• Home
  • About
    • Client Reviews
    • Patent Samples
    • Accolades
    • About Firm
    • Technologies
    • FAQs
  • Services
    • Patents
      • Patent Consultation
      • Patent Search Service
      • Patent Application Service
      • Patent Prosecution
      • Utility Patents
      • Design Patents
      • Patent Defense
      • Patent Enforcement
      • Working with In-House Attorneys
    • Trademarks
      • Trademark Search
      • Trademark Application Services
      • Trademark Prosecution
      • Trademark Enforcement
      • Trademark Defense
    • Licensing
    • Worldwide IP
    • Risk Management
    • Due Diligence
  • Industries
    • Browse Patent Samples
    • Automotive Patents
    • Construction Patents
    • Consumer Products Patents
    • Electronics Patents
    • Food, Beverage, & Other Culinary Patents
    • Manufacturing Patents
    • Medical Products & Devices Patents
    • Optics Patents
    • Software & App Patents
    • Tools & Equipment Patents
  • Learning Resources
    • First-Time Inventor?
    • Why Patent Your Invention in a Bad Economy?
    • Videos on Patents
    • Search 180+ Articles
      • Patent process
        • Overview of Patent Process
          • Patent process timeline and major milestones
          • Patent Process: Invention to Patent Granted (Simplified)
          • Patent process, overall steps and procedures
        • Overview of the examination process within the USPTO
          • Highs and lows of securing patent protection for your invention
          • What is the Patent Office procedure after filing a patent application?
        • Benefits of a Patent Search
          • What is a patent search and How to do it?
        • Patent attorneys, agents and the USPTO can help with the patent process
        • USPTO Website
      • Invention Agreements
        • What is an NDA and when to use them?
        • How to use a contract to protect your invention?
        • Working with others without losing your IP rights
        • Patent Assignments for Independent Contractors
        • Losing Invention Rights When Hiring or Collaborating with Others
        • Avoid Problems: Get an Invention Assignment Agreement
      • Protect Inventions
        • Misconceptions of Provisional Patent Applications
        • Do you need to get your patent attorney to sign an NDA?
        • Can a confidentiality agreement protect me like a patent application?
        • Four types of intellectual property to protect your idea and how to use them
          • Overview of Patents and Intellectual Property
          • Patent protection benefits and why every inventor should consider getting one
          • 8 tips to successfully protect your idea
          • Benefits of Patent Protection
          • Best uses for design patents
        • Reasons to only market your invention after securing patent pendency
          • Dangers of 1 yr grace period under first-inventor-to-file system
          • File a patent application before telling others about the invention
        • Risks and benefits of securing software patent protection
          • Strategy to overcome patentable subject matter rejection
        • Pros and cons of filing a continuation-in-part application
          • What is a continuation patent application?
      • How Patent Applications Work: the Basics
        • How to respond to an office action?
        • Request for non-publication of a patent application
        • Anatomy of a Patent Document
        • How to write a broad patent application?
        • Design patents: pros and cons
      • Patent costs
        • How much does it cost to get a utility patent?
        • Provisional Patent Application: Cheap Alternative?
        • Patent Cost Framework and cash flow
        • Provisional patent application: a cheap option?
        • Cheap provisional patent applications
      • Patent infringement
        • Basics of writing a patent claim for a patent application
        • Patent Marking: Everything you wanted to know
        • Avoiding Patent Infringement
        • Can I Copy My Competitor’s Product?
        • Can I Copy My Competitor’s Product? (Design Patent)
      • Worldwide patents
        • Pros and cons of securing worldwide patent protection and their steps
        • Foreign patent filing to secure protection in other countries
      • Responding to Office Actions
        • Overview of Office Actions
      • Trademarks
        • Trademark Registration: common law, state and federal
        • How to obtain a federal trademark registration?
        • How to select a trademark?
          • Protect your idea when pitching to an investor, potential licensee, or buyer
  • Schedule Consultation
  • Contact

Top-Rated Orange County Patent Lawyer | Helping Inventors in Orange County, Los Angeles County & Beyond | OC Patent Lawyer, Irvine CA

Orange County Patent Attorney

(949) 433-0900
You are here: Home / Patent Infringements / Active inducement of infringement in physician patient relationships

Active inducement of infringement in physician patient relationships

February 9, 2017 by James Yang

Physician-Patient RelationshipBackground

In Eli Lilly v. Teva (Fed. Cir. 2017), the patent owner (Eli Lilly) sued Teva under a theory of active inducement of infringement.  In particular, the patent owner asserted that Teva induced others to infringe Eli Lilly’s patent (U.S. Pat. No. 7,772,209). Teva was not accused of directly infringing the patent itself, but instead was accused of indirectly infringing the patent by actively inducing physicians to directly infringe the patent. This case was further complicated because the patent claims asserted against Teva were method claims and one entity or person has to be responsible for completing all of the steps in the method claims.  Here, the physicians completed some, but not all, of the patented method steps while the physician’s patients completed the remaining steps of the method claim.  Fortunately, for the patent owner, there are ways to make one entity responsible for the actions of another.  See Akamai.

Defendant’s actions

In the present case, the defendants prepared to launch a generic version of a patented chemotherapy drug.  The drug would be sold with specific instructions (i.e., Physician Prescription Information) to be followed by both the physician and the patient in order to mitigate harmful side effects of the chemotherapy drug.

The patient would self-administer folic acid and the physician would administer the chemotherapy drug. The patented method steps required administration of the folic acid and a separate step of administering the chemotherapy drug. The physician performed a step of the patented method and the patient performed the other step. However, neither the physician nor the patient performed all of the steps.

Active inducement of infringement

However, to find a party liable for active inducement of infringement, a single actor must be responsible for the infringement. Since neither the physician nor the patients completed all the steps, infringement could still be found if the acts of one were attributable to the other such that a single entity was responsible for infringement. In this case, the single entity would be the physician.

Two types of circumstances

There are two types of circumstances that may make the actions of one person attributable to another. The first is when that entity “directs or controls” the other’s performance.  The second is when the actors form a joint enterprise. In this case, the patent owner did not allege that the patient and physician formed a joint enterprise. As such, the sole issue here was whether the physician directed and controlled the performance of the administration of the folic acid by the patient so as to hold the physician responsible for the acts of the patient.

The court explained that directing and controlling can be found based on a two prong analysis wherein an actor “(1) ’conditions participation in an activity or receipt of a benefit’ upon another’s performance of one or more steps of the patented method, and (2) ’establishes the manner and timing of that performance.’” The court also left open the possibility that other factual scenarios could exist that could still lead to the conclusion that one actor is directing and controlling the performance by another.

First prong

The court agreed that the evidence showed the physicians conditioned administration of the chemotherapy drug based on whether the patient self-administered folic acid. The Physician Prescription Information explained that the folic acid was a requirement for the patient if they want to receive the chemotherapy drug because folic acid reduced the severity of hematologic and gastrointestinal toxicity of the chemotherapy drug. The Physician Prescription Information also repeatedly stated that physicians should instruct patients to take folic acid. The Physician Prescription Information also informed patients that physicians may withhold the chemotherapy drug if the patients failed to self-administer folic acid. The patent owner’s expert also testified that it wouldn’t be safe to take the chemotherapy drug without taking the folic acid. Thus, administration of the folic acid by the patient at home and as directed was an absolute requirement. Also, if the physician realized that the patient did not take folic acid, the physician was instructed not to give the chemotherapy drug to the patient.

Teva attempted to characterize the instruction as mere guidance and insufficient to show “conditioning”. However, the written Instructions and the expert testimony regarding the critical nature of folic acid in the administration of the chemotherapy drug supported a finding that physicians crossed the line from merely guiding or instructing patients to take folic acid, to conditioning treatment with the chemotherapy drug based on whether the patient self-administered folic acid.

In the physician-patient relationship, the patient was not legally obligated to take folic acid and the defendant attempted to use this fact to show that the physician did not condition treatment with the chemotherapy drug based on the patient self-administering the folic acid.  Nevertheless, the court did not require a legal contract for there to be sufficient direction or control by one actor to another.

Second prong

The second prong of the test required that the physician establish the manner and timing of performance.  The defendant argued that the product labeling gave patients wide latitude to select the dose, the dosage form and the timing of folic acid self-administration. Nevertheless, the court recognized that the Physician Prescription Information provided very specific information on how and when to take folic acid. In particular, the physician prescription information instructed physicians not only to tell patients to take folic acid orally but also to take 400 µg to 1000 µg of folic acid once daily beginning seven days before the first dose of the chemotherapy drug.

The court clarified that the finding of infringement was not based solely on the physician-patient relationship. In a physician-patient relationship, the physician gives patients directions of care.  However, the court did not want to make a blanket rule that all directions by physicians to patients would be tantamount to physicians directing and controlling patients.  The court clarified that there must be more than just the physician-patient relationship in order for the physician to be said to direct and control the actions of the patient.

Specific intent to induce others to directly infringe

As indicated above, the patent owner drug company did not sue the physicians (its customers) for patent infringement. Rather, the patent owner sued a competing drug manufacturer that made a generic version of the chemotherapy drug under a theory of active inducement of infringement of a patent. In particular, the patent owner asserted that the competitor chemotherapy drug manufacturer induced the physicians to directly infringe the patented method through the combined actions of the physicians and the patients.

To show active inducement of infringement, the patent owner must prove specific intent to infringe and action to actively induce infringement. In this case, the instructions provided in the Physician Prescription Information was not merely a suggestion or recommendation but instead repeatedly reinforced the importance of taking folic acid. It required the patient to self-administer folic acid at home under the direction and control of the physician and was not vague in its instructions. Because of this, the court found the necessary specific intent on the part of Teva to induce physicians to infringe the method claims.

For these reasons, the court held Teva liable for active inducement of infringement of a patent.

Legal lesson

The legal value of this case is in the discussion of what acts are sufficient to constitute “direction and control” by one party over another. In this case, the physician had a high degree of latitude to withhold the chemotherapy drug treatment if the folic acid was not properly administered by the patient, while being admonished to instruct the patient to self-administer folic acid and how such folic acid was to be self-administered. The bottom line is that the physician had a great deal of control over the patient and could withhold treatment based on whether the patient followed the physician’s directions.

The further one goes away from having such a tight grip over another entity and what that entity does, the court would be less likely to find that the actions of one entity would be attributable to the other entity.

Related Articles for Patent Infringement

  • Basics of writing a patent claim for a patent application
  • Avoiding Patent Infringement
  • Can I copy my competitor’s product?
  • Can I copy my competitor’s Product? (Design Patent)
  • Attacking patent claims as indefinite made easier
  • Reducing Scope of Doctrine of Equivalents Via Ensnarement Defense
  • Broken chain of priority invalidates patent
  • Combine Claim Elements to Avoid Infringement
  • How to invalidate a patent based on a restriction requirement
  • Active inducement of infringement in physician patient relationships
  • Irreparable harm easier to prove for grant of patent based injunction
  • Everyone in the supply chain could be sued for patent infringement
  • Penalty for False Patent Marking
  • CAFC defines competitive injury for false patent marking
  • Process patent blocks importation of product
  • Facebook
  • Twitter
  • LinkedIn

Author

James Yang is a patent attorney. For more than 16 years, James Yang has been representing clients to secure patent protection for their inventions and register trademarks to protect their brands. If you need help, call him at (949) 433-0900. Read More…

Popular Posts

  • Patent process overview
  • Patent process explained
  • How much does a patent cost?
  • Why patent your invention in a bad economy?

Patent Book

Navigating the Patent System - new book by Orange County patent attorney, James Yang

Navigating the Patent System: Learn the patent process and strategies to protect your invention

Read for Free
Buy at Amazon

RECEIVE PATENT ARTICLES

Stay up to date on major changes and get tips on the patent process.

We respect your privacy.

Popular Posts

Patent process overview
Patent process explained
How much does a patent cost?
Trademark process and costs
Patent process and costs

 

Services

Patent Consultations
Patent Searches
Patent Applications
Utility Patents
Design Patents
Patent Prosecution Services
Patent Defense Services
Patent-Law Counsel for In-House Attorneys
Trademark Overview
Trademark Search Services
Trademark Application Services
Trademark Prosecution Services
Trademark Enforcement Services
Trademark Defense Services
See All Services

Industries

Automotive Patents
Consumer Products Patents
Culinary Patents
Manufacturing Patents
Medical Patents
Optics Patents
Software & App Patents
See All Industries

Contact

James Yang
OC Patent Lawyer
2372 Morse Ave., Suite #178
Irvine, CA 92614
Tel: (949) 433-0900

Connect

  • Facebook
  • LinkedIn

Sitemaps

Sitemap: Pages | Sitemap: Posts

Terms of Use and Privacy Policy

By accessing this blog, you agree that no attorney-client relationship is formed except by a subsequent written retainer agreement. Also, you agree to not send confidential information unless directed by me to do so. The information posted on this blog is legal information and not legal advice.
Complete Terms of Use
Complete Privacy Policy

ADA Compliance

OC Patent Lawyer aims to ensure that its services are accessible to people with disabilities.
Accessibility Statement

Service Area

From our office in Irvine, California, we serve clients from all areas within Orange County and Los Angeles County, California.

© 2023 · James Yang, Your Entrepreneur and Mid-Size Business Patent Attorney