Patent-Extender Drugs: Loop-holes in the Law

1. Patent-Extender Drugs: Loop-holes in the Law Sandy H. Yoo 4/14/06

2. “Patent-extender” Drugs An increasingly widespread tactic used by pharmaceutical companies to extend the life of their drug patents by creating a slightly altered version of the original drug, which is then eligible under FDA rules for at least another few years of market monopoly. Novak V. Bristol-Myers Squibb lobbies for a patent loop-hole. Time Magazine. Nov 2001

3. Overview of FDA approval process • Pre-Clinical testing on animals • Investigational New Drug (IND) Application • Clinical Studies • Phase I • Phase II • Phase III • New Drug Application (NDA) • NDA review for approval or non-approval • Division Director “sign-off” on new drug

4. Center for Drug Evaluation and Research (CDER) • CDER is FDA’s branch responsible for approving new prescription drugs and generic drugs • They oversee approval of IND, NDA, and review and give final approval or disapproval of drugs

5. Pre-clinical Trials • Manufacturers test their new drug on animals to ask: • Is my drug safe to test in humans? • Is there enough evidence of its pharmacological action to justify further clinical studies in humans? • If the answers are YES, they submit an IND for approval to test in humans.

6. Clinical Studies: Phase I • Initial introduction of new investigational drug into humans • Determine drug’s action, properties, and side-effects in humans • Usually conducted in healthy human volunteers

7. Clinical Studies: Phase II • Early controlled clinical studies to obtain effectiveness of the drug for a particular indication • Usually well-controlled, closely monitored • Conducted in a relatively small number of patients (several hundred people)

8. Clinical Studies: Phase III • Expanded controlled and uncontrolled trials to evaluate risk-benefit ratio of drug • Involves several hundred to thousands of people • Gives basis for extrapolating data results to general population • At any of the 3 phases, FDA can place a clinical hold

9. New Drug Application & Review • Data from pre-clinical trials and Phases I, II, III studies become part of the NDA • NDA undergoes formal review by CDER • The drug can be legally marketed once division director “signs-off” on new drug

10. New Drug Development Process

11. Generic Drugs Approval Process • Generics use “abbreviated” new drug application (ANDA) • Do not have to include preclinical and clinical data to establish safety and effectiveness • Instead must prove BIOEQUIVALENCE • If all requirements are met, generic is approved

12. Hatch-Waxman Act 1984 • Company can seek approval to market a generic before expiration of a brand-name patent • “Abbreviated” new drug application (ANDA) • 1st company to submit ANDA gets 180-exclusivity • Patent holder may file infringement suit • This delays approval of ANDA for 30-months

13. NDA’s Drug Classifications • New Molecular Entity • New Salt • New Formulation • New Combination of Two or More Drugs • Duplication of Product (i.e., new manufacturer) • New Indication (claim) (includes switch from prescription to OTC) • Already Marketed Drug Product - No Previously Approved NDA

14. To name a few…

15. References • US FDA Center for Drug Evaluation and Research. Available at: http://www.fda.gov/cder/ • Novak V. Bristol-Myers Squibb lobbies for a patent loophole. Time 2001, Nov 2. • Field A. Doctoring the Hatch-Waxman Act. Stanford Graduate School of Business Research Paper.