The USPTO announced today proposed rulemaking for changing its policy related to claim interpretation in Patent Trial and Appeal Board (“PTAB”) proceedings (not including patent examination). Currently, the broadest reasonable interpretation (“BRI”) standard is applied when analyzing claims. The proposed new rules would result in “the same as the standard applied in federal district courts and International Trade Commission (“ITC”) proceedings;” i.e., “ordinary and customary meaning” according to “a person of ordinary skill in the art in question at the time of the invention,”[1] and “reasonable certainty” for definiteness analysis[2]. In addition, it is proposed that the USPTO/PTAB “will consider any prior claim construction determination concerning a term of the involved claim in a civil action, or an ITC proceeding, that is timely made of record in an IPR, PGR, or CBM proceeding.”
Continue Reading USPTO Announces Notice of Proposed Rulemaking for Claim Construction Standard used in PTAB Proceedings

Seyfarth Shaw is pleased to announce The BioLoquitur Bulletin: Drugs Available in 2018 for Generic Competition, published by the Life Sciences team. The BioLoquitur Bulletin provides a brief overview of selected New Chemical Entities (NCE) that were approved by the FDA in the year 2014. While not every NCE will be a target for

This webinar is hosted by The Knowledge Group.

On April 17th at 10 a.m. ET, Dr. Dean Fanelli and Dr. Thomas Haag, along with Jens Viktor Nørgaard of HØIBERG, Niklas Mattsson of Awapatent, Mr. Glyn Truscott of Elkington + Fife LLP and Jennifer O’Farrell of Boult Wade Tennant, will present a live webcast on

Seyfarth Shaw Offers Hatch-Waxman And Biosimilars Litigation: 2017 Year-in-Review

Today’s rapid scientific and technological advances demand not only a thorough understanding of the complex technology, but also a meticulous application of intellectual property law to protect the technology.

Seyfarth’s Intellectual Property and Hatch-Waxman Litigation practitioners are pleased to announce the release of Hatch-Waxman And Biosimilars

As a special feature of our blog, we include special guest postings by experts, clients, and other professionals—please enjoy this blog entry which includes guest author Rolf J. Haag.[1]

It has been impossible to miss the surreal volatility in Bitcoin’s per unit price—having gone from $1,000 in January 2017 to almost $20,000 (~$750B mkt. cap) toward the end of last year and retracting to under $8,000 (~$500B mkt. cap) in February 2018. Whether these G-LOC-inducing price undulations are reflective of a radical paradigm shift in the mode of financial transactions, history’s greatest pyramid scheme, or some mix thereof, remains to be seen.
Continue Reading Will Blockchain Revolutionize Bio/Pharma R&D, Tech Transfer, and IP?

The Federal Circuit’s Review of Bayer’s Erectile Dysfunction Treatment Suggests Tolerance for a Wide Girth When Aiming for a Narrow Point

In Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. November 1, 2017), the Federal Circuit overturned the District of Delaware’s finding that Watson failed to prove by clear and convincing evidence that the subject matter encompassed by the claims of Bayer’s U.S. Patent 8,613,950 (the ‘950 patent) was obvious under 35 USC 103. The CAFC invalidated claims 9 and 11 of the ’950 patent as unpatentably obvious. The Federal Circuit made this determination de novo based on the underlying findings of fact from the district court.
Continue Reading When Are Swashbuckling Experts Seemingly ‘Flooding’ a Court with Large Number of References?

shutterstock_99945896The value of an early stage biotech company is driven primarily by the quality and scope of its intellectual property. As such, these companies’ primary goal is to stake out and consolidate a defensible claim in their technology space.

In sizing up an early stage company’s IP portfolio during due diligence, many investors and acquirers

In only the second decision of its kind, the U.S. Food and Drug Administration (FDA) approved Celltrion’s biosimilar Inflectra™ (infliximab-dyyb), a reproduction of Janssen Biotech’s immunosuppressant Remicade® (infliximab). Inflectra is, however, the first biosimilar monoclonal antibody to be approved in the U.S.
Continue Reading Newly Approved Biosimilar Inflectra™ Market Launch Held Up in Court

The United States government enjoys immunity from suit under the doctrine of sovereign immunity, the legal privilege by which American federal, state, and tribal governments cannot be sued. There are, however, statutes that grant limited waivers of the U.S. government’s sovereign immunity, e.g. with respect to: claims of monetary damages arising out of contracts with the government or for bad faith actions of government employees against a plaintiff.
Continue Reading Does the scope of immunity from assertions of patent infringement against U.S. government contractors under 28 U.S.C. § 1498 extend to acts of indirect infringement?

In a separate post, we discussed induced infringement of method claims in view of the Supreme Court’s review of Commil USA v. Cisco Systems.1 In this post, we discuss the differences in the standards for proving willful infringement and induced infringement, and the opinion requirements, if any, for each.

Continue Reading What’s the Intent? Comparing Induced Infringement and Willfulness