News & Analysis as of September 19, 2024

United States Patent and Trademark Office

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The Leahy-Smith America Invents Act is a United States federal statute enacted in 2011 aimed at simplifying the U.S. patent system and allowing inventions to be brough to market sooner. The AIA makes significant changes to the patent system, including changing from a first-to-invent scheme to a first-to-file scheme, eliminating interference proceedings and developing post-grant opposition. less -

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

WilmerHale on 7/3/2024

Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

Goodwin on 1/3/2023

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

USPTO Outlines New Initiatives Regarding Drug Pricing

Goodwin on 7/13/2022

On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more

Biosimilars 2021 Year in Review

Fish & Richardson on 1/12/2022

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Anticipating President Biden’s Intellectual Property Policy in an Historical Context

Porter Hedges LLP on 6/10/2021

Presidential administrations have affected intellectual property (IP) policy since the very beginning of United States history. In his first State of the Union address in 1790, President George Washington addressed patents....more

Drug Patent Invalid Due to Poor Quality Translation

Bradley Arant Boult Cummings LLP on 9/28/2020

In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

Goodwin on 8/24/2019

Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

U.S. Court Of Appeals For The Federal Circuit Has Held That Neither State Agencies Nor Indian Tribes Enjoy Sovereign Immunity,...

Ladas & Parry LLP on 7/16/2019

On July 20, 2018 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (Dyk, Moore and Reyna JJ) held that Native American (“Indian”) Tribes do...more

Why Biotech and Pharma Patents Survive IPR

Troutman Pepper on 2/21/2019

When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

Morrison & Foerster LLP on 11/7/2018

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

McDonnell Boehnen Hulbert & Berghoff LLP on 4/5/2017

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more

Bass Continues Fishing; Pharma Seeks Sanctuary

Troutman Pepper on 4/1/2016

It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs. Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and...more

Big Pharma Seeks Exemption From Patent Law

Tucker Arensberg, P.C. on 10/5/2015

Implementation of the America Invents Act (“AIA”) has brought substantial changes to the patent law of the United States over the last several years. One of the most significant provisions of the AIA was the creation of inter...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on 10/5/2015

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Will New PTAB Rules Impact IPRs Filed By Kyle Bass Hedge Fund?

Foley & Lardner LLP on 8/24/2015

On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more

Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act

McDonnell Boehnen Hulbert & Berghoff LLP on 8/7/2015

Last month, in a letter to Congressional leadership, 79 Members of Congress expressed their support for the Innovation Act (H.R. 9) but sought inclusion of language in the bill "to preserve the integrity of the Drug Price...more

Group of National and State Organizations Asks Congress to Enact Legislative Reforms to Maintain Strong Patent System

McDonnell Boehnen Hulbert & Berghoff LLP on 6/2/2015

Last month, more than 90 national and state advocacy organizations sent a letter to the leadership of the House and Senate Judiciary Committees, urging Congress to enact legislative reforms that will maintain a strong and...more

PGR Report -- The Attack of 35 U.S.C. § 112

McDonnell Boehnen Hulbert & Berghoff LLP on 9/12/2014

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

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