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Patent Law. A Brief Overview for Clinical Research. Thomas Goodness, Ph.D., J.D. Introduction. Intellectual property (IP) will become an issue at some point in your professional life Decisions must be made by you or the UK administration Governing law and its application Federal

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Patent law

Patent Law

A Brief Overview for Clinical Research

Thomas Goodness, Ph.D., J.D.


Introduction

Introduction

  • Intellectual property (IP) will become an issue at some point in your professional life

  • Decisions must be made by you or the UK administration

  • Governing law and its application

    • Federal

    • UK Administrative

    • State


Purpose

Purpose

  • Set your expectations about the IP process

    • Promote mutual understanding between you and UK Administration

    • Minimize surprise during the process

  • Help you make informed decisions

  • Set your expectations about the process

    • Promote mutual understanding between you and UK Administration

    • Minimize surprise during the process

  • Help you make informed decisions


Outline

Outline

  • When will IP become an issue?

  • For each situation

    • What decisions will be made?

    • What law guides those decisions?

    • Examples


Definitions

Definitions

  • IP = “Patent Rights”

  • “Patent Rights” refers to a right to stop others from

    • Making

    • Using

    • Selling

    • Importing (sometimes)

    • Your invention


Definitions continued

Definitions (continued)

  • Clinical Research involves both

    • Human subjects

    • Pre-Clinical research using animals


When will ip become an issue

When will IP become an issue?

  • Terms of agreements that precede clinical research

  • IP created by you during research

  • IP (owned by others) that you use during research


When will ip become an issue1

When will IP become an issue?

  • Terms of agreements that precede clinical research

  • IP created by you during research

  • IP (owned by others)that you use during research


Terms of agreements

Terms of agreements

  • Who owns future IP developed during research

  • University owns the IP by default

  • Frequently the other party wants UK to transfer ownership to them

  • Conflict between UK and Sponsor

  • Conflict between UK and the Research Scientist


How uk gets ownership of ip

How UK Gets Ownership of IP

  • Federal law, ownership of patentable inventions starts with the inventor (you).

  • UK AR’s, the University owns employee IP

    • developed using University Resources, and/or

    • developed within the scope of employment

  • This is enforceable under state contract law

  • This is a common arrangement

    • At other Universities

    • In Industry


Uk s terms for future ip

UK’s Terms for Future IP

  • UK owns IP developed solely by UK employeesduring sponsored research

  • Sponsor owns IP developed solely by Sponsor employees

  • If employees of UK and Sponsor jointly develop IP, the IP is owned jointly by UK and Sponsor.


Terms proposed by sponsor

Terms Proposed by Sponsor

  • Sponsor owns all IP developed by Scientist during the Sponsored Research

  • All means

    • Inventions necessary to use the results of research

    • Inventions that are only peripheral to the research


The problem uk vs the sponsor

The Problem: UK vs. the Sponsor

  • IP is property

    • Transfer of UK property is regulated by state law

    • Compliance with state law is impossible when transferring “future” IP to another

  • UK’s IP terms are the norm, make deviations difficult to explain to the authorities


How do we resolve

How do we resolve?

  • Types of Agreements

    • Federal Research Grants

    • Clinical Trials Agreement

    • Pre-clinical Research

      • Privately Sponsored Projects Agreement

      • Material Transfer

  • Arranged in increasing order of conflict potential

  • Resolution differs somewhat by type of agreement


Federal research grants

Federal Research Grants

  • Applies to research sponsored, in whole or in part, by a federal agency

  • Bayh-Dole Act

    • University owns IP by default

    • May be transferred to Principal Investigator

    • Federal Government reserves rights

    • Transfer to third parties is expressly forbidden


Clinical trials agreements

Clinical Trials Agreements

  • We may offer to transfer future IP that will never exist (Unique to CTA)

  • Scientist must perform a rigidly defined protocol, leaving little room for invention

  • We offer to transfer future IP necessary to practice Sponsors technology


Pre clinical research

Pre-clinical Research

  • These solutions also apply to Clinical Trials

  • We always offer an option to license future IP to the other party

  • Rarely, we offer a royalty-free non-exclusive license to the other party


When will ip become an issue2

When will IP become an issue?

  • Terms of agreements that precede clinical research

  • IP created by you during research

  • IP that you use during research


Ip created during research

IP created during research

  • Am I ready disclose my IP?

  • Who are the inventors?

  • Will a patent application be filed on my IP?


Ip created during research1

IP created during research

  • Am I ready disclose my IP?

  • Who are the inventors?

  • Will a patent application be filed on my IP?


Am i ready disclose my ip

Am I ready disclose my IP?

  • Disclose when your invention is ready for a patent application

  • Your invention has two parts

    • Conception (Idea)

    • Reduction to practice

      • Actual reduction to practice

      • Constructive reduction to practice

  • Your invention is ready to file when you have both


Actual r eduction to practice

Actual Reduction to Practice

  • Means you have data suggesting your invention works

  • Human medicine, animal/cell culture data is sufficient when there is a known reasonable correlation between models and humans

  • Actual reduction to practice is required when it is not apparent that your invention will work when you describe your idea


Example actual reduction

Example: Actual Reduction

  • Sustained Release Drug Delivery Device

  • Inventors: Smith, Ashton and Pearson


Constructive r eduction to practice

Constructive Reduction to Practice

  • Means you have no data, not really reduced to practice

  • Considered reduced to practice when it is described (with drawings) in a patent application

  • Constructive reduction to practice is acceptable when it is obvious that your invention will work solely from its description

  • Does not apply to most clinical inventions


Example constructive reduction

Example: Constructive reduction

  • Title and inventors unknown

  • Also delivers drugs to the eye

  • Description is sufficient to illustrate efficacy


Hypothetical example readiness

Hypothetical example: Readiness

  • Facts: Scientist has a great idea for a drug candidate that should ameliorate the long term effects following hemorrhagic stroke , and wants to file a patent before disclosing in a grant application

  • Result: No disclosure is necessary, the invention is not reduced to practice, so no patent application can be filed


Hypothetical example readiness1

Hypothetical example : Readiness

  • Facts: Scientist has data showing that drug ameliorates the effects of hemorrhagic stroke in an accepted mouse model of human stroke

  • Result: Ready for disclosure, the data was generated in a model known to be reasonably correlated with human condition


Hypothetical example readiness2

Hypothetical example : Readiness

  • Facts: Scientist has data showing that drug ameliorates the effects of hemorrhagic stroke in a controversial zebra fish model of human stroke

  • Result: Not yet ready for disclosure, but a close call


Ip created during research2

IP created during research

  • Am I ready disclose my IP?

  • Who are the inventors?

  • Will a patent application be filed on my IP?


Who are the inventors

Who are the Inventors?

  • Deceptively simple concept

  • University inventors often draw on their concept of authorship

  • Criteria for inventorship is different from authorship

  • Getting it wrong can have harsh consequences


Authorship of journal articles

Authorship of Journal Articles

  • Major contributors to the content

  • Principal Investigator

  • Technical assistants performing the majority of the actual work

  • Sources of important material


Inventorship

Inventorship

  • Definition dictated by Federal law

  • Anyone who contributed an idea

    • That forms the basis of an element of the invention

    • Without which there would be no invention

  • Correct inventorship is a precondition for a valid patent.


Inventorship1

Inventorship

  • Definition dictated by Federal law

  • Anyone who contributed an idea

    • That forms the basis of an element of the invention

    • Without which there would be no invention


Bad news about inventorship

Bad News about Inventorship

  • A technical assistant who does all the work, but merely followed directions is not an inventor

  • A technical assistant who does all the work, but solves problems which do not relate to an element of the invention is not an inventor

  • A PI who pays for all the work, but does not contribute an idea is not an inventor


Bad news about inventorship1

Bad News about Inventorship

  • An inventor is often presented with the difficult choice between

    • Dealing with the hurt feelings of non-inventors, or

    • An invalid patent (and the lost income from that patent)


Ip created during research3

IP created during research

  • Am I ready disclose my IP?

  • Who are the inventors?

  • Will a patent application be filed on my IP?


Will a patent application be filed

Will a patent application be filed?

  • An application will not be filed if the invention does not meets the criteria for patentability.

  • Three criteria for a patentable invention

    • Useful

    • Novel (New)

    • Non-obvious


Meaning of novelty

Meaning of Novelty

  • United States

    • No person invented before you, and

    • Publication/Sale

      • Either you have not published or offered to sell the invention before filing a patent application OR

      • Your invention

        • was in public use, or

        • appeared in a “printed publication” or

        • was offered for sale,

        • one year has not elapsed


Meaning of novelty1

Meaning of Novelty

  • Rest of the World

    • “Absolute novelty”

    • Prior to filing a patent application, the invention did not appear in a printed publication or in public use

    • You are the first to file a patent application claiming the invention

      • Initial filing can be in the US


Novelty meaning and relevance of public use

Novelty: Meaning and Relevance of Public Use

  • Using the completed invention in the presence of people who have no confidential relationship with the inventor

  • If there is public use of the invention, please disclose your invention to us before one year has passed.

  • If disclosed later, your invention cannot be patented (will not be novel)


Novelty meaning and relevance of p rinted publication

Novelty: Meaning and Relevance of Printed Publication

  • Must be

    • be in a fixed form (not an oral presentation)

    • disclosed to those not in a confidential relationship

    • have sufficient detail about the invention to enable the invention to be practiced.

  • Can be a poster presentation!

  • Starts the one-year novelty clock!


Preserving novelty

Preserving Novelty

  • Worldwide

    • Maintain confidentiality until you file a patent application

  • Only in the United States

    • File a patent application

    • Before one year has passed

    • After publication or offer for sale


Preserving novelty1

Preserving Novelty

  • Procedure for impending publication

    • File a detailed disclosure with us

      • Including a statement of usefulness

      • Reveals everything needed to make and/or use your invention

    • Notify us that publication is imminent

    • We can file a “cover sheet” provisional patent application

    • Deemed filed the day we place it in the mail


Will a patent application be filed1

Will a patent application be filed?

  • An application will not be filed if the invention does not meets the criteria for patentability.

  • Three criteria for a patentable invention

    • Useful

    • Novel (New)

    • Non-obvious


Obviousness

Obviousness

  • When we tell inventors that their invention is not novel,

    • they take it pretty well

    • they understand that their invention may have appeared in some obscure journal

  • When we tell inventors that their invention is obvious

    • they take offense

    • “Your baby is ugly”


Meaning of obviousness

Meaning of Obviousness

  • Not an insult

  • Legal term

  • All of the pieces of your invention are in the public domain

  • Someone (in an obscure journal) has suggested putting the pieces together to make your invention

  • No remedy (but you can attack the elements)


When will ip become an issue3

When will IP become an issue?

  • Terms of agreements that precede clinical research

  • IP created by you during research

  • IP (owned by others) that you use during research


Ip owned by others

IP owned by others

  • Patent infringement

  • Unauthorized

    • Making

    • Using

    • Selling

    • Importing

  • The patented invention of another


Remedies for infringement

Remedies for Infringement

  • Injunction, stopping you from practicing the technology

  • Money damages

    • Willful Infringement

      • You know you are infringing

      • Treble damages


Avoiding infringement

Avoiding Infringement

  • Buy the technology you need for your research from an authorized dealer, or

  • Enter into a license agreement with the inventor


Avoiding infringement1

Avoiding Infringement

  • “Physicians’ Immunity” Statute

  • Activities in preparation of an NDA


Physicians immunity good

Physicians’ Immunity (Good)

  • A patent on a medical procedure cannot be enforced against a medical practitioner using that medical procedure on a body.

    • “Body” includes a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.

    • Provides immunity to those working at the direction of the practitioner

  • Provides immunity to the institution affiliated with the practitioner


Physicians immunity bad

Physicians’ Immunity (Bad)

  • Does not apply

    • When the procedure involves the use of a patented medical device.

    • The provision of pharmacy or clinical laboratory services, unless provided in a physicians office.

    • To patents applied for before September 30, 1996


Preparation of an nda

Preparation of an NDA

  • it is not "an act of [patent] infringement to … use … or import into the United States a patented invention … solely for uses reasonable related to the development and submission of information under a Federal law which regulates the … use … of drugs.”

  • Interpreted very broadly


Preparation of an nda1

Preparation of an NDA

  • To be entitled to this defense you must:

    • have a reasonable basis for believing that a patented compound may work,

    • through a particular biological process,

    • to produce a particular physiological effect,

    • use the compound in research that would be appropriate to include in a submission to the FDA.


Preparation of an nda2

Preparation of an NDA

  • You are entitled to this defense even though:

    • the drug is not yet the subject of an FDA submission or

    • a patented compound is used in experiments that are not ultimately submitted to the FDA


Summary

Summary

  • There are legal constraints preventing UK from transferring IP to a sponsor

  • File your disclosures with us when you have data

  • Be ruthless in naming the correct inventors

  • Keep in mind that some technology you use may be patented


Where to get more information

Where to Get More Information

  • Our web site: http://www.rgs.uky.edu/IP

  • Patent office web site: http://www.uspto.gov


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