2011-11-23: 欧盟的补充保护证书（SPC）是什么？为什么会有negative term?

德国华孙专利律师和律师事务所，2011年11月23日，德国慕尼黑

问：欧盟的补充保护证书（SPC）是什么？为什么会有negative term?

答：根据Article 63(1) EPC，欧洲专利保护期限是20年。但是Article 63(2)(b) EPC进一步规定成员国可以对满足一定要求的欧洲专利的保护期进行延长：

"Article 63 Term of the European patent 
(2) Nothing in the preceding paragraph shall limit the right of a Contracting State to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents: 
(a) ...
(b) if the subject‑matter of the European patent is a product or a process for manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State."

欧盟的补充保护证书（SPC, Supplementary Protection Certificate）主要用来补偿开发的新药品在新药审批过程中所没有享受到的市场垄断权。欧洲专利授权后需要去各个成员国申请SPC。因为基于一项专利可以开发多种不同药品，因此，一件专利是可以有多个SPC的。欧盟的SPC制度在Regulation (EC) No 469/2009 （附件1，Regulation (EC) No 1768/92的codified version）中作了详细的规定。其中Article 13对其保护期作了规定：

"Article 13
Duration of the certificate
1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years.
2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.
3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.
4. ..."

即：一般来说，SPC保护期最长5年，计算方法是"被第一次批准投放市场的日期 减去 基础专利的申请日 再减去 5年"。但是，如果Article 36, Regulation (EC) No 1901/2006 适用（即如果实施了"儿科调查计划", "paediatric investigation plan"），则SPC的期限可以被延长6个月。

需要注意的是，如果欧洲专利的申请日与被第一次批准投放市场的日期相差小于5年，其保护期就会使负值，在该情况下一般不会授予SPC，因为保护期负值（negative term）表示对基础专利原有的20年期限并不能延长。但是，如果申请日与被第一次批准投放市场的日期之间的间隔在4年半到5年之间，并且实施了“儿科调查计划”，则SPC的negative term可以再加6个月，这样先得到一个negative term的SPC还是有意义的（因为之后可以根据实施了“儿科调查计划”再申请延长半年）。

目前，欧盟各个成员国对于能否授予negative term的SPC还有争议。