News & Analysis as of September 21, 2024

America Invents Act › Prescription Drugs

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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 -

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on 6/10/2024

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...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

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

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on 5/9/2019

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...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

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

Foley & Lardner LLP on 6/18/2018

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on 8/3/2017

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more

Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

Polsinelli on 5/3/2017

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787...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

Inter Partes Review Proceedings: A Third Anniversary Report

Perkins Coie on 9/18/2015

When inter partes review (IPR) proceedings became effective in September 2012, few people would have predicted the transformative effect it would have on patents and the litigation landscape. Three years in, IPR has become...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

The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

McDonnell Boehnen Hulbert & Berghoff LLP on 2/26/2015

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013)

McDonnell Boehnen Hulbert & Berghoff LLP on 5/24/2013

Enactment of the Leahy-Smith America Invents Act in 2011 focused the patenting community on the changes of U.S. patent law from "first to invent" under the 1952 Patent Act to "first inventor to file" under the AIA as the...more

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America Invents Act › Prescription Drugs

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