上次在《淺談美國專利聯結制度系列:學名藥180天市場專屬權之起源》一文中提到,專利聯結制度的核心措施,在於當簡易新藥上市程序(Abbreviated New Drug Application,簡稱ANDA)申請人聲明所申請藥物有paragraph IV 情況,也就是申請上市之藥品相對應之原廠藥所涉及專利有無效或不侵害原廠藥之專利之情形,必須通知或橘皮書記載專利權人,一般亦是NDA許可證之持有人。被通知人如果依法提出專利訴訟,則美國食品藥品管理局(Food and Drug Administration,簡稱FDA)將在30個月內暫停ANDA核准程序。這30個月期間並非新藥專屬權,然而暫停審理的法律效果,就形同資料專屬期延長,因此對於學名藥上市具有重大影響。本次文章將介紹30個月暫停核准期間定義、立法目的、起算等相關問題。
30個月暫停核准期間的啟動的要件之一,必須是橘皮書上相對應藥品記錄的專利權人在45天提出專利訴訟。理論上,這30個月暫停核准期間的啟動可以排除FDA核准ANDA之申請,因此有利於NDA(完整新藥申請資料,new drug application,簡稱NDA)廠商,因此似乎應由NDA廠商通知FDA專利訴訟已經提出,然而在法規上卻要求由ANDA廠商來通知FDA專利訴訟已經提出。站在ANDA申請人的角度來看,當ANDA通知FDA訴訟已經啟動,ANDA申請人可以聲明30個月暫停核准期間於何時結束,FDA何時可以核准ANDA申請,攸關ANDA進入市場的時間,因此由ANDA申請人通知FDA專利訴訟已經開始亦無不妥。
至於,美國聯邦專利局的上訴委員會(Patent Trial and Appeal Board ,簡稱PTTB)有關專利無效程序的決定是否可以主張30個月期間?當PTTB在舉發過程中宣告專利無效後,經過聯邦上訴法院確認,如果與先前專利訴訟聯邦法院一審認定不同時,禁制令是否可以依據後來上訴法院確認判決廢棄呢?關於這點在實務上的運作存有爭議(註7)。在2014年7月聯邦法院在ePlus, Inc. v. Lawson Software, Inc.(註8)案件,就處理有關在專利侵權訴訟與專利局舉發結果不同時,禁制令是否維持的問題做出決定。這個決定勢必對於以PTTB無效程序決定是否主張30個月期間有所影響。
30個月暫停核准期間延長、縮短
法規雖然規定30個月暫停核准期間,但是30個月並非絕對期間,30個月期間可能延長或縮短(註9)。依照§355(j)(5)(B)(iii) 規定,法院可以調整30個月的期間,倘若訴訟當事人未能合理配合加快訴訟的進行。在Eli Lilly & Co. v. Teva乙案中(註10),法院闡釋所謂:「訴訟當事人未能配合加速訴訟的進程,法院有權調整30個月的期間」,其調整權包括縮短或延長30個月的期間。
實務上,新藥廠商善於利用訴訟的策略延長30個月期間,以阻礙ANDA申請的核准。例如在Eli Lilly v. Zenith Goldine乙案中,由於Zenith並未配合提出證據,對於有舉證義務部分,逾越法院所要求專家報告提出期間,法院為做出最終判決,因而延長30個月的期間(註11)。同樣的在Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc.(註12)乙案中,法院也延長30個月期間,因為Teva並未適當參與專利訴訟。
另外,當專利權人有不當延滯訴訟,法院也可能縮短30個月的期間。在 Dey. L.P. V. Eon Labs 案件中(註13),由於專利權人Dey 在訴訟過程中不斷變更主張,例如對於有關專利權人的歸屬問題上持續變更主張,並且無法提出重要證人以證明係為發明人,甚至到了證據調查階段結束之前,Dey都無法確認發明人,且若干涉及專利有效性證據也都無法提出。因此法院基於Eon請求,提前結束了30個月期間。
21 U.S.C.A. § 355(j)(5)(B)(iii) (“If the applicant made a certification described in subclause
(IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless, before the
expiration of 45 days after the date on which the notice described in paragraph (2)(B) 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 subsection (b)(1) or (c)(2) of this section
before the date on which the application (excluding an amendment or supplement to the application),
which the Secretary later determines to be substantially complete, was submitted. 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.”).
21 C.F.R. § 314.107(f) (“(f) Computation of 45-day time clock. (1) The 45-day clock described
in paragraph (b)(3) of this section begins on the day after the date of receipt of the applicant's
notice of certification by the patent owner or its representative, and by the approved application
holder. When the 45th day falls on Saturday, Sunday, or a Federal holiday, the 45th day will be
the next day that is not a Saturday, Sunday, or a Federal holiday.”).
21 U.S.C.A. § 355(j)(5)(B)(iii) (“If … action is brought for infringement of the patent that is
the subject of the [Paragraph IV] certification…[if] such an action is brought before the expiration
of such days [45-day window], 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.”). See also 21 C.F.R. § 314.107(b)(3)(i)(A)
(“Disposition of patent litigation. Except as provided in paragraphs (b)(3)(ii), (b)(3)(iii), and
(b)(3)(iv) of this section, if 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 by the
patent owner of the notice of certification from the applicant under 314.52 or 314.95, 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.”).
Shashank Upadhye, Generic Pharmaceutical Patent and FDA Law, section 11, 2014 database.
21 U.S.C.A. § 355(j)(5)(B)(iii)(I).
In re Terazosin Hydrochloride Antitrust Litigation, 352 F. Supp. 2d 1279.
Intellectual Property Litigation, IPR’s and the Hatch-Waxman 30-Month Stay of FDA Approval
August 12, 2014,also available at http://www.fr.com/fish-litigation/iprs-hatch-waxman-30-month-stay-fda-approval/
2014 WL 3685911, (Fed. Cir. July 25, 2014)
See Shashank Upadhye, Generic Pharmaceutical Patent and FDA Law, section 11:13-162014 Database。
Eli Lilly & Co., 557 F.3d at 1350. (citing Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1337 n.5 (Fed. Cir. 2003))
Eli Lilly & Co. v. Zenith Goldline Pharmaceuticals, Inc., 58 U.S.P.Q.2d 1543, 2001 WL 238090 (S.D.Ind. 2001)