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Intellectual Property Strategies

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  • 1. Intellectual Property Strategies ANDAs & 505(b)(2) NDAs Navigating the Regulatory and Development Pathways October 10 -11, 2005 Wyndham Newark Airport Elizabeth, New Jersey Stan Antolin and Walter Boyd Patent Attorneys Smith Moore LLP Greensboro, NC 336.378.5200 336.378.5400 (fax) www.smithmoorelaw.com
  • 2. The Drug Price Competition and Patent Term Restoration Act Patents and FDA Hatch-Waxman Act www.smithmoorelaw.com
  • 3. Agenda Patents & Patent Infringement Hatch-Waxman • ANDAs • 505(b)(2) NDAs Avoiding Patent Infringement www.smithmoorelaw.com
  • 4. Typical Patent Life Cycle 0 yrs. 10 yrs. 20 yrs. 5 yrs. 15 yrs. 2.5 yrs Idea @ 3-4.5 yrs Issues Patent Term Ends Office Action File Application @ 1.5 yrs Publishes www.smithmoorelaw.com
  • 5. Typical Drug Development Cycle FDA Approval Preclinical FDA Clinical Market Studies Trials + NDA Exclusivity 0 yrs. 10 yrs. 20 yrs. 5 yrs. 15 yrs. 2.5 yrs Idea Office Action @ 3-4.5 yrs Issues Patent Term Ends File Application @ 1.5 yrs Publishes www.smithmoorelaw.com
  • 6. Hatch-Waxman FDA Approval Preclinical FDA Clinical Market Studies Trials + NDA Exclusivity 0 yrs. 10 yrs. 20 yrs. 5yrs. 15 yrs. 2.5 yrs Idea Office Action @ 3-4.5 yrs Issues Patent Term Extended File Application @ 1.5 yrs Publishes www.smithmoorelaw.com
  • 7. Typical Generic Development Cycle File Patent Cert File DMF File ANDA ANDA Approval Stability Validation & Brand Portfolio Patent Sourcing Form & pK Approval Product Review Review Pre-Form Pilot Bio Study Prep 9 mo. 2 mo. 6-12 mo. 12 mo. 5 mo. 12-18 mo. www.smithmoorelaw.com
  • 8. What Can Be Patented? “Anything under the sun made by man”- capable of being a machine, process, article of manufacture, composition, or an improvement thereof www.smithmoorelaw.com
  • 9. Useful Patentable Novel Invention Non-obvious New chemical entities Patentable Compositions of matter Subject Matter (pharmaceutical) Polymorphs Relevant to Methods of treatment FDA Approval New indications www.smithmoorelaw.com
  • 10. What is a Patent? Does not give the The right to exclude owner any right to others from making, make or use his using, selling, offering own claimed for sale, or importing into the U.S. the product or process product or process of 20 year term from the claim filing date www.smithmoorelaw.com
  • 11. The Patent Bargain For the U.S., law requires full disclosure of the claimed invention as of the day of filing www.smithmoorelaw.com
  • 12. Patent Infringement Focus on Claims Literal Infringement • every claim element in accused product/process Doctrine of Equivalents • accused device differs in inconsequential ways from claim www.smithmoorelaw.com
  • 13. Hatch-Waxman Brand Drug Companies may seek restoration of some of the patent life lost during the period of FDA testing/approval up to five years (or no more than 14 years between FDA approval and patent expiration) www.smithmoorelaw.com
  • 14. Hatch-Waxman FDA Approval Preclinical FDA Clinical Market Studies Trials + NDA Exclusivity 0 yrs. 10 yrs. 20 yrs. 5 yrs. 15 yrs. 2.5 yrs Idea @ 3-4.5 yrs Issues Patent Term Extended Office Action File Application @ 1.5 yrs Publishes www.smithmoorelaw.com
  • 15. Hatch-Waxman Generic Manufacturers • permitted to use safety and effectiveness data submitted by Brand companies • need only demonstrate chemical and biological equivalence • may begin testing before the patent on the proprietary drug expires • first generic company to file an ANDA gets 180 days of “exclusivity” www.smithmoorelaw.com
  • 16. Avoiding Patent Infringement Under Hatch-Waxman, generic companies filing ANDAs are required to certify with the FDA that their “copycat” drug will not infringe each and every existing patent on the innovative drug they seek to copy, which are listed in a printed compendium known as “Approved Drug Products with Therapeutic Equivalence,” but most commonly called “The Orange Book” www.smithmoorelaw.com
  • 17. Typical Generic Development Cycle File Patent Cert File DMF File ANDA ANDA Approval Stability Validation & Brand Portfolio Patent Sourcing Form & pK Approval Product Review Review Pre-Form Pilot Bio Study Prep 9 mo. 2 mo. 6-12 mo. 12 mo. 5 mo. 12-18 mo. www.smithmoorelaw.com
  • 18. Brand Patent Portfolio 26 yrs. 6 yrs. 16 yrs. 21 yrs. 11 yrs. 8.5 yrs. New Process for Chemical Entity Idea File App. @ 3-4.5 yrs Issues 20 yrs. Patent Term 21.2 yrs. 1.2 yrs. 11.2 yrs. 16.2 yrs. 6.2 yrs. 3.7 yrs. New Indication Idea File App. @ 3-4.5 yrs Issues 20 yrs. Patent Term 10 yrs. 20 yrs. 25 yrs. 0 yrs. 5yrs. 15 yrs. 2.5 yrs New Chemical Entity @ 3-4.5 yrs Issues Idea Office Action Patent Term Extended File App. @ 1.5 yrs Publishes www.smithmoorelaw.com
  • 19. Exclusivity Extensions Secondary Product Aspect Patents Such As • polymorph • salts • processes • formulations • uses Authorized Generics Pediatric Exclusivity Reformulations www.smithmoorelaw.com
  • 20. Generics’ Response Patent Space Analysis • study Brand’s patent portfolio for weaknesses • file blocking patents • study Brand’s patents for flaws • reexamination • negotiation with Brand • license and/or cooperative work with Brands Design Around Brand’s Patent ANDA or 505(b)(2) NDA • infringement settlements • declaratory actions www.smithmoorelaw.com
  • 21. Types of ANDA Filings Paragraph I Generic Entry No patent filed One or more FDA Approval generic applicants Immediate may enter the Paragraph II market Patent has expired FDA Approval Paragraph III May approve, Patent will expire Valid after on ‘X’ date patent expiry Generic Entry May or may not enter, Depends on Paragraph IV FDA Approval the court ruling in Patent not expired May approve favor or against Generic claims before patent the generic Patent ‘invalid’ expiry applicant or ‘not infringed’ www.smithmoorelaw.com
  • 22. Paragraph IV 180-Day Period of Exclusivity • first generic company to file an ANDA is given the exclusive right to market its generic version of a patented drug for 180 days 30-Month Stay Protection • when a generic company files an ANDA, the Brand company has 45 days to decide whether to sue the company for patent infringement • filing the lawsuit stays FDA’s approval of ANDA until the earliest of date of patent expiration • final determination of non-infringement or patent invalidity by a • court expiration of 30 months from the receipt of notice of the • paragraph IV certification www.smithmoorelaw.com
  • 23. Paragraph IV Paragraph IV Certification If patent holder does not sue within 45 days, Patent has not expired, but generic applicant FDA may approve ANDA; generic applicant certifies that patent is invalid or not infringed is entitled to 180-day exclusivity by its product When 30-month stay expires If patent holder sues within 45 days, the action automatically triggers a 30-month stay on FDA action FDA may approve ANDA; first generic applicant is entitled to 180-day exclusivity When 30-month stay has not expired If court rules in favor of generic company, FDA may approve ANDA; first generic applicant is entitled to 180-day exclusivity If court rules in favor of brand-name company, FDA may not approve ANDA If patent expires; FDA may approve until patent expires; no generic may enter ANDA; one or more generics may until patent expires; no applicant is entitled to enter; no applicant is entitled to 180- 180-day exclusivity day exclusivity www.smithmoorelaw.com
  • 24. Generic Development Cycle Paragraph IV & Litigation FDA Starts 30-month Stay of Approval File Appellate Patent Court Cert File Decision DMF Lower Brand Files File ANDA Launch Court Infringement ANDA Approval Decision Suit Generic Development Program 30 mo. 6-12 mo. 34 - 40 mo. 3 mo. Timeline is 66 to 72 months If 1st generic and successful, granted 180 days of generic market exclusivity www.smithmoorelaw.com
  • 25. Patent Infringement Suits Costly • average cost of defending over $2 million Time-Consuming • average time - filing to final appeal is about 3-5 years www.smithmoorelaw.com
  • 26. Patent Infringement Suits Risk Reduction Measures • always seek advice of patent counsel before beginning any activity • freedom-to-operate, more than just “The Orange Book” • increased damage awards for infringers who do not seek advice of patent counsel before undertaking activity that is found to infringe www.smithmoorelaw.com
  • 27. Patent Infringement Suits Risk Reduction Measures • only a well-reasoned opinion of invalidity or noninfringement can protect against an increased damages award • the attorney providing the opinion must be a patent attorney www.smithmoorelaw.com
  • 28. Contact Information Walter Boyd Stan Antolin Smith Moore LLP Smith Moore LLP 300 N. Greene Street 300 N. Greene Street Suite 1400 Suite 1400 Greensboro, NC 27401 Greensboro, NC 27401 336.378.5516 336.378.5537 336.378.5400 (fax) 336.378.5400 (fax) stan.antolin@smithmoorelaw.com walter.boyd@smithmoorelaw.com www.smithmoorelaw.com