INTELLECTUAL PROPERTY PROTECTION OF BIOTECH IN THE U.S. Marc S. Friedman Chair, Intellectual Property Practice Sills Cummis Epstein & Gross P.C. 30 Rockefeller Plaza New York, New York

Sills Cummis Epstein & Gross A Professional Corporation 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

Sills Cummis Epstein & Gross A Professional Corporation INTERNATIONAL TREATIES Patent Cooperation Treaty — central filing a national filings GATT and NAFTA which harmonize patent procedures

Sills Cummis Epstein & Gross A Professional Corporation 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

Sills Cummis Epstein & Gross A Professional Corporation 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

Sills Cummis Epstein & Gross A Professional Corporation 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!”

Sills Cummis Epstein & Gross A Professional Corporation GENERIC DRUGS AND HATCH-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

Sills Cummis Epstein & Gross A Professional Corporation 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”

Sills Cummis Epstein & Gross A Professional Corporation 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

Sills Cummis Epstein & Gross A Professional Corporation 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

Sills Cummis Epstein & Gross A Professional Corporation 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.

Sills Cummis Epstein & Gross A Professional Corporation GRAZIE PER LAS VOSTRA ATTENZIONE! Marc S. Friedman Sills Cummis Epstein & Gross P.C. Phone (212)