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Patent Infringement: What It Is, What It Isn't and Why It Matters To You

Patent infringement occurs when someone uses an invention without authorization from the patent owner. There are two types of infringement: direct infringement, which includes making, using, selling, offering to sell, or importing the patented invention; and indirect infringement, which includes inducing others to infringe or contributing to their infringement. To determine if infringement occurred, the claims of the patent are analyzed and compared to the allegedly infringing product or process. There are some exceptions to infringement, such as experimental use or use related to obtaining FDA approval. Invalidity, inequitable conduct, and improper inventorship are common defenses to infringement. Remedies for infringement include injunctions and monetary damages.

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Tushar Shirsath
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53 views

Patent Infringement: What It Is, What It Isn't and Why It Matters To You

Patent infringement occurs when someone uses an invention without authorization from the patent owner. There are two types of infringement: direct infringement, which includes making, using, selling, offering to sell, or importing the patented invention; and indirect infringement, which includes inducing others to infringe or contributing to their infringement. To determine if infringement occurred, the claims of the patent are analyzed and compared to the allegedly infringing product or process. There are some exceptions to infringement, such as experimental use or use related to obtaining FDA approval. Invalidity, inequitable conduct, and improper inventorship are common defenses to infringement. Remedies for infringement include injunctions and monetary damages.

Uploaded by

Tushar Shirsath
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Patent Infringement: what it is, what

it isn't and why it matters to you.


Tina McKeon, Ph.D.

FIRE Series: University of Rochester Medical Center


Office of Technology Transfer
The U.S. Patent Office and the Courts

Chart by R. Polk Wagner


Infringement

Patents grant their owners the right to exclude others from


practicing 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
Issued Patent
Right to Exclude

– NOT an affirmative right

– A ticket to the courthouse


Infringement
How 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: every
element required by the claim must be present in the accused
composition or method either literally or under Doctrine of
Equivalents
Elements recited
Cheese

Edible Salad

2 Slices of Bread

Meat Product
October 23, 1980
Hamburger Weekly
Say Goodbye to Unmanageable Burgers
-J. Fadrigo Accused Burger I
Finally, the scientists at Acme Burger
emerged from the depths of their
laboratories. With their resurfacing,
the scientists brought the latest in
burger technology. This revolutionary
new burger has an edible salad
component, meat product and cheese,
all between the two slices of bread. The
edible salad component makes for a
better handling burger. Look for these
new burgers to hit the market early next
year.
October 23, 1980
Hamburger Weekly
Say Goodbye to Unmanageable
Burgers
-J. Fadrigo Accused Burger II
Finally, the scientists at Acme Burger
emerged from the depths of their
laboratories. With their resurfacing,
the scientists brought the latest in
burger technology. This revolutionary
new burger has an edible salad
component and meat product, both,
between the two slices of bread. The
edible salad component is covered with
a cheese-flavored sauce. Look for these
new burgers to hit the market early
next year.
Literal Infringement Analysis
The Claimed Two Slices of Cheese Edible Salad Meat Product Literal
Burger Bread Infringement?

#1 Yes

#2 No
Non-literal Infringement Analysis
The Claimed 2 Slices Cheese Edible Meat Infringement under the
Burger Of Bread Salad Product Doctrine of
Equivalents?

#2 Yes, if cheese-
flavored dressing is the
Cheese legal equivalent to
Flavored cheese.
Dressing
Exceptions to Infringement
Research or De minimis Exception

Exception related to FDA approval


Research Exception

Narrow exception

– “For amusement, to satisfy idle curiosity, or for strictly


philosophical inquiry”
Madey v. Duke
Former faculty member sued the university for infringing his
patented free electron laser technology
University moved to dismiss the complaint based on
experimental use by a nonprofit research institution
Court rejected research exception because the infringing
activities were in furtherance of Duke’s commercial
activities (educating students and obtaining grant support)

Employees at a research university may infringe valid


patents when conducting their research activities!
FDA Exception
It shall not be an act of infringement to make, use, offer to
sell, or sell within the United States or import into the
United States a patented invention…. solely for uses
reasonably related to the development and submission of
information under a Federal law which regulates the
manufacture, use, or sale of drugs or veterinary biological
products.
Integra LifeSciences v. Merck KGaA

Integra’s patents claimed RGD peptides.


Merck KGaA (and Scripps) used the claimed RGD peptides to
develop non-infringing agents.
Integra sued Merck (and Scripps) for infringement
Merck argued that they were not infringing because their work with
Scripps falls under the statutory safe harbor provision.
Integra Life Sciences v. Merck KGaA (cont.)
Supreme Court:
– Merck’s preclinical use of the patented peptides falls within
the safe harbor; their use was sufficiently related to the
FDA approval process
Integra Life 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 any
exception for research
– Try to claim your compounds bound to some physical
structure (e.g., bound to an assay plate or bead)
Practical impact for non-patent holder
– Document uses related to future FDA approval
Defenses
Invalidity
Unenforceability (inequitable conduct)
Improper inventorship
Invalidity
The claimed subject matter was not new
The claimed subject matter was obvious
The specification is not a sufficient written description
The specification does not enable others to practice the
invention claimed
Inequitable Conduct
Each person associated with prosecuting an application in the USPTO has a duty
of 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 infringement
Requires both intent to deceive PTO and materiality (relevance) of the
information
If duty of candor is violated, entire patent is unenforceable

Practical impact: Check the Invention Disclosure Statement and make sure all of
the statements in the application and those made during its prosecution are
accurate.
Remedies
Patent Act provides for both injunctive relief for patent
infringement 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 attorney’s fees may be
awarded in exceptional cases
Medical practitioner exception to remedies
Entity with which medical
Licensed practitioner or acting practitioner has a professional
No remedies are available from
under direction of same affiliation for performing medical
activity

“a medical practitioner or a related medical entity”

with respect to a “medical practitioner’s performance of a


medical activity that constitutes an infringement”
Not the use of a patented machine,
Performance of a medical or manufacture, or composition; practice of a
surgical procedure on a patented method of using a composition; or
body; the practice of a process in violation of a
biotechnology patent
Summary
Infringement is the unauthorized use of an invention claimed
in a valid patent
Exceptions and defenses to patent infringement are relevant
to university employees
Take steps to make your own patents strong (valid,
enforceable and with proper inventorship)
Take steps to avoid infringing a third party’s patent
Remedies and damages can be substantial
Questions

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