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The first copy of stone medicine was approved to be sued, and the East Sunshine patent challenge was successful, what is the difference between the two?

 Last Update: 2022-10-25
 Source: Internet
 Author: User

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"Challenging a patent is not that the patent is flawed, but that the challenge itself can be profitable
.
Patent litigation is about profiting from the average opportunity to take advantage of the law; If you have enough chips in your hand and believe that you will always win a few, the inevitable result is: the more you bet, the more you win"
.

—Martin Voet, "Generic Drugs Challenge Patents"

Today, a "war of words" about patent challenges has exploded in the medical circle, involving a "love-hate entanglement" between Shiyao Ouyi and Roche:

On October 11, the generic version of mabaloxavir tablets of Shiyao Ouyi was approved for marketing by the State Food and Drug Administration (approval number: Sinopharm H20223746).

On October 18, Roche, the original research company of mabaloxavir tablets, issued a statement, claiming that the active ingredient is protected
by China invention patent No.
ZL201180056716.
8.

The validity period of the patent will not expire
until September 21, 2031.

Interestingly, another anti-influenza drug company, East Sunshine, issued an announcement today (October 19):

The self-developed fingolimod capsules have been successfully challenged for the first generic patent and have been approved for marketing in
the United States.

The first copy of stone medicine was approved to be sued, and the East Sunshine patent challenge was successful, what is the difference between the two?

Was it imitated only 3 months after approval?

In the statement, Roche Pharma pointed out that Sofuda (the trade name of the original drug mabaloxavir) and its active ingredients are protected
by China invention patent No.
ZL201180056716.
8.

The patent relates to a compound patent, which is valid for stability until its expiration on September 21, 2031
.

Image source: Roche Pharmaceuticals official micro

It is reported that mabaloxavir is a new generation of anti-influenza drugs jointly developed by Shionogi Shionogi of Japan and Roche Pharmaceutical of Switzerland, which was first marketed in Japan in 2018 and approved by the FDA in the same year, which is the first anti-influenza drug with a new mechanism of action in the past 20 years, which is of great significance
.

In April 2021, mabaloxavir was approved for listing in China and was included in medical insurance
in the same year.

However, in July 2021, CDE accepted and publicized the marketing application
of the Class 4 generic drug mabaloxavir tablets submitted by CSPC Ouyi.

Roche Pharmaceutical wrote in a statement full of grievances: "Within three months of the approval of our innovative drug, Ouyi submitted a generic drug marketing application
.
Since then, Roche and Shiyao Ouyi have been involved in a patent dispute
.

Interestingly, in 2021, Liu Yitong initiated an invalidation request
for the patent name "Prodrug of a substituted polycyclic carbamoylpyridone derivative" (patent number: ZL201180056716.
8).

However, the State Intellectual Property Office made a decision to review the invalidation request No.
47328, rejecting the request and maintaining the validity of
the patent right.

This case was listed on the official website
of the Intellectual Property Office as one of the "Top Ten Invalid Cases of Reexamination" last year.

Image source: State Intellectual Property Office

So, since the State Intellectual Property Office has issued a judgment that the ZL201180056716.
8 patent held by Shionoyi continues to be valid, why does Shioyao insist on imitating it and actively apply for approval?

Because, unprofitable is not early
.

Before mabaloxavir, another anti-flu drug was oseltamivir
.

Guangdong Dongguang Pharmaceutical's generic drug Kewei occupies most of the domestic influenza market, once reaching more than 6 billion yuan in revenue
.

Therefore, it is conceivable that stone medicine may want to lay out in advance and create the myth of domestic anti-influenza again!

Speaking of East Sunshine, it has also been involved in a protracted patent dispute with Novartis, the "Fingolimod" case
.
First of all, the result, in this case, East Sunshine successfully challenged the Fingolimod patent and successfully entered the US market
.

Why did East Sunshine succeed in the challenge?

Fingolimod (Chinese trade name: Gerinya) is the world's first orally administered drug for the treatment of multiple sclerosis, jointly developed by Novartis and Mitsubishi Pharmaceutical of Japan, and launched in
the United States in September 2010.

Novartis' fengolimod hydrochloride capsules listed in the United States in 2010 have a specification of 0.
5mg
.
Before the drug was marketed, Novartis had only filed one compound protection patent, US5604229 (patent No.
229), which was filed in 1997 and expired
in 2019.

Figure US5604229 (Patent No.
229)

According to East Sunshine's official website, East Sunshine's imitation of Fingolimod was approved in July 2011 and declared in
China, the United States and the European Union.
In September 2014, he submitted an initial ANDA generic application to the US FDA with a PIV patent statement, and subsequently issued a challenge letter
to the original research company.

In March 2015, Novartis sued HEC Pharm in the New Jersey court for patent infringement on patent No.
229, which was the first patent confrontation
in the "Fingolimod" case.
The lawsuit ended
in September of that year.

In addition to East Sunshine, Novartis and Ezra also had a dispute over patent No
.
229, and in the end, the court ruled to uphold Novartis' patent until 2019.

In the first round, Novartis won
by retaining the core patent.

Novartis then sued East Sunshine, Torrent and other companies under composition patent US8324283 (Patent No.
283), however, the federal court upheld the U.
S.
Patent Trial and Appeal Board (PTAB) ruling that Novartis Patent No.
283 lacked inventive step
.

Finally, at the end of 2017, East Sunshine reconciled
with Novartis.

In the second round, it was a draw
.

Figure US8324283 (Patent No.
283)

In December 2015, Novartis introduced the newly granted US9187405 patent (Patent No.
405).

Around Patent 405, Novartis has engaged in infringement and invalidation disputes
with other generic drug companies, including East Sunshine.

In addition to East Sunshine, several other companies have chosen to settle
.

In the latest ruling, the patent 405 in question was found to be a new purpose patent that expires in 2027 and covers the dosing regimen
of fingolimod.
However, East Sunshine was not satisfied, and lost the lawsuit in the first instance and the second instance.

Finally, on June 22, 2022, the Federal Court overturned the initial decision and ruled that the '405 patent was invalid, and on October 18, the formal decision to invalidate the 405 patent was issued
.

At this point, East Sunshine has become the only manufacturer in the American ANDA lawsuit that challenged the Fingolimod patent and persisted to the final victory!

The third round of patent clashes, the victory of Edom Sunshine is temporarily over!

Figure US9187405 patent (patent No.
405)

The reason why East Sunshine won the final victory is actually quite simple, that is, to survive until the expiration
of the core patent of the original drug.

But this does not mean that passive waiting is enough, it can be seen that Novartis from the beginning of the core patent No.
229, to No.
283, and then to patent No.
405, basically from the opponent can make a trip to make a trip, can survive an opponent is an opponent
.

East Sunshine's insistence allows it to land on the US market in 2022, and companies that choose to settle early may have to wait until the expiration of No.
283 and No.
405 to copy the drug
.
Apparently missed the best imitation period
.

This point is of great reference significance for stone medicine or other generic drug companies, the first is not to do unnecessary struggle on the core patent, and the second is to actively strive for
supplementary patents after the core patent expires.

What is a patent challenge?

It remains to be seen
what the follow-up development of Roche and stone medicine Ouyi will be.

But this matter, bringing the "patent challenge" into the vision of pharmaceutical people, what is the patent challenge? What is its commercial value?

In "Generic Drug Challenge Patent", the patent challenge is explained as follows:

What is a challenge patent? For example: you build a house, you put a lock on the door, and after a while, whoever can open the lock can legally live in it
.

As long as the generic drug can unlock the patent, the documents and data
submitted to the FDA of the patented drug can be used for free.

In fact, by giving the first generic drug (FTF) to try to unlock it for a certain period of time (180 days of exclusivity), the law is encouraging generic drugs to do so
.

However, the golden 180 days is only the sales value
of the first generic drug in 180 days.

Generic drugs are often challenged by high-value, patented drugs, often by pharmaceutical giants
.

These pharmaceutical giants are generally public companies, and their stock prices and market values are huge
.

Every patent lawsuit, every debate outcome, every judgment, and every FDA approval causes stock price fluctuations
.

Therefore, some original drugs may choose to settle rather than sue
even when patent litigation has obvious advantages.
Because they really can't afford to lose the case
.

On the other hand, the difference between the "profit and loss valuation" of patented drugs and the "valuation of market entry rights" of generic drugs is so huge, and generic drugs use the psychological advantage of this value difference to challenge patented drugs
.

brief summary

From the perspective of the "Fingolimod" case, it is advisable to establish and promote key generic drugs 10 years in advance
.

But judging from the "Fingolimod" case, this undoubtedly also plunged Shi Yao Ouyi into a protracted patent dispute
.
To be sure, SIPO is certain that Roche owns the core patent rights of mabaloxavir
.

The fact that generic drugs have been approved by the National Medical Products Administration does not mean that generic drugs
can be produced and sold immediately.
Otherwise, it is direct infringement, after all, East Sunshine can only be listed
after the core patent of Fingolimod expires in 2019.

In nine years, Roche's patent rights will expire, and the probability of these nine years will be a patent war in turn, and the game has just begun
.

Reference sources:

1.
State Medical Products Administration:

1.
State Medical Products Administration: 2.
State Intellectual Property Office:

2.
State Intellectual Property Office: 3.
Guangdong Province Trade Friction Response Comprehensive Service Platform: http://gdfairtrade.
cn/sitecn/aljl/info_1611.
aspx?id=7904

3.
Guangdong Province Trade Friction Response Comprehensive Service Platform: http://gdfairtrade.
cn/sitecn/aljl/info_1611.
aspx?id=7904

4.
East Sunshine official website

4.
East Sunshine official website 5.
Intellectual property https://baijiahao.
baidu.
com/s?id=1737137890695939040&wfr=spider&for=pc

5.
Intellectual property https://baijiahao.
baidu.
com/s?id=1737137890695939040&wfr=spider&for=pc

6.
Meng Bayi: Business Strategies for Patent Challenges in U.
S.
Generic Drugs (Part 4) https://news1.
yaozh.
com/archive/21227.
html

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