聯(lián)邦巡回法院并存意見書建議全院重審先前判例中關(guān)于不適格專利主題的裁決

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發(fā)布：IPRdaily中文網(wǎng)（IPRdaily.cn）

作者：Robert Mallin律師 及Jason Jang律師

供稿：Brinks Gilson & Lione律師事務(wù)所

原標(biāo)題：聯(lián)邦巡回法院并存意見書建議全院重審先前判例中關(guān)于不適格專利主題的裁決

本月，美國(guó)聯(lián)邦巡回上訴法院在Roche Molecular Systems, Inc. v. Cepheid案件裁決中，支持了地區(qū)法院作出的因不適格專利主題導(dǎo)致專利無效的簡(jiǎn)易判決（summary judgment）。上訴法院認(rèn)為在先前判例In re BRCA1- & BRCA2-遺傳性癌癥測(cè)試專利訴訟 中含有與本案權(quán)利要求類似的技術(shù)，借此作為本案裁決依據(jù)。在一份并存意見書（concurring opinion）中，O’Malley法官建議全院重審BRCA1案的裁決。如果這一建議得到支持，它將會(huì)增強(qiáng)對(duì)其它生物技術(shù)發(fā)明的專利保護(hù)。

案件背景

原告Roche的美國(guó)專利5,643,723（723專利）包含使用一種被稱為“引物（primer）”的短單鏈核苷酸序列檢測(cè)病原菌方法的權(quán)利要求，以及其它針對(duì)“引物”本身的權(quán)利要求。

Roche指控Cepheid侵犯其723專利，Cepheid遞交了一份根據(jù)35 U.S.C. § 101請(qǐng)求批準(zhǔn)專利無效的簡(jiǎn)易判決動(dòng)議。美國(guó)加州北區(qū)地方法院根據(jù)聯(lián)邦巡回法院在BRCA1案中關(guān)于“引物”無效性的裁決，批準(zhǔn)了該動(dòng)議。具體來說，地區(qū)法院認(rèn)為本案權(quán)利要求根據(jù)§ 101為不適格專利主題，因?yàn)楸景浮耙铩睓?quán)利要求中所羅列的基因序列與自然界中發(fā)現(xiàn)的完全相同，并且與In Re BRCA1案中被裁定為不適格的專利主題沒有區(qū)別。

多數(shù)意見

聯(lián)邦巡回法院依據(jù)此前對(duì)BRCA1的裁決，維持了本案專利為不適格主題的簡(jiǎn)易判決。特別是，多數(shù)意見指出723專利中的“引物”具有與天然存在的DNA內(nèi)相同的核苷酸序列，就如BRCA1中的“引物”一樣。多數(shù)意見駁回了Roche的論點(diǎn)：基于3-prime end和3-prime羥基的存在，其合成的“引物”與天然存在的基因不同。多數(shù)意見認(rèn)為“該論點(diǎn)已在BRCA1案中闡述過。”

并存意見書

多數(shù)意見認(rèn)為BRCA1案的裁決促使723專利的權(quán)利要求為不適格專利主題這一結(jié)論獲得O’Malley法官認(rèn)同，但她單獨(dú)撰寫一份并存意見書以闡述她進(jìn)一步的觀點(diǎn)，既聯(lián)邦巡回法院應(yīng)至少對(duì)BRCA1案中關(guān)于“引物”權(quán)利要求的裁決進(jìn)行全院重審（revisit en banc）。在BRCA1案件之初，涉及一項(xiàng)對(duì)駁回初步禁令動(dòng)議的上訴。O’Malley法官指出BRCA1案的證據(jù)記錄不完整，并且聯(lián)邦巡回法院從BRCA1案中未獲得對(duì)本案某些論點(diǎn)和證據(jù)的支持，例如由Roche呈交的那些可支持“引物”權(quán)利要求屬于適格專利主題的材料。比方說，Roche證明了所主張的“引物”在結(jié)構(gòu)上可能與自然界中發(fā)生的任何結(jié)構(gòu)不同的方式。

O’Malley法官還將本案與最高法院在Association for Molecular Pathology v. Myriad Genetics, Inc.中的裁決進(jìn)行區(qū)分。特別是，與Myriad案中的權(quán)利要求不同，其既不是“以化學(xué)成分表示”也不依賴于“以任何方式通過分離特定DNA部分而導(dǎo)致的化學(xué)變化，”723專利中的“引物”權(quán)利要求明確使用化學(xué)成分表達(dá)，并且依賴于在非自然位置（non-naturally occurring location）存在的3-prime end和3-prime羥基。

啟示

O’Malley法官所建議的一些修改主張或可使Roche的“引物”專利成為適格專利主題，并且?guī)椭渌婕昂铣蒁NA的專利權(quán)利要求。如O’Malley法官建議全院重審BRCA1案得到支持，將可能帶來增強(qiáng)對(duì)其它生物技術(shù)發(fā)明的專利保護(hù)。

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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作者：Robert Mallin律師 及Jason Jang律師

供稿：Brinks Gilson & Lione律師事務(wù)所

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