All this is due to the unprecedented patent right of Hepudin (patent number 99 126580.7). It turned out that as early as June 8, 2006 18, the patent protection of "Hepudin" was about to expire. At that time, many domestic pharmaceutical companies were already brewing a research and development boom of lamivudine, in order to let the majority of hepatitis B patients use domestic lamivudine with high quality and low price as soon as possible. However, to the delight of Chinese people, only the administrative protection right of Hepudin patent expired on June 5438+1October 65438+1October 2006. It also owns the patents on the preparation method of lamivudine active ingredients and the synthesis method of drug carriers in China, that is, the patent on the preparation method of 1, 3- oxocyclopentane nucleoside analogue pharmaceutical composition.
Claim 1, a compound containing (-)-cis -4- amino-1-(2- hydroxymethyl-1, 3- oxocyclopentane -5- yl) -( 1H)- pyrimidine -2- one.
The chemical name crossed above is the chemical name of lamivudine. That is to say, patent 99 126580.7 protects the preparation method of imported lamivudine preparation (or pharmaceutical composition). The technical feature of this preparation method is "mixing the raw materials of lamivudine with pharmaceutical excipients", that is to say, as long as the raw materials of lamivudine and pharmaceutical excipients are mixed and made into tablets, capsules, granules and other preparations, it will be infringed.
It is precisely because of this patent barrier that domestic companies' generic lamivudine has been frozen for many years, so it can't be produced and listed, thus "Hepudine" can monopolize the China market for ten years. In Europe and America, lamivudine has long been listed as a generic drug, and its retail price is only one-fifth of that of adefovir dipivoxil, another anti-hepatitis B virus drug. But in China, its retail price is twice as high as that of domestic adefovir dipivoxil, and it has remained high for a long time. Obviously, the lingering pain in the hearts of the industry and hepatitis B patients is really the pain of patent barriers and the pain of high drug prices! . In fact, when Hepudin was unique in the world, the public had long questioned its expensive drug prices and patents. For the benefit of the majority of patients with hepatitis B, after several years of investigation and evidence collection, the claimant for invalidation decided that the Hepudin patent did not meet the provisions of the third paragraph of Article 22 of the Patent Law of China. So in March 2009, Beijing Huake United Patent Office was entrusted to submit a request for invalidation with the patent number of 99 126580.7 to the China National Intellectual Property Administration Reexamination Board. At the same time, relevant evidence was submitted: as early as1June 26, 989, the structure of racemic compound of lamivudine was disclosed in foreign literature. According to the common sense that can be predicted by those skilled in the field, the cis-structure of racemic compounds is lamivudine, so it is not creative to mix them with pharmaceutical excipients to make preparations, because pharmaceutical preparations are all made of raw materials and pharmaceutical excipients, such as tablets, capsules, granules and so on.
According to the third paragraph of Article 22 of the Patent Law of our country, creativity means that compared with the existing technology, patented technology needs to have outstanding substantive characteristics and then make remarkable progress. When evaluating whether an invention is creative or not, we should compare it with the nearest existing technology to determine its distinguishing features and the technical problems actually solved, and then examine whether the existing technology as a whole gives inspiration for applying the above distinguishing features to the nearest existing technology to solve its existing technical problems. If this revelation exists in the prior art and the technical effect of the obtained invention is predictable, the invention is not creative.
After formal examination, the Patent Reexamination Board accepted the request for invalidation of the patent on May 28th, 20 10, and forwarded the copy of the evidence sought by the requester to the patentee. At the same time, a collegial panel was set up to review the case. On September 20 10, the Patent Reexamination Board conducted an oral hearing on this case. The collegial panel of the Patent Reexamination Board fully investigated the reasons, facts and evidence of the request for invalidation and listened to the opinions fully stated by both parties. Finally, the collegiate bench thinks that the combination of 1 and the patentee's claim 1 with the evidence 1 and common sense does not have outstanding substantive characteristics and significant progress, and does not have the creativity as stipulated in the third paragraph of Article 22 of the Patent Law. 2. Compared with the combination of evidence 1 and common sense, the patentee's claim 2-4 does not have outstanding substantive features and significant progress, and does not have creativity as stipulated in the third paragraph of Article 22 of the Patent Law. So far, after two years, the "Hepudin" patent lawsuit that has been tried twice has been settled. It is painful to learn from this belated ruling. 1990, when lamivudine was granted the basic patent in the United States, the patent law of China at that time did not protect this kind of compound, and China, where the market economy order was first established, only granted the patent to the pharmaceutical method at that time. Up to now, although the imported lamivudine has expired in foreign countries, there is no innovative patent for its preparation method in China, which makes domestic hepatitis B patients have no choice but to buy imported lamivudine instead of buying domestic generic drugs equivalent to imported drugs like other diseases.
This ruling seems unable to change the heavy drug burden borne by hepatitis B patients in China in recent years 1 1, nor can it rewrite the product "Hepudin" as an insurmountable barrier to the localization of lamivudine, although the patent protection period of GSK is less than half a year. ...
However, we applaud the decision of the State Intellectual Property Patent Reexamination Board. We are still applauding for defending the public rights and interests and not afraid to compete with multinational pharmaceutical companies! It is reported that domestic pharmaceutical companies have obtained the production approval of lamivudine tablets and started to go on sale step by step. The retail price is much lower than that of imported Hepudine, which not only provides more economical treatment options for the majority of hepatitis B patients, but also opens a new chapter for the localization of Lamivudine. Let hepatitis B patients in China have less pain and more hope. On 20 10, Anhui Baker Biopharmaceutical Co., Ltd. successfully obtained the production approval of lamivudine tablets for treating hepatitis B and AIDS in three specifications. At the same time, Baker's series of anti-HBV and anti-AIDS pharmaceutical preparations such as entecavir dispersible tablets, zidovudine tablets, nevirapine and bifudine tablets will be registered by SDFA one after another and obtained production approval.
After Baker's domestic lamivudine tablets were approved, Baker immediately showed a sense of civic responsibility, immediately contacted the health departments in Sichuan, Henan and other places, and actively donated medicines. 20 10,1165438+1On October 27th, under the leadership of Mr. Wang Zhibang, Chairman of Anhui Baker, the company donated lamivudine tablets worth more than 4 million yuan to Sichuan CDC and Shanghai Public Health Clinical Center.
Hepatitis B and AIDS are not terrible. Under the strong leadership and care of the party and the government, and with the joint efforts of all social organizations and groups, the whole society will take active actions, care for others, treat itself well, our society will be more harmonious and stable, and the people will live a happier and healthier life.