PHARMACEUTICAL LAW GROUP PC

Transcription

1 in L PHARMACEUTICAL LAW GROUP PC AT THE INTERSECTION OF FDA REGULATION AND INTELLECTUAL PROPERTY 900 SEVENTH STREET, NW - SUITE WASHINGTON, DC T F SEP 29 A 11 : 50 GREGORY J. GLOVER, MD GREGOR Y.GLOVERgPHARMALAWSRP.COM September 23, 2010 BY PRIORITY MAIL Documents Management Branch Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland Re: Citizen Petition Dear Madam or Sir: I have enclosed an original and three copies of a citizen petition filed on behalf of Hoffmann-La Roche Inc. The petition requests that the United States Food and Drug Administration ("FDA") confirm that the agency will stay approval of Abbreviated New Drug Application ("ANDA") No , absent another specified event under 21 U.S.C. 355(j)(5)(B)(iii), for 30 months from July 26, 2010, the date Roche received a notice that Orchid Healthcare ("Orchid") had amended its ANDA, changing its Paragraph III certification to a Paragraph IV certification with respect to a patent that was listed in the Orange Book prior to the filing of its ANDA. I look forward to receiving confirmation of the filing and docket number for this petition. Enclosures F DA- 20(

2 PHARMACEUTICAL LAW GROUP PC AT THE INTERSECTION OF FDA REGULATION AND INTELLECTUAL PROPERTY p 900 SEVENTH STREET, NW - SUITE WASHINGTON, DC T F SEP 2 c1 A 11 : SO September 23, 2010 Documents Management Branch Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland CITIZEN PETITION On behalf of Hoffmann-La Roche Inc. ("Roche"), the undersigned submits this petition pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act ("FDCA") and in accordance with 21 C.F.R to request that the Commissioner of Food and Drugs take the actions described below. I. Action Requested Roche requests that the United States Food and Drug Administration ("FDA") confirm that the agency will stay approval of Abbreviated New Drug Application ("ANDA") No , absent another specified event under 21 U.S.C. 355(j)(5)(B)(iii), for 30 months from July 26, 2010, the date Roche received a notice that Orchid Healthcare ("Orchid") had amended its ANDA, changing its Paragraph III certification to a Paragraph IV certification with respect to a patent that was listed in the Orange Book prior to the filing of its ANDA. Statement of Grounds Roche is the NDA holder for the Boniva Once-Monthly drug product which has been marketed in the United States since Patents listed in the Orange Book at the time of approval included, among others, U.S. Patent No. 4,927,814 ("the '814 patent") which claims sodium ibandronate, the active ingredient in Boniva. On or about May 16, 2007, Orchid filed an ANDA to market a generic copy of the Boniva Once-Monthly drug product. On August 13, 2007, Roche received a notice indicating that Orchid had filed a Paragraph IV certification for two of the listed patents. According to the notice, Orchid did not file a Paragraph IV certification for the '814 patent. Instead, Orchid filed a Paragraph III certification with respect to that patent, indicating that Orchid did not intend to seek approval to market the Bonivae Once-Monthly drug product prior to the expiration of the '814 patent.

3 Now, several years later, on July 26, 2010, Roche received a notice that Orchid had amended its ANDA to change its Paragraph III certification with respect to the '814 patent to a Paragraph IV certification. (See Exhibit A.) On September 3, 2010, within 45 days of receiving the notice, Roche initiated a suit against Orchid alleging infringement of the '814 patent. (See Exhibit B-1.) 1 Since the '814 patent was listed in the Orange Book prior to the filing of Orchid's ANDA, the approval of Orchid's ANDA is now subject to a 30-month stay of approval starting on July 26, 2010, the date that Roche received the Paragraph IV notice with respect to the '814 patent. Both the relevant statutory language enacted in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) and FDA's subsequent draft guidance document2 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 by Roche. However, in oral and written communications, Orchid has raised questions about the applicability of the 30-month stay in this circumstance. Accordingly, this citizen petition seeks confirmation that, absent another specified event under 21 U.S.C. 355(j)(5)(B)(iii), Orchid's ANDA is subject to a 30-month stay of approval starting on July 26, 2010, the date that Roche received notice of the Paragraph IV certification with respect to the '814 patent. A. Statutory Background The Drug Price Competition and Patent Term Restoration Act of 1984 (known as the "Hatch-Waxman Act") established an abbreviated pathway for the approval of generic copies of brand name drugs. The Hatch-Waxman Act also established limited periods of protection for the safety and effectiveness data submitted by the brand name manufacturers and procedures to protect patents that covered the brand name products. The patent procedures include a requirement that the brand name manufacturer submit to FDA information on patents "with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug." 3 The relevant patents are listed in FDA's publication, Approved Drug Products with Pharmaceutical Equivalence Evaluations (the "Orange Book"). When an applicant submits an ANDA to market a generic version of an approved drug, the ANDA must include one of four certifications concerning the listed patents. 4 The third and fourth certifications are relevant to this petition. The Paragraph III certification notes the date of expiration of the relevant patent and indicates that the ANDA applicant will not seek approval to market its product before that date. The Paragraph IV certification notes that the ANDA applicant is seeking approval to market the generic product before the expiration of the patent based on its assertion that the listed patent "is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted."5 I Subsequently, on September 7, Roche amended the complaint to correct a typographical error. (See Exhibit B-2.) 2 See infra, note U.S.C. 355(b)(1); 21 C.F.R (b) U.S.C. 355(j)(2)(A)(vii) U.S.C. 355(j)(2)(A)(vii)(IV). 2

4 ANDA applicants are required to notify each NDA and patent holder of the Paragraph IV certification. 6 If the patent holder brings suit against the ANDA applicant within 45 days of receipt of the Paragraph IV notice, FDA cannot approve the ANDA for a period of 30 months while the litigation is pending, subject to modification by the court. 7 Under the Hatch-Waxman Act, an ANDA could be subject to multiple, non-concurrent 30-month stays based on patents for the brand name product that were issued after the ANDA had been filed. In 2003, the Medicare Prescription Drug, Improvement, and Modernization Act ("MMA")8 amended the Hatch-Waxman Act to limit the circumstances in which the approval of an ANDA would be subject to a 30-month stay. The MMA restricts the 30-month stay to cases in which the patent that is the subject of the relevant certification is listed in the Orange Book before the ANDA is submitted to FDA. 9 Accordingly, when a patent is listed in the Orange book after an ANDA has been submitted, that ANDA is not subject to a 30-month stay -- even if the ANDA applicant submits a paragraph IV certification with respect to the new patent. In this way, the MMA provisions prevent ANDAs from being subject to multiple, non-concurrent 30- month stays resulting from patents being listed in the Orange Book after an ANDA is filed. The MMA was effective on August 18, 2003 and applied to all patents listed on or after that date. Moreover, in 2004, FDA issued a draft guidance regarding the availability of 30-Month stays following enactment of the MMA. 1 FDA noted in the guidance that the MMA generally precludes multiple 30-month stays by permitting 30-month stays only if the patent was submitted to FDA prior to submission of the ANDA. The effect of precluding stays for later-listed patents is that most ANDA applications will be subject to only a single 30-month stay." But, FDA acknowledged that multiple 30-month stays still may be possible in certain circumstances. The guidance cites as an example an ANDA that contains both a paragraph III and paragraph IV certification, where the applicant subsequently converts the paragraph III certification to a paragraph IV certification. "For instance, an ANDA... may contain a paragraph IV certification to a patent at the time of first submission that gives rise to one 30-month stay. If the same application also contains a paragraph III certification to a different patent that was submitted to FDA (1) on or after August 18, 2003, and (2) before the ANDA... application was submitted, and the applicant subsequently converts this certification to a paragraph IV certification, a second 30- month stay could be possible. This is because the new paragraph IV certification is subject to the MMA and references a patent submitted to FDA before the applicant's ANDA was submitted." U.S.C. 355(j)(2)(B)(ii) U.S.C. 355(j)(5)(B)(iii). 8 Pub. L. No , 117 Stat (2003). 9 MMA 1101(a); 21 USC 355 (j)(5)(b)(iii). 10 FDA, Draft Guidance for Industry, Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of Questions and Answers (October 2004), available at " Id. at Id. at

5 This example corresponds precisely to the facts and issues presented in this citizen petition. Accordingly, 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. B. Factual Background Roche is the NDA holder for the Boniva Once-Monthly drug product which is marketed in the United States under New Drug Application ("NDA") No and which was approved as an NDA supplement on March 24, As required by section 505(b) of FDCA, Roche submitted patent information for listing in the Orange Book. Patents listed at the time of approval of the Boniva Once-Monthly drug product included: U.S. Patent No. 4,927,814 ("the '814 patent), claiming sodium ibandronate, the active ingredient in Boniva (see Exhibit C 13 and Exhibit D 14); U.S. Patent Number 6,294,196 ("the '196 patent"), claiming a solid dosage form containing sodium ibandronate; and U.S. Patent No. 7,192,938 ("the '938 patent"), claiming a method of treating osteoporosis by administering 150 mg of sodium ibandronate once a month. On or about May 16, 2007, several pharmaceutical companies, including Orchid Healthcare, filed ANDAs to market generic copies of the Boniva Once-Monthly drug product. On August 13, 2007, Roche received a notice from Orchid indicating that Orchid had filed and ANDA containing Paragraph IV certifications for the '196 patent and the '938 patent. (See Exhibit E.) The Paragraph IV certification indicated that Orchid intended to seek approval to market a copy of Roche's Boniva Once-Monthly drug product prior to the expiration of those patents. In addition, since the '814 patent had not yet expired, Orchid filed a Paragraph III certification with respect to the '814 patent. The Paragraph III certification indicated that Orchid intended to wait until the expiration of the '814 patent to seek final approval to market its copy of the Boniva Once-Monthly drug product. Within 45 days of receiving the notice from Orchid, Roche initiated a patent infringement suit based on the '938 patent and the '196 patent. Based on Roche's timely suit on the '938 and '196 patents, the approval of Orchid's ANDA was stayed for 30-months starting on May 16, 2008, the date of expiration of Roche's five-year NCE data exclusivity. Subsequently, Roche dismissed the claims for infringement of the '196 patent; however, the 30-month stay continued based on the claim of infringement of the '938 patent. Subsequently, on August 12, 2008, U.S. Patent Number 7,410,957 ("the '957 patent") was issued to Roche. The '957 patent claims the treatment of osteoporosis by administration of 150 mg of sodium ibandronate once a month. Roche timely submitted to FDA information on the '957 patent so that it could be listed in the Orange Book. Orchid amended its ANDA to file a Paragraph IV certification with respect to the '957 patent, and within 45 days Roche initiated a patent infringement suit against Orchid. No additional 30-month stay was placed on the approval of the Orchid ANDA based on the 2007 changes in the law (described above) that limited 30-month stays for patents listed after the filing 13 FDA Form 3542a was submitted at the time of the submission of the NDA Supplement for the 150 mg Bonivae Once-Monthly drug product on April 30, Although FDA Form 3542 was submitted upon the approval of the NDA Supplement for the 150 mg Boniva Once-Monthly drug product on March 25, 2005, the form is dated January 25, 2005 in error. 4

6 of an ANDA. Soon after filing suit for infringement of the '957 patent, Roche dismissed the claims for infringement of the '938 patent. Accordingly, the 30-month stay associated with the '938 patent terminated. Similarly, on May 18, 2010, US Patent Number 7,718,634 ("the '634 patent") was issued to Roche. The '634 patent claims the treatment and prevention of osteoporosis by administering 150 mg of sodium ibandronate once a month. Roche timely filed information on the '634 patent so that it could be listed in the Orange Book. On June 24, 2010, Roche received notice from Orchid that it had amended its ANDA to file a Paragraph IV notice with respect to the '634 patent. Within 45 days Roche initiated a patent infringement suit against Orchid, and as described above, no additional 30-month stay was placed on the approval of Orchid's ANDA. Most recently, on July 26, 2010, Roche received a notice that Orchid had amended its ANDA to change its Paragraph III certification with respect to the '814 patent to a Paragraph IV certification. (See Exhibit A.) On September 3, 2010, within 45 days of receiving the notice, Roche initiated a suit against Orchid alleging infringement of the '814 patent. Orchid's notice of Paragraph IV certification with respect to the '814 patent was dated Friday, July 23, 2010 and was transmitted by "Courier and Certified Mail." Roche received it on Monday, July 26, With respect to the calculation of the 45-day period, 21 C.F.R (f) provides: "(f) Approval. If the requirements of this section are met, FDA will presume the notice to be complete and sufficient, and it will count the day following the date of receipt of the notice by the patent owner or its representative and by the approved application holder as the first day of the 45-day period provided for in section 505(j)(4)(B)(iii) of the act. FDA may, if the applicant provides a written statement to FDA that a later date should be used, count from such later date." This means that the first day of the 45-day period was Tuesday, July 27, Moreover, 21 C.F.R also states, in pertinent part: "(f) Computation of 45-day time clock (1) The 45-day clock described in paragraph (b)(3) of this section begins on the day after the date of receipt of the applicant's notice of certification by the patent owner or its representative, and by the approved application holder. When the 45th day falls on Saturday, Sunday, or a Federal holiday, the 45th day will be the next day that is not a Saturday, Sunday, or a Federal holiday." Therefore, the forty-fifth day fell on Thursday, September 9, Roche filed suit on Friday, September 3, 2010 (see Exhibit B-1) and filed an amended complaint (to correct a typographical error in the expiration date of the '814 patent) on Tuesday, Sept. 7, 2010 (see Exhibit B-2). Since the '814 patent was listed in the Orange Book prior to the filing of Orchid's ANDA, the approval of Orchid's ANDA is now subject to a 30-month stay of approval starting on July 26, 2010, the date of the Paragraph IV notice with respect to the '814 patent. 5

7 C. Argument The relevant statutory language enacted in the MMA and FDA's subsequent draft guidance 15 make clear that a 30-month stay applies to Orchid's ANDA based on the new Paragraph IV certification with respect to the '814 patent and the timely patent infringement suit by Roche. The unambiguous language of 21 U.S.C. 355(j)(5)(B)(iii) provides that, when an ANDA applicant submits a paragraph IV certification for 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. The statute states, in relevant part: "(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(8)(i) or such shorter or longer period as the court may order....,,16 As noted above, FDA's draft guidance on the MMA cites as an example an ANDA that contains both a Paragraph III and Paragraph IV certification (both patents are submitted to FDA after August 18, 2003, and before submission of the ANDA), where the applicant subsequently converts the Paragraph III certification to a Paragraph IV certification. In that case, FDA considered a second 30-month stay to be appropriate "because the new paragraph IV certification is subject to the MMA and references a patent submitted to FDA before the applicant's ANDA was submitted."17 Here, the Orchid ANDA was initially subject to a 30-month stay based on the Paragraph IV certification and a timely patent infringement suit related to the '938 patent. The original 30- month stay terminated when Roche dismissed the claims of infringement related to the '938 patent. 15 See note 10, supra U.S.C. 355 (j)(5)(b)(iii). 17 Draft Guidance for Industry, supra note 10 at 8. 6

8 Furthermore, at the time Orchid filed its ANDA, the '814 patent was listed in the Orange Book, and Orchid's application included a Paragraph III certification to the '814 patent. However, on July 26, 2010, Roche received notice that Orchid had amended its ANDA to change the paragraph III certification for the '814 patent to a paragraph IV certification. These facts correspond precisely to the example in the FDA guidance in which a separate non-concurrent 30- month stay is available under the MMA based on the conversion of a Paragraph III certification to a Paragraph IV certification for a patent that was listed before the ANDA was filed. Accordingly, in light of Roche's timely patent infringement suit based on Orchid's new Paragraph IV certification, FDA should stay approval of ANDA No , absent another specified event under 21 U.S.C. 355(j)(5)(B)(iii), for 30 months from July 26, 2010, the date Roche received a notice that Orchid had amended its ANDA to include a paragraph IV certification with respect to the '814 patent. III. Environmental Impact This petition is categorically exempt from the requirement for an environmental assessment or an environmental impact statement pursuant to 21 C.F.R and IV. Economic Impact Information on the economic impact of the petition will be provided upon request. Certification Pursuant to 21 C.F.R (b), the undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition. Pursuant to 21 U.S.C. 355(q)(1)(H), I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information which are unfavorable to the petition were disclosed to me. I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about the following date: September 3, 2010, the date on which Roche filed a lawsuit in response to Orchid's notice that it had amended its ANDA to contain a Paragraph IV certification to the '814 patent. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I 7

9 received or expect to receive those payments from the following persons or organizations: Roche. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition. Respectfullyḃmitted, Gregory J Pharmaceutical aw Group PC 900 Seventh Street, NW Suite 650 Washington, DC Tel: Fax: Gregory.Glover@PharmaLawGrp.com 8

10