大家好,
這裡有兩題有關美國專利的問題 我不是很了解
麻煩請各位指點一下
謝謝
EPO每年市場有1 billion for therapy, 1 million for research
- Research tool的license fee: 10-50 K
- Research tool 的license royalties: 1-5%
- Therapy的license fee: 50-250 K
- Therapy的license royalties: 5-15%
而 rEPO主要市場為research, 有些可能用在therapy
Patents from FTO search:
#526- PSC for serum-free media cell sf900+, issue 8/15/2000, file 10/8/1988, expire10/8/2015
#008- Amgen for DNA encoding EPO, issue 10/27/1987, expire 10/27/2004 (17 yrs)
#933- Amgen for EPO differs from human, issue 8/20/1996, expire 8/20/2013
#096- PSC for rEPO from sf900+, issue 9/11/2011, expire 10/8/2015
Pig: PCV2 的ORF2重組可做成預防PMWS的疫苗, 這種疫苗使用serum-free media cell sf900+製成. PCV2的市場每年約1 million (farmer最高可接受一劑疫苗$1), 假設我的公司每季$0.2, 跟M, P, I三家公司比起來各便宜了$0.1, patent issue fee約10-50K, royalties約1-10%, 還有一堆專利& license的規定, 以及FDA approval & veterinary license
#526- PSC for serum-free media cell sf900+, issue 8/15/2000, file 10/8/1988, expire10/8/2015
#808- Wyeth for PVC2 ORF2 (reduce viral load), issue 10/20/2009, expire 2/4/2018
#783- Merial for PCV2 ORF2, issue 11/16/2010, expire 5/21/2018
假設我的產品也包含PCV2 ORF2, 11/1/2015提交給FDA准許上市
Question (1): #526, #808, #783 這三個patent哪些需要in-licensed? Why?
Question (2): 假設我是第四個進入市場的, 占了市場四分之一, 銷售總額$250,000 (1 million的四分之一). 不要有royalties, 一劑 $0.2; 如果有附加的royalties, 只能接受一劑 $0.1-0.2; Royalties will be on net sale 一劑$0.8-0.6
假設PSC, Wyeth, Merial 都有license, whould you propose as any of PSC, Wyeth, Merial? (包含royalties何時可以開始之類的因素)
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第二題:
產品被USDA批准為preventing vaccine, 但也想要被批准成為 (1) 從媽媽那裏得到抗體可對抗PCV2 的protecting pig, (2)減低PCV2 感染的症狀 (therapy), (3) 有(1)+(2)的功用
FTO search identifies:
#001- intervet, issue 8/30, expire 9/8/2026, for protecting piglets who have maternally‐derived antibodies against PCV2 by administering PCV2 ORF2, including from baculovirus expression
#285 & #306- Boehringer Ingelheim, 分別issued 6/28/2011 & 3/22/2011, expire 12/28/2026 & 12/29/2025
請問這三個patrnt, 哪個需要用於(1), (2), (3)? WHY? |
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