Biotechnology and IP By
Dr. Kalyan Kankanala
Blog: www.bananaip.com/sinapse-blog
US Patent Law and Biotechnology
Overview
• Article 1 Section 1 Clause 8
• Quid Pro Quo
• Incentives
• Title 35
• www.uspto.gov
• www.fedcir.gov
Patentability requirements
• Patentable subject matter
• Utility
• Novelty
• Nonobviousness
• Specification
INVENTIONS
Subject Matter
Usefulness
Novelty
Non-obviousness
Specification
PATENTS
Kalyan’s Patent Filter Model
Patentable Subject Matter
• Section 101 - Process, machine, manufacture, composition of matter and Improvements
• Funk Bros. v. Kalo
• Diamond v. Chakrabarty
• Pioneer Hibebred v. J.E.M.
Arguments and Issues
Funk Bros
• Rhizobium bacteria
• Innoculum of mutually inhibiting bacteria
• Is it a product of nature?
Chakrabarty's case
• Psuedomonas bacteria
• Four different plasmids inserted.
• Is it a product of Nature?
Utility
• Current
• Substantial
• Credible
• Brenner v. Manson
• Gene/protein sequences
Novelty
• Section 102
• Known or used
• Patented or published
• Public use or On sale
• Abandoned
• Foreign Priority
• Patented in another country
Novelty
• Derived
• Suppressed or Concealed
• Diligence
• Single prior art reference
• Isolated or purified- activity
• Hybritech v. Monoclonal
Nonobviousness
• Scope of prior art
• Differences- invention and prior art
• Level of ordinary skill
• Secondary Indicia
• At the time of conception
• Obvious to try
Hybritech v. Monoclonal
• immunometric assays using monoclonal antibodies
Prior Art
• a. Kohler and Milstein's Nobel Prize-Winning Work for Producing Monoclonal antibodies in vitro;
• b. The Work of Drs. Oi and Herzenberg, in which they used monoclonal antibodies to "map" epitopes or determine the number and location of different antibody binding sites on a known quantity of IgE antigen by attaching to it an antibody bound to a carrier and exposing that antigen to other monoclonal antibodies;
• c. The Frankel Article that disclosed Monoclonal Antibodies Having Affinities of 109 liters/mole; and
• d. Articles "Predicting" Widespread Use of Monoclonal antibodies.
In re Deuel:
• Isolated and purified DNA and cDNA sequences encoding heparin-binding growth factors ("HBGFs")
Prior Art
• Bohlen's patent application disclosed a group of protein growth factors designated as heparin-binding brain mitogens ("HBBMs") useful in treating burns and promoting the formation, maintenance, and repair of tissue, particularly neural tissue. Bohlen determined the first 19 amino acids of the proteins' N-terminal sequences, which were found to be identical for human and bovine HBBMs. He provided no teachings concerning DNA or cDNA coding for HBBMs in his application.
Prior Art
• Maniatis described a method of isolating DNAs or cDNAs by screening a DNA or cDNA library with a gene probe. The reference outlined a general technique for cloning a gene but did not describe how to isolate a particular DNA or cDNA molecule.
Recent Developments
• KSR Vs. Teleflex
• In re Kubin
Specification
• Written Description
• Enablement
• Best Mode
• Claims
• Object: Notice and Dissemination
Example
• A stent coated with taxol for "treating or preventing recurrent stenosis.
• Prior ArtStents Existing
• Taxol known for Tumor treatment by angiogenesis
• Article - Re-stenosis dangers and need for a treatment - suggests various options
Have a nice day
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