DEPARTMENT OF HEALTH &. HUMAN SERVICES

Food and Drug Administration Rockville MD 20857

FEB 2 2 2011

Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC 20001-3886

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) 78-998 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 78-998, 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 of the '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.

2 2 1 CFR 314.430(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 314.105 or tentative approval letter is sent to the applicant under 314.107, 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 78-998 in December 2009. 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.§.

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i. BACKGROUND

A. Roche's NDA for Boniva

FDA approved Roche's new drug application (NDA) 21-455 for Boniva (ibandronatesodium) tablets, 2.5 miligrams (mg), on May 16, 2003, for the treatment and preventionof 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 NCEexclusivity, ANDAs for the drug product that contained a paragraph iv certification toany patent that claimed the listed drug or a use of that drug could not be submitted untilMay 16,2007 (4 years from the date ofNDA approval) (see section 505G)(5)(F)(ii) of theAct; 21 CFR 314.108(b)(2)).

On August 12,2003, in connection with its NDA for Boniva, Roche submitted patentinformation for listing in FDA's Approved Drug Products With Therapeutic EquivalenceEvaluations (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, whichextended the expiration date until March 17,2012 (Orchid Comments at 2-3). The' 196patent expires on October 7,2019.3

On March 24, 2005, an NDA supplement providing for the once-monthly dosage regimenof 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 once-monthly NDA supplement on April 30, 2004, and again on March 25,2005, upon FDA'sapproval of the NDA supplement (Petition at 4, Exhibit C, and Exhibit D). Roche listedthe following additional patents in the Orange Book after it obtained approval for itsNDA supplement: U.S Patent No. 7,192,938 (the '938 patent); U.S. Patent No. 7,410,957(the '957 patent); and U.S. Patent

No. 7,718,634 (the '634 patent), each of which expireson May 6,2023.4

B. Orchid's ANDA for a Generic Version of Boniva

Orchid submitted ANDA 78-998 on May 16,2007, to market a generic version of Bonivaonce-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 paragraphiV 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 theexpiration 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 45days of receiving the notice of the paragraph iV certifications from Orchid (Petition at 4).

3 The Orange Book.

4 Id.

2

Because Boniva was granted 5 years ofNCE exclusivity, and Roche's suit forinfringement was fied within the I-year period beginning 4 years after approval of theNDA, the 30-month stay was extended by an amount of time such that 7.5 years wouldelapse from the date ofNDA approval (see section 505G)(5)(F)(ii) of the Act). Thus, the

stay was extended until November 16,2010.5 According to the Petition, Rochesubsequently dismissed the claims for infringement of both the '196 and '938 patents

(Petition at 4-5; Roche Supplemental Letter at 2).

Orchid amended its ANDA in 2008 to contain a paragraph iv certification to the '957patent, and Roche initiated a patent infringement suit within 45 days of receiving theparagraph iv notice (Petition at 4). In June 2010, Orchid again amended its ANDA tocontain a paragraph iv certification to the '634 patent, and within 45 days of receivingnotice of the paragraph iv certification, Roche fied a patent infringement suit (Petition at5).6

Subsequently, and most relevant to the Petition, on July 23,2010, Orchid amended itsANDA to change the paragraph III certification with respect to the '814 patent to aparagraph 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 alleginginfringement 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 submitinformation for each patent that claims the drug or method of using the drug that is thesubject of the NDA and for which "a claim of patent infringement could reasonably beasserted if a person not licensed by the patent owner engaged in the manufacture, use, orsale of the drug" (sections 505(b)(1) and (c)(2) of the Act). FDA publishes this patentinformation in the Orange Book. With respect to each listed patent, an ANDA mustprovide 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 ofBoniva's 5-year NeE exclusivity (Petition at 4). However, because Boniva had NeE exclusivity, andRoche's patent infringement action commenced during the I-year period beginning 4 years after NDAapproval, the 30-month stay period was extended by the amount of time that is required for 7.5 years tohave 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 thePetition correctly recognizes that the original stay expires on November 16,2010, its calculation of suchstay 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.

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(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 theapplication is submitted (a paragraph iv certification); . . . .

(Section 505G)(2)(A)(vii) of the Act. See also 21 CFR 314.94(a)(12)(i)(A).)

An ANDA applicant submitting a paragraph iv certification to a listed patent mustprovide 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 isinvalid or not infringed (section 505G)(2)(B) of the Act). In the case of a patent(s) forwhich information was submitted to FDA before the date on which the ANDA issubmitted, should the NDA holder or patent owner initiate a patent infringement actionagainst the ANDA applicant within 45 days of receiving the required notice, approval ofthe ANDA wil be stayed for 30 months from the date of receipt of the notice, unless acourt 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 stayregardless of when the patent at issue was submitted to FDA. This resulted in ANDAsbeing subjected to multiple overlapping 30-month stays, as NDA holders submitted newpatents to FDA well after the ANDA had been submitted and after the initiation of anearlier 30-month stay (see Federal Trade Commission, Generic Drug Entry Prior toPatent Expiration: An FTC Study, at iv-v (July 2002), available on the Internet athttp://ww.ftc.gov/os/2002/07/genericdrugstudy.pdf). Concern over the significantdelays in generic drug approvals resulting from multiple 30-monthstays led toamendment of the 30-month stay provision as part of the Medicare Prescription Drug,Improvement, and Modernization Act (MMA).7 The MMA included provisionsmodifying section 505G)(5)(B)(iii) of the Act to reduce the availability of 30-month stays(149 Congo Rec. S15882 at S15884 (Nov. 25,2003) (statement of

Senator Kennedy thatHatch- Waxman provisions ofMMA "wil stop the multiple, successive 30-month staysthat the Federal Trade Commission identified as having delayed approval of genericversions 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 wheninformation concerning the patent(s) at issue in the paragraph IV-related litigation wassubmitted by the NDA holder to FDA before the ANDA was submitted (section505(j)(5)(B)(iii) of the Act). No 30-month stay is available when the NDA holder orpatent owner sues as a result of a paragraph iv certification to a patent for whichinformation is first submitted following the submission of the ANDA (FDA draftguidance for industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and

7pub.L.No.108-173.

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505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare PrescriptionDrug, Improvement, and Modernization Act of 2003, Questions and Answers (DraftGuidance), at 8 (Oct. 2004)).8 As noted in the Draft Guidance, "(tJhe MMA generallyprecludes multiple 30-month stays for those applications to which it applies" but does notpreclude multiple 30-month stays in all circumstances (Draft Guidance at 8). The DraftGuidance explains that:

(tJhe relevant provisions of the MMA apply to patents submitted to FDA

on or after August 18,2003. For ANDAs and 505(b)(2) applicationswith paragraph IV certifications to a patent submitted to FDA on or afterAugust 18,2003, the MMA provides that a 30-month stay may beavailable for litigation related to that patent only if the patent wassubmitted to FDA before the date that the ANDA or 505(b)(2)application (excluding an amendment or supplement) was submitted. Inother 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 or505(b)(2) application was submitted. Because of this limitation, in mostcases, ANDAs and 505(b)(2) applications wil be subject to no more thanone 30-month stay.

(Draft Guidance at 8.) (Emphasis in original; footnotes omitted.)

The Draft Guidance cautions, however, that "(mJultiple 30-month stays. . . may bepossible in certain cases" (Draft Guidance at 8). One scenario envisioned by the DraftGuidance in which multiple 30-month stays are possible is one in which an ANDAcontaining a paragraph III and a paragraph iv certification (to patents submitted afterAugust 18, 2003, and before the ANDA was submitted) is amended by the ANDAapplicant to convert the paragraph III certification to a paragraph iv certification (DraftGuidance at 8-9). In such a scenario, both the original paragraph iv certification and thenew 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 toqualified drug products approved in an application under section 505(b) of the Act. Thisexclusivity, referred to as new chemical entity (NCE) exclusivity, protects such drugproducts from competition from certain products described in sections 505G) and505(b )(2) of the Act. This exclusivity does not block acceptance and review of stand-alone NDAs (supported entirely by data developed by the applicant or to which theapplicant has a right of reference).

Specifically, 5-year exclusivity for a 505(b) application as the exclusivity relates to thesubmission of ANDAs is provided for in section 505G)(5)(F)(ii) of the Act, which statesin pertinent part that:

8 The Draft Guidance is available at

http://www . fda. gov / downloads/Drugs/Guidanceeomp lianceRegulatory Information/Guidances/ucm0728 87 .

pM. The Draft Guidance, when finalized, wil represent FDA's current thinking on the topic.

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If an application submitted under subsection (b) for a drug, no activeingredient (including any ester or salt of the active ingredient) of whichhas been approved in any other application under subsection (b), isapproved. . . no application may be submitted under this subsection

(505(j)J which refers to the drug for which the subsection (b) applicationwas submitted before the expiration of five years from the date of theapproval of the application under subsection (b), except that such anapplication may be submitted under this subsection after the expiration offour years from the date of the approval of the subsection (b) applicationif it contains a certification of patent invalidity or noninfringementdescribed in subclause (N) of paragraph (2)(A)(vii). . . .9

Briefly stated, this provision grants exclusivity, generally of 5 years, to a drug approvedunder an NDA that contains no active ingredient (including any ester or salt of the activeingredient) previously approved by the Agency. An applicant can submit an ANDA after4 years if the applicant opts to include in its application a paragraph iv certification withrespect to a patent that claims the drug or method of using the drug that is the subject ofthe NDA (section 505G)(5)(F)(ii) of the Act).

If a patent infringement action is commenced during the I-year period beginning 48months after the date of approval of the NDA, the 30-month stay period referred to insection 505G)(5)(B)(iii) ofthe Act is extended by the amount of time required for 7.5years 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 DraftGuidance make clear that a 30-month stay applies to Orchid's ANDA based on theparagraph iv certification with respect to the' 814 patent and the timely patentinfringement suit fied by Roche (Petition at 2 and 6). Specifically, you rely on thelanguage of21 U.S.C. 355G)(5)(B)(iii) (section 505(j)(5)(B)(iii) of the Act), whichprovides that when an ANDA applicant submits a paragraph iv certification to a patentlisted in the Orange Book prior to the submission of the ANDA, and the patent holderbrings an infringement action within 45 days of receipt of notice of the paragraph ivcertification, FDA must stay the approval of the ANDA for 30 months beginning on thedate of the receipt ofthe notice (Petition at 6). You thus claim that because (1) Rochefiled information regarding the '814 patent for listing in the Orange Book before the dateon which Orchid's ANDA was submitted, (2) Orchid made a paragraph iv certificationto 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 forinfringement 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 notrelevant to the issues raised in the Petition and is not addressed in this response.

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2010, the date Roche received Orchid's paragraph iv notice with respect to the '814patent (Petition at 6-7).

In addition, you assert that the Draft Guidance acknowledges that, although the MMAgenerally precludes multiple 30-month stays by permitting such stays only if the patentwas submitted to FDA prior to submission of the ANDA, multple 30-month stays arepossible in certain circumstances (Petition at 3). Specifically, you note that the DraftGuidance cites as an example a situation in which an ANDA contains both a paragraphIII and paragraph.IV certification, and the applicant converts the paragraph IIIcertification to a paragraph iV certification, where the patent at issue "was submitted toFDA (1) on or after August 18,2003, and (2) before the ANDA ... application wassubmitted" (Petition at 3, citing Draft Guidance at 8-9). In this example, the applicant'sconversion of its paragraph III certification to a paragraph iv certification gives rise to a30-month stay (Draft Guidance at 8-9). You claim that "(tJhis example correspondsprecisely 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 aParagraph 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 ivcertification with respect to the '814 patent and Roche's resulting patent infringementsuit. We reach this conclusion regardless of whether the MMA applies to the facts athand.1o Once Orchid changed the paragraph III certification to a paragraph ivcertification with respect to the '814 patent, and within 45 days of receiving notice of theparagraph iv certification Roche sued Orchid for infringement of the' 814 patent, thestatutory requirements for a 30-month stay with respect to this paragraph IV certificationwere met, as the information concerning the '814 patent was submitted to FDA before thesubmission 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 patentlisted in the Orange Book at the time of the submission of the ANDA, later amended theANDA to change the paragraph III certification to a paragraph iv certification, and wassubsequently and timely sued for patent infringement. In such circumstances, we apply a30-month stay beginning on the date that notice of the paragraph iv certification wasreceived 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 ANDAbeginning 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 operativesubmission of patent information occurred on the original patent listing date for the '814 patent (prior toAugust 18,2003), or when patent information was submitted in connection with the once-monthly NDAsupplement (after August 18,2003). Because we conclude that the relief requested in the Petition must begranted regardless of whether the MMA applies, we need not resolve the issue of which patent listing dateapplies.

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upon the expiration of the' 814 patent on March 17, 2012, or earlier if the patentinfringement suit is resolved in favor of Orchid. FDA policy has been that when a patentfor which there is a paragraph iv certification expires, the applicant must revise its patentcertification from a paragraph iV to a paragraph II certification. If the applicant does notchange the certification, FDA wil deem it to be a paragraph II certification (see RanbaxyLabs. 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, 1282-84,363U.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 itsapplication 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 publichealth (Orchid Comments at 3). Second, Orchid asserts that the NCE exclusivityprovision, 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 themore general provision in Section 505G)(5)(B)(iii)" (Orchid Comments at 4). Orchidthus claims that approval of Orchid's ANDA is subject only to the 7.5-year stay set forthin section 505G)(5)(F)(ii) ofthe Act, which would delay approval of the ANDA untilNovember 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 involvethe unique situation... where the stay of approval is governed by the specific NCEexclusivity statute" and because it predated the decision of the District of ColumbiaCircuit in Teva Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010) (OrchidComments at 5). Finally, Orchid claims that no 30-month stay is available becauseRoche 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). Weaddress each of these claims below.

First, Orchid's reliance on section 505(q)(l)(A)(ii) ofthe Act, which states that FDAshall not delay approval of a pending application "because of any request to take anyform of action relating to the application" unless FDA determines "that a delay isnecessary 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 petitionhad been fied. Certainly, section 505(q)(l)(A)(ii) of the Act cannot be fairly read asmeaning that statutory provisions relating to 30-month stays for ANDAs that would applyif no petition were submitted must be disregarded simply because someone files apetition relating to those dates. In addition, nothing in the legislative history suggests thatthis was the Congressional intent, and Orchid has not provided any other basis for us totake such a position.

Second, we disagree that the 7.5-year stay of approval is the only stay to which Roche isentitled. The fact that Boniva had NCE exclusivity and was entitled to the 7.5-year stayof approval under section 505G)(5)(F)(ii) of the Act does not change the analysis that a30-month stay ensues when a paragraph III certification is changed to a paragraph ivcertification for a patent that was listed before the ANDA was submitted. There isnothing in the language of the statutory NCE exclusivity provision, section

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505G)(5)(F)(ii) of the Act, that precludes the availability of a 30-month stay when aparagraph III certification is changed to a paragraph iv certification under circumstancessuch 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 ofapproval available to Roche" (Orchid Comments at 5). We believe that it would not beappropriate-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 delayedchallenges to its patents than a sponsor that submits a product that does not qualify forNCE exclusivity.

Third, for the reasons stated, we reject the position that the rationale for allowing multiple30-month stays in the situation described in the Draft Guidance is inapplicable tosituations in which NCE exclusivity is implicated. Moreover, we do not believe that adifferent result is dictated by the Teva decision.12 That decision should not be considereda wholesale license to disregard the statute's language in support of an asserted statutorypurpose to benefit generic applicants. Orchid apparently takes the position that thestatutory language requiring a 30-month stay should be disregarded because "thestructure and purpose of the MMA, ... is to prevent multiple 30-month stays and newopportunities for brand companies to further delay the approval of pending ANDAs byobtaining multiple 30-month stays" (Orchid Comments at 6). Here, however, thestatutory language does not bar multiple 30-inonth stays. Instead, it prohibits such staysrelating to patent information filed after the ANDA has been submitted (whether or notrecognizing such a stay would result in multple stays). Nothing in either the structure orpurpose of this amendment suggests that it would be appropriate to ignore the statutorylanguage and deny a stay that is not coextensive with an earlier stay simply because theANDA applicant chose not to fie paragraph iv challenges to all pending patents at thesame time.

13

Finally, Orchid's claim that, even if FDA applies the 30-month stay provision, Roche isnot entitled to such a stay because it submitted patent information relating to the patentterm extension for the' 814 patent afer Orchid submitted its ANDA is misguided. Asdiscussed above, Roche first submitted patent information for the' 814 patent in 2003 inconnection with the original NDA for Boniva, and again in 2004 and 2005 in connectionwith 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 dateof the approval of the subsection (b) application" (section 505(j)(5)(F)(ii) of the Act). Here, because of thedelayed challenge to the patent, the action for patent infringement was not commenced during that timeperiod. Moreover, the statutory language speaks only of the 30-month stay being "extended," not, asOrchid 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). Weassume, however, that it is ultimately intending to assert that the Teva decision should lead FDA to declineto 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.

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Orchid's ANDA in 2007 (Petition at 4, Exhibit C, and Exhibit D). The fact that Rochesubsequently submitted updated patent information to reflect the patent term extensionfor the '814 patent, after Orchid's ANDA submission, does not change the analysis aboveor our determination that a 30-month stay is appropriate here. Furthermore, even if wewere 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 litigationresulting from paragraph iv certifications as to patents "for which information wassubmitted" 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 submittedbefore Orchid's ANDA was submitted. Accepting Orchid's position would have theeffect of disqualifying patents for 30-month stays whenever extensions of those patentswere granted after ANDAs had been submitted. Because extensions of patents wereintended to provide an incentive for innovation, this would be a very odd result. Asnoted, 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'sparagraph iV certification and Roche's resulting patent infringement suit regarding the'814 patent. FDA thus confirms that it wil stay approval of ANDA 78-998, absentanother specified event under section 505(j)(5)(B)(iii) of the Act, for a period that beginson July 26,2010. However, as noted above, this stay wil end upon the expiration of the'814 patent on March 17,2012, or earlier if the patent infringement suit is resolved infavor of Orchid.

Sincerely,

Jane oodcock, 11.D.DirectorCenter for Drug Evaluation and Research

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