한국로슈, 타미플루 특허권 신청법 공지

한국로슈가 조류인플루엔자 치료제인 타미플루의 특허권 신청 방법을 제약협회를 통해 국내 제약사에게 공지했다．

공문을 통해 회사측은 "로슈 그룹은 타미플루의 생산을 늘리기 위해 서브라이센스(재사용 특허) 방식으로 대화를 나눌 준비가 돼 있다"며 "타미플루를 생산한 능력이 있다고 생각되는 업체·정부와 서브라이센스에 관해 논의할 것이며 기술적인 방법에 관한 자문도 제공할 것"이라고 밝혔다．

국내 업체나 한국정부가 타미플루 생산을 원할 경우 스위스 본사를 통해 이를 신청할 수 있다며 신청방법도 자세히 설명했다<하단 공문 참조>．

하지만 로슈측은 자사가 생산하는 타미플루와 동등한 품질을 보장하기 위해 신청 업체의 생산을 허용할 지 여부는 매우 엄격하게 평가할 것이라고 덧붙였다．

또한 "현재 일부 국가의 몇 회사에서 타미플루를 공급할 수 있다고 주장하는 회사들이 있으나 타미플루의 생산 과정이 복잡하기 때문에 이들 주장의 정확성에는 의심이 간다"고 주장했다．

<한국로슈 측이 국내 제약사들에게 공지한 타미플루 관련 공문>

Dear Sirs

Below you will find our communication regarding the subject of Tamiflu sub-license production.May we ask you to circulate the information to the members of your association as you feel appropriate.

Expansion of Tamiflu capacity

The Roche group is indeed exploring the cooperation with additional partners - besides the external parties that have already been involved from the very beginning - to scale up the production of Tamiflu.There were already a few statements by some companies in different countries who claim to be in a position to supply the product.As the manufacturing process is quite complex and lenghty, there has been some skepticism about the accuracy of these statements.

Nevertheless in support of the global effort to fight a potential pandemic, Roche would be prepared to discuss such sub-licenses to increase the manufacturing of Tamiflu, provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specifications, safety and regulatory guidelines.

The process to apply to our headquarter in Switzerland is as follows:

The request must be sent in writing on official notepaper to global.tamiflu.supply@roche com
Requests addressed to Roche will be acknowledged, i.e. we will confirm in writing that we received the request
The request will then be screened according to an internal check list
Roche will then contact the companies /governments we consider capable of producing substantial amounts of Tamiflu and provide them with a set of questions to evaluate their technical capabilities.
On the basis of the answers to this questionnaire it can then be decided who we consider capable of producing substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications, safety and regulatory guidelines.
A letter will be sent to the company stating that Roche will be entering into further discussion with them regarding capabilities.
A further process to move forward will be agreed.

We need to apply this strict process to guarantee the production quality to ensure that patients receive a product of the equivalent quality that is produced by Roche.

Please let us know if we can be of any further assistance.

Best regards

Urs H.Flueckiger
President Roche Korea