The document discusses patent infringement, including what constitutes infringement, exceptions, defenses, and remedies. Direct infringement occurs when an invention claimed in a valid patent is made, used, sold, or imported without authorization. Exceptions to infringement include research/experimental use and activities reasonably related to FDA approval. Defenses include invalidity of the patent, inequitable conduct, and improper inventorship. Remedies for infringement include injunctions and damages, with enhanced damages possible for exceptional cases.

1. 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.

2. The U.S. Patent Office and the Courts Chart by R. Polk Wagner

3. 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

4. Issued Patent Right to Exclude NOT an affirmative right A ticket to the courthouse

5. 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

6. Elements recited Meat Product 2 Slices of Bread Edible Salad Cheese

7. 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.

8. 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.

9. Literal Infringement Analysis The Claimed Burger Two Slices of Bread Cheese Edible Salad Meat Product Literal Infringement? #1 Yes #2 No

10. 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.

11. Exceptions to Infringement Research or De minimis Exception Exception related to FDA approval

12. Research Exception Narrow exception “ For amusement, to satisfy idle curiosity, or for strictly philosophical inquiry”

13. 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!

14. 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.

15. 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.

16. 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

17. 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

18. Defenses Invalidity Unenforceability (inequitable conduct) Improper inventorship

19. 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

20. 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.

21. 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

22. 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

23. 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

24. Questions