not fall into the scope of patent protection of the related original drug composition
.

In short, for generic drug companies, requesting to declare the patent invalidation of the original research drug is still the king of patent challenges, but how to choose the time for filing the invalidation request and the time for submitting the generic drug application, so as to ensure that it can be the first approved listing applicant and first Winning a one-year market exclusivity period for a successful invalid request will greatly test the timing decisions made by generic drug companies
.

4.
Is the 9-month waiting period feasible in judicial and administrative procedures?

4.
Is the 9-month waiting period feasible in judicial and administrative procedures?

Based on the current judicial situation in China, industry peers are generally worried about whether the court can make the first or second instance judgment within the nine-month waiting period; in fact, whether the Beijing Intellectual Property Court can make the first-instance judgment within nine months has to make a decision.
Question mark
.
The author also had this concern when the "Patent Law Amendment" published Article 75 of the Drug Patent Linkage Law last year [7]
.
However, after reading the "Implementation Measures" and "Judicial Interpretation", the author thinks that it is still feasible
.

The reason for this type of lawsuit is whether it falls within the scope of protection of patent rights.
According to the "Judicial Interpretation", generic drug companies are required to submit copies of necessary technical materials that are declared to the National Food and Drug Administration and correspond to whether they fall within the scope of protection of relevant patent rights.

.
All colleagues (patent attorneys) who have done patent infringement analysis or litigation understand that to determine whether the accused technical solution falls within the scope of patent protection, the main content is to separate the accused technical solution and the corresponding claims in the patent according to technical characteristics , And then conduct comparison and analysis to form a claim comparison table (we call it the claim chart in the industry), and this comparison table is in accordance with the "Implementation Measures".
Generic drug companies need to submit to the Drug Administration when they apply for listing
.
In other words, this kind of litigation is like a patent invalidation procedure.
The facts of the case are very clear.
The disputes are concentrated in the claim comparison table.
This is a combination of technical issues and patent law issues.
The difficulty may mainly lie in how to determine whether they are equivalent
.
The author personally feels that this type of litigation is not like other litigations.
A large amount of trial time in the court is spent investigating the facts of the case.
According to the State Intellectual Property Office, the average time for invalidation of a drug patent is 6-8 months.
Such lawsuits set up some accelerated procedures similar to the green channel, and the 9-month waiting period can still be expected
.

The "Implementation Measures" stipulate that for a 9-month waiting period, the Food and Drug Administration shall make corresponding handling in conjunction with the effective judgment of the People's Court or the administrative ruling of the Intellectual Property Office
.
Administrative rulings here can still be appealed in accordance with the law, not final rulings
.
However, if the administrative ruling is finally overturned by the court, the following two situations will occur:

(1) The result of the administrative ruling was that it did not fall into the scope of protection of patent rights, and generic drugs were produced and sold on the market, but the court finally determined that they fell within the scope of protection of patent rights; at this time, the patentee could seek relief by filing a patent infringement lawsuit
.
However, generic drug companies may have built their generic drug production lines, and the behavior of the generic drug companies was caused by a wrong administrative ruling.
Therefore, the author suggests that in the subsequent patent infringement litigation, whether it is to stop the infringement or to compensate for the loss.
It is necessary to consider these plots of generic drug companies
.

(2) The result of the administrative ruling falls within the scope of protection of patent rights, but the court finally determined that it does not fall within the scope of protection of patent rights
.
In this case, generic drugs can of course be put on the market for production and sales, but who should make up for the loss of the delayed listing to the generic drug companies?

Therefore, regarding the provision that administrative rulings do not need to be finalized, the author speculates that it may be similar to the invalidity of patents, and the proportion of invalidation decisions in the courts is actually very low; judging whether it falls within the scope of patent protection is the same as patent invalidation.
There are inherent advantages at the level of patent law, and the error rate should be low
.
This analysis is of course only a speculation of the author
.

In short, as a brand-new legal system in China, the drug patent linkage system will inevitably encounter problems of one kind or another in practice in the future.
This is all reasonable
.
Just like the Hatch-Waxman Act in the United States, although it was established in 1984, the FDA only approved three patent challenges from 1993 to 1998
.
Through the 1998 and 2003 amendments, US drug patent challenges began to increase year by year, and the frequency of challenges became higher and higher, and the proportion of successful generic drug companies was more obvious [8]
.
Our "Implementation Measures" specifically marked "Trial", so it can be expected that China's drug patent linkage system will continue to be improved in the future, in order to find a real balance between encouraging innovation and drug availability, and ultimately benefiting the general public
.
The future can be expected!

Reference materials:

[1] Relevant policies on encouraging innovation in pharmaceuticals and medical devices to protect the rights and interests of innovators (draft for comments), May 12, 2017

[2] FEDERAL FOOD, DRUG, AND COSMETIC ACT

[3] This piece of information was quoted by Zhihu and Dingxiangyuan forums, but the author and the original source were not available
.

[4] Lu Zhouhuang, Mist and Dilemma: Is it a trend for generic drugs to be marketed during the patent validity period? , China Intellectual Property Magazine, https://mp.
weixin.
qq.
com/s/dbT6Si3DQthK-Vzz2pqeqA

[5] Same as above

[6] FEDERAL FOOD, DRUG, AND COSMETIC ACT

[7] Zhang Yaohong, Some Humble Opinions on Drug Patent Link Regulations in the Amendment to the Patent Law (Draft), Intellectual Property, https://mp.
weixin.
qq.
com/s/V9LsRLtK3nNZQCsXUjUK2w

[8] Meng Bayi, The Commercial Value and Business Strategy of Patent Challenges in American Generic Drugs (1), Yaozhi News, https://news.
yaozh.
com/archive/20339.
html