6.2 訪談結果分析-我國產業現況尚不適合引進專利連結
2.3.5 原專利藥廠推出原廠學名藥
此種方法目的是為減損學名藥廠之 180 天之獨家市場銷售權利：此乃因 FDA 認為，
在第一家學名藥廠依 ANDA 上市而取得 180 天之獨家銷售權之期間，仍可核准原廠學 名藥之上市43。原廠學名藥上市將使藥品價格產生競爭，可嘉惠民眾使其有機會使用更 便宜之藥物，本不違反 HWA 之立法精神，惟原廠學名藥之推出，可能降低學名藥廠透 過 Paragraph IV 模式申請上市許可之誘因，蓋 Paragraph IV Certification 對於學名藥廠最 大之誘因即在於 180 天之市場獨家銷售權，若在獨家銷售期間仍容許原廠學名藥上市，
將大大減少學名藥廠本來可於 180 天內獲得之利益，尤其考慮到在此 180 天內消費者之
40 THE CONGRESS OF THE UNITED STATES CONGRESSIONAL BUDGET OFFICE, supra note 29.另外參照黃慧嫺，
「專利、學名藥廠專利侵權訴訟可否私了」，生技與醫療器材報導，第 76 期，第 24-25 頁，2005 年 10 月。
41 同註 40，黃慧嫺，「專利、學名藥廠專利侵權訴訟可否私了」，生技與醫療器材報導，第 76 期，第
24-25 頁，2005 年 10 月。
42 Beth Understahl, Authorized Generics: Careful Balance Undone, 16FORDHAM INTELL.PROP.MEDIA &ENT. L.J.355, 385-86 (2005).
43 Petition of Mylan Pharm. Inc., F.D.A. Docket No. 2004P-0075 (Feb. 2, 2004), available at www.fda.gov/ohrms/dockets/dailys/04/021804/04p-0075-cp00001-voll.pdf
(last visited Feb. 18, 2009); See also, Petition of Teva Pharm. USA, Inc., F.D.A. Docket No. 2004P-0261 (June 9, 2004), available at
www.fda.gov/ohrms/dockets/dailys/04/June04/061004/04p-0261-cp00001-01-voll.pdf (last visited Feb. 18,
消費慣性—若購買該學名藥在此 180 天中成為消費者習慣後，往後學名藥廠可能實際上 享有超過 180 天之市場利益，若此利益因原廠學名藥進駐市場而喪失，將減少學名藥廠 生產學名藥之動力，從學名藥業的發展而言可能具有不良影響。
2.4 2003 年 HWA 之修正
有鑒於上述理論與實務上操作發生之缺失，美國於 2003 年制訂 Medicare Prescription Drug, Improvement, and Modernization Act(MMA)44，對於 HWA 做出以下修正：
首先，為避免原廠之多重專利申請之訴訟策略，FDA 於修正後制訂新規則45，規定 提出 Paragraph IV Certification 之學名藥，每一種藥最多只能適用一次最長 30 個月的停 止審查。此外並對於得登錄於橘皮書之專利內容加以限縮，以減少侵權情形之發生46。 並且對於學名藥廠需挑戰其有效性之專利，限於學名藥廠提出 ANDA 前已登載於橘皮 書上之專利為限。種種措施在在反映美國政府根絕多重專利訴訟戰爭的決心。除此之 外，新法規定 ANDA 申請人必須於 FDA 受理 Paragraph IV Certification 之申請後 20 日 內通知原專利權人，以避免學名藥廠拖延其告知義務47。
再者，若專利權人未於45日內起訴，新法案賦予ANDA申請者得以主動提起確認之 訴(Declaratory Judgment)之權利，但提起確認之訴之前提，必須建立於ANDA所有人於 45日內充份告知專利權人並揭露其必要之產品資訊，以供專利權人有充分判斷是否提起 訴訟之機會48。是以若原專利藥廠未於45日內就專利侵權與否起訴時，ANDA 申請人得 向法院提起確認之訴，進而使法院得於FDA 上市許可審查核准通過之前， 對於該學名 藥是否侵權做出判決， 以減少學名藥上市後受侵權訴訟之可能，前述2.3.3節所述「被 開槍的風險」即可降低。
其三，對於原專利藥廠與學名藥之和解協議，MMA 於其中增訂，雙方所達成並簽
2009).
44 The Medicare Prescription Drug, Improvement, and Modernization Act, Pub. L. No. 108-173, 117 Stat. 2067 (2003), available at http://www.ustreas.gov/offices/public-affairs/hsa/pdf/pl108-173.pdf (last visited Feb.
19, 2009).
45 Final Rule on Generic Drugs, The Medicare Prescription Drug, Improvement, and Modernization Act, Pub. L.
No. 108-173, 117 Stat. 2067 (2003), available
athttp://www.cms.hhs.gov/MMAUpdate/downloads/PL108-173summary.pdf (last visited Feb. 19, 2009).
46 根據新法，應登錄於橘皮書之專利資訊，僅包括藥物活性成分、劑型、組合物、及用途。相關立法評
析請參照朱世霓，「美國學名藥上市長路漫漫」，科技法律透析，第 23 頁，2003 年 3 月。
47 21 U.S.C. §355(j)(2)(B)(ii).
48 21U.S.C. §355(j)(5)(C)(i), 35 U.S.C. §271(e)(5).
署的協議應向競爭主管機關申報49，根據該規定，該訴專利訴訟和解之私下協議至遲應 萬美元之經費予 FDA，用以改善學名藥計畫(Generic Drug Program)之執行成效53，並增 聘專家進行學名藥之審核，並設法改善內部審核作業，據報告指出，經此一番大刀闊斧 整頓後，應可縮短學名藥審查時間近三個月54。
49 參照 Title XI of the MMA—Access to Affordable Pharmaceuticals.
50 參照 Section 1112 of Subtitle B (Federal Commission Review) of Title XI of the MMA。
51 同註 1，第 4 頁。
52 FDA 於 2003 年修法後發布新登錄規則(Food and Drug Administration Final Rule 02N-0417, 21 C.F.R.
§314.53 (b)(1), 21 C.F.R. §514.53(b)(2), Comments to Final Rule 02N-0417 at 18,28,29)，將關於專利得登 錄之類型予以限縮，茲整理如下：
1. Any patents claiming metabolites, intermediates, or packaging features may not be submitted for listing in the Orange Book.
2. Polymorph patents may be submitted if they claim the same active ingredient as the approved product.
However, the applicant must now certify that they have test data demonstrating that a drug product containing the polymorph will perform the same as the original drug product, including demonstration of bioequivalence and comparative in vitro dissolution testing on the polymorph and the original drug product.
3. Product-by-process patents are listable in the Orange Book; however, new declaration forms require the applicant to certify that the patent being submitted is a product-by-process patent in which the product claimed is novel, as opposed to the process being novel. This certification is intended to eliminate the submission of patents that are actually process patents, which cannot be submitted for listing.
4. Patents on unapproved methods of use cannot be submitted. Furthermore, patent information submitted claiming approved methods of use must identify each individual claim and the corresponding use or indication in the approved drug labeling. The applicant must also publish this information under the "use code description" in the Orange Book
53 Gardiner Harris, Bush to Back Measure on Generic Drug, THE NEW YORK TIMES, June 12, 2003, at section C p.1, available at
http://query.nytimes.com/gst/fullpage.html?res=9C02E3DF1E39F931A25755C0A9659C8B63 (last visited Mar. 4, 2009).
54 United States of Food and Drug Administration, FDA Sees Rebound in Approval of Innovative Drugs in 2003 New Innovation Initiative Anticipated to Speed Approvals in Years Ahead, Jan. 15, 2004 ,
http://www.fda.gov/bbs/topics/NEWS/2004/NEW01005.html last visited Mar. 4, 2009).另可參照，黃慧嫻，
「簡介美國學名藥競爭規範及新近鼓勵學名藥近用之措施」，收錄於技術尖兵，第 112 期，頁 24-27，
2004 年 4 月。
三，從實際案例看美國專利連結制度之缺陷
3.1 GlaxoSmithKline v Apotex (Paxil®)55