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Adding to the ANDA to Avoid Infringement• Where the ANDA defines it product in a way that directly
addresses the question of infringement, the ANDA product cannot literally infringe under Section 271(e)(2) as a matter of law. The Federal Circuit has determined that the ANDA alone can “mandate[] a finding of no literal infringement.”
– Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241 (Fed. Cir. 2000)
– Tyco Healthcare Group LP v. Mut. Pharm. Co., No. 07-1299, 2009 U.S. Dist. LEXIS 68176 (D.N.J. Aug. 4, 2009)
• Hypothetical infringement inquiry is grounded in the ANDA application.
Optimizing a Brand’s Exclusivity• Obtain additional patents
– Claims directed to the formulation, PK properties, etc.
• Adjust the formulation– Controlled-release– Abuse-resistant
• Get approval for additional indications
• Product switching strategies– Immediate-release to extended-release dosage form– Basic drug molecule to a prodrug of the same drug molecule– Basic formulation to “abuse-resistant” formulation
Challenges to the 180-day Exclusivity Period: Forfeiture• Failure to Market. The first applicant fails to market the drug by the
later of –
(aa) the earlier of the date that is – (AA) 75 days after the date on which the approval of the application of the first applicant is made effective under (B)(iii); or(BB) 30 months after the date of submission of the application of the first applicant; or
(bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under (B)(iv), at least one of the following has occurred:(AA) . . . a court enters a final decision from which no appeal . . . has been or can be taken that the patent is invalid or not infringed.(BB) . . . a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.(CC) The patent information submitted under (b) or (c) is withdrawn by the holder of the application approved under (b).
A First Applicant forfeits 180-day exclusivity if it fails to market by the later of:
Regulatory Events Patent Events
THE EARLIER OF:
With respect to the first applicant(s), or any other applicant with tentative approval, and with respect to each patent for which the first applicant(s) submitted a Paragraph IV Certification qualifying it for exclusivity, 75 days after any one of the following “has occurred": 75 days after final
approval of the first applicant’s ANDA; or
30 months after submission of the first applicant’s ANDA.
A court issues a final non-appealable decision that the patent(s) is/are invalid or not infringed (whether in an infringement action or a declaratory judgment action); A court signs a settlement or consent decree that includes a finding that the patent(s) is invalid or not infringed; or The patent is withdrawn from the Orange Book
Other Forfeiture Events• First applicant withdraws ANDA
• First applicant amends ANDA to withdraw PIV certifications
• First applicant fails to obtain tentative approval within 30 months from filing, unless the failure is caused by a change in or review of the approval requirements
Failure to Obtain Tentative Approval• Added by Medicare Modernization Act
• Forfeiture occurs when “[t]he first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.” 21 U.S.C. § 355(j)(5)(D)(i)(IV).
• Has not yet been litigated by either a first ANDA applicant who has forfeited 180-day exclusivity on these grounds or by a subsequent ANDA applicant challenging the first applicant’s retention of 180-day exclusivity
Failure to Obtain Tentative Approval• In contrast to the “failure to market” provision, the
“failure to obtain tentative approval” provision calculates the 30-month period from the date the ANDA is filed as opposed to the date of ANDA submission
– Reasonable to use the date that qualifies the first ANDA applicant for 180-day exclusivity, i.e., the date that the ANDA is sufficiently complete to permit substantive review
• Rationale: 180-day exclusivity provided to the first applicant “carries with it the requirement that – to maintain that eligibility – the first applicant must work diligently to obtain a tentative approval before the 30-month period expires.”
Exceptions to Failure to Obtain Tentative Approval Provision• Exception for a change in or a review of the requirements
for approval of the application imposed after the date on which the application is filed
• Acarbose: – CP filed relating to BE methodology for acarbose products after the 30-month
period had run served to change the BE requirements– Filing and FDA evaluation of CP delayed approval of Cobalt’s ANDA – Cobalt did not forfeit its exclusivity for failure to obtain tentative approval
• Nateglinide: – At least one first ANDA applicant (of many) failed to obtain tentative approval
within 30 months– If a first applicant loses 180-day exclusivity, its ANDA can still be approved during
the 180-day period– Once any first applicant (eligible or ineligible for 180-day exclusivity) gets final
approval and begins commercial marketing, the 180-day clock begins to run.
• Where tentative approval is not received within 30 months, FDA may nevertheless defer making a decision on forfeiture unless and until another applicant becomes eligible for approval within 180 days after the first applicant begins commercial marketing.
– Example: Triamcinolone Acetonide • “The agency notes that Barr failed to obtain tentative
approval of this ANDA within 30 months after the date on which the ANDA was filed. See section 505(j)(5)(D)(i)(IV) of the Act. However, the agency is not making a formal determination at this time of Barr's eligibility for 180-day generic drug exclusivity. It will do so only if another applicant becomes eligible for approval within 180 days after Barr begins commercial marketing of Triamcinolone Acetonide Nasal Spray, 0.055 mg.”
Exceptions to Failure to Obtain Tentative Approval Provision
FDAAA Tolling Provision• Enacted Sept. 27, 2007• “[I]f the filing of an application resulted in first-
applicant status . . . and approval of the application was delayed because of a petition, the 30-month period . . . is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in part, the petition.” 21 U.S.C. § 355(q)(1)(G).
FDAAA Tolling Provision• Any citizen petition submitted prior to Sept. 27,
2007 will not be subject to the provisions of FDCA 505(q)/21 U.S.C. § 355(q).– See Guidance for Industry: Citizen Petitions and Petitions
for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act 4 (Jan. 2009).
• FDA recommends that citizen petitions not be filed regarding BE guidances; instead, FDA requests comments on the BE docket (established for individual BE guidances).