We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Supreme Court Ruling Strengthens Patent Holders’ Claims in Infringement Cases

Supreme Court Ruling Strengthens Patent Holders’ Claims in Infringement Cases

May 29, 2015

A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for medical devicemakers to sue for patent infringement, a patent law attorney said.

The 6-2 ruling, with one abstention, in Commil USA v. Cisco Systems means plaintiffs will no longer need to prove their patents are good to bring a claim, says Jonathan Losk, a partner with Knobbe Martens. Previously, defendants could not be held liable for infringement if they had a good faith belief the patent was invalid.

The case involved allegations by Commil that Cisco infringed upon a patent for a method of implementing short-range wireless networks. The case went to trial, and Cisco was held liable for direct and induced infringement, despite the defendant’s claim that it had a “good-faith belief” that the patent was invalid. The U.S. District Court for the Eastern District of Texas deemed Cisco’s supporting evidence inadmissible, and the Federal Circuit affirmed the decision.

In upholding the appeals court and lower court rulings, the Supreme Court said “a defendant’s belief regarding patent validity is not a defense to an induced infringement claim.”

While this is good news for devicemakers, there are steps they can take better protect intellectual property, says Losk. For starters, companies should file separate patents on the device, the device system, the method for treating patients with the device and the manufacturing process. The patent applications should “give breadth and length to your intellectual property protections,” Losk says. He spoke at an FDAnews webinar last week.

Protect Critical Assets

Companies should take extra care to protect critical assets — those that, if usurped by competitors, could disrupt the business, Losk says. This normally involves identifying an asset owner, implementing primary and secondary safeguards and restricting access based on the need to know. In addition, firms should forensically capture and review every computing asset when it is replaced or when an employee leaves.

Losk also recommends correlating patents with business value models by developing a list of key clinical value features and mapping patent claims against these features. He further advises adding restrictive labeling to devices, such as one-time use restrictions, or restricting implied licenses for use.

Once patents are attained, companies should monitor the landscape for possible infringement, which can be done by searching the USPTO database, watching key foreign markets and watching for FDA clearances, CE marks, or other regulatory authorizations for products similar to your own, Losk says.

Losk also recommends establishing a firm internal policy that any unsolicited product concepts be channeled to a single individual or office, normally patent counsel or business development. He cites the example of a physician sharing an invention with a devicemaker’s sales rep, who then takes the product to the corporate office where in-house R&D staff have been working on the same concept. Without any internal policy, the physician might expect a lucrative business agreement, and failure to get one could lead to loss of a customer or a lawsuit, the attorney says.

Companies can further protect themselves if they accept only copies of filed patent applications, which will require inventors to protect their concepts before disclosing them. When accepting a concept, the firm should issue a nondisclosure agreement limiting access to the product idea to a few company representatives.

View the decision in Commil USA v. Cisco Systems at www.fdanews.com/06-01-15-CommilvCisco.pdf. — Elizabeth Orr

Upcoming Events

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 19May

    CDRH’s New Accreditation Scheme for Conformity Assessment: Impacts on Your Future Testing Plans and FDA Submissions

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Sanofi-logo.gif

    Sanofi’s Sarclisa Earns Second EC Clearance for Multiple Myeloma

  • emergency use authorization approved

    Qorvo Biotechnologies Earns EUA for Rapid COVID-19 Antigen Test

  • Withdraws cubes

    Zynteglo Gene Therapy Withdrawn in Germany

  • CE mark

    Empowered Diagnostics Earns CE Mark for Rapid COVID-19 Antigen Test

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing