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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