Presentation on Patent Risk Management – Dr. Kalyan and Mr.Vikram 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. 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. Risk Sources
• Internal
– Generation
– Excavation
– Protection
– Management
• External
– Infringement
– Transactions

3. •Patent Risks

4. Patent Rights
• Territory
• Product Patent -
Make, Use, Sell, Offer for Sale
and Import.
• Process patent - Use

5. Infringement
• Types
– Direct
•Literal
•Equivalent
– Indirect

6. Direct Infringement
• Claim Construction
• Comparison
• Claim by claim - element by
element

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. 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. Claim Elements
• 10 percent by weight
Benzocaine
• Propylene glycol or Glycerine

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. 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. 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. NTP v. RIM
• Black Berry Technology
• RIM held liable for infringement
• Damages – 612 million dollars

14. Indirect Infringement
• Contributory Infringement
• Inducement to infringe

15. Defenses
• Government use
• Research Exemptions
• Experiments or education
• FDA approval
• Other Defenses

16. Steps
• FTO Search and Analysis
• Infringement analysis
• Technology Landscape

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. 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. 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. 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. 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. 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. Risk Management
• Risk Assessment and Categorization
• Actions
– Search and FTO Analysis
– Technology Landscaping
• Options
– Work around
– Collaborate
– License
– Infringe
– Defend

24. IP Resources
•
•
www.bananaip.com/sinapse-blog

25. IP Resources
www.bananaip.com

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. Thank you
• For the ppt and other information visit
• www.bananaip.com/sinapse-blog