RNA干扰 (RNA干扰) 是转录后基因沉默的进化上高度保守的过程 (私人协约) 通过双链RNA (DS RNA) 导致mRNA序列的序列特异性降解.
RNAi是一种生物过程，其中RNA分子抑制基因表达, 典型地通过使特定mRNA分子的破坏. RNAi技术被广泛应用于基因敲除, 功能基因组学, 医药和生物技术领域. 由于RNA干扰似乎有广泛的应用, 它打开了生物技术公司门口 鉴定 RNAi的专利的申请.
Instead of drug sales, RNAi generates income by leveraging 知识产权 (IP). Patentable inventions in this area include molecular features, modifications that enhance compound efficacy and gene-specific RNAi targets, 等等. 通过 licensing their inventions, companies can extract fees for use of their technology. As with any new invention, 该 patents are granted only for any processes and/or products which are deemed novel, non-obvious and industrially applicable. Meeting these criteria isn’t easy. According to Angrist et al1, 多于 2,000 RNAi patent applications for new inventions have been filed with the US Patent and Trademark Office (美国专利商标局) yet only a few patents have been issued.
The major patentability issues in RNAi are:
- lack of adequate description to support broad claims;
- lack of disclosure of target site accessibility for the gene at issue;
- claim defines the invention in purely functional terms and lacks structural correlates;
- RNAi described only by function may lack adequate written description to enable a person skilled in art to reproduce the invention without further research.
How to overcome the patentability issues?
A key challenge for reviewers is to confirm that a given application doesn’t overlap with ‘prior art’, meaning previously disclosed technology including published patent applications or granted patents. Reviewers need to wade through the application and determine who filed the given invention first so that patentability rights can be granted to the right inventors.
The major patentability issues in RNAi can be resolved by:
- Narrowing the claims to iRNAs inhibiting expression of known nucleic acid encoding a protein with adequate written description;
- Tabulating analysis on what is shown in the specification and what was known to public about the various versions of the gene before the time of filing (analysis on prior art);
- Provide evidence to proof the said RNAi targets functionally correlate with targeting other versions of the gene. If more evidence is disclosed, possibly more aspects can be claimed.
As the issue of the patentability of genetic materials is under debate and in some countries these genetic materials are not considered patentable subject matter; they decline to grant patent protection to genetic sequences, considering them to be part of nature. 然, in many countries (例如. the US and much of Europe) molecules such as RNA and DNA that have been isolated using a specific method and characterized according to their function and potential utility may be patented.
新近, Australian Patent Office – Arrowhead Research Corporation  APO 70 (13 十月 2016) decided that in the case of gene-based pharmaceuticals, namely interfering RNA (iRNA) compositions; do represent patentable subject matter in Australia. Previously iRNA compositions were considered patent ineligible, now this decision sets a significant legal precedent in relation to the patentability of the iRNA in Australia. In addition it provides important guidance in relation to the patentability of other gene-based inventions as well.
As RNAi research moves forward, a key question remains: how will iRNA compounds be delivered to their targets? Delivery methods leave the door open for more patents covering other advancement in iRNA technology. Hope this will help to improve the RNAi technology especially in medicine and biotechnology field for the wellbeing of humanity.
1 Angrist, 中号. & Cook-Deegan, R.M. The New Atlantis 11,87–96 (2006).