b*****t
发帖数: 9671 | 1 皑皑，影响别人赚钱了
真够亏的
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留美博士后山寨进口抗癌药昨开庭受审从 喷嚏网----阅读、发现和分享：8小时外的健
康生活！ 作者：xilei这是新中国成立以来杭州最大数额的非法生产经营假药案，查处
药品价值达2781万元。
主犯丁某，47岁，美国著名医科大学博士后，美籍华人。
7年前，丁学成归国，在杭州某高校担任博导，同时，也是杭州一家生物医药技术开
发公司的老总。
昨天，丁出现在杭州市中级人民法院1号庭。瘦高个，颧骨很高，穿蓝色衬衫。标准
普通话，声音有磁性。
检察官宣读起诉书：“2008年下半年至2009年11月间，丁在未取得药品生产经营许可
证的情况下，指令胡×（丁公司员工）生产埃罗体等治疗肿瘤用药，而后邮寄给深圳的
××进行分装对外销售。……鉴定价值2781万元，有效成分达到同类正品标准……情节
特别严重，应当以非法经营罪追究其刑事责任。”
丁嗫嚅：“不能那样估价，实际上我卖给病人家属，只有市场价的十分之一不到……
我不是要扰乱市场秩序，而是正品药的价格，病人没法承受啊。”
丁生产的药，都是相当昂贵的进口处方药，如埃罗体（治疗肺癌）、依玛体（治疗白
血病）、索伦尼克（治疗肾癌）等。一瓶药，三十来片，市场价一两万。
2008年下半年，丁开始用自己的技术炮制进口抗癌药。他掌控原料和配方，然后让所
在公司的一名职员在江苏宜兴的两间出租屋内生产药片。再把药片快递到深圳去，让人
负责包装和销售。2009年11月25日，丁邮寄药片时被抓获。
法庭辩论环节，丁缓缓地说了很长一段话：
“我是一名科学家，回国后只想为国家为人民做点事情。做违法的事？我的人生规划
里从来没有这一项。
“只是，后来我不得不这么做。我一直从事新药研究，一天一位护士长找到我，说自
己妹妹得了癌症，用的药一瓶就要两万多，一个月一瓶，家里实在负担不起，让我帮帮
她。那个护士长给我下跪……
“我触动很大。我有这个技术，我有能力帮他们，但是由于专利垄断，我没有办法取
得这个药的生产经营权……后来我自己的姐姐也得了癌症，她的经济条件也不好，我就
用自己的技术给她做药，效果很好。
“我没有主动去卖药，都是我的学生、同事或者听过我讲座的人，慕名找上来。他们
希望我帮助他们，很多次我都无偿为他们提供药品，从来没有出过事故……我帮助了将
近一两百个人。这个只是我的副业，我的主要精力还是科研，我没有想过牟利，只想帮
他们……”
丁的律师擦了一下眼睛，有些动情地说：“他是在做善事，他是在救人，只因为原本
救人的药定了个要人命的价格……虽然他的小作坊，环境上可能达不到国家要求，但是
药品质量是没有问题的，药监局也证实了这点。”
丁的父亲在旁听席上不住抹眼泪。
检察官说：“不管动机如何，结果如何，都必须在国家法律的框架内，因为药品安全
事关人民群众身体健康和生命安全。”
法庭择日宣判。 | g******o
发帖数: 33 | 2 中国的法官太二了，看看烙印怎么玩的。
Cipla launched a generic version of valganciclovir in 2008 while the anti-
viral was under patent in India
The Indian Patent Office has reversed an earlier decision granting patent
rights to an anti-viral drug valganciclovir marketed by Roche.
Valganciclovir is used for the treatment of active cytomegalovirus (CMV)
retinitis that occur in people living with HIV.
The Indian Patent Office at Chennai, in a decision released on April 30,
2010, has set aside the patent granted to Roche for valganciclovir, after
declaring that the drug lacked inventive step that qualifies one new product
or inventions to secure patent protection in India.
The Patent Office granted a patent to Roche for valganciclovir (Valcyte) in
June 2007.
Valganciclovir, which is an ester prodrug of ganciclovir. Ganciclovir is a
known compound and hence valganciclovir did not have an inventive step. In
addition, valganciclovir did not satisfy the requirement of showing
increased therapeutic efficacy as required under section 3(d) of the patent
law.
The contentious Section 3(d) of India’s Patent Act, last year, Section 3(d)
restricts what can be patented. In particular, the section states that
salts and other derivatives of known substances “shall be considered to be
the same substance, unless they differ significantly in properties with
regard to efficacy”.
Several NGOs involved in anti-HIV campaign and human rights groups were
opposing the granting patent protection to valganciclovir.
However, the Chennai Patent Office did not hear the opposing arguments of
public interest groups including the Indian Network for People Living with
HIV/AIDS (INP+) and the Tamil Nadu Networking People with HIV/AIDS (TNNP+),
and went ahead granting the patent for valganciclovir in 2007.
The public interest group approched court.In December 2008, the Madras High
Court in Chennai decided to set aside Roche’s patent until these arguments
could be heard.
Following the rejection of the pre-grant opposition by the patent office,
the public interest groups approached India’s Supreme Court.
The Supreme Court directed the groups to join the post-grant opposition
proceedings that were already taking place through oppositions filed by
generic companies and the Delhi Network of Positive People (DNP+).
Roche, however, challenged DNP+.
The Indian Patent Office has now recognised only the validity of one of the
process claims made by Roche and determined that the Swiss giant’s claims
for a product patent on valganciclovir were invalid. It has also held that
patients groups can file post-grant oppositions.
Valganciclovir is also used for post operative treatment for patients who
have received an organ transplant.
A patient would require 264 oral doses given over four months for the
effective treatment of cytomegalovirus (CMV) infection. This could be a
heavy burden for the patient as the overall cost of the treatment come reach
upto Rs 2,74,560 per patient.
Domestic pharmaceutical major Cipla launched a copycat version of Swiss drug
-maker Roche’s valganciclovir, in India in September 2008, even while the
drug enjoyed patent protection in following the grant of patent in 2007.
In August 2009, the Indian Supreme Court dismissed the special leave
petition filed by Roche on a generic version of its erlotinib (Tarceva) from
Cipla, challenging the order passed by a the division bench of the Delhi
High Court in April 2009.
Erlotinib or Tarceva, a lung cancer drug originally invented by Swiss pharma
firm Hoffman La Roche Ltd, was granted a patent in India in September 2007.
Despite this, Cipla Ltd of Mumbai launched a generic version of erlotinib
branded Erlocip last year.
While launching the drug, Cipla was quoted as saying that they intended to
launch their own version of the drug at a lesser price – Rs 1,600 ($41) a
tablet. Roche’ selling price was Rs 4,800 ($122) per a Tarceva tablet.
Following this, Roche sued Cipla for patent infringement in the Delhi High
Court and applied for a temporary injunction. During hearings, Cipla
maintained that the patent was invalid and should be revoked. Cipla claimed
that erlotinib (Tarceva) is a derivative of an earlier substance called
gefatinib, and therefore should not have been granted a patent, unless
increased efficacy can be proved.
The trial judge refused to grant an interim injunction on the ground that
since Cipla was selling the drug at 1/3rd of the price of Roche, an
injunction would mean impeding affordable access for a large number of
cancer patients in India. Therefore, “public interest” demanded that no
injunction (restraining order) be granted.
However, a High Court bench vacated its interim order by which Cipla was
restrained from exporting the drug to other countries in which La Roche has
patent rights.
The Delhi High Court dismissed the plea of the Swiss company saying that the
Indian company should be restrained from manufacturing and selling the
generic drug till the issue of patent rights was decided through litigation.
The Swiss company had approached the Division Bench of the High Court after
a single Bench had dismissed its plea to restrain Cipla.
The Court also imposed a cost of Rs five lakh (US $ 10,000) on Roche.
India’s patent law allows companies to oppose patents both before and after
grant.
Significantly, Indian Patent Office, Chennai’s decision to revoke
valgancicyclovir patent comes at a time when the Indian Pharmaceutical
Alliance (IPA) plans to challenge the applications of up to 90 drug patents
held by multinational and local pharmaceutical companies at the country’s
patent offices.
The number of patent claims that will face opposition comprise about a tenth
of the total applications filed across the country’s four patent offices
between October 2009 and February 2010.
This is going to be a continuous process and IPA will challenge other patent
claims as well from now on, IPA,, whose members include major domestic
drugmakers such as Sun Pharma and Dr Reddy’s Laboratories, declared
recently. | r****c
发帖数: 1494 | | v**********m
发帖数: 5516 | 4 检察官说：“不管动机如何，结果如何，都必须在国家法律的框架内，因为药品安全
事关人民群众身体健康和生命安全。”
国家法律的框架是不是只保护国内太子党买办和国际大财团的利益？普通人死去的时候
这个政府是不是在救人？
看到这则新闻真觉TMD。中国政府早该主动得去敲国际财团的脑袋，取得generic药物的
生产许可，而不是在濒临死亡的人上敲诈。 |
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