Patent Risk Management
Dr. Kalyan C. Kankanala
Vikram Pratap Singh Thakur
Website: www.bananaip.com
Blog: www.bananaip.com...
Risk Sources
• Internal
– Generation
– Excavation
– Protection
– Management
• External
– Infringement
– Transactions
•Patent Risks
Patent Rights
• Territory
• Product Patent -
Make, Use, Sell, Offer for Sale
and Import.
• Process patent - Use
Infringement
• Types
– Direct
•Literal
•Equivalent
– Indirect
Direct Infringement
• Claim Construction
• Comparison
• Claim by claim - element by
element
Claim Construction
• Claim
• Preamble
• Transition
• Body
• “ What I claim is a composition for treatment of pain
comprisi...
Claim Construction
• Preamble - A composition for
treatment of pain
• Transition Phrase - comprising
• Body - 10 percent b...
Claim Elements
• 10 percent by weight
Benzocaine
• Propylene glycol or Glycerine
Is this product
infringing?
• 1. What I claim is a composition for
treatment of pain comprising;10
percent by weight Benzo...
Doctrine of Equivalence
• Equivalents of a claim
• In substance equivalent
• Function-Way-Result Test
• Prosecution Histor...
Lalabhai v. Chimanlal
• Process of treating dry fruits
• Comparison
• Sulphuric Acid - Washing Soda
• muriatic acid - Acet...
NTP v. RIM
• Black Berry Technology
• RIM held liable for infringement
• Damages – 612 million dollars
Indirect Infringement
• Contributory Infringement
• Inducement to infringe
Defenses
• Government use
• Research Exemptions
• Experiments or education
• FDA approval
• Other Defenses
Steps
• FTO Search and Analysis
• Infringement analysis
• Technology Landscape
Example 1
• Claim 1- In an micronized glyburide anti-
diabetic pharmaceutical composition as a unit
dose, containing one o...
Product
• Micronized glyburide compositions with anhydrous
lactose as the principal excipient.
• Additional facts: Patent ...
Example 2
• Title of Invention - Polymerization of Ethylene
• Claim 1. Polymerization catalyst comprising the
product form...
Process
• The process comprises of polymerization of
butadiene. The polymerization process
includes the reaction of three
...
Example 3
• Claim 1. A hydrosol which comprises solid
particles of a cyclosporin and a stabilizer
which maintains the size...
Product
• Product is in the form of a capsule that
contains cyclosporin dissolved in a
small amount of ethanol instead of ...
Risk Management
• Risk Assessment and Categorization
• Actions
– Search and FTO Analysis
– Technology Landscaping
• Option...
IP Resources
•
•
www.bananaip.com/sinapse-blog
IP Resources
www.bananaip.com
Indian Patent law and
Practice
Patents play a very vital role in providing
business and competitive advantage to
knowledge...
Thank you
• For the ppt and other information visit
• www.bananaip.com/sinapse-blog
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Patent Risk Management

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Patent Risk Management

  1. 1. Patent Risk Management Dr. Kalyan C. Kankanala Vikram Pratap Singh Thakur Website: www.bananaip.com Blog: www.bananaip.com/sinapse-blog Copyright 2010 BananaIP
  2. 2. Risk Sources • Internal – Generation – Excavation – Protection – Management • External – Infringement – Transactions
  3. 3. •Patent Risks
  4. 4. Patent Rights • Territory • Product Patent - Make, Use, Sell, Offer for Sale and Import. • Process patent - Use
  5. 5. Infringement • Types – Direct •Literal •Equivalent – Indirect
  6. 6. Direct Infringement • Claim Construction • Comparison • Claim by claim - element by element
  7. 7. Claim Construction • Claim • Preamble • Transition • Body • “ What I claim is a composition for treatment of pain comprising; 10 percent by weight Benzocaine and atleast one of propylene glycol and glycerine as a co-solvent.”
  8. 8. Claim Construction • Preamble - A composition for treatment of pain • Transition Phrase - comprising • Body - 10 percent by weight Benzocaine and atleast one of propylene glycol and glycerine as a co-solvent.
  9. 9. Claim Elements • 10 percent by weight Benzocaine • Propylene glycol or Glycerine
  10. 10. Is this product infringing? • 1. What I claim is a composition for treatment of pain comprising;10 percent by weight Benzocaine and atleast one of propylene glycol and glycerine as a co-solvent. • “A gel for treating neuropathies causing pain at a site by inducing analgesia. The gel is administered intradermally. The gel has 8-12 percent by weight of Benzocaine and D-Sorbitol and Water as co- solvents.”
  11. 11. Doctrine of Equivalence • Equivalents of a claim • In substance equivalent • Function-Way-Result Test • Prosecution History Estoppel • Obviousness Test – Material Effect – Part of prior art
  12. 12. Lalabhai v. Chimanlal • Process of treating dry fruits • Comparison • Sulphuric Acid - Washing Soda • muriatic acid - Acetic acid • Sulphur dioxide fumes under pressure - Sulphur dioxide fumes without pressure
  13. 13. NTP v. RIM • Black Berry Technology • RIM held liable for infringement • Damages – 612 million dollars
  14. 14. Indirect Infringement • Contributory Infringement • Inducement to infringe
  15. 15. Defenses • Government use • Research Exemptions • Experiments or education • FDA approval • Other Defenses
  16. 16. Steps • FTO Search and Analysis • Infringement analysis • Technology Landscape
  17. 17. Example 1 • Claim 1- In an micronized glyburide anti- diabetic pharmaceutical composition as a unit dose, containing one or more pharmaceutically acceptable excipients, the improvement which comprises: spray-dried lactose as the preponderant excipient in said composition, being present therein at about not less that seventy percent (70%) by weight of the final composition.
  18. 18. Product • Micronized glyburide compositions with anhydrous lactose as the principal excipient. • Additional facts: Patent holder’s representative said that spray-dried lactose is a critical feature of the present invention. Using lactose which is not spray- dried does not yield a formulation which is easily and readily manufacturable. • Is the product infringing? • Pharmacia & Upjohn Co. v. Mylan Pharmaceuticals, Inc.,170 F.3d 1373 (C.A.Fed. (W.Va.), 1999)
  19. 19. Example 2 • Title of Invention - Polymerization of Ethylene • Claim 1. Polymerization catalyst comprising the product formed by mixing an effective amount of an aluminium trialkyl with a compound of a metal selected from the group consisting of salts, freshly precipitated oxides and hydroxides of metals of Groups IV-B, V-B and VI-B of the Periodic System, including thorium and uranium.
  20. 20. Process • The process comprises of polymerization of butadiene. The polymerization process includes the reaction of three components, i.e. aluminum triethyl, titanium tetrachloride and iodine in the presence of butadiene to produce cis -polybutadiene. • Is the claimed product being infringed by the working of this process? • Ziegler v. Phillips Petroleum Company 483 F.2d 858 (5th. Cir., 1973)
  21. 21. Example 3 • Claim 1. A hydrosol which comprises solid particles of a cyclosporin and a stabilizer which maintains the size distribution of said particles, wherein said cyclosporin has a water solubility below 0.5 grams per 100 milliliters, and said particles have a weight ratio of cyclosporin to water of about 1:300 to about 1:1500 and a weight ratio of cyclosporin to said stabilizer of about 1:1 to about 1:50.
  22. 22. Product • Product is in the form of a capsule that contains cyclosporin dissolved in a small amount of ethanol instead of a hydrosol. • Novartis Pharmaceuticals Corp. v. Eon Labs Mfg. 363 F.3d 1306 (Fed. Cir., 2004)
  23. 23. Risk Management • Risk Assessment and Categorization • Actions – Search and FTO Analysis – Technology Landscaping • Options – Work around – Collaborate – License – Infringe – Defend
  24. 24. IP Resources • • www.bananaip.com/sinapse-blog
  25. 25. IP Resources www.bananaip.com
  26. 26. Indian Patent law and Practice Patents play a very vital role in providing business and competitive advantage to knowledge driven companies. In order to maximize business benefits from inventive activities, companies must be aware of the dynamics of patent law and activities of competitors. Swift response to changes in law and patent behavior of other companies is necessary to deal with cut throat competition. The rapid progress of patent activity in India requires every organization to be alert and watchful in order to survive and succeed in the market place. For more information on the book please visit: www.indianpatentlaw.com
  27. 27. Thank you • For the ppt and other information visit • www.bananaip.com/sinapse-blog

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