Patent Risk Management

Dr. Kalyan C. Kankanala

Vikram Pratap Singh Thakur

Website: www.bananaip.com

Blog: www.bananaip.com/sinapse-blog

Copyright 2010 BananaIP

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

comprising; 10 percent by weight Benzocaine and atleast one of propylene glycol and glycerine as a co-solvent.”

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.

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 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.”

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

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

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 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.

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)

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.

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)

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.

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)

Risk Management

• Risk Assessment and Categorization

• Actions

– Search and FTO Analysis– Technology Landscaping

• Options

– Work around– Collaborate– License– Infringe– Defend

IP Resources•

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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 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

Thank you

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