本案是一个非常有趣的案例，被诉侵权人因为药物审批，承认其药物产品的组分与涉案专利是等效的，但是，又主张专利权人因为在审查历史中修改了权利要求，应当禁止反悔，不应再主张等同侵权。然而，美国地区法院认为专利权人的修改没有导致放弃，因而，通过简易判决就认定构成等同侵权，联邦上诉法院予以维持，这种情形比较罕见。这个案件给我们的启示是，只有在审查过程中的修改确实导致放弃了保护范围，才会引发禁止反悔的问题，如果修改实际上没有放弃保护范围，也就不会导致禁止反悔。每日IP英文已经满400期了，感谢大家的一路支持！欢迎大家转发，欢迎大家留言讨论，永远爱你们！
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 (Nonprecedential opinion)Lilly’s US7772209 claims a particular treatment scheme for pemetrexed disodium that includes a pre-treatment with folic-acid to avoid the harsh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)
您不会经常看到这种情况-地区法院根据Apotex在等同原则下的侵权行为做出了简易判决。在上诉中，联邦巡回法院确认-没有发现错误。（非同寻常的意见）
礼来公司的US7772209要求保护培美曲塞二钠的一种特殊处理方案，该方案包括用叶酸进行预处理以避免严重的副作用。参见，Crouch, Eligibility Cannot be Raised in IPR Appeal (2019)。Apotex的产品使用的盐略有不同- 培美曲塞二钾。 为了获得药品批准，Apotex需要其版本与之等效，但它仍希望避免根据等同原则侵权。
尽管Apotex（隐含地）承认其版本是等效的，但该公司认为，由于审查历史禁止反言（PHE），礼来应避免在此提起DoE侵权。尤其是，礼来公司在专利起诉期间对有关权利要求术语进行了缩小的修正，以避开现有技术，现在又寻求通过等同来收回领地。
我上面的简化图可以解决问题。礼来公司的原始专利申请并未明确要求使用“培美曲塞二钠”(pemetrexed disodium)，而是使用了更广泛的术语“抗叶酸剂”(antifolate)。在起诉过程中，礼来公司缩小了索赔范围，以避免使用某些现有技术-删除了较宽泛的“抗叶酸”(antifolate)限制，而用较窄的“培美曲塞二钠”(pemetrexed disodium)代替。
从属权利要求中没有一个明确记载了培美曲塞二钠。但是，最初的一个权利要求将抗叶酸剂仅限于礼来的培美曲塞二钠品牌“ ALIMTA”。另外，说明书指出，用于实施本发明的“最优选的”抗叶酸剂是“培美曲塞二钠（ALIMTA），由礼来公司制造”。根据不清楚的驳回理由MPEP 2173.05（u），在审查过程中也删除了对ALIMTA的权利要求。
审理历史禁止反言PHE：我们知道，在审查过程中进行的范围缩小的修改会引起“审查历史禁止反言”的推论，该推论将禁止专利权人对放弃的主题主张构成等同侵权。
地方法院发现没有放弃，联邦巡回法院确认。这里首要的是简单的权利要求书的解释-原始（从属）权利要求书记载为“ ALIMTA”，而现在权利要求书记载为“培美曲塞二钠”。地区法院认为这些是同义词，联邦巡回法院同意了。Apotex认为应将ALIMTA视为涵盖所有形式的培美曲塞，因此将其删除应作为附加了限缩性修改。但是，法院基于专利文件中的内在证据拒绝了该论点。这是Apotex对上诉提出的唯一论点，因此败诉了。
法院没有针对更大的修改（抗叶酸=>培美曲塞二钠）提出的PHE。中间有一个延续申请，但是“您不能使用延续案来避免限缩性修改。” 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.
