On March 22, 2010, 的Federal Circuit issued an important 整个 维持美国《美国法典》第35卷下的单独书面说明要求的决定。§ 112. In 阿里亚德 Pharmaceuticals,Inc.诉Eli Lilly and Co., 的Court rejected 的patent owner’s contention that 的written description requirement is simply a part of 的enablement requirement, which requires that 的specification teach how to make and use 的invention. The Court had received over 25 amicus briefs. The decision keeps intact 的ability of patent infringement defendants to use 的written description requirement to force a narrow construction of broad claims and to invalidate genus claims where 的written description is expressly or implicitly limited to a species.

阿里亚德(Ariad)和包括麻省理工学院(MIT)和哈佛大学(Harvard)在内的一些研究机构已起诉礼来(Lilly)侵犯美国专利号6,410,516("the ‘516 patent"). The ‘516 patent relates to 的mechanism by which transcription factor NF-κB activates gene expression underlying 的body’s immune responses to infection. The inventors recognized that 上 e could reduce 的harmful symptoms of certain diseases by suppressing NF-κB活性,以及​​广泛要求保护的方法,可通过减少NF-调节细胞对外部刺激的反应κB activity. While 的specification hypothesized three types of molecules with 的potential to reduce NF-кB activity, 的claims are not directed to any specific substance that reduces NF-кB activity.

在2006年进行了14天的陪审团审判后,陪审团发现礼来’s Evista® and Xigris®产品侵犯了Ariad’s patent, and that 的asserted claims were not invalid for anticipation, lack of enablement or inadequate written description. Lilly appealed and, in 2009年4月, a Federal Circuit panel reversed 的jury’s verdict 上 written description, holding 的asserted claims invalid for lack of an adequate written description as required by 35 U.S.C. §112,第一段。阿里亚德上演了请愿 整个, challenging 的existence of a written description requirement separate from 的enablement requirement. In light of 的long-running controversy concerning 的distinctness and proper role of 的written description requirement, 的Court granted 阿里亚德’s petition, vacating 的prior panel opinion and directing 的parties to brief two questions:

(1)是否35 U.S.C.§112第1款包含书面描述要求和启用要求?
(2) If a separate written description requirement is set forth in 的statute, 什么 is 的scope and purpose of that requirement?

In a fairly straightforward analysis, 的majority opinion upheld 的existence of a separate written description requirement based 上 interpretation of 的statute, Supreme Court precedent, and 遵循先例 基于联邦巡回法庭的先例。多数人还指出阿里亚德’第112条明确要求的让步"a written description of 的invention." 阿里亚德 argued, however, that this was part of 的enablement requirement: "规范必须首先确定‘什么 的invention is, for otherwise it fails to inform a person of skill in 的art 什么 to make and use.’"法院认为这一论点是"没有实际差异的区别," and commented:

"although written description and enablement often rise and fall together, requiring a written description of 的invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and thus satisfy enablement, but that have not been invented, and thus cannot be described. For example, a propyl or butyl compound may be made by a process analogous to a disclosed methyl compound, but, in 的absence of a statement that 的inventor invented propyl and butyl compounds, such compounds have not been described and are not entitled to a patent."

阿里亚德进一步辩称,识别发明的第一步仅适用于优先权的背景下(即在起诉过程中修改的权利要求; 35​​ U.S.C.§§119,120;和干扰),因为原始要求“构成自己的描述。”法院也驳回了这一论点,指出它在规约中没有任何依据,广泛的主张并不一定表明申请人具有"足以支持属要求的发明物种。"法院重申,对属的充分描述反而需要披露属于该属范围内的代表性物种或该属成员共有的结构特征,以便本领域技术人员可以“可视化或识别”属的成员。引用 Regents of 的University of California v. Eli Lilly & Co.,119 F.3d 1559,1568-69(Cir。1997)。

多数人继续重申其"相当统一的标准" to be applied when assessing 的adequacy of 的written description: 

  • 说明必须“clearly allow persons of ordinary skill in 的art to recognize that [the inventor] invented 什么 is claimed,”或者换句话说,必须"reasonably convey to those skilled in 的art that 的inventor had 拥有 of 的claimed subject matter as of 的filing date." Vas-Cath Inc.诉Mahurkar,935 F.2d 1555,1563(Cir。1991)。的 阿里亚德 法院澄清说"possession" must be shown "in 的four corners of 的specification."
     
  • Whether a claim is supported by an adequate written description is a question of fact, which varies depending 上 的nature and scope of 的claims and 上 的complexity and predictability of 的relevant technology.
     
  • A description that merely renders 的invention obvious does not satisfy 的requirement. 洛克伍德诉美国航空公司,107 F.3d 1565,1571-72(Fed。Cir。1997)

Finally, 的majority rejected 阿里亚德’s policy argument that 的written description doctrine "disadvantages universities to 的extent that basic research cannot be patented." The Court noted: "That is no failure of 的law’s interpretation, but its intention. 专利权 are not awarded for academic theories, no matter how groundbreaking or necessary to 的later patentable inventions of others." Upon confirming 的existence of 的written description requirement, 的majority adopted 的analysis of 的panel decision, and invalidated 阿里亚德’s ‘516 patent based 上 的written description requirement.

毫不奇怪,联邦巡回法院的几位法官"additional views",持不同意见。纽曼法官加入了多数意见,但单独写信阐明她认为是"沉浸在修辞中"在大多数人看来,包括"第112节中逗号位置的语法差异。"纽曼法官认为,在证明专利制度的实际应用之前,可能不会对专利制度进行基础研究。一旦发生这种情况,专利权人有义务描述和启用该主题,以获取其专有权利,从而增加该实际应用的商业价值。加贾尔萨法官同意多数意见,但指出– correctly —第112条第1款的案文"是立法模棱两可的典范。"但是,加加尔萨法官认为,单独的书面说明要求不会产生重大的实际影响,"并在优先权范围内更好地服务于《专利法》的目标。"

In his dissenting opinion, Judge Rader, joined by Judge Linn, strongly disagreed with 的majority’的法定分析,并认为"Supreme Court precedent is fully consistent with 的logical reading of 的statute and impeaches this court’s 越权 对原始权利要求实施新的书面描述要求,这种要求最早出现于 Regents of 的University of California v. Eli Lilly & Co.,119 F.3d 1559,1566-69(Cir。1997)。" Judge Rader also observed 的tension between 的written description requirement and established rules of claim construction, whereby claims must be read in view of 的specification. Rader posits:

If this court followed its own rule and ensured that claims do not enlarge 什么 的inventor has described, then 的claims would never have a scope that exceeds 的disclosure in 的rest of 的specification. Thus, this court would never find a claim that “lacks support” (again, 什么ever that means) in 的rest of 的patent document. In other words, this court’仅当本法院无视其自身的债权解释规则时,新的书面描述学说才具有意义。

Judge Rader concludes that proper enforcement of 的enablement requirement, which is clear in 的statute, "提供了一个描述已经运行了数十年(即使不是几个世纪)的奇妙测试。"

However, unlike 的inequitable conduct doctrine, for which Judge Rader’s (and Judge Newman’s) criticisms have been gaining momentum, 的Court’s support for 的written description requirement appears to be 上 solid ground. Absent input from 的Supreme Court, it will remain a viable tool for accused infringers to force a narrow construction of or invalidate claims that are significantly broader than 的written description.

作者:
史蒂文·汉勒
(714)424-8293
[email protected]