U.S. Patent Grantand Infringement Basics

Kristine H. JohnsonMacMillan, Sobanski & Todd, LLC

johnson@mstfirm.com

35 U.S.C. 154 - Patent Grant

(a) IN GENERAL.-• (1) CONTENTS.-Every patent shall contain a short

title of the invention and a grant to the patentee, his heirs or assigns, of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States, and, if the invention is a process, of the right to exclude others from using, offering for sale or selling throughout the United States, or importing into the United States, products made by that process, referring to the specification for the particulars thereof.

35 USC 154 - Patent Term

• (a)(2) TERM.-Subject to the payment of fees under this title, such grant shall be for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under section 120, 121, or 365(c) of this title, from the date on which the earliest such application was filed.

• (3) PRIORITY.-Priority under section 119, 365(a), or 365(b) of this title shall not be taken into account in determining the term of a patent.

271(a) Direct Infringement

• (a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

271(b) Inducing Infringement

• (b) Whoever actively induces infringement of a patent shall be liable as an infringer.

271(c) Contributory Infringement

• (c) Whoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination, or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.

271(d) through (i)

• (d) Acts of patent owner

• (e) Waxman Hatch provisions for pharmaceutical industry

• (f) exported items and methods

• (g) certain defenses

• (h) definition

• (i) definition

Issued Patent

• Right to Exclude

– NOT an affirmative right

– A ticket to the courthouse

Infringement

• 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

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

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 patents!

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.

Practical impact of FDA exception

• 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 to Infringement

• 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

Inequitable Conduct

• 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

• 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”

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?

Please Ask!

Thank you to Ms. Jenna Cogswell at MST who helped prepare these slides!

Contact us at johnson@mstfirm.com or 419.255.5900 for permission to use these slides, or to ask questions. We are happy to let others use these slides, but we would like to know who they helped.