Biotech Patent Questions, Answered
生物技术专利常见问题解答
When should a biotech startup file its first patent application?
Before any public disclosure, including a paper, poster, pitch deck shared without an NDA, or grant abstract. A U.S. provisional application secures a filing date for 12 months while you generate more data.
生物技术初创企业应何时提交首件专利申请？
应在任何公开披露之前提交，包括论文、海报、在未签保密协议情况下分享的融资演示文稿，或基金申请摘要。美国临时申请可锁定申请日 12 个月，让您在此期间继续积累数据。
Can I patent an antibody, a cell therapy or an mRNA construct?
Generally yes, if the claims cover something new, non-obvious and adequately described and enabled. Written description and enablement are where biologics claims most often fail, so claim drafting has to be tied closely to your data.
抗体、细胞疗法或 mRNA 构建体可以申请专利吗？
一般可以，前提是权利要求涵盖新颖、非显而易见且有充分描述和可实施性支持的内容。书面描述和可实施性是生物制品权利要求最常失败的环节，因此权利要求的撰写必须与您的数据紧密结合。
What is a freedom-to-operate opinion, and do I need one?
An FTO opinion assesses whether your product or process infringes someone else's in-force patents. Investors and partners often expect one before a financing, a license or the clinic. More on FTO and due diligence.
什么是自由实施（FTO）意见？我需要吗？
FTO 意见评估您的产品或工艺是否侵犯他人有效的专利。投资人和合作方通常希望在融资、许可或进入临床之前看到 FTO 意见。了解更多关于 FTO 与尽职调查。
How long does it take to get a U.S. patent?
Typically two to four years from filing, depending on the art unit and on how prosecution goes. Track One prioritized examination can shorten this.
获得美国专利需要多长时间？
通常自申请之日起需要两到四年，取决于审查部门及审查过程。Track One 优先审查可缩短这一时间。
What is inter partes review?
A proceeding at the Patent Trial and Appeal Board to challenge a patent's validity over prior patents and publications. It is usually faster and cheaper than district court litigation.
什么是多方复审（IPR）？
在专利审判和上诉委员会（PTAB）进行的程序，可依据在先专利和出版物质疑专利的有效性，通常比联邦地区法院诉讼更快、成本更低。
Do you work with inventors and companies outside California?
Yes. I serve clients in Westlake Village, Thousand Oaks and the Conejo Valley, and because patent practice before the USPTO is federal, I represent clients anywhere in the U.S. I also work in Mandarin.
是否为加州以外的发明人和企业服务？
是的。我为西湖村、千橡市及康尼霍谷的客户提供服务；由于在 USPTO 的专利业务属于联邦事务，我可以代理全美各地的客户，并可使用普通话沟通。