联邦巡回法院并存意见书建议全院重审先前判例中关于不适格专利主题的裁决

　　本月，美国联邦巡回上诉法院在Roche Molecular Systems, Inc. v. Cepheid案件裁决中，支持了地区法院作出的因不适格专利主题导致专利无效的简易判决(summary judgment)。上诉法院认为在先前判例In re BRCA1- & BRCA2-遗传性癌症测试专利诉讼 中含有与本案权利要求类似的技术，借此作为本案裁决依据。在一份并存意见书(concurring opinion)中，O’Malley法官建议全院重审BRCA1案的裁决。如果这一建议得到支持，它将会增强对其它生物技术发明的专利保护。

　　案件背景

　　原告Roche的美国专利5,643,723(723专利)包含使用一种被称为“引物(primer)”的短单链核苷酸序列检测病原菌方法的权利要求，以及其它针对“引物”本身的权利要求。

　　Roche指控Cepheid侵犯其723专利，Cepheid递交了一份根据35 U.S.C. § 101请求批准专利无效的简易判决动议。美国加州北区地方法院根据联邦巡回法院在BRCA1案中关于“引物”无效性的裁决，批准了该动议。具体来说，地区法院认为本案权利要求根据§ 101为不适格专利主题，因为本案“引物”权利要求中所罗列的基因序列与自然界中发现的完全相同，并且与In Re BRCA1案中被裁定为不适格的专利主题没有区别。

　　多数意见

　　联邦巡回法院依据此前对BRCA1的裁决，维持了本案专利为不适格主题的简易判决。特别是，多数意见指出723专利中的“引物”具有与天然存在的DNA内相同的核苷酸序列，就如BRCA1中的“引物”一样。多数意见驳回了Roche的论点：基于3-prime end和3-prime羟基的存在，其合成的“引物”与天然存在的基因不同。多数意见认为“该论点已在BRCA1案中阐述过。”

　　并存意见书

　　多数意见认为BRCA1案的裁决促使723专利的权利要求为不适格专利主题这一结论获得O’Malley法官认同，但她单独撰写一份并存意见书以阐述她进一步的观点，既联邦巡回法院应至少对BRCA1案中关于“引物”权利要求的裁决进行全院重审(revisit en banc)。在BRCA1案件之初，涉及一项对驳回初步禁令动议的上诉。O’Malley法官指出BRCA1案的证据记录不完整，并且联邦巡回法院从BRCA1案中未获得对本案某些论点和证据的支持，例如由Roche呈交的那些可支持“引物”权利要求属于适格专利主题的材料。比方说，Roche证明了所主张的“引物”在结构上可能与自然界中发生的任何结构不同的方式。

　　O’Malley法官还将本案与最高法院在Association for Molecular Pathology v. Myriad Genetics, Inc.中的裁决进行区分。特别是，与Myriad案中的权利要求不同，其既不是“以化学成分表示”也不依赖于“以任何方式通过分离特定DNA部分而导致的化学变化，”723专利中的“引物”权利要求明确使用化学成分表达，并且依赖于在非自然位置(non-naturally occurring location)存在的3-prime end和3-prime羟基。

　　启示

　　O’Malley法官所建议的一些修改主张或可使Roche的“引物”专利成为适格专利主题，并且帮助其它涉及合成DNA的专利权利要求。如O’Malley法官建议全院重审BRCA1案得到支持，将可能带来增强对其它生物技术发明的专利保护。

　　附：英文全文

　　Federal Circuit Concurring Opinion Recommends En Banc Review Of Prior Ineligible Subject Matter Decision

　　On October 9, 2018, the United States Court of Appeals for the Federal Circuit affirmed a grant of summary judgment of invalidity due to patent-ineligible subject matter in Roche Molecular Systems, Inc. v. Cepheid, No. 2017-1690, applying its prior holding concerning claims directed to similar technology in In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755, 760 (Fed. Cir. 2014). In a concurring opinion, Judge O’Malley recommended that the full court revisit the holding in BRCA1. If the full court decides to revisit BRCA1, this could strengthen patent protection for other biotech inventions.

　　Background

　　Roche’s U.S. Pat. No. 5,643,723 includes claims directed to a method for detecting a pathogenic bacterium using a short, single-stranded nucleotide sequence known as a “primer” and other claims directed to the primers themselves.

　　Roche accused Cepheid of infringing the ‘723 patent and Cepheid filed a motion for summary judgment of invalidity under 35 U.S.C. § 101. The U.S. District Court for the Northern District of California granted the motion, relying on the Federal Circuit’s holding in BRCA1 relating to primers. Specifically, the district court held that the claims were unpatentable under § 101 because “the primer claims in this case, which have genetic sequences identical to those found in nature, are indistinguishable from those held to be directed to nonpatentable subject matter in In Re BRCA1.”

　　Majority Opinion

　　The Federal Circuit affirmed the summary judgment of patent ineligibility based on its prior holding in BRCA1. Specifically, the majority noted that the primers of the ‘723 patent have identical nucleotide sequences as naturally occurring DNA, just like the primers in BRCA1. The majority rejected Roche’s argument that its synthetic primers differed from those in the naturally-occurring gene based on the presence of a 3-prime end and 3-prime hydroxyl group, noting that the “same argument was made in BRCA1.”

　　Concurring Opinion

　　Although Judge O’Malley agreed with the majority that BRCA1 compelled the conclusion that the claims of the ‘723 patent are not patent-eligible subject matter, she wrote separately to express her further view that the Federal Circuit should revisit en banc the holding in BRCA1 at least with respect to Roche’s primer claims. BRCA1 involved an appeal from the denial of a preliminary injunction motion brought early in that case. Judge O’Malley noted that the record in BRCA1 was underdeveloped and the Federal Circuit in BRCA1 did not have the benefit of certain arguments and evidence, such as those presented by Roche, which could support a finding that the primer claims are patent eligible. For example, Roche demonstrated the ways in which the claimed primers may differ structurally from anything that occurs in nature.

　　Judge O’Malley also distinguished the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). In particular, unlike the claims in Myriad, which were neither “expressed in terms of chemical composition, nor” reliant “in any way on the chemical changes that result from the isolation of a particular section of DNA,” the primer claims in the ’723 patent are expressed in terms of chemical composition and are reliant on the presence of a 3-prime end and a 3-prime hydroxyl group at a nonnaturally occurring location.

　　Takeaway

　　Some of the alleged modifications that Judge O’Malley suggests might render Roche’s primers patent eligible and could save other patent claims directed to synthetic DNA. If the full court agrees with Judge O’Malley’s suggestion to revisit BRCA1, this may strengthen patent protection for other biotech inventions.

　　

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