INTELLECTUAL PROPERTY PROTECTION OF BIOTECH IN THE U.S.

1. INTELLECTUAL PROPERTY PROTECTION OF BIOTECHIN THE U.S. Marc S. Friedman Chair, Intellectual Property Practice Sills Cummis Epstein & Gross P.C. 30 Rockefeller Plaza New York, New York 10112 mfriedman@sillscummis.com

2. LEGISLATION GOVERNING IP RIGHTS IN BIOTECH • 35 U.S.C. § 101 et seq. • Governs all inventions including biotech • Novelty, utility non-obviousness • 20 years • Right to exclude • Recently amended § 103(c) to address collaborations between companies and universities

3. INTERNATIONAL TREATIES • Patent Cooperation Treaty — central filing a national filings • GATT and NAFTA which harmonize patent procedures

4. NEW IP ISSUES IN BIOTECH • Recent explosion in biotech and life sciences research • Novel and improved therapeutics and diagnostics • Improved plants and animals • New forensic detection methods • New ethical dilemmas such as embryonic stem cell research (destruction of early life, costs, etc.) • High costs such as HIV Aids protease inhibitors • Introduction of GMO’s (genetically modified animals) into the food supply

5. PATENT ESSENTIALS • “First to invent,” not “first to file” • One year “bar” • Must be filed in the name of the inventor • Claims must be novel, non-obvious and enabled and described by the teachings of the patent application

6. NEW ISSUES IN BIOTECH IP • Issue: should biologics be eligible for patent protection? (generally yes, although Title 35 precludes patenting a “product of nature”) • Patents allowed for transgenic plants and animals, embryonic stem cells, isolated human genes, isolated microbia, etc. “Anything under the sun!”

7. GENERIC DRUGS ANDHATCH-WAXMAN • When should a generic be allowed prior to the expiration of a patent • To expedite generics before a patent expires, Congress created a “safe harbor” to shelter the new generic from patent liability • Balances interest of patentee against the public’s interest of having the generic available upon expiration of the patent

8. REMEDIES FOR INFRINGEMENT • Injunctive relief • Destruction of the infringing goods • Damages • Up to 3x damages for willful infringement • Litigation costs (average $1.5mm per side) • Available only to the “big boys”

9. PATENT RENEWALS • 20 years from filing date or 17 from issuance • Can be extended for drugs based upon delays in the FDA regulatory approval process – up to four extensions of up to one year each

10. TRADEMARKS AND BIOTECH • Protects names and logos as designators of the source of origin • A registered trademark for a biologic can be valuable in distinguishing it from others (e.g., Viagra) • Remedies include injunctive relief and damages based upon lost sales or royalties

11. HOW TO MAXIMIZE THE VALUE OF BIOTECH IP • Diligently developing and commercializing the product • Protecting the IP through a careful program of patents, trademarks, trade secrets • Licensing out patents it cannot produce on its own or entering into collaboration agreements, joint venture agreements, etc.

12. GRAZIE PER LAS VOSTRA ATTENZIONE! Marc S. Friedman Sills Cummis Epstein & Gross P.C. Phone (212) 500-1550 mfriedman@sillscummis.com