Howson "joined" CSPC successfully "sniped" Pfizer's sunitinib patent and was invalidated!

On April 8, 2021, the Reexamination and Invalidation Division of the State Intellectual Property Office announced the invalidation of Pfizer’s sunitinib patent.

The 02815892.

01 The only approved original research drug patent is challenged

"Sunitinib" (trade name: Sutent) was approved in the United States and Europe in 2006 and is widely used in the first-line treatment of kidney cancer.

The patent of "Sunitinib" in my country expires in 2021 at the earliest.

Patent No.

CSPC Ouyi and Jiangsu Haosen Pharmaceutical Group Co.

After passing the formal examination, the State Intellectual Property Office accepted the invalidation request of CSPC Ouyi and Jiangsu Haosen Pharmaceutical Group Co.

Famathias Earp John submitted a statement of opinions in response to the above-mentioned invalidation request.

The collegiate panel issued an oral hearing notice to both parties on August 28, 2020, and the oral hearing is scheduled to be held on September 21, 2020.

The collegiate panel believes that when judging creativity, it must first compare the claimed technical solution with the closest prior art, find out the distinguishing features of the two, determine the technical problem actually solved by the technical solution, and then examine the prior art Whether there is an enlightenment in introducing the distinguishing feature into the closest prior art to solve the above technical problem, if there is such an enlightenment in the prior art, the claim is not creative.

Based on the above decision points, the collegiate panel made an examination decision on the invalidity of the patent for invention No.

02 Pharmaceutical companies join forces to sniper to seize the first imitation opportunity

This is not the first time that CSPC Ouyi has challenged Pfizer's sunitinib patent.

CSPC Ouyi filed a request for invalidation of the patent for the patent titled "pyrrole-substituted 2-indolinone protein kinase inhibitor" (patent number: ZL01807269.

The application date of the patent ZL01807269.

In 2020, the State Food and Drug Administration and the State Intellectual Property Office issued the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Draft for Comment)".

In February 2021, the State Intellectual Property Office issued the "Administrative Adjudication Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Draft for Comment)" which did not mention the encouragement of the first successful patent challenge and the first approved chemical generic drug applicant Matters.

The policy benefits of the 12-month exclusive period for the first imitation were not released.
CSPC Ouyi and Jiangsu Haosen Pharmaceutical Group succeeded in the patent challenge, but they could not enjoy the benefits of the exclusive period for the first imitation.
Of course, there is no policy to clarify whether such several joint patent challenges will all enjoy the exclusive period of first imitation at the same time.

In fact, after CSPC Ouyi applied for the challenge patent, in December 2019, the sunitinib malate capsule (12.
5mg) of CSPC Ouyi Pharmaceutical was launched.
In May 2020, Jiangsu Haosen Pharmaceutical Co.
, Ltd.
was launched in the same dosage form and specification.
In March 2021, Hainan Kelun will also be on the market with the same dosage form and specification.
Before the patent challenge is successful, CSPC Ouyi Pharmaceutical and Jiangsu Haosen Pharmaceutical may have patent risks in their marketing.
After the patent challenge is successful, CSPC Ouyi Pharmaceutical and Jiangsu Haosen Pharmaceutical will have no risk in marketing, but they have to face generic drugs from other manufacturers that are about to be approved, such as Chia Tai Tianqing and Qilu.

This is not the first time that my country's pharmaceutical companies have jointly attacked the patented products of multinational pharmaceutical companies.
In August 2020, Jiangsu Hausen Pharmaceutical Group Co.
, Ltd.
, Sichuan Kelun Pharmaceutical Research Institute Co.
, Ltd.
, Jiangsu Wanbang Biochemical Pharmaceutical Group Co.
, Ltd.
, Hangzhou Sino-American Huadong Pharmaceutical Co.
, Ltd.
initiated a patent invalidation application for the same patent (patent number: CN201310414119.
9) for the patent of empagliflozin compound, removing the "patent barrier" for the listing of generic drugs.
In 2020, with the exception of Hangzhou Sino-US Huadong Pharmaceutical Company, the other four companies' Enpagliflozin will be listed.

03 Patent invalidation, "unlocking" centralized procurement of generic drugs

Since the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Draft for Comment)" mentioned that the first successful patent challenge and the first approved chemical generic drug applicant to give incentives, the current patent challenge basically invalidates the request People are all pharmaceutical companies.

Pharmaceutical companies are also increasingly actively launching patent challenge litigation.

Alogliptin benzoate tablets, a dipeptidyl peptidase-IV (DPP-4) inhibitor, is mainly used to treat type 2 diabetes.
It was first developed by Takeda Pharmaceutical Co.
, Ltd.
, and was launched in Japan in 2010.
It was approved to be listed in China in 2009, and the product name is "Nisina".

In September 2018, Yabao Pharmaceutical Group Co.
, Ltd.
(hereinafter referred to as the petitioner) filed an invalidation request with the State Intellectual Property Office for the patentee’s ZL201210332271.
8, ZL201210399309.
3 and ZL200680042417.
8 invention patents.
After trial, the State Intellectual Property Office issued an examination decision No.
38950 in February 2019 to maintain the validity of the patent right of ZL200680042417.
8; made an examination decision No.
38951 announcing the partial invalidity of the patent right of ZL201210332271.
8; and made an examination No.
38952 It was decided to declare all the patent rights of ZL201210399309.
3 invalid.
Along with this case, there was also a request for invalidation of invention patents against ZL201210399309.
3 and ZL201210332271.
8.

The patent right of ZL200680042417.
8 is valid, the application date is September 2006, and the patent expiration is expected to be 2026.
However, the National Bureau still approved the listing of Alogliptin Benzoate Tablets from Yabao Pharmaceutical in November 2019.
In 2020, Alogliptin benzoate tablets from Jiangsu Zhongtian, Jiangsu Deyuan, Jiangsu Nuotai Aosino, Sinopharm Group Guorui, Hunan Qianjin Xiangjiang and Guangdong Dongyang Sunshine will all be approved for listing.
However, the fourth and fifth batches of national centralized purchases have not included alogliptin benzoate tablets on the list for the time being.

Since the purchase of drugs in quantities is directly related to the competition between the original research drugs and generic drugs, the patent problem has become an important issue that cannot be avoided in the procurement of drugs in quantities.
The industry’s most concern is whether generic drugs can participate in mass procurement when the patents of the original research drugs are declared invalid and are in the process of patent administrative litigation.
If the future patent administrative litigation revokes the review decision declaring the patent right to be invalid, and the State Intellectual Property Office renews the review decision to maintain the patent right, how can the interests of the patentee of the original research drug be protected?

This actually relates to whether the patent invalidation procedure is similar to a quasi-judicial procedure at the trial level or is it an administrative act of administrative adjudication?

Similar to a quasi-judicial procedure at the trial level, a patent invalidation request review decision is similar to a ruling at the first trial level, and the effect is to be determined after it is made, and it is necessary to wait for the conclusion of the subsequent judicial process.
So if the patent right of the original research drug is declared invalid and is in the process of patent administrative litigation, because the review decision of the request for invalidation has not yet taken effect, the patent right of the original research drug is still in a legally valid state, and generic drugs cannot participate in mass purchases.

If the examination decision of the request for patent invalidation is an administrative ruling type of administrative act, the administrative act shall have deterministic, definitive, binding and enforceable power from the day it is made, and the administrative act shall be presumed to be legal and effective before it is revoked by the final administrative judgment.
After the review decision of the invalidation request is made, an external announcement shall be made, and it shall have legal effect from the date of announcement, so generic drugs can participate in mass purchases.

As mentioned above, the start date of the fourth batch of centralized procurement with a large amount of Enpagliflozin is still the period within which the original patentee can still sue after the judgment of invalidation of the patent is announced.
Judging from the state’s initiation of centralized procurement, the patent invalidation request review decision is more likely to be an administrative ruling, so in the future, even if the State Intellectual Property Office makes a new review decision to maintain the validity of the patent right, the review decision of the According to the law, even if it is revoked in the patent administrative litigation, the patentee of the original research drug can only watch the product being purchased in a centralized manner, and cannot obtain compensation.
However, in this case, it may not even be possible to stop the products that are already being collected.

In the fourth batch of centralized procurement, ticagrelor is the product for which centralized procurement has been carried out before the patent has expired.
The most important thing about ticagrelor is the patent ZL 99815926.
3 (expired on December 2, 2019) which protects the compound structure and the patent ZL01810582.
3 (mainly protects the crystal form I, crystal form III and crystal form IV, 2021 Expires on May 31, 2021) and its division ZL200610002509.
5 (protected crystal form II, expires on May 31, 2021).

The patent ZL99815926.
3 had twists and turns, and it was invalidated by Xinlitai, but was revoked after AZ appealed.
Although the patent ZL 99815926.
3 has expired on December 2, 2019, the patent ZL01810582.
3 (mainly protecting crystal form I, crystal form III and crystal form IV, expires on May 31, 2021) and Its division ZL200610002509.
5 (protected crystal form II, expires on May 31, 2021).

In general, the draft of the first generic drug exclusivity regulations has allowed companies to start trying to challenge patent invalidation.
However, because there was no official draft for the first generic drug exclusivity period, after the company's patent was invalidated, other competing products were successively approved.
At present, patent invalidation is an administrative act of administrative adjudication, and generic drugs can be purchased in a centralized manner immediately after the patent is invalidated.