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

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

Meat Product

2 Slices of Bread

Edible Salad

Cheese

Accused Burger I

HamburgerHamburger WeeklyWeeklyOctober 23, 1980

Say Goodbye to Unmanageable Burgers-J. Fadrigo

Finally, the scientists at Acme Burgeremerged from the depths of their laboratories. With their resurfacing, the scientists brought the latest in burger technology. This revolutionarynew 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 thesenew burgers to hit the market early next year.

Accused Burger II

October 23, 1980

HamburgerHamburger WeeklyWeeklySay Goodbye to Unmanageable Burgers

-J. Fadrigo

Finally, the scientists at Acme Burgeremerged from the depths of their laboratories. With their resurfacing, the scientists brought the latest in burger technology. This revolutionarynew 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 thesenew burgers to hit the market early next year.

Literal Infringement AnalysisThe Claimed

BurgerTwo Slices of

BreadCheese Edible Salad Meat Product Literal

Infringement?

#1 Yes

#2 No

Non-literal Infringement AnalysisThe Claimed

Burger2 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

Research Exception

Narrow exception

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

Madey v. DukeFormer 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 infringementMerck 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

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

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