The patent link system is on the string, under the trend of centralized procurement, will the domestic first generic drug market monopolize it?

A few days ago, according to external media reports, Baxalta, a subsidiary of Takeda, has reached a settlement with Bayer over a patent dispute over hemophilia therapy
.

The case can be traced back to December 2016 when Bayer filed a lawsuit against Baxalta (at the time Baxalta was a subsidiary of Shire, and later Shire was acquired by Takeda).
Bayer argued that Baxalta's Adynovate violated its recombinant factor VIII for hemophilia Technology patents
.
The patent infringement comes from a license agreement between Baxalta and Nektar Therapeutics, and Bayer collaborated with Nektar in 2000 for hemophilia treatment

In 2019, the court ordered Takeda to pay Bayer US$155 million in compensation for patent infringement, after which the fine was increased by US$18 million to US$173 million

At this point, the five-year patent dispute case between the two companies has come to an end

It is reported that many international pharmaceutical companies usually use patent thresholds to protect self-developed products
.
A good patent layout can achieve the effect of prolonging the life cycle of medicines

On the domestic side, in the past, most domestic pharmaceutical companies focused on generic drugs, and their awareness of intellectual property rights was relatively weak compared to the international community

It is worth mentioning that on the evening of May 18, CDE issued a notice on the public testing of the patent information registration platform related to the early resolution of drug patent disputes, and officially launched the online test of the "China Listed Drug Patent Information Registration Platform"

The content of the notice mentioned that the marketing authorization holders of drugs that have been marketed in China are invited to actively participate in the registration and testing of relevant drug patent information
.
In order to facilitate work connection, after the implementation of the early resolution mechanism for drug patent disputes, relevant patent information that has been registered as required during the test period will be disclosed after confirmation by the drug marketing license holder, as chemical generic drugs, traditional Chinese medicines with the same name, and biosimilars Information on the basis of the patent statement made by the drug applicant

At present, some specific patent requirements are not reflected in the statement on the CDE official website

From the perspective of the Orange Book patent links in the United States, the US patent link system has two main lines:

One is that when a generic drug manufacturer submits an abbreviated new drug application (ANDA), it initiates a patent challenge to the original original drug.
The first generic drug manufacturer that succeeds in the challenge will receive a 180-day market-exclusive reward;

Second, the original research drug company filed an infringement lawsuit against the generic drug manufacturer.
Regardless of the outcome of the lawsuit, the approval for the marketing of the generic drug will be postponed for 30 months.
The original drug company can continue to enjoy this period of time known as the "approval waiting period" Market monopoly
.

These two main lines are based on the patent information disclosed in the Orange Book.
It can be seen that the patent link system is more of a judge, and it is by no means simply inclined to protect one party
.

       When moving the patent linkage system to China, the "quantity procurement" system with Chinese characteristics must also be mentioned
.
Under the centralized procurement system, China did not pay as much attention to the first imitation as the United States
.
This is because during the period from the first imitation approval to market development, other generic drug companies will receive the approval certificate, and once the number of companies reaches the standard, it may automatically trigger centralized procurement.
The volume of generic drugs is slower and there is no market exclusivity period.
The United States is so attractive
.

       The introduction of the patent linkage system will benefit a large number of innovative pharmaceutical companies and some characteristic API companies in the future
.
For generic drug companies, it will make them more passive, and companies need to adjust relevant strategies to deal with them
.

       Reference material: Knowing the column "Medical Rhapsody"