Biotechnology and IP

By
Kalyan C Kankanala
Chief Knowledge Officer
Brain League IP Services
kalyan@brainleague.com

Copyright, Brain League IP Services,

Non-commercial use is permitted
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 Kalyan’s Patent
Filter Model
Subject Matter

Usefulness

Novelty

Non-obviousness

Specification

PATENTS
How to frame an issue?
 Example
• Example: A stabs B with a long knife after being
provoked byB's statemements about his wife.
• Issue
• Whether A's act of stabing B with a long knife
with the intention of killing him amounts to
murder under section 300 of IPC?
• Wheter A's act of stabing B after being
provoked by B's humiliating statements
amounts to murder under section 300 of IPC?
 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
• Know of 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
• Differeneces- invention and prior art
• Level of oridnary skill
• Secondary Indiicia

• 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. [Id.]
 In re Deuel:

• Isolated and purified DNA and cDNA

molecules 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
 Thank you

Kalyan C. Kankanala
Chief Knowledge Officer,
Brain League IP Services
Email: kalyan@brainleague.com
Ph: 91-80-41489502/4
URL: www.brainleague.com
Blog: http://indianipinfo.blogspot.com/

Copyright, Brain League IP Services,

Non-commercial use is permitted