The new patent law is officially implemented! Innovative drug patent protection period can be extended to 14 years

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

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

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.

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 for invention 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.

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

For the former, the scope of application of this clause is not limited to medicines, but all industries.

The second paragraph clearly states "to compensate for the time taken for the approval of new drugs on the market.

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.

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.

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.

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 provides for tripartite departments.

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.

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 approval and the resolution of patent disputes at the stage of drug marketing approval application, 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 sued in the people's court, 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 puts forward the “waiting period” for the first generic drug company to apply for a challenge patent when it is approved by the Food and Drug Administration and the “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 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 pending 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; Make clear regulations, etc.

03 Impact and Coping Strategies

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 survive 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.