Tina McKeon, Ph.D.

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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
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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 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

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Issued Patent

• Right to Exclude
• NOT an affirmative right
• A ticket to the courthouse

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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

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Elements recited
Cheese
Edible Salad
2 Slices of Bread
Meat Product
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Accused Burger I
October 23, 1980
Hamburger Weekly
Say Goodbye to Unmanageable Burgers -J.
Fadrigo 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.
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Accused Burger II
October 23, 1980
Hamburger Weekly
Say Goodbye to Unmanageable Burgers -J.
Fadrigo 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.
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Literal Infringement Analysis
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Non-literal Infringement Analysis
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Exceptions to Infringement

• Research or De minimis Exception
• Exception related to FDA approval

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Research Exception

• Narrow exception
• For amusement, to satisfy idle curiosity, or for
  strictly philosophical inquiry

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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
  Dukes commercial activities (educating students
  and obtaining grant support)
• Employees at a research university may
  infringe valid patents when conducting their
  research activities!

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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.

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Integra LifeSciences v. Merck KGaA

• Integras 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.

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Integra Life 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 the FDA approval process

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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

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Defenses

• Invalidity
• Unenforceability (inequitable conduct)
• Improper inventorship

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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

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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.

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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 attorneys fees
  may be awarded in exceptional cases

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Medical practitioner exception to remedies
Entity with which medical practitioner has a
professional affiliation for performing medical
activity
Licensed practitioner or acting under direction
of same

• No remedies are available from
• a medical practitioner or a related medical
  entity
• with respect to a medical practitioners
  performance of a medical activity that
  constitutes an infringement

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
Performance of a medical or surgical procedure on
a body
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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 partys
  patent
• Remedies and damages can be substantial

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Questions