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从Helsinn v. Teva案看申请前商业行为形成的专利障碍

  • Categories:最新消息
  • Author:华讯知识产权
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  • Time of issue:2019-02-01 00:36
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(Summary description)2019年1月22日,美国最高法院针对「先前私下订定的合约」是否形成「on-salebar」作出意见,认为在专利申请前,即使相关产品是秘密销售,公众无法获取产品的技术细节,也可能成为专利无效的证据。On-SaleBar(销售阻碍)根据美国的发明法案(AIA),在专利申请前(包括新颖性优惠期前)有销售行为或是销售之要约等行为,表示「发明已经完成(reducedtopractice)」,并能提出专利申

从Helsinn v. Teva案看申请前商业行为形成的专利障碍

(Summary description)2019年1月22日,美国最高法院针对「先前私下订定的合约」是否形成「on-salebar」作出意见,认为在专利申请前,即使相关产品是秘密销售,公众无法获取产品的技术细节,也可能成为专利无效的证据。On-SaleBar(销售阻碍)根据美国的发明法案(AIA),在专利申请前(包括新颖性优惠期前)有销售行为或是销售之要约等行为,表示「发明已经完成(reducedtopractice)」,并能提出专利申

  • Categories:最新消息
  • Author:华讯知识产权
  • Origin:
  • Time of issue:2019-02-01 00:36
  • Views:
Information

2019年1月22日,美国最高法院针对「先前私下订定的合约」是否形成「on-sale bar」作出意见,认为在专利申请前,即使相关产品是秘密销售,公众无法获取产品的技术细节,也可能成为专利无效的证据。

On-Sale Bar(销售阻碍)

根据美国的发明法案(AIA),在专利申请前(包括新颖性优惠期前)有销售行为或是销售之要约等行为,表示「发明已经完成(reduced to practice)」,并能提出专利申请,就使得这个行为构成专利的先前技术。("the invention was reduced to practice and therefore was ready for patenting before the critical date", Helsinn v. Teva (Fed. Cir. 2017))

 

Critical Date(关键日期)

Critical Date(关键日期)为pre-AIA美国专利申请日前一年,或是AIA有效申请日前一年的那天。所述销售阻碍(On-Sale Bar)的Pfaff原则主要是基于两个条件:(1)在关键日期(critical date)前申请专利范围中的发明已经商业销售,或已经有供应要约,以及(2)发明预备好可申请专利。(Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998))

 

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. 案件背景

Ø   请愿人(上诉):Helsinn Healthcare S. A. (赫尔辛医疗公司)

系争技术是用于治疗癌症病人化疗引起的恶心和呕吐的药物Aloxi(学名为Palonosetron,中文为帕洛诺司琼),请愿人Helsinn与美国制药公司MGI签订销售合约,合约载明保密的义务,两年多后(2003年),Helsinn提出美国临时专利申请案(provisional application),之后在10年内提出4件主张此临时案优先权的后续申请案(US7,947,724、US7,947,725、US7,960,424、US8,598,219),第四件在2013年,刚好是AIA施行的那年,这件专利在包括中国的全球几十个国家和地区进行了申请,但在中国未获得授权。

2011年,以色列仿制药巨头Teva(梯瓦制药公司)从FDA寻求审批销售Aloxi,Helsinn发现后起诉Teva侵犯其美国专利US8,598,219,Teva抗辩称此产品在Helsinn的专利申请日(因为涉及有效申请日/新颖性优惠期等日期,这里称critical date)前已经有销售之要约(offer for sale),认为专利不具新颖性(35 U.S.C. 102),因此专利是无效的。

Ø   地方法院阶段

地院经调查后,认为这个案件中Helsinn和MGI双方都未公开过相关发明的技术方案,不适用35 U.S.C. 102不具新颖性的規定,因此专利有效。

Ø   CAFC阶段

法官认为发明在critical date前的销售/销售之要约表示已经完成且预备提出专利申请,而以on-sale bar判定系争专利相关申请专利范围无效。

Ø   议题一:在此critical date以前的销售之要约(包括销售)行为(即便没有公开发明细节)是否构成新颖性前案?

议题二:「秘密合约或交易」是否仍阻碍专利新颖性?

 

美国最高法院见

一、被要求保密的第三方商业销售可能会让发明落于102(a)规范的「on-sale」。

"A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under §102(a)."

 

二、最高法院前例解释支持本次意见,所述102规定的「sale或offer of sale」不仅只在让公众知悉的发明才能成为先前技术。

"This Court’s precedent interpreting that provision supports the view that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art."

 

三、同意CAFC决定,认同最高法院pre-AIA前例所认定「秘密销售」可以无效后续专利权。

"The Federal Circuit had made explicit what was implicit in this Court’s pre-AIA precedent, holding that “secret sales” could invalidate a patent."

 

四、如果AIA后的102用相同语言,也适用过去司法解释。

"the Court applies the presumption that when Congress reenacted the same “on sale” language in the AIA, it adopted the earlier judicial construction of that phrase."

 

五、AIA后102(a)(1)增加的「or otherwise available to the public」这句话仍不足以让法院认为有改变「on sale」的意义。

"The addition of the catchall phrase “or otherwise available to the public” is not enough of a change for the Court to conclude that Congress intended to alter the meaning of “on sale."

[法条补充] 102(a)(1)

35 U.S.C. 102 CONDITIONS FOR PATENTABILITY; NOVELTY

(a) NOVELTY; PRIOR ART.--A person shall be entitled to a patent unless--

(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention;

 

结语

根据这件美国最高法院的意见,专利法35 U. S. C. §102(b)/102(a)(1)的一年新颖性优惠期条款中「disclosure」即涵盖了「秘密"销售"合约」,最高法院强调这是涉及「商业销售」的合约,表示发明已经完成,落于102下解释的「critical date of on-sale」,因此必须在销售合约后一年内提出发明相关的专利申请案(第一案)。

根据Helsinn v. Teva案内容,Helsinn与药厂MGI合约载明专利药的方程式内容,使得法院判定在专利critical date前已经商业营销,也就是发明已经完成,触发on-sale bar,这表示critical date前「合约内是否载明专利内容」是触发on-sale bar的关键因素之一。所述on-sale bar不仅包括销售,还包括销售要约(offer for sale),也就是供货商与经销商/批发商之间的合约,法院祭出on-sale bar就是要避免发明人利用商业手法超越专利的法定期限。

因此,专利布局非常重要,重要到需要在完成发明前就布好局,不能将「卖这个东西不代表揭露其中发明内容」当作「申请在后」的一种安慰,最好还是在销售前已经完成专利申请,或是在优惠期内完成申请,并且还要考虑各国不同的优惠期规定,都要个别符合法规才行。

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Electronic Arts pledges free use for five accessibility patents

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