Labeling and Induced Infringement in Pharma Patent Litigation and Protecting IP Rights

A live 90-minute CLE webinar with interactive Q&A


Thursday, July 13, 2017
1:00pm-2:30pm EDT, 10:00am-11:30am PDT


This CLE webinar will provide guidance to patent counsel on the implications of recent cases for labeling and discuss strategic considerations of label language. The panel will offer best practices for labeling.

Description

A drug label may play an important role in Hatch-Waxman patent litigation, particularly in relation to induced infringement of method-of-use patent claims.

35 U.S.C. §271(b) requires that the accused “actively induces infringement.” As the Supreme Court explained a few years ago in Global-Tech v. SEB (U.S. 2011), “actively induces infringement” means the accused knew of the patent and knew the induced acts were infringing. In Hatch-Waxman litigation, the first prong of Global-Tech is easily shown by the patents listed in the Orange Book and the generic manufacturer’s paragraph IV certification. The second prong of specific intent to induce infringement may be proven by the instructions and information in a drug label.

In addition, according to the Supreme Court in Limelight Networks Inc. v. Akamai Techs. Inc. (Akamai III), 134 S. Ct. 2111 (2014), liability for inducement requires a finding of direct infringement. On remand, the Federal Circuit concluded that a single entity is responsible for the performance of method steps when that entity “directs or controls others’ performance,” or when “the actors form a joint enterprise.”

Although the Federal Circuit explained that the type of conduct sufficient to amount to the required “direction or control” is something that is to be decided on a case-by-case basis, directing or controlling others’ performance includes circumstances in which an alleged infringer (1) “conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method,” and (2) “establishes the manner or timing of that performance.” Akamai Technologies Inc. v. Limelight Networks Inc. (Akamai V), 797 F.3d 1020 (Fed. Cir. 2015) (en banc) (per curiam).

The Supreme Court decision in Commil USA L.L.C. v. Cisco Sys. Inc. (U.S. 2015), that a defendant’s good faith belief that a patent is invalid is not a defense to induced infringement under 35 U.S.C. § 271(b) is also relevant to the analysis. On remand, the Federal Circuit rendered a judgment of noninfringement (Commil USA L.L.C. v. Cisco Sys. Inc. (Fed. Cir. 2015).

In Eli Lilly and Co. v. Teva Parenteral Medicines Inc., __ F.3d __ (Fed. Cir. Jan. 12, 2017), the Federal Circuit found direct infringement attributable to physicians and held defendants liable for inducing that infringement because the “evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishe[d] the requisite intent for inducement.”

Listen as our authoritative panel of patent attorneys discuss the implications of Lilly and label language for induced infringement. The Orange Book listed patent’s label may be written that the generic manufacturer is more vulnerable to a finding of induced infringement. The panel will offer guidance on strategic considerations and best practices for label language.

Outline

  1. Implications of Lilly for induced infringement
  2. Other Federal Circuit induced infringement decisions post-Commil
    1. Takeda Pharma U.S.A. v. Hikma Am Inc. (Fed. Cir. May 6, 2015)
    2. Braintree Labs Inc. v. Breckenridge Pharm. Inc. (Fed. Cir. May 5, 2017).
  3. How do Novo v. Caraco and use codes fit in?
  4. Strategic considerations of label language for induced infringement

Benefits

The panel will review these and other key issues:

  • What impact will recent decisions have on label language?
  • How do use codes fit in?
  • What strategic considerations should patent owners keep in mind when labeling drugs?

Faculty

Thomas L. Irving, Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.

Barbara R. Rudolph, Ph.D., Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Dr. Rudolph has successfully litigated complex Hatch-Waxman Paragraph IV Abbreviated New Drug Application and biotechnology cases over the past twenty years. She serves as lead counsel in pharmaceutical and biotechnology disputes and has extensive litigation experience in federal courts. She has argued before the U.S. Court of Appeals for the Federal Circuit and authored an amicus brief submitted to the U.S. Supreme Court in a landmark biotechnology patent case. She devises strategies to protect clients' valuable intellectual property involving sophisticated technologies in the pharmaceutical and biotechnology industries.


Live Webinar

Live Webinar $297.00

Add a colleague on the same connection in the same room for only $97.00 in the shopping cart or by calling customer service.

This webinar is eligible for at least 1.5 general CLE credits.

CLE credits are not available for PR.

*In KS, OH, PA, for more than 1 attendee on the connection you must contact Strafford CLE via email or call 1-800-926-7926 ext. 35 prior to the program for special instructions.


Recordings

CLE On-Demand - Streaming Video

Includes recorded streaming video of full program plus PDF handouts.

On-demand is the only recorded format recognized for CLE credits in DE, IN, KS, LA, MS, NC, OH, OK, SC, TN, VA, WI.

AK, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN*, KS, KY, LA, ME, MN, MO, MT, NC, ND, NH**, NJ, NM, NV, NY, OH*, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)

*Only available for attorneys admitted for more than two years. For OH CLE credits, only programs recorded within the current calendar year are eligible - contact the CLE department for verification.

**NH attendees must self-determine if a program is eligible for credit and self-report their attendance.

CLE On-Demand Video $297.00
Available 48 hours after the live event

How does this work?


Recorded Event

Includes full event recording plus handouts (available after live webinar).

Strafford is an approved provider and self-study CLE credit is available in most states.

AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KY, ME, MN, MO, MT, ND, NJ, NM, NY, OR, PA, TN, TX, UT, VT, WA, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)

Strafford will process CLE credit for one person on each recording.

Additional copies of a recording can be purchased at a discount. Please call Strafford Customer Service toll-free at 1-800-926-7926 ext 10 or email customerservice@straffordpub.com to place your order.

Recorded Webinar Download $297.00
Available 48 hours after the live event

How does this work?

Recorded Audio Download (MP3) $297.00
Available 24 hours after the live event

How does this work?

DVD (Slide Presentation with Audio) $297.00 plus $9.45 S&H
Available ten business days after the live event

How does this work?


Registration Plus Recorded Event

Best value!

Live Webinar & Webinar Download $394.00

Recorded Webinar Download Only $97.00 with Registration/Webinar Combo

Live Webinar & Audio Download $394.00

Recorded Audio Download (MP3) Only $97.00 with Registration/MP3 Combo

Live Webinar & DVD $394.00 plus $9.45 S&H

DVD (Slide Presentation with Audio) Only $97.00 with Registration/DVD Combo


Webinar

Strafford webinars offer several options for participation: online viewing of speaker-controlled PowerPoint presentations with audio via computer speakers or via phone; or audio only via telephone (download speaker handouts prior to the program).  Please note that our webinars do not feature videos of the presenters.

or call 1-800-926-7926

Can't Attend the Live Program?

CLE Credits By State

See CLE State Map >

or call 1-800-926-7926

Customer Reviews

Strafford provided an enthusiastic presentation that focused on patent practice, not theory.

David H. Vance

Vance Intellectual Property

I liked the practical insights, particularly when tied to cases the presenters had worked on.

Michael Gray

Kohler

The webinar was clearly presented and organized. It was a good mixture of the law and practice.

David N. Crapo

Gibbons

The subject-matter was engaging, well-presented and relevant.

Nicholas Buckland

Field Fisher Waterhouse

The speakers were well prepared and knowledgeable.

Kathleem Murphy

San Francisco General Hospital

or call 1-800-926-7926

Patent Law Advisory Board

Charles S. Baker

Partner

Locke Lord

David S. Bloch

Partner

Winston & Strawn

Irah H. Donner

Partner

Manatt

Ian N. Feinberg

Partner

Feinberg Day Alberti & Thompson

Anthony J. Fitzpatrick

Partner

Duane Morris

David Segal

Senior IP Counsel

Intel

Astrid R. Spain

Partner

Jones Day

Mark P. Wine

Partner

Orrick

or call 1-800-926-7926

Our Guarantee

Strafford webinars are backed by our 100% Unconditional Money-Back Guarantee: if you are not satisfied with any of our products, simply let us know and get a full refund. For more information regarding complaints and refunds, please contact us at 1-800-926-7926 ext 10. Complaints regarding this program can be submitted via the course evaluation found in the “Thank you” e-mail at the end of the course.