FDA Regulatory Exclusivity and Patent Protection for Drugs

1. FDA Regulatory Exclusivity and Patent Protection for Drugs American Intellectual Property Law Assn. IP Practice in Japan Committee October 25-36, 2005 Darryl Webster Wyeth

2. FDA Regulatory Exclusivity and Patent Protection for Drugs • The dovetail of regulatory exclusivity and patent protection has always been viewed as a basic stimulus for the pharmaceutical industry.

3. FDA Regulatory Exclusivity and Patent Protection for Drugs • Where is the U.S. without innovation? ….from satellites to cancer treatments to the wireless world. • Technology is key – Our Mantra!

4. FDA Regulatory Exclusivity and Patent Protection for Drugs The dovetail: Part A – the patent system • Goals: permit inventors/companies enough exclusivity to receive a return on the effort invested in the invention

5. FDA Regulatory Exclusivity and Patent Protection for Drugs The dovetail: Part B – regulatory exclusivity • The FDA issues marketing approvals and provides the approval holder with data exclusivity. Depending on the type of approval, the exclusivity last 3, 5 and 7 years. • Again, we reward technological advancement and effort

6. FDA Regulatory Exclusivity and Patent Protection for Drugs Exclusivity for Registration Data: period of non-reliance and non-disclosure that a government must provide to pharmaceutical registration data. Pharmaceutical registration data are proprietary data generated by scientific research conducted to demonstrate the efficacy and safety of new medicines and submitted to regulatory authorities for marketing approval.

7. FDA Regulatory Exclusivity and Patent Protection for Drugs • Most developed countries provide some form of protection for data exclusivity. • General Principle: without data exclusivity, innovators would be placed at an unfair commercial disadvantage when compared to their generic competitors, which do not face ever-increasing costs incurred through the FDA’s drug approval process. • About 1983, the page turned on this dovetail. Some say, a new book was written.

8. FDA Regulatory Exclusivity and Patent Protection for Drugs • 1983 Roche v. Bolar, suit filed • 1984 CAFC decision, 733 F.2d 858 • 1984 Sept. 24th, Drug Price Restoration and Patent Term Restoration Act (Hatch-Waxman Act) • The dovetail redefined for non-biologics?

9. FDA Regulatory Exclusivity and Patent Protection for Drugs • Roche v. Bolar, 733 F 2d, 858 (Fed. Cir. 1984), concerning the sleeping pill, Dalmane. Patent expired Jan. 17 1984,and issued 17 years earlier in 1967. • Bolar desired to sell a generic on Jan. 18, 1984. Bolar are the “conflict between” the FDA and patent law in that the FDA process extended the patent term if Bolar wasn’t permitted to obtain approval on the date of patent expiration

10. FDA Regulatory Exclusivity and Patent Protection for Drugs • Roche v. Bolar Bolar argued the “conflict” the FDA and patent law in that the FDA process unfairly extended the patent term if Bolar was not permitted to obtain approval on the date of patent expiration. Hence, the FDA laws extended the the market exclusivity of the statutory patent term.

11. FDA Regulatory Exclusivity and Patent Protection for Drugs • Key points : The ANDA (Abbreviated New drug Application), a cornerstone for generic producers. The balancing act between regulatory and patents; should the regulatory process itself be an extension of exclusivity to patent owners? Biologics: Hatch-Waxman did not effect the Public Health Services Act.

12. FDA Regulatory Exclusivity and Patent Protection for Drugs

13. FDA Regulatory Exclusivity and Patent Protection for Drugs • As the U.S. patent and regulatory systems continue to “evolve”, the average drug research and development time moves to 10 years, while the total costs are often now exceeding $750 million dollars.

14. FDA Regulatory Exclusivity and Patent Protection for Drugs • From the 1965 to 1985 to 2005: Where is the industry? Where is the dovetail today? • For the largest major markets, the U.S. has the shortest data exclusivity protection for innovative drugs. The U.S. is at 5 years for most new drug entities (7 years for orphan drugs). • If you list a patent in the FDA Orange Book system, the de facto exclusivity is about 7.5 years, but the regulatory package for ANDA is filed for initiating the approval process at 4 years, not 5 years). • Pediatric Exclusivity (+6 months) available for some drugs.

15. FDA Regulatory Exclusivity and Patent Protection for Drugs • From the 1960 to the 1980s to today: Where is the industry? Where is the dovetail today in the U.S.? • The EU is 10 years for data exclusivity • Japan is moving from 6 years for exclusivity for collecting product efficacy and safety information, with no generic filing prior the expiration of the 6-year period to a form of data exclusivity of 8 years.

16. FDA Regulatory Exclusivity and Patent Protection for Drugs • Additional changes in the dovetail: As the U.S. systems provide less protection for innovators, other countries look to provide more forms of protection Japan plans to adopt “Complementary Patent Registration Framework”. Objectives: reduce corporate exposure to patent disputes and other risks; reduce the burden of filing patent applications defensively; and keep innovative technologies within Japan longer than today.

17. FDA Regulatory Exclusivity and Patent Protection for Drugs • U.S. concerns • In the U.S., does the dovetail of patent laws and regulatory now fall short of other countries that are home to worldwide industry leaders?

18. FDA Regulatory Exclusivity and Patent Protection for Drugs • Looking back over 40 years… • Where will today’s dovetail takes the U.S. pharmaceutical industry tomorrow? • Will the U.S. move to narrow the differences between its regulatory laws and those of Japan and the EU? Remind the naysayer of the 20 year term! • Hope I’m around to update you on the next significant changes.

19. FDA Regulatory Exclusivity and Patent Protection for Drugs The views presented and discussed are the views of the presenter and do not represent the views or opinions of Wyeth Thank you.