Tina McKeon, Ph.D. FIRE Series: University of Rochester Medical Center Office of Technology Transfer Patent Infringement: what it is, what it isn't and why it matters to you.
The U.S. Patent Office and the Courts Chart by R. Polk Wagner
Patents grant their owners the right to exclude others from practicing the claimed invention.
Unauthorized practice is infringement.
Making the invention
Using the invention
Selling the invention
Offering the invention for sale
Importing the invention
Contributing to infringement
Right to Exclude
NOT an affirmative right
A ticket to the courthouse
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 Meat Product 2 Slices of Bread Edible Salad Cheese
Accused Burger I Hamburger Weekly October 23 , 1980 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.
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.
Literal Infringement Analysis The Claimed Burger Two Slices of Bread Cheese Edible Salad Meat Product Literal Infringement? #1 Yes #2 No
Non-literal Infringement Analysis The Claimed Burger 2 Slices Of Bread Cheese Edible Salad Meat Product Infringement under the Doctrine of Equivalents? #2 Cheese Flavored Dressing Yes, if cheese- flavored dressing is the legal equivalent to cheese.
Exceptions to Infringement
Research or De minimis Exception
Exception related to FDA approval
“ 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!
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.)
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
Unenforceability (inequitable conduct)
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
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.
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
No remedies are available from
“ a medical practitioner or a related medical entity ”
with respect to a “medical practitioner’s performance of a medical activity that constitutes an infringement”
Licensed practitioner or acting under direction of same Entity with which medical practitioner has a professional affiliation for performing medical activity Performance of a medical or 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
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