New rules for natural products research
New rules for natural products research
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DOI：
10.1038/12921
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发表时间：
1999-09-01
影响因子：
46.9
通讯作者：
Gollin, MA
中科院分区：
文献类型：
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作者：
Gollin, MA
资源声明他们使用了经过认证的质粒。下级法院认为该专利因欺诈而不可执行，这是一种禁树的非法果实。然而，上诉法院推翻了这一判决，认为如果告知了真相，就不会影响对专利的审查。换句话说，专利中的错误陈述不是“实质性的”。这个案例告诉我们，如果一项发明是基于受污染的研究材料，例如违反法律从一个国家走私出去的植物样本，而发明者在专利中对此撒谎，那么就可能构成欺诈。然而，发明者必须通过虚假陈述获得一些好处，例如第一个做出发明。在自然产品专利中，标明生物材料来源国已经是一种常见做法（如果不要求的话）。1997年，欧洲议会更进一步，通过了一项措施，要求专利申请人说明生物材料的原产地，并提供证据证明该材料是按照原产地有效的准入和出口限制使用的（例如，进入阿坝）。最终，欧盟委员会拒绝了这一提议，理由是它超出了《生物多样性公约》的要求。然而，如果这样的提议被任何国家采用，那么缺乏来源国的批准将注定专利的失败。同样，虚假陈述将被视为实质性的，并将危及专利。违反规则的第二个后果是，如果研究人员从来源国非法转移生物材料，然后从材料中获利，来源国或受影响的人可以在美国法院根据挪用理论和相关理论收回全部或部分利润。因此，对于那些在将样本带回家之前未能就阿坝达成协议的人来说，存在真实的法律的风险。法院可能为成功的产品规定的条件可能比一开始谈判的条件要苛刻得多，因为成功仍然是一个极不可能的结果。在需要阿坝的国家，这种风险最高。第三，生物材料的清洁所有权现在意味着它是合法获得的，并得到了最初控制它的人的事先知情同意，如果没有清洁所有权，材料的价值就会严重降低。非法样本的收集者将无法在研究人员的正常行为过程中将其传递给合作者，合作伙伴或第三方。如果不能保证收集的材料符合所有适用的法律和法规，包括利益分享，那么精明的生物材料接收者将不会接受材料。此外，如果供应商证明样本是正确获得的，而不是，那么接收者可以向收集者提出合同索赔。为了确保自1993年（《生物多样性公约》生效日期）以来收集的材料的所有权链干净、无云，需要建立对新规则的遵守。根据《生物多样性公约》，1993年以前收集的材料是“不受影响的”，因此主权权利和事先知情同意的义务不适用。尽管如此，来源国也基于政治（如果不是法律的）理由，对《生物多样性公约》之前的材料提出要求，因此，表明《生物多样性公约》之前的材料是在事先知情同意和利益分享的情况下收集的，可能是有利的。国际农业研究咨询小组的中心已经通过了一项信托协议，根据该协议，他们在《生物多样性公约》之前的大量收藏品将以信托形式持有，以造福于农业部门。
RESOURCES stating that they had used a certified plasmid. The lower court held the patent unenforceable for fraud, the illegitimate fruit of a forbidden tree. However, the appeals court reversed, holding that it would not have affected examination of the patent if the truth had been told. In other words, the misrepresentation in the patent was not “material.” This case teaches that if an invention is based on tainted research material, such as a plant sample smuggled out of a country in violation of its laws, and the inventor lies about it in a patent, a case of fraud might be made. However, the inventor must have gained some advantage by the misrepresentation, such as being the first to make the invention. It is already common practice (if not required) for natural product patents to identify the country from which biological material was obtained. In 1997, the European Parliament went further by adopting a measure that would have required a patent applicant to indicate the geographical place of origin of biological material, and to provide evidence that the material had been used in accordance with access and export restrictions in force in the place of origin (eg, entering an ABA). Ultimately, the European Commission rejected that proposal on the grounds that it exceeded the requirements of the CBD. However, if such a proposal were ever adopted in any country, then an absence of source country approval would doom a patent. Likewise, a misrepresentation would become considered material, and would jeopardize the patent. A second consequence of breaking the rules is that if a researcher removes biological material illegally from a source country, and then profits from the material, the source country or affected person could recover all or some of the profits, in a US court, based on a theory of misappropriation and related doctrines. Thus, there is a real legal risk for someone who fails to reach agreement on an ABA before taking a sample home. The conditions a court might impose for a successful product could be much more onerous than one that could be negotiated at the outset, when success is still a highly unlikely outcome. This risk is highest in a country that requires an ABA. Third, clean title to biological material now means that it was obtained legitimately, and with prior informed consent from whomever had initial control over it. If there is no clean title, the value of the material is seriously reduced. The collector of an illegitimate sample will not be able to pass it on, in turn, to collaborators, partners, or third parties in the normal course of conduct for researchers. Absent assurances that the material was collected in compliance with all applicable laws and regulations including benefit sharing, a savvy recipient of biological material will not accept material.Moreover, if the supplier certifies that a sample was properly obtained, and it was not, then the recipient could assert a contractual claim for damages back against the collector. To assure a clean, cloud-free chain of title for materials collected since 1993 (the CBD’s effective date), compliance with the new rules needs to be established. Material collected before 1993 is “grandfathered” under the CBD, such that sovereign rights and the obligation of prior informed consent do not apply. Nonetheless, claims to such pre-CBD material are being asserted by source countries, too, on political, if not legal grounds, so it could be advantageous to show that pre-CBD material was collected with prior informed consent and benefit sharing. The centers of the Consultative Group on International Agriculture Research have adopted a trust agreement whereby their extensive pre-CBD collections are held in trust for the benefit …