The new patent law is officially implemented! The patent protection period of innovative drugs can be extended up to 14 years. How to deal with the original research drugs? How will generic drug companies challenge?

On June 1, 2020, the newly revised "Patent Law of the People's Republic of China" was officially implemented.

A week ago, on May 24, the State Intellectual Property Office also issued the "Interim Measures for the Processing of Related Examinations Regarding the Implementation of the Revised Patent Law" "

The "Patent Law" and its "supporting facilities" have been implemented almost simultaneously.

Among them, Articles 42 and 76, which are closely related to the pharmaceutical industry, namely the "New Drug Patent Term Compensation System" and "Drug Patent Link System" have attracted the attention of the industry

01 Compensation for the term of patent right

Article 42 of Chapter 5 of the New Patent Law proposes for the first time a new drug patent right period compensation system from the legislative level.

The original text is as follows:

Where an invention patent has been granted four years from the date of application for a patent for invention and three years have passed since the date of the request for substantive examination, the patent administration department of the State Council shall, at the request of the patentee, deal with the unreasonable delay in the process of granting the patent Compensation for the duration of the patent right shall be granted, except for unreasonable delay caused by the applicant
.

In order to compensate for the time spent in the review and approval of new drugs, the patent administration department of the State Council shall, at the request of the patentee, grant compensation for the duration of the patent right for the new drug-related invention patents that have been approved for marketing in China
.

The compensation period shall not exceed five years, and the total effective patent right period after the new drug is approved for marketing shall not exceed 14 years

In fact, the two clauses of Article 42 are aimed at two different compensation situations.

The former refers to “protection and compensation related to patent examination”, and the latter refers to “patent compensation related to new drug review”

For the former, the scope of application of this clause is not limited to medicines, but all industries.
For patents that are more complicated in technology and take up a lot of examination time, the examination will have a greater impact on the interests of patent applicants, starting from the date of the invention patent application.
At the end of four years, and three years from the date of filing for the implementation of the examination, and then obtain a Chinese patent authorization, the Patent Administration Department of the State Council will affirm the patentee’s request and give compensation
.

But if it is due to unreasonable delays, it will not be compensated

The second paragraph is clearly stated that "the review and approval of new drugs on the market to compensate for the time it takes"
.

As we all know, the research and development of new drugs is a arduous and long process.

Therefore, the patentee can apply for compensation for the patent right period, and the compensation period does not exceed five years, and the total effective patent right period after the new drug is approved for marketing does not exceed 14 years
.

The above-mentioned experts pointed out that “the time when the drug is approved for marketing is mainly used, minus the day of the patent application date, and then subtract five years to obtain the value.

But in fact, the expert also revealed that there are still disputes over the interim measures for the implementation of the new revised patent law.
For example, the time limit given in the interim measures issued on May 24 is "from the date when the new drug marketing authorization request is approved.
" Within three months, submit a request for compensation for the duration of the patent right in paper form"
.

This clause means that the patent law will be implemented on June 1.
New drugs approved from March 1 can enjoy this compensation period, and those approved before March 1 will not be entitled to this compensation period
.

Some legal experts pointed out that “if new drugs that have been approved for marketing in China before the patent law amendment takes effect are excluded from the scope of application of the drug patent protection period compensation system, and different applications for patent protection will be granted based on different approval times.
The stipulation of the window period for time limit compensation may be unfair to the relevant right holders
.
"

However, the above-mentioned intellectual property office experts also pointed out that the implementation rules are still interim measures and will still be revised based on industry recommendations
.

02 Drug Patent Link System

In addition to the contradiction in the patent term of the new drug listing, another contradiction in the pharmaceutical industry that cannot be ignored is that after the new drug is listed, the disputes between the original research drug company and the generic drug company are endless and continuous
.

The aforementioned experts pointed out that "the core of this contradiction lies in the fact that there is no effective balance mechanism between the drug examination center and the patent office, including the court
.
"

Therefore, the new patent law makes provisions for tripartite departments.
The original text of Article 76 of Chapter VII is as follows:

In the process of drug marketing review and approval, if a dispute arises between the drug marketing authorization applicant and the relevant patentee or interested party due to the patent right of the drug applied for registration, the relevant party can sue the people’s court and request the drug to be registered.
A judgment is made on whether the relevant technical solutions fall within the scope of protection of the patent rights of others' drugs
.
The drug regulatory department of the State Council may, within the prescribed time limit, make a decision on whether to suspend the approval of the listing of relevant drugs in accordance with the effective judgment of the people's court
.
Applicants for drug marketing authorization and relevant patentees or interested parties may also request administrative rulings from the Patent Administration Department of the State Council for disputes over patent rights related to the drugs for which registration is applied for
.

The drug regulatory department of the State Council, in conjunction with the patent administrative department of the State Council, shall formulate specific measures for the connection between the approval of drug marketing authorization and the resolution of patent disputes in the drug marketing authorization application stage, which shall be implemented after the approval of the State Council
.

The above clause means that disputes between the original research drug company and the generic drug company can be brought to the people's court for litigation, or the patent administration department of the State Council can request an administrative ruling
.
It is worth noting that this is actually moving the resolution of drug patent disputes before the market application.
This clause is conducive to "not only not damaging the innovation enthusiasm of the original research drug, but also encouraging the introduction of generic drugs as soon as possible, while reducing prices
.
Relevant law professors explained that “every country has a way to approve the listing of generic drugs.
Internationally, once a patented drug expires, it will face a patent cliff and the price of the drug will drop significantly
.
There is a great need for a system to balance the interests of all parties
.
"

In fact, in response to the disputes between the original research drug and the generic drug and the listing of the first generic drug, before the passage of the new patent law, the State Food and Drug Administration issued the "Implementation Measures for the Early Resolution of Drug Patent Disputes (Trial)" for comments.
This draft of the opinion proposes a "waiting period" for the first generic drug company to apply for a challenge patent during the approval of the Food and Drug Administration and a "market exclusivity period" for the first generic drug
.

Among them, Article 8 states that “[Waiting Period] From the date of filing or accepting the case by the People’s Court or the Patent Administration Department of the State Council, the drug regulatory department of the State Council shall set a 9-month waiting period for the registration application of chemical generic drugs.
The review agency does not stop the technical review
.
"

Article 11 proposes that “[Encouragement Policy] For the first chemical generic drug that successfully challenged the patent and was approved for marketing, a period of market exclusivity shall be granted.
The drug regulatory department of the State Council shall not allow the drug to be approved within 12 months from the date of approval.
Re-approve the listing of generic drugs of the same variety, and the period of market exclusivity does not exceed the patent right period of the drug being challenged
.
During the period of market exclusivity, the national drug review agency will not stop the technical review
.
Registration applications for chemical generic drugs that have passed the technical review are waiting for the market 20 working days before the expiration of the exclusivity period, the relevant chemical generic drug application will be transferred to the administrative examination and approval link
.
"

The draft and the newly revised patent law are generally considered by the industry to protect the patents of original research drugs and encourage the listing of generic drugs.
The above-mentioned law professor believes that “the core of the patent linkage system is that if generic drugs succeed in challenging patents, they can obtain The market exclusivity period is equivalent to a patented drug, and its pricing can reach about 80% of the price of the patented drug
.
After the market exclusivity period, other generic drugs can be launched in large quantities, and the price will drop all at once.
The ultimate goal is hope Generic drugs will be listed as soon as possible
.
"

In addition, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" also proposed a clearer mechanism for early resolution of drug patent disputes, including the establishment of a patent registration platform for listed drugs in China; It is clearly defined and so on
.

03Impact and response strategy

In the industry conference held not long ago, some experts in drug review summarized the impact of the revision of the patent law on the pharmaceutical industry, which are mainly divided into the following points:

First, it will create a new pattern of patent protection and litigation of Chinese medicines, and legal workers from innovative drugs, generic drug companies or related IP will eagerly show their talents;

The second is to encourage drug R&D and innovation, and effectively improve the public's access to innovative drugs;

The third is to extend the protection period of pharmaceutical patents to protect the investment income of pharmaceutical companies.
The development of new drugs requires venture capital, so that it has an adequate launch mechanism;

The fourth is to implement drug patent links to effectively protect patentees;

Fifth, the early resolution of drug patent disputes effectively restrained the listing of generic drugs from forced imitation;

Sixth, reduce the risk of patent infringement of generic drugs and promote the high-quality development of our generic drugs.
If patents can be bypassed or better improvements can be made, such generic drugs must be more advanced and more effective;

Seven is to strengthen technology to eliminate the fittest and promote the transformation and upgrading of the pharmaceutical industry
.

Eighth, in order to obtain an exclusive period in the generic drug market, generic drug companies will actively challenge new drug patents;

Ninth, standardizing drug patent examination standards and improving quality and stability can effectively promote the healthy development of pharmaceutical innovation
.

Regarding how companies respond, the expert emphasized that whether it is an original research drug company or a generic drug company, the time limit stipulated in our patent law should be set and pay close attention to the patent information of the other party
.