1. Pharma Workshop IV Patent Linkage in the USA Lawrence T. Welch Eli Lilly and Company

2. Hatch-Waxman Act – Submission of Patent Information Applicant shall file with the application the patent number and the expiration date of any patent which claims the drug... or which claims a method of using the drug and with respect to which a claim of patent infringement could reasonably be asserted.... 21 U.S.C. § 355(b)(1) 2 October 21, 2009 James P. Leeds

3. Hatch-Waxman Act – Patent Certification Provision An abbreviated application for a new drug shall contain- (vii) a certification,... with respect to each patent...- (I) that such patent information has not been filed, (II) that such patent has expired, (III) of the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed... 21 U.S.C. § 355(j)(2)(A)

4. Submission of Patent Information to FDA NDA, amendment, supplement after NDA or supplement approval newly listed patents 21 C.F.R. § 314.53(c) 4 October 21, 2009 James P. Leeds

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6. 6 Hatch-Waxman Act – Enable and Encourage Competition ANDA approval process copy of reference (approved) drug reliance on innovators safety and efficacy data requires only bioequivalence § 505(b)(2) approval process variant of reference (approved) drug partial reliance in innovators safety and efficacy data requires some additional studies October 21, 2009 James P. Leeds

7. 7 Patent Challenges Applicant must provide certification for Orange Book listed patents for reference drug I.no patent information II.patent has expired III.date of patent expiration IV.patent invalid or not infringed First ANDA applicant with ¶ IV certification eligible for 180-day exclusivity 30-month stay of approval is available October 21, 2009 James P. Leeds

8. 8 Patent Challenges If multiple patents are listed for reference drug, generics may file ANDAs with both ¶ III and ¶ IV certifications. Generics can request/receive approval for one or more of the innovators indications. October 21, 2009 James P. Leeds

9. 9 Hatch-Waxman Act – Timing for Generics Paragraph IV certification 4 years after first approval for NCEs anytime for non-NCEs FDA approval of ANDA Innovator brings suit expiration of 30-month stay court decision finding patent invalid, unenforceable, or not infringed expiration of 180-day exclusivity No suit by innovator immediately after review October 21, 2009 James P. Leeds

10. Hatch-Waxman Act – 180-Day Exclusivity Provision The approval of the application... shall be made effective... (iv) If the application contains a [paragraph IV] certification... and is for a drug for which a previous application has been submitted under this subsection [containing] such a certification, the application shall be made effective not earlier than one hundred and eighty days after – (I) first commercial marketing, or (II) date of court decision, whichever is earlier. 21 U.S.C. § 355(j)(5)(B)

11. 180-Day Exclusivity - Successful Defense Requirement If an ANDA contains a certification that a relevant patent is invalid, unenforceable, or will not be infringed and the application is for a generic copy of the same listed drug for which one or more substantially complete ANDAs were previously submitted containing a certification that the same patent was invalid, unenforceable, or would not be infringed and the applicant submitting the first application has successfully defended against a suit for patent infringement... approval of subsequent ANDAs will be made effective no sooner than 180 days from whichever of the following dates is earlier: (i) first commercial marketing; or (ii) date of a court decision. 21 C.F.R. § 314.107(c)(1)(emphasis added)

12. 35 USC 271(e)(2) 2) It shall be an act of infringement to submit - (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent. 12

13. 35 USC 271(e)(4) 4) For an act of infringement described in paragraph (2)- (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 …and (C) damages or other monetary relief may be awarded … if there has been commercial manufacture, use, offer to sell, or sale. The remedies prescribed by subparagraphs (A), (B), and (C) are the only remedies which may be granted by a court for an act of infringement described in paragraph (2), except that a court may award attorney fees under section 285.section 285 13

14. Company Confidential Copyright © 2010 Eli Lilly and Company 14 What Does an Ideal PL Law Look Like? Patent notification Require patent information in drug registration applications Require publication of drug patent status information Certification process Require a generic applicant to certify in its drug registration its position on the listed patents relevant to its generic application Notice to the originator Reqire a generic applicant to notify the innovator of its application for drug registration and explain the reasons for claiming that the underlying patent will not be infringed or is invalid Allow for a reasonable period of time for the originator to file an infringement suit and inform the regulatory agency – the reasonable period of time depends on local legal procedures and review times Automatic stay of approval Require suspension of market approval of a generic drug until resolution of the patent dispute Back to Contents