第七章 結論與建議
第三節 對未來研究的建議
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第三節 對未來研究的建議
本研究係就專利發明人適格與專利權歸屬的議題進行探討，雖然鎖定在生技 製藥產業併購交易的盡職調查情況下，但是併購交易中許多第一手的機密文件與 資料，非當事人實難取得。為了克服此資料取得的困難，本研究係藉由美國法院 判決所揭露的資料加以探討，倘若未來有相關實務經驗的研究者，在可能的情況 下可就第一手文件資料進行整理與討論，如此將能提供更多實務層面的分析與探 討。
本研究提及台灣生技製藥公司存在有高階經理人為專利發明人比例過高的 情形，然受限於時間與資源，並未對其他產業中相同的情況加以調查與探討，亦 未從企業管理的層面上就此議題加以分析研究；建議有興趣的研究者可以對此加 以研究並提出建議。
雖然透過詳細且確實的盡職調查，就專利發明人適格以及專利權歸屬的情況 加以確認，但仍無法百分之百保證日後不會有相關的訴訟產生；在美國或歐洲有 些國家的公司有提供專利保險的服務，藉由專利保險來分散這些不可預知的風險，
建議未來亦可透過研究針對相關的議題進行探討。
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參考文獻
專書
01. 林正寶, 謝銘元. 企業併購
:
國際觀點. 二版 ed. 台北市: 新陸書局出版, 2015.02. 陳哲宏, 陳逸南, 謝銘洋, and 徐宏昇. 專利法解讀. 一版. ed. 臺北市: 月 旦出版, 1994.
03. 陳桂恒, and 蘇宜成. 生技醫藥研發成果商業化理論與實務
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技術.
法規.
智 財.
商業及策略評估. 初版. ed. 台北市: 華泰文化, 2012.04. 游明德, 李宜樺, 林瓊瀛, 翁麗俐, 黃小芬, 楊敬先, 劉國佑, and 謝淑美.
企業併購策略與最佳實務. 二版 ed. 台北市: 資誠教育基金會, 2014.
05. 謝銘洋. 智慧財產權法. 七版 ed. 台北市: 元照, 2016.
期刊論文
01. Adda, C. Gogoris, and J. Clarke Patricia. "Patent Due Diligence in Biotechnology Transactions." Nature Biotechnology 19, no. 2 (2001): 175.
02. Hantos, Susanne. "Helping Others Acquire, License or Invest in Patents with Confidence – a Guide for Patent Searchers to Patent Due Diligence." World Patent Information 32, no. 3 (2010): 188-97.
03. Konski, Antoinette F., and Linda X. Wu. "Inventorship and Authorship." Cold Spring Harbor Perspectives in Medicine 5, no. 11 (2015): a020859.
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04. Richman, Barak D., Will Mitchell, Elena Vidal, and Kevin Schulman.
"Pharmaceutical M&Amp;a Activity: Effects on Prices, Innovation, and Competition.". Loyola University of Chicago Law Journal 48, no. 3 (2017): 787-819.
05. Sheldon, Jeffrey G. "Intellectual Property Due Diligence in Acquisitions and Mergers." The Licensing Journal 24, no. 8 (2004): 9-15.
06. Walsh, Gary. Pharmaceutical Biotechnology: Concepts and Applications. John Wiley & Sons, 2007.
07. 王世晞. "製藥產業之演進、現況、與趨勢." 國立臺灣大學, 2004.
08. 王立達, and 陳師敏. "專利間接侵權之制度規範：我國判決實證研究與法制 建議." 科技法學評論 11, no. 2 (2014): 41-86.
09. 王偉霖. "我國學術機構技術移轉機制實施成效與法律制度之檢討." 科技法 學評論 4, no. 2 (2007): 59-96.
10. 王靖傑. "企業策略與國家文化對跨國購併之影響 : 以鴻海購併夏普為例."
國立政治大學, 2016.
11. 王碩汶. "專利稽核之研究." 世新大學, 2008.
12. 江雅鈴. "從生技新藥產業觀點探討大學之智慧財產管理." 國立政治大學, 2008.
13. 吳東哲. "藥品的核准前專利爭端解決程序－ 美國專利連結為借鏡." 碩士論 文--國立政治大學法律科際整合研究所 104., 2016.
14. 呂明美. "企業策略性併購之法律分析及個案研究." 國立臺灣科技大學, 2012.
15. 宋皇志. "專利交易之交易風險及其控管策略." 科技管理學刊 20, no. 4 (2015): 1-27.
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16. 侯旻伸. "企業併購中法律盡職調查之目的及其範圍." 國立臺北大學, 2014.
17. 洪子秋. "生技製藥產業之技術商品化研究--由法規政策面分析." 國立政治 大學, 2010.
18. 范文昇. "論美國專利法及拜杜法案對生技產業發展之影響―兼論我國專利 法及科學技術基本法." 東吳大學, 2006.
19. 康琦. "論大學之科技研發成果與智慧財產權之運用—以專利管理為核心之 探討." 國立東華大學, 2006.
20. 郭靜芬. "從國際生技製藥業併購趨勢看台灣生技公司被併購價值." 國立臺 灣大學, 2017.
21. 陳則銘. "企業併購之相關智慧財產管理策略與法律規劃研究－以併購美國 高科技公司時之專利查核評估探微." 國立政治大學, 2004.
22. 陳斌. "美國專利法第 271 條(G)項「方法專利侵權」之研究." 國立交通大學, 2004.
23. 黃秀禎. "實地查核程序在企業併購之重要性分析." 國立臺北大學, 2008.
24. 楊芳祝. "生技製藥公司併購中智慧財產權相關法制及實務之研究." 東吳大 學, 2017.
25. 楊智傑. "反省美國拜杜法的理論與經驗." 科技法學評論 6, no. 1 (2009): 207-40.
26. 葉雲卿. "學研機構專利權共有型態與專利權歸屬之研究." 智慧財產評論 15, no. 1 (2018): 1-68.
27. 劉振泰, 蔡岳勳. "從美國專利改革法案看美國專利法新穎性要件之變革."
智慧財產評論 13, no. 1 (2015): 119-65.
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28. 蔡佳臻. "企業併購中智慧財產權相關問題之研究─以專利與品牌為中心."
世新大學, 2010.
29. 蔣瑞琴. "美國專利侵權訴訟之證據能力與舉證責任." 國立交通大學, 2005.
30. 蕭秉國. "論美國高科技產業併購專利策略與其法律問題研究." 中原大學, 2004.
產業研究報告
01. EvaluatePharma, "World Preview 2017, Outlook to 2022" (2017, Jun).
02. Igeahub, "TOP 10 Pharmaceutical Companies 2018" (2018).
03. J.P.Morgan, "2018 Global M&A Outlook" (2018).
04. QuintilesIMS Institute, "Outlook for Global Medicines through 2021" (2016).
05. The Pharmaceutical Research and Manufacturers of America, "Biopharmaceutical research industry profile 2016" (2017).
06. 中華民國經濟部工業局, "2017 生技產業白皮書" (2017).
07. 中華民國經濟部工業局, "2018 生技產業白皮書" (2018).
法院判決
01. 131 S. Ct. 2188 (2011).
02. 303 F.R.D. 254 (W.D.Pa. 2014).
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03. 443 F. Supp. 2d 570 (S.D.N.Y. 2006).
04. 447 US 303 (1980).
05. 487 F. Supp. 2d 1099, 1117-19 (N.D. Cal., 2007).
06. 583 F.3d 832, 841-842(Fed. Cir., 2009).
07. 838 F.3d 1283 (Fed. Cir. 2016)
08. 智慧財產法院 98 年度民專更（ㄧ）字第 1 號民事判決。
09. 智慧財產法院 101 年度民專訴字第 100 號。
10. 最高法院 104 年度台上字第 2077 號民事裁定。
網路資料
01. Drug Behemoth Novartis Simultaneously Announces Three Huge Deals. 來源：
http://www.businessinsider.com/r-novartis-exchanges-assets-with-glaxosmithkline-2014-22, (最後瀏覽日：2018.11.25.)
02. FDA, "Approved Risk Evaluation and Mitigation Strategies (REMS)" 來源:
https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm （ 最 後 瀏 覽
日:2018.11.25）03. FDA, "Developing Products for Rare Diseases & Conditions”, 來 源 :
https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/de fault.htm （最後瀏覽日: 2018.11.25）
04. Gilead bets $11 billion on hepatitis in Pharmasset deal. 來 源 ：
https://www.reuters.com/article/us-gilead-pharmasset-idUSTRE7AK0XU20111121, (最後瀏覽日：2018.11.25.)
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05. Pfizer, Allergan scrap $160 billion deal after U.S. tax rule change. 來 源 ： https://www.reuters.com/article/us-allergan-m-a-pfizer-idUSKCN0X3188, (最後 瀏覽日：2018.11.25.)
06. 林 孝 樺 , " 專 利 懸 崖 對 藥 廠 R&D 的 影 響 ", (2015). 來 源 ：
http://www.phycos.com.tw/articles/162, (最後瀏覽日：2018.11.25).
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Petar Vazharov7 5
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(註 1) 指本研究檢索期間內之歷任董事長及總經理。
(註 2) 原為宇昌生技，2009 年更名為中裕新藥。
(註 3) 原為杏國生技，2012 年更名為杏國新藥。
(註 4) 原為順天生技，2014 年更名為順天醫藥。
(註 5) 原為基亞疫苗, 2017 年更名為高端疫苗。
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Gordon Binder, Kevin Sharer, Robert Bradway
Gordon Binder, Kevin Sharer, Robert Bradway
1045 0
Gilead Sciences, Inc.
Donald Rumsfeld, John Martin
John Martin,
John Milligan 478 0
Celgene Corporation
Robert Hugin;
Mark Alles
John Jackson, Sol Barer, Robert Hugin, Mark Alles
310 1 (註 2)
Biogen, Inc.
William Young, Stelios
Papadopoulos
James Mullen, George Scangos, Michel Vounatsos
413 0
Regeneron Pharmaceuticals, Inc.
P. Roy Vagelos Leonard Schleifer 440 0
Mylan Inc. Mike Puskar, Robert Coury
Mike Puskar, Robert Coury, Heather Bresch
97 0
Alexion
Pharmaceuticals, Inc.
Max Link, David Brennan
Lenard Bell, David Hallal, Ludwig Hantson
87 0
Vertex
Pharmaceuticals, Inc.
Jeffrey Leiden
Joshua Boger, Matthew Emmens, Jeffrey Leiden
866 0
BioMarin Pharmaceutical, Inc.
Fred Price, Jean-Jacques Bienaimé
Fred Price, Jean-Jacques Bienaimé
79 0
CytRx Corporaton Max Link, Steven Kriegsman
Max Link,
Steven Kriegsman 14 0
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Total 3829 1 (註 1) 指本研究檢索期間內之歷任董事長及執行長。
(註 2) Patent no.: US 7,435,726
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附錄四 本文相關美國專利法律條文原文
35 U.S.C. §100 Definitions.
(f) The term "inventor" means the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention.
(g) The terms "joint inventor" and "coinventor" mean any 1 of the individuals who invented or discovered the subject matter of a joint invention.
35 U.S.C. §101 Inventions patentable.
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. §115 Inventor’s oath or declaration.
(a) NAMING THE INVENTOR; INVENTOR’S OATH OR DECLARATION.—An application for patent that is filed under section 111(a) or commences the national stage under section 371 shall include, or be amended to include, the name of the inventor for any invention claimed in the application. Except as otherwise provided in this section, each individual who is the inventor or a joint inventor of a claimed invention in an application for patent shall execute an oath or declaration in connection with the application.
(b) REQUIRED STATEMENTS.—An oath or declaration under subsection (a) shall contain statements that—
(1) the application was made or was authorized to be made by the affiant or declarant; and
(2) such individual believes himself or herself to be the original inventor or an original joint inventor of a claimed invention in the application.
(c) ADDITIONAL REQUIREMENTS.—The Director may specify additional information relating to the inventor and the invention that is required to be included in an oath or declaration under subsection (a).
(d) SUBSTITUTE STATEMENT.—
(1) IN GENERAL.—In lieu of executing an oath or declaration under subsection (a), the applicant for patent may provide a substitute statement under the
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circumstances described in paragraph (2) and such additional circumstances that the Director may specify by regulation.
(2) PERMITTED CIRCUMSTANCES.—A substitute statement under paragraph (1) is permitted with respect to any individual who—
(A) is unable to file the oath or declaration under subsection (a) because the individual—
(i) is deceased;
(ii) is under legal incapacity; or
(iii) cannot be found or reached after diligent effort; or
(B) is under an obligation to assign the invention but has refused to make the oath or declaration required under subsection (a).
(3) CONTENTS.—A substitute statement under this subsection shall—
(A) identify the individual with respect to whom the statement applies;
(B) set forth the circumstances representing the permitted basis for the filing of the substitute statement in lieu of the oath or declaration under subsection (a);
and
(C) contain any additional information, including any showing, required by the Director.
(e) MAKING REQUIRED STATEMENTS IN ASSIGNMENT OF RECORD.—
An individual who is under an obligation of assignment of an application for patent may include the required statements under subsections (b) and (c) in the assignment executed by the individual, in lieu of filing such statements separately.
(f) TIME FOR FILING.—The applicant for patent shall provide each required oath or declaration under subsection (a), substitute statement under subsection (d), or recorded assignment meeting the requirements of subsection (e) no later than the date on which the issue fee is paid.
(g) EARLIER-FILED APPLICATION CONTAINING REQUIRED STATEMENTS OR SUBSTITUTE STATEMENT.—
(1) EXCEPTION.—The requirements under this section shall not apply to an individual with respect to an application for patent in which the individual is named as the inventor or a joint inventor and that claims the benefit under section 120 , 121, 365(c), or 386(c) of the filing of an earlier-filed application, if—
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(A) an oath or declaration meeting the requirements of subsection (a) was executed by the individual and was filed in connection with the earlier-filed application;
(B) a substitute statement meeting the requirements of subsection (d) was filed in connection with the earlier filed application with respect to the individual; or
(C) an assignment meeting the requirements of subsection (e) was executed with respect to the earlier-filed application by the individual and was recorded in connection with the earlier-filed application.
(2) COPIES OF OATHS, DECLARATIONS, STATEMENTS, OR ASSIGNMENTS.—Notwithstanding paragraph (1), the Director may require that a copy of the executed oath or declaration, the substitute statement, or the assignment filed in connection with the earlier-filed application be included in the later-filed application.
(h) SUPPLEMENTAL AND CORRECTED STATEMENTS; FILING ADDITIONAL STATEMENTS.—
(1) IN GENERAL.—Any person making a statement required under this section may withdraw, replace, or otherwise correct the statement at any time. If a change is made in the naming of the inventor requiring the filing of 1 or more additional statements under this section, the Director shall establish regulations under which such additional statements may be filed.
(2) SUPPLEMENTAL STATEMENTS NOT REQUIRED.—If an individual has executed an oath or declaration meeting the requirements of subsection (a) or an assignment meeting the requirements of subsection (e) with respect to an application for patent, the Director may not thereafter require that individual to make any additional oath, declaration, or other statement equivalent to those required by this section in connection with the application for patent or any patent issuing thereon.
(3) SAVINGS CLAUSE.—A patent shall not be invalid or unenforceable based upon the failure to comply with a requirement under this section if the failure is remedied as provided under paragraph (1).
(i) ACKNOWLEDGMENT OF PENALTIES.—Any declaration or statement filed pursuant to this section shall contain an acknowledgment that any willful false statement made in such declaration or statement is punishable under section 1001 of title 18 by fine or imprisonment of not more than 5 years, or both.
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35 U.S.C. §116 Inventors.
(a) JOINT INVENTIONS.—When an invention is made by two or more persons jointly, they shall apply for patent jointly and each make the required oath, except as otherwise provided in this title. Inventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent.
(b) OMITTED INVENTOR.—If a joint inventor refuses to join in an application for patent or cannot be found or reached after diligent effort, the application may be made by the other inventor on behalf of himself and the omitted inventor. The Director, on proof of the pertinent facts and after such notice to the omitted inventor as he prescribes, may grant a patent to the inventor making the application, subject to the same rights which the omitted inventor would have had if he had been joined. The omitted inventor may subsequently join in the application.
(c) CORRECTION OF ERRORS IN APPLICATION.—Whenever through error a person is named in an application for patent as the inventor, or through an error an inventor is not named in an application, the Director may permit the application to be amended accordingly, under such terms as he prescribes.
35 U.S.C. §161 Patents for plants.
Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. §171 Patents for designs.
(a) IN GENERAL.—Whoever invents any new, original, and ornamental design for an article of manufacture may obtain a patent therefor, subject to the conditions and requirements of this title.
(b) APPLICABILITY OF THIS TITLE.—The provisions of this title relating to patents for inventions shall apply to patents for designs, except as otherwise provided.
(c) FILING DATE.—The filing date of an application for patent for design shall be the date on which the specification as prescribed by section 112 and any required drawings are filed.
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35 U.S.C. §256 Correction of named inventor.
(a) CORRECTION.—Whenever through error a person is named in an issued
(a) CORRECTION.—Whenever through error a person is named in an issued