案件資訊：
上訴人：IN RE: JANSSEN BIOTECH, INC., NEW YORK UNIVERSITY
系爭專利：US6,284,471（PTAB no. 90/012,851）
本案緣起USPTO、PTAB都在ex parte re-examination程序中作出因為重複專利（doctrine of obviousness-type double patenting）使得系爭專利無效（Claims 1-7）的決定。
系爭專利US6,284,471提出一種抗TNFA抗體（Anti-TNFalpha）以及相關測試（ANTI-TNFα ANTIBODIES AND ASSAYS EMPLOYING ANTI-TNFα ANTIBODIES），這是關於組織中腫瘤壞死因子"tumor necrosis factor"的抗體。
1. A chimeric antibody comprising at least part of a human immunoglobulin constant region and at least part of a non-human immunoglobulin variable region, said antibody capable of binding an epitope specific for human tumor necrosis factor TNFα, wherein the non-human immunoglobulin variable region comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 3 and SEQ ID NO: 5.
PTAB no. 90/012,851：
本次系爭專利的"母案"與PTAB結論：
法院先說明"doctrine of obviousness-type double patenting"：這個不予專利理由是要禁止核准與"第一件"專利沒有專利性區隔（patentably distinct）的"第二件"專利，避免不當延長專利權。
“The doctrine of obviousness-type double patenting is intended to prevent the extension of the term of a patent by prohibiting the issuance of the claims of a second patent that are not patentably distinct from the claims of the first patent.”
一些歷史：
本案爭議在專利權人Janssen主張系爭專利在35 U.S.C. § 121 的保護範圍內（避風港safe-harbor）。實務上，即便是121規範下的延續專利，仍會面對落入重複專利的問題（MPEP 804），而本次系爭專利是一路CIP下來的案子，這樣的案子是否仍在避風港內？甚至比CA/DIV案更有風險。
系爭專利面對自己的母案（No. 08/013,413）的阻礙，系爭專利屬於一個龐大專利家族的一員，常見於生技公司的專利佈局，其中不免會自己踩到自己，法院就將這些系爭關係畫個簡圖：
法院也同時理出相關專利的審查過程，包括在許多相近技術之間曾經處理的限制選擇、重複專利核駁、修正...等，細節過多不在此討論，有興趣者可看判決書。
2013年，系爭專利被提起再審程序（reexamination），USPTO即作出重複專利核駁，專利權人為了要直接取得更早母案'413的優先權而刪除了不被'413涵蓋的揭露內容與專利範圍，另一目的也想將系爭專利從CIP變成DIV案。
但是USPTO並不認同，即便Janssen作出了一些舉措，仍認為系爭專利有重複專利的問題。到了PTAB，委員會意見是，當過去專利權人主動/深思熟慮地提出CIP案（使用了母案內容以及母案以外的內容），此時，並不允許（或說認同）專利權人在再審程序中通過修正排除過去處心積慮佈局得到的專利，來獲得「避風港」的好處。
"The Board “found no reason to permit Janssen now, by amendment, to acquire the benefit of the safe harbor when Janssen voluntarily and deliberately filed a continuation-in-part application with claims directed to subject matter absent from the ’413 application and outside the scope of its restriction."
PTAB似乎是不認同專利權人在面對重複專利問題時的"心態"。
"The Board then applied the one-way test for double patenting because it found that there were at least four instances where Janssen’s actions “constituted deliberate and unnecessary actions that lengthened the prosecution time of the ’093 application.”"
專利權人上訴CAFC：
進入CAFC的主要議題是，是否系爭專利'471可以在專利法121條的避風港內而排除基於自己母案'272與'195的核駁意見？
反過來講，若專利處於「避風港」內（延續案形成的家族內），則可以排除重複專利的核駁意見（應該是指obviousness-type double patenting）。
法院的態度是：根據案例Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir. 2008)的啟示，DIV申請案與專利才在121法條規範的避風港內。
"Our precedent is clear: aside from the original application and the original patent, the protection afforded by § 121 is limited to divisional applications and patents issued on divisional applications."
此案例還有個特別的議題是：如本次系爭專利專利權人的行為，當多年後，CIP專利在再審程序中面對重複專利駁回時，可否通過修正將CIP改成DIV案而重新落於121條避風港內？
答案：Searle案已給答案：不行。此案表示，專利權人不能簡單在"reissue程序"中把CIP案改成DIV案而重回避風港。
"In Searle we answered this question in the reissue context, holding that the patent owner could not take advantage of the safe-harbor provision simply by designating the CIP as a divisional application in a reissue application years after the fact. 790 F.3d at 1354–55."
這似乎是「動機與心態」的考驗，當專利已經獲准多年，也可能享受了一段時間的好處，專利權人不能通過（很明顯的動機）修正又"回溯"到當初的樣貌，甚至是要刻意排除當初專利申請的企圖，這個動機並不容於法。
"We are persuaded by the reasoning in Searle that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.4 In Searle, the court assumed the reissue patent was properly grant-ed and still concluded the safe harbor did not apply."
因此，即便專利權人"多年後"通過修正讓專利從CIP轉變到DIV的狀態，這可能OK，卻不能"重回"避風港。
本案結論：程序上，不能將核准時為CIP案日後轉變成DIV案（其目的是重回避風港，更是司馬昭之心），系爭專利不適用避風港，使得專利落於顯而易見性重複專利中，專利無效。
"The ’471 patent cannot retroactively become, for the purposes of § 121, a “patent issued on” a divisional application after it already issued on a CIP application; not even if that CIP application is effectively redesignated as a divisional application during reexamination."
"Thus, here too, even assuming Janssen’s amendments made during reexamination were to become effective by way of a reexamination certificate, we conclude that the ’471 patent is not entitled to safe-harbor protection."
"Because the safe-harbor provision of 35 U.S.C. § 121 does not apply to the ’471 patent to protect it from invali-dation based on the ’272 and ’195 reference patents, and because Janssen is not entitled to the two-way test for obviousness-type double patenting, we affirm the Board’s rejection of claims 1–7 of the ’471 patent as unpatentable under the doctrine of obviousness-type double patenting."
my two cents:
本案例釐清「基於121法條的safe harbor」：
嚴格來說，僅DIV處於121避風港內；CIP案並不在避風港內。
本部落格曾有不少有關double patenting的報導，但並未涵蓋所有MPEP 804的情況，應該還有機會繼續補充，例如：
http://enpan.blogspot.tw/2011/02/double-patenting-i.html
http://enpan.blogspot.tw/2011/02/double-patenting-ii.html
http://enpan.blogspot.tw/2013/03/double-patenting-iii.html
http://enpan.blogspot.tw/2015/11/double-patenting-iv.html
涉及法條：35 U.S.C. § 121 Divisional Applications
If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions. If the other invention is made the subject of a divisional application which complies with the requirements of section 120 it shall be entitled to the benefit of the filing date of the original application. A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application. The validity of a patent shall not be questioned for failure of the Director to require the application to be restricted to one invention.
判決書：http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-1257.Opinion.1-19-2018.1.PDF（備份：https://app.box.com/s/gtlxnb68vnze4jo0d03329sje7f965p0）
參考資料：
https://patentlyo.com/patent/2018/01/patent-blockbuster-remicade.html
https://www.bitlaw.com/source/mpep/804.html
Ron
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