016-Patent_Infringement

8/7/2019 016-Patent_Infringement

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Tina McKeon, Ph.D.

FIRE Series: University of Rochester Medical Center Office of Technology Transfer

Patent Infringement: what it is, whatit isn't and why it matters to you.


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The U.S. Patent Office and the Courts

Chart by R. Polk Wagner


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Infringement

Patents grant their owners the right to exclude others frompracticing the claimed invention.

Unauthorized practice is infringement.Direct infringement Making the invention Using the invention Selling the invention Offering the invention for sale

Importing the invention

Indirect infringement Inducing infringement Contributing to infringement


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Issued PatentRight to Exclude

NOT an affirmative right

A ticket to the courthouse


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InfringementHow is infringement determined?

Determine the scope of the claim(s) Compare the elements of the claim to the composition or method

accused of infringement using the all elements rule: everyelement required by the claim must be present in the accusedcomposition or method either literally or under Doctrine of Equivalents


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Elements recited

Meat Product

2 Slices of Bread

Edible Salad

Cheese


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Accused Burger I

HamburgerHamburger WeeklyWeeklyOctober 23 , 1980

Say Goodbye to Unmanageable Burgers-J. Fadrigo

Finally, the scientists at Acme Burger

emerged from the depths of theirlaboratories. With their resurfacing,the scientists brought the latest inburger technology. This revolutionarynew burger has an edible saladcomponent, meat product and cheese,all between the two slices of bread. Theedible salad component makes for abetter handling burger. Look for thesenew burgers to hit the market early nextyear.


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Accused Burger II

October 23 , 1980

HamburgerHamburger WeeklyWeeklySay Goodbye to UnmanageableBurgers

-J. Fadrigo

Finally, the scientists at Acme Burgeremerged from the depths of theirlaboratories. With their resurfacing,the scientists brought the latest inburger technology. This revolutionarynew burger has an edible saladcomponent and meat product, both,between the two slices of bread. Theedible salad component is covered witha cheese-flavored sauce. Look for thesenew burgers to hit the market early

next year.


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L iteral Infringement AnalysisThe Claimed

Burger Two Slices of

BreadCheese Edible Salad Meat Product Literal

Infringement?

#1 Yes

#2 No


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Non-literal Infringement AnalysisThe Claimed

Burger 2 SlicesOf Bread

Cheese EdibleSalad

MeatProduct

Infringement under theDoctrine of Equivalents?

#2

CheeseFlavoredDressing

Yes, if cheese-

flavored dressing is thelegal equivalent tocheese.


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Exceptions to InfringementResearch or De m inimis Exception

Exception related to FDA approval


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Research ExceptionNarrow exception

For amusement, to satisfy idle curiosity, or for strictlyphilosophical inquiry


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Madey v. DukeFormer faculty member sued the university for infringing hispatented free electron laser technologyUniversity moved to dismiss the complaint based onexperimental use by a nonprofit research institutionCourt rejected research exception because the infringingactivities were in furtherance of Dukes commercialactivities (educating students and obtaining grant support)

Employees at a research university may infringe valid patentswhen conducting their research activities!


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FDA ExceptionIt shall not be an act of infringement to make, use, offer tosell, or sell within the United States or import into the United

States a patented invention. solely for uses reasonablyrelated to the development and submission of informationunder a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.


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Integra L ifeSciences v. Merck KGaAIntegras patents claimed RGD peptides.Merck KGaA (and Scripps) used the claimed RGD peptides todevelop non-infringing agents.

Integra sued Merck (and Scripps) for infringementMerck argued that they were not infringing because their work withScripps falls under the statutory safe harbor provision.


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Integra L ife Sciences v. Merck KGaA (cont.)Supreme Court: Mercks preclinical use of the patented peptides falls within

the safe harbor; their use was sufficiently related to theFDA approval process


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Integra L ife Sciences v. Merck KGaA (cont.)

Practical impact for patent holder: Try to claim methods of using your compounds for research

( e.g., as controls); the law is more unsettled regarding anyexception for research

Try to claim your compounds bound to some physicalstructure ( e.g. , bound to an assay plate or bead)

Practical impact for non-patent holder Document uses related to future FDA approval


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DefensesInvalidityUnenforceability (inequitable conduct)

Improper inventorship


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InvalidityThe claimed subject matter was not newThe claimed subject matter was obvious

The specification is not a sufficient written descriptionThe specification does not enable others to practice theinvention claimed


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Inequitable ConductEach person associated with prosecuting an application in the USPTO has a dutyof candor to the Office

Must provide information that would be material to patentability (if in doubt,

disclose!) Must not provide false information

Often raised as a defense to charge of infringementRequires both intent to deceive PTO and materiality (relevance) of theinformation

If duty of candor is violated, entire patent is unenforceable

Practical impact: Check the Invention Disclosure Statement and make sure allof the statements in the application and those made during its prosecution areaccurate.


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RemediesPatent Act provides for both injunctive relief for patentinfringement and damages ; no less than a reasonable royalty (if cannot prove lost profits)If product not marked, no damages until actual notice of infringement given.Enhanced damages (up to 3x) and attorneys fees may beawarded in exceptional cases


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Medical practitioner exception to remedies

No remedies are available from

a medical practitioner or a related medical entity

with respect to a medical practitioners performance of amedical activity that constitutes an infringement

Licensed practitioner or actingunder direction of same

Entity with which medicalpractitioner has a professional

affiliation for performing medicalactivity

Performance of a medicalor surgical procedure on a

body;

Not the use of a patented machine,manufacture, or composition; practice of a

patented method of using a composition; or the practice of a process in violation of a

biotechnology patent


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SummaryInfringement is the unauthorized use of an invention claimedin a valid patent

Exceptions and defenses to patent infringement are relevantto university employeesTake steps to make your own patents strong (valid,enforceable and with proper inventorship)Take steps to avoid infringing a third partys patentRemedies and damages can be substantial


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Questions

Documents

016-Patent_Infringement