Iff/]) FEB Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC

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1 DEPARTMENT OF HEALTH &. HUMAN SERVICES FEB Food and Drug Administration Rockville MD Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC Re: Docket No. FDA-2010-P-0518 Dear Mr. Glover: This letter responds to your citizen petition submitted on behalf of Hoffmann-La Roche Inc. (Roche), which was received by the Food and Drug Administration (FDA or Agency) on September 29, 2010 (Petition). Your petition requests that FDA confirm that it will stay approval of abbreviated new drug application (ANDA) for a generic version of Boniva (ibandronate sodium), absent another specified event under 21 U.S.C. 355G)(5)(B)(iii) (section 505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (the Act)), for 30 months from July 26, 2010, the date Roche received a notice that Orchid Healthcare (Orchid) had amended ANDA , changing its paragraph III certification to a paragraph IV certification l with respect to U.S. Patent No. 4,927,814 (the '814 patent).2 We have carefully considered your petition, comments to your petition submitted by Orchid on November 12, 2010 (Orchid Comments), and the supplemental information you submitted on November 16, 2010 (Roche Supplemental Letter). For the reasons described below, your petition is granted in part, and denied in part. FDA will recognize the 30-month stay, but that stay will tenninate upon expiration ofthe '814 patent. I A "paragraph III certification" is a certification under section 505(j)(2)(A)(vii)(IIl) of the Act that states the date on which the patent will expire. When such a certification is filed, the ANDA applicant agrees that its application will not be approved until the date of patent expiration (see section 505(j)(5)(B)(ii) of the Act). A "paragraph IV certification" is a certification under section 505(j)(2)(A)(vii)(IV) of the Act that states that the patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted. When a paragraph IV certification is submitted, the approval of the ANDA is not delayed by the patent unless a 30-month stay applies under section 505(j)(5)(B)(iii) of the Act. Whether such a stay applies here is the issue addressed in the Petition, and in this response CFR (b) provides that "FDA will not publicly disclose the existence of an application or abbreviated application before an approval letter is sent to the applicant under or tentative approval letter is sent to the applicant under , unless the existence of the application or abbreviated application has been previously publicly disclosed or acknowledged." FDA issued a tentative approval to Orchid for ANDA in December See Tentative Approvals - December 2009, available at hjm;!!w.w_w:.!!~r;:..essdata. fda.gov/s rh?t~!.g~r!9j"!!g.~!!~fq!!!i!1g~?<",cfn:!7.fljs.~~.«lli>n.::j3.s<p9-iti. T~n.rnti.y.ej\pP.lQY..~J.. Iff/])

2 i. BACKGROUND A. Roche's NDA for Boniva FDA approved Roche's new drug application (NDA) for Boniva (ibandronate sodium) tablets, 2.5 miligrams (mg), on May 16, 2003, for the treatment and prevention of osteoporosis in postmenopausal women, and granted it new chemical entity (NCE) exclusivity under section 505G)(5)(F)(ii) of the Act. Because of Boniva's NCE exclusivity, ANDAs for the drug product that contained a paragraph iv certification to any patent that claimed the listed drug or a use of that drug could not be submitted until May 16,2007 (4 years from the date ofnda approval) (see section 505G)(5)(F)(ii) of the Act; 21 CFR (b)(2)). On August 12,2003, in connection with its NDA for Boniva, Roche submitted patent information for listing in FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) for the '814 patent and U.S. Patent No. 6,294,196 (the '196 patent). The '814 patent originally had an expiration date of July 9, 2007; however, on July 2,2007, Roche obtained a patent term extension for the '814 patent, which extended the expiration date until March 17,2012 (Orchid Comments at 2-3). The' 196 patent expires on October 7, On March 24, 2005, an NDA supplement providing for the once-monthly dosage regimen of Boniva tablets, 150 mg, was approved for the same indication as the original NDA. Roche submitted patent information for the' 814 patent in connection with the oncemonthly NDA supplement on April 30, 2004, and again on March 25,2005, upon FDA's approval of the NDA supplement (Petition at 4, Exhibit C, and Exhibit D). Roche listed the following additional patents in the Orange Book after it obtained approval for its NDA supplement: U.S Patent No. 7,192,938 (the '938 patent); U.S. Patent No. 7,410,957 No. 7,718,634 (the '634 patent), each of which expires (the '957 patent); and U.S. Patent on May 6, B. Orchid's ANDA for a Generic Version of Boniva Orchid submitted ANDA on May 16,2007, to market a generic version of Boniva once-monthly tablets, and filed paragraph iv certifications to the' 196 and' 93 8 patents (Petition at 1 and 4; Orchid Comments at 3). Orchid did not at that time file a paragraph iv certification to the '814 patent, but instead filed a paragraph III certification, indicating that it did not intend to seek approval to market the product prior to the expiration of the '814 patent (Petition at 1 and 4; Orchid Comments at 3). Roche initiated a patent infringement suit based on the' 196 and '938 patents within 45 days of receiving the notice of the paragraph iv certifications from Orchid (Petition at 4). 3 The Orange Book. 4 Id. 2

3 Because Boniva was granted 5 years ofnce exclusivity, and Roche's suit for infringement was fied within the I-year period beginning 4 years after approval of the NDA, the 30-month stay was extended by an amount of time such that 7.5 years would elapse from the date ofnda approval (see section 505G)(5)(F)(ii) of the Act). Thus, the stay was extended until November 16, According to the Petition, Roche subsequently dismissed the claims for infringement of (Petition at 4-5; Roche Supplemental Letter at 2). both the '196 and '938 patents Orchid amended its ANDA in 2008 to contain a paragraph iv certification to the '957 patent, and Roche initiated a patent infringement suit within 45 days of receiving the paragraph iv notice (Petition at 4). In June 2010, Orchid again amended its ANDA to contain a paragraph iv certification to the '634 patent, and within 45 days of receiving notice of the paragraph iv certification, Roche fied a patent infringement suit (Petition at 5).6 Subsequently, and most relevant to the Petition, on July 23,2010, Orchid amended its ANDA to change the paragraph III certification with respect to the '814 patent to a paragraph iv certification (Petition at 2,5, and Exhibit A; Orchid Comments at 3). Roche received notice of the amendment and new paragraph iv certification on July 26, 2010, and within 45 days, on September 3,2010, initiated a suit against Orchid alleging infringement of the '814 patent (Petition at 2,5, and Exhibit B-1; Orchid Comments at 3). C. Statutory and Regulatory Requirements 1. Thirty-Month Stay Under the 1984 Hatch-Waxman Amendments to the Act, an NDA applicant must submit information for each patent that claims the drug or method of using the drug that is the subject of the NDA and for which "a claim of patent infringement could reasonably be asserted if a person not licensed by the patent owner engaged in the manufacture, use, or sale of the drug" (sections 505(b)(1) and (c)(2) of the Act). FDA publishes this patent information in the Orange Book. With respect to each listed patent, an ANDA must provide a certification: 5 The Petition erroneously maintains that, based on Roche's timely suit on the '938 and' 196 patents, the approval of Orchid's ANDA was stayed for 30 months beginning May 16, 2008, the date of expiration of Boniva's 5-year NeE exclusivity (Petition at 4). However, because Boniva had NeE exclusivity, and Roche's patent infringement action commenced during the I-year period beginning 4 years after NDA approval, the 30-month stay period was extended by the amount of time that is required for 7.5 years to have elapsed from the date of approval of the NDA (see section 505(j)(5)F)(ii) of the Act). Thus, the applicable stay period would end 7.5 years after May 16,2003 (i.e., November 16,2010). While the Petition correctly recognizes that the original stay expires on November 16,2010, its calculation of such stay is not consistent with section 505(j)(5)(F)(ii) of the Act. 6 The issue ofa 30-month stay for the '957 and '634 patents was not raised in the Petition and is not, therefore, addressed in this response. 3

4 (i) that such patent information has not been fied (a paragraph I certification J, (ii) that such patent has expired (a paragraph II certification), (iii) of the date on which such patent wil expire (a paragraph III certification), or (iv) that such patent is invalid or wil not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted (a paragraph iv certification);.... (Section 505G)(2)(A)(vii) of the Act. See also 21 CFR (a)(12)(i)(A).) An ANDA applicant submitting a paragraph iv certification to a listed patent must provide the NDA holder and the patent owner with notice of its patent certification, including a description of the legal and factual basis for its assertion that the patent is invalid or not infringed (section 505G)(2)(B) of the Act). In the case of a patent(s) for which information was submitted to FDA before the date on which the ANDA is submitted, should the NDA holder or patent owner initiate a patent infringement action against the ANDA applicant within 45 days of receiving the required notice, approval of the ANDA wil be stayed for 30 months from the date of receipt of the notice, unless a court orders otherwise (section 505G)(5)(B)(iii) of the Act). Until August 18,2003, section 505G)(5)(B)(iii) of the Act permitted a 30-month stay regardless of when the patent at issue was submitted to FDA. This resulted in ANDAs being subjected to multiple overlapping 30-month stays, as NDA holders submitted new patents to FDA well after the ANDA had been submitted and after the initiation of an earlier 30-month stay (see Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study, at iv-v (July 2002), available on the Internet at Concern over the significant delays in generic drug approvals resulting from multiple 30-monthstays led to amendment of the 30-month stay provision as part of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA).7 The MMA included provisions modifying section 505G)(5)(B)(iii) of the Act to reduce the availability of 30-month stays Senator Kennedy that (149 Congo Rec. S15882 at S15884 (Nov. 25,2003) (statement of Hatch- Waxman provisions ofmma "wil stop the multiple, successive 30-month stays that the Federal Trade Commission identified as having delayed approval of generic versions of several blockbuster drugs and cost consumers bilions of dollars")). Under the Act as amended by the MMA, a 30-month stay is available only when information concerning the patent(s) at issue in the paragraph IV-related litigation was submitted by the NDA holder to FDA before the ANDA was submitted (section 505(j)(5)(B)(iii) of the Act). No 30-month stay is available when the NDA holder or patent owner sues as a result of a paragraph iv certification to a patent for which information is first submitted following the submission of the ANDA (FDA draft guidance for industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 7pub.L.No

5 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Questions and Answers (Draft Guidance), at 8 (Oct. 2004)).8 As noted in the Draft Guidance, "(tjhe MMA generally precludes multiple 30-month stays for those applications to which it applies" but does not preclude multiple 30-month stays in all circumstances (Draft Guidance at 8). The Draft Guidance explains that: the MMA apply to patents submitted to FDA (tjhe relevant provisions of on or after August 18,2003. For ANDAs and 505(b)(2) applications with paragraph IV certifications to a patent submitted to FDA on or after August 18,2003, the MMA provides that a 30-month stay may be available for litigation related to that patent only if the patent was submitted to FDA before the date that the ANDA or 505(b)(2) application (excluding an amendment or supplement) was submitted. In other words, the MM precludes 30-month stays for later listed patents, that is, those patents submitted to FDA on or after the date the ANDA or 505(b)(2) application was submitted. Because of this limitation, in most cases, ANDAs and 505(b)(2) applications wil be subject to no more than one 30-month stay. (Draft Guidance at 8.) (Emphasis in original; footnotes omitted.) The Draft Guidance cautions, however, that "(mjultiple 30-month stays... may be possible in certain cases" (Draft Guidance at 8). One scenario envisioned by the Draft Guidance in which multiple 30-month stays are possible is one in which an ANDA containing a paragraph III and a paragraph iv certification (to patents submitted after August 18, 2003, and before the ANDA was submitted) is amended by the ANDA applicant to convert the paragraph III certification to a paragraph iv certification (Draft Guidance at 8-9). In such a scenario, both the original paragraph iv certification and the new paragraph iv certification could give rise to separate 30-month stays. 2. Five- Year Exclusivity The Hatch-Waxman Amendments also provide for the granting of 5-year exclusivity to qualified drug products approved in an application under section 505(b) of the Act. This exclusivity, referred to as new chemical entity (NCE) exclusivity, protects such drug products from competition from certain products described in sections 505G) and 505(b )(2) of the Act. This exclusivity does not block acceptance and review of standalone NDAs (supported entirely by data developed by the applicant or to which the applicant has a right of reference). Specifically, 5-year exclusivity for a 505(b) application as the exclusivity relates to the submission of ANDAs is provided for in section 505G)(5)(F)(ii) of the Act, which states in pertinent part that: 8 The Draft Guidance is available at fda. gov / downloads/drugs/guidanceeomp lianceregulatory Information/Guidances/ucm pm. The Draft Guidance, when finalized, wil represent FDA's current thinking on the topic. 5

6 If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved... no application may be submitted under this subsection (505(j)J which refers to the drug for which the subsection (b) application was submitted before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in subclause (N) of paragraph (2)(A)(vii)....9 Briefly stated, this provision grants exclusivity, generally of 5 years, to a drug approved under an NDA that contains no active ingredient (including any ester or salt of the active ingredient) previously approved by the Agency. An applicant can submit an ANDA after 4 years if the applicant opts to include in its application a paragraph iv certification with respect to a patent that claims the drug or method of using the drug that is the subject of the NDA (section 505G)(5)(F)(ii) of the Act). If a patent infringement action is commenced during the I-year period beginning 48 months after the date of approval of the NDA, the 30-month stay period referred to in section 505G)(5)(B)(iii) ofthe Act is extended by the amount of time required for 7.5 years to have elapsed from the date ofnda approval (section 505G)(5)(F)(ii) of the Act). II. ANALYSIS You claim that the relevant statutory language enacted in the MMA and the Draft Guidance make clear that a 30-month stay applies to Orchid's ANDA based on the paragraph iv certification with respect to the' 814 patent and the timely patent infringement suit fied by Roche (Petition at 2 and 6). Specifically, you rely on the language of21 U.S.C. 355G)(5)(B)(iii) (section 505(j)(5)(B)(iii) of the Act), which provides that when an ANDA applicant submits a paragraph iv certification to a patent listed in the Orange Book prior to the submission of the ANDA, and the patent holder brings an infringement action within 45 days of receipt of notice of the paragraph iv certification, FDA must stay the approval of the ANDA for 30 months beginning on the date of the receipt ofthe notice (Petition at 6). You thus claim that because (1) Roche filed information regarding the '814 patent for listing in the Orange Book before the date on which Orchid's ANDA was submitted, (2) Orchid made a paragraph iv certification to the '814 patent (after initially fiing a paragraph III certification for the patent), and (3) Roche filed a patent infringement lawsuit within 45 days of receiving notice for infringement of the '814 patent, the Act requires a 30-month stay beginning July 26, 9 A parallel exclusivity provision, section 505( c )(3)(E)(ii) of the Act, blocks acceptance of 505(b )(2) applications that refer to the original NDA during the exclusivity period. That provision, however, is not relevant to the issues raised in the Petition and is not addressed in this response. 6

7 2010, the date Roche received Orchid's paragraph iv notice with respect to the '814 patent (Petition at 6-7). In addition, you assert that the Draft Guidance acknowledges that, although the MMA generally precludes multiple 30-month stays by permitting such stays only if the patent was submitted to FDA prior to submission of the ANDA, multple 30-month stays are possible in certain circumstances (Petition at 3). Specifically, you note that the Draft Guidance cites as an example a situation in which an ANDA contains both a paragraph III and paragraph.iv certification, and the applicant converts the paragraph III certification to a paragraph iv certification, where the patent at issue "was submitted to FDA (1) on or after August 18,2003, and (2) before the ANDA... application was submitted" (Petition at 3, citing Draft Guidance at 8-9). In this example, the applicant's conversion of its paragraph III certification to a paragraph iv certification gives rise to a 30-month stay (Draft Guidance at 8-9). You claim that "(tjhis example corresponds precisely to the facts and issues presented in this citizen petition" and, therefore, that "Orchid's recent conversion of its Paragraph III certification for the' 814 patent to a Paragraph iv certification gives rise to a new 30-month stay for Orchid's ANDA" (Petition at 4). We agree that Roche is entitled to a 30-month stay stemming from Orchid's paragraph iv certification with respect to the '814 patent and Roche's resulting patent infringement suit. We reach this conclusion regardless of whether the MMA applies to the facts at hand.1o Once Orchid changed the paragraph III certification to a paragraph iv certification with respect to the '814 patent, and within 45 days of receiving notice of the paragraph iv certification Roche sued Orchid for infringement of the' 814 patent, the statutory requirements for a 30-month stay with respect to this paragraph IV certification were met, as the information concerning the '814 patent was submitted to FDA before the submission of Orchid's ANDA to FDA. Indeed, it is the Agency's practice to apply a 30-month stay in these circumstances; namely, where an ANDA applicant initially filed a paragraph III certification to a patent listed in the Orange Book at the time of the submission of the ANDA, later amended the ANDA to change the paragraph III certification to a paragraph iv certification, and was subsequently and timely sued for patent infringement. In such circumstances, we apply a 30-month stay beginning on the date that notice of the paragraph iv certification was received by the patent holder and, if there are no other issues preventing final approval, grant tentative approval of the ANDA pending expiration of the 30-month stay. While we agree that Roche is entitled to a 30-month stay of approval of Orchid's ANDA beginning July 26, 2010, it should be noted that this 30-month stay wil be terminated 10 Determination of whether or not the MMA applies depends on whether one concludes that the operative submission of patent information occurred on the original patent listing date for the '814 patent (prior to August 18,2003), or when patent information was submitted in connection with the once-monthly NDA supplement (after August 18,2003). Because we conclude that the relief requested in the Petition must be granted regardless of whether the MMA applies, we need not resolve the issue of which patent listing date applies. 7

8 upon the expiration of the' 814 patent on March 17, 2012, or earlier if the patent infringement suit is resolved in favor of Orchid. FDA policy has been that when a patent for which there is a paragraph iv certification expires, the applicant must revise its patent certification from a paragraph iv to a paragraph II certification. If the applicant does not change the certification, FDA wil deem it to be a paragraph II certification (see Ranbaxy Labs. Ltd v. FDA, 307 F. Supp. 2d 15, 19,21 (D.D.C. 2004), afjd, 96 Fed. Appx. 1 (D.C. Cir 2004), and Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 1278, ,363 U.S. App. D.C. 440 (D.C. Cir. 2004)). Orchid argues that the 30-month stay related to the '814 patent should not apply to its application on several grounds. First, Orchid argues that Roche is not entitled to a 30- month stay because delay in approval of its ANDA is not necessary to protect the public health (Orchid Comments at 3). Second, Orchid asserts that the NCE exclusivity provision, section 505G)(5)(F)(ii) of the Act, is "specific to Orchid's ANDA and, therefore, governs any stay of FDA approval associated with the ANDA, instead of the more general provision in Section 505G)(5)(B)(iii)" (Orchid Comments at 4). Orchid thus claims that approval of Orchid's ANDA is subject only to the 7.5-year stay set forth in section 505G)(5)(F)(ii) ofthe Act, which would delay approval of the ANDA until November 16,2010 (i.e., 7.5 years after Boniva's approval) (Orchid Comments at 5). Third, Orchid asserts that the Draft Guidance is inapplicable "because it does not involve the unique situation... where the stay of approval is governed by the specific NCE exclusivity statute" and because it predated the decision of the District of Columbia Circuit in Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010) (Orchid Comments at 5). Finally, Orchid claims that no 30-month stay is available because Roche submitted updated patent information relating to the patent term extension for the '814 patent after Orchid submitted its ANDA (Orchid Comments at 2 and 6-8). We address each of these claims below. First, Orchid's reliance on section 505(q)(l)(A)(ii) ofthe Act, which states that FDA shall not delay approval of a pending application "because of any request to take any form of action relating to the application" unless FDA determines "that a delay is necessary to protect the public health," is misplaced. Here, FDA's recognition of the 30- month stay is dictated by the statute itself, and would occur whether or not the petition had been fied. Certainly, section 505(q)(l)(A)(ii) of the Act cannot be fairly read as meaning that statutory provisions relating to 30-month stays for ANDAs that would apply if no petition were submitted must be disregarded simply because someone files a petition relating to those dates. In addition, nothing in the legislative history suggests that this was the Congressional intent, and Orchid has not provided any other basis for us to take such a position. Second, we disagree that the 7.5-year stay of approval is the only stay to which Roche is entitled. The fact that Boniva had NCE exclusivity and was entitled to the 7.5-year stay of approval under section 505G)(5)(F)(ii) of the Act does not change the analysis that a 30-month stay ensues when a paragraph III certification is changed to a paragraph iv certification for a patent that was listed before the ANDA was submitted. There is nothing in the language of the statutory NCE exclusivity provision, section 8

9 505G)(5)(F)(ii) of the Act, that precludes the availability of a 30-month stay when a paragraph III certification is changed to a paragraph iv certification under circumstances such as those described in the Petition. i i Orchid offers no support, and we can find none, for its assertion that the "specific (7.5-year stayj provision controls and is the sole stay of approval available to Roche" (Orchid Comments at 5). We believe that it would not be appropriate-and that Congress did not intend-for an innovator sponsor that obtains approval of a new chemical entity to receive less protection with respect to delayed challenges to its patents than a sponsor that submits a product that does not qualify for NCE exclusivity. Third, for the reasons stated, we reject the position that the rationale for allowing multiple 30-month stays in the situation described in the Draft Guidance is inapplicable to situations in which NCE exclusivity is implicated. Moreover, we do not believe that a different result is dictated by the Teva decision.12 That decision should not be considered a wholesale license to disregard the statute's language in support of an asserted statutory purpose to benefit generic applicants. Orchid apparently takes the position that the statutory language requiring a 30-month stay should be disregarded because "the structure and purpose of the MMA,... is to prevent multiple 30-month stays and new opportunities for brand companies to further delay the approval of pending ANDAs by obtaining multiple 30-month stays" (Orchid Comments at 6). Here, however, the statutory language does not bar multiple 30-inonth stays. Instead, it prohibits such stays relating to patent information filed after the ANDA has been submitted (whether or not recognizing such a stay would result in multple stays). Nothing in either the structure or purpose of this amendment suggests that it would be appropriate to ignore the statutory language and deny a stay that is not coextensive with an earlier stay simply because the ANDA applicant chose not to fie paragraph iv challenges to all pending patents at the same time. 13 Finally, Orchid's claim that, even if FDA applies the 30-month stay provision, Roche is not entitled to such a stay because it submitted patent information relating to the patent term extension for the' 814 patent afer Orchid submitted its ANDA is misguided. As discussed above, Roche first submitted patent information for the' 814 patent in 2003 in connection with the original NDA for Boniva, and again in 2004 and 2005 in connection with the once-monthly NDA supplement, each of which preceded the submission of II By its terms, this provision affects the 30-month stay only in circumstances in which "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" (section 505(j)(5)(F)(ii) of the Act). Here, because of the delayed challenge to the patent, the action for patent infringement was not commenced during that time period. Moreover, the statutory language speaks only of the 30-month stay being "extended," not, as Orchid argues, being curailed or disallowed. 12 Orchid argues that the Draft Guidance should not be considered controllng because of the Teva decision, not that the Agency should reach a different result because of that decision (Orchid eomments at 6). We assume, however, that it is ultimately intending to assert that the Teva decision should lead FDA to decline to recognize the 30-month stay at issue here. 13 There is, of course, also the question of whether the MMA even applies to this application. See footnote 10. Because we reach the same result, whether or not the MMA applies, we do not here resolve that issue. 9

10 Orchid's ANDA in 2007 (Petition at 4, Exhibit C, and Exhibit D). The fact that Roche subsequently submitted updated patent information to reflect the patent term extension for the '814 patent, after Orchid's ANDA submission, does not change the analysis above or our determination that a 30-month stay is appropriate here. Furthermore, even if we were to accept, for purposes of this argument, that the MMA applied to the facts at hand, the statutory language is clear that a 30-month stay is available with respect to litigation resulting from paragraph iv certifications as to patents "for which information was submitted" to FDA before Orchid's ANDA was submitted (see section 505G)(5)(B)(iii) of the Act). Here, it is undisputed that information on the '814 patent was submitted before Orchid's ANDA was submitted. Accepting Orchid's position would have the effect of disqualifying patents for 30-month stays whenever extensions of those patents were granted after ANDAs had been submitted. Because extensions of patents were intended to provide an incentive for innovation, this would be a very odd result. As noted, a fair reading of the statute leads to rejection of Orchid's position on this point. III. CONCLUSION For the reasons stated above, your petition is granted in that FDA confirms that a 30- month stay beginning July 26, 2010, applies to Orchid's ANDA based on Orchid's paragraph iv certification and Roche's resulting patent infringement suit regarding the '814 patent. FDA thus confirms that it wil stay approval of ANDA , absent another specified event under section 505(j)(5)(B)(iii) of the Act, for a period that begins on July 26,2010. However, as noted above, this stay wil end upon the expiration of '814 patent on March 17,2012, or earlier if the patent infringement suit is resolved in favor of Orchid. the Sincerely, Jane oodcock, 11.D. Director Center for Drug Evaluation and Research 10