A will consider the nature (e.g., major or minor) of the deficiencies, including the number of deficiencies in the ANDA in determining whether an ANDA is incomplete on Its face (see section V.J.2).Regulatory Deficiencies (§ 314.101(e))Clarifies that FDA will refuse to file a 505(bX2) application or refuse to receive an ANDA if submission is not permitted under sections 505(c)(3)(E)(ii), 505(j)(5)(F)(ii), 505A(b)(1)(A)(i)(I), 505A(c)(1)(A)(i)(I), or 505E(a) of the FD&C Act (see section V.A.7).21 C.F.R. § 314.105 Approval of an NDA and an ANDA (§ 314.105)Removes the proposed statement that an NDA is approved on the date of the issuance of the approval letter, and clarifies that a new drug product may not be marketed until the “date of approval,” rather than the “date of the approval letter” (see section V.A.3).Clarifies that approval of a 505(b)(2) application or ANDA also may be delayed by a period of exclusivity for the listed drug under section 505E of the FD&C Act (see section V.A.7)21 C.F.R. § 314.107 Disposition of patent litigation (§ 314.107(b)(3))Revises § 314.107(b)(3)(v) to more dearly describe the timing of approval o f a 505(b)(2) application or ANDA when a preliminary injunction is entered by a Federal district court before the expiration of a 30-month stay (or 7-1/2 years where applicable) (see section V.M.2.g).Clarifies that the 30-month period (or 7-1/2 years where applicable) will be terminated if the court(s) enter(s) an order of dismissal without a finding of infringement in each pending suit for patent infringement brought within 45 days of receipt of the notice of paragraph IV certification sent by the 505(b)(2) or ANDA applicant (see section V.M.2.j).Delay due to exclusivity (§ 314.107(d)).Clarifies that approval of a 505(b)(2) application or ANDA also may be delayed by a period of exclusivity for the listed drug under section 505E of the FD&C Act (see section V.M.4).Notification of court actions or written consent to approval (§ 314.107(e))Requires submission of

y (“CGT”) 180-day exclusivity) we’ve found it a bit frustrating that the Orange Book does not always capture the running of a period of 180-day exclusivity. And, in our experience, that’s happened because, despite boilerplate ANDA approval letter language that a company “[p]lease submit a correspondence to this ANDA informing the Agency of the date you begin commercial marketing,” some generic drug manufacturers have failed to notify FDA about the date of first commercial marketing of a drug product so that the Agency can update the Orange Book with the appropriate “PC” (Patent Challenge) exclusivity expiration date. (Failure to notify has not been an issue with CGT 180-day exclusivity, but it’s worth noting that notice timing is important—see our previous post here.)Back in October 2016 when FDA updated the Agency’s Hatch-Waxman regulations to incorporate some of the changes made by the 2003 Medicare Modernization Act (see our previous post here), the Agency added a new regulation: 21 C.F.R. § 314.107(c)(2). That regulation, which concerns the timing of approval of “subsequent Paragraph IV ANDA” (i.e., an ANDA potentially blocked from final approval because of a first applicant’s eligibility for, or the running of, 180-day exclusivity) states:A first applicant must submit correspondence to its ANDA notifying FDA within 30 days of the date of its first commercial marketing of its drug product or the reference listed drug.

In the event that an ANDA applicant settles a patent litigation by obtaining a waiver or license to exclusivity or patent rights possessed by the NDA holder, patentee, or their exclusive licensee(s), the ANDA may be approved on the waiver or license date if the ANDA applicant submits “written consent” obtained from the patent and/or NDA holder for that approval. See 21 C.F.R. § 314.107(b)(3)(vi). FDA describes acceptable “written consent” as “[a] letter to FDA from the patent owner(s) or exclusive patent licensee that provides consent to approval of the 505(b)(2) application or ANDA any time on or after the date of consent,” which may be submitted to FDA either alone or in combination with any actual settlement and/or license agreement.

The resulting harm to all customers – including federal and state government, municipal and employee health plans and the uninsured – leaves these payers no option to choose lower-priced versions of Nexium and flies in the face of the FDA’s stated goals and regulations designed to promote timely access to less expensive generics.Among other things, Attorney General Jepsen urges FDA to utilize its “active pursuit” regulation at 21 C.F.R. § 314.107(c)(3) to determine that Ranbaxy is no longer eligible for 180-day exclusivity for generic NEXIUM. That regulation states that “if FDA concludes that the applicant submitting the first application is not actively pursuing approval of its abbreviated application, FDA will make the approval of subsequent [ANDAs] immediately effective if they are otherwise eligible for an immediately effective approval.”

FDA has not yet considered a forfeiture under the second condition.Second, FDA’s ANDA regulations (at 21 C.F.R. § 314.107(c)(3)) have for decades allowed the Agency to conclude that 180-day exclusivity will not be awarded to a first applicant that does not diligently pursue ANDA approval: “If FDA concludes that a first applicant is not actively pursuing approval of its ANDA, FDA may immediately approve an ANDA(s) of a subsequent applicant(s) if the ANDA(s) is otherwise eligible for approval.” In promulgating this regulation (59 Fed. Reg. 50,338, 50,354 (Oct. 3, 1994)), FDA commented that:For purposes of this rule, the phrase “actively pursuing approval” is intended to encompass a drug sponsor’s good faith effort to pursue marketing approval in a timely manner.

Please submit correspondence to this ANDA notifying the Agency within 30 days of the date of the first commercial marketing of this drug product or the RLD. If you do not notify the Agency within 30 days, the date of first commercial marketing will be deemed to be the date of the drug product’s approval. See 21 CFR 314.107(c)(2).We knew there had to be more to FDA’s decision, so we obtained a copy of the Agency’s November 9, 2017 Exclusivity Determination. Apparently FDA was forced to make the determination early, prior to approving Teva’s ANDA, in light of approval decisions that needed to be made on subsequent Paragraph IV ANDAs.According to FDA, different changes or approval requirement reviews imposed after the November 21, 2007 (5 mg, 10 mg and 20 mg) and October 14, 2008 (2.5 mg) ANDA submission dates nullified the 30-month period under FDC Act § 505(j)(5)(D)(i)(IV) for each strength.

“In sum, Deva has not pointed to statutory or regulatory authority, or any case law, showing that this Court may order the FDA to terminate the 30-month stay of Deva’s ANDA.” Moreover, while Deva represented that Allergan had provided written consent, “the proper course is for Deva to submit that consent to the FDA, which would have the authority under 21 C.F.R. § 314.107(b)(3)(vi) to terminate the stay and grant approval of Deva’s ANDA.”No OTDP for Firazyr®Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC, 06/05/18 (D. Del.) C.A. No. 15-1102-GMS The district court held that Shire’s patent covering Firazyr® was not invalid for obviousness-- type double patenting.

A:The Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman equivalent for generic animal drugs. FDA has not yet proposed regulations to implement the law.Q20: How many times has FDA used its “active pursuit” regulation at 21 C.F.R. § 314.107(c)(3) (“[I]f FDA concludes that the applicant submitting the first application is not actively pursuing approval of its abbreviated application, FDA will make the approval of subsequent [ANDAs] immediately effective if they are otherwise eligible for an immediately effective approval.”) to effectively take away a first applicant’s 180-day exclusivity eligibility?A:None.Q21: What case (and involving what drug) was the first judicial test of the 3-year exclusivity provisions of the Hatch-Waxman Amendments?A:Zenith Labs., Inc. v. Bowen, Case No. 85-cv-3646 (D.N.J. 1986), which involved the drug Tolazamide.

Q19: What U.S. law is modeled after the Hatch-Waxman Amendments, and how long has it taken FDA to issue implementing regulations?Q20: How many times has FDA used its “active pursuit” regulation at 21 C.F.R. § 314.107(c)(3) (“[I]f FDA concludes that the applicant submitting the first application is not actively pursuing approval of its abbreviated application, FDA will make the approval of subsequent [ANDAs] immediately effective if they are otherwise eligible for an immediately effective approval.”) to effectively take away a first applicant’s 180-day exclusivity eligibility?Q21: What case (and involving what drug) was the first judicial test of the 3-year exclusivity provisions of the Hatch-Waxman Amendments?Q22: Who is Gary P. Jordan?Q23: Who is Marion J. Finkel?Q24: What is the only instance in which a court has ordered FDA to approve an ANDA during another sponsor’s period of 180-day exclusivity?

In turn, this would prevent courts from having to weigh in on whether importation under the PLAIR request is proper.Although ANDA (and 505(b)(2)) applicants are currently required to notify FDA of court actions (see 21 C.F.R. § 314.107(e)), it seems unlikely that the FDA components to which these notifications are sent (i.e., the Office of Generic Drugs or a particular Division in the Office of New Drugs) would, as a matter of course, apprise the Agency’s PLAIR team in the event a PLAIR has been (or will be requested). As such, this proposed additional element to a PLAIR request seems to make sense.Second, the authors suggest a revision to 35 U.S.C. § 271(e)(4), as reflected in the bolded and italicized typeface below:For an act of infringement [caused by filing an ANDA with a Paragraph IV certification] – (A) the court shall order the effective date of any approval of the drug . . . to be a date which is not earlier than the date of the expiration of the patent which has been infringed, (B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological prod