Bindu Sharma

Bangalore [INDIA] Email: [email protected], [email protected] Phone: 9845693459

Disclaimer
The idea of this presentation is to give broad idea on patent

infringement and the way to minimize patent infringement risk by appropriate patent search and claim analysis. The contents of the presentation shall not be taken as legal advice.
The contents of the presentation are generic and dont refer to any

territory in particular. For specific issues related to patent infringement, kindly consult a patent practitioner in the required jurisdiction.

Patent

Latin word patere, which means "to lay open" (i.e., to make available for public inspection) A patent is a statutory grant by Govt for new inventions conferring certain monopoly rights on the grantee for a defined period, subject to certain conditions. Invention means a product or a process that isNovel, has an inventive step and is capable of industrial application.

Patent rights are territorial Term of patent is 20 years from date of filing.

Product or process patent

A pharmaceutical preparation comprising ..

Process to prepare alkansulphonamides having a formula

Patent rights
Negative rights The mere granting of a patent does not ensure that

it would enable the inventor to make, use or sell the invention.

In fact, in making, using or selling his or her own

invention, the inventor may find that he or she infringes the patent right of others.

Rights of patentee (patent holder)

Product: The patentee has exclusive right to prevent third parties, who

do not have his consent, from the act of: Making Using Offering for sale Selling or Importing for those purposes that product in India

Rights of patentee (patent holder)

Process: The patentee has exclusive right to prevent third parties, who

do not have his consent, from the act of: Using that process Offering for sale Selling or Importing for those purposes the product obtained directly by that process in India

Transfer of rights

License

Transfer of rights
Transmission

Assignment

Infringement
Unauthorized use of IP No consent, license, assignment

Infringement
Product: Infringement takes place when someone makes, uses, offers

for sale, sells or imports the patented product in India without consent of patentee.
Process: Infringement takes place when someone uses that process,

offers for sale, sells or imports for those purposes the product obtained directly by that process in India.

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To-do before commercialization

Thorough prior art search to identify Step 2 and 4. If they are patented, compare the claims with the process you are going

to use.
If you are likely to infringe, take license from patent holder or dont use

step 2 and 4.

Risk factors
Patents that have a high likelihood of being infringed and therefore

require a license; or
Patents that may be infringed, depending upon how claims are

interpreted; or
Patents that are clearly outside the field of the product and require no

license.

Anatomy of patent
Title Field of invention Background Summary Brief description of drawings Description

Claims
Abstract Drawings

Claims
Legal protection Scope of patent Infringement of claims Interpretation of claims, very critical

issue

Types of patent infringement

Direct
Literal Doctrine of equivalence

Indirect
Induced Contributory

Burden of proof
Obligation of a party on one side of a dispute or issue to provide

sufficient evidence in support of their position

Product: Patentee or plaintiff

(who initiates lawsuit)

Process: Defendant

Consequences of infringement
Injunction Damages Account of profit Infringing articles may be seized, forfeited or destroyed

Freedom to operate (or clearance studies)

A kind of patent search that is performed to determine whether a

particular action, such as testing or commercialising a product can be done by a company without infringing valid intellectual property rights of others or not.
Not only patents but also trademark and other applicable forms of IP. If you want to commercialise a new variety of rice seed in your own

country, you will have complete freedom to operate only if there are no patents, plant variety rights, trademarks or other IP rights covering the seed, the process used to make it or the way you wish to market it or in your country.
FTO is a strategic risk-management tool

Benefits
Gives clarity of prior art Saves from litigation Risk assessment tool but not full proof guarentee Shall be done even during the conceptualization of a research or

exploring areas which are open for research

 Three pharmaceutical companies, Cambridge Antibody Technology,

Micromet AG, and Enzon Pharmaceuticals, announced that they had signed a non-exclusive cross-license agreement. In the agreement, all three parties obtained substantial "freedom to operate" under some of each othersintellectual property, to conduct research and develop a defined number of therapeutic and diagnostic antibody-based products

Scope of FTO
Only patents NOT publications

Only valid patents

Granted patents

Published patent applications

Limited by territory

FTO necessary for pharma industry

Generic pharmaceutical try to match every brand name drug with a

copycat version.
Launching drugs before expiry of patent is risky

Process flow
Understanding background Identification of prior art Sort out valid patents/application Claim analysis and mapping Preparation of report

Critical issues in identification

Patent term calculation Patent expiry and restoration Supplementary Protection Certificate Patent application watch

Who should do it?

Search can be done by a searcher, expert in

domain.
Legal opinion shall be given by a legal person,

attorney who specializes in patent law of the particular country

Willful infringement
A well-reasoned opinion of counsel that the patent

is invalid or that the patent is not infringed is the best way to minimize the risk of increased damages.
If one obtains and acts on the counsels competent

invalidity or non-infringement advice, courts will most often refraining from finding willful infringement, even if one ultimately loses the litigation and is found infringing.

Defenses
Experiment or research Imparting of instructions to the students

All revocation grounds may be used as defense

Roche Products Inc. v. Bolar Pharmaceutical Co

Bolar was a generic drug manufacturer Roche was a brand-name pharmaceutical company

which made and sold Valium, the active ingredient of which was protected by patent

Before patent expiration, Bolar used the patented

chemical in experiments to determine if its generic product was bioequivalent to Valium in order to obtain FDA approval for its generic version of Valium

Roche Products Inc. v. Bolar Pharmaceutical Co

Bolar also applied to the marketing authorities prior to expiry of patent Bolar conducted clinical trials with the active ingredient. Roche filed infringement suit Bolar argued that its use of the patented product was not infringement

Bolar also argued that public policy in favor of availability of generic drugs immediately following patent expiration justified the experimental use of the patented chemical because denying such use would extend Roches monopoly beyond the date of patent expiration.

Roche Products Inc. v. Bolar Pharmaceutical Co

The Court of Appeals for the Federal Circuit rejected Bolars contention as

Bolars experiments had a business purpose

Court decided that apparent policy conflicts between statutes such as the

Food and Drug Act and the Patent Act should be decided by congress and not the courts permitting use of patented products in experiments for the purpose of obtaining FDA approval

Shortly after Roche v Bolar was decided, congress did pass a law

Smithkline Beecham V Fujimoto Pharmaceutical Co

Tokyo District Court, 1998
SmithKline Beecham had filed a process patent in Japan on Cimetidine in

September 1973.

Largely used in the treatment of heartburn and peptic ulcers, (sold widely

under the trademark Tagamet )

It was granted after 8 years (1981) and was valid September 5, 1993

In December 1986, Fujimoto imported the infringing product from

Yugoslavia (now Solvenia) and sold 68,000 tablets in Japan

Fujimoto also manufactured a generic version of Cimetidine Cylock SB claimed that Fujimoto had infringed their patent from December 1986-

September 1993

Smithkline Beecham V Fujimoto Pharmaceutical Co

Fujimoto argued that their process was not covered by the SmithKline

patent

Burden of proof on Fujimoto Fujimoto produced such evidence but internal inconsistencies in the

evidence led the court to disregard it completely. Court rejected the argument that product was not novel
The Judge found Fujimoto liable for patent infringement

The Court awarded SB and SBS Yen 500 million($4.2 million) in

royalties and Yen 2.5 billion($21 million) in lost profit based on a 15% profit rate

This is the largest award ever in a Japanese patent infringement case

Golden rice
Beta-carotene-containing rice, vita-min A deficiency (VAD)

is a major problem affecting primarily children under age five and pregnant and lactating women.

Night blindness and permanent blindness. No attention was given to FTO until the first material was

nearly ready for transfer to developing countries.

FTO review was commissioned by the International Rice

Research Institute, a centre of the Consultative Group on International Agricultural Research (CGIAR), with funding from the Rockefeller Foundation (led by one of us [AK]).

Golden rice
About 70 patents and patent applications were applicable to the

improved rice
FTO analysis also demonstrated that licenses to only a few would be

required for the transfer to and use of Golden Rice in developing countries.
The relevant intellectual property was quickly assembled (or in-

licensed) into a package. That package then was licensed, essentially royalty-free, to public sector institutions in developing countries. This approach, in essence, represents the various aspects of FTO, from analysis to strategy, to action

Obtaining Freedom to Operate

Fortunately, these constraints were resolved in a few months in the year

2000 by a straightforward IP management strategy comprising four goals: Identification of major IP components
Interpretation, with Zeneca, of the relevance of the FTO review to the

proposed humanitarian use in developing countries

in licensing for humanitarian use, led by Zeneca, of IP components it did

not already own.

Licensing by Zeneca, as Syngenta, via the inventors of the assembled (or

bundled) intellectual property to public sector institutions in developing countries that could use the rights for the benefit of resource-poor farmers, and others, deficient in vitamin A

Possible way out

Purchase the patent or in-licensing Cross-licensing Inventing around Patent pools: A patent pool is that formed by Sony, Philips and Pioneer

for inventions that are essential to comply with certain DVD-Video and DVD-ROM standard specifications.

Thank you.
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