Hatch-Waxmann Act.pptx

Hatch waxmann act regarding patent condition

1. Hatch-Waxman Act & Amendments Presented by – Dhakane Sumeet S. JSPM’S Rajrshi Shahu College Of Pharmacy And Research M. Pharm Pharmaceutics 1

2. Introduction Also called as Drug Price Competition and Patent Term Restoration Act 1984. This act established approval pathway for Generic drug ANDA This act encourages manufacturer of generic drug Enacted in 1984 Henry Waxman of California sponsored the act 2

3. History Before 1962 new drug approval was based on safety only In 1962 Efficacy made compulsory for marketing approval. Before this act there was no provision for patent term extension. Generic drug companies were required to submit comprehensive NDA which was costly & Time consuming. If any drug was covered by patent, testing could not begin until patent is expired 3

4. Objectives Reducing cost associated with approval of generic drug. Allow early experimental use. Motivating generic drug manufacturer. For getting marketing approval for generic drug without conducting clinical trial. Patent term extension. ( to compensate time lost in process) 4

5. General provisions- creation of section 505 (j) This act amended federal food and Drug act and created approval process for generic drug with section 505 (j) This Established Abbreviated NDA (ANDA )approval process . This Act allows generic version of previously approved innovator drug without submitting NDA. ANDA refers previously approved NDA and relies on agency's finding of safety and effectiveness of listed product. 5

6. Contd. Time required for ANDA approval depends on parts of patent protection of innovator drug. This law established process that - applicant need to certify patent listed. - & provide notice to NDA holder and patent owner. If patent litigation is filled it can impose 30 month stay on approval of ANDA 6

7. Contd. When applicant submit ANDA he/she must certify one of the following things under section 505(j)(2)(A)viii Para I – This certify that patent is not filled. Para II - This certify that patent is expired. Para III – This certify that patent will expire on particular date. Para IV – This certify that patent is invalid or will not be infringed by drug for which process is begun 7

8. Generic drug Manufacturer Warns notice Brand manufacturer/ innovator & explains either patent is expired / invalid / or not be violated by generic version In reply Innovator can fill Patent Infringement If filled after 45 days If filled within 45 days No action by FDA No approval by FDA for 30 month if patent is Infringed After 30 month FDA will decide it should be granted or Not 8

9. Amendments A) New Drug Exclusivity i ) Non-patent Exclusivity 1) Orphan Drug Exclusivity It is granted to drug that treat disease or condition which affects less than 2 lakh people in US. Or For those it is unlikely that US sales will recoup its development cost. Valid For 7 Years. But only applicable for use of drug treating rare disease or condition. 9

10. 2) New Chemical Entity (NCE) Exclusivity Granted only if FDA not previously approved that NCE. NCE prevents Generic Company from filling application for approval of generic drug for 5 years from 1 st approval of NDA Generic company may file ANDA with para IV certification 4 year after NDA approval 10

11. 3) New Clinical Study Exclusivity It is applicable when new clinical study leads new Formulation or Changed dosing regimen. If applicant is applying through this exclusivity he/she must submit report of clinical investigation conducted, this will be essential for approval. This is also called as Data Exclusivity. This prohibit FDA from approving generic drug application for new dosage form or use for 3 year . 11

12. 4) Pediatric Drug Exclusivity It is applicable only when FDA request NDA holder to conduct study of drug with pediatric population This adds the patent / marketing exclusivity for 6 month Exclusivity Type Term Orphan Drug Exclusivity 7 Year New Chemical Entity (NCE) Exclusivity 5 Year New Clinical Study Exclusivity 3 Year Pediatric Drug Exclusivity 6 Months Generic Markating 180 Days 12

13. ii) Patent Exclusivity / Orange Book NDA holder must provide FDA with Patent number & Expiration date of patent that claims - drug, API, Formulation of active ingredient or - method of using drug intermediate or . method of making drug When FDA approves New Drug Application, FDA publishes the patent information in FDA’s approved product with therapeutic equivalence determining Publication which is known as orange book 13

14. Challenging Patent Exclusivity As already mentioned in provision. A generic company submitting ANDA application must make one of following certification for each patent. Para I – This certify that patent is not filled. Para II - This certify that patent is expired. Para III – This certify that patent will expire on particular date. Para IV – This certify that patent is invalid or will not be infringed by drug for which process is begun 14

15. Para IV certification is potential trigger for hatch-Waxman act patent litigation Filling application with para IV certification is act of patent infringement. Generic drug applicant making para IV certification must provide notice to NDA holder and patentee if he has different form NDA & should give proof of for believing that the listed patents are invalid or not infringed. 15

16. ANDA Exclusivity The First Filer / Applicant with para IV concerning reference listed drug is entitled to 180 days . During this period FDA will not approve other ANDA having Para IV of certification of generic Version of Reference Listed Drug. However in some condition the filer may forfeit his Exclusivity. First filer Blocks f inal approval of other ANDA with Para IV certification For 180 days. 16

17. Dr. Reddy’s Was the First Company to Get 180 - days Exclusivity for marketing of Fluoxetine 40 mg capsule It was discovered by Eli Lilly and Company Brand name -Prozac 17

18. Patent term Extension This act provide patent Extension for patent covering certain product & method subject to FDA approval Only one extension can be granted concerning particular product. Extension given to only patent that claims - drug Product - method of using Drug product - method of Mfg. Drug product 18

19. Patent Litigation under Act Time required for aspect of Litigation may affect FDA approval process. The generic drug applicant cant file decretory judgment action against NDA holder for 45 Days after notice letter If patentee files within 45 day, FDA may not grant final approval of generic application for 30 months. But if not filed within 45 day no action by FDA. 19

20. Benefit of Hatch-Waxman Act For Branded Manufacturer Extension of Patent Orange book provides public notice of Patent Allow restoration of patent disputes. 30 month stay on approval of generic drug (ANDA) 20

21. Thank You 21