CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No.25 - September 26, 2001
TOPICS THIS ISSUE:
- Viagra Patent Challenged by Bloc of Chinese Companies
- Artificial Heart Technology Advances Another Step
- Indiana Hospital Follows Nanjing Lead?
- List of China GMP Facilities (Continued)
Viagra Patent Challenged by Bloc of Chinese Companies
15 Chinese pharmaceutical companies are banding together to challenge the patent for Pfizer's anti-impotence drug Viagra.
Companies afraid of losing investments and profits recently filed an appeal with the State Intellectual Property Office (SIPO) to withdraw the patent which recently came into effect.
Senior official Gong Baomin, at SIPO said they will perhaps make a ruling in half a year after examining the appeal, but Pfizer is taking no chances. A spokesman at Pfizer said they will use unspecified countermeasures to challenge the appeal.
Baiyunshan Pharmaceutical Co. in Guangzhou has invested RMB 1 million in the development of a new impotence drug containing sildenafil citrate, a generic name for Viagra. Xu Chinjiang, manager, says that with the patent in effect, their efforts are now pointless.
However, he admitted that whereas Pfizer began applying for a patent in 1994, Baiyunshan only began development of the sildenafil citrate-based drug in 2000.
(Source: AFX - Asia)
Artificial Heart Technology Advances Another Step
Four hours after surgery, Su Qing awoke and was able to hear her own heart beating normally in her chest after the artificial heart implanted in her body for over 48 days was removed in Shanghai East Hospital.
The 21-year-old university student is happy to begin to return to her life. Chief surgeon Liu Zhongmin and assistants were also grateful. In China and Asia, this is the first successful surgery to remove a partially transplanted artificial heart, showing how the use of artificial hearts has developed.
On July 25, Su's heart suddenly stopped beating due to serious inborn thicken cardiomyopathy, which is characterized by very narrow left ventricular and outflow obstruction.
During emergency treatment, her heart stopped working over 10 times. She had to depend on the artificial heart to maintain her life, said Chief Surgeon Liu.
After 48 days of rest, Su's heart had recovered its functions and is capable of supporting blood flow without the assistance of the artificial heart. Doctors also said Su's physical condition is normal after surgery, and abnormal symptoms have disappeared.
The artificial heart process is an advanced medical technology developed only in the last 10 years. It is a relatively new area in China. Besides heart transplants, the technology brings hope for many serious heart disease patients at late stages, when drugs and other medical treatment fail.
Liu said the artificial heart can provide the patient with another chance of survival by allowing the heart to recover the ability to function. He added that the imported artificial hearts are quite expensive, and they are exploring other ways to save more patients.
In China about 1 million patients die of heart failure every year and only 30 patients have been fortunate enough to be implanted with matching hearts. Headed by Liu, Shanghai East Hospital has made impressive improvements in this field. So far, four patients have been implanted with artificial hearts in the hospital.
In another ward of the hospital is 34-year-old Ding Xiaolan, who has survived eight months after being implanted with an artificial heart, the longest lifespan of such a patient in Asia. The woman was the first patient implanted with an artificial heart in Asia on January 18. She, like Su Qing, was suffering from severe dilated cardiomyopathy.
(Source: Xinhua News Agency)
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Indiana Hospital Follows Nanjing Lead?
Wishard Health Services in Indiana recently implemented more restrictive policies regarding drug sales agents. Drug company sales representatives are now banned from patient care areas in the city's fifth largest hospital. We note that this policy is similar to that adopted by hospitals in Nanjing (see Lex Pharma newsletter of September 11, 2001)
Officials at the Indiana hospital were concerned that sales representatives are able to sway doctors' opinions as to what medicine to prescribe. Dr. Robert B. Jones, medical director of Wishard said "We're spending 38 percent more on pharmaceuticals this year than two years ago." It is believed that aggressive sales techniques are leading doctors to prescribe newer and more expensive medicines instead of older and cheaper counterparts. In the Nanjing case, drug companies are entering into purchase agreements with hospitals, which in the future may include restrictive language as to the activities of sales representatives.
Wishard's Dr. Jones, although admitting the usefulness of the information about medication and medical services that drug company representatives can provide, said that salespeople calling on doctors in patient care areas is simply disruptive and that because "a pharmaceutical rep is a salesperson", it not consistent with the environment they want to create. This is a similar description of the problems caused by having drug representatives in China hospitals: "Many patients have been complaining that the presence of the drug reps disturbs the normal order and working environment of the hospital."
Wishard has banned food provided by drug firms and product displays. In Nanjing, the hospital prohibited promotion activities in any form, such as commissions based on promotion, advertising commissions and free sample drugs.
With regard to free samples, Wishard is attempting to create a central pharmacy to which drug companies can deliver free samples of drugs as opposed to individual doctors.
(Source: The Associated Press)
List of GMP Facilities (Continued)
Name of Enterprises | Certified Scope |
151. Guangxi Pubei Pharmaceutical Factory | High Dose Injection, Tablet |
152. Guangxi Weijian Pharmaceutical Co., Ltd. | Capsule |
153. Xiangtan Second Pharmaceutical Factory | Freeze-dried Powder-Injection |
154. Shenzhen Xinpeng Biological Products Co., Ltd. | Recombination Human Granulocyte Colony Stimulating Factor Production Workshop |
155. Liuzhi Dahua Pharmaceutical Factory | High Dose Injection, Low Dose Injection |
156. Guizhou Tiandi Pharmaceutical Co., Ltd. | High Dose Injection |
157. Shunde Nanfang Bio-Pharmaceutical Co., Ltd. | Recombination Human Granulocyte-Macrophage Colony Stimulating Factor Production Workshop |
158. Heilongjiang Tiger Pharmaceutical Co., Ltd. | Powder-Injection |
159. Hainan Mankexing Pharmaceutical Factory | Tablet, Capsule |
160. Heibei Yibang Bio-Pharmaceutical Co., Ltd. | Blood Products |
161. Changzhou Siyao Pharmaceutical Co., Ltd. | Freeze-dried Powder-Injection, High Dose Injection |
162 Shanghai Qiaoyuan Bio-Pharmaceutical Co., Ltd. | Freeze-dried Powder-Injection |
163. Guizhou Xintian Pharmaceutical Co., Ltd. | Capsule, Granule |
164. Nimeike Pharmaceutical (Zhongshan) Co., Ltd. | Tablet, Capsule (Cephalosporin), Ointment |
165. Wanding Pharmaceutical Factory | High Dose Injection |
166. Changchun Tiancheng Pharmaceutical Co., Ltd. | High Dose Injection, Low Dose Injection, Freeze-dried Powder-Injection |
167. Kunming Longjin Pharmaceutical Co., Ltd. | Freeze-dried Powder-Injection |
168. Heifei Second Pharmaceutical Factory | High Dose Injection |
169. Anhui Xinli Pharma. Co., Ltd. (Ma-an shan Factory) | Freeze-dried Powder-Injection(Hormone) |
170. Hubei Sibao Pharmaceutical Co., Ltd. | Capsule, Granule |
171. Shenyang Kangii Pharmaceutical Factory | Recombination Human Leukotaxin-2 Production Workshop, Freeze-dried Powder-Injection |
172. Dalian Songliao Biological Products Factory | Freeze-dried Powder-Injection |
173. Kunming Nanjiang Pharmaceutical Factory | High Dose Injection (Glass Container product line) |
174. Guangdong Taiyangshen Licheng Pharmaceutical Factory | High Dose Injection, Factory Low Dose Injection, Capsule, Granule, Tablet |
175. Huainan Jiulonggang Pharmaceutical factory | High Dose Injection |
176. Shenzhen Kexing Biological Products Co., Ltd. | Recombination Human Interferon a1b, Recombination Human Leukotaxin-2 Production Workshop |
177. Kunming Pharmaceutical Co., Ltd. | Raw Material Medicine (Artemether) Low Dose Injection (Powder-Injection branch factory) |
178. He'nan Lianhua Yingtang Pharm. Co., Ltd. | Raw Material Medicine (Cartose) |
179. Nanjing Xiaoying Pharmaceutical Factory | High Dose Injection, Tablet |
180. He'nan Shuaike Pharmaceutical Co., Ltd. | High Dose Injection |
181. Shenyang Shangzhinei Pharma. Co., Ltd. | Tablet, Capsule, Injection Granule |
182. Bofu-Yipusheng (Tianjin) Pharmaceutical Co., Ltd. | Powder |
183. Tianjin Taihe Pharmaceutical Co., Ltd. | Freeze-dried Powder-Injection |
184. Jiangsu Pengyao Pharmaceutical Co., Ltd. | High Dose Injection |
185. Xi'an Qianhe Pharmaceutical Co., Ltd. | Tablet, Capsule |
186. Hu'nan Xianglongtang Pharmaceutical Co., Ltd. | Capsule |
187. Wuhan Hualong Bio-Pharmaceutical Co., Ltd. | Low Dose Injection, Freeze-dried Powder-Injection |
188. Wuhan Hualong Bio-Pharmaceutical Co., Ltd. | High Dose Injection |
189. Tianjin Jinlan Pharmaceutical Co., Ltd. | High Dose Injection |
190. Xiamen Factory | Tablet, Capsule, Granule |
191. Yiqiao (Hu'nan) Pharmaceutical Co., Ltd. | Freeze-dried Powder-Injection |
192. Jilin Huinan Changlong Biochem. Pharm. Co., Ltd. | Freeze-dried Powder-Injection, Low Dose Injection, Tablet, Capsule, Granule |
193. Beijing Nuohua Pharmaceutical Co., Ltd. | Capsule |
194. Liaoning Tianlong Pharmaceutical Co., Ltd. | Powder-Injection (Cephalosporin), Freeze-dried Powder-Injection, High Dose Injection, Low Dose Injection |
195. He'nan Aolinte Pharmaceutical Factory | Tablet, Capsule |
196. Weihai Lutan Pharmaceutical Co., Ltd. | Tablet |
197. Yantai Beifang Pharmaceutical Co., Ltd. | Low Dose Injection, Freeze-dried Powder-Injection |
198. Shangdong Zibo Xinda Pharmaceutical Co., Ltd. | Tablet, Capsule (Cephalosporin), Granule (Cephalosporin) |
199. China Zhonghui Pharmaceutical Co., Ltd. | Capsule, Granule |
200. Xi'an Lijun Pharmaceutical Co., Ltd. | Freeze-dried Powder-Injection |
Lehman Lee & Xu
China Lawyers, Notaries, Patent, Copyright and Trademark Agents
http://www.chinalaw.cc/
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The China Lex Pharma Law Newsletter is intended to be used for news purposes only. It should not be taken as comprehensive legal advice, and Lehman, Lee & Xu will not be held responsible for any such reliance on its contents.
