本案是一個非常有趣的案例,被訴侵權人因為藥物審批,承認其藥物產品的組分與涉案專利是等效的,但是,又主張專利權人因為在審查歷史中修改了權利要求,應當禁止反悔,不應再主張等同侵權。然而,美國地區法院認為專利權人的修改沒有導致放棄,因而,通過簡易判決就認定構成等同侵權,聯邦上訴法院予以維持,這種情形比較罕見。
這個案件給我們的啟示是,只有在審查過程中的修改確實導致放棄了保護範圍,才會引發禁止反悔的問題,如果修改實際上沒有放棄保護範圍,也就不會導致禁止反悔。每日IP英文已經滿400期了,感謝大家的一路支持!歡迎大家轉發,歡迎大家留言討論,永遠愛你們!
Doctrine of Equivalents in Lilly v. Apotex
December 21, 2020Dennis Crouch | Patently-O-Dennis CrouchEli Lilly and Co v. Apotex, Inc. (Fed. Cir. 2020)You don’t see this often — the district court held on summary judgment that Apotex infringes under the doctrine of equivalents. On appeal, the Federal Circuit has affirmed – finding no error. (Nonprecedential opinion)Lilly’s US7772209 claims a particular treatment scheme for pemetrexed disodium that includes a pre-treatment with folic-acid to avoid the harsh side-effects. See, Crouch, Eligibility Cannot be Raised in IPR Appeal (2019). Apotex’s product uses a slightly different salt – pemetrexed dipotassium. Apotex needs its version to be the equivalent in order to receive drug approval, but it would prefer to still avoid infringement under the Doctrine of Equivalents.Although Apotex (implicitly) admits that its version is an equivalent, the company argues that Lilly should be estopped from pursuing DoE infringement here because of Prosecution History Estoppel (PHE). In particular, Lilly made a narrowing amendment to the claim term in question during patent prosecution to avoid the prior art and now seeks to reclaim that ground via equivalents.My simplistic drawing above does the trick. Lilly’s original patent filing did not expressly claim the use of 「pemetrexed disodium,」 but rather used the broader term 「an antifolate.」 During prosecution, Lilly narrowed its claims to avoid some prior art — deleting the broader 「antifolate」 limitation and replacing it with the narrower 「pemetrexed disodium.」None of the dependent claims expressly recited Pemetrexed Disodium. However, one original claim had limited the antifolate to 「ALIMTA,」 which is Lilly’s brand of Pemetrexed Disodium. In addition, the specification noted that the 「most preferred」 antifolate for the practicing the invention is 「Pemetrexed Disodium (ALIMTA), as manufactured by Eli Lilly & Co.」 The claim to ALIMTA was also deleted during prosecution based upon an indefiniteness rejection.
MPEP 2173.05(u).
PHE: We know that a narrowing amendment made during prosecution creates a presumption of Prosecution History Estoppel that would bar the patentee from asserting infringement-by-equivalents over the surrendered subject-matter.The district court found no surrender, and the Federal Circuit affirmed. The first bit here is easy claim construction — the original (dependent) claim recited 「ALIMTA」 and now the claim recites 「pemetrexed disodium.」 The district court found these to be synonymous, and the federal circuit agreed. Apotex had argued that ALIMTA should have been seen as encompassing all forms of pemetrexed, and thus its deletion would serve as an additional narrowing amendment. The courts, however, rejected that argument based upon in intrinsic evidence within the patent documents. This was the sole argument raised on appeal by Apotex and thus lost the case.The court does not address PHE stemming from the bigger amendment (antifolate => pemetrexed disodium). There was a continuation application in-between, but you 「can’t use continuations to avoid fact of narrowing amendment.」 Robert A. Matthews, 2 Annotated Patent Digest § 14:82.
Eli Lilly and Co v. Apotex, Inc. (Fed. Cir. 2020)
您不會經常看到這種情況-地區法院根據Apotex在等同原則下的侵權行為做出了簡易判決。在上訴中,聯邦巡迴法院確認-沒有發現錯誤。(非同尋常的意見)
禮來公司的US7772209要求保護培美曲塞二鈉的一種特殊處理方案,該方案包括用葉酸進行預處理以避免嚴重的副作用。參見,Crouch, Eligibility Cannot be Raised in IPR Appeal (2019)。Apotex的產品使用的鹽略有不同- 培美曲塞二鉀。 為了獲得藥品批准,Apotex需要其版本與之等效,但它仍希望避免根據等同原則侵權。
儘管Apotex(隱含地)承認其版本是等效的,但該公司認為,由於審查歷史禁止反言(PHE),禮來應避免在此提起DoE侵權。尤其是,禮來公司在專利起訴期間對有關權利要求術語進行了縮小的修正,以避開現有技術,現在又尋求通過等同來收回領地。
我上面的簡化圖可以解決問題。禮來公司的原始專利申請並未明確要求使用「培美曲塞二鈉」(pemetrexed disodium),而是使用了更廣泛的術語「抗葉酸劑」(antifolate)。在起訴過程中,禮來公司縮小了索賠範圍,以避免使用某些現有技術-刪除了較寬泛的「抗葉酸」(antifolate)限制,而用較窄的「培美曲塞二鈉」(pemetrexed disodium)代替。
從屬權利要求中沒有一個明確記載了培美曲塞二鈉。但是,最初的一個權利要求將抗葉酸劑僅限於禮來的培美曲塞二鈉品牌「 ALIMTA」。另外,說明書指出,用於實施本發明的「最優選的」抗葉酸劑是「培美曲塞二鈉(ALIMTA),由禮來公司製造」。根據不清楚的駁回理由MPEP 2173.05(u),在審查過程中也刪除了對ALIMTA的權利要求。
審理歷史禁止反言PHE:我們知道,在審查過程中進行的範圍縮小的修改會引起「審查歷史禁止反言」的推論,該推論將禁止專利權人對放棄的主題主張構成等同侵權。
地方法院發現沒有放棄,聯邦巡迴法院確認。這裡首要的是簡單的權利要求書的解釋-原始(從屬)權利要求書記載為「 ALIMTA」,而現在權利要求書記載為「培美曲塞二鈉」。地區法院認為這些是同義詞,聯邦巡迴法院同意了。Apotex認為應將ALIMTA視為涵蓋所有形式的培美曲塞,因此將其刪除應作為附加了限縮性修改。但是,法院基於專利文件中的內在證據拒絕了該論點。這是Apotex對上訴提出的唯一論點,因此敗訴了。
法院沒有針對更大的修改(抗葉酸=>培美曲塞二鈉)提出的PHE。中間有一個延續申請,但是「您不能使用延續案來避免限縮性修改。」 Robert A. Matthews, 2 Annotated Patent Digest § 14:82。
Source: https://patentlyo.com/patent/2020/12/doctrine-equivalents-apotex.htmlEach article is copyrighted to their original authors. The news is for informational purposes only and does not provide legal advice.