在此介紹這個公司的理由是,這個公司的訴訟(到CAFC)教導我們許多專利說明書的事情,至少如以下本部落格曾經報導的案例:
- 說明書揭露的程度 - Ariad v. Eli Lilly (Fed. Cir. 2010)(https://enpan.blogspot.com/2015/06/ariad-v-eli-lilly-fed-cir-2010.html)
- 找到先前技術具有結合動機的事實 - Harbor-UCLA v. Eli Lilly (CAFC 2017)(https://enpan.blogspot.com/2017/04/harbor-ucla-v-eli-lilly-cafc-2017.html)
- 一個有關說明書揭露規範的案例(https://enpan.blogspot.com/2014/07/blog-post_15.html)
- 涉及BEST MODE的案例:BEST MODE在美國專利法改革的角色(https://enpan.blogspot.com/2012/09/best-mode.html)
本篇報導CAFC有關專利非顯而易見性(non-obviousness)以及專利適格性(patent eligibility)是否可以為IPR上訴議題的案例,又是Eli Lilly公司所貢獻:
Neptune Generics v. Eli Lilly (Fed. Cir. 2019)
Mylan Labs v. Eli Lilly (Fed. Cir. 2019)
案件資訊:
上訴人:NEPTUNE GENERICS, LLC, FRESENIUS KABI USA, LLC / MYLAN LABORATORIES LIMITED, FRESENIUS KABI USA, LLC
被上訴人/專利權人:ELI LILLY & COMPANY
系爭專利:US7,772,209
涉及的IPR案:IPR2016-00237, IPR2016-00240, IPR2016-01190, IPR2016-01191, IPR2016-01335, IPR2016-01337, IPR2016-01341, IPR2016-01343
IPR最終意見:April 26, 2019
系爭專利US7,772,209關於一種Antifolate combination therapies(抗葉酸組合療法)。
Claim 1:
1. A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein
the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.
12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:
a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
c) administration of pemetrexed disodium.
Google翻譯Claim 1:
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1.向有需要的患者施用培美曲塞二鈉的方法,包括給予有效量的葉酸和有效量的甲基丙二酸降低劑,然後給予有效量的培美曲塞二鈉,其中
甲基丙二酸降低劑選自維生素B12,羥基鈷胺素,氰基-10-氯鈷胺素,高鈷酸高鈷胺,高氯酸10-鈷胺素,疊氮鈷胺,鈷胺素,氰鈷胺素或氯鈷胺素。
雖是不懂這類技術,但看來專利範圍提出的給藥方法就是提供一些藥劑的組合配方,這個專利被多方提出IPR異議,PTAB對於IPR的決定是,各異議人提出證據並未證明系爭專利為顯而易見,而另外提出系爭專利並不符合專利適格性的理由則不被接受,原因是,專利適格性(subject matter eligibility)並不能成為IPR上訴議題(101也不是IPR審理議題)。
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PTAB意見是,針對異議人提出的先前技術,其中揭露的成份雖有其特徵,但是在治療癌症的情形下,並沒有理由如系爭專利使用維生素B12和葉酸進行預處理的步驟,主要爭點在於Pretreatment with Vitamin B12("The Board found that that a skilled artisan would not have been motivated to administer an MMA lowering agent, such as vitamin B12, in addition to folic acid.")。這就是一個標準的前案是否教示系爭專利的議題。
非顯而易見性爭議涉及多件先前技術的組合,而其中關鍵是,在系爭專利所屬的醫藥領域,先前技術(組合)是否可以教示"所有"系爭專利想要解決與補足的部分,如維生素B12和葉酸不足產生的疾病(deficiencies),在本案例中,PTAB委員認為先前技術即便揭露了成份,但對於成份比例卻僅補足了部分的不足,事實證明先前技術並未讓相關領域技術人員具有採用如系爭專利中成份的動機。
異議人也同時提出專利不具適格性的理由,但這個法律議題並不能在IPR解決,IPR僅處理102, 103議題。("Congress expressly limited the scope of inter partes review to a subset of grounds that can be raised under 35 U.S.C. §§ 102 & 103.")
最終,CAFC確認PTAB決定,系爭專利有效。
判決文:http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1257.Opinion.4-26-2019.pdf(備份:https://app.box.com/s/914noc7mvgw8s1ulmh0e9o49ehi1vm0n)
資料來源:
https://patentlyo.com/patent/2019/04/eligibility-cannot-raised.html
Ron
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