Medical network - January 6 for global pharmaceutical companies, hepatitis b drug market in China is one of the most attractive "fat", in the next decade, China will still main hepatitis b is one of the biggest market, the size of the market is expected to nearly $923 million increase from 2014 in 2024 to more than $1.4 billion. To this, a battle began about hepatitis b drug patent protection began.
The number of chronic hepatitis b carriers in China about 34% of the world. GlobalData data according to the research and consulting company, in the next decade, China will still main hepatitis b is one of the biggest market, the size of the market is expected to nearly $923 million increase from 2014 in 2024 to more than $1.4 billion.
But this decade, also is extremely has the potential to be hepatitis b drug profit in China at the end of the golden decade. Statistical data according to the national health development planning commission, China's implementation of the comprehensive prevention and control of viral hepatitis is given priority to with inoculation of strategy has obtained the remarkable result, incidence of hepatitis b report is on the decline, is expected to gradually into the low hepatitis b endemic countries ever since.
Staggered under various environment, multinational drug companies, domestic generics are more important than any time before the ten years of market competition, and is, therefore, a race began on hepatitis b drug patent protection.
On April 26, 2016, the Beijing municipal higher people's court decided the case no. 1448, gilead sciences co., LTD. (GileadSciences) rejection of the appeal, that the patent (China patent no. : 200710196265.3) containing specific ratio of tenofovir two pyrazole cefuroxime ester of fumaric acid salt, the patent is invalid. And this is only in recent years, the hepatitis b drug patents for a microcosm.
A tight domestic generics
Since the late 1990 s, including glaxosmithkline, bristol-myers squibb, novartis and other multinational companies have targeted the Chinese market, import immediately into the liver disease drugs, and quickly occupied the market dominant position.
But in recent years, as the domestically produced generic drugs examination and approval, listed in succession, multinational drug companies are, though, including glaxosmithkline, imported hepatitis b drug suppliers have reduce the price, but domestically produced generic drugs due to no longer requires a lot of research and development investment, low price still runs away once completely belongs to hepatitis b drugs imported beer.
Hepatitis b in domestic market, companies in jiangsu zhengda shine is the most outstanding in the generic drugs. In 2014, zhengda shine with entecavir generic drugs, such as to achieve the annual sales of 10 billion yuan, including entecavir sales accounted for 20%. Zhengda shine, make sales of imports of entecavir bristol-myers squibb overwhelmed in partial provinces and cities in nearly two years of the tender, losing.
For a generic version of domestic enterprises, for so many years waiting for is to import drug patents expire time node. "A lot of foreign drugs, as long as they applied for clinical abroad, we start in domestic synchronous development, to submit for approval, then the patent expired in the first place to the market. If such as patents expire do is too late to start." Zhengda sunny pharmaceutical group co., LTD., vice President of tian zhoushan revealed after the first financial journalist.
Patent expired, let domestic generics in nearly two years of hepatitis b market feeling, also is so, the Chinese and foreign drug companies once again played a "patent protection for the" idea.
The battle of patent unfinished
On April 26, 2016, the Beijing municipal higher people's court decided the case no. 1448, gilead sciences co., LTD. (GileadSciences) rejection of the appeal, that the patent (China patent no. : 200710196265.3) containing specific ratio of tenofovir two pyrazole cefuroxime ester of fumaric acid salt, the patent is invalid.
The antiviral drug tenofovir chemical name full name is fumaric acid tenofovir two pyrazole cefuroxime ester, in China, one of the indications for chronic hepatitis b.
Gilead sciences, from California, its product tenofovir hand three patents in China. Are compounds patent (patent no. : 97197460.8), patent (patent no. : 98807435.4) and compound salt salt specific scale patent (patent no. : 200710196265.3). And the trial, according to the last item on the patent is invalid judgment, the first two entanglements of patent protection is still to be solved. This also means that tenofovir patent lawsuits in China haven't finished.
This is not the only in recent years in a lawsuit about hepatitis b drug patent protection.
In 2010, the board copy entecavir, the weather is fine, bristol-myers squibb, the imitation by tort litigation. But in 2015, bristol-myers squibb, generic sued zhengda shine its entecavir was overruled by Beijing high court, the final sentences of bristol-myers squibb entecavir patent is invalid in China, zhengda termination to continue to sell the weather is fine.
Another generics companies in Shanghai Mr Sharp, targeting the generic tenofovir. In a 2011 interview, Mr Sharp Peng Zhien says the patent of a major defect, chairman of the company, do not belong to the major innovation. Peng Zhien hope, the patent in China can be cancelled. Was on May 13, the sharp the company submitted to the state intellectual property office of the patent reexamination board the "tenofovir invalid patent applied for" the evidence, the state intellectual property office of the accepted. But that year in April, Gillette company for patent infringement, has put the sharp company to court. The two sides remain impenetrable.
Why for
According to the Chinese center for disease control and prevention of statistics, at present China has about 90 million hepatitis b carriers, including 28 million patients with chronic hepatitis b, and 7.6 million hepatitis c infections.
According to the world health organization definition of hepatitis b infection: more than 8% of the country or region is defined as the high epidemic areas; Hepatitis b infection rate is less than 2% of the country or region is defined as a low epidemic areas; The hepatitis b infection rate was 2% ~ 8% of the country or region is defined as the epidemic areas.
1992 years ago, our country belongs to high hepatitis b endemic areas, hepatitis b surface antigen positive rate is as high as 9.75%, every year because of hepatitis b virus infection related diseases and deaths, about 270000 people.
China's ministry of health in 1992 hepatitis b vaccine immunization management, for all the neonatal hepatitis b vaccination, but vaccines and immunization fee should be paid by the parents, The hepatitis b vaccine in 2002 formally incorporated into epi, free hepatitis b vaccination to all newborns, but pay vaccination fee; All free on June 1, 2005.
Inhibition of vaccination of hepatitis b infection in a few years has obtained the remarkable effect.
National hepatitis b serological survey in 2006 showed that the hepatitis b virus infection rate fell to 7.18% in China, children under the age of 15 hepatitis b infection rate decreased obviously. In 2014, our country again for 1 ~ 29 people hepatitis b serum epidemiological investigation. 1 ~ 4 years old children of the nation's hepatitis b surface antigen prevalence rate has fallen to 0.32%, compared with 0.96% in 2006 fell 66%, 5 ~ 14 years old adolescents hepatitis b surface antigen prevalence rate dropped to 0.94%, down 61% compared with 2006.
This means that these children after ten years in reproductive age, the maternal and infant hepatitis b block will no longer become the main problem of hepatitis b prevention. And, as long as adhere to the promotion of the hepatitis b vaccine inoculation, again lead several decades, our country will become low hepatitis b endemic countries.
Under such hepatitis b market judgment, patent dispute is particularly important: multinational drug companies hope to achieve more medicines within the patent protection period value, while domestic generics companies hope can enter the market faster, pie before dividends to disappear.
Letting drug firms to tension from hepatitis b patients based on China's future will not only reduced the judgment. Zhongshan hospital affiliated to fudan university liver oncology aoj constant told reporters, the first finance and economics, director of the existing drugs for the treatment of hepatitis b on the market at present is not completely cure hepatitis b, need "duration", but a completely new drugs to cure hepatitis b has been in clinical stage, "2 ~ 3 years is expected to entered the market." And at that time, old and new drugs will be further compressed alternately existing drugs market share. |
