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| Title: | 論化學發明之非顯而易知性—美國聯邦巡迴上訴法院案例分析
Non-obviousness in chemical invention - an analysis of CAFC case study |
| Authors: | 黃俊傑
Hwang, Jiunn-Jye |
| Contributors: | 熊誦梅
楊雲驊
Hsiung, Sung-Mei
Yang, Yun-Hua
黃俊傑
Hwang, Jiunn-Jye |
| Keywords: | 化學發明
非顯而易知性
顯而易知的嘗試
先導化合物分析
Chemical invention
Non-obviousness
Obvious to try
Lead compound analysis |
| Date: | 2017 |
| Issue Date: | 2017-07-11 11:56:33 (UTC+8) |
| Abstract: | 化學發明是專利申請領域別中另一個重要的領域，醫學藥品的龐大商機是重要的推手，因為大多數藥物的活性成份為有機小分子化合物，且研發一新藥，須費時10到15年，研發經費估計高達26億美金，各大專利藥廠當然積極申請專利，保護投資。另一方面，Hatch-Waxman Act鼓勵學名藥可以盡早上市，使一般民眾能以較便宜的價格取得所需藥品。在美國藥品市場數千億美元的商機吸引下，學名藥廠積極挑戰專利藥廠之專利權。其中非顯而易知性要件認定，為雙方訴訟爭點。
然，化學發明的非顯而易知性要件認定之所以異於機械、電子、電機等技術，在於我們無法準確預測在奈米尺度的化學反應與分子的物性與化性，因而產生化學反應結果的不可預期性。而藥物研發是先從資料庫中，篩選出具一定活性的化合物作為先導化合物，經由取代基的引入、改變，或官能基的置換，結合活性與化合物結構關係（SAR），達成先導化合物結構最佳化，以快速、準確的找出候選藥物分子，進入臨床實驗。
2007年，美國聯邦最高法院在KSR案，針對非顯而易知性，重申Graham 案建立的非顯而易知性判斷法則的重要性，與重新適用顯而易知的嘗試。KSR判決後，許多文章討論KSR判決將不只針對機械組合發明，同時也將會對醫藥化學發明非顯而易知性之認定標準，產生一定的影響。
本論文研究KSR判決後， CAFC使用顯而易知的嘗試、與先導化合物分析（lead compound analysis）判斷準則，於醫藥產業化學發明專利的非顯而易知性的判決。CAFC於涉及組合藥物或配方調配案件，使用顯而易知的嘗試審查基準；使用先導化合物分析，都涉及系爭藥物中「活性成份結構」的非顯而易知性認定，CAFC針對不同類型的化學發明案件，採用了不同的審查基準。
KSR判決雖然重新啟用「顯而易知的嘗試」判斷準則，且CAFC適用「顯而易知的嘗試」的案件，亦明顯的增加。唯，本論文研究發現，於醫藥產業化學發明專利的非顯而易知性的判決，仍明顯高於對非藥品相關案件。
Chemical invention is one of key art in patent application driving from the huge market size of medicines, in which active ingredients are organic molecules. The average cost to research and develop each successful drug is estimated to be $2.6 billion US dollars, and took 10 to 15 years. In other word, whether pharmaceutical companies can recover their investment in drug development heavily depends on the patent protection of their drugs. On the other hand, the Hatch-Waxman Act introduced in 1984 created the generic drug pathway to the market, so general public can obtain the drugs at a affordable price. However, within this framework, the validity of drug patents are often challenged by generic manufactures, mainly the "non-obviousness" requirement in patent system.
During this lengthy and expensive drug discovery, chemist often entails making small modifications to lead compounds to establish structure-activity relationship (SAR) to speed up the process. Those modifications might be deemed “obvious to try”—and then studying the largely unpredictable, yet critical, resulting biological effects.
In 2007, the Supreme Court of the United States, in KSR decision, reasserted that a prima facie case of obviousness may be determined by the framework set forth in Graham and "obvious to try" test. Since then, there are predictions that KSR decision will have a substantial impact in pharmaceutical and life sciences arts.
This study, we examine the CAFC ruling in pharmaceutical arts regarding to "non-obviousness" issue by "obvious to try" and "lead compound analysis" test after the KSR decision. And found that the "non-obviousness" judgment of the chemical invention patent in the pharmaceutical industry was still significantly higher than that of the non-drug-related cases. |
| Reference: | 一、中文
（一）書名
1. 朱懷祖，新藥科技與智慧財產權保護，載：藥物科技發展與智財權保護：藥事法第四十條之一、之二修法論文集，中華景康藥學基金會，2006年。
（二）期刊
1. 朱淑尹，美國專利連結制度中專利登錄的介紹與探討，智慧財產權月刊，196期，頁21， 2015年4月。
2. 李森堙，談美國專利非顯而易知性與 TSM 判準之爭議，科技法律透析，第19 卷第 10 期，頁42，2007年10月。
3. 李素華，醫藥發明之專利個案探討：以我國長青樹藥品專利為例，臺大法學論叢，第41卷第2期，頁647，2012年6月。
4. 許義明，美國藥物專利之非顯而易知性審查-2007年KSR v. Teleflex判決後之看法(上)，萬國法律，155期，頁64，2007年10月。
5. 張哲倫，專利連結之歷史、緣由及其政策功能，智慧財產權月刊，196期，頁5， 2015年4月。
6. 董安丹，美國專利法上非顯著性之判斷（上）-化學發明非顯著性之研究，智慧財產權，39期，頁30，2002年3月。
7. 董安丹，美國專利法上非顯著性之判斷（下）-化學發明非顯著性之研究，智慧財產權，40期，頁33，2002年4月。
8. 熊誦梅，眾裡尋他千百度：談所屬技術領域中之通常知識者－從最高行政法院98年度判字第1277號判決談起，月旦法學雜誌，191期，頁129，2011年3月。
9. 鄭煜騰，美國專利法上化學發明之非顯而易知性研究（上），智慧財產權，153期，頁110，2011年9月。
10. 鄭煜騰，美國專利法上化學發明之非顯而易知性研究（下），智慧財產權，154期，頁55，2011年10月。
11. 鄭煜騰，王偉霖，美國專利法上的非顯而易知性研究，智慧財產評論，第9卷第2期，頁60，2011年12月。
12. 謝祖松，美國專利法上「具有通常技術者」之探討，臺北大學法學論叢，76期，頁43，2010年12月。
（三）論文
1. 胡閏祺，論美國專利法上非顯而易見性要件–以KSR v. Teleflex案為中心，國立中正大學財經法律學研究所碩士論文，2010年3月。
2. 黃柏維，從美國專利法析論非顯而易知性之相關爭議，國立政治大學智慧財產研究所碩士論文，2012年7月。
二、英文
（一）Books
1. PHILIP W. GRUBB and PETER R. THOMSEN, PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY: FUNDAMENTALS OF GLOBAL LAW, PRACTICE AND STRATEGY (5th ed. 2010).
（二）Periodicals
1. Standards of Obviousness and the Patentability of Chemical Compounds, 87 Harvard L. Rev. 607 (1974).
2. Briana Barron, Structural Uncertainty: Understanding The Federal Circuit’s Lead Compound Analysis, 16 Marq. Intell. Prop. L. Rev. 401 (2012).
3. Renee Bouley, et al., Discovery of Antibiotic (E)-3-(3-Carboxyphenyl)-2- (4-cyanostyryl)quinazolin-4(3H)-one, 137 J. Am. Chem. Soc. 1738 (2015).
4. Renee Bouley, et al., Structure-Activity Relationship for the 4(3H)-Quinazolinone Antibacterials, 59 J. Med. Chem. 5011 (2016).
5. Scott R. Conley, Irrational Behavior, Hindsight, and Patentability: Balancing the “Obvious to Try” Test with Unexpected Results, 51 IDEA 271 (2011).
6. Rebecca S. Eisenberg, Pharma’s Nonobvious Problem, 12 Lewis & Clark L. Rev. 375 (2008).
7. S. J. Lee and J. M. Butler, Teaching, Suggestion and Motivation: KSR v. Teleflex and the Chemical Arts, 17 Fordham Intell. Prop. Media & Ent. L. J. 915 (2007).
8. Guyan Liang, The Validity Challenge To Compound Claims And The (Un?)predictability Of Chemical Arts, 13 Wake Forest J. Bus. & Intell. Prop. L. 38 (2012).
9. Janice M. Mueller, Chemicals, Combinations, and ‘Commonsense’: How the Supreme Court’s KSR Decision Is Changing Federal Circuit Obviousness Determinations in Pharmaceutical and Biotechnology Cases, 35 N. KY. L. Rev. 281 (2008).
10. Peter I. O’Daniel, et al., Discovery of a New Class of Non- β -lactam Inhibitors of Penicillin-Binding Proteins with Gram-Positive Antibacterial Activity, 136 J. Am. Chem. Soc. 3664 (2014).
11. Robert H. Resis, Lessons to Learn: from Post-KSR Pharmaceutical Obviousness Decisions, 2 Landslide 38 ( November/December 2009).
12. Neil E. Rigler, and Henry R. Hass, Synthesisof Compounds with Hypnotic Properties. I. Alkoxymethylhydantoins, 58 J. Am. Chem. Soc. 474 (1936).
13. Roland K. Robins , Frederick Furcht, Alan D. Grauer and Jesse W. Jones, Potential Purine Antagonists. 11, Synthesis of Some 7- and 5,7-Substituted Pyrazolo [4,3-d lpyrimidines, 78 J. Am. Chem. Soc. 2418 (1956).
14. Douglas L. Rogers, Federal Circuit`s Obviousness Test For New Pharmaceutical Compounds: Gobbledygook?, 14 CHI. -KENT J. INTELL. PROP. 49 (2014).
15. Benjamin N. Roin, Unpatentable Drugs and the Standards of Patentability, 87 Tex. L. Rev. 503 (2009)
16. Brian Sodikoff, Christopher B. Ferenc and Patrick Abbott, Enantiomer Patents: Innovative or Obvious?, 12 Pharmaceutical Law & Industry Report 184 (2014).
17. Edward Spink, et al., Structure-Activity Relationship for the Oxadiazole Class of Antibiotics, 58 J. Med. Chem. 1380 (2015).
18. Michael H. Teschner and Keir J. LoIacono, Structure Has Little To Do With Structual Obviousness, New Jersey Law Journal, April 15, (2013).
19. Andrew V. Trask, “Obvious to Try”: A Proper Patentability Standard in the Pharmaceutical Art? 76 Fordam L. Rev. 2625 (2008).
20. David Tseng, Not All Patents Are Created Equal: Bias Against Predictable Arts Patents in the Post-KSR Landscape, 13 CHI. -KENT J. INTELL. PROP. 165 (2013).
21. Harold C. Wegner, Chemical and Biotechnology Obviousness in a State of Flux, 26 Biotechnology Law Report 437 (2007).
（三）Cases
1. Graham v. John Deere Co., 383 U.S. 1 (1966).
2. KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007).
3. In re Hass, 141 F.2d 122 (C.C.P.A. 1944).
4. In re Henze, 181 F.2d 196 (C.C.P.A. 1950).
5. In re Papesch, 315 F.2d 381 (C.C.P.A. 1963).
6. In re Stemniski, 444 F.2d 581 (C.C.P.A. 1971).
7. In re Dillon, 919 F.2d 688 (Fed. Cir. 1990) (en banc).
8. Pfizer, Inc. v. Apotex, Inc., 488 F.3d 1377 (Fed. Cir. 2007).
顯而易知的嘗試（obvious to try）
9. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007).
10. Sanofi-Synthelabo v. Apotex Inc., 550 F.3d 1075 (Fed. Cir. 2008).
11. Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009).
12. Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346 (Fed. Cir. 2013).
13. Leo Pharm. Products, Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013).
14. Hoffmann-La Roche Inc. v. Apotex, Inc., 748 F.3d 1326 (Fed. Cir. 2014).
15. Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., 748 F.3d 1354 (2014).
16. Shire LLC v. Amneal Pharms., LLC, 802 F.3d 1301 (Fed. Cir. 2015).
先導化合物分析（lead compound analysis）
17. Yamanouchi Pharmaceutical Co., Ltd. v. Danbury Pharmacal, Inc., 231 F.3d 1339 (Fed. Cir. 2000).
18. Eli Lilly and Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369 (Fed. Cir. 2006).
19. Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007).
20. Eisai Co. Ltd. v. Dr. Reddy`s Laboratories, Ltd., 533 F.3d 1353 (Fed. Cir. 2008).
21. Procter & Gamble Co. v. Teva Pharms.USA, Inc., 566 F.3d 989 (Fed. Cir. 2009).
22. Altana Pharma AG v. Teva Pharms.USA, Inc., 566 F.3d 999 (Fed. Cir. 2009).
23. Daiichi Sankyo Co., Ltd. v. Matrix Laboratories, Ltd., 619 F.3d 1346 (Fed. Cir. 2010).
24. Otsuka Pharm.Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012).
25. In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511 (Fed. Cir. 2012).
26. Pfizer Inc. v. Teva Pharms.USA, Inc., 555 Fed. Appx. 961 (Fed. Cir. 2014).
27. Bristol-Myers Squibb Co. v. Teva Pharms.USA, Inc., 752 F.3d 967 (Fed. Cir. 2014).
三、其他參考資料
1. Federal Register, Vol. 75, No. 169, 53643, September 2010.
2. IMS Institute report: Global Medicines Use in 2020: Outlook and Implications.
3. IMS Institute report: Medicines Use and Spending in the U.S.: A Review of 2015 and Outlook to 2020.
4. IMS report: Price Declines after Branded Medicines Lose Exclusivity in the U.S..
5. Mark A. Lemley, Expecting the Unexpected, working paper, September, 2015.
6. ndp | analytics: The Innovative Pharmaceutical Manufacturing Industry: Economic Growth.
7. PhRMA industry profile 2016.
8. PhRMA report: Biopharmaceutical R&D: The Process Behind New Medicines.
9. PharmaCompass - Final Annual report 2015_Compilation 25042016. |
| Description: | 碩士
國立政治大學
法學院碩士在職專班
99961018 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0099961018 |
| Data Type: | thesis |
| Appears in Collections: | [法學院碩士在職專班] 學位論文
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