個月自動停止核准期

國

立 政 治 大 學

‧

N a tio na

l C h engchi U ni ve rs it y

第四項 30 個月自動停止核准期

第一款 概論

30 個月自動停止核准期 (Automatic 30-Month Stay)，是專利連結架構下其中 一個延遲核准日的設計

³⁴⁵

，在核准前訴訟發生後，自動延遲 505(b)(2)/ANDA 核 准日，原則上以 30 個月為準。

FD&C Act 規定，若原開發藥廠/專利權人在收到通知後的 45 天內，就早於 後續 505(b)(2)/ANDA 送件日而登錄，且為 Paragraph IV 切結標的之專利，提起 專利侵權訴訟，則 FDA 可以在原開發藥廠/專利權人收到通知後的 30 個月，或 者訴訟當事人對訴訟有拖延/不合作，法院以命令延長/縮短的期間屆滿後，核准 該 505(b)(2)/ANDA 申請

³⁴⁶

。當然，如果在上述的 45 天期間沒有專利訴訟發生，

就沒有 30 個月自動停止核准期的適用，505(b)(2)/ANDA 可以直接依 FDA 審查 的結果，取得上市核准

³⁴⁷

。

另外，在對照藥品取得 5 年 NCE 專屬期的狀況下，如果於專屬期結束的前 一年內，505(b)(2)/ANDA 提出申請，並發生專利訴訟，30 個月自動停止核准期 會被延長為對照藥品核准後的 7 又 1/2 年 (即 5 年 + 30 個月)。換句話說，30 個 月自動停止核准期和 NCE 專屬期並不重疊

³⁴⁸

。

345 會延遲核准日的設計，除了專利連結架構下的 30 個月自動停止核准期、首位進行 Paragraph

IV 之 ANDA 申請人的 180 天專屬期，另外還有之前介紹過的非專利專屬期 (5 年 NCE 專屬 期、3 年 NCI 專屬期、7 年罕見疾病藥品/孤兒藥專屬期、6 個月兒童用藥品專屬期等)

346 21 U.S.C. §§ 355(c)(3)(C), 355 (j)(5)(B)

347 當然，前提是沒有其他非專利專屬期的適用。

348 21 U.S.C. § 355(c)(3)(E)，21 U.S.C. § 355 (j)(5)(F) 也有類似規定

The approval of such an application shall be made effective in accordance with this paragraph except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (C) shall be extended by such amount of time (if

‧

any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application.

349 “this provision was added by the committee on energy and commerce to accommodate the competing concerns of the PMA and the generic manufacturers. the PMA was willing to compromise on the provisions of title i of the bill (relating to abbreviated new drug application procedures (ANDAs)) in exchange for some greater protection of existing human pharmaceutical patents. the generic manufacturers, on the other hand, were willing to live with an eighteen-month rule because of other provisions of the bill.” H.R. 98-857 (Part II), 98^th Cong. 2d Sess (1984)

350 “The thirty-month stay serves ‘to create an adequate window of time during which to litigate the question of whether a generic will infringe the patented product ....’ “

Ben Venue Labs., Inc. v. Novartis Pharmaceutical Corp., 146 F.Supp.2d 572, 579 (D.N.J.2001) (citing, generally, 130 Cong. Rec. H9118 (daily ed. Sept 6, 1984) (statement of Rep. Waxman);

130 Cong. Rec. S10504 (daily ed. Aug. 10, 1984) (statement of Sea Hatch)).

351 “In 1984, the supporters of the 30-month stay argued that because generic drug companies were small and essentially judgment-proof, the prospect of damages in a patent infringement action would not deter infringement by these companies.” Generic Pharmaceutical Association, Generic Pharmaceutical Association (GPhA) Materials for January 30, 2002 Meeting with FDA (2002) http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand Approved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM197646.

pdf (last visited 2015.9.21)

352 “The stay provides a safety net and an incentive to patentees who would otherwise not be inclined to bring a suit against the generic because at the time the ANDA is filed, the patentee has not suffered any economic loss. Where no commercial activity has yet taken place, a patentee becomes susceptible to having its patent found invalid or not infringed.” Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp., 482 F.3d 1330 (Fed. Cir. 2007)

‧ (Automatic Market Exclusivity)

³⁵³

，就可以了解其真正的目的，是架空由法院核 發的暫時禁制令

³⁵⁴

，迴避了最高法院在 Winter v. Natural Resources Defense

353 “This 30-month stay amounts to an automatic preliminary injunction against the generic company and FDA…the 30-month stay provision has proven to be a powerful tool for brand-name companies, who in essence are able to receive up to two and one-half years of automatic market exclusivity as a result of an Orange Book listing.” Generic Pharmaceutical Association, supra note 370.

354 本文使用「架空」，而非「取代」，是因為美國的核准前訴訟，仍有臨時禁制令的適用，與

自動停止核准期平行存在而不互斥。但實際上，在提起訴訟的前 30 個月，專利權人多只會 依賴自動停止核准期，直到上述期間屆滿以後，專利權人才會轉而聲請臨時禁制令。

355 “A plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.” Winter v.

Natural Resources Defense Council, Inc., 129 S.Ct. 365 (2008)

356 Aidan Hollis, Closing the FDA's Orange Book: Current drug regulations invite abuse of patent laws, Regulation 24, p.14-17 (2007) also available at

http://object.cato.org/sites/cato.org/files/serials/files/regulation/2001/12/v24n4-2.pdf (2015.9.12)

‧ 國

立 政 治 大 學

‧

N a tio na

l C h engchi U ni ve rs it y

2002 年，FTC 在官方報告中，指出原開發藥廠觸發多次 30 個月自動停止核 准期，大幅延遲後續 505(b)(2)/ANDA 取得上市核准，在心血管藥品 Hytrin、抗 憂鬱藥品 Paxil、癌症藥品 Taxol 等幾個暢銷藥品 (Blockbuster)，自動停止核准期 甚至累計達到 60~75 個月之多，數家原開發藥廠在這段獨佔期間，銷售額高達 10 億美金以上，儼然成為嚴重的問題

³⁵⁷

。

2003 年，美國國會以 MMA 修正 FD&C Act，要求核准前訴訟中的爭執專利，

登錄時間必須早於後續 505(b)(2)/ANDA 之送件日，才能觸發 30 個月自動停止核 准期

³⁵⁸

。

2015 年，FDA 終於提出行政法規修正草案，以落實 2003 年 MMA，並大幅 修正了 30 個月自動停止核准期、45 天期間之規定，包含對新登錄專利的處理、

複數送件通知對 30 個月自動停止核准期起算的影響、30 個月自動停止核准期終 止事由，以及通知 FDA 的時限等

³⁵⁹

。

357 FTC , FTC Generic Drug Entry Prior to Patent Expiration , p.49 (2002)

http://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiratio n-ftc-study/genericdrugstudy_0.pdf (last visited 2015.1.30)

358 21 U.S.C. § 355(c)(3)(C)，21 U.S.C. § 355 (j)(5)(B) 也有類似規定

“…before the expiration of 45 days after the date on which the notice described in subsection (b)(3) of this section is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) of this section before the date on which the application (excluding an amendment or supplement to the application) was submitted…”

359 FDA, supra note 60, at6859-6869。

‧

• FD&C Act / Hatch-Waxman Amendments (21 U.S.C. 355)

• 專利連結制度建立

1989

• Code of Federal Regulations / Proposed rule (21 C.F.R. § 314.107)

• 30個月自動停止核准期的構成要件、期間計算、45天期間的計算、通 知FDA義務

1994

• Code of Federal Regulations / Final rule (21 C.F.R. § 314.107)

• 30個月自動停止核准期的構成要件、期間計算、45天期間的計算、通

• Code of Federal Regulations / Proposed rule (21 C.F.R. 314.52/314.95)

• 505(b)(2)/ANDA申請人，不須就申請後所登錄的新專利進行通知 (間 接相關)、終止事由詳細化

2003

• Code of Federal Regulations / Final rule (21 C.F.R. 314.52/314.95)

• 505(b)(2)/ANDA申請人，不須就申請後所登錄的新專利進行通知 (間接相關)、終止事由詳細化

2003

• FD&C Act / Medicare Prescription Drug, Improvement, and Modernization Act (21 U.S.C. 355)

• 早期訴訟中之專利，必須早於505(b)(2)/ANDA送件日而登錄，才能 觸發30個月自動停止核准期

2015

• Code of Federal Regulations / Proposed rule (21 C.F.R. § 314.107)

• 提議落實MMA規定，釐清30個月自動停止核准期、45天期間的計算，

加重通知FDA之義務

‧ 國

立 政 治 大 學

‧

N a tio na

l C h engchi U ni ve rs it y

根據現行的 FD&C Act，觸發 30 個月自動停止核准期的要件為：(1) 專利權 人在 45 天期間內提起專利侵權訴訟、(2) 訴訟中的系爭專利，為 505(b)(2)/ANDA 進行 Paragraph IV 切結之標的、(3) 訴訟中的系爭專利，其專利資訊的登錄日，

必須早於 505(b)(2)/ANDA 之送件日 (排除更正與修正之送件日)

³⁶⁰

。本研究以下 將詳細介紹。

第一目 45 天期間內提起專利侵權訴訟

30 個月自動停止核准期的第一個要件，是在 45 天期間內有專利侵權訴訟發 生；反之，如果專利權人並未在這 45 天期間，就登錄且附帶 Paragraph IV 切結 專利提起訴訟，當然就不會觸發 30 個月自動停止核准期。但應該注意的是，30 個月自動停止核准期，由於辨識階段不要求逐項登錄的影響，即使專利權人以和 藥品毫無關聯的請求項提告，仍可以觸發自動停止核准期。

第二目 Paragraph IV 切結

30 個 月 自 動 停 止 核 准 期 的 第 二 個 要 件 ， 要 求 所 訴 訟 的 專 利 必 須 是 505(b)(2)/ANDA 中進行 Paragraph IV 切結的標的。換句話說，如果訴訟中的專利，

只是 Paragraph I~III 切結/section viii 聲明之標的，或者根本沒有被登錄到橘皮書 上，都不能觸發 30 個月自動停止核准期。

360 21 U.S.C. § 355(c)(3)(C)，21 U.S.C. § 355 (j)(5)(B) 也有類似規定

If the applicant made a certification described in clause (iv) of subsection (b)(2)(A) of this section, the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) of this section is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) of this section before the date on which the application (excluding an amendment or supplement to the application) was submitted. If such an action is brought before the expiration of such days, the approval may be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under subsection (b)(3) of this section or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, …In such an action, each of the parties shall reasonably cooperate in expediting the action.

‧ Paragraph IV 切結更改為 Paragraph III 切結/section viii 聲明，也無法立即、直接 終止 30 個月自動停止核准期

³⁶¹

。不過，根據法院實務，若 505(b)(2)/ANDA 申請

361 “It should be noted that if the paragraph IV certification that gave rise to the 30- month stay (or 71⁄2 years where applicable) is subsequently amended to a statement under § 314.50(i)(1)(iii) or

§ 314.94(a)(12)(iii) with respect to one or more methods of use, the 30-month stay (or 71⁄2 years where applicable) will not be terminated in the absence of a qualifying event under §

314.107(b)(3).”見 FDA, supra note 60, at6862。

362 “In sum, Defendant no longer seeks approval of its ANDA until after expiration of all the applicable patents. As such, Defendant cannot sell a drug product under its ANDA that would infringe Plaintiffs' patents. Consequently, there is no longer a case or controversy between the parties; the matter is moot. The Court lacks jurisdiction to continue this matter, and, therefore, grants Defendant's motion to dismiss.” AstraZeneca AB v. Anchen Pharmaceuticals Inc., 2014 WL 2611488 (D.N.J. 2014) see also Ferring B.V. v. Watson Laboratories, Inc.-Fla, 764 F.3d 1382 (Fed Cir 2014)

363 CAFC 認為，這種選擇性提起訴訟的手段，明確違背了 HWA 加速藥品上市的目的。“By filing a lawsuit on only one its five patents certified under paragraph IV in Teva's ANDA, Novartis has tried to simultaneously leverage the benefits provided to a patentee under the Hatch–Waxman Act and avoid the patentee's accompanying responsibilities. Novartis' '937 patent suit against Teva has invoked the statutory automatic 30–month stay and is concurrently insulating the four method patents from a validity challenge. In the statute, Congress explicitly required that in exchange for the 30–month stay, patentees were to ‘reasonably cooperate in expediting the action’ of whether the paragraph IV patents were invalid or not infringed.FN8 21 U.S.C. § 355(j)(5)(B)(iii).

Novartis' action insulates it from any judicial determination of the metes and bounds of the scope of the claims of its four Famvir® method patents in relation to design-around, a determination that is central to the proper function of our patent system and is a central purpose of the

Hatch–Waxman Act.” Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp., 482 F.3d 1330 (Fed. Cir. 2007)

‧

364 505(b)(2)/ANDA 申請人也可以進行 Paragraph III 切結，等待專利期間屆滿，或者進行 section viii 聲明，與專利連結脫鉤，不過後者只適用於藥品使用方法專利，選擇有限。

365 近年藥品的登錄專利數量，甚至可以高達 18 個。H.R. REP. 98-857 FDA, Orange Book, available at

http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=206619&Product_

No=001&table1=OB_Rx (last visited 2015.10.14)

366 FTC , FTC Generic Drug Entry Prior to Patent Expiration , p.36, 45-46 (2002)

http://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiratio n-ftc-study/genericdrugstudy_0.pdf (last visited 2015.1.30)

367 “The single 30-month stay provisions are a centerpiece of this legislation, allowing lower-priced generic products to enter the market more quickly. As a result, this provision must not be

construed as requiring an ANDA applicant to file a new application where, before its enactment, the applicant would have been allowed to file an amendment or supplement to an existing application. Such a construction would run directly contrary to Congress’ intent.” 見 FDA, supra note 60, at6862。

368 21 U.S.C. §§ 355(c)(3)(C), 355 (j)(5)(B)

…for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) of this section before the date on which the application (excluding an amendment or supplement to the application) was submitted…

‧

(single 30-month stay provisions)，但實際上僅阻絕了以「新登錄專利」觸發多次 30 個月自動停止核准期的態樣，如果是早在 505(b)(2)/ANDA 送件日以前，就已

505(b)(2)/ANDA 申請人可能只對一部份登錄專利進行 Paragraph IV 切結，另一部分則暫時 進行 Paragraph III 切結/section viii 聲明，先迴避一部份的專利訴訟，接著在核准前適當的時 間點，再將上述 Paragraph III 切結/section viii 聲明，更改為 Paragraph IV 切結，就會再次觸 發一個新的 30 個月自動停止核准期。

370目前比較令人擔心的情況，是原開發藥廠故意改變配方，強迫 ANDA 申請人也要變更所申

請的藥品內容，被迫重新切結、通知、觸發另一個 30 個月自動停止核准期。FDA, FDA/CDER to Covington & Burling LLP (Genzyme Corporation) - Petition Approval, FDA Docket No.

2010P-0223 (2010)

http://www.regulations.gov/#!documentDetail;D=FDA-2010-P-0223-0010 (last visited 2015.10.18)

371 Proposed 21 C.F.R. § 314.107(b)(2) (2015)

Patent information filed after submission of 505(b)(2) application or ANDA. If the holder of the approved NDA for the listed drug submits patent information required under § 314.53 after the date on which the 505(b)(2) application or ANDA was submitted to FDA, the 505(b)(2) applicant or ANDA applicant must comply with the requirements of § 314.50(i)(4) and (i)(6) and §

314.94(a)(12)(vi) and (a)(12)(viii) regarding amendment of its patent certification or statement. If the applicant submits an amendment certifying under § 314.50(i)(1)(i)(A)(4) or §

314.94(a)(12)(i)(A)(4) that the relevant patent is invalid, unenforceable, or will not be infringed, and complies with the requirements of § 314.52 or § 314.95, the 505(b)(2) application or ANDA may be approved immediately upon submission of documentation of receipt of notice of paragraph IV certification under § 314.52(e) or § 314.95(e). The 45-day period provided for in section 505(c)(3)(C) and (j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act does not apply in these circumstances. 見 FDA, supra note 60, at6893。

‧

372 “in light of the foregoing, the net effect of the sawyer amendment would have been to

substantially delay generics from getting onto the market when they seek to challenge the validity of a patent. according to the statistics of the judicial conference of the united states, the median time between filing and disposition of a patent suit is 36 months. annual report of the director of the administrative office of the united states courts-- 1982, at 253. over ten percent of these cases take more than 77 months. thus, a requirement that fda defer generic approval until after a court decision of patent invalidity would substantially delay fda approvals. of course, in the event that the fda approves a generic because of the expiration of 18 months without a court decision, and it is later determined that the patent is valid, the patent owner may still recover damages from the generic. therefore, in most cases the bill affords greater protection for patent holders than current law.” H.R. 98-857 (Part II), 98^th Cong. 2d Sess (1984)

373 “The legislative history indicates that the thirty-month stay was a hard-won compromise between brand-name manufacturers, generics manufacturers, and other stakeholders. The length of the stay was the subject of heated debate in the House. 130 Cong. Rec. H24426–31 (Sept. 6, 1984). Initially, the House version of the bill provided for a stay of just eighteen months. H.R.

3605, 98th Cong. § 101 (as reported by H. Comm. on the Judiciary, Aug. 1, 1984). The Senate version, which ultimately prevailed, described a thirty-month stay. S. 2926, 98th Cong. § 101 (1984).” Eli Lilly and Co. v. Teva Pharmaceuticals USA, Inc., 557 F.3d 1346 (Fed. Cir. 2009)

374 “As Congressman Waxman explained in greater detail: ‘What the 18–month or 30–month issue deals with is, should not the litigation be resolved, at what point would we allow the generic manufacturer to go on the market with the generic product anyway. The 30–month period is one that gave further assurance to the brand-name drug manufacturer that the generic drug

manufacturer would not put his competitor on the market until that court de-cision came through.’130 Cong.Rec. 24,427 (1984). (emphasis added).

It thus appears that the stay period was extended primarily for the benefit of the brand-name drug manufacturers who wanted to keep generic competition off the market for as long as possible. By contrast, there is no indication that the stay period was extended for the purpose of providing first-to-file generic manufacturers with a completely risk-free environment in which to exercise their exclusivity. Nor is there any indication that the extension was based on something other than a recognition that patent litigation is often complex and could take longer than 18 months to resolve in the district court.” Mylan v. Shalala, 81 F.Supp.2d 30 (D.D.C. 2000)

‧ 的原開發藥廠

³⁷⁶

。另外，若有複數專利存在，505(b)(2)/ANDA 申請人很可能會 在不同的時間點進行數個 Paragraph IV 切結，30 個月自動停止核准期的起算將

…beginning on the date of the receipt of the notice provided under subsection (b)(3) of this section…

376 21 C.F.R. § 314.107(b)(3)(i)(A)

…approval may be made effective 30 months after the date of the receipt of the notice of certification by the patent owner or by the exclusive licensee (or their representatives) unless the court has extended or reduced the period because of a failure of either the plaintiff or defendant to cooperate reasonably in expediting the action; or…

377 21 C.F.R. § 314.107(b)(4) Multiple certifications.

If the applicant has submitted certifications under § 314.50(i) or § 314.94(a)(12) for more than one patent, the date of approval will be calculated for each certification, and the approval will become effective on the last applicable date.

378 Proposed 21 C.F.R. § 314.107(b)(3)(i)(A) (2015)

Except as provided in paragraphs (b)(3)(ii) through (b)(3)(viii) of this section, if, with respect to patents for which required information was submitted under § 314.53 before the date on which the 505(b)(2) application or ANDA was submitted to FDA (excluding an amendment or

supplement to the 505(b)(2) application or ANDA), the applicant certifies under § 314.50(i) or § 314.94(a)(12) that the relevant patent is invalid, unenforceable, or will not be infringed, and the patent owner or its representative or the exclusive patent licensee brings suit for patent

infringement within 45 days of receipt of the notice of certification from the applicant under § 314.52 or § 314.95, the 505(b)(2) application or ANDA may be approved 30 months after the later of the date of the receipt of the notice of certification by any owner of the listed patent

‧

or by the NDA holder who is an exclusive patent licensee (or their representatives) unless the court has extended or reduced the period because of a failure of either the plaintiff or defendant to cooperate reasonably in expediting the action; or…

379 專利無法執行這個中止事由，是由行政法規所解釋而來。如果專利權人在專利取得的過程

中，對 USPTO 有隱匿、提供不實資訊的不正當行為 (inequitable conduct in patenr presecution)，

有可能導致專利無法執行。見 Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011)；21 C.F.R. § 314.107 (b)(3)(ii) (1994)

…(ii) If before the expiration of the 30-month period, or 7 1/2 years where applicable, the court issues a final order that the patent is invalid, unenforceable, or not infringed, approval may be made effective on the date the court enters judgment…

380 21 U.S.C. §§ 355(c)(3)(C), 355 (j)(5)(B) (1984)

(B) The approval of an application submitted under paragraph (2) shall be made effective on the last applicable date determined under the following:…

(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless an action is brought for

infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that—

(I) if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision, (II) if before the expiration of such period the court decides that such patent has been

infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, United States Code, or

(III) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision.

In such an action, each of the parties shall reasonably cooperate in expediting the action.

‧ (settlement order) 與合意判決 (consent decree)，都可以終止自動停止核准期，並 不要求一定要是確定判決

^382,383

，但根據 2015 年的行政法規修法草案，在當事人 向 CAFC 聲請院聯席會議重審 (rehearing en banc) 的狀況下，FDA 還是認為只 有正式的命令 (Mandate) 可以終止自動停止核准期

³⁸⁴

。

381 21 C.F.R. § 314.107(e) (1994)

(1) References to actions of “the court” in paragraphs (b) and (c) of this section are to the court that enters final judgment from which no appeal can be or has been taken.

(2) For purposes of establishing the effective date of approval based on a court judgment, the following dates shall be deemed to be the date of the final decision of the court on the patent issues:

(i) If the district court enters a decision that the patent is invalid, unenforceable, or not infringed, and the decision is not appealed, the date on which the right to appeal lapses.

(ii) If the district court enters a decision that the patent is invalid, unenforceable, or not infringed, and the decision is appealed, the date of the first decision or order by a higher court holding or affirming the decision of the district court that the patent is invalid, unenforceable, or not infringed.

(iii) If the district court enters a decision that the patent is infringed, and the decision is appealed, the date on which the district court enters a judgment that the patent is invalid, unenforceable,

(iii) If the district court enters a decision that the patent is infringed, and the decision is appealed, the date on which the district court enters a judgment that the patent is invalid, unenforceable,

在文檔中 藥品的核准前專利爭端解決程序－ 美國專利連結為借鏡 - 政大學術集成 (頁 141-200)