China's State Intellectual Property Office (SIPO) has declared the entire patent of Gilead Sciences (US)'s HIV/AIDS and hepatitis B drug Viread (tenofovir) invalid, after a challenge brought by a local Chinese firm.
IHS Global Insight perspective | |
Significance | China's State Intellectual Property Office (SIPO) has cancelled the entire patent relating to Gilead Sciences (US)'s Viread (tenofovir), in a landmark ruling following last year's law change to permit compulsory licensing in China. |
Implications | The hepatitis B and HIV/AIDS treatment was declared invalid on grounds of novelty following a challenge from Shanghai-based Aurisco. |
Outlook | Gilead Sciences states that it is still considering whether to appeal SIPO's decision; there is precedent for SIPO's judgments to be overturned on appeal, as previously occurred in relation to the patent of Pfizer (US)'s Viagra (sildenafil). |
The Patent Reexamination Board of China's State Intellectual Property Office (SIPO) has declared invalid the entire patent of US firm Gilead Sciences' hepatitis B and AIDS drug Viread (tenofovir), as reported by Daily Economic News on 18 July.
The challenge was brought by Chinese company Aurisco, which pointed to deficiencies in the drug's patent on novelty grounds. The firm argued that the core patent for tenofovir has been in the public domain since 1985, when the active ingredient was discovered in what is now the Czech Republic, while other patents are for auxiliary ingredients to aid absorption. Viread was first approved as an imported drug by the China Food and Drug Administration (CFDA) in 2008, with patent protection originally scheduled to continue until 2017.
Outlook and implications
SIPO last year announced a change to China's intellectual property (IP) laws permitting compulsory licensing, when sources indicated Viread as one of the government's targets (see China: 12 June 2012: Change to China's IP Law Facilitates Issuing of Compulsory Licences). Gilead Sciences reportedly responded to the threat by offering substantial donations of Viread if purchasing levels were maintained, according to Médecins sans Frontières (source: Reuters). China had been one bright spot for Gilead Sciences among emerging markets, after Viread's patent was rejected in India and Brazil, and is the subject of a compulsory licence in Indonesia. In 2011 Gilead made Viread and other anti-retrovirals available to developing economies through the Medicines Patent Pool, but China was not a party to this arrangement (see United States - India: 12 July 2011: Gilead Expands Global HIV/AIDS Access Programme with Four Licensing Deals).
The Chinese government's desire to make the nucleotide analogue reverse transcriptase inhibitor more readily available reflects the heavy burden of both diseases: China has over 30 million chronic hepatitis B sufferers, one-third of the world total (source: World Health Organization), with treatment costs amounting to over CNY100 billion annually (source: Daily Economic News). Incidence of HIV/AIDS is also on the increase, causing 11,575 deaths in China during 2012, a worrying 24.89% year-on-year (y/y) increase to become the number one cause of death among the Ministry of Health's "notifiable diseases". The Global Fund to Fight AIDS, Tuberculosis and Malaria ceased providing grants to China to fight HIV from 2013, increasing the government's desire to seek lower-cost sources of treatment.
The announcement will see a dent in Viread's revenues, which grew by 15% year-on-year (y/y) to USD848.7 million globally in 2012. Aurisco, Qilu Pharmaceutical, and Chengdu Brilliant Pharmaceutical are among the Chinese firms that currently produce or have generic versions of Viread at the latter stages of development. Aurisco's chairman, Peng Zhi'en, expects the Chinese market to amount to CNY1 billion even with the onset of locally produced generics sold at one-twentieth of the price of Viread (source: Daily Economic News).
The source reports that Gilead Sciences is considering the option of appealing the decision. China's intellectual property protection has been improved to a great extent, and if Gilead does decide to appeal there is precedent set for the Patent Reexamination Board's judgments to be overturned, as previously occurred with Pfizer (US)'s Viagra (sildenafil) in 2004.
Related articles
- India: 28 June 2013: Shilpa Medicare signs deal with MPP and Gilead to in-license HIV drugs
- Indonesia: 12 October 2012: Indonesia issues compulsory licences against seven HIV, hepatitis drugs
- India: 3 September 2009: Delhi Patent Office Refuses to Patent Gilead's Viread
- Brazil: 10 April 2008: Brazilian Government Seeks to Override Patent on AIDS Drug Tenofovir