IP Academy 2016 - Paul Hastings€¦ · ©2016 Paul Hastings LLP FDA RULEMAKING TIMELINE MMA passed...

IP Academy 2016

FDA’s Final Rule Implementing the M.M.A. and the Potential Impact on Hatch-Waxman Patent Litigation

Isaac S. AshkenaziPartnerPaul Hastings LLP

Jason T. ChristiansenSenior AssociatePaul Hastings LLP

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www.paulhastings.com ©2016 Paul Hastings LLP

LIMITATIONS OF THIS PRESENTATION

► This presentation cannot and will not cover every aspect of the FDA Final Rule

► We analyzed provisions of the FDA Final Rule that we think have potential to impact strategies for bothlitigation and settlement of Hatch-Waxman patent disputes

► If you have any questions about specific factual situations, we would be happy to discuss individual situations with you

► The discussion in the presentation refers to ANDAs for simplicity and unless otherwise noted, the discussion also applies to 505(b)(2) applications and we have cited to both the ANDA and 505(b)(2) portion of the regulations

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OVERVIEW

► Background

► Submission of Patent Information and Use Codes

► Timely and Untimely Filing of Patent Information

► FDA’s New Patent Listing Dispute

► Patent Certifications and 30-Month Stays

► Interpreting the Effective Date of FDA Final Rule

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BACKGROUND FOR FDA FINAL RULE

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MEDICARE MODERNIZATION ACT OF 2003 (“MMA”)► Hatch-Waxman Act reflected Congress’ efforts to make available

more low-cost generic drugs by establishing a generic drug approval procedure with new incentives for drug developers

► MMA added several provisions that affect patent infringement suits:

Converted from patent-based approach to a product-based approach for evaluating 180-day exclusivity and 30-month stays

MMA generally limits the availability of multiple 30-month stays

81 Fed. Reg. 69580 at 69582 (Oct. 6, 2016)

Commencement and forfeiture of the 180-day exclusivity period were added in order to reduce potential bottlenecks to generic approval

21 U.S.C. § 355(j)(5)(D)(i)

Congress “creat[ed] a mechanism, in the form of a legal counterclaimfor generic manufacturers to challenge patent information a brand has submitted to the FDA”

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 1678 (2012)

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FDA RULEMAKING TIMELINE

MMA passed on Dec. 8, 2003

Proposed Rule implementing MMA,

published Feb. 6, 2015(80 Fed. Reg. 6802-6896)

2003 2015 2016

Comments from 13 public sources on Proposed Rule

(April – Sep. 2015)(FDA-2011-N-0830)

FDA Final Rule implementing MMA,

published Oct. 6, 2016(81 Fed. Reg. 69580-69658)

Effective Date ofFDA Final Rule(Dec. 5, 2016)

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SUBMISSION OF PATENT INFORMATIONAND USE CODES

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SUBMISSION OF PATENT INFORMATION► NDA applicant must submit information about certain patents or

claims

Drug substance (active ingredient)

Drug product (finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance)

Method-of-use (covering pending indication(s))

► NDA holder must also submit information about these types ofpatents within 30 days after the date of approval

21 C.F.R. § 314.53(c)(ii)

Other than “use codes” for method-of-use claims (discussed later),information submitted post-approval is the same as pre-approval

► Patent information submitted on Form FDA 3542a (pre-approval) or Form FDA 3542 (post-approval) are verified under penalty of perjury

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SUBMISSION OF PATENT INFORMATION► The following types of patents must not be submitted to the FDA for

inclusion in the Orange Book:

Process patents / methods of making

Packaging Patents

Metabolites

Intermediates21 C.F.R. § 314.53(b)(1)

► Can file suit against ANDA or 505(b)(2) on non-Orange Booklisted patents

See, e.g., Merck Sharp & Dohme Corp. v. Sandoz, Inc., No. 12-3289,2013 WL 591976 (D.N.J. Feb. 14, 2013);

Glaxo Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997)

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SUBMISSION OF PATENT INFORMATION:METHOD-OF-USE PATENTS

► Method-of-use patent information submission requirements for pending and approved NDAs

Must submit information only on patents that “claim indications or other conditions of use”

Whether patent claims one or more methods of using the drug product and a description of each method-of-use and related patent claim of the patent

Identification with specificity of the section(s) and subsection(s) of the labeling for the drug product that describes the claimed method-of-use

If the method-of-use patent also claims the drug substance ordrug product, the applicable information for those types of patents

21 C.F.R. § 314.53(b)(1); 81 Fed. Reg. 69580 at 69589-600

*text in bold and underline above represents a new requirement added in the FDA Final Rule

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SUBMISSION OF PATENT INFORMATION:METHOD-OF-USE PATENTS

► For approved NDAs, use code information must now also include:

“adequate information to assist 505(b)(2) and ANDA applicants in determining whether a listed method-of-use patent claims a use for which the 505(b)(2) or ANDA applicant is not seeking approval”

► “[I]f the method(s) of use claimed by the patent does not cover an indication or other approved condition of use in its entirety, then the applicant must describe only the specific approved method-of-use claimed by the patent for which a claim of patent infringementcould reasonably be asserted if a person not licensed by theowner of the patent engaged in the manufacture, use, or saleof the drug product”

21 C.F.R. § 314.53(c)(2)(ii)(P)(3)

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SUBMISSION OF PATENT INFORMATION: SIGNIFICANCE OF USE CODES► “The FDA does not attempt to determine if [the use code] is accurate.

Rather, the FDA assumes that it is so and decides whether to approve a generic drug on that basis. As a result, the breadth of the use code may make the difference between approval and denial of a generic company’s application.”

Caraco Pharm. Labs., Ltd. v. Novo Nordisk, 132 S.Ct 1670, 1675 (2012)

► ANDA applicants can submit a section viii statement, in lieu of or in addition to a PIV certification, asserting that it will not market the drug for one or more methods-of-use covered by the NDA holder’s patent(s)

Would need to include proposed labeling that “carves out” from the approved label the still patented methods-of-use

21 C.F.R. §§ 314.94(a)(12)(iii), 314.50(i)(1)(iii)

May permit ANDA applicants to avoid 30-month stay and obtainimmediate approval for non-carved out indication(s)

► But FDA will not approve an ANDA if the proposed carve-out label overlaps at all with the NDA holder’s use code(s)

21 C.F.R. § 314.107(b)(1)(ii); 81 Fed. Reg. 69580 at 69624

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SUBMISSION OF PATENT INFORMATION:OVERBROAD USE CODES► Novo Nordisk’s PRANDIN® is “indicated as an adjunct to diet and exercise to

improve glycemic control in adults with type 2 diabetes mellitus”

► The Prandin® Package Insert states in the DOSAGE AND ADMINISTRATION section “If PRANDIN monotherapy does not result in adequate glycemic control, metformin or a thiazolidinedione may be added.”

► Courts have construed this as PRANDIN® being indicated for three uses:

Monotherapy treatment

Treatment in combination with thiazolidinediones

Treatment in combination with metformin

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S.Ct 1670 (2012);Novo Nordisk A/S v. Caraco Pharm. Labs, Ltd., 601 F.3d 1359 (Fed. Cir. 2010);

Novo Nordisk A/S v. Caraco Pharm. Labs, Ltd., 656 F.Supp. 2d 729, 730 (E.D. Mich. 2009)

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SUBMISSION OF PATENT INFORMATION:OVERBROAD USE CODES► Novo had a patent for only one of the three FDA-approved uses of PRANDIN®:

Claims a “method for treating [diabetes by] administering . . . repaglinide in combination with metformin”

Caraco, 132 S.Ct at 1678 (2012)

► At time Caraco filed its ANDA, use code U-546 for PRANDIN® covered “[u]se of repaglinide in combination with metformin to lower blood glucose”

Id. at 1679

Commensurate in scope with patent claim and the FDA-approved indication

► Caraco’s initial ANDA filing included a PIV Certification for Novo’s only listed patent, but based on FDA’s suggestion, Caraco filed a section viii statement carving out the use of repaglinide with metformin to obtain approval for theother two uses

► Before FDA approved the ANDA, Novo changed its use code to U-968 for“[a] method for improving glycemic control in adults with type 2 diabetes”

Id. at 1679

Essentially identical to FDA-approved indication, but broader than patent claim

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SUBMISSION OF PATENT INFORMATION:METHOD-OF-USE PATENT CLARIFYING REVISIONS

► FDA “decline[d] to provide hypothetical examples” of the new use code requirements, but provided “general principles [that] illustrate the clarifying revisions to the regulations regarding the content of use codes”

1. “Patented method-of-use is broader than an indication or other approved condition of use: The use code must only describe a patented method-of-use that is described in FDA-approved product labeling. If the method-of-use claimed by the patent uses different terminology than the approved labeling and/or is broader than an indication or other approved condition of use, then the use code would need to be phrased more narrowly than the patent claim to only describe the specific patented method-of-use that is described in FDA-approved product labeling.”

81 Fed. Reg. 69580 at 69598-99

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2. “Patented method-of-use is coextensive with an indication or other approved condition of use: The use code must describe only the specific approved method-of-use claimed by the patent.”

o Novo’s Original U-546 Use Code

3. “Patented method-of-use is narrower than an indication or other approved condition of use: If the method-of-use claimed by the patent does not cover an indication or other approved condition ofuse in its entirety, then the NDA holder must describe only thespecific approved method-of-use claimed by the patent—not the broader indication or other approved condition of use that may include, but is broader than, the use claimed by the patent.”

o Novo’s revised U-968 Code would violate this

81 Fed. Reg. 69580 at 69598-599

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► FDA also noted “if the patent claims a novel dosing regimen for a particular indication, the use code must specifically describe the protected dosing regimen for a particular indication and not only the indication to which the dosing regimen relates”

FDA described this as taking a “similar approach” to the Caraco situation previously discussed

81 Fed. Reg. 69580 at 69599

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TIMELY AND UNTIMELY SUBMISSIONOF PATENT INFORMATION

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TIMELY SUBMISSION OF PATENT INFORMATION► Patents issued on or before NDA approval

Must submit with original NDA filing issued patents covering the drug substance, drug product, and proposed method-of-use

If a patent issues after the NDA is filed but before it is approved, applicant must submit required information within 30 days of issuance

Failure to timely submit patent information prior to the approval of an NDA should not invoke untimely filing of patent information provisions

21 C.F.R. § 314.53(d)(1)

► Must also submit patent information within 30 days after the dateof approval of the NDA

21 C.F.R. § 314.53(c)(ii)

► Must also submit required patent information with filing of certain types of supplements

21 C.F.R. § 314.53(d)(2)

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TIMELY SUBMISSION OF PATENT INFORMATION► Patents issued after an NDA is approved

Must submit required patent information for any newly-issued patent for the drug substance, drug product, or method-of-use within 30 days of the date of issuance of the patent

21 C.F.R. § 314.53(d)(3)

► Duty to reevaluate with supplement

NDA holder must reevaluate whether (1) listed patent(s) still claim, and (2) unlisted patents claim, the product as changed by the supplement and, if necessary, correct or remove patent information from the listat the time of the approval of the supplement

81 Fed. Reg. 69680 at 69601; 21 C.F.R. §§ 314.53(d)(2), 314.53(f)(2)

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CONSEQUENCES OF TIMELY FILED PATENT INFORMATION AFTER ANDA OR 505(B)(2) FILED

► Patents issued after an NDA is approved

If ANDA is pending at time of new patent issuance and publication of the patent information, ANDA applicant “must comply with the requirements . . . regarding amendment of its patent certification or statement,” though an additional “30-month stay of approval is not available in these circumstances”

81 Fed. Reg. 69580 at 69624; 21 C.F.R. §§ 314.53(d)(3), 314.107(b)(2)

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UNTIMELY SUBMISSION OF PATENT INFORMATION► Patent information is considered untimely submitted if the “holder of

the approved NDA for the listed drug does not file with FDA the required information on the patent within 30 days of issuance of the patent”

21 C.F.R. §§ 314.94(a)(12)(vi), 314.50(i)(4)

► An amendment to the description of the approved method(s) of use claimed by a patent will be considered untimely filed patent information unless it is submitted within 30 days of:

patent issuance;

approval of a corresponding change to product labeling;

FDA’s request in response to a patent listing dispute; or

a decision by the USPTO or a Federal court that is specific to the patent and alters the construction of a method-of-use claim(s) of the patent

21 C.F.R. §§ 314.94(a)(12)(vi), 314.53(f)(1); 81 Fed. Reg. 69580 at 69606

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CONSEQUENCES OF UNTIMELYSUBMITTING PATENT INFORMATION► ANDA submitted (with appropriate patent certification(s) or

statement(s)) prior to submission of untimely filed patent information

Not required to submit a patent certification or section viii statement to address the patent or patent information that is late-listed with respect to the pending ANDA

21 C.F.R. §§ 314.94(a)(12)(vi), 314.50(i)(4)(ii)

If ANDA applicant makes voluntary certification for untimely filed patent information, it may be withdrawn

21 C.F.R. §§ 314.94(a)(12)(viii), 314.50(i)(4)(i)

ANDA applicant is not required to submit a supplement to change a submitted certification when information on a patent is submitted afterthe approval of the ANDA

21 C.F.R. §§ 314.94(a)(12)(viii)(C)(2), 314.50(i)(6)(iii)(B)

► ANDA submitted after submission of untimely filed patent information (or did not contain appropriate patent certification(s)/statement(s))

Must submit appropriate patent certification(s) or statement(s) for untimely filed patent information

21 C.F.R. §§ 314.94(a)(12)(vi), 314.50(i)(4)(ii)

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PATENT LISTING DISPUTE

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PATENT LISTING DISPUTE: DRUG SUBSTANCE AND PRODUCT CLAIMS► Patent listing disputes for drug substance or drug product claims

Person sends statement of dispute that describes the specific grounds for disagreement regarding accuracy or relevance of patent information

FDA sends statement of dispute to the NDA holder “without review or redaction”

“NDA holder must confirm the correctness of the patent informationand include the signed verification . . . or withdraw or amend thepatent information in accordance with paragraph (f)(2) of thissection within 30 days of the date on which the Agency sends the statement of dispute”

21 C.F.R. § 314.53(f)(1)(i)(A)

► “A 505(b)(2) application or ANDA must contain an appropriate certification or statement for each listed patent, including the disputed patent, during and after the patent listing dispute”

21 C.F.R. §314.53(f)(1)(ii) (emphasis added)

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PATENT LISTING DISPUTE:METHOD-OF-USE CLAIMS

► For a dispute regarding the accuracy or relevance of patent information regarding an approved method of using the drug product, this statement of dispute must:

Be only a narrative description of no more than 250 words;

Explain the person’s interpretation of the scope of the patent; and

Only contain information for which the person consents to disclosure21 C.F.R. § 314.53(f)(1)

► FDA will send the text of the statement of dispute to the NDAholder without review or redaction

Id.

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► In response to the patent listing dispute, the NDA holder must within 30 days:

Confirm the correctness of its description of the approved method-of-use claimed by the patent in the “Use Code’’ or withdraw or amend the patent information;

Provide a narrative description of no more than 250 words explaining why the existing or amended ‘‘Use Code’’ describes only the specific approved method-of-use claimed in the patent; and

Include a signed verification

► Narrative description must contain only information for which the NDA holder consents to disclosure because FDA will send to the person who submitted the patent listing dispute without review or redaction

21 C.F.R. § 314.53(f)(1)(i)(B)

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► If the NDA holder confirms the correctness of the patent information, provides the required narrative description, and includes the signed verification within 30 days of the date on which the Agency sends the statement of dispute, the Agency will not change the patent information in the Orange Book

21 C.F.R. § 314.53(f)(1)(i)(B)(1)

► If the NDA holder responds to the patent listing dispute with amended patent information, provides the required narrative description, and includes the signed verification within 30days of the date on which the Agency sends the statementof dispute, FDA will update the Orange Book to reflect theamended patent information

21 C.F.R. § 314.53(f)(1)(i)(B)(2)

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PATENT LISTING DISPUTE: CONSEQUENCES

► “A 505(b)(2) application or ANDA must contain an appropriate certification or statement for each listed patent, including the disputed patent, during and after the patent listing dispute”

21 C.F.R. § 314.53(f)(1)(ii)

► Patent listing dispute will “not have an impact on the availability of a 30-month stay if other statutory and regulatory criteria are met”

81 Fed. Reg. 69580 at 69606

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► “[I]f an NDA holder responds to the patent listing dispute with an amendment to its use code more than 30 days after the date on which FDA sends the statement of dispute to the NDA holder, FDA will consider the amendment to be untimely filing of patent information because the submission does not comply with the requirements of § 314.53(f)(1)”

81 Fed. Reg. 69580 at 69606 (emphases added)

► “FDA will promptly post information on its Web site regarding whether a patent listing dispute has been submitted for apublished description of a patented method-of-use for a drug product and whether the NDA holder has timely responded tothe patent listing dispute”

21 C.F.R. § 314.53(f)(1)(iii)

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► May require early disclosure of claim scope with 250 word limitation and 30 days’ notice

► Statements made in FDA Patent Listing Dispute will likely be discoverable in any later litigation

► NDA holders should consider conducting a detailed analysis of their patent portfolio at a very early stage to be prepared to respond to any FDA Patent Listing Disputes

► Does not affect the availability of patent delisting counterclaimsin response to infringement suits under 21 U.S.C. § 355(D)(ii)

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PATENT LISTING DISPUTE: FDA’S INCREMENTAL APPROACH

► FDA also initially proposed that if the NDA holder:

“confirms the accuracy of its submitted patent information in response to FDA’s request”

“fails to timely respond to the request”; or

“submits a revision to the use code that does not provide adequate clarity for FDA to determine whether the scope of a proposed [505(b)(2)/ANDA] labeling carve-out would be appropriate based on the NDA holder’s use code and approved labeling”

► “FDA would review a proposed labeling carve-out(s) for the 505(b)(2) application or ANDA with deference to the 505(b)(2)or ANDA applicant’s interpretation of the scope of the patent”

81 Fed. Reg. 69580 at 69604

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PATENT LISTING DISPUTE:FDA’S INCREMENTAL APPROACH

► After receiving comments, FDA declined to implement this “deference” standard

FDA decided to take “an incremental approach and evaluate whether FDA’s revisions to the regulations on submission of method-of-use patent information and patent listing dispute procedures adequately address the problem of overbroad and ambiguous use codes before [it] determine[s] whether a process to review a proposed labeling carve-out with deference to the 505(b)(2) and/or ANDA applicant(s)’ interpretation ofthe scope of the patent is also needed”

81 Fed. Reg. 69580 at 69604

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PATENT CERTIFICATIONS AND 30-MONTH STAYS

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PIV CERTIFICATION: TIMING OF NOTICE► ANDA applicant may not send valid PIV notice before receiving

paragraph IV acknowledgment letter

No consequence for not sending notice within 20 days21 C.F.R. §§ 314.52(b)(2), 314.95(b)(2)

► Also required to send paragraph IV notice letter for certification submitted in an amendment / supplement to the ANDA at the time of submission

81 Fed. Reg. 69580 at 69609, 69611; 21 C.F.R. §§ 314.52(d)(1), 314.95(d)(1)

► 505(b)(2) applicant must send PIV notice letter on or after the date of filing of the 505(b)(2) application

No consequence for not sending notice within 20 days21 C.F.R. §§ 314.52(b)(1)-(2); 81 Fed. Reg. at 69580 at 69610

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PIV CERTIFICATION: TIMING OF NOTICE► For Orange Book patents listed after ANDA is filed, ANDA applicant

may not send valid notice of paragraph IV certification before the first working day after the day the patent is listed in the Orange Book

21 C.F.R. §§ 314.94(a)(12)(viii)(C)(1)(ii), 314.95(b)(2)

► Notice must be sent to patent owner and NDA holder

“Patent owner is the owner of the patent for which information is submitted for an NDA,” which may be obtained from the USPTO

“NDA holder is the applicant that owns an approved NDA”21 C.F.R. §§ 314.3(b), 314.52(a), 314.107(f)(2)

► Unless court has changed, ANDA application may be approved 30 months after the later of :

the date of the receipt of the notice of certification by any owner of thelisted patent, or

the date of the receipt of the notice of certification by the NDA holder (or its representative(s))

21 C.F.R. § 314.107(b)(3)

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PIV CERTIFICATION: METHOD-OF-USE PATENTS► FDA acknowledges that:

It is taking a “claim-based approach to patent certification requirements for patents that include a method-of-use claim”

“ANDA applicant may submit a [section viii] statement with respect to one or more method-of-use claims and a paragraph IV certification with respect to the remaining patent claims”

81 Fed. Reg. 69580 at 69607

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ONLY ONE LISTED DRUG NEED BE CITED/CERTIFIED TO BY 505(b)(2) APPLICANT

► Only pharmaceutically equivalent products that were approved before a 505(b)(2) application was filed need to be listed

“This illustrates one of many circumstances in which the timing of submission of an application has certain statutory or regulatory implications”

81 Fed. Reg. 69580 at 69620-621

► Only need to identify one pharmaceutically equivalent drug product in a 505(b)(2) application as a “listed drug”

Only patents listed for that “listed drug” need to be certified againstId.

► May give rise to litigation after approval on patents related toother drug products that are not “listed” in a 505(b)(2) application

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REISSUE PATENTS TREATED AS DIFFERENT BUNDLE OF RIGHTS

► FDA did not finalize proposed rule to treat original patent and the reissued patent as a “single bundle of patent rights” for purposes of patent certifications, 30-month stays, and/or 180-day exclusivity

► Reconsidered in light of Mylan Pharms., Inc. v. FDA, 594 Fed. Appx. 791 (4th Cir. 2014)

Finding in pre-MMA context that reissue patent can be separate basis for 180-day exclusivity because it “is a separate grant of rights”

► Accordingly, FDA will treat the reissued patent as “separate anddistinct from the original patent” for purposes of patent certification, 30-month stays, and/or 180-day exclusivity

81 Fed. Reg. 69580 at 69600-601

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REISSUE PATENTS TREATED AS DIFFERENT BUNDLE OF RIGHTS

► Because original patent is surrendered on reissuance, any 30-month stay based on original patent will no longer be valid

► Original patent that has been reissued would remain listed in the Orange Book until FDA determined that:

there is no first applicant based on a PIV certification to that patent, or

“after the 180-day exclusivity period of a first applicant based on that patent has expired or has been extinguished”

81 Fed. Reg. 69580 at 69601

► FDA did not address ability to trigger a forfeiture event

Federal Circuit has held DJ jurisdiction exists for disclaimed patentin order to trigger forfeiture of a first-filer’s 180-day exclusivity

Apotex, Inc. v. Daiichi Sankyo, Inc., 781 F.3d 1356 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 481, 193 L. Ed. 2d 360 (2015)

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PI BEFORE EXPIRATION OF 30-MONTH OR 7½ YEAR STAY EXTENDS STAY PERIOD

► FDA will extend a 30-month stay if there is a preliminary injunction granted by a federal district court “before the expiration the 30-month period, or 7½ years where applicable” 21 C.F.R. § 314.107(b)(3)(v); 81 Fed. Reg. 69580 at 69626 (declining to adopt comment recommendingfinal approval “so that the product can be marketed without delay at such time as the injunction is lifted”)

Consistent with FDA 2010 Aricept® decisionSept. 17, 2010 FDA Letter re: ANDA 77-344

FDA declined to expand to situations where the PI was obtained after the expiration of the 30-month stay or 7½ year period

81 Fed. Reg. 69580 at 69626

FDA declined to extend to voluntary agreement by “applicant not to begin marketing the drug product or to provide prelaunch notice”

Id.

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CONVERSION OF (FINAL) APPROVAL TO TENTATIVE APPROVAL► “Conversion of approval to tentative approval. If FDA issues an

approval letter in error or a court enters an order requiring, in the case of an already approved 505(b)(2) application or ANDA, that the date of approval be delayed, FDA will convert the approval to a tentative approval if appropriate.”

21 C.F.R. § 314.107(g); see also Mylan Labs., Inc. v. Thompson, 389 F.3d 1272 (D.C. Cir. 2004)

FDA clarified that “court” in this context refers to either a district court or appellate court

No limitation on whether the approved drug has already beenmarketed

But, some ambiguity with respect to the term “if appropriate”

o FDA declined to remove because the qualifier “also modifies FDA’sissuance of an approval letter in error, and the appropriateness ofconversion to tentative approval may depend on a variety of factors.”

81 Fed. Reg. 69580 at 69629; 21 C.F.R. § 314.107(g)

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AMENDING PATENT CERTIFICATIONS:PATENTS DETERMINED TO BE INFRINGED

► ANDA applicant required to submit amendment to change its paragraph IV certification to paragraph III certification if:

Court enters a final decision from which no appeal has been or can be taken that the patent at issue is valid and infringed; or

Court signs and enters a settlement order or consent decree in an action that includes finding of infringement (unless patent also found to be invalid)

21 C.F.R. §§ 314.50(i)(6)(i), 314.94(a)(12)(viii)(A)

► Impact: Comments to 2015 proposed Final Rule by FDAsuggest that conversion of PIV to PIII not required if thesettlement order or consent decree “permit[s] market entrybefore patent expiration”

80 Fed. Reg. 6802 at 6813 (Feb. 6, 2015)

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PIV CERTIFICATION: LICENSES► PIV certification must be filed “if the ANDA is for a drug or method of

using a drug claimed by a patent and the applicant has a licensing agreement with the patent owner”

21 C.F.R. §§ 314.94(a)(12)(v), 314.50(i)(3)

► Commentators proposed that FDA change these sections to refer more broadly to “agreements” to include additional forms of agreements, such as covenants not to sue

81 Fed. Reg. 69580 at 69608

FDA declined this suggestion based on the statutory requirement that patents should be listed if “a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in themanufacture, use, or sale of the drug”

81 Fed. Reg. 69580 at 69608

FDA also stated that as a “practical matter,” if a patent owner provides a covenant not to sue on a patent and a PIV is filed, patent owner wouldnot sue within 45 days and there would be no 30-month stay preventing approval, so a change is unnecessary

81 Fed. Reg. 69580 at 69608-612

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INTERPRETING THE EFFECTIVE DATE

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INTERPRETING THE EFFECTIVE DATE► “[E]ffective December 5, 2016”

► Applies to any new submission, including but not limited to:

NDAs / ANDAs

Amendments / supplements (including patent certifications or statements)

Submission of patent information and requests by the NDA holder to amend or withdraw a patent or patent information

Written consent to approval received by FDA on or after the effective date

Submission of a new patent listing dispute

Notification of court actions

► Can “submit a request under § 314.53(f)(1) for an NDA holder to confirm the accuracy or relevance of previously submitted patent information in light of requirements for submission of patent information on and after the effective date of this final rule”

81 Fed. Reg. 69580 at 69632

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INTERPRETING THE EFFECTIVE DATE► Potential for “retroactive” effect

FDA updated its definition of “date of approval” for an NDA for which FDA intends to recommend controls under the Controlled Substances Act to be the later of the date on the approval letter from the FDA stating that the NDA or ANDA is approved or the date of any interim final rule controlling the drug is issued

81 Fed. Reg. 69580 at 69653; 21 C.F.R. § 314.3(b)

Prior to the enactment of the Improving Regulatory Transparency forNew Medical Therapies Act (“IRTNMTA”) on November 25, 2015,date of approval was the date of the FDA letter, regardless of howlong it took for a drug to be scheduled by the DEA

IRTNMTA has no effective date provision, so it is effective whenenacted

May have impact on existing regulatory exclusivity and/or ANDA filing dates

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QUESTIONS?

Thank you!

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PRESENTERS

Isaac S. AshkenaziPartner, Litigation Department

New York, NY 10166T: 1.212.318.6432F: 1.212.230.7892

[email protected]

Isaac S. Ashkenazi is a partner in the Litigation practice of Paul Hastings. Mr. Ashkenazi focuses his practice on complex patent litigation primarily in the pharmaceutical, chemistry, and biotechnology fields. He has experience with a broad range of technologies, including pharmaceutical compounds, proteins, polymers, formulations, and chemical and synthetic processes. Mr. Ashkenazi has represented life sciences companies in patent cases involving a wide variety of therapeutics, including oncology drugs, proton pump inhibitors, sleep agents, respiratory agents, antiemetics, and cholesterol lowering and antidiabetic agents.

Representative Matters:

• Secured a trial court victory for Helsinn Healthcare S.A. in multi-defendant Hatch-Waxman litigation related to patents covering its injectable anti-emetic Aloxi®

• Obtained favorable settlements on behalf of Allos Therapeutics, Inc.’s with multiple defendants seeking approval for generic versions of its Folotyn® cancer treatment

• Successfully defended Sunovion Inc.’s patent covering its popular sleep aid Lunesta® in one of the largest Hatch-Waxman Act litigations

50


PRESENTERS

Jason T. ChristiansenSenior Associate, Litigation Department

Houston / New YorkT: 713.860.7333 / 212.318.6051

F: [email protected]

Jason T. Christiansen is a senior associate in the Litigation practice of Paul Hastings and is based in the firm's Houston and New York offices. Mr. Christiansen focuses his work on complex, high-stakes litigation with an emphasis on Hatch-Waxman patent litigation as well as patent infringement litigation in the chemical, pharmaceutical, and biotech areas. He has successfully been an integral part of teams representing major corporations in pre-trial matters, at trial, and in significant settlement negotiations.Representative Matters:

Represented Teijin in Hatch-Waxman litigation involving its patents covering the drug product Uloric®, including drafting and negotiating multiple settlements

Obtained favorable settlements with multiple defendants on behalf of Boehringer Ingelheim in multiple Hatch-Waxman litigations concerning its drug product Aggrenox®

Obtained appellate victory reversing the district court’s erroneous summary judgment of noninfringement and preventing a generic from launching its product prior to the expiration of the pediatric exclusivity period for Sunovion’stop-selling sleep medication, Lunesta®

Analyzed patent portfolio in connection with determining which patents to provide patent information to the FDA when filing NDA

21 OfficesACROSS THE AMERICAS, ASIA

AND EUROPE

1 Legal TeamTO INTEGRATE WITH THE STRATEGIC

GOALS OF YOUR BUSINESS

THE AMERICAS

AtlantaChicagoHouston

Los AngelesNew York

Orange County

Palo AltoSan Diego

San FranciscoSão Paulo

Washington, D.C.

ASIA

BeijingHong Kong

SeoulShanghai

Tokyo

EUROPE

BrusselsFrankfurtLondonMilanParis

51

THE AMERICAS ASIA EUROPEAtlanta1170 Peachtree Street, N.E.Suite 100Atlanta, GA 30309t: +1.404.815.2400f: +1.404.815.2424

Chicago71 S. Wacker DriveForty-fifth FloorChicago, IL 60606t: +1.312.499.6000f: +1.312.499.6100

Houston600 Travis StreetFifty-Eighth FloorHouston, TX 77002t: +1.713.860.7300f: +1.713.353.3100

Los Angeles515 South Flower StreetTwenty-Fifth FloorLos Angeles, CA 90071t: +1.213.683.6000f: +1.213.627.0705

New York200 Park AvenueNew York, NY 10166t: +1.212.318.6000f: +1.212.319.4090

Orange County695 Town Center DriveSeventeenth FloorCosta Mesa, CA 92626t: +1.714.668.6200f: +1.714.979.1921

Palo Alto1117 S. California AvenuePalo Alto, CA 94304t: +1.650.320.1800f: +1.650.320.1900

San Diego4747 Executive DriveTwelfth FloorSan Diego, CA 92121t: +1.858.458.3000f: +1.858.458.3005

San Francisco55 Second StreetTwenty-Fourth FloorSan Francisco, CA 94105 t: +1.415.856.7000f: +1.415.856.7100

São Paulo Rua Funchal, 418 Conj 3401 CVila OlímpiaSão Paulo - SP04551-060Brazil

Washington, D.C.875 15th Street, N.W.Washington, D.C. 20005t: +1.202.551.1700f: +1.202.551.1705

Beijing19/F Yintai Center Office Tower2 Jianguomenwai AvenueChaoyang DistrictBeijing 100022, PRCt: +86.10.8567.5300f: +86.10.8567.5400

Hong Kong21-22/F Bank of China Tower1 Garden RoadCentral Hong Kongt: +852.2867.1288f: +852.2526.2119

Seoul33/F West Tower Mirae Asset Center126, Eulji-ro 5-gil, Jung-gu, Seoul, 04539, Koreat: +82.2.6321.3800f: +82.2.6321.3900

Shanghai43/F Jing An Kerry Center Tower II1539 Nanjing West RoadShanghai 200040, PRCt: +86.21.6103.2900f: +86.21.6103.2990

TokyoArk Hills Sengokuyama Mori Tower40th Floor, 1-9-10 Roppongi Minato-ku, Tokyo 106-0032 Japant: +81.3.6229.6100f: +81.3.6229.7100

BrusselsAvenue Louise 480-5B1050 BrusselsBelgiumt: +32.2.641.7460f: +32.2.641.7461

FrankfurtSiesmayerstrasse 21D-60323 Frankfurt am MainGermanyt: +49.69.907485.0f: +49.69.907485.499

LondonTen Bishops SquareEighth FloorLondon E1 6EGUnited Kingdomt: +44.20.3023.5100f: +44.20.3023.5109

MilanVia Rovello, 120121 MilanoItalyt: +39.02.30414.000f: +39.02.30414.005

Paris96, boulevard Haussmann75008 ParisFrancet: +33.1.42.99.04.50f: +33.1.45.63.91.49

For further information, you may visit our home page atwww.paulhastings.com or email us at [email protected]


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