Hatch waxman act my ppt

Hatch waxman act
Regulatory affairs (ceutics)

1. HATCH-WAXMAN ACT PREPARED BY:-(02) MANSI GANGWAR SUBJECT:- REGULATORY AFFAIRS BRANCH:- PHARMACEUTICS 1

2. CONTENT Introduction Objective Significance General provision of hatch- Waxman act Provision with regard to paragraph IV filing Substantially complete ANDA Multiple ANDA submission Hatch-Waxman trade off New drug exclusivity Delay in generic entry C onclusion 2

3. WHAT IS HATCH-WAXMAN ACT ? The "DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984," also known as the HATCH-WAXMAN AMENDMENTS , established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In 1984, Two American politicians Orrin Grant Hatch & Henry Arnold Waxman sponsored the Official act known as Hatch-Waxman Act. 3

4. In 1984 United States Federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States This act was needed to promote generic drug and innovators. “AIM: To make available more low cost generic drugs” 4

5. OBJECTIVES OF HATCH-WAXMAN ACT:- The main objectives of the HWA were as follows: 1 ) Reducing the cost associated with the approval of a generic drug: No need to do clinical trials , required from the generic drug manufacturers was to prove that his generic version is bioequivalent(80-125 %) to the innovator drug. 2) Allowing Early-Experimental-Use : Before the Hatch-Waxman Act even the experimental use of a patented drug was considered to be infringement. This resulted in undue prolongation of patent protection for the innovator drug as the approval of the generic version would take another 2-3 years to enter the market. 5

6. Hence, it was an objective of the Hatch-Waxman Act to allow the early experimental use of the patented drug and not to consider this pre-patent-expiration use as infringement . 3. Compensating the branded drugs manufacturers for the time lost from the patent term because of the regulatory approval formality: The branded drug manufacturers were allowed a Patent Term Extension (maximum of 5 years) to compensate for the time lost in the time-consuming regulatory approvals. 6

7. 4.Motivating the generic drug manufacturers: The Hatch-Waxman Act also established the concept of Market Exclusivity in the Federal Food, Drugs and Cosmetic Act . Under this provision, exclusive marketing rights for 180 days were granted to the generic drug manufacturer who was the first one to file the application for marketing of the generic version of the innovator drug. This provision provided incentive for the generic drug manufacturers to file Abbreviated New Drug Application (ANDA) and promoted healthy competition so that drugs could be available to public at relatively lower prices once they go off-patent. 7

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9. GENERAL PROVISIONS OF HATCH WAXMAN ACT The Hatch-Waxman Act provides an expedited USFDA drug approval program for speedy generic drugs entry in the market. It provides patent term extension for innovator drugs and Market Exclusivity for the generic drugs manufacturer as an incentive for continued innovation. The Hatch-Waxman Act added two provisions to the Federal Food, Drug and Cosmetics Act namely Section 505(b)(2) and Section 505(j). Section 505(b)(2) was added with respect to New Drug Application and Section 505 (j) was added with respect to ANDA . For filling ANDA, generic company must include a patent certification as per section 505(j) (2) (A) of the H atch Waxman act. This certification has to make one of the following statement:- 9

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11. 11 ANDA APPROVALS

12. PROVISIONS WITH REGARD TO PARAGRAPH IV FILING An ANDA certified under paragraphs I or II is approved immediately after meeting all applicable regulatory and scientific (efficacy, safety and bioequivalence) requirements. This means that the generic drugs manufacturer may get immediate approval for manufacturing the generic versions of the branded drugs upon filing an ANDA If , the patent information on the branded drug has not been filed by the branded drug manufacturer or if the patent for the branded drug has expired. 12

13. A Para III filing is made when the ANDA applicant does not have any plans to sell the generic drug until the original drug is off patent. In case of Para III the application is processed for approval, however its approval status depends upon the product’s patent expiry . ANDA approval under Para III certification is made effective from the date of patent expiration . An ANDA applicant filing a Paragraph IV certification must notify the proprietor of the patent. The patent holder may bring a patent infringement suit within 45 days of receiving such notification. 13

14. If the patent owner timely brings a patent infringement charge against the ANDA applicant, then the USFDA suspends the approval of the ANDA until : The date of the court’s decision that the listed drug patent is either invalid or not infringed; T he date on which the listed drug patent expires , if the court finds the listed drug’s patent is infringed; or T he date that is 30 months from the date the owner of the listed drug’s patent received notice of the filing of a Para IV certification. (Subject to modification by the court). This means that for 30 months from the date of receipt of notice of Para VI filing, no ANDA can be approved. 14

15. In other words, once the branded drug company indicates its intent to begin a patent infringement suit against the generic company as a result of the paragraph IV filing, the USFDA is prohibited from approving the drug in question for thirty months or until such time that the patent is found to be invalid or not infringed. If , prior to the expiration of thirty months, the court holds that the patent is invalid or would not be infringed, then the USFDA approves the ANDA when that decision occurs . Conversely, if the court holds that the patent is valid and would be infringed by the product proposed in the ANDA prior to the expiration of thirty months, then the USFDA does not approve the ANDA until the patent expires. 15

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19. The first generic applicant to file a Paragraph IV certification is awarded a 180-day market exclusivity period by the USFDA. Who challenges a listed patent by filling a paragraph IV certification and there by runs the risk of having to defend a patent infringement suit The statue provides that the first applicant to file a substantially complete ANDA containing a para IV certification to a listed patent will be eligible for a 180-day period of exclusivity beginning either from the date it begins commercial marketing to the generic drug product. FOR EXAMPLE :- 180 day exclusivity was granted to Ranbaxy and Watson laboratories for marketing generic version of Lipitor . 19

20. The 180-day market exclusivity period ordinarily begins on the earlier of two dates: The day the approved generic drug is first commercially marketed ; or The day a court decision holds that the patent which is the subject of the certification is invalid or not infringed. A successful defense of a patent infringement suit is not necessary to obtain this exclusivity period 20

21. SUBSTANTIALLY COMPLETE ANDA: Under the proposed rule, only the applicant submitting the first “Substantially complete ANDA” with a paragraph IV certification with respect to patent in the Orange book for the listed drug would be eligible for exclusivity. To be “Substantially complete” it is proposed that the application must contain all of the information required like bioequivalence , etc. If a new bioequivalence study is required to obtain approval of the ANDA then the application would be considered not substantially complete and the applicant would not be eligible for exclusivity. 21

22. Another way to lose exclusivity is to withdraw paragraph IV certification either voluntarily or as a result of a settlement or defeat in patent litigation by first applicant. Now in such case if first applicant again submit paragraph IV certificate and there are no subsequent applicants for 180 days exclusivity then first applicant would be eligible for exclusivity. If there is other applicant that has submitted a paragraph IV certification for the same drug product neither the first applicant nor the any subsequent applicant would be eligible 180 day exclusivity. The FDA has provided an exception in its proposed rule with respect to loss of exclusivity due to an ANDA being not substantially complete. 22

23. MULTIPLE ANDA SUBMISSION Multiple generic applicants submit ANDA’s with paragraph IV certification to the same patents on the same day; The agency explained that when, on the same day, more than one applicant submits an ANDA for the same drug containing a para IV certification to a listed patent, and no such certificate was submitted previously, all the applicants will share exclusivity. Exclusivity will be triggered for all first applicants for a specific listed patent when one of them begins to market its product (or on the date of any court decision finding that patent invalid, unenforceable, or not infringed, if earlier) 23

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25. HATCH-WAXMAN TRADE -OFF 25 BRAND -30 MONTHS STAY Automatic injunction Notice of generic competition BRANDS GENERICS GENERIC- 180 DAY EXCLUSIVITY 1st successful Para IV filer A big head start on others

26. BENEFICTS FOR GENERIC MANUFACTURES 180-day market exclusivity for first successful challenger to Orange Book patent Allows generics to challenge Orange Book patents without risk of damages “ Safe Harbor” rule allows generics to perform bioequivalence and other testing relating to regulatory approval without risk of patent infrin gement 26 “ Dr Reddy’s was the first Indian company to get the 180-day exclusivity for marketing fluoxetine 40 mg capsule in august 2001 ”

27. BENEFITS FOR BRANDED MANUFACTURER Orange Book provides public notice of patents Allows for resolution of patent disputes prior to generic entry 30-month stay of FDA approval of generic drugs Patent Term Restoration Allows for Several Market Exclusivities: Data Exclusivity 5 years for New Chemical Entity (NCE) Drug 3 years for non-NCE Drug Orphan Drug (7 years) Pediatric (PEDS) (6 months) 27

28. NEW DRUG EXCLUSIVITY ( A)Non-patent Exclusivities provide legal opportunities to extend the period free of competition called non-patent exclusivity provisions ( 1) Orphan drug exclusivity, which is granted to drugs : (Drugs for a rare or unusual diseases are often treated as orphan drug) a) That treat a disease or condition that affects less than 200,000 people in the US; or b) For which it is unlikely that US sales of the drug will recoup its development costs. This exclusivity period is seven years, but only applies to use in treating the specific rare disease or condition 28

29. (2) New chemical entity (NCE) exclusivity This is granted if the FDA has not previously approved the “active drug moiety” (active moiety is defined as any ion or molecule which is attributed to the drug physiological or pharmacological action) New Chemical Entity exclusivity bars a generic drug company from filing an application for approval of a generic drug five years from the first approval of the relevant NDA. However , a generic drug company may file an ANDA with a Paragraph IV certification four years after the first NDA approval 29

30. (3)New clinical study exclusivity. This applies when new clinical studies lead to new or changed formulations, dosing regimens or patient population. The applicant is entitled to this exclusivity if an application or supplement contains reports of new clinical investigations conducted or sponsored by the applicant that were essential for approval. This exclusivity, sometimes called data exclusivity, prohibits the FDA from approving a generic drug application for the new dosage form or use for three years after the first NDA approval. However , it does not otherwise bar approval of generic drug applications 30

31. ( 4)Paediatric exclusivity This applies if the FDA requested that the NDA holder conduct studies with the drug in pediatric populations. Paediatric exclusivity adds six months of exclusivity to any marketing or patent exclusivity The paediatric studies are conducted on a drug which already has NDA approval and in response to a request from FDA to conduct such a study and the report of which has to be submitted to FDA. Even if the study fails or the results are unsuccessful the exclusivity is independent of it. The exclusivity is granted to all of the applicants dosages or formulation and indications for the drug with an existing marketing exclusivity or a patent with the same active ingredient. 31

32. 32 Types Term New chemical entity exclusivity 5 years New clinical study exclusivity 3 years Orphan drug exclusivity 7 years Paediatric exclusivity 6 months 180 day generic market exclusivity 180 days

33. (B ) Patent exclusivity & the orange book An NDA holder must provide the FDA with the patent number and expiration date of any patent that claims either: a) The drug, including the active ingredient and the formulation for the active ingredient. b ) A method of using the drug, but not other inventions such as: metabolites ; synthetic intermediates; or methods of making the drug. 33

34. ORANGE BOOK 34 The orange book is a resource which identifies drug product approved on the basis of safety and effectiveness by the FDA and related patent and exclusivity information The orange book is available on the internet and is updated monthly.

35. DELAY IN GENERIC ENTRY Reverse payment agreements Sham litigations Sham citizens petitions Walker process Product hopping 35

36. REVERSE PAYMENT AGREEMENTS Both parties decide it is in their mutual best interests to settle via a significant payment from the patent owner/branded to the generic to keep the generic drug off the market. The generic may make more money than by rushing to market the drug. The branded may also make more money by paying the generic to defer marketing the drug for a certain period of time. 36

37. SHAM LITIGATION Brand sues generic for patent infringement. Court finds for generic, often trigers , and holds patent invalid or unenforceable. Hatch-Waxman 30-month stay allows brand to win even if they lose. Plaintiffs must prove brand’s infringement suit is objectively and subjectively baseless. 37

38. SHAM CITIZEN PETITIONING Companies can petition FDA to not approve an ANDA Should be based on safety or formulation concerns Citizen’s Petitions delay approval of ANDAs  Ripe for abuse, and often abused Delay itself is the goal Same standard as Sham Litigation 38

39. PRODUCT HOPPING Delay sometimes allows brands to introduce new versions of the product. Changes are often minimal but can defeat generic competition. Brands actively convert the market – Free samples – Pulling the “old” product from the market. 39

40. TRIGGER PERIOD Sometime there is unnecessary delay in entry of generic drug into the market. This can happen because of delay in approval of ANDA by FDA or because of some kind of settlement between first generic (first ANDA approver) and innovator. Thus as per rule until first generic finishes 180 day exclusitivity period no other generic manufacturer can be granted 180 exclusitivity period . As a result innovator and first generic enjoys undue advantage. To counter this FDA has involved new concept called “Triggering period ” Under this concept the commencement of the 180-day exclusivity period for the first applicant is either the first commercial marketing of the first applicant’s product, or a decision of a court holding the patent invalid, not infringed, or unenforceable, whichever is earlier. 40

41. CONCLUSION The Hatch Waxman Act extended the life of the pharmaceutical patents up to 14 years from the time the NDA is approved by the FDA , provided additional market exclusivity for the new uses or new formulations, allowed potential generic manufacturers to conduct work related to marketing approval of the drug without the charge of patent infringement, permitted generic manufacturers to use safety and effectiveness research performed by the brand name pharmaceutical companies, introduced the concept of bioequivalence to obtain the approval of generic drug, and simplified generic drug approval process by introducing ANDA, and 41

42. encouraged patent challenges by providing 180-day market exclusivity for the first generic manufacturer who files ANDA, Hatch Waxman Act led to the birth of generic industry, It also gave protection to innovators in terms of 30 month stay, market exclusivities and patent term extensions, But, the brand companies are taking advantage of the loopholes of HWA in the form of authorized generics and reverse payment agreements , Brand companies are also involved in sham litigations to take advantage of 30 month stay provision, Maintaining the balance between these two important contributors to health care will be essential in meeting the goals of affordable health care and innovative research . 42

43. 43 THANKY YOU THANK YOU