Nearly 20 original research drugs have encountered patent challenges!

The newly revised "Patent Law of the People's Republic of China" came into effect on June 1, and will give innovative drug and generic drug companies two-way opportunities and challenges

With the gradual advancement of domestic generic drug consistency evaluation and centralized drug procurement policies, the competitive pressure of generic drug companies has increased sharply
.

For most domestic pharmaceutical companies whose main business is the development of generic drugs, challenging the patents of original research drugs by multinational pharmaceutical companies can enable them to bring their approved or under-development generic drugs to the market earlier than expected

The author's preliminary search on the patent invalidation decision of the State Intellectual Property Office found that the number of invalidation decision numbers published by the State Intellectual Property Office in 2020 is basically the same as the previous two years (2018-2019) (29 and 27 respectively)
.

It is worth noting that in the past two years (2019-2020) of invalidation decisions, more than half of all invalidation decisions (59% and 54%, respectively)

Of course, the successful patent invalidation challenge has also prompted some generic drugs to go on the market in advance, including blockbuster drugs, and some drugs for rare diseases (such as infantile hemangioma, idiopathic pulmonary fibrosis)
.

Sorafenib

Sorafenib is a targeted liver cancer drug developed by Bayer and was approved to enter China in 2006
.

Although the patent for sorafenib compound (ZL00802685.

8) expired in 2020, and the crystal form patent (ZL200580040775.
0) was declared invalid by the national intellectual property rights in the request for invalidation in Hangzhou, China and East China in 2018, the drug’s The preparation patent (ZL200680007187.
1) originally had to expire in 2026

At present, Chongqing Yaoyou and other two companies have obtained two approval document numbers for generic drugs of sorafenib tosylate tablets in China, and there are also four approval document numbers for the application of generic drugs for the market
.

Rivaroxaban

Rivaroxaban is a blockbuster anticoagulant drug developed by Bayer and was approved to enter China in 2009
.

The original compound patent ZL00818966.

8 expired on December 11, 2020.

At present, 14 domestic companies, including Chia Tai Tianqing Pharmaceutical, have obtained 19 rivaroxaban generic drug approval document numbers, and the approval number of the generic drug listing application for this variety has also reached 41
.

Tenofovir Propofol Fumarate

  

  Tenofovir propofol fumarate is a blockbuster hepatitis B drug developed by Gilead, which was approved for import in China in 2018
.

  

  The original compound preparation method patent ZL200410097845.
3 was challenged by the patent invalidation of Fujian Guangshengtang Pharmaceutical Industry, and the State Intellectual Property Office made a partial invalidation decision in January 2020
.

However, tenofovir generics of propofol fumarate are also restricted by other patents of the original research, such as the authorized compound patent (ZL01813161.

  

  At present, 6 companies including Chengdu Better Pharmaceuticals have obtained 5 approval numbers for propofol tenofovir fumarate tablets, and the number of application acceptance numbers for generic drugs for this variety has also reached 20
.

In the next few years, the probability of the original research patent being invalidated is extremely high

    

Ibrutinib

  

  Ibrutinib is an oncology drug jointly developed by Pharmacyclics and Johnson & Johnson's Janssen Company.
It was approved to enter China in 2018
.

  

  The original core compound patents ZL201210217024.
3 and ZL200680056438.
5 of the drug will expire in 2026.
Nanjing Huaxun Intellectual Property Consulting Co.
, Ltd.
failed to challenge its patent invalidation.
The State Intellectual Property Office made a decision on the above two patents in June 2020.
Maintain effective decisions
.

  

  At present, there is currently no generic drug of Ibrutinib capsules on the market in China, and Simcere has submitted an application for the generic drug of this category
.

    

Lurasidone

  

  Lurasidone is a schizophrenia drug developed by Japan's Sumitomo Pharmaceuticals and was approved for import in China in 2018
.

  

  Although the original compound patents are not protected in China, two formulation patents (ZL201010564784.
2, ZL200680018223.
4) will be protected until 2026.
After an individual request for invalidation, they were announced by the State Intellectual Property Office in November 2020.
All are invalid
.

  

  At present, there is no generic drug for lurasidone hydrochloride tablets on the market in China, and Zhejiang Hisun Pharmaceutical and other companies have submitted applications for the generic drug for this variety
.

    

Propranolol Oral Solution

  

  Propranolol oral solution is a typical "old drug with new use".
It was developed by the French pharmaceutical manufacturer Pierre Fabre Dermatologie Laboratories to treat infantile hemangioma.
Imported from China
.

The critical-use patent (ZL200880111892.

  

  At present, there is no generic drug for propranolol hydrochloride oral solution in the domestic market, and two companies including Yabao Pharmaceutical have submitted applications for the generic drug for the market
.

    

other

  

  The patents related to original research drugs such as Engligliflozin, nintedanib, vothiaxetine hydrobromide, and sofosbuvir have also encountered invalidation challenges
.

  

  At the same time, with the improvement of China's pharmaceutical companies' innovation capabilities, more and more domestically-made innovative drugs have also been approved for listing in China
.

As the original domestically developed new drug, it has also begun to become a target for competitors to challenge patents
.
According to the ten major annual patent reexamination invalidation cases announced by the State Intellectual Property Office from 2017 to 2020, 2 to 3 drug patent cases are involved each year.
Among them, CSPC's domestically produced innovative drug butylphthalide encountered the challenge of patent invalidation last year.

.

  

statement

From the perspective of drug patent protection, the original research company often lays out the patent network of drugs through compounds, salt forms, crystal forms, synthetic routes, preparations, uses, etc.
, and legal proceedings may be involved after the patent invalidation decision
.
This article only provides limited information that has been disclosed or as of press time.
Please do not use this as a basis for registration and declaration of non-infringement of intellectual property rights during the development of generic drugs
.