intellectual property protection and the life sciences Aidic

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					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 10112
         mfriedman@sillscummis.com
     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) 500-1550
      mfriedman@sillscummis.com



          Sills Cummis Epstein & Gross
               A Professional Corporation

				
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