INTELLECTUAL PROPERTY PROTECTION OF BIOTECH IN THE U.S.

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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_at_sillscummis.com

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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

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INTERNATIONAL TREATIES

• Patent Cooperation Treaty central filing a
  national filings
• GATT and NAFTA which harmonize patent procedures

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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 GMOs (genetically modified
  animals) into the food supply

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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

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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!

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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
  publics interest of having the generic available
  upon expiration of the patent

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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

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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

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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

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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.

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GRAZIE PER LAS VOSTRA ATTENZIONE!

• Marc S. Friedman
• Sills Cummis Epstein Gross P.C.
• Phone [phone]
• mfriedman_at_sillscummis.com