Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala Contact Us for Intellectual Property Services BananaIP Counsels Regd Office No.40,3rd Main Road,JC Industrial Estate, Kanakapura Road,Bangalore – 560 062. Email: contact@bananaip.com Telephone: +91-80-26860414 /24/34

1. Biotechnology and IP
By
Dr. Kalyan Kankanala
Blog: www.bananaip.com/sinapse-blog

2. US Patent Law and
Biotechnology

3. Overview
• Article 1 Section 1 Clause 8
• Quid Pro Quo
• Incentives
• Title 35
• www.uspto.gov
• www.fedcir.gov

4. Patentability requirements
• Patentable subject matter
• Utility
• Novelty
• Nonobviousness
• Specification

5. INVENTIONS
Subject Matter
Usefulness
Novelty
Non-obviousness
Specification
PATENTS
Kalyan’s Patent
Filter Model

6. 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

7. Funk Bros
• Rhizobium bacteria
• Innoculum of mutually inhibiting
bacteria
• Is it a product of nature?

8. Chakrabarty's case
• Psuedomonas bacteria
• Four different plasmids inserted.
• Is it a product of Nature?

9. Utility
• Current
• Substantial
• Credible
• Brenner v. Manson
• Gene/protein sequences

10. Novelty
• Section 102
• Known or used
• Patented or published
• Public use or On sale
• Abandoned
• Foreign Priority
• Patented in another country

11. Novelty
• Derived
• Suppressed or Concealed
• Diligence
• Single prior art reference
• Isolated or purified- activity
• Hybritech v. Monoclonal

12. Nonobviousness
• Scope of prior art
• Differences- invention and prior art
• Level of ordinary skill
• Secondary Indicia
• At the time of conception
• Obvious to try

13. Hybritech v. Monoclonal
• immunometric assays using monoclonal
antibodies

14. 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.

15. In re Deuel:
• Isolated and purified DNA and cDNA
sequences encoding heparin-binding
growth factors ("HBGFs")

16. 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.

17. 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.

18. Recent Developments
• KSR Vs. Teleflex
• In re Kubin

19. Specification
• Written Description
• Enablement
• Best Mode
• Claims
• Object: Notice and Dissemination

20. 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

21. Have a nice day
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