PKUCare Pharmaceutical R&D Center’s Victorious Challenge for Bayer’s patents
On 7th February, Patent Reexamination Board of the State Intellectual Property Office (SIPO) issued the Written Decision for the Invalid Declaration Request Review, to announce the complete invalidation of Bayer’s patent right for “Moxifloxacin/ Preparation of Sodium Chloride ”. At this point, with the joint efforts of Founder Government Affairs Department, PKU International HealthCare Group and PKUCare Pharmaceutical R&D Center, the request which lasted for nearly a year for the invalidation of Bayer’s patents of “Moxifloxacin/ Large Infusion Preparation of Sodium Chloride ” proposed by PKU International HealthCare Group was concluded with the full victory of PKU International HealthCare Group. It is not only the very rare case in the pharmaceutical industry that domestic company challenged the world’s leading company’s patents with success, but also the invalid patent case with the biggest sales amount of the involved product in mainland China, which shall serve as the “First Case” of the foreign-related patents in China’s pharmaceutical industry.
As Bayer’s exclusive product in the world market, Moxifloxacin is the fourth generation quinolone broad-spectrum antibiotics, which is widely used to treat adult upper respiratory tract, lower respiratory tract infections as long as skin and soft tissue infections. In 1999, Moxifloxacin was firstly launched on the market in Germany, the global market sales in 2012 is 1.19 billion US dollars; in 2004, it was sold to China, the Chinese market sales in 2011 is around 1.1 billion RMB, among which, the sales of Moxifloxacin/ Large Infusion Preparation of Sodium Chloride is over 0.7 billion RMB. For a long time, because of the wide scope of the patent protection of Moxifloxacin/ Large Infusion Preparation of Sodium Chloride, patent barriers were created. As a result, the domestic drug manufacturers could not produce generic drugs so as to form the competition and bring the prices down. Finally, the high drug prices were transferred to the patients and state finance.
In early 2012, through tremendous amount of research work, researchers of PKUCare Pharmaceutical R&D Center retrieved the literature published before the patent’s priority date, which recorded the technical solution of “effective ingredients Moxifloxacin + injection isotonic regulator 0.4-0.9% sodium chloride”. With this clue, after several discussions and confirmations with Founder Government Affairs Department, PKUCare Pharmaceutical R&D Center further cured and locked the relevant evidences of Bayer’s patents’ novelty and creativity.
With full preparation, PKU International HealthCare Group made a request to SIPO for the invalidation declaration of the patent rights on 25th April, requesting SIPO to declare that Bayer’s above mentioned patent rights are all invalid. After that, both parties could not come to an agreement through several times of negotiation. On 7th February 2013, SIPO issued invalid decision to declare that Bayer’s “Moxifloxacin/ Preparation of Sodium Chloride” patents rights are all invalid. PKU International HealthCare Group broke the Moxifloxacion patents monopoly of the foreign powerful enterprise.
All this time, as an integral part of the pharmaceutical industry chain of PKU International HealthCare Group, PKUCare Pharmaceutical R&D Center has been constantly improving innovative R&D mechanism and has greatly enhanced the initiative and enthusiasm of the researchers and strengthened the innovative ability in research. During this patent invalidation application process, with the scientific concept of seeking truth from facts, researchers of PKUCare Pharmaceutical R&D Center advanced Bayer’s Moxifloxacin/ Preparation of Sodium Chloride patent expire date from 25th July 2020 to early of 2013, which is the best verification of its research ability and professionalism.
Furthermore, this achievement breaks Moxifloxacin/ Preparation of Sodium Chloride’s patent drug monopoly, which will bring opportunities to domestic pharmaceutical manufacturers to copy this product and greatly reduce the prices for these preparation drugs. From now on, Chinese people could use high-quality fourth generation antibiotics with comparatively low price, which also makes contributions to the Chinese even the universal human’ heath rights.